8 Malignant disease and immunosuppression

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/204225.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/202611.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4702.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4684.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4689.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/211004.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4691.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4693.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4697.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4699.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4678.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4680.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4682.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4711.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4714.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4719.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4721.htm

Restrictions:

Restricted to specialist use only in accordance with regional protocols.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4707.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4709.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4711.htm

Restrictions: Restricted to specialist use only. Restricted to use for treatment of CLL in accordance with regional protocol.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/27475.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4731.htm

Restrictions:

Restricted to specialist use only. Restricted to use only for bladder, pancreatic or lung cancer in accordance with regional protocols.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/37649.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4735.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4737.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/200049.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4740.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/202606.htm#_202606

Restrictions:

Restricted to use in accordance with regional protocols.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/106025.htm

Restrictions:

Restricted to specialist use only. Restricted to use in accordance with regional protocols.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/36783.htm

Restrictions: Restricted to specialist use only.

Prescribing Notes:

Excludes liposomal formulations.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4726.htm

Prescribing Notes:

The following indications are formulary but use is restricted to specialists and according to regional protocols:

• Restricted to specialist use for the 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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/129178.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/PHP18405-teysuno.htm?q=teysuno&t=search&ss=text&p=1#PHP18405-teysuno

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4756.htm

Restrictions: Restricted to specialist use only. Restricted to use in accordance with regional protocols.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/65135.htm

Restrictions: Restricted to specialist use only.

Prescribing Notes:

Excludes Etopophos®

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4748.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4750.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4753.htm

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

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/129183.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/11766.htm

Restrictions: Restricted to specialist use only.

Prescribing Notes:

Alternative name: asparaginase

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/11770.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/11773.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/39251.htm

Restrictions: Restricted to specialist use only. Excludes Siklos® which is not recommended for use by the SMC.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/11776.htm

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)

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/106029.htm

Restrictions: Restricted to specialist use only. Restricted to use in the treatment of colorectal cancer in accordance with regional protocol.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/60755.htm

Restrictions: Restricted to specialist use only. Restricted to use in accordance with regional protocols.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/81882.htm

Restrictions: Restricted to specialist use in accordance with regional protocol for chronic myelogenous leukaemia (CML).

Prescribing Notes:

The regional protocol for the use of nilotinib in CML is available here

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/200921.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/21851.htm

Restrictions: Restricted to use by specialists in haematological oncology for patients with hairy cell leukaemia.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/11781.htm

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/11787.htm

Restrictions: Restricted to use in accordance with regional protocol. 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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/129971.htm

Restrictions: Specialist use only in accordance with regional protocol.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/77218.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/60767.htm

Restrictions: Restricted to specialist use only. Restricted to use in accordance with regional protocols.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/65167.htm

Restrictions: This is an orphan product and restricted to specialist initiation.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/106417.htm

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

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/208714.htm

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

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/129403.htm

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.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/PHP34301-afatinib.htm?q=afatinib&t=search&ss=text&p=1#_hit

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

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/PHP33788-aflibercept.htm?q=aflibercept&t=search&ss=text&p=2#_hit

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/11754.htm

Restrictions:

Restricted to specialist use in accordance with regional protocols.

Restrictions:

Use as monotherapy for the treatment of adults with metastatic Merkel cell carcinoma (MCC) is restricted to specialist use in accordance with regional protocol.

Restrictions: Restricted to specialist use in accordance with regional protocol.

Prescribing Notes:

The Regional Protocol can be accessed here (NHS network access required)

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/PHP18848-axitinib.htm

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).

Prescribing Notes:

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP5437-avastin.htm?q=bevacizumab&t=search&ss=text&p=3#PHP5437-avastin

Restrictions: Restricted to specialist use for the treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL) in accordance with regional protocol (in development).

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

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/128313.htm

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.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP33921-bosulif.htm#PHP33921-bosulif

Restrictions:

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 (see link below).

Prescribing Notes:

• For the reginal protocol for patients  relapsed or refractory CD30+ Hodgkin lymphoma (HL)  click here
• Use in patients with relapsed or refractory systemic anaplastic large cell lymphoma remains non-Formulary.
• Treatment of adults with CD30+ Hodgkin lymphoma at increased risk of relapse or progession following autologous stem cell trasplant is not recommended by SMC and remains non-Formulary
• Treatment of adults with CD30+ cutaneous T-cell lymphoma after at least one prior systemic therapy is not recommended by SMC and is non-Formulary

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP18904-adcetris.htm?q=adcetris&t=search&ss=text&p=1#PHP18904-adcetris

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.

Restrictions:

Restricted to specialist use in accordance with regional protocol - click here.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP93594-cabozantinib.htm?q=cabozantinib&t=search&ss=text&tot=3&p=1#_hit

Restrictions: Restricted to specialist use only.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/11760.htm

Restrictions:

Use in combination with dexamethason for the treatment of adults with multiple myeloma who have received at least one prior therapy is restricted to specialist use in accordance with regional protocol - click here for protocol.

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:

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)

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/PHP18995-crizotinib.htm?q=crizotinib&t=search&ss=text&p=1#_hit

Restrictions:

Please see prescribing notes.

Prescribing Notes:

Restricted to specialist use in accordance with regional protocol (click here) for use in patients with unresectable or metastatic BRAF V600 mutation-positive metastatic melanoma who have received no prior therapy.

Non-Formulary indications:

• In combination with trametinib for the treatment of adults with advanved non-small cell lung cancer with BRAF V600 mutation.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP34376-dabrafenib.htm?q=dabrafenib&t=search&ss=text&p=1#_hit

Restrictions:

Multiple Myeloma: Use as monotherapy for the treatment of adults with relapsed and refractory mutiple myeloma is restricted to specialist use in accordance with regional protocol as a fourth-line treatment option.

Restrictions: See Prescribing Notes for further details.

Prescribing Notes:

Formulary indications:

• 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.

Restrictions: Restricted to use specialist use in accordance with regional protocol (see Prescribing Notes below for link to protocol)

Prescribing Notes:

Locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimen for advanced disease- please click here for 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

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP5531-everolimus.htm?q=everolimus&t=search&ss=text&p=1#_hit

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.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP5534-gefitinib.htm?q=gefitinib&t=search&ss=text&p=1#_hit

Restrictions:

Restricted to specialist use in accordance with regional protocols for the following indications:

• First line treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy in concordance with regional protocol click here
• 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 concordance with regional protocol click here
• Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) in concordance with regional protocol click here

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)

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.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP34935-idelalisib.htm?q=IDELalisib&t=search&ss=text&p=1#_hit

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

Restrictions: Restricted to specialist use in adult patients with advanced (unresectable or metastatic) melanoma as first-line therapy and in adults who have received prior therapy.

Prescribing Notes:

The Regional Protocol can be accessed here (NHS network access required)

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/PHP5476-yervoy.htm?q=ipilimumab&t=search&ss=text&p=3#PHP5476-yervoy

Restrictions: Restricted to specialist use only in accordance with regional protocol (see link in Prescribing Notes below).

Prescribing Notes:

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

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.

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: 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 relevant regional protocols 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.
• 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. 
• Renal Cell Carcinoma: Monotherapy for the treatment of advanced renal cell carcinoma after prior therapy in adults. Click here for regional protocols.
• Hodgkin Lymphoma: Treatment of adults with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Click here for regional protocols.
• Squamous Cell Cancer of Head and Neck: Monotherapy for adults progressing on or after platinum-based therapy is subject to a two-year stopping rule. Click here for regional protocols.

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)

Restrictions: Restricted to specialist use in accordance with regional protocol (in development) as 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.

Restrictions:

Use in combination with doxorubicin as a first-line treatment for advanced soft-tissue sarcoma that is not amenable to curative treatment with surgery or radiotherapy is restricted to specialist use in accordance with regional protocol.

Prescribing Notes:

Click here for regional protocol for treatment of soft-tissue sarcoma

Restrictions: Treatment of adult patients with locally advanced or metastatic epidermal groth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC) is restricted to specialist use in accordance with regional protocol (in development) in patients who have received previous treatment with an EGFR tyrosine kinase inhibitor.

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.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP5564-abraxane.htm?q=paclitaxel&t=search&ss=text&p=3#PHP5564-abraxane

Restrictions:

Restricted to specialist use in accordance with regional protocol in combination with an aromatase inhibitor for first-line treatment of HR-positive HER2-negative locally advanced or metastatic breast cancer.

Prescribing Notes:

Click here for regional protocol 

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 

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP5481-panitumumab.htm?q=PANITUmumab&t=search&ss=text&tot=7&p=1#_hit

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: Monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults previously untreated with ipilimumab- click here for protocol.
• NSCLC:
  • 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 - click here for protocol
  • 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 (subject to a two-year clinical stopping rule) - click here for protocol
• Urothelial Carcinoma: 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)
• Classical Hodgkin Lymphoma: 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).

Prescribing Notes:

Not recommended by SMC:

• Monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults previously treated with ipilimumab remains non-formulary.

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:

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP33907-ponatinib.htm?q=ponatinib&t=search&ss=text&p=1#_hit

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.
• Hepatocellular Carcinoma: As monotherapy for adults who have been previously treated with sorafenib

Prescribing Notes:

Non-Formulary indications:

• Metastatic colorectal cancer (CRC) in adult patients who have been previously treated with, or are not considered candidates for, available therapies.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP34180-stivarga.htm#PHP34180-stivarga

Restrictions:

Restricted to specialist use in accordance with regional protocol 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.

Restrictions: For restrictions see prescribing notes below.

Prescribing Notes:

Restricted to specialist use in accordance with regional protocol for 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.

Non-formulary indication:

Treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP18721-jakavi.htm#PHP18721-jakavi

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.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP5545-nexavar.htm?q=sorafenib&t=search&ss=text&p=2#PHP5545-nexavar

Restrictions:

In combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation is restricted to specialist use and as 1st line treatment option in accordance with regional protocol (in development).

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:

• Use in the treatment of HER2 postive early breast cancer and metastatic breast cancer is restricted to use in accordance with regional protocol (click here).
• 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 (click here).

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/88513.htm

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.

Restrictions:

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 is restricted to specialist use in accordance with regional protocol - click here for protocol

Restrictions: Restricted to specialist use for first-line treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma pending regional protocol.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/PHP17983-vemurafenib.htm

Restrictions:

• Use as monotherapy for chronic lymphocyctic 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. Click here for regional protocol.