North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

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Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter

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Cancer Drug Fund List

Northern Cancer Alliance

Northern England Clinical Networks Palliative and End of Life Care Guidelines

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08.02.04

Other immunomodulating drugs

Daclizumab (Zinbryta^®)

Formulary

150mg subcutaneous injection
- Approved for the treatment of highly active relapsing-remitting mutiple sclerosis that has failed to respond to other treatment in adults in line with NICE and NHS England Commissioning Policy.
- Subject to restricted use by EMA

Diroximel fumarate (Vumerity^®)

Formulary

231mg capsules
- Approved for treating relapsing-remitting multiple sclerosis in line with NICE

NICE TA794: Diroximel fumarate for treating relapsing–remitting multiple sclerosis

Osimertinib (Tagrisso)

Formulary

40mg and 80mg tablet
Approved for the treatment of EGFR mutation-positive non-small-cell lung cancer in line with NICE
Approved for treating epidermal growth factor receptor (EGFR) T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults in line with NICE

NICE TA 653: Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer

NICE TA654: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer

NICE TA761 Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection

Ponesimod (Ponvory^®)

Formulary

20mg tablets
- Approved for treating relapsing–remitting multiple sclerosis with active disease defined by clinical or imaging features in adults in line with NICE

NICE TA767: Ponesimod for treating relapsing–remitting multiple sclerosis

Siponimod (Mayzent^®)

Formulary

0.25mg and 2mg tablets
- approved for treating secondary progressive multiple sclerosis in adults in line with NICE

NICE TA656: Siponimod for treating secondary progressive multiple sclerosis

08.02.04

Interferon Alfa

Interferon Alfa-2b
(IntronA)

Formulary

Interferon Alfa-2b (Roferon-A^®)

Formulary

Peginterferon Alfa (Pegasys^®, ViraferonPeg^®)

Formulary

Approved for hepatitis B and C in accordance with NICE guidelines and NHS England Commissioning Policies.

NICE CG165: Hepatitis B (chronic): diagnosis and management

NICE TA106: Hepatitis C - peginterferon alfa & ribavirin

NICE TA200: Hepatitis C - peginterferon alfa & ribavirin

NICE TA300: Hepatitis C - peginterferon alfa

NICE TA75: Hepatitis C - pegylated interferons, ribavirin & alfa interferon

NICE TA96: Hepatitis B - peginterferon alfa

08.02.04

Interferon beta

Interferon Beta (Avonex^®)

Formulary

MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome

NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis

Interferon Beta (Betaferon^®)

Formulary

MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome

NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis

Interferon beta (Extavia^®)

Formulary

MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome

NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis

Interferon Beta (Rebif^®)

Formulary

MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome

NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis

Peginterferon Beta-1a (Plegridy^®)

Formulary

Approved treating relapsing–remitting multiple sclerosis in adults in line with NICE.

NICE TA624: Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis

08.02.04

Interferon gamma

08.02.04

Aldesleukin

08.02.04

BCG bladder instillation

BCG 81mg vial (connaught)
(bladder instillation)

Formulary

08.02.04

Canakinumab

08.02.04

Dimethyl fumarate

Dimethyl fumarate (Tecfidera^®)

Formulary

Approved as a option for treating adults with active relapsing-remitting multiple sclerosis that isn’t highly active or rapidly evolving severe relapsing-remitting multiple sclerosis NICE and NHS England Commissioning Policy.

Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)

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

MHRA Drug Safety Update (March 2015): Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia

NICE TA320: Dimethyl fumarate for multiple sclerosis

08.02.04

Fingolimod

Formulary

Approved for the treatment of highly active relapsing–remitting multiple sclerosis in line with NICE and NHS England Commissioning Policy.

Approved for patients who have progressed on glatiramer acetate and for those patients who are at high risk of progressive multifocal leukoencephalopathy (PML) in line with NHS EnglandClinical Commissioning Policy.

Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)

Letter sent to healthcare professionals (Jan 2016): Fingolimod (Gilenya▼): risks related to effects on the immune system

MHRA Drug Safety Update (Apr 2016): Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections

MHRA Drug Safety Update (Apr 2017): Multiple sclerosis therapies: signal of rebound effect after stopping or switching therapy

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 (Jan 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

NICE TA254: Fingolimod for highly active relapsing remitting multiple sclerosis

08.02.04

Glatiramer acetate

Glatiramer Acetate

Formulary

Approved for treating multiple sclerosis in line with NICE and NHS Engand commissioning policy.

NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis

Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)

08.02.04

Histamine

08.02.04

Lenalidomide, pomalidomide, and thalidomide

Lenalidomide

Formulary

Approved for multiple myeloma in line with NICE - approved for myelodysplastic syndrome with 5q deletion in line with NICE.
Approved in combination with dexamethasone for previously untreated multiple myeloma in line with NICE
Approved in combination with dexamethasone for multiple myeloma after one treatment with bortezomib
Approved for maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma in adults in line with NICE
Approved with rituximab for previously treated follicular lymphoma (grade 1 to 3A) in adults in line with NICE

Letter sent to healthcare professionals (Nov 2016): lenalidomide (Revlimid▼): new advice about viral reactivation

MHRA Drug Safety Update (Feb 2011): Lenalidomide: risk of thrombosis and thromboembolism

MHRA Drug Safety Update (Jan 2013): Lenalidomide (Revlimid): risk of serious hepatic adverse drug reactions

MHRA Drug Safety Update (May 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)

MHRA Drug Safety Update (Nov 2011): Lenalidomide (Revlimid▼): update on risk of second primary malignancy

NICE TA171: Lenalidomide for the treatment of multiple myeloma in people who have received at least 2 prior therapies

NICE TA27: Lenalidomide with rituximab for previously treated follicular lymphoma

NICE TA322: Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality

NICE TA586: Lenalidomide plus dexamethasone for multiple myeloma after 1 treatment with bortezomib

NICE TA587: Lenalidomide plus dexamethasone for previously untreated multiple myeloma

NICE TA680: Lenalidomide maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma

Pomalidomide (Imnovid^®)

Formulary

For the treatment of multiple myeloma previously treated with lenalidomide and bortezomib in line with NICE and NHS Commissioning Policy

NICE TA427: Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib

Thalidomide

Formulary

Approved in combination with an alkylating agent and a corticosteroid for the first-line treatment of multiple myeloma in line with NICE.
Approved for the treatment of bleeding from bowel angiodysplasia in patients with an inherited/acquired bleeding disorder on specialist advice only.
Approved for the treatment of severe epistaxis as a result of hereditary haemorrhagic telangiectasia (HHT) who have failed all other treatments.

Letter sent to healthcare professionals in June 2016: Thalidomide Celgene®: New important advice regarding viral reactivation and pulmonary hypertension

MHRA Drug Safety Update (December 2015): Thalidomide: reduced starting dose in patients older than age 75 years

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 (May 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)

NICE TA228: Bortezomib and thalidomide for the first‑line treatment of multiple myeloma

08.02.04

Mifamurtide

Formulary

Approved for high-grade resectable non-metastatic osteosarcoma in line with NICE.

NICE TA235: Osteosarcoma - mifamurtide: guidance

08.02.04

Natalizumab

Formulary

Approved for rapidly evolving severe relapsing remitting multiple sclerosis in line with NICE and NHS England commissioning policy.

Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)

MHRA Drug Safety Update (Apr 2016): Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy— updated advice to support early detection

MHRA Drug Safety Update (May 2011): Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy is increased in patients who have had previous immunosuppressant treatment

NICE TA127: Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis

08.02.04

Teriflunomide

Formulary

Approved as a option for treating adults with active relapsing-remitting multiple sclerosis that isn’t highly active or rapidly evolving severe relapsing-remitting multiple sclerosis NICE and NHS England Commissioning Policy.

Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)

NICE TA303: Teriflunomide for treating relapsing–remitting multiple sclerosis

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Key

	Restricted Drug
	Unlicensed
	Link to adult BNF
	Link to children's BNF
	Link to SPCs
	Cytotoxic Drug
	Controlled Drug

	High Cost Medicine
	NHS England
	Homecare
	ICB
	Low carbon footprint
	Medium carbon footprint
	High carbon footprint

Status	Description
	Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.
	Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic. The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible. SCGs are available or are being developed for most of the drugs listed as AMBER.
	Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria. These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary. In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary. If the drug requires urgent initiation, it is expected that the specialist undertakes the initial prescribing responsibility for an appropriate period of time, usually a minimum of 28 days. A GREEN+ drug can only be recommended to primary care for initiation if does not need to be initiated within 28 days.
	Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible.
	UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.
	Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care.