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Bedfordshire and Luton Joint Formulary
Bedfordshire Hospitals NHS Foundation Trust
Bedfordshire, Luton and Milton Keynes ICB
Formulary Chapter: 8 - Malignant disease and immunosuppression 
Notes:

Any drug not listed on the Formulary should be considered Non-Formulary - Not recommended for prescribing
08.02.04 Other immunomodulating drugs

Dimethyl fumarate 120mg & 240mg (Tecfidera®)
(Capsules)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Approved in line with NICE TA320 for relapsing-remitting multiple sclerosis.

Must not be prescribed on FP10 prescriptions

BNF BNFc SPC
MHRA Drug Safety Update (April 2016) - Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy MHRA Drug Safety Update (January 2021): Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia NICE TA320: Dimethyl fumarate for treating relapsing‑remitting multiple sclerosis

Diroximel fumarate (Vumerity®)
(231 mg gastro-resistant hard capsules)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

For use in accordance with the following NICE TA:

BNF BNFc SPC
NICE TA794 Diroximel fumarate for treating relapsing–remitting multiple sclerosis

Fingolimod 500microgram
(Capsules)

RED
Restricted Drug Restricted
FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Approved in-line with NICE TA254.
BNF BNFc SPC
NICE TA254: Fingolimod for highly active relapsing remitting multiple sclerosis MHRA Drug Safety Update (January 2013) - Fingolimod (Gilenya▼): bradycardia and heart block MHRA Drug Safety Update (April 2016) - Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections MHRA Drug Safety Update (Dec 2017): Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk MHRA Drug Safety Update (Dec 2017): Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections MHRA Drug Safety Update (January 2021): Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis MHRA Drug Safety Update (Sept 2019): Fingolimod (Gilenya¥): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception

Isatuximab (SARCLISA®)
(20mg/mL concentrate for solution for infusion)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING - Blueteq or high cost drug form required - see link from formulary homepage.

For use in accordance with the following NICE TA(s) only (via Cancer Drugs Fund):-

BNF BNFc SPC
NICE TA658: Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma NICE TA1098: Isatuximab in combination for untreated multiple myeloma when a stem cell transplant is unsuitable

Lenalidomide ( )

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

5mg, 10mg, 15mg & 25mg Capsules

Approved for specialist prescribing in accordance with NICE TA's below. 


BNF BNFc SPC BlueTeq
MHRA Drug Safety Update (February 2011) - Lenalidomide: risk of thrombosis and thromboembolism MHRA Drug Safety Update (May 2013) - Thalidomide: risk of second primary malignancies MHRA Drug Safety Update: Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19) (April 2020) NICE TA171: Multiple myeloma - lenalidomide NICE TA322: Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality NICE TA505: Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma (superseded by NICE TA870) NICE TA586: Lenalidomide plus dexamethasone for multiple myeloma after 1 treatment with bortezomib NICE TA587: Lenalidomide plus dexamethasone for previously untreated multiple myeloma NICE TA627: Lenalidomide with rituximab for previously treated follicular lymphoma NICE TA680: Lenalidomide maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma NICE TA695: Carfilzomib with dexamethasone and lenalidomide for previously treated multiple myeloma NICE TA870: Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma NICE TA883: Tafasitamab with lenalidomide for treating relapsed or refractory diffuse large B-cell lymphoma (not recommended) NICE TA917: Daratumumab with lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is unsuitable NICE TA1098: Isatuximab in combination for untreated multiple myeloma when a stem cell transplant is unsuitable

Mogamulizumab (Poteligeo ®)
(4 mg/mL concentrate for solution for infusion.)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING - Blueteq or High cost drug form required - see link from Formulary homepage.

For use in accordance with the following NICE TA(s):

BNF BNFc SPC
NICE TA 754 Mogamulizumab for previously treated mycosis fungoides and Sézary syndrome

Nivolumab (Opdivo®)
(10mg/1mL concentrate for solution for infusion)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Restricted - prescribing by Consultant Oncologists in accordance with NICE TAs below.

BNF BNFc SPC
MHRA Drug Safety Update (October 2019): Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation MHRA Drug Safety Update (July 2017) -Nivolumab (Opdivo▼), pembrolizumab (Keytruda▼): reports of organ transplant rejection NICE TA384: Nivolumab for treating advanced (unresectable or metastatic) melanoma NICE TA400: Nivolumab in combination with ipilimumab for treating advanced melanoma NICE TA417: Nivolumab for previously treated advanced renal cell carcinoma NICE TA462:Nivolumab for treating relapsed or refractory classical Hodgkin lymphoma NICE TA483: Nivolumab for previously treated squamous non-small-cell lung cancer NICE TA484: Nivolumab for previously treated non-squamous non-small-cell lung cancer NICE TA490:Nivolumab for treating squamous cell carcinoma of the head and neck after platinum-based chemotherapy NICE TA558: Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease NICE TA581: Nivolumab with ipilimumab for untreated advanced renal cell carcinoma NICE TA655: Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy NICE TA684: Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease NICE TA707: Nivolumab for previously treated unresectable advanced or recurrent oesophageal cancer NICE TA713 Nivolumab for advanced non-squamous non-small-cell lung cancer after chemotherapy NICE TA724: Nivolumab with ipilimumab and chemotherapy for untreated metastatic non-small-cell lung cancer NICE TA736: Nivolumab for treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy NICE TA746: Nivolumab for adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer NICE TA780: Nivolumab with ipilimumab for untreated advanced renal cell carcinoma NICE TA817: Nivolumab for adjuvant treatment of invasive urothelial cancer at high risk of recurrence NICE TA818: Nivolumab with ipilimumab for untreated unresectable malignant pleural mesothelioma NICE TA857: Nivolumab with platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric, gastro-oesophageal junction or oesophageal adenocarcinoma NICE TA865: Nivolumab with fluoropyrimidine- and platinum-based chemotherapy for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma NICE TA876: Nivolumab with chemotherapy for neoadjuvant treatment of resectable non-small-cell lung cancer NICE TA964: Cabozantinib with nivolumab for untreated advanced renal cell carcinoma NICE TA980: Nivolumab for adjuvant treatment of completely resected melanoma at high risk of recurrence in people 12 years and over (TERMINATED APPRAISAL) NICE TA1065: Nivolumab plus ipilimumab for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency

Nivolumab / Relatlimab (Opdualag®)
(240 mg/80 mg concentrate for solution for infusion)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

For use in accordance with the following NICE TA(s):

BNF BNFc SPC
NICE TA950: Nivolumab–relatlimab for untreated unresectable or metastatic melanoma in people 12 years and over

Ocrelizumab (Ocrevus®)
(Infusion)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage. Restricted - prescribing by Consultant Neurologists and clinical nurse specialists (MS) according to the following NICE TAs.

BNF BNFc SPC
NICE TA533: Ocrelizumab for treating relapsing–remitting multiple sclerosis NICE TA585 Ocrelizumab for treating primary progressive multiple sclerosis

Pomalidomide (Imnovid®)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

For specialist prescribing in line with the following NICE TAs only (NB NICE TA 658 - via Cancer Drugs Fund).

BNF BNFc SPC
MHRA Drug Safety Update (May 2016) - Pomalidomide (Imnovid▼): risk of hepatitis B reactivation MHRA Drug Safety Update: Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19) (April 2020) NICE TA 658 Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma NICE TA427: Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib

Ponesimod (Ponvory®)
(20 mg tablets)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING -Blueteq or high cost drug form required - see link from formulary homepage.

For use in accordance with the following NICE TA(s):

BNF BNFc SPC BlueTeq
NICE TA 767 Ponesimod for treating relapsing–remitting multiple sclerosis

Siponimod (Mayzent®)
(0.25mg and 2 mg film-coated tablets)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING - Blueteq or high cost drug form required - see link from formulary homepage.

For use in accordance with the following NICE TAs only:-

BNF BNFc SPC
NICE TA 656 Siponimod for treating secondary progressive multiple sclerosis

Teriflunomide (Aubagio®)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

14mg Film Coated Tablets

For specialist prescribing in-line with NICE TA303

BNF BNFc SPC
NICE TA303: Teriflunomide for relapsing remitting MS

Thalidomide (Pharmion®)

RED
Restricted Drug Restricted

50mg Capsules

NOTE: Patient, prescriber and supplying pharmacy must comply with a pregnancy prevention programme. Every prescription must be accompanied by a complete Prescription Authorisation Form.
1. Restricted -to prescribing by Oncologists only.
2. Restricted - prescribing by Haematologists only in accordance with NICE TA 228. Blueteq or high cost drug form required.

BNF BNFc SPC
MHRA Drug Safety Update (July 2011) - Thalidomide: risk of arterial and venous thromboembolism MHRA Drug Safety Update (May 2013) - Thalidomide: risk of second primary malignancies MHRA Drug Safety Update: Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19) (April 2020) NICE TA 228: Bortezomib and thalidomide for the first-line treatment of multiple myeloma

Ublituximab (Briumvi®)
(150 mg concentrate for solution for infusion)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

For use in accordance with the following NICE TA:

BNF BNFc SPC
NICE TA1025: Ublituximab for treating relapsing multiple sclerosis

Avacopan (Tavneos®)
(10mg capsules)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING - Blueteq or high cost drug form required

Commissioned by NHSE in line with NICE TA825.

For use in accordance with NICE guidance access will be via referral to tertiary centre

 

BNF BNFc SPC BlueTeq
NICE TA825: Avacopan for treating severe active granulomatosis with polyangiitis or microscopic polyangiitis
08.02.04 Interferon Alfa
08.02.04 Interferon beta
08.02.04 Aldesleukin
08.02.04 Glatiramer acetate
08.02.04 Natalizumab
Classifications
GREEN
May be initiated in any care setting
Amber SPA
Specialist to advise therapy and provide first 28 days supply, continuation in Primary Care
Amber SPIS
Specialist to initiate and stabilise medicine prior to continuation in Primary Care
SCG
To be prescribed as per Shared Care Guidance. If no SCG in place status reverts to red.
RED
Red medicines are designated as specialist only medicines which should only be prescribed by a specialist, usually within secondary care (either due to the requirement for specialist knowledge, long-term monitoring requirements, or restrictions that mean medicine supplies are only available to hospitals).
DNP
A decision has been made either locally and/or nationally not to routinely commission this preparation. Do not prescribe.
SELF
To be purchased over the counter. May be prescribed for chronic, long term conditions or on admission to hospital if essential.