North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

Search

Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter

Chapter Links...

Cancer Drug Fund List

Northern Cancer Alliance

Northern England Clinical Networks Palliative and End of Life Care Guidelines

Details...

08.03.04.01

Breast cancer

Abemaciclib (Verzenios^®)

Formulary

50mg, 100mg and 150mg tablets

Approved as an options for treating locally advanced or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based therapy in adults in line with NICE

Approved with fulvestrant for treating hormone receptor-positive, HER2 negative advanced breast cancer after endocrine therapy in line with NICE

MHRA Drug Safety Update (June 2021): CDK4/6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼): reports of interstitial lung disease and pneumonitis, including severe cases

NICE TA 563: Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer

NICE TA725: Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy

NICE TA810: Abemaciclib with endocrine therapy for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence

Alpelisib (Piqray^®)

Formulary

50mg, 150mg and 200mg tablets
Approved with fulvestrant for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated, locally advanced or metastatic breast cancer in adults in line with NICE

NICE TA816: Alpelisib with fulvestrant for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer

Anastrozole

Formulary

NICE CG164: Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer

Exemestane

Formulary

Fulvestrant (Faslodex^®)

Formulary

NICE TA239: Fulvestrant for the treatment of locally advanced or metastatic breast cancer

Letrozole

Formulary

Palbociclib (Ibrance^®)

Formulary

75mg, 100mg & 125mg capsules
Approved for use with an aromatase inhibitor for the treatment of previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in line with NICE
Approved with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy in line with NICE

NICE TA495: Palbociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer

NICE TA836: Palbociclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy

MHRA Drug Safety Update (June 2021): CDK4/6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼): reports of interstitial lung disease and pneumonitis, including severe cases

Raloxifene

Formulary

60mg tablets

Ribociclib (Kisqali^®)

Formulary

200mg tablets
Approved for use with an aromatase inhibitor for the treatment of previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in line with NICE and NHS England Commissioning Policy
Approved for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy in line with NICE

NICE TA496: Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer

NICE TA687: Ribociclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy

MHRA Drug Safety Update (June 2021): CDK4/6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼): reports of interstitial lung disease and pneumonitis, including severe cases

Tamoxifen

Formulary

Approved formulations include:
- 10mg and 20mg tablets;
- 10mg in 5ml sugar free oral solution.

NICE CG164: Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer

NICE CG81: Advanced breast cancer: diagnosis and treatment

NICE NG101: Early and locally advanced breast cancer: diagnosis and management

....

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.