North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

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08.01.03

Antimetabolites

Azacitidine

Formulary

Approved for myelodysplastic syndromes, CLL and AML - in line with NICE guidance.

NICE TA218: Azacitidine for myelodysplastic syndromes

NICE TA399: Azacitidine for treating acute myeloid leukaemia with more than 30% bone marrow blasts

NICE TA827: Oral azacitidine for maintenance treatment of acute myeloid leukaemia after induction therapy

Capecitabine

Formulary

Only approved for use in accordance with NICE guidance.

Approved in combination with gemcitabine following surgery for pancreatic cancer in line with NHS England Clinical Commissioning Policy

NICE TA100: Colon cancer (adjuvant) - capecitabine and oxaliplatin

NICE TA191: Gastric cancer (advanced) - capecitabine

NICE TA61: Colorectal cancer - capecitabine and tegafur uracil

NHS England SSC1959 - Clinical Commissioning Policy: Gemcitabine and capecitabine following surgery for pancreatic cancer (all ages)

MHRA Drug Safety Update (Jan 2014): Capecitabine: risk of severe skin reactions - discontinue treatment

MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

Cladribine

Formulary

10mg in 10ml solution for preparing infusions; 2mg in 1ml subcutaneous injection
Approved for Hairy cell leukaemia only.

10mg tablets
Approved for treating highly active multiple sclerosis in adults in line with NICE

MHRA Drug Safety Update (Dec 2017): Cladribine (Litak, Leustat) for leukaemia: reports of progressive multifocal encephalopathy (PML); stop treatment if PML suspected

MHRA Drug Safety Update (Mar 2022): Cladribine (Mavenclad): new advice to minimise risk of serious liver injury

NICE TA616: Cladribine for treating relapsing–remitting multiple sclerosis

Clofarabine (Evoltra^®)

Formulary

Cytarabine

Formulary

A cytarabine 50mg vial - intrathecal injection (cytarabine encapsulated in liposomes) is also approved for use.

Daunorubicin/cytarabine (Vyxeos^®)

Formulary

Daunorubicin 44mg/cytarabine 100mg powder for solution for infusion

Approved for untreated acute myeloid leukaemia in line with NICE

NICE TA 552: Liposomal cytarabine–daunorubicin for untreated acute myeloid leukaemia

MHRA Drug Safety Update (July 2020): Liposomal and lipid- complex formulations: name change to reduce medication errors

Fludarabine Phosphate

Formulary

Approved for the second line therapy of B-cell CLL in line with NICE.
Note: fludarabine is not approved for monotherapy in the first line treatment of CLL - this is in line with NICE.

NICE TA119: Fludarabine monotherapy for the first-line treatment of chronic lymphocytic leukaemia

NICE TA29: Guidance on the use of fludarabine for B-cell chronic lymphocytic leukaemia

Fluorouracil

Formulary

A fluorouracil 10mg in 0.4ml subconjunctival injection (unlicensed) is also approved for use.
FOLFIRINOX is approved for the management of selected patients with inoperable pancreatic cancer in patients with performance status 0-1.

MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

Gemcitabine

Formulary

Approved in combination with paclitaxel for metastatic breast cancer in line with NICE.

NECDAG approved for the second line treatment of women with partially platinum – sensitive, platinum resistant or platinum refractory advanced ovarian cancer (To be used when liposomal doxorubicin [Caelyx] is unavailable).

Approved for pancreatic cancer in line with NICE.

Approved for the treatment of recurrent ovarian cancer in line with NICE.

Approved in combination with capecitabine following surgery for pancreatic cancer in line with NHS England Clinical Commissioning Policy

NICE NG85: Pancreatic cancer in adults: diagnosis and management

NICE TA116: Gemcitabine for the treatment of metastatic breast cancer

NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer

NHS England SSC1959 - Clinical Commissioning Policy: Gemcitabine and capecitabine following surgery for pancreatic cancer (all ages)

Mercaptopurine

Formulary

A mercaptopurine 20mg in 1ml suspension (unlicensed) is also approved for use.
Note: when prescribed for inflammatory bowel disease.

NENC Shared Care Protocol - Azathioprine and mercaptopurine within adult services (non-transplant indications)

Methotrexate

Formulary

Approved formulations:
- Methotrexate 2.5mg tablets
- Methotrexate 10mg in 5ml oral solution. unlicensed
- Methotrexate injections (various strengths) – including prefilled syringes.
- Methotrexate 5mg in 2ml intrathecal injection.

NOTE: when used in chronic inflammatory conditions, e.g. Crohn’s disease, rheumatoid arthritis.
NOTE: Subcutaneous injection for chronic inflammatory conditions in Tees SICBL

MHRA Drug Safety Update (August 2023): Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions

MHRA Drug Safety Update (Sept 2020): Methotrexate once weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing

South Tyneside & Sunderland APC Shared Care Guideline - Methotrexate in Neurology

Nelarabine

(Atriance^®)

Formulary

Pemetrexed

Formulary

Approved for:
- Mesothelioma in line with NICE (funding has to be agreed on an individual patient basis if treatment is not in line with NICE).
- Combination with cisplatin for the first line treatment of locally advanced or metastatic NSCLC (non-squamous cell histology) in line with NICE.
- Maintenance treatment of locally advanced or metastatic NSCLC (non-squamous cell histology) in line with NICE.
- Maintenance treatment of non-squamous non-small lung cancer after pemetrexed and cisplatin in line with NICE and NHS England Commissioning Policy.
Note: pemetrexed is not approved for locally advanced or metastatic NSCLC as per NICE.

NICE TA124: Pemetrexed for the treatment of non-small-cell lung cancer

NICE TA135: Pemetrexed for the treatment of malignant pleural mesothelioma

NICE TA181: Pemetrexed for the first-line treatment of non-small-cell lung cancer

NICE TA190: Pemetrexed for the maintenance treatment of non-small-cell lung cancer

NICE TA402: Pemetrexed maintenance treatment for non-squamous non-small-cell lung cancer after pemetrexed and cisplatin

Raltitrexed (Tomudex^®)

Formulary

Tegafur with Gimeracil and Oteracil

Formulary

MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

Tegafur with Uracil

Formulary

Approved for metastatic colorectal cancer in line with NICE.

NICE TA61: Guidance on the use of capecitabine and tegafur with uracil for metastatic colorectal cancer

MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

Tioguanine

Formulary

50mg in 1ml suspension is also approved.unlicensed

Trifluridine and tipiracil

Formulary

15 mg/6.14 mg, 20 mg/8.19 mg film-coated tablets
Approved for previously treated metastatic colorectal cancer in adults in line with NICE and NHS England Commissioning Policy (SSC1662).
Approved for treating metastatic colorectal cancer in adults who have had 2 lines of treatment in line with NICE

NICE TA 405 - Trifluridine–tipiracil for previously treated metastatic colorectal cancer

NICE TA1008 : Trifluridine–tipiracil with bevacizumab for treating metastatic colorectal cancer after 2 systemic treatments

NICE TA852: Trifluridine–tipiracil for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma after 2 or more treatments

....

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.