Drugs
208
Abiraterone
Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicatedABI1
For the treatment of patients with hormone-relapsed (castrate-resistant) metastatic prostate cancer with disease progression during or following treatment with docetaxel-containing chemotherapy where the following criteria have been met:ABI2
Abiraterone with androgen deprivation therapy for newly diagnosed high-risk hormone-sensitive metastatic prostate cancerABI4
Abiraterone with androgen deprivation therapy for high-risk non-metastatic (M0) hormone-sensitive prostate cancer planned for radical radiotherapyABI5
Atezolizumab
The first line treatment of locally advanced or metastatic urothelial cancer in patients who are ineligible for cisplatin-based chemotherapy and whose tumours have PD-L1 expression of 5% or more where all the following criteria are mett:ATE1
Atezolizumab monotherapy for the treatment of PD-L1 positive or negative locally advanced or metastatic non-small cell lung cancer after chemotherapy where all the following criteria are met:ATE2
Atezolizumab for locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy where all the following criteria are met:ATE3
Atezolizumab monotherapy for PD-L1-positive (≥50% TC or ≥10% IC) untreated locally advanced or metastatic non-small-cell lung cancer (stage IIIB/IIIC/IV) without EGFR or ALK alterationsATE9
Atezolizumab monotherapy for adjuvant treatment after complete tumour resection in adult patients with UICC/AJCC 8th edition stage IIB or IIIA or N2 only IIIB non-small cell lung cancer and whose disease is all of the following: has PD-L1 expression on ≥50% of tumour cells, is not EGFR mutant or ALK-positive and has not progressed on recently completed adjuvant platinum-based chemotherapy where the following criteria have been met:ATE10
(no indication text)ATE9
Bevacizumab at a dose of 7.5mg/Kg
In combination with 1st line chemotherapy AS INDUCTION TREATMENT for patients with stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma where the following criteria have been met: Note: there is a separate form BEV9 for the use of bevacizumab at a dose of 15mg/Kg in combination with 1st line chemotherapy AS INDUCTION TREATMENT for advanced ovarian cancer Note: there is a separate form BEV10 for the use of bevacizumab monotherapy at a dose of 7.5mg/Kg as MAINTENANCE treatment after completion of induction chemotherapy Note: there is a separate form OLAP4 for the use of bevacizumab at a dose of 15mg/kg in combination with olaparib as MAINTENANCE treatment after completion of induction chemotherapyBEV3
Bevacizumab 7.5 mg/kg as maintenance monotherapy after completion of 1st line platinum-based induction chemotherapy with bevacizumab for previously untreated advanced ovarian cancerBEV10
(no indication text)BEV10
Blinatumomab
The treatment of relapsed/refractory Philadelphia negative B-precursor acute lymphoblastic leukaemia in ADULT patientsBLI1
The treatment of relapsed/refractory Philadelphia negative B-precursor acute lymphoblastic leukaemia in CHILD patientsBLI2
The treatment of patients in first complete haematological complete remission and with minimal residual disease post 1st line induction chemotherapy in B-precursor acute lymphoblastic leukaemia in ADULT patients where all the following criteria are met:BLI3
Blinatumomab for relapsed or refractory CD19-positive acute lymphoblastic leukaemia (ALL) in childrenBLI4
The treatment of ADULT patients in first morphological complete remission and without minimal residual disease after 1st line intensive induction and intensification chemotherapy for Philadelphia chromosome negative B-cell precursor acute lymphoblastic leukaemiawhere all the following criteria are met:BLI5
Blinatumomab for consolidation treatment of Philadelphia-negative CD19-positive B-cell precursor acute lymphoblastic leukaemia (ALL) in MRD-negative complete remission in post-pubescent childrenBLI6
(no indication text)BLI6
Lenvatinib monotherapy
Lenvatinib monotherapy for the 1st line treatment of adults with advanced hepatocellular carcinoma (Child-Pugh A)
(no indication text)
Osimertinib in combination with pemetrexed and platinum-based chemotherapy
Osimertinib in combination with pemetrexed and platinum-based chemotherapy for the 1st line treatment of EGFR exon 19 deletion or exon 21 (L858R) substitution mutation-positive locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC)
(no indication text)
Sorafenib
The treatment of differentiated thyroid cancer after radioactive iodine where the following criteria are met:SOR2
Sorafenib monotherapy for the treatment of Child-Pugh A locally advanced or metastatic hepatocellular carcinomaSOR3
Sorafenib maintenance for the treatment of FLT3-Internal Tandem Duplication (FLT3- ITD) acute myeloid leukaemia (AML) post allogeneic haematopoietic stem cell transplantation (allo-HSCT) IN ADULTS where the following criteria are met:SOR5
Sorafenib maintenance for the treatment of FLT3-Internal Tandem Duplication (FLT3- ITD) acute myeloid leukaemia (AML) post allogeneic haematopoietic stem cell transplantation (allo-HSCT) IN POST- PUBESCENT CHILDREN where the following criteria are met:SOR6
Tivozanib
Tivozanib for the treatment of advanced renal cell carcinoma (RCC) as 1st line therapy, or as 2nd line therapy after 1st line nivolumab plus ipilimumab or pembrolizumab plus lenvatinibTIV1
(no indication text)TIV1
Abemaciclib (in combination with an aromatase inhibitor)
The treatment of previously untreated, hormone receptor-positive, HER2- negative, locally advanced or metastatic breast cancer where the following criteria have been met:ABEM1_v1.2
Abemaciclib (in combination with fulvestrant)
The treatment of hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer where the following criteria have been met:ABEM2
Abemaciclib in combination with endocrine therapy
As adjuvant treatment for high-risk hormone receptor-positive and HER2- negative early breast cancer where the following criteria have been met:ABEM3
Acalabrutinib monotherapy
For the treatment of patients with previously untreated chronic lymphatic leukaemia which has a 17p deletion or TP53 mutation where the following criteria have been met:ACA1_v1.2
For the treatment of patients with previously treated chronic lymphatic leukaemia where the following criteria have been met:ACA2_v1.4
For the treatment of patients with previously untreated chronic lymphatic leukaemia which does not have a 17p deletion or a TP53 mutation and in whom chemotherapy with FCR or BR is unsuitable where the following criteria have been met:ACA3_v1.3
Alectinib
Alectinib monotherapy for adjuvant treatment in adults after complete tumour resection in patients with UICC/AJCC 8th TNM edition stage IIA or IIB or IIIA or N2 only IIIB non-small cell lung cancer whose tumours have an ALK gene rearrangement where the following criteria have been met:ALE2
Alectinib monotherapy
For anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously untreated with an ALK inhibitor where the following criteria are met:ALE1_v1.5
Alpelisib in combination with fulvestrant
For treatment of hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in patients previously treated with a CDK4/6 inhibitor and an aromatase inhibitor where the following criteria have been met:ALP1
Amivantamab in combination with lazertinib
For the first line treatment of locally advanced or metastatic non-small cell lung cancer in adults whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations where the following criteria have been met:AMI1
Apalutamide in combination with androgen deprivation therapy (ADT)
For the treatment of non-metastatic hormone-resistant (castration-resistant) prostate cancer in patients who are at high risk of developing metastatic disease where the following criteria have been met:APA1
For the treatment of patients with newly diagnosed metastatic hormone-sensitive prostate cancer who are ineligible for chemotherapy with docetaxel where the following criteria have been met:APA2
Arsenic trioxide
Arsenic trioxide for treating newly diagnosed low to intermediate risk acute promyelocytic leukaemia in ADULTS where all the following criteria are met:ARS1
Arsenic trioxide for treating relapsed/refractory acute promyelocytic leukaemia in ADULTS where the following criteria are met:ARS2
Arsenic trioxide for treating newly diagnosed low to intermediate risk acute promyelocytic leukaemia in CHILDREN where the following criteria are met:ARS3
Arsenic trioxide for treating relapsed/refractory acute promyelocytic leukaemia in CHILDREN where the following criteria have been met:ARS4
Arsenic trioxide in combination with all-trans retinoic acid (ARTA)
Arsenic trioxide in combination with all-trans retinoic acid (ARTA) for the treatment of high-risk acute promyelocytic leukaemia (>=18 years old) where the following criteria are met:ARS5
Arsenic trioxide in combination with all-trans retinoic acid (ARTA) for the treatment of high-risk acute promyelocytic leukaemia (Children aged 12 months to <18 years old) where the following criteria have been met:ARS6
Asciminib
For the treatment of patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukaemia previously treated with two or more tyrosine kinase inhibitors where the following criteria have been met:ASC1
Atezolizumab (in combination with bevacizumab, carboplatin and paclitaxel)
The first line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer with a PD-L1 tumour proportion score of 0-49% and without EGFR and ALK mutations where the following criteria are met:ATE4
The treatment of adult patients with EGFR or ALK or ROS1 or MET exon 14 or KRAS G12C or RET or BRAF mutation positive locally advanced or metastatic non-squamous non-small cell lung cancer after failure of appropriate targeted therapy where the following criteria are met:ATE5
Atezolizumab in combination with bevacizumab
For the first-line systemic treatment of adult patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma where the following criteria have been met:ATE8
Atezolizumab in combination with carboplatin and etoposide
For the first-line treatment of adult patients with extensive-stage small cell lung cancer where the following criteria have been met:ATE7
Atezolizumab in combination with nab-paclitaxel
For treating untreated PD-L1-positive, triple negative, unresectable, locally advanced or metastatic breast cancer for patients whose tumours express PD-L1 at a level of 1% or more where the following criteria have been met:ATE6_v1.1
Avapritinib monotherapy
For the treatment of aggressive systemic mastocytosis or aggressive systemic mastocytosis with an associated haematological neoplasm or mast cell leukaemia where the following criteria have been met:AVA1
Avelumab
The treatment of previously untreated (with systemic therapy) metastatic Merkel cell carcinoma where all the following criteria are met:AVE1
The treatment of previously treated (with systemic cytotoxic chemotherapy) metastatic Merkel cell carcinoma where all the following criteria are met:AVE2
Avelumab in combination with axitinib
For use in treatment-naïve patients with advanced, favourable risk, renal cell carcinoma where the following criteria have been met:AVE3
Axicabtagene ciloleucel
Axicabtagene ciloleucel for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or high grade B-cell lymphoma and either in patients who relapse within 12 months of completion of 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation or who are refractory to 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation where the following criteria are met: This form is for the approval of leucapheresis and manufacture of CAR-T cells. There is a second part to this form which relates to the subsequent infusion of CAR-T cells and this will be available after submission of the first part. The second part of the form (AXI02b) can only be completed as a continuation of this first part of the form (AXI02a) and must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of axicabtagene ciloleucelAXI02a_v1.0
Axicabtagene ciloleucel for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma and in adult patients either who relapse within 12 months of completion of 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation or who are refractory to 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation where the following criteria are met: This second part of the form is to document the date of infusion of CAR-T cell therapy and for registration of this infusion with NHS England so that the treating Trust is reimbursed for the cost of axicabtagene ciloleucel. There is a first part of the form for the approval of leucapheresis and manufacture of CAR-T cells which has already been completed (AXI02a). This second part of the form (AXI02b) should only be completed as a continuation form once the date of CAR-T cell infusion is known.AXI02b_v1.0
Axicabtagene ciloleucel for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) and transformed lymphoma to DLBCL in patients previously treated with two or more lines of systemic therapy where the following criteria are met: This form is for the approval of leucapheresis and manufacture of CAR-T cells. There is a second part to this form which relates to the subsequent infusion of CAR-T cells and this will be available after submission of the first part. The second part of the form (AXI01b) can only be completed as a continuation of this first part of the form (AXI01a) and must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of axicabtagene ciloleucelAXI01a
Axicabtagene ciloleucel for treating relapsed/refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL) to DLBCL in patients aged 18 years and over where the following criteria are met: This second part of the form is to document the date of infusion of CAR-T cell therapy and for registration of this infusion with NHS England so that the treating Trust is reimbursed for the cost of axicabtagene ciloleucel. There is a first part of the form for the approval of leucapheresis and manufacture of CAR-T cells which has already been completed (AXI01a). This second part of the form (AXI01b) should only be completed as a continuation form once the date of CAR-T cell infusion is known.AXI01b
Azacitidine
Oral azacitidine as maintenance therapy in newly diagnosed AML patients in remission following at least induction chemotherapy and who are not candidates for, or who choose not to proceed to, haemopoietic stem cell transplantation where the following treatment criteria have been met:AZA1
Belantamab mafodotin in combination with bortezomib and dexamethasone
Belantamab mafodotin in combination with bortezomib and dexamethasone as 2nd line treatment of relapsed or refractory myeloma in adult patients who previously received lenalidomide as part of 1st line systemic therapy where the following criteria have been met:BELA1
Belantamab mafodotin with pomalidomide and dexamethasone
Belantamab mafodotin with pomalidomide and dexamethasone as 2nd line treatment of relapsed or refractory myeloma in adult patients who previously received lenalidomide as part of 1st line systemic therapy where the following criteria have been met:BELA2
Belzutifan monotherapy
For adult patients with von Hippel-Lindau (VHL) disease who require systemic therapy for VHL associated renal cell carcinoma, central nervous system haemangioblastomas or pancreatic neuroendocrine tumours, AND for whom localised procedures are unsuitable or undesirable where the following criteria have been met: This form BELZUT1a is for the FIRST ever application for a patient to commence belzutifan for the above indication. The form BELZUT1b is for either continuation of belzutifan beyond disease progression in one dominant tumour but with continued benefit in other equally dominant VHL associated tumours or a subsequent restart of belzutifan for a different VHL associated tumour to the one which previously resulted in the original indication for belzutifan treatment, and for which localised procedures are unsuitable or undesirable.BELZUT1a
For adult patients with von Hippel-Lindau (VHL) disease who require EITHER continuation of belzutifan beyond disease progression in one dominant tumour but who have continued benefit in other equally dominant VHL associated tumours OR a subsequent re-start of therapy for a different VHL associated tumour to the one which previously resulted in the original indication for belzutifan treatment, and AND for which localised procedures are unsuitable or undesirable where the following criteria have been met: The Form BELZUT1a is for the FIRST ever application for a patient to commence belzutifan for a VHL associated tumour for which localised procedures are unsuitable or undesirable. This BELZUT1b form is for either continuation of belzutifan beyond disease progression in one dominant tumour but with continued benefit in other equally dominant VHL associated tumours or a subsequent restart of belzutifan for a different VHL associated tumour to the one which previously resulted in the indication for belzutifan treatment, and for which localised procedures are unsuitable or undesirable.BELZUT1b
Bendamustine
The first line treatment of low grade lymphoma where all the following criteria are met:BEN1
The first line treatment of mantle cell non- Hodgkin's lymphoma where all the following criteria are met:BEN2
The treatment of relapsed low grade lymphoma where all the following criteria are met:BEN6
Bevacizumab
The first line treatment of recurrent or metastatic cervical cancer in combination with chemotherapy where all the following criteria are met:BEV2
The third line treatment of low grade gliomas of childhood where all the following criteria are met:BEV8
Bevacizumab at a dose of 15mg/Kg
in combination with 1st line chemotherapy AS INDUCTION TREATMENT patients with stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma where the following criteria have been met: Note: there is a separate form BEV3 for the use of bevacizumab at a dose of 7.5mg/Kg in combination with 1st line chemotherapy AS INDUCTION TREATMENT for advanced ovarian cancer Note: there is a separate form BEV10 for the use of bevacizumab monotherapy at a dose of 7.5mg/Kg as MAINTENANCE treatment after completion of induction chemotherapy Note: there is a separate form OLAP4 for the use of bevacizumab at a dose of 15mg/kg in combination with olaparib as MAINTENANCE treatment after completion of induction chemotherapyBEV9
Bevacizumab with FIRST LINE fluoropyrimidine-based chemotherapy
For metastatic or locally advanced and inoperable colorectal cancer where the following criteria have been met:BEV11
Bevacizumab with SECOND LINE fluoropyrimidine-based chemotherapy
For metastatic or locally advanced and inoperable colorectal cancer where the following criteria have been met:BEV12
Bosutinib
Bosutinib for previously treated chronic myeloid leukaemiaBOS1
Brentuximab
Treatment of brentuximab-naïve relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant in ADULT patients where the following criteria are met:BRE3 (formerly BRE2)
Treatment of brentuximab-naïve relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant in CHILD patients where the following criteria are met:BRE4 (formerly BRE2)
Treatment of brentuximab-naïve relapsed/refractory Hodgkin lymphoma following at least 2 prior therapies when autologous stem cell transplant or multi-agent chemotherapy is not a treatment option in ADULT patients where the following criteria are met:BRE5 (formerly BRE2)
Treatment of brentuximab-naïve relapsed/refractory Hodgkin lymphoma following at least 2 prior therapies when autologous stem cell transplant or multi-agent chemotherapy is not a treatment option in CHILD patients where the following criteria are met:BRE6 (formerly BRE2)
Re-use of brentuximab in relapsed/refractory Hodgkin lymphoma in ADULT patients:BRE7
Re-use of brentuximab in relapsed/refractory Hodgkin lymphoma in CHILD patients:BRE8
The treatment of relapsed or refractory systemic anaplastic large cell lymphoma in ADULT patients, where the following criteria have been met:BRE9 (formerly BRE1)
The treatment of relapsed or refractory systemic anaplastic large cell lymphoma in CHILD patients, where the following criteria have been met:BRE10 (formerly BRE1)
Brentuximab vedotin
The treatment of CD30+ cutaneous T cell lymphoma following at least 1 prior systemic therapy in ADULT patients where the following criteria are met: Note: there is a separate Blueteq form for the use of brentuximab vedotin in children with cutaneous T cell lymphomaBRE11
The treatment of CD30+ cutaneous T cell lymphoma following at least 1 prior systemic therapy in CHILD patients where the following criteria are met: Note: there is a separate Blueteq form for the use of brentuximab vedotin in adults with cutaneous T cell lymphomaBRE12
Brentuximab vedotin in combination with chemotherapy
For previously untreated systemic anaplastic large cell lymphoma (sALCL) in CHILD patients where the following criteria are met:BRE14
Brentuximab vedotin in combination with cyclophosphamide, doxorubicin and prednisone
For previously untreated systemic anaplastic large cell lymphoma (sALCL) in an ADULT patient where the following criteria have been met:BRE13
Brentuximab vedotin in combination with doxorubicin, vinblastine and dacarbazine
For treating adult patients with previously untreated stage III or IV Hodgkin lymphoma where the following criteria have been met:BRE15
Brexucabtagene autoleucel
Brexucabtagene autoleucel modified CAR- T cells for treating relapsed/refractory Philadelphia negative or positive B cell precursor acute lymphoblastic leukaemia in patients aged 26 years and older where the following criteria are met: This form is for the approval of leucapheresis and manufacture of CAR-T cells. There is a second part to this form which relates to the subsequent infusion of CAR-T cells and this will be available after submission of the first part. The second part of the form (BREX01b) can only be completed as a continuation of this first part of the form (BREX01a) and BREX01b must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of brexucabtagene autoleucelBREX01a
Brexucabtagene autoleucel for treating relapsed/refractory Philadelphia negative and positive B cell acute lymphoblastic leukaemia in patients aged 26 years and over where the following criteria are met: This second form is to document the date of infusion of CAR T cell therapy and for registration of this infusion with NHS England so that the treating Trust is reimbursed for the cost of brexucabtagene autoleucel. There is a first form for the approval of leucapheresis and manufacture of CAR T cells. This second form must use the same unique Blueteq identifier number generated when this patient was registered for leucapheresis and CAR T cell manufacture using the first formBREX01b_v1.0
Brexucabtagene autoleucel (formerly known as KTE-X19 (Tecartus®))
For treating mantle cell lymphoma (MCL) in adults previously treated with two or more lines of systemic therapy where the following criteria have been met: This form is for the approval of leucapheresis and manufacture of CAR-T cells. There is a second part to this form which relates to the subsequent infusion of CAR-T cells and this will be available after submission of the first part. The second part of the form (KTE01b) can only be completed as a continuation of this first part of the form (KTE01a) and must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of brexucabtagene autoleucel.KTE01a_v1.2
For treating relapsed/refractory mantle cell lymphoma (MCL) in patients aged 18 years and over where the following criteria have been met: This second part of the form is to document the date of infusion of CAR-T cell therapy and for registration of this infusion with NHS England so that the treating Trust is reimbursed for the cost of brexucabtagene autoleucel. There is a first part of the form for the approval of leucapheresis and manufacture of CAR-T cells which has already been completed (KTE01a). This second part of the form (KTE01b) should only be completed as a continuation form once the date of CAR-T cell infusion is known.KTE01b_v1.3
Brigatinib
Brigatinib for anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer previously treated with crizotinib where all the following criteria have been met:BRI1
Brigatinib monotherapy
For anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously untreated with an ALK inhibitor where the following criteria have been met:BRI2_v1.3
Cabazitaxel
Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxelCABA1
Cabozantinib
The treatment of medullary thyroid cancer where all the following criteria are met:CABO1
The treatment of previously treated advanced renal cell carcinoma where the following criteria are met:CABO2
The treatment of treatment-naïve to vascular endothelial growth factor (VEGF)- targeted therapy and with intermediate or poor risk advanced renal cell carcinomawhere the following criteria are met:CABO3
For the second line of tyrosine kinase inhibitor systemic therapy of Child-Pugh A locally advanced or metastatic hepatocellular carcinoma previously treated with sorafenib where the following criteria have been met:CABO4
Cabozantinib in combination with nivolumab
For use in treatment-naïve patients with intermediate or poor risk advanced renal cell carcinoma for whom combination treatment with either nivolumab plus ipilimumab or lenvatinib plus pembrolizumab would otherwise be suitable where the following criteria have been met:CABNIV1_v1.0
Capivasertib in combination with fulvestrant
Capivasertib in combination with fulvestrant for hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in patients previously treated with a CDK4/6 inhibitor and an aromatase inhibitor where the following criteria have been met:CAP1
Carfilzomib
The treatment of previously treated multiple myeloma where all the following crtieria are met:CAR1
Carfilzomib in combination with lenalidomide and dexamethasone
For the treatment of previously treated multiple myeloma in patients who have had 1 prior line of systemic therapy where the following criteria have been met:CAR2
Cemiplimab
Cemiplimab monotherapy for the treatment of adult patients with locally advanced or metastatic cutaneous squamous cell carcinoma where the following treatment criteria have been met:CEM1
Ceritinib
Ceritinib for anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer previously treated with crizotinib where the following criteria are met:CER1
For anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously untreated with an ALK inhibitor where the following criteria have been met:CER2
Cetuximab
Cetuximab in combination with chemotherapy for the first cytotoxic-containing treatment of recurrent/metastatic squamous cell cancer of the head and neck only originating in the oral cavity where the following criteria are met:CET3_V1.1
Cetuximab in combination with FOLFIRINOX/ FOLFOXIRI (5- fluorouracil, irinotecan and oxaliplatin) chemotherapy
For chemotherapy-naïve metastatic or locally advanced and inoperable colorectal cancer where the following criteria have been met:CET4_v1.2
Cetuximab in combination with irinotecan-based chemotherapy
For chemotherapy-naive metastatic or locally advanced and inoperable colorectal cancer where all the following criteria are met:CET1_v1.2
Cetuximab in combination with oxaliplatin-based chemotherapy
For chemotherapy-naive metastatic or locally advanced and inoperable colorectal cancer where all the following criteria are met:CET2_v1.3
Clofarabine
The treatment of relapsed/refractory acute lymphoblastic leukaemia where all the following criteria are met:CLO1
Crizotinib
For anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously untreated with an ALK inhibitor where the following criteria have been met:CRI1
1st or subsequent line systemic therapy for ROS1-positive inoperable locally advanced/metastatic non squamous non-small cell lung cancer where the following criteria have been met:CRI3
Dabrafenib (as Finlee®) in combination with trametinib (as Spexotras®)
For the treatment of paediatric patients aged 1-17 years with BRAF V600E mutation positive glioma where the following criteria have been met:DABTRA4
Dabrafenib in combination with trametinib
For the first line treatment of metastatic BRAF V600 mutation positive non-small cell lung cancer where the following criteria have been met:DABTRA3
Dacomitinib
The treatment of untreated EGFR mutation-positive non-small-cell lung cancer where all the following criteria have been met:DACO1
Daratumumab
The treating of relapsed and refractory multiple myeloma where all the following criteria are met:DAR1
Daratumumab (in combination with bortezomib and dexamethasone)
For treating relapsed multiple myeloma in patients who have had only 1 line of therapy and are transplant ineligible where the following criteria have been met:DAR2
Daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone
For the treatment of newly diagnosed and treatment-naive patients with systemic immunoglobulin light chain amyloidosis (AL) where the following criteria have been met:DAR5
Daratumumab in combination with bortezomib, thalidomide and dexamethasone
For induction and consolidation therapy of transplant-eligible multiple myeloma where the following criteria have been met:DAR3
Daratumumab in combination with lenalidomide and dexamethasone
For the treatment of newly diagnosed and treatment-naive patients with multiple myeloma who are INELIGIBLE for an autologous stem cell transplant where the following criteria have been met:DAR4
Darolutamide in combination with androgen deprivation therapy (ADT)
For the treatment of non-metastatic hormone-resistant (castration-resistant) prostate cancer in patients who are at high risk of developing metastatic disease where the following criteria have been metDARO1
For the treatment of patients with newly diagnosed metastatic hormone-sensitive prostate cancer who are unsuitable for treatment with docetaxel where the following criteria have been met:DARO3
Darolutamide in combination with docetaxel and androgen deprivation therapy (ADT)
For the treatment of patients with newly diagnosed metastatic hormone-sensitive prostate cancer where the following criteria have been met:DARO2
Dasatinib
Dasatinib for treating imatinib-resistant or imatinib-intolerant Philadelphia chromosome positive chronic phase chronic myeloid leukaemia in children where the following criteria have been met:DAS4
Dasatinib for the treatment of untreated chronic phase chronic myeloid leukaemiaDAS6
Dinutuximab beta
Dinutuximab beta as part of 1st line therapy for high risk neuroblastoma in patients aged 12 months and above and who have both responded to induction chemotherapy and been treated with myeloablative therapy and stem cell transplantation where the following criteria are met:DIN1
Dinutuximab beta for the treatment of RELAPSED or REFRACTORY neuroblastoma in patients aged 12 months and above and who have then both responded to intensive induction chemotherapy used to treat high risk 1st line patients and been treated with myeloablative therapy and stem cell transplantation where the following criteria are met:DIN2
Dostarlimab
Dostarlimab monotherapy for patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) recurrent/advanced endometrial carcinoma after prior platinum-based chemotherapy where the following criteria have been met:DOS1
Dostarlimab in combination with platinum-containing chemotherapy (carboplatin and paclitaxel)
For the 1st line treatment of adult patients with mismatch repair deficient or microsatellite instability-high endometrial carcinoma who have recurrent or primary advanced disease and who are not candidates for potentially curative surgery or radiotherapy or chemoradiotherapy but are eligible for systemic therapy where the following criteria have been met:DOS2
For the 1st line treatment of mismatch repair proficient (pMMR) or microsatellite stable endometrial carcinoma in adult patients who have recurrent or primary advanced disease and who are not candidates for potentially curative surgery or radiotherapy or chemoradiotherapy but are eligible for systemic therapy where the following criteria have been met:DOS3
Durvalumab
The treatment of PD-L1 ≥1% positive locally advanced and unresectable non-small-cell lung cancer which has not progressed following concurrent platinum-based chemoradiotherapy where all the following criteria are met:DUR1_v1.2
Durvalumab monotherapy for patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based chemoradiotherapy where the following criteria have been met:DUR7
Durvalumab in combination with chemotherapy
For the treatment of neoadjuvant treatment and then continued as adjuvant monotherapy in adults with previously untreated UICC/AJCC 8th edition stage IIA or IIB or IIIA or N2 only IIIB non-small cell lung cancer AND who are candidates for potentially curative surgery where the following criteria have been met:DUR3_v1.1
Durvalumab in combination with etoposide plus either carboplatin or cisplatin
For the first-line treatment of adult patients with extensive-stage small cell lung cancer where the following criteria have been met:DUR4
Durvalumab in combination with gemcitabine and cisplatin
For the 1st line treatment of patients with locally advanced or unresectable or recurrent or metastatic biliary tract cancer where the following criteria have been met:DUR2_v1.0
Durvalumab in combination with platinum-containing chemotherapy (carboplatin and paclitaxel)
For the 1st line treatment of mismatch repair deficient (dMMR) or microsatellite instability-high endometrial carcinoma in adult patients who have recurrent or primary advanced disease and who are not candidates for potentially curative surgery or radiotherapy or chemoradiotherapy but are eligible for systemic therapy where the following criteria have been met:DUR5
Durvalumab in combination with tremelimumab
For first-line systemic treatment of adult patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma where the following criteria have been met:DUR6
Durvalumab with gemcitabine and cisplatin
For neoadjuvant treatment then alone for adjuvant treatment of muscle-invasive bladder cancer where the following criteria have been met:DUR8
Elacestrant monotherapy
For the treatment of oestrogen receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in patients previously treated with at least 12 calendar months of therapy with a CDK4/6 inhibitor-based combination where the following criteria have been met:ELAC1
Elranatamab
For the treatment of relapsed or refractory myeloma in adult patients who have relapsed or are refractory to their last anti-myeloma regimen AND have received at least 3 prior lines of systemic therapies which must have included at least one proteasome inhibitor, at least one immune-modulatory agent and at least one anti-CD38 antibody where the following criteria have been met:ELR1
Encorafenib (in combination with binimetinib)
The treatment of unresectable stage III or stage IV BRAF V600 mutation positive malignant melanoma where the following criteria are met:ENC1_v1.1
Encorafenib in combination with cetuximab
For previously treated BRAF V600E mutation positive metastatic or locally advanced and inoperable colorectal cancer where the following criteria have been met:ENC2_v1.2
Enfortumab vedotin in combination with pembrolizumab
Enfortumab vedotin with pembrolizumab for untreated, unresectable or metastatic urothelial cancer, when platinum-based chemotherapy is suitable where the following criteria have been met:ENF1
Entrectinib
Entrectinib response assessment and treatment continuation form in the treatment of patients who have solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion AND disease which is locally advanced or metastatic or for which surgical resection is likely to result in severe morbidity AND who have no satisfactory treatment options where the following criteria have been met: This form ENT1b requires information as to the RECIST response assessment made at 10 weeks after initiation of entrectinib. In addition, form ENT1b must be completed for continuation of funding for entrectinib to occur beyond the initial 12 week period otherwise the dispensing Trust will not receive reimbursement for further entrectinib. Note: the ENT1a form is for the initiation of treatment with entrectinib and is only for funding of the first TWELVE weeks of entrectinib treatment. A PET/CT/MR scan of index assessable/measureable disease and the brain must be done prior to commencing entrectinib and repeated at 10 weeks after the start of treatment (if not indicated before 10 weeks on account of assessing risk of disease progression).ENT1b_v1.0
Entrectinib for ROS1-positive recurrent or locally advanced or metastatic non-small-cell lung cancer previously untreated with a ROS1 inhibitor therapy where the following criteria have been met:ENT2
Enzalutamide
Enzalutamide for the treatment of patients with hormone-relapsed (castrate-resistant) metastatic prostate cancer before chemotherapy is indicated where the following criteria have been met:ENZ4
Enzalutamide for the treatment of patients with hormone-relapsed (castrate-resistant) metastatic prostate cancer with disease progression during or following treatment with docetaxel-containing chemotherapy where the following criteria have been met:ENZ5
Enzalutamide in combination with androgen deprivation therapy (ADT)
For the treatment of patients with newly diagnosed metastatic hormone-sensitive prostate cancer where the following criteria have been met:ENZ3
Epcoritamab monotherapy
Epcoritamab monotherapy for previously treated adult patients with relapsed/refractory follicular lymphoma who have received 2 or more lines of systemic therapy where the following criteria have been met:EPC2
For the treatment of previously treated adult patients with diffuse large B-cell lymphoma who have received 2 or more lines of systemic therapy which have included polatuzumab vedotin unless the use of polatuzumab vedotin was contraindicated where the following criteria have been met:EPC1
Eribulin
Eribulin for treating locally advanced or metastatic breast cancer after 2 or more lines of systemic anti-cancer treatment where the following criteria have been met:ERIB1
Everolimus
Everolimus with exemestane for treating advanced breast cancer after endocrine therapyEVE1
Everolimus for advanced renal cell carcinoma after previous treatmentEVE5
The treatment of unresectable or metastatic neuroendocrine tumours of pancreatic origin with disease progression where all the following criteria are met:EVE6
Fedratinib
For the treatment of patients with myelofibrosis previously treated with ruxolitinib where the following criteria have been met:
Fruquintinib
Fruquintinib for patients with either metastatic or locally advanced and inoperable colorectal cancer who have received 2 or more prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin-and irinotecan-based chemotherapies with or without anti-VEGF agents and/or anti- EGFR-based agents AND for whom the combination of trifluridine plus tipiracil and bevacizumab is unsuitable where the following criteria have been met:FRU1
Futibatinib
For the treatment of patients for locally advanced or metastatic cholangiocarcinoma which has a fibroblast growth factor receptor 2 gene fusion/rearrangement in patients with disease progression during or after previous systemic therapy where the following criteria have been met:FUT1
Gemtuzumab ozogamicin
Gemtuzumab ozogamicin as part of chemotherapy for previously untreated CD33 positive acute myeloid leukaemia in patients AGED 15 YEARS AND OVER where the following criteria are met:GEM1
Gemtuzumab ozogamicin as part of chemotherapy for previously untreated CD33 positive acute myeloid leukaemia in CHILD patients AGED LESS THAN 15 YEARS where the following criteria are met:GEM2
Gilteritinib
For treating relapsed/refractory FLT3 mutation positive acute myeloid leukaemia in adults where the following criteria have been met:GILT1
Glofitamab in combinaton with gemcitabine and oxaliplatin
Glofitamab with gemcitabine and oxaliplatin for treating relapsed or refractory diffuse large B-cell lymphoma where the following criteria have been met:GLO2
Glofitamab monotherapy
For the treatment of previously treated adult patients with diffuse large B-cell lymphoma who have received 2 or more lines of systemic therapy where the following criteria have been met:GLO1_ver1.2
Ibrutinib
For the treatment of relapsed/ refractory mantle cell lymphoma in patients who have either only received 1 prior line of systemic therapy or been treated with ≥2 prior lines if 2nd line therapy was initiated before NICE’s recommendation in January 2018 where all the following criteria are met:IBR5
Ibrutinib monotherapy for the treatment of patients with previously treated chronic lymphatic leukaemia where the following criteria have been met:IBR10_v1.2
Ibrutinib in combination with venetoclax
For the 1st line treatment of previously untreated chronic lymphatic leukaemia where the following criteria have been met:IBR11
Ibrutinib monotherapy
Ibrutinib monotherapy for the treatment of patients with chronic lymphatic leukaemia which has a 17p deletion or TP53 mutation where the following criteria have been met:IBR9_v1.1
Inotuzumab ozogamicin
The treatment of relapsed/refractory Philadelphia positive and Philadelphia negative B cell precursor acute lymphoblastic leukaemia in ADULT patients where all the following criteria are met:INO1
The treatment of relapsed/refractory Philadelphia positive and negative B cell precursor acute lymphoblastic leukaemia in CHILD patients where all the following criteria are met:INO2
Isatuximab in combination with bortezomib, lenalidomide, and dexamethasone
For the treatment of UNTREATED multiple myeloma when a stem cell transplant is UNSUITABLE where the following criteria have been met:ISA2
Isatuximab in combination with pomalidomide and dexamethasone
Isatuximab in combination with pomalidomide and dexamethasone for the 4th line treatment of adult patients with relapsed/refractory multiple myeloma where the following criteria have been met:ISA1_v1.1
Ivosidenib in combination with azacitidine
For newly diagnosed and untreated adult acute myeloid leukaemia with an isocitrate dehydrogenease-1 (IDH1) R132 mutation in patients who are not eligible for standard induction chemotherapy where the following criteria have been met:IVO2_v1.0
Ivosidenib monotherapy
For the treatment of patients with locally advanced or metastatic cholangiocarcinoma which has an isocitrate dehydrogenase-1 (IDH1) R132 mutation in patients with disease progression during or after previous systemic therapy and where the following criteria have been met:IVO1_v1.0
Ixazomib with lenalidomide and dexamethasone
The treament of relapsed or refractory multiple myeloma where all the following criteria are met:IXA1_v1.1
Larotrectinib
For the treatment of adults and children who have solid tumours (including primary cerebral tumours) that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion AND disease which is locally advanced or metastatic or for which surgical resection is likely to result in severe morbidity AND who have no satisfactory treatment options where the following criteria have been met: This LAR1a form is for the initiation of treatment with larotrectinib and is only for funding of the first TWELVE weeks of larotrectinib treatment. PET/CT/MR scans of index assessable/measureable disease and also of the brain must be done prior to commencing larotrectinib and repeated at 10 weeks after the start of treatment (if not indicated before 10 weeks on account of assessing risk of disease progression). A RECIST response on the repeated assessment must be made. Form LAR1b which requires information as to this RECIST response assessment must then be completed for continuation of funding for larotrectinib beyond the initial 12-week period otherwise the dispensing Trust will not receive reimbursement for further larotrectinib.LAR1a_v1.1
Larotrectinib response assessment and treatment continuation form in the treatment of patients who have solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion AND disease which is locally advanced or metastatic or for which surgical resection is likely to result in severe morbidity AND who have no satisfactory treatment options This form LAR1b requires information as to the RECIST response assessment made at 10 weeks after initiation of larotrectinib. In addition, form LAR1b must be completed for continuation of funding for larotrectinib to occur beyond the initial 12 week period otherwise the dispensing Trust will not receive reimbursement for further larotrectinib. Note: the LAR1a form is for the initiation of treatment with larotrectinib and is only for funding of the first TWELVE weeks of larotrectinib treatment. A PET/CT/MR scan of index assessable/measureable disease and the brain must be done prior to commencing larotrectinib and repeated at 10 weeks after the start of treatment (if not indicated before 10 weeks on account of assessing risk of disease progression).LAR1b_v1.0
Lenalidomide
The treatment of myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality where the following criteria are met:LEN4
Lenalidomide monotherapy as maintenance treatment in newly diagnosed patients with multiple myeloma who have undergone autologous stem cell transplantation where the following criteria have been met:LEN6_v1.3
Lenalidomide in combination with dexamethasone
The 1st line treatment in transplant ineligible patients with multiple myeloma in whom thalidomide is contraindicated or who cannot tolerate thalidomide where the following criteria have been met:LEN1
The 2nd line treatment in transplant ineligible patients with multiple myeloma previously treated with a 1st line bortezomib-containing regimen where the following criteria have been met:LEN2
The 3rd or later line of treatment in transplant ineligible patients with multiple myeloma previously treated with at least 2 prior regimens where the following criteria are met:LEN3
Lenalidomide in combination with rituximab
For previously treated follicular lymphoma (grades 1-3a) where all the following criteria have been met:LEN5
Lenvatinib
The treatment of differentiated thyroid cancer after radioactive iodine where all the following criteria are met:LNV2
Lenvatinib in combination with pembrolizumab
Lenvatinib in combination with pembrolizumab for use in treatment-naïve patients with intermediate or poor risk advanced renal cell carcinoma for whom treatment with nivolumab plus ipilimumab would otherwise be suitable where the following criteria have been met:LNV4
Lenvatinib with everolimus
The treatment of previously treated advanced renal cell carcinomaLNV1
Liposomal cytarabine and daunorubicin
The treatment of adults with newly diagnosed acute myeloid leukaemia (AML) that is secondary to therapy or myelodysplasia or chronic myelomonocytic leukaemia where the following criteria are met:LCD1
Lisocabtagene maraleucel
Lisocabtagene maraleucel for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or high grade B-cell lymphoma or primary mediastinal large B-cell lymphoma or follicular lymphoma grade 3B either in patients who relapsed within 12 months of completion of 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation or who are refractory to 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation where the following criteria have been met: This form is for the approval of leucapheresis and manufacture of CAR-T cells. There is a second part to this form which relates to the subsequent infusion of CAR-T cells and this will be available after submission of the first part. The second part of the form (LIS1b) can only be completed as a continuation of this first part of the form (LIS1a) and must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of lisocabtagene maraleucelLIS01a
Lisocabtagene maraleucel for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or high grade B-cell lymphoma (HGBCL) or primary mediastinal large B-cell lymphoma (PMBCL) or follicular lymphoma grade 3B (FL3B) and in adult patients either who relapse within 12 months of completion of 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation or who are refractory to 1st line chemoimmunotherapy AND who would otherwise be intended for potential stem cell transplantation where the following criteria have been met: This second part of the form is to document the date of infusion of CAR-T cell therapy and for registration of this infusion with NHS England so that the treating Trust is reimbursed for the cost of lisocabtagene maraleucel. There is a first part of the form for the approval of leucapheresis and manufacture of CAR-T cells which has already been completed (LIS1a). This second part of the form (LIS1b) should only be completed as a continuation form once the date of CAR-T cell infusion is known.LIS01b
Loncastuximab tesirine monotherapy
For the further treatment of adult patients with diffuse large B-cell lymphoma or high grade B-cell lymphoma who have received previous treatment with 2 or more lines of systemic therapy (which have included polatuzumab vedotin unless the use of polatuzumab vedotin was contra-indicated) and in addition are not candidates for any future CAR T cell therapy where the following criteria have been met:LON1_v1.0
Lorlatinib
For anaplastic lymphoma kinase positive advanced non-small-cell lung cancer previously treated with 1st line alectinib or 1st line brigatinib or 1st line ceritinib or 1st line crizotinib followed by a 2nd line ALK tyrosine kinase inhibitor therapy (brigatinib or ceritinib) or after disease progression during adjuvant alectinib or within 6 months of completion of adjuvant alectinib where the following criteria have been met:LOR1
Lorlatinib monotherapy
Lorlatinib monotherapy for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously untreated with an ALK inhibitor where the following criteria have been met:LOR2
Lutetium oxodotreotide
Lutetium oxodotreotide for unresectable or metastatic, progressive, well differentiated and somatostatin receptor positive gastroenteropancreatic neuroendocrine carcinoma where all the following criteria are met:LUT1
Midostaurin
Midostaurin for treating newly diagnosed FLT3 mutation positive acute myeloid leukaemia (FLT3-ITD or FLT3-TKD) in ADULTS where the following criteria are met:MID1
For aggressive systemic mastocytosis or aggressive systemic mastocytosis with an associated haematological neoplasm or mast cell leukaemia where the following criteria have been met:MID2
For treating newly diagnosed FLT3 mutation positive acute myeloid leukaemia (FLT3-ITD or FLT3-TKD) in POST PUBESCENT CHILDREN LESS THAN 18 YEARS OLD where the following criteria have been met:MID3
Mogamulizumab
Mogamulizumab as 3rd line systemic therapy or beyond 3rd line systemic therapy for patients with stage IIB to IVB mycosis fungoides where the following criteria have been met:MOG1
Mogamulizumab as 2nd line systemic therapy or beyond 2nd line systemic therapy for patients with stage IVA to IVB Sezary syndrome where the following criteria have been met:MOG2
Momelotinib monotherapy
For the treatment of moderately to severely anaemic patients with myelofibrosis and disease-related splenomegaly or symptoms where the following criteria have been met:MOM1
Nab-Paclitaxel
Paclitaxel as albumin-bound nanoparticles (nab-paclitaxel) for breast cancer where the following criteria have been met:NAB1
Nab-paclitaxel with gemcitabine
The treatment of untreated metastatic pancreatic cancer only if other combination chemotherapies are unsuitable and they would otherwise have gemcitabine monotherapyNAB2
Nelarabine
The treatment of refractory T-cell acute lymphoblastic leukaemia or refractory T-cell lymphoblastic non-Hodgkin's lymphoma where all the following criteria are met:NEL1
Neratinib
The extended adjuvant therapy for hormone receptor positive HER2-overexpressed early breast cancer after completion of adjuvant therapy with HER2 targeted monotherapy with trastuzumab where the following criteria have been met:NER1
Nilotinib
Nilotinib for the treatment of untreated chronic phase chronic myeloid leukaemiaN/A
For treating imatinib-resistant or imatinib-intolerant Philadelphia chromosome positive chronic phase chronic myeloid leukaemia in children where the following criteria have been met:NIL4
Niraparib
Niraparib as maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who have a recent FIRST RELAPSE of platinum-sensitive disease and who are now in response following a SECOND platinum-based chemotherapy where the following criteria have been met: There is a separate form (NIR2) for niraparib as maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who do NOT have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who are in response following platinum-based SECOND or subsequent line chemotherapy.NIR1
Niraparib as maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who do NOT have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who have a recent FIRST OR SUBSEQUENT relapse of platinum-sensitive disease and who are now in response following a SECOND OR SUBSEQUENT platinum-based chemotherapy where the following criteria have been met: There is a separate form (NIR1) for niraparib as maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who are in response following a platinum-based SECOND line chemotherapy.NIR2
Niraparib monotherapy as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy AND who HAVE a deleterious or suspected deleterious BRCA germline and/or somatic BRCA mutation [NICE TA673] where the following criteria have been met: There is a separate form NIR4 for use of niraparib monotherapy as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy and who DO NOT HAVE a deleterious or suspected deleterious BRCA germline and/or somatic BRCA mutationNIR3
Niraparib monotherapy as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy AND who DO NOT HAVE a deleterious or suspected deleterious BRCA germline and/or somatic BRCA mutation [NICE TA673] There is a separate form NIR3 for use of niraparib monotherapy as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy and who HAVE a deleterious or suspected deleterious BRCA germline and/or somatic BRCA mutationNIR4
Nivolumab
Nivolumab for previously treated advanced renal cell carcinomaNIV1
The treatment of relapsed or refractory classical Hodgkin Lymphoma in ADULT patients where all the following criteria are met:NIV2
Nivolumab monotherapy for the treatment of PD-L1 positive NON- SQUAMOUS locally advanced or metastatic disease non-small cell lung cancer after chemotherapy where the following criteria have been met:NIV4
Nivolumab monotherapy for the treatment of SQUAMOUS locally advanced or metastatic non-small cell lung cancer after chemotherapy where the following criteria have been met:NIV5
The treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum-based chemotherapy where all the following crtieria are met:
Nivolumab for the adjuvant treatment of newly diagnosed and completely resected stage III or completely resected stage IV malignant melanoma where the following criteria are met:NIV7
Nivolumab monotherapy (with or without initial combination treatment with ipilimumab) for treating unresectable or advanced malignant melanoma (form a): REGISTRATION OF START OF NIVOLUMAB MONOTHERAPY OR OF PREVIOUSLY COMMENCED AND CURRENTLY CONTINUED NIVOLUMAB MONOTHERAPY (WITHOUT INITIAL COMBINATION WITH IPILIMUMAB) OR OF PREVIOUSLY COMMENCED AND CURRENTLY CONTINUED NIVOLUMAB MONOTHERAPY AFTER INITIAL COMBINATION WITH IPILIMUMAB (clinicians starting patients on nivolumab plus ipilimumab combination treatment should only use this form after the ipilimumab part of the treatment has been completed). This form comes in 3 parts 1. The first part is for patients who are either scheduled to commence nivolumab monotherapy or who commenced and continue to receive nivolumab monotherapy or who continue to receive nivolumab monotherapy after initial combination treatment with ipilimumab. The second part of the form which must use the same unique Blueteq identifier is for those benefitting patients who choose to electively discontinue nivolumab after 2 or more years of treatment. 2. The second part (patient details will be automatically entered) will only appear once the first part of the form is approved and should be completed at the time of elective discontinuation of nivolumab. The third part of the form which must use the same unique Blueteq identifier is for those patients registered as having electively and previously stopped nivolumab and in whom there is disease progression for which the clinician wishes to re-commence nivolumab monotherapy. 3. The third part of the form (patient details will be automatically entered) will only appear once the second part of the form has been approved.NIV8a
Nivolumab for treating unresectable or advanced malignant melanoma (form b): REGISTRATION OF DISCONTINUATION OF NIVOLUMAB This second part of the form which must use the same unique Blueteq identifier is for those patients in stable or response remission who have chosen to electively discontinue nivolumab; this second part must be completed at the time of discontinuation of nivolumab. The third part of the form which must use the same unique Blueteq identifier is for those patients registered as having electively and previously stopped nivolumab and in whom there is disease progression for which the clinician wishes to re-commence nivolumab; this third part of the form (patient details will be automatically entered) will only appear once the second part of the form has been approved.NIV8b
Nivolumab for treating unresectable or advanced malignant melanoma (form c): RE-START OF NIVOLUMAB MONOTHERAPY The third part of the form which must use the same unique Blueteq identifier is for those patients registered as having electively and previously stopped nivolumab and in whom there is disease progression for which the clinician wishes to re-commence nivolumab as the next systemic treatment.NIV8c
For the treatment of adult patients with unresectable locally advanced or recurrent or metastatic squamous cell carcinoma of the oesophagus previously treated with a fluoropyrimidine and platinum-based combination chemotherapy where the following criteria have been met:NIV15
Nivolumab monotherapy for adjuvant treatment after complete tumour resection in adult patients with high risk muscle invasive urothelial cancer with tumour cell PD-L1 expression of ≥1% and in whom adjuvant treatment with platinum-based chemotherapy is unsuitable where the following criteria have been met:NIV19
Nivolumab plus chemotherapy for neoadjuvant treatment and then continued as adjuvant monotherapy in adults with previously untreated UICC/AJCC 8th edition stage IIA or IIB or IIIA or N2 only IIIB non-small cell lung cancer AND who are candidates for potentially curative surgery where the following criteria have been met:NIV25
As 2nd line or subsequent line treatment for malignant pleural and peritoneal mesothelioma which has progressed during/after 1st line chemotherapy with pemetrexed-and platinum-based chemotherapy where the following criteria have been met:NIV13CV_v1.1
Nivolumab and ipilimumab
For patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic or locally advanced and inoperable colorectal cancer after prior fluoropyrimidine-based chemotherapy for metastatic disease where the following criteria have been met:
Nivolumab as adjuvant monotherapy
For patients with completely resected oesophageal or gastro-oesophageal carcinoma who have residual pathological disease at surgery following prior neoadjuvant chemoradiotherapy where the following criteria has been met:NIV17
Nivolumab in combination with ipilimumab
For the 1st line treatment of intermediate or poor risk advanced renal cell carcinoma where the following criteria are met:NIV9
For treatment of unresectable malignant mesothelioma previously untreated with systemic therapy where the following criteria have been met:NIV20
Nivolumab in combination with platinum and fluoropyrimidine-based chemotherapy
For previously untreated unresectable advanced or recurrent or metastatic squamous cell carcinoma of the oesophagus with a tumour cell PD-L1 expression of 1% or more and a PD-L1 combined positive score of <10 where the following criteria have been met:
For previously untreated advanced or metastatic HER-2 negative adenocarcinomas of the stomach, gastro-oesophageal junction or oesophagus which express PD-L1 with a combined positive score of 5 or more where the following criteria have been met:
Nivolumab in combination with relatlimab (Opdualag ®)
As first immunotherapy for treating unresectable or metastatic melanoma in patients aged 12 years or more where the following criteria have been met:NIVREL1
Nivolumab plus chemotherapy
For the neoadjuvant treatment of adults with previously untreated UICC/AJCC 8th edition stage IIA or IIB or IIIA or N2 only IIIB non-small cell lung cancer and who are candidates for potentially curative surgery where the following criteria have been met:NIV23
Nivolumab with ipilimumab
Nivolumab plus ipilimumab for previously untreated patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic or locally advanced and inoperable colorectal cancer where the following criteria have been met:NIV24
Obecabtagene autoleucel
Obecabtagene autoleucel (obecel) CAR-T cells for treating relapsed/refractory Philadelphia negative or positive B cell precursor acute lymphoblastic leukaemia in patients aged 26 years and older where the following criteria have been met: This form is for the approval of leucapheresis and manufacture of CAR-T cells. There is a second part to this form which relates to the subsequent infusion of CAR-T cells and this will be available after submission of the first part. The second part of the form (OBE01b) can only be completed as a continuation of this first part of the form (OBE01a) and OBE01b must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of obecabtagene autoleucel (obecel). Note: the second part of the form (OBE01b) will only appear after the above first part of the form (OBE01a) has been fully completed and submitted. To complete the second part of the form, the user will have to complete a continuation request for the OBE1a application.OBE01a
Obecabtagene autoleucel (obecel) for treating relapsed/refractory Philadelphia negative and positive B cell acute lymphoblastic leukaemia in patients aged 26 years and older where the following criteria have been met: This second form is to document the date of infusion of CAR T cell therapy and for registration of this infusion with NHS England so that the treating Trust is reimbursed for the cost of obecabtagene autoleucel (obecel). There is a first form for the approval of leucapheresis and manufacture of CAR T cells. This second form must use the same unique Blueteq identifier number generated when this patient was registered for leucapheresis and CAR T cell manufacture using the first form.OBE01b
Obinutuzumab
Obinutuzumab in combination with chlorambucil for untreated chronic lymphocytic leukaemia where the following criteria have been met:OBI2
The treatment of untreated advanced follicular lymphoma where all the following crtieria are met:OBI1
Obinutuzumab with bendamustine
The treatment of follicular lymphoma refractory to rituximab where the following criteria apply:OBIBEN1
Olaparib
Olaparib monotherapy as adjuvant treatment of high-risk TRIPLE NEGATIVE early breast cancer treated with neoadjuvant or adjuvant chemotherapy and definitive local therapy in patients with a deleterious or suspected deleterious germline BRCA mutation where the following criteria have been met:OLAP5
Olaparib monotherapy for metastatic castration-resistant prostate cancer bearing germline and/or somatic BRCA 1 or 2 mutations in patients who have progressed following previous treatment with an androgen receptor targeted agent AND HAVE ALSO BEEN TREATED WITH DOCETAXEL where the following criteria have been met:OLAP7
Olaparib monotherapy for metastatic castration-resistant prostate cancer bearing germline and/or somatic BRCA 1 or 2 mutations in patients who have progressed following previous treatment with an androgen receptor targeted agent AND HAVE NOT BEEN PREVIOUSLY TREATED WITH DOCETAXEL where the following criteria have been met:OLAP8
Olaparib as monotherapy for treatment of adults with deleterious or suspected deleterious germline BRCA1 or 2 mutations who have HER-2 negative locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane in the adjuvant/neoadjuvant/advanced disease settings and also treated with prior endocrine-based therapy if the patient has hormone-receptor positive disease where the following criteria have been met:OLAP10
Olaparib in combination with abiraterone
The treatment of metastatic hormone-relapsed (castrate-resistant) prostate cancer in patients who are treatment naïve to androgen receptor inhibitors and in whom chemotherapy is not yet clinically indicated or appropriate where the following criteria have been met:OLAP9_v1.1
Olaparib in combination with bevacizumab
As maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy AND whose cancer has a positive status for homologous recombination deficiency as defined by the presence of either a deleterious or suspected deleterious BRCA 1/2 germline and/or somatic mutation or genomic instability where the following criteria have been met: There is a separate form OLAP1a for use of olaparib monotherapy as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy AND whose cancer has the presence of a deleterious or suspected deleterious BRCA 1/2 germline and/or somatic mutationOLAP4_v1.1
Olaparib in combination with hormone therapy
As adjuvant treatment of high-risk HORMONE RECEPOR POSITIVE HER 2 NEGATIVE early breast cancer treated with neoadjuvant or adjuvant chemotherapy and definitive local therapy in patients with a deleterious or suspected deleterious germline BRCA mutation where the following criteria have been met:OLAP6
Olaparib in its tablet formation
For the maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy AND who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation where the following criteria have been met: THIS FORM IS FOR INITIATION OF MAINTENANCE OLAPARIB AS A SINGLE AGENT ONLY. THIS FORM IS FOR INITIATION OF MAINTENANCE OLAPARIB TABLETS IN THIS INDICATION. A separate CDF form OLAP1b is only for those patients with stable residual disease for whom it is appropriate to continue maintenance olaparib tablets after completion of 2 years of maintenance olaparib therapy. OLAP1b must be completed in such patients for funding of olaparib tablets to continue beyond 2 years A separate form (OLAP4) is to be used for olaparib in combination with bevacizumab as maintenance treatment in this 1st line indication.OLAP1a
For the maintenance treatment in patients with high grade epithelial BRCA mutation positive stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who responded to platinum-based FIRST line chemotherapy AND who still have stable residual disease after 2 years of olaparib maintenance therapy and who are planned to continue with maintenance olaparib where the following criteria have been met: THIS FORM IS FOR CONTINUATION OF MAINTENANCE OLAPARIB AFTER COMPLETION OF 2 YEARS OF TREATMENT. A separate form OLAP1a is used for initiating maintenance olaparib shortly after completion of 1st line chemotherapy.OLAP1b
For the maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who HAVE a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who have a recent FIRST RELAPSE of platinum-sensitive disease and who are now in response following a SECOND platinum-based chemotherapy where the following criteria have been met: There is a separate form OLAP1 for olaparib in its tablet formulation as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation who are in response following platinum-based FIRST line chemotherapy. There is also a separate form OLAP3 for olaparib in its tablet formulation as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation who are in response following platinum-based THIRD or subsequent line chemotherapy.OLAP2
For maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who have a recent SECOND OR SUBSEQUENT relapse of platinum-sensitive disease and who are now in response following a THIRD OR SUBSEQUENT platinum-based chemotherapy where the following criteria have been met: This OLAP3 form should also be used for patients transitioning from olaparib capsules to olaparib tablets in this particular indication for maintenance therapy after 3rd or subsequent platinum-based chemotherapy. There is a separate form OLAP1 for olaparib in its tablet formulation as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation who are in response following platinum-based FIRST line chemotherapy. There is also a separate form OLAP2 for olaparib in its tablet formulation as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation who are in response following platinum-based SECOND line chemotherapy.OLAP3
Osimertinib
The the second-line treatment of locally advanced or metastatic epidermal growth factor receptor T790M mutation-positive non small cell lung cancer in adults where all the following criteria are met:OSI1
For the first line treatment of locally advanced or metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer in adults where the following criteria have been met:OSI2_v1.5
Osimertinib for adjuvant treatment in adults after complete tumour resection in patients with UICC/AJCC 8th edition stage IB or stage IIA or stage IIB or stage IIIA or N2 only stage IIIB non-small cell lung cancer whose tumours have either an EGFR exon 19 deletion or an exon 21 (L858R) substitution mutation where the following criteria have been met:OSI3
Palbociclib (in combination with an aromatase inhibitor)
The treatment of previously untreated, hormone receptor-positive, HER2- negative, locally advanced or metastatic breast cancerPAL1
Palbociclib in combination with fulvestrant
For hormone receptor-positive, HER2- negative, locally advanced or metastatic breast cancer where the following criteria are met:PAL2
Panitumumab in combination with FOLFIRINOX or FOLFOXIRI (5-fluorouracil, irinotecan and oxaliplatin) chemotherapy
For chemotherapy-naive untreated metastatic or locally advanced and inoperable colorectal cancer where the following criteria have been met:PAN3
Panitumumab in combination with irinotecan-based chemotherapy
For chemotherapy-naive metastatic or locally advanced and inoperable colorectal cancer where the following criteria are met:PAN1_v1.3
Panitumumab in combination with oxaliplatin-based chemotherapy
For chemotherapy-naive metastatic or locally advanced and inoperable colorectal cancer where the following criteria are met:PAN2_v1.2
Panobinostat
Panobinostat for treating multiple myeloma after at least 2 previous treatmentsPANO1
Pegylated Liposomal Doxorubicin
The treatment of sarcomas where all the following criteria are met:PDL1
Pembrolizumab
Pembrolizumab for resectable, locally advanced, head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a combined positive score of 1 or more where the following criteria have been met:PEMB34
Pembrolizumab monotherapy for the treatment of PD-L1 positive locally advanced or metastatic non-small cell lung cancer after chemotherapy where the following criteria are met:PEMB1
The treatment of relapsed or refractory classical Hodgkin lymphoma in ADULTS who are stem cell transplant-ineligible and have failed brentuximab vedotin where the following criteria have been met:PEMB5
The treatment of relapsed or refractory classical Hodgkin lymphoma in CHILDREN who are stem cell transplant-ineligible and have failed brentuximab vedotin where the following criteria have been metPEMB6
Pembrolizumab for adjuvant treatment of melanoma with high risk of recurrence where the following criteria have been met:PEMB7
Pembrolizumab in combination with pemetrexed-and platinum-based chemotherapy for the first line treatment of PD-L1 positive or negative locally advanced or metastatic non-squamous non-small cell lung cancer where all the following criteria are met:PEMB8
Pembrolizumab monotherapy for treating unresectable or advanced malignant melanoma (form a): REGISTRATION OF START OF PEMBROLIZUMAB MONOTHERAPY OR OF PREVIOUSLY COMMENCED AND CURRENTLY CONTINUED PEMBROLIZUMAB MONOTHERAPY This form comes in 3 parts. 1. The first part is for patients who are either scheduled to commence pembrolizumab monotherapy or who commenced and continue to receive pembrolizumab monotherapy. 2. The second part of the form which must use the same unique Blueteq identifier is for those benefitting patients who choose to electively discontinue pembrolizumab after 2 or more years of treatment; this second part (patient details will be automatically entered) will only appear once the first part of the form is approved and should be completed at the time of elective discontinuation of pembrolizumab. 3. The third part of the form which must use the same unique Blueteq identifier is for those patients registered as having electively and previously stopped pembrolizumab and in whom there is disease progression for which the clinician wishes to re-commence pembrolizumab; this third part of the form (patient details will be automatically entered) will only appear once the second part of the form has been approved.PEMB9a
Pembrolizumab monotherapy for treating unresectable or advanced malignant melanoma (form b): REGISTRATION OF DISCONTINUATION OF PEMBROLIZUMAB This second part of the form which must use the same unique Blueteq identifier is for those patients in stable or response remission who have chosen to electively discontinue pembrolizumab; this second part must be completed at the time of discontinuation of pembrolizumab. The third part of the form which must use the same unique Blueteq identifier is for those patients registered as having electively and previously stopped pembrolizumab and in whom there is disease progression for which the clinician wishes to re-commence pembrolizumab; this third part of the form (patient details will be automatically entered) will only appear once the second part of the form has been approved.PEMB9b
Pembrolizumab monotherapy for treating unresectable or advanced malignant melanoma (form c): RE-START OF PEMBROLIZUMAB MONOTHERAPY The third part of the form which must use the same unique Blueteq identifier is for those patients registered as having electively and previously stopped pembrolizumab and in whom there is disease progression for which the clinician wishes to re-commence pembrolizumab as the next systemic treatment.PEMB9c
For previously untreated metastatic or unresectable recurrent PD-L1 positive head and neck squamous cell carcinoma (HNSCC) where the following criteria have been met:PEMB12
For the 1st line treatment of patients with either metastatic or locally advanced and inoperable colorectal cancer exhibiting microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) where the following criteria have been met:PEMB14_v1.2
For relapsed/refractory classical Hodgkin lymphoma in patients aged 3 years and older who have been treated with stem cell transplantation but never previously received brentuximab vedotin where the following criteria have been met:PEMB16
Pembrolizumab monotherapy for relapsed/refractory classical Hodgkin lymphoma in patients aged 3 years and older who have NOT been previously treated with stem cell transplantation or brentuximab vedotinPEMB17
Pembrolizumab monotherapy for adjuvant treatment after complete tumour resection of renal cell carcinoma in adult patients at increased risk of recurrence following nephrectomy or following nephrectomy and resection of all metastatic disease where the following criteria have been met:PEMB19_v1.1
Pembrolizumab for the adjuvant treatment of newly diagnosed and completely resected stage IIB or stage IIC malignant melanoma where the following criteria have been met:PEMB20_v1.0
Pembrolizumab in combination with chemotherapy as neoadjuvant treatment and then continued as adjuvant monotherapy after definitive surgery for patients with previously untreated locally advanced or early stage triple negative breast cancer at high risk of recurrence where the following criteria have been met:PEMB21
Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy for previously untreated advanced HER-2 negative gastric or gastro-oesophageal junction adenocarcinoma either of which expresses PD-L1 with a combined positive score of 1 or more where the following criteria have been met:PEMB29
Pembrolizumab in combination with chemotherapy
Pembrolizumab in combination with chemotherapy for neoadjuvant treatment and then continued as adjuvant monotherapy in adults with previously untreated UICC/AJCC 8th edition stage IIA or IIB or IIIA or N2 only IIIB non-small cell lung cancer AND who are candidates for potentially curative surgery where the following criteria have been met:PEMB30_v1.1
Pembrolizumab in combination with chemotherapy with or without bevacizumab
For the treatment of persistent, recurrent or metastatic cervical cancer in patients whose tumour PD-L1 expression test results have a combined positive score (CPS) of 1 or more where the following criteria have been met:PEMB22
Pembrolizumab in combination with lenvatinib
For the treatment of patients with endometrial carcinoma who have progressive disease during or following prior platinum-containing therapy given in any setting for advanced or recurrent or metastatic disease and who are not candidates for potentially curative surgery or radiotherapy or chemoradiotherapy where the following criteria have been met:PEMB23
Pembrolizumab in combination with paclitaxel or nab-paclitaxel
The treatment of previously untreated locally advanced unresectable or metastatic triple negative breast cancer in patients with PD-L1 expression test results of immune cell (IC) <1% and a combined positive score (CPS) of 10 or more where the following criteria have been met:PEMB18_v1.2
Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy
For previously untreated advanced oesophageal carcinoma which expresses PD-L1 with a combined positive score of 10 or more where the following criteria have been met:PEMB15
Pembrolizumab in combination with platinum-containing chemotherapy (carboplatin and paclitaxel)
Pembrolizumab in combination with platinum-containing chemotherapy (carboplatin and paclitaxel) for the 1st line treatment of mismatch repair deficient (dMMR) or microsatellite instability-high endometrial carcinoma in adult patients who have recurrent or primary advanced disease and who are not candidates for potentially curative surgery or radiotherapy or chemoradiotherapy but are eligible for systemic therapy where the following criteria have been met:PEMB32
Pembrolizumab in combination with platinum-containing chemotherapy (carboplatin and paclitaxel) for the 1st line treatment of mismatch repair proficient (pMMR) or microsatellite stable endometrial carcinoma in adult patients who have recurrent or primary advanced disease and who are not candidates for potentially curative surgery or radiotherapy or chemoradiotherapy but are eligible for systemic therapy where the following criteria have been met:PEMB33
Pembrolizumab monotherapy
For the subsequent treatment of patients with previously treated unresectable or metastatic COLORECTAL cancer exhibiting microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) where the following criteria have been met:PEMB24
For the treatment of patients with ENDOMETRIAL carcinoma exhibiting microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) and who have progressive disease during or following prior platinum-containing therapy given in any setting for advanced or recurrent or metastatic disease and who are not candidates for potentially curative surgery or radiotherapy or chemoradiotherapy where the following criteria have been met:PEMB25
For the subsequent treatment of patients with previously treated unresectable or metastatic GASTRIC cancer exhibiting microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) where the following criteria have been met:PEMB26
For the subsequent treatment of patients with previously treated unresectable or metastatic SMALL INTESTINAL carcinoma exhibiting microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) where the following criteria have been met:PEMB27
For the subsequent treatment of patients with previously treated unresectable or metastatic BILIARY TRACT cancer exhibiting microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) where the following criteria have been met:PEMB28
Pembrolizumab monotherapy for adjuvant treatment after complete tumour resection in adult patients with UICC/AJCC 8th edition stage IIA or IIB or IIIA or N2 only IIIB non-small cell lung cancer and whose disease has not progressed on recently completed adjuvant platinum-based chemotherapy where the following criteria have been met:PEMB31
Pemigatinib
For locally advanced or metastatic cholangiocarcinoma which has a fibroblast growth factor receptor 2 gene fusion/rearrangement in patients with disease progression during or after previous systemic therapy where the following criteria have been met:PEMIG1
Pertuzumab
Neoadjuvant pertuzumab plus trastuzumab in NODE POSITIVE patients for the neoadjuvant treatment of locally advanced, inflammatory or early breast cancer at high risk of recurrence (PER2a) where the following criteria have been met This form (introduced in November 2019) is for patients known to be pathologically node positive prior to commencing neo-adjuvant therapy. On commencing adjuvant treatment with pertuzumab, form PER4a (for node positive patients) must be completed. For patients with locally advanced, inflammatory or early breast cancer who are node negative or of unknown nodal status when commencing neo-adjuvant pertuzumab, form PER2b must be used for the neoadjuvant part of treatment followed by form PER4b for the adjuvant part of treatment only if the histology post-surgery is node +ve.PER2a
Neoadjuvant pertuzumab plus trastuzumab in patients who are NODE NEGATIVE or of UNKNOWN NODAL STATUS for the neoadjuvant treatment of locally advanced, inflammatory or early breast cancer at high risk of recurrence (PER2b) where the following criteria have been met: This form (introduced November 2019) is for patients who are node negative or of unknown nodal status prior to commencing neo-adjuvant therapy. If a biopsy post-surgery shows that the patients are found to be node positive, then for them to commence adjuvant treatment with pertuzumab and trastuzumab, form PER4b must be completed. For patients with locally advanced, inflammatory or early breast cancer who are node positive when commencing neo-adjuvant chemotherapy in combination with pertuzumab and trastuzumab, form PER2a must be used followed by form PER4b when commencing adjuvant treatment with pertuzumab and trastuzumabPER2b
Pertuzumab in combination with trastuzumab and chemotherapy as adjuvant therapy for axillary node positive HER2-positive early breast cancer and with NO preceding neoadjuvant chemotherapy in combination with pertuzumab and trastuzumab (PER3) where the following criteria have been met: Note: there is a separate form PER4a for adjuvant pertuzumab for node positive patients who received neoadjuvant chemotherapy in combination with pertuzumab and trastuzumab and who continue on to adjuvant treatment after surgery. For patients who were node negative or of unknown nodal status when commencing neo-adjuvant chemotherapy in combination with pertuzumab and trastuzumab and in whom surgery has demonstrated node positive disease, form PER4b must be used for adjuvant pertuzumab.PER3
Pertuzumab in combination with trastuzumab as adjuvant therapy for patients with HER2-positive early breast cancer which was diagnosed as being NODE POSITIVE prior to neoadjuvant treatment and has now completed neoadjuvant pertuzumab in combination with trastuzumab and chemotherapy and surgery (PER4a) where the following criteria have been met: These patients must have had form PER2a completed for the neoadjuvant portion of their therapy. For patients who were node negative or of unknown nodal status prior to commencing neo-adjuvant therapy, form PER2b (neoadjuvant portion) should have been completed and form PER4b is for adjuvant pertuzumab in such PER2b patients who are found to be node positive after surgery. For node positive patients who did not receive neo-adjuvant chemotherapy with pertuzumab, form PER3 should be used for adjuvant treatment of pertuzumab + trastuzumab.PER4a
Pertuzumab in combination with trastuzumab as adjuvant therapy for HER2- positive early breast cancer patients thought to be node negative or of unknown nodal status prior to neoadjuvant chemotherapy and found to be axillary node positive AFTER completion of neoadjuvant pertuzumab/trastuzumab and surgery (PER4b) where the following criteria have been met: These patients must have completed form PER2b for the neoadjuvant portion of their therapy. PER2b patients (node negative or of unknown nodal status prior to neoadjuvant chemotherapy) who are node negative after surgery cannot have adjuvant pertuzumab as NICE has only recommended adjuvant pertuzumab in patients who are node positive. For patients known to be node positive prior to commencing neoadjuvant therapy, forms PER2a (neoadjuvant portion of treatment) and PER4a (adjuvant portion of treatment) must be used. For node positive patients who did not receive neoadjuvant chemotherapy, applications for adjuvant pertuzumab should proceed directly to adjuvant treatment in combination with pertuzumab and trastuzumab (form PER3).PER4b
Pertuzumab (in combination with trastuzumab and a taxane or capecitabine)
The first line treatment of locally advanced or metastatic breast cancer where all the following criteria are met:PER1
Polatuzumab vedotin in combination with bendamustine and rituximab
For previously treated patients with relapsed or refractory diffuse large B-cell lymphoma and who are not candidates for haematopoietic stem cell transplantation where the following criteria have been met:POL1
Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone
For people with previously untreated diffuse large B-cell lymphoma where the following criteria have been met:POL2_v1.2
Pomalidomide
Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomibPOM1
Ponatinib
The treatment of Philadelphia chromosome positive acute lymphoblastic leukaemia where all the following criteria are met:PON1
The treatment of chronic phase, accelerated phase or blast phase chronic myeloid leukaemia where all the following criteria are met:PON6
Quizartinib
For the treatment of adult patients for treating newly diagnosed FLT3-ITD mutation positive acute myeloid leukaemia where the following criteria have been met:QUIZ1
Radium-223
Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastasesN/A
Regorafenib
The treatment of previously treated unresectable or metastatic gastrointestinal stromal tumours where all the following criteria are met:REG1
The second line of tyrosine kinase inhibitor systemic therapy of Child-Pugh A locally advanced or metastatic hepatocellular carcinoma previously treated with sorafenib where the following criteria are met:REG2_v1.1
For patients with either metastatic or locally advanced and inoperable colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy and anti-EGFR-based treatment where the following criteria have been met:REG3
Ribociclib (in combination with an aromatase inhibitor)
The treatment of previously untreated, hormone receptor-positive, HER2- negative, locally advanced or metastatic breast cancerRIB1_v1.4
Ribociclib in combination with fulvestrant
The treatment of hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer where the following criteria have been met:RIB2
Rucaparib
As maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who have a recent FIRST OR SUBSEQUENT relapse of platinum-sensitive disease and who are now in response following a SECOND OR SUBSEQUENT platinum-based chemotherapy where the following criteria have been met: There is a separate form (RUC2) for rucaparib as maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who do NOT have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who are in response following platinum-based SECOND or subsequent line chemotherapyRUC1
As maintenance treatment in patients with high grade epithelial ovarian, fallopian tube or primary peritoneal carcinoma who do NOT have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who have a recent FIRST OR SUBSEQUENT relapse of platinum-sensitive disease and who are now in response following a SECOND OR SUBSEQUENT line platinum-based chemotherapy where the following criteria have been met: There is a separate form RUC1 for rucaparib as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who have a deleterious or suspected deleterious germline and/or somatic BRCA mutation and who are in response following a platinum-based SECOND OR SUBSEQUENT line chemotherapyRUC2
As maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy AND who DO NOT HAVE a deleterious or suspected deleterious BRCA germline and/or somatic BRCA mutation BUT DO HAVE a positive status for homologous recombination deficiency as defined by the presence of genomic instability where the following criteria have been met:RUC3
As maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy for a tumour which has a NEGATIVE status for a deleterious or suspected deleterious BRCA germline and/or somatic BRCA mutation AND a NEGATIVE or UNKNOWN status for homologous recombination deficiency as defined by the presence of genomic instability where the following criteria have been met:RUC4
Ruxolitinib
Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with intermediate-2 or high-risk myelofibrosis where the following criteria have been met:RUX1_v2.1
For the treatment of polycythaemia vera for adult patients who are resistant to treatment with hydroxycarbamide or who cannot tolerate treatment with hydroxycarbamide where the following criteria have been met:RUX2
Sacituzumab govitecan
For the treatment of patients with previously treated unresectable locally advanced or metastatic triple negative breast cancer where the following criteria have been met:SAC1_v1.1
Selinexor in combination with bortezomib and dexamethasone
For the treatment of multiple myeloma in transplant ineligible patients who have had only 1 prior line of systemic therapy where the following criteria have been met:SELIN1_v1.1
For the treatment of multiple myeloma in transplant ineligible patients who have had only 2 prior lines of systemic therapy and who are refractory to lenalidomide where the following criteria have been met:SELIN3
Selinexor in combination with dexamethasone
For the treatment of multiple myeloma in patients who have had at least 4 prior lines of systemic therapy and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents and an anti- CD38 monoclonal antibody and which has also demonstrated disease progression on the last therapy where the following criteria have been met:SELIN2
Selpercatinib
Selpercatinib as monotherapy for the 1st line treatment of adult patients with previously untreated advanced non-small cell lung cancer (NSCLC) exhibiting a RET gene fusion where the following criteria have been met:SEL4
For the treatment of adults or adolescents aged 12 years and older with previously treated RET fusion positive non-medullary thyroid cancer where the following criteria have been met:SEL1
For the treatment of adults or adolescents aged 12 years and older with previously treated RET mutant medullary thyroid cancer where the following criteria have been met:SEL2
Selpercatinib as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) exhibiting a RET gene fusion and who have previously received immunotherapy and/or platinum-based chemotherapy where the following criteria have been met:SEL3
For the treatment of adults and adolescents aged 12 years and older with RET fusion positive non-medullary thyroid cancer previously UNTREATED with any kinase inhibitor therapy where the following criteria have been met:SEL5
For the treatment of adults or adolescents aged 12 years and older with RET mutant medullary thyroid cancer previously UNTREATED with any kinase inhibitor therapy where the following criteria have been met:SEL6
Sotorasib
Sotorasib as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) exhibiting a KRAS G12C mutation and who have been previously treated with at least 1 prior systemic therapy for advanced NSCLC where the following criteria have been met:SOT1_v1.2
Sunitinib
The treatment of unresectable or metastatic neuroendocrine tumours of pancreatic origin with disease progression where all the following criteria are met:SUN1
Talazoparib monotherapy
Talazoparib as monotherapy for treatment of adults with deleterious or suspected deleterious germline BRCA1 or 2 mutations who have HER-2 negative locally advanced or metastatic breast cancer previously treated with an anthracycline and/or taxane in the adjuvant/neoadjuvant/advanced disease settings and also treated with prior endocrine-based therapy if the patient has hormone-receptor positive disease where the following criteria have been met:TAL1
Talazoparib plus enzalutamide
For the treatment of metastatic hormone-relapsed (castrate-resistant) prostate cancer in patients who are treatment naïve to androgen receptor inhibitors and in whom chemotherapy is not yet clinically indicated or appropriate where the following criteria have been met:TAL2
Talimogene Laherparepvec
Talimogene laherparepvec for treating unresectable metastatic melanomaTALI1
Talquetamab monotherapy
For treating relapsed or refractory multiple myeloma after 3 or more treatments where the following criteria have been met:TALQ1
Tebentafusp
Tebentafusp as monotherapy for adult patients with human leukocyte antigen HLA- A*02:01 positive unresectable or metastatic uveal melanoma where the following criteria have been met:TEB1
Teclistamab
For the treatment of relapsed or refractory myeloma in adult patients who have relapsed or are refractory to their last anti-myeloma regimen AND have received at least 3 prior lines of systemic therapies which must have included at least one proteasome inhibitor, at least one immune-modulatory agent and at least one anti-CD38 antibody and where the following criteria have been met:TEC1
Tepotinib
Tepotinib as monotherapy for the treatment of adult patients with untreated advanced/metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations where the following criteria are met:TEP1
Tepotinib as monotherapy for the treatment of adult patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations where the following criteria are met:TEP2
Tisagenlecleucel
Tisagenlecleucel-modified CAR-T cells for treating relapsed/refractory Philadelphia negative and positive B cell acute lymphoblastic leukaemia in patients aged 25 years and under where the following criteria are met: Note: This form is for the approval of leucapheresis and manufacture of CAR-T cells. There is a second part to this form which relates to the subsequent infusion of CAR-T cells and this will be available after submission of the first part. The second part of the form (TIS01b) can only be completed as a continuation of this first part of the form (TIS01a) and must be completed on infusion of CAR-T cells otherwise the treating Trust will not be reimbursed for the cost of tisagenlecleucelTIS01a
Tisagenlecleucel for treating relapsed/refractory Philadelphia negative and positive B cell acute lymphoblastic leukaemia in patients aged 25 years and under where the following criteria are met: Note: This second part of the form is to document the date of infusion of CAR-T cell therapy and for registration of this infusion with NHS England so that the treating Trust is reimbursed for the cost of tisagenlecleucel. There is a first part of the form for the approval of leucapheresis and manufacture of CAR-T cells which has already been completed (TIS01a). This second part of the form (TIS01b) should only be completed as a continuation form once the date of CAR T cell infusion is known.TIS01b
Trametinib
For serous low grade ovarian or peritoneal cancer for disease which has recurred or progressed following at least one platinum-based chemotherapy regimen where the following criteria have been met:TRAM1
Trametinib and Dabrafenib
Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma where the following criteria have been met:TRADAB1
Dabrafenib in combination with trametinib for the adjuvant treatment of completely resected stage III BRAF V600 positive malignant melanoma where the following criteria are met:TRADAB2
Dabrafenib in combination with trametinib for BRAF V600-mutated anaplastic thyroid cancer (ATC) for ADULT patients where the following criteria have been met:TRADAB3
Trastuzumab deruxtecan
For treating over-expressed HER2 positive unresectable locally advanced or metastatic breast cancer in patients who have received 2 or more anti-HER2 therapies and who have received trastuzumab emtansine in the advanced/metastatic disease setting where the following criteria have been met:TRAD1_v1.1
For treating over-expressed HER2 positive unresectable locally advanced or metastatic breast cancer in patients who have received 1 or more anti-HER2 therapies and who are treatment-naïve for trastuzumab emtansine in the advanced/metastatic disease setting where the following criteria have been met:TRAD2_v1.1
Trastuzumab Emtansine
The treatment of HER2-positive locally advanced/ unresectable or metastatic (Stage IV) breast cancer where all the following criteria are met:TRA1
Trastuzumab emtansine MONOTHERAPY
As adjuvant therapy for patients with HER2-positive early breast cancer who have residual invasive disease following the combination of taxane-based and HER2-targeted neoadjuvant systemic therapy and surgery where the following criteria have been met:TRA2
Treosulfan (Trecondi®) in combination with fludarabine
Treosulfan (Trecondi®) in combination with fludarabine for part of conditioning treatment prior to allogeneic haemopoietic stem cell transplantation for malignant disease in ADULTS for whom a reduced intensity conditioning regimen (such as low dose busulfan with fludarabine) would otherwise be suitable where the following criteria have been met: There is a separate form TRE2 for treosulfan in combination with fludarabine for part of conditioning treatment prior to allogeneic haemopoietic stem cell transplantation for malignant disease in PAEDATRIC PATIENTS OLDER THAN 1 MONTH AND YOUNGER THAN 18 YEARS for whom a reduced intensity conditioning regimen (such as low dose busulfan with fludarabine) wouldTRE1
Treosulfan (as Trecondi®) in combination with fludarabine for part of conditioning treatment prior to allogeneic haemopoietic stem cell transplantation for malignant disease in PAEDIATRIC PATIENTS OLDER THAN 1 MONTH AND YOUNGER THAN 18 YEARS for whom a reduced intensity conditioning regimen (such as low dose busulfan with fludarabine) would otherwise be suitable where the following criteria have been met: There is a separate form TRE1 for treosulfan in combination with fludarabine for part of conditioning treatment prior to allogeneic haemopoietic stem cell transplantation for malignant disease in ADULTS for whom a reduced intensity conditioning regimen (such as low dose busulfan with fludarabine) would otherwise be suitable.TRE2
Trifluridine plus tipiracil
For patients with either metastatic or locally advanced and inoperable colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy and anti-EGFR-based treatment where the following criteria have been met:TRI1_v1.2
For the third or more line of systemic therapy for locally advanced or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction where the following criteria have been met:TRI2_v1.1
Trifluridine plus tipiracil in combination with bevacizumab
For patients with either metastatic or locally advanced and inoperable colorectal cancer who have received 2 or more prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin-and irinotecan-based chemotherapies with or without anti-VEGF agents and/or anti- EGFR-based agents where the following criteria have been met:TRI3
Tucatinib in combination with trastuzumab and capecitabine
For treating over-expressed HER2 positive unresectable locally advanced or metastatic breast cancer after 2 or more anti-HER2 treatment regimens where the following criteria have been met:TUC1
Venetoclax (in combination with rituximab)
The treatment of previously treated chronic lymphatic leukaemiaVEN3_v1.7
Venetoclax in combination with azacitidine
For untreated adult acute myeloid leukaemia in patients unsuitable for intensive chemotherapy where the following criteria have been met:VEN8
Venetoclax in combination with low dose cytarabine
For previously untreated adult acute myeloid leukaemia in patients unsuitable for intensive chemotherapy and who have a bone marrow blast count >30% where the following criteria have been met:VEN9
Venetoclax in combination with obinutuzumab
For the treatment of patients with previously untreated chronic lymphatic leukaemia in whom chemotherapy with the combinations of either FCR or BR would otherwise have been SUITABLE where the following criteria have been met:VEN7_v1.1
For the treatment of patients with previously untreated chronic lymphatic leukaemia which has a 17p deletion or TP53 mutation where the following criteria have been met:VEN5
For the treatment of patients with previously untreated chronic lymphatic leukaemia in whom chemotherapy with the combinations of either FCR or BR would otherwise have been UNSUITABLE where the following criteria have been met:VEN6
Venetoclax monotherapy
Treatment of chronic lymphatic leukaemia in the ABSENCE of 17p deletion (and absence of TP53 mutation if tested) where the following criteria have been met:VEN1_v1.1
The treatment of previously treated chronic lymphatic leukaemia in the PRESENCE of 17p deletion or TP53 mutation where the following criteria have been met:VEN2_v1.1
Vismodegib
For patients with multiple basal cell carcinomas (BCC) in adults where the following criteria have been met:VIS2
Zanubrutinib
Zanubrutinib monotherapy for the treatment of patients with previously treated Waldenstrom’s macroglobulinaemia and who would otherwise be next treated with bendamustine plus rituximab where the following criteria have been met:ZAN1
Zanubrutinib monotherapy for the treatment of patients with marginal zone lymphoma treated with at least 1 prior anti-CD20-based therapy where the following criteria have been met:ZAN5
For the treatment of patients with relapsed/refractory mantle cell lymphoma in patients who have received only 1 prior line of systemic therapy where the following criteria have been met:ZAN6
Zanubrutinib monotherapy
For the treatment of patients with previously untreated chronic lymphatic leukaemia which has a 17p deletion or TP53 mutation where the following criteria have been met:ZAN2_v1.0
For the treatment of patients with previously untreated chronic lymphatic leukaemia which does not have a 17p deletion or a TP53 mutation and in whom chemotherapy with FCR or BR is unsuitable where the following criteria have been met:ZAN3_v1.0
For the treatment of patients with previously treated chronic lymphatic leukaemia where the following criteria have been met:ZAN4_v1.0
Entry Detail
Select a drug from the list to see all its indications and criteria