8.1. Cytotoxic drugs
8.1.1. Alkylating drugs
Restrictions:
First-line treatment of chronic lymphocytic leukaemia (CLL) in patients for whom fludarabine combination chemotherapy is not appropriate is restricted to use in accordance with regional protocol.
Restrictions:
Use in newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation is restricted to specialist use only in whom 90% or more of the tumour has been resected. Use as an adjunct to surgery in patients with recurrent histologically proved glioblastoma multiforme for whom surgical resection is indicated is restricted to specialist use only.
Prescribing Notes:
- The SMC advice relating to carmustine is available here
- Only NICE Multiple Technology Appraisals are applicable to Scotland, and NICE TA121 relating to the use in newly-diagnosed patients is also relevant.
Restrictions:
Restricted to specialist use for the topical treatment of mycosis fungoides-type cutaneous T cell lymphoma (MF-type CTCL).
Restrictions:
Restricted to specialist use only. The use in combination with other chemotherapy for conditioning prior to haematopoietic progenitor cell transplantation (HPCT) in haematological diseases or the treatment of solid tumours when high dose chemotherapy with HPCT support is appropriate is not recommended by SMC and is non-Formulary.
Restrictions:
Restricted to specialist use in accordance with regional protocol (in development) in patients with malignant disease for whom a reduced intensity conditioning regimen is required prior to allogeneic haematopoietic stem cell transplantation.
8.1.2. Anthracyclines and other cytotoxic antibiotics
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following:
- AML: The treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (AML) or AML with myelodysplasiarelated changes. Please click here for regional protocol, NHS network access required.
Restrictions:
Restricted to specialist use only. Use in the treatment of ovarian cancer is restricted to use in accordance with regional protocol. It is not approved for the treatment of HIV-related Kaposi’s sarcoma, metastatic breast cancer or second line treatment for progressive multiple myeloma.
8.1.3. Antimetabolites
Restrictions:
Use for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) is restricted to specialist use in accordance with regional protocol, which excludes the routine use in chronic myelomonocytic leukaemia (CMML).
Prescribing Notes:
The regional protocol for azacitadine for intermediate-2 and high-risk myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) is available here
The treatment of adults aged 65 years or older who are not eligible for haematopoitec stem cell transplantation (HSCT) with acute myeloid leukaemia (AML) with >30% bone marrow blasts is not recommended for use in NHSScotland by the SMC and is non-Formulary.
Restrictions:
Restricted to specialist use in accordance with regional protocol for the indication outlined below.
Acute myeloid leukaemia
Maintenance therapy in adult patients with acute myeloid leukaemia who achieved complete remission or complete remission with incomplete blood count recovery following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, haematopoietic stem cell transplantation.
Restrictions:
Restricted to specialist use only. Restricted to use in accordance with regional protocols.
Restrictions:
Restricted to specialist use only.
Prescribing Notes:
Excludes liposomal formulations.
Restrictions:
Restricted to specialist use only. Restricted to use for treatment of CLL in accordance with regional protocol.
Restrictions:
Restricted to specialist use only. Restricted to use only for bladder, pancreatic or lung cancer in accordance with regional protocols.
Restrictions:
Use in oncology is restricted to specialist use only. Oral use in the unlicensed indications of inflammatory bowel disease (see section 1.5) and autoimmune hepatitis is restricted to specialist initiation only in patients who fail to tolerate azathioprine.
Prescribing Notes:
Near Patient Testing (NPT) arrangements for GPs may be in place for this medicine. See the relevant section in the Prescribing Resources page for current information.
Restrictions:
Restricted to specialist use only. Use in the treatment of cancer is restricted to specialist use only, other indications require specialist initiation, but may be suitable for continuation by the GP.
Restrictions:
Restricted to use only in patients in whom nelarabine is being used as a treatment to bridge to allogeneic stem cell transplant and restricted to use by specialists in haemato-oncology. It is not cost-effective when used for palliation.
Restrictions:
The following indications are formulary but use is restricted to specialists and according to regional protocols:
- Treatment of chemotherapy-naïve patients with stage III/IV unresectable malignant pleural mesothelioma. Use in the second line monotherapy of non-small cell lung cancer (NSCLC) is restricted to use according to regional protocol.
- Use as monotherapy for maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominently squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. For regional protocol click here.
- In combination with cisplatin as adjuvant treatment for patients with completely resected stage IIA to IIIA nonsquamous non–small-cell lung cancer (off label indication).
Restrictions:
Use in adults for the treatment of advanced gastric cancer in combination with cisplatin is restricted to specialist use in accordance with regional protocol.
8.1.4. Vinca alkaloids and etoposide
Restrictions:
Restricted to specialist use only. Restricted to use in accordance with regional protocols.
8.1.5. Other antineoplastic drugs
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following:
Breast Cancer: click here for regional protocols [NHS network access required]
- Treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
- Treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy in women who have progressed on or after (neo) adjuvant endocrine therapy, or progressed during first-line endocrine-based therapy for advanced breast cancer.
- In combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Restrictions:
Restricted to specialist use only in the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for VHL associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable or undesirable click here for protocol [NHS network access required]
Restrictions:
Restricted to specialist use in accordance with regional protocols for the following indications:
- Monotherapy for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) who have a 17p deletion or TP53 mutation and in whom chemo-immunotherapy is unsuitable.
- Monotherapy for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) without a 17p deletion or TP53 mutation and who are ineligible for fludarabine, cyclophosphamide and rituximab (FOR) therapy.
- Monotherapy for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukaemia (CLL) who have had at least one previous therapy, in whom chemo-immunotherapy is unsuitable.
Restrictions:
Use as monotherapy for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s) is restricted to specialist use in accordance with regional protocol.
Prescribing Notes:
Use of afatinib for monotherapy of advanced or metastatic non small cell lung cancer of squamous histology progressing on or after platinum-based chemotherapy is not recommended for use by the SMC and is non-Formulary.
Restrictions:
In combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy, aflibercept is indicated in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin containing regimen. It is restricted to specialist use in accordance with regional protocol.
Prescribing Notes:
For the relevant regional protocol please click here
Restrictions:
Restricted, as monotherapy, to first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) in accordance with regional protocol click here (NHS network access required).
Restrictions:
Restricted to specialist use only in accordance with regional protocol for the indication listed below:
- In combination with all-trans-retinoic acid (ATRA [tretinoin]) for the induction of remission, and consolidation in adult patients with newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count ≤10 x 103/µl), characterised by the presence of the t(15;17) translocation and/or the presence of the Pro Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene. Please click here for regional protocol (NHS network access required).
Restrictions:
Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), and without a known T315I mutation is restricted to specialist use in accordance with regional protocol (in development).
Restrictions:
The following indications are restricted to specialist use only in accordance with regional protocols:
- NSCLC: Monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Patients with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)-positive tumour mutations should also have received targeted therapy before receiving atezolizumab. The protocol can be accessed here (NHS network access required). This is also subject to a two-year stopping rule.
- NSCLC: Monotherapy as adjuvant treatment following complete resection for adults with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥ 50% of tumour cells and whose disease has not progressed following platinum-based adjuvant chemotherapy.
- SCLC: In combination with carboplatin and etoposide for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
- Breast Cancer: In combination with nab-paclitaxel for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
- Hepatocellular Carcinoma (HCC): In combination with bevacizumab for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma
(HCC) who have not received prior systemic therapy. Access protocol here (NHS network access required).
Prescribing Notes:
Not recommended by SMC:
- Use as monotherapy for locally advanced or metastatic urothelial carcinoma after prior platinum-containing chemotherapy is not recommended for use by the SMC and is non-Formulary.
- In combination with bevacizumab, paclitaxel and carboplatin, or in combination with nab-paclitaxel and carboplatin, for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC)
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- Use as monotherapy for the treatment of adults with metastatic Merkel cell carcinoma (MCC) click here for protocol (NHS network access required)
- Use in combination with axitinib for the first-line treatment of adults with advanced renal cell carcinoma click here for protocol (NHS network access required)
- Monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are progression-free following platinum-based chemotherapy.
Restrictions:
Restricted to specialist use in accordance with regional protocol only for the following indications:
- In combination with paclitaxel for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents (for regional protocol click here).
- In combination with carboplatin and paclitaxel, for the front-line treatment of advanced (International Federation of Gynaecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer is included in the GGC Adult Formulary pending protocol for the indication in question. It is restricted to specialist use in accordance with regional protocol (click here) for patients with FIGO stage IV disease.
- In combination with paclitaxel and cisplatin for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix is restricted to specialist use in accordance to regional protocol (in development).
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
Melanoma:
- In combination with encorafenib for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 mutation.
Restrictions:
Restricted to specialist use in accordance to regional protocols for the following indications and restrictions:
- The treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL) in accordance with regional protocol click here (NHS network access required).
- Monotherapy for the treatment of adults with Philadelphia chromosome negative, CD19 positive, B-precursor acute lymphoblastic leukaemia (ALL) in first complete remissions with minimal residual disease (MRD) greater than or equal to 0.1%. Click here for regional protocol NHS network access required).
Prescribing Notes:
Use as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL) is not recommended by SMC and is non-Formulary.
Restrictions:
Restricted to specialist use according to regional protocols.
Prescribing Notes:
The following indications are Formulary for bortezomib in accordance with regional protocols:
- The first-line treatment of multiple myeloma in combination with an alkylating agent and a corticosteroids
- in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with bone marrow transplant
- in combination with dexamethasone and thalidomide for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
- In combination with rituximab, cyclophosphamide, doxorubicin and prednisolone for the treatment of adults with previously untreated mantle cell lymphoma who are unsuitable for haematopoetic stem cell transplantation (click here)
For the NICE advice regarding bortezomib for multiple myeloma click here
Restrictions:
Use in the treatment of adults with Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate, is restricted to specialist use in accordance with regional protocol.
Prescribing Notes:
The treatment of adults with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) is not recommended by SMC and is non-Formulary.
Restrictions:
Restricted to specialist use in accordance with regional protocols for the following indications:
Hodgekin Lymphoma:
- Treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, is restricted to specialist use in accordance with regional protocol. click here for regional protocol (NHS network access required)
Cutaneous T-cell lymphoma:
- The treatment of adults with CD30+ cutaneous T-call lymphoma (CTCL) after one prior systemic therapy is restricted to those patients with advanced CTCL, defined as mycosis fungoides stage IIB and above, primary cutaneous anaplastic large cell lymphoma or Sezary Syndrome. Click here for regional protocol (NHS network access required)
Systemic anaplastic large cell lymphoma:
- For the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma(sALCL) in combination with cyclophosphamide, doxorubicin and prednisone (CHP). Click here for regional protocol (NHS network access required)
Prescribing Notes:
The following indications are not recommended by the SMC and are non-Formulary:
- Treatment of adults with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant
- Treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine (SMC non-submission)
Restrictions:
Restricted to specialist use in accordance with regional protocols for the following:
NSCLC:
- As monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Please click here for regional protocol (NHS network access required).
- As monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.
Restrictions:
Use in combination with prednisolone ir prednisone for the treatment of hormone refractory metastatic prostate cancer is restricted to specialist use in patients who have received at least 225mg/m2 (three cycles) of docetaxel and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in accordance with regional protocol click here (NHS network access required).
Restrictions:
Restricted to specialist use in accordance with regional protocol - click here.
Prescribing Notes:
The following indications are not recommended for use by the SMC and are non-Formulary:
- Treatment of advanced renal cell carcinoma (RCC) in treatment-naive adults with intermediate or poor risk
- Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma
- Monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy
- Monotherapy treatment of hepatacellular carcinoma in adults who have been previously treated with sorafenib
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- Use in combination with dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior therapy - click here for protocol [NHS network access required].
- Use in combination with lenalidomide and dexamethasone for the treatment of adults with multiple myeloma is restricted to use in patients who have received only one prior therapy - click here for protocol [NHS network access required].
Prescribing Notes:
Use in combination with daratumumab and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy is not recommended by SMC and is non-Formulary.
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
Cutaneous Squamous Cell Carcinoma (CSCC)
- Monotherapy for the treatment of adults with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Click here for regional protocol [NHS network access required].
Prescribing Notes:
Use as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC is not recommended by SMC and is non-Formulary.
Restrictions:
Restricted to specialist use in accordance with regional protocol in adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Prescribing Notes:
- The regional protocol for treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib can be found here (NHS network access required).
- Use as monotherapy for the first-line treatment of adults with ALK-positive advanced NSCLC is not recommended by SMC.
Restrictions:
Cetuximab may be used by specialists in accordance with regional protocol for the indications and restrictions listed in the prescribing notes section below:
Prescribing Notes:
- Head and neck cancer
- EGFR-expressing RAS wild-type metastatic colorectal cancer in combination with irinotecan or oxaliplatin-based chemotherapy in patients who not previously received chemotherapy (first-line treatment). For regional protocol click here
Restrictions:
Restricted to specialist use only.
Prescribing Notes:
Alternative name: asparaginase
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- First-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
- The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The regional protocol can be accessed here (NHS network access required)
- The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). The regional protocol can be accessed here (NHS network access required)
Restrictions:
Restricted to specialist use in accordance with regional protocols for the following indications:
- Unresectable or metastatic BRAF V600 mutation-positive metastatic melanoma who have received no prior therapy click here for protocol [NHS network access required]
- In combination with trametinib for the adjuvant treatment of adults with stage III melanoma with a BRAF V600 mutation following complete resection click here for protocol [NHS network access required]
- In combination with trametinib for the treatment of adults with locally advanced or metastatic anaplastic thyroid cancer with evidence of a BRAF V600E mutation and with no satisfactory locoregional treatment options (off label use).
Prescribing Notes:
The following indications are not recommended for use by the SMC and are non-Formulary:
- In combination with trametinib for the treatment of adults with advanced non-small cell lung cancer with BRAF V600 mutation.
Restrictions:
Monotherapy, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations, is restricted to specialist use only in accordance with regional protocol (click here, NHS network access required).
Restrictions:
Restricted to specialist use in accordance with regional protocols for the following indications:
Multiple Myeloma: accessed regional protocols here [NHS network access required]
- Use as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma is restricted to use as a fourth-line treatment option.
- In combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received one prior therapy only.
- Use in combination with bortezomib, thalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
- In combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
Amyloidosis:
- Use in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of newly-diagnosed systemic light chain (AL) amyloidosis.
Prescribing Notes:
The following indications for the infusion preparation are not recommended by SMC and are non-Formulary:
Multiple Myeloma:
- In combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
- Combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indication:
- Non-metastatic castration-resistant prostate cancer (nmCRPC) in men who are at high risk of developing metastatic disease click here for local protocol [NHS network access required].
- Treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel click here for protocol [NHS network access required].
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following:
- Treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase is restricted to specialist use only in accordance with regional protocol - click here.
- Treatment of adult patients with chronic, accelerated or blast phase chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate is restricted to specialist use only in accordance with regional protocol - click here.
Prescribing Notes:
The following indications are not recommended by the SMC and are non-Formulary:
- ALL: Treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy (non-submission to SMC)
Restrictions:
Restricted to specialist use only. Use for adjuvant and metastatic breast cancer, metastatic prostate cancer, non-small cell lung cancer and cancer of the head and neck is restricted to use in accordance with regional protocols. The use of docetaxel in metastatic gastric adenocarcinoma has not been accepted by SMC and remains non-Formulary.
Restrictions:
Restricted to specialist use in accordance with regional protocol for:
- Monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following:
- NSCLC: As monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 (programmed cell death ligand 1) on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy. Please click here for regional protocol, NHS network access required.
- Biliary tract cancer: In combination with gemcitabine and cisplatin for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer click here for protocol [NHS network access required]
Prescribing Notes:
Non-formulary indications:
- In combination with etoposide and either carboplatin or cisplatin for the first-line treatment of adults with extensive-stage small cell lung cancer is not recommended by SMC.
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
Melanoma:
- in combination with binimetinib for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 mutation. Click here for regional protocol (NHS network access required).
Colorectal Cancer:
- In combination with cetuximab for the treatment of adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation who have received prior systemic therapy. Click here for regional protocol (NHS network access required).
Restrictions:
Restricted to use specialist use in accordance with regional protocol for locally advanced or metastatic breast cancer in adult patients who have progressed after at least two chemotherapeutic regimen for advanced disease- please click here for regional protocol.
Prescribing Notes:
Non-formulary indication:
- Treatment of adult patients with unresectable lipsarcoma, who have received prior anthracycline containing thearpy (unless unsuitable) for advanced or metastatic disease, is not recommended by SMC.
Restrictions:
Restricted to use in accordance with regional protocols (see prescribing notes for Formulary indications).
Prescribing Notes:
Erlotinib is Formulary in accordance with the restrictions above for the following indications:
- First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations (West of Scotland protocol available here)
- Locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen except in patients who do NOT have an activating EGFR mutation (West of Scotland protocol available here)
Erlotinib is not recommended (and non-Formulary) for the following indications:
- Monotherapy for maintenance treatment in patients with locally advanced or metastatic NSCLC with stable disease after 4 cycles of standard platinum-based first-line chemotherapy
- in combination with gemcitabine for the treatment of metastatic pancreatic cancer
Restrictions:
Monotherapy for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors is restricted to specialist use in accordance to regional protocol.
Restrictions:
The following oncology indications are formulary but restricted to specialist use in accordance with regional protocols:
- Treatment of unresectable or metastatic, well or moderately-differentiated neuroendocrine tumours of pancreatic origin (pNET) in adults with progressive disease. Regional protocol for pNET can be accessed here
- Treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy. For regional protocol click here
- Treatment of hormon receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Regional protocol under development.
- Treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease is restricted to specialist use in accordance with regional protocol click here
The following other indication(s) are restricted to specialist use only:
- Adjunctive treatment of patients with refractory partial-onset seizures, with or without secondary generalisation, that are associated with tuberous sclerosis complex (TSC).
Prescribing Notes:
The following indications have not been accepted by SMC and remain non-Formulary:
- The treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications but who do not require immediate surgery.
- Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a cardiac transplant or prophylaxis of organ rejection in patients receiving a hepatic transplant.
- Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogenic renal transplant
Restrictions:
Restricted to specialist use for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
Restrictions:
Restricted to specialist use in accordance with regional protocol (in development) in patients with previously untreated locally advanced or metastatic NSCLC with activating EGFR-TK mutations i.e. as a first-line therapy.
Restrictions:
The following indications are restricted to specialist use in accordance with regional protocol:
- Acute Myeloid Leukaemia (AML): As monotherapy for the treatment of adults with relapsed or refractory AML with a FLT3 mutation. Click here for protocol (NHS network access required)
Restrictions:
Restricted to specialist use only. Excludes Siklos® which is not recommended for use by the SMC.
Restrictions:
Restricted to specialist use in accordance with regional protocols for the following indications:
Chronic lymphocytic leukaemia click here for regional protocol [NHS network access required]
- First line treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy
- Treatment of adults with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy and for whom fludarabine-based regimens are inappropriate
- In combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)
Mantle cell lymphoma click here for regional protocol [NHS network access required]
- Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
Waldenstrom's macroglobulinaemia click here for regional protocol [NHS network access required]
- In combination with rituximab for the treatment of adults with Waldenstrom's macroglobulinaemia
- As a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia who have received at least
one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy is restricted to patients who have received at least one prior therapy.
Prescribing Notes:
Ibrutinib remains non-Formulary for the following indications:
- Use in combination with bendamustine and rituximab for the treatment of adult patients with chronic lymphocytic leukaemia who have received at least one prior therapy (Not recommended for use in NHSScotland by the Scottish Medicines Consortium)
- Use as a single agent for the treatment of adults with previously untreated chronic lymphocytic leukaemia (and who do not have 17p deletion or TP53 mutation)
- In combination with obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL)
- As single agent treatment for Waldenstrom's macroglobulinaemia who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy
- In combination with rituximab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia
Restrictions:
Restricted to specialist use in accordance with regional protocols (under development) for the indications outlined in the prescribing notes below.
Prescribing Notes:
- Relapsed chronic lymphocytic leukaemia (CLL) patients who are unsuitable for chemotherapy. For relevant protocol please click here
- CLL in treatment-naive patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy
- FL that is refractory to two prior lines of treatment. For relevant protocol please click here
Non-formulary indication:
- Use in combination with ofatumumab for the treatment of adult patients with chronic lymphocytic leukaemia who have received at least one prior therapy, or first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies is not recommended by SMC.
Restrictions:
Restricted to use in accordance with regional protocols (see prescribing notes for Formulary indications)
Prescribing Notes:
Imatinib is Formulary in accordance with the restrictions above for the following indicaitons in adults:
- Treatment of adult patients with KIT (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) (West of Scotland protocol available here)
- Adjuvent treatment of adult patients who are at significant risk of relapse following resection of KIT (CD 117)-positive GIST (West of Scotland protocol available here)
- Chronic myeloid leukaemia in accordance with regional Clinical Management Guideline (under review)
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- Monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). This indication is further restricted to patients for whom the intent is to proceed to stem cell transplantation. The protocol can be accessed here (NHS network access required).
Restrictions:
Restricted to specialist use only. Restricted to use in the treatment of colorectal cancer in accordance with regional protocol.
Restrictions:
Restricted to specialist use only in accordance with regional protocol for the following:
- Hepatocellular carcinoma: As monotherapy in adults with advanced or unresectable hepatocellular carcinoma who have recieved no prior systemic therapy. Please click here for regional protocol, NHS netwroks access required.
- Thyroid Carcinoma: Treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI) - click here for regional protocol (NHS network access required)
- Renal Cell Carcinoma:
- In combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior endothelial growth factor (VEGF)-targeted therapy. Click here for regional protocol (NHS network access required)
- Treatment of adults with advanced renal cell carcinoma (RCC), in combination with pembrolizumab, as first-line treatment
Restrictions:
Use as monotherapy for the adults with ALK-positive advanced non-small cell lung cancer (NSCLC) who disease has progressed after;
- Alectinib or certinib as the first ALK tyrosine kinase inhibitor(TKI) or
- crizotinib and at least one other ALK TKI
is restricted to specialist use in accordance with regional protocol click here (NHS network access required).
Prescribing Notes:
This medicine has a conditional marketing authorisation and will be re-evaluated by the Scottish Medicines Consortium (SMC) in due course.
Restrictions:
Treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults is restricted to specialist use only in accordance with regional protocol click here.
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- In combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy for adults with newly diagnosed acute myeloid leukaemia (AML) who are FMS like tyrosine kinase 3 (FLT3) mutation-positive. The protocol can be accessed here (NHS network access required).
Prescribing Notes:
Use as monotherapy for the treatment of adults with aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm or mast cell leukaemia is not recommended by SMC and is non-Formulary.
Restrictions:
Restricted to specialist use in accordance with regional protocol in patients with advanced mycosis fungoides or Sezary syndrome (stage ≥IIB MF and all SS) following at least one prior systemic therapy, who are clinically ineligible for or refractory to treatment with brentuximab vedotin. Click here for regional protocol [NHS network access required]
Restrictions:
The extended adjuvant treatment of early-stage HER2-overexpressed/amplified breast cancer in adults who have completed adjuvant trastuzumab-based therapy lsee that one year ago is restricted to specialist use in accordance with regional protocol.
Restrictions:
Please see under prescribing notes below.
Prescribing Notes:
Use in combination with docetaxel for the treatment of adults with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy is restricted to specialist use in accordance with regional protocol click here.
Restrictions:
Restricted to specialist use in accordance with regional protocols for the following indications:
- Monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy in patients who do not have a germline BRCA mutation.
- Monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO stages III or IV) high-grade ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
Restrictions:
Restricted to specialist use in accordance with relevant regional protocols [NHS network access required] for the following indications:
- Melanoma (click here for regional protocols):
- Monotherapy for the treatment in advanced (unresectable or metastatic) melanoma in adult patients previously untreated with ipilimumab
- First-line treatment in combination with ipilimumab for advanced (unresectable or metastatic) melanoma in adults.
- Monotherapy for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
- Lung Cancer (click here for regional protocols):
- Treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
- Treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. Treatment with nivolumab is subject to a two-year clinical stopping rule.
- In combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable (tumours ≥4 cm or node positive) non-small cell lung cancer in adults.
- Renal Cell Carcinoma (click here for regional protocols):
- Monotherapy for the treatment of advanced renal cell carcinoma after prior therapy in adults.
- In combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC).
- In combination with cabozantinib for the first-line treatment of advanced renal cell carcinoma in adults.
- Hodgkin Lymphoma (Click here for regional protocols): Treatment of adults with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
- Squamous Cell Cancer of Head and Neck (Click here for regional protocols): Monotherapy for adults progressing on or after platinum-based therapy is subject to a two-year stopping rule.
- Oesophageal Squamous Cell Carcinoma (click here for regional protocols):
- Monotherapy for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
- In combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression ≥1%.
- Colorectal cancer (click here for regional protocol): In combination with ipilimumab for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy
- Mesothelioma (click here for regional protocols):
- In combination with ipilimumab for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
- Second or subsequent line in patients with pleural or peritoneal mesothelioma in whom the disease has progressed on or after platinum-based chemotherapy (off label indication).
- Oesophageal or gastro-oesophageal junction cancer (click here for regional protocols):
- Monotherapy for the adjuvant treatment of adult patients with completely resected oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.
- In combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥5
- Urothelial Carcinoma (click here for regional protocols): Monotherapy for adjuvant treatment in patients with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression of ≥1% who are at high risk of recurrence after undergoing radical resection of MIUC.
Prescribing Notes:
Nivolumab is currently non-formulary for the following indications:
- Urothelia Carcinoma: Monotherapy for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy (Not recommended for use in NHSScotland)
- Non-Small Cell Lung Cancer: In combination with ipilimumab and 2 cycles of platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.
- Oesophageal Carcinoma: In combination with ipilimumab for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell programmed death ligand (PD-L1) expression ≥ 1% (not recommended as non-submission to SMC).
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- Ovarian Cancers: Click here for regional protocol [NHS network access required]
- Monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
- Maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA 1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
- Monotherapy maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
- In combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.
- Breast cancer (click here for regional protocols):
- As monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have human epidermal growth factor receptor 2 (HER2)-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
- Prostate Cancer: click here for regional protocols [NHS network access required]
- Monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
Prescribing Notes:
Non-formulary indications:
- Monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen is not recommended by SMC.
- Monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments is not recommended by SMC.
Restrictions:
The following indications are restricted to specialist use in accordance with regional protocols:
- Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC) is restricted to patients who have received previous treatment with an EGFR tyrosine kinase inhibitor (protocol in development).
- Monotherapy for the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations is further subject to a three-year clinical stopping rule (protocol in development).
- As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer
(NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
Restrictions:
Restricted to specialist use only. Restricted to use in accordance with regional protocols.
Restrictions:
Restricted to specialist use only as outlined in the Prescribing Notes below.
Prescribing Notes:
Restricted to use in the treatment of lung cancer (click here for protocol), ovarian cancer (click here for protocol) and metastatic breast cancer (click here for protocol) only in accordance with regional protocols.
Use in the treatment of AIDS related Kaposi’s sarcoma is non-Formulary.
Restrictions:
Restricted to specialist use in accordance with regional protocol (see below) for the first-line treatment of adults with metastatic adenocarcinoma of the pancreas. First-line use with carboplatin in non-small cell lung cancer is not recommended by SMC and is non-Formulary.
Prescribing Notes:
Regional protocol for the first-line treatment of adults with metastatic adenocarcinoma of the pancreas click here.
Restrictions:
Restricted to specialist use in accordance with regional protocols for the indications listed below.
Prescribing Notes:
- In combination with an aromatase inhibitor for first-line treatment of HR-positive HER2-negative locally advanced or metastatic breast cancer. Click here for regional protocol.
- Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy. Protocol under development.
Restrictions:
The following indications are restricted to specialist use in accordance with regional protocol:
- First-line RAS-wild type metastatic colorectal cancer in combination with either FOLFOX or FOLFIRI
Prescribing Notes:
For relevant NICE advice please click here
Restrictions:
First-line treatment of advanced renal cell carcinoma (RCC) should be in accordance with regional protocol.
Prescribing Notes:
The following indications are not recommended for use by SMC and are non-Formulary
- Second-line treatment of advanced renal cell carcinoma (RCC)
- Treatment of adult patients with selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.
For the relevant SMC advice click here
Restrictions:
Restricted to specialist use in accordance with regional protocol as part of combination treatment in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.
Restrictions:
Restricted to specialist use in accordance with regional protocols:
- Melanoma (click here for protocols, NHS network access required):
- Monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults previously untreated with ipilimumab.
- Monotherapy for the adjuvant treatment of adults with Stage IIB, IIC or Stage III melanoma and lymph node involvement who have undergone complete resection.
- NSCLC (click here for regional protocols, NHS network access required):
- Treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand (PD-L1) and who have received at least one prior chemotherapy regimen.
- Monotherapy for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥50% tumour proportion score (TPS) with no epidermal growth factor receptor (EGFR) or anaplastic lyphoma kinase (ALK) positive tumor mutations.
- Use in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations is restricted to specialist use in accordance with regional protocols (in development) only in patients whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.
- Use in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults is restricted to specialist use in accordance with regional protocols (in development) only in patients whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.
- Urothelial Carcinoma (click here for regional protocol, NHS network access required):
- Monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (subject to a two-years clinical stopping role).
- In combination with lenvatinib, for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation (subject to a two-year clinical stopping rule).
- Classical Hodgkin Lymphoma (click here for regional protocol, NHS network access required):
- Monotherapy for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedorin, or who are transplant-ineligible and have failed brentuximab vedotin (subjected to a two-year clinical stopping rule).
- Monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option is subject to a two-year stopping rule (protocol in development).
- Renal Cell Carcinoma (Click here for regional protocol, NHS network access required):
- In combination with axitinib for the first line treatment of advanced renal cell carcinoma (RCC) in adults (subject to a two-year clinical stopping rule).
- As monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
- Head and Neck Squamous Cell Carcinoma (HNSCC, click here for protocol, NHS network access required): Use as monotherapy or in combination with platinum and fluorouracil chemotherapy, for the first-line treatment of metastatic or unresectable recurrent HNSCC in adults whose tumours express PD-L1 with a combined positive score of ≥1 (subject to a two-year clinical stopping rule).
- Colorectal cancer (click here for regional protocols, NHS network access required): monotherapy for the first-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults is subject to a two-year clinical stopping rule.
- Oesophageal or gastroesophageal junction cancer: (click here for reginal protocols, NHS network access required): In combination with platinum and fluoropyrimidine based chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS≥10 (subject to a two-year clinical stopping rule).
- Triple-negative breast cancer: (click here for regional protocols, NHS network access required):
- In combination with paclitaxel or nab-paclitaxel, for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥10 and who have not received prior chemotherapy for metastatic disease (subject to a two-year clinical stopping rule).
- In combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, for the treatment of adults with locally advanced, or early stage triple-negative breast cancer (TNBC) at high risk of recurrence.
- Cervical Cancer: In combination with chemotherapy, with or without bevacizumab, for perstistant, recurrent or metastatic cervical cancer in patients whose tumours express PD-L1 with a CPS ≥1 (subject to a two-year clinical stopping rule).
Prescribing Notes:
Not recommended by SMC and non-formulary:
- Advanced (unresectable or metastatic) melanoma: monotherapy in adults previously treated with ipilimumab remains non-formulary.
- Locally advanced or metastatic urothelial carcinoma: monotherapy in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥10 remains non-formulary.
- Monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥50% TPS and progressing on or after platinum-containing chemotherapy
- In combination with pemetrexed and platinum chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations.
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- Treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Restrictions:
Restricted to use by specialists in haematological oncology for patients with hairy cell leukaemia.
Restrictions:
Restricted to specialist use in accordance with regional protocols.
Prescribing Notes:
Breast Cancer: click here for regional protocols [NHS network access required]
- In combination with trastuzumab and chemotherapy in the neoadjuvant treatment of adults with HER2 positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
- In combination with trastuzumab and docetaxel in adults with HER2 positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
- Use in combination with trastuzumab and chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (restricted to use in patients with lymph node-positive disease)
Restrictions:
Restricted to specialist use in accordance with regional protocols.
Prescribing Notes:
Breast Cancer: click here for regional protocols [NHS network access required]
- Use in the treatment of HER2 positive early breast cancer and metastatic breast cancer is restricted to use in accordance with regional protocol.
- In combination with chemotherapy in the neoadjuvant treatment of adults with HER2 positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
- In combination with docetaxel in adults with HER2 positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
- Use in combination with chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (restricted to use in patients with lymph node-positive disease).
Restrictions:
The following indications are restricted to specialist use in accordance with regional protocol:
- B-cell Lymphoma: click here for protocol [NHS network access required]
- Use in combination with bendamustine and rituximab for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for haematopoietic stem cell transplant.
- In combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL), restricted to patients with an International Prognostic Index (IPI) score of 2 to 5..
Restrictions:
Restricted to specialist use in accordance with regional protocol for the indications listed in the Prescribing Notes below
Prescribing Notes:
Chronic myeloid leukaemia (CML):
The treatment of chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) in adults:
- resistant to dasatinib or nilotinib
- who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate
- who have the T215 mutation
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL)
The treatment of Philadelphia chromosome positive acute lymphoblastic leukaemia in adults:
- who are resistant to dasatinib, intolerant of dasatinib and for whom subsequent treatment with imatinib is clinically appropriate
- with the T3151 mutation
To access the regional protocol click here
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- NSCLC: As monotherapy for the treatment of patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer not previously treated with a RET inhibitor. Click here for regional protocol [NHS network connection required]
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- Gastrointestinal Stromal Tumours (GIST): For the treatment of adults patients with unresectable or metastatic gastrointestinal stromal tumours who progressed on or are intolerant to prior treatment with imatinib and sunitinib in accordance with regional protocol click here (NHS network access required).
- Hepatocellular Carcinoma: As monotherapy for adults who have been previously treated with sorafenib click here (NHS network access required).
- Colorectal cancer: Monotherapy for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy click here for protocol [NHS network access required]
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- in combination with an aromatase inhibitor for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer as initial endocrine-based therapy. Protocol can be accessed here (NHS network access required).
- For the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have relapsed on or within 12 months of completing (neo) adjuvant endocrine therapy, or those who progressed on first-line endocrine-based therapy for advanced breast cancer.
Restrictions:
The use as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy is restricted to specialist use in accordance with regional protocol in patients who do not have a BRCA mutation
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- The treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis (regional protocol)
- The treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea (hydroxycarbamide). Click here for regional protocol (NHS network access required)
Prescribing Notes:
The following indications are not recommended by SMC and are non-Formulary:
- treatment of patients aged 12 years and older with acute graft versus host disease who have inadequate response to corticosteroids
- patients aged 12 years and older with chronic graft versus host disease who have inadequate response to corticosteroids
Restrictions:
Restricted to specialist use in accordance with regional protocol:
- Monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib click here for protocol [NHS network access required].
- Monotherapy for the treatment of adults with advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) in treatment-naïve patients who have not previously received a RET-inhibitor or any other systemic treatments for their advanced stage of disease click here for regional protocol [NHS network access required].
Prescribing Notes:
Non-formulary indications:
- Monotherapy for the treatment of adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy is not recommended by SMC.
Restrictions:
For restrictions please see prescribing notes below.
Prescribing Notes:
- The treatment of patients with progressive, locally advanced or metastatic, differentiated thyroid carcinoma, refractory to radioactive iodine is restricted to specialist use in accordance with regional protocol.
Hepatocellular carcinoma:
- Restricted to specialist use for the treatment of patients with advanced hepatocellular carcinoma who have failed or are unsuitable for surgical or loco-regional therapies in accordance with regional protocol.
Restrictions:
Restricted to specialist use in accordance with regional protocol for
- Monotherapy for the treatment of adult patients with KRAS G12C-mutated, locally advanced or metastatic, non-small cell lung cancer (NSCLC), who have progressed on, or are intolerant to platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy.
Restrictions:
Restricted to use in accordance with regional protocol for:
- The treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults is restricted to use in accordance with regional protocol. Click here for regional protocol [NHS network access required]
- As second line treatment of poor or intermediate risk advanced/metastatic renal cell carcinoma in patients who have received nivolumab in combination with ipilimumab as first line treatment (off label indication).
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- Non-Small Cell Lung Cancer (NSCLC): Treatment of advanced NSCLC harbouring mesenchymal-epithelial transition gene (MET) exon 14 (METex14) skipping alterations.
Restrictions:
First-line treatment of adult patients with advanced renal cell carcinoma (RCC) is restricted to specialist use only in accordance with regional protocol click here (NHS network access required).
Restrictions:
Restricted to specialist use only. Restricted to use in the treatment of ovarian and cervical cancer in accordance with regional protocols. Monotherapy for the treatment of adult patients with relapsed small cell lung cancer is restricted to use according to regional protocol, however it should be noted that the IV formulation is non-Formulary for this indication.
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indication:
- Sarcoma: Adults with advanced soft-tissue sarcoma after failure of anthracyclines and ifosamide, or who are unsuited to receive these agents click here for protocol [NHS network access required]
Restrictions:
Restricted to specialist use in accordance with regional protocol in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation after first-line treatment.
Prescribing Notes:
Non-Formulary indications:
- In combination with dabrafenib for the treatment of adults with advanved non-small cell lung cancer with BRAF V600 mutation.
Restrictions:
Restricted to specialist use only for the indications listed in the Prescribing notes below.
Prescribing Notes:
Breast Cancer: click here for regional protocols [NHS network access required]
- Use in the treatment of HER2 positive early breast cancer and metastatic breast cancer is restricted to use in accordance with regional protocol (click here).
- In combination with pertuzumab and chemotherapy in the neoadjuvant treatment of adults with HER2 positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
- In combination with pertuzumab and docetaxel in adults with HER2 positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
- Use in combination with pertuzumab and chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (restricted to use in patients with lymph node-positive disease)
Cancer of the gastro-intestinal tract: click here for regional protocol [NHS network access required]
- Use, in combination with capecitabine or fluorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease, is restricted to patient whose tumours have HER2 overexpression defined by immunohistochemistry (IHC) 3+ ("HER2 high expresser") in accordance with regional protocol.
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- As monotherapy for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received one or more prior anti-HER2-based regimens. Click here for regional protocol [NHS network access required].
- As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (protocol in development).
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- As a single agent for treatment of adults with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients whould have either received prior therapy for locally advanced or metastatic disease, or developed disease recurrance during or within six months of completing adjuvant therapy. Click here for regional protocol.
- As a single agent for the adjuvant treatment of adults with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2 targeted therapy.
Restrictions:
Restricted to specialist use only. Restricted to use in accordance with regional protocols.
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- Treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti vascular endothelial growth factor agents, and anti-epidermal growth factor receptor agents - click here for protocol (NHS network computer or connection required)
- As monotherapy for the third-line treatment of adults with metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction. Click here for protocol (NHS network computer or connection required)
Restrictions:
Restricted to specialist use in accordance with regional protocol for the following indications:
- In combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens.
Restrictions:
Restricted to specialist use for first-line treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma pending regional protocol.
Restrictions:
The following indication is restricted to specialist use in accordance with regional protocols (click here, NHS network access required):
- Use as monotherapy for chronic lymphocytic leukaemia (CLL) either in the presence of 17p deletion or TP53 mutation in adults unsuitable for, or have failed a B-cell receptor pathway inhibitor, or in the absence of 17p deletion or TP53 mutation in adults who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
- Use in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. Protocol under development.
- In combination with obinutuzumab for the treatment of previously untreated chronic lymphocytic leukaemia (CLL) in
- adults without 17p deletion or TP53 mutation who are not fit to receive FCR chemo-immunotherapy
- adults with 17p deletion or TP53 mutation
- In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) in patients without del (17p)/TP53 mutation who are fit to receive fludarabine, cyclophosphamide and rituximab (FCR) chemoimmunotherapy.
- In combination with a hypomethylating agent for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
Prescribing Notes:
Use In combination with low-dose cytarabine for the treatment of adult patients with newly-diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy is not recommended for use in NHS Scotland and remains non-formulary.
Restrictions:
Restricted to specialist use as:
- Monotherapy for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy, is restricted to specialist use in accordance with regional protocol click here [NHS network access required]
- Monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) click here for protocol [NHS network access required]