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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08.03.04.02

Prostate cancer and gonadorelin analogues

Radium-223 dichloride
(Xofigo^®)

Formulary

Provided by radiotherapy department in accordance with NICE

NICE TA412: Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases

MHRA Drug Safety Update (December 2017): Radium-223 dichloride (Xofigo▼): do not use in combination with abiraterone and prednisone/prednisolone, following clinical trial signal of increased risk of death and fractures

NICE NG131: Prostate cancer: diagnosis and management

08.03.04.02

Gonadorelin analogues

Clinicians are encouraged to prescribe the least expensive product that is clinically appropriate.

Goserelin

First Choice

Approved formulations include 3.6mg and 10.8mg implants.

Leuprorelin Acetate

First Choice

Approved formulations include leuprorelin 3.75mg & 11.25mg prefilled syringes.

Triptorelin

First Choice

Approved formulations include triptorelin 3mg, 11.25mg and 22.5mg IM injection for the treatment of prostate cancer

Please note for the treatment of precocious puberty please refer to Chapter 6 Drugs affecting gonadotrophins

Degarelix

First Choice

Approved formulations include 80mg and 120mg vials (with diluent).
Approved for the first line treatment of advanced hormone dependant prostate cancer with a PSA > 20ng/l at presentation
- -approved as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases in line with NICE.

NICE TA404: Degarelix for treating advanced hormone-dependent prostate cancer

Buserelin
(Prostate)

Alternatives

Approved formulations include:
- 5mg in 5ml injection;
- 150 microgram metered dose nasal spray.

08.03.04.02

Anti-androgens

Abiraterone

Formulary

Approved for castration-resistant metastatic prostate cancer in line with NICE.
Approved for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated in line with NICE and NHS England Commissioning Policy.

NICE TA259: Abiraterone for castration resistant prostate cancer

NICE TA387:Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated

Apalutamide (Erleada^®)

Formulary

60mg tablets
Approved for treating hormone‑relapsed non‑metastatic prostate cancer that is at high risk of metastasising in adults in line with NICE
Approved for treating hormone-sensitive metastatic prostate cancer in adults in line with NICE, only if:
- docetaxel is not suitable

NICE TA740: Apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer

NICE TA741: Apalutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer

Bicalutamide

Formulary

Initiate with specialist advice.

Cyproterone

Formulary

Darolutamide (Nubeqa^®)

Formulary

300mg tablets
Approved for treating hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease in line with NICE
Approved with andorgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer in line with NICE and NHSE Specialised Commissioning guidance

NICE TA660: Darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer

NICE TA903: Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer

Enzalutamide

Formulary

Approved for use in adults with metastatic hormone-relapsed prostate cancer, who have not had chemotherapy in line with NICE.
Approved for treating hormone-sensitive metastatic prostate cancer in line with NICE

NICE TA316: Enzalutamide for prostate cancer

NICE TA377: Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated

NICE TA712: Enzalutamide for treating hormone-sensitive metastatic prostate cancer

Flutamide
(UNDER REVIEW)

Formulary

08.03.04.02

Radiopharmaceuticals

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Key

	Notes
	Section Title (top level)
	Section Title (sub level)
	First Choice item
	Non Formulary section
	Restricted Drug
	Unlicensed
	Display tracking information
	Link to adult BNF
	Link to children's BNF
	Link to SPCs

	Cytotoxic Drug
	Controlled Drug
	High Cost Medicine
	NHS England
	Homecare
	CCG

Traffic Light Status Information

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. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.
	Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.
	Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.
	NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.
	UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.
	NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.