Alpelisib in combination with fulvestrant [ALP1]
For treatment of hormone receptor- positive, HER2-negative, locally advanced or metastatic breast cancer in patients previously treated with a CDK4/6 inhibitor and an aromatase inhibitor where the following criteria have been met:
- This application for alpelisib in combination with fulvestrant is being made by and the first cycle of alpelisib plus fulvestrant will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti- cancer therapy.
- The patient has histologically or cytologically documented hormone receptor positive and HER-2 negative breast cancer.
- The patient’s breast cancer has a PIK3CA mutation identified in a tumour or plasma specimen using a validated test. Note: patients with an AKT1 or PTEN genomic alteration but without a PIK3CA genomic alteration are not eligible for alpelisib plus fulvestrant.
- The patient has metastatic or locally advanced breast cancer which is not amenable to curative treatment.
- The patient is male or female and if female is either post-menopausal or if pre- or peri-menopausal has undergone ovarian ablation or suppression with LHRH agonist treatment.
- The patient has progressive disease after previous endocrine-based therapy.
- The patient has been previously treated with an aromatase inhibitor. Please record in which places in the treatment pathway the patient had aromatase inhibitor therapy:
- solely for early breast cancer or
- solely for locally advanced/metastatic breast cancer or
- in both early and advanced breast cancer settings
- The patient has been previously treated with a CDK4/6 inhibitor. Please record in which places in the treatment pathway the patient had CDK4/6 inhibitor therapy:
- solely for early breast cancer or
- solely for locally advanced/metastatic breast cancer or
- in both early and advanced breast cancer settings Note: the company submitted a case to NICE for consideration of clinical and cost effectiveness only in patients previously treated with a CDK4/6 inhibitor. This population is narrower than that in the marketing authorisation.
- The patient has had no prior treatment with fulvestrant for any indication unless this patient is switching from treatment with capivasertib plus fulvestrant due to toxicity (see criterion 10 below). Note: the marketing authorisation of alpelisib states that the efficacy of alpelisib in combination with fulvestrant is not considered to be established in patients previously treated with fulvestrant.
- The patient has not previously received any treatment with a PIK3CA-targeted drug (such as capivasertib) unless this patient has received previous treatment with capivasertib plus fulvestrant but such treatment with capivasertib plus fulvestrant has had to be stopped within 6 months of its start solely as a consequence of excessive toxicity and in the clear absence of disease progression and if all other treatment criteria on this form apply. Please record which scenario applies to this patient:
- the patient has not previously received any treatment with a PIK3CA-targeted drug or
- the patient has received previous treatment with capivasertib plus fulvestrant but such treatment with capivasertib plus fulvestrant has had to be stopped within 6 months of its start solely as a consequence of excessive toxicity and in the clear absence of disease progression and all other treatment criteria on this form apply
- The patient has an ECOG performance status of 0 or 1.
- Alpelisib will only be given in combination with fulvestrant.
- Treatment with alpelisib will continue until there is progressive disease or excessive toxicity or until the patient chooses to discontinue treatment, whichever is the sooner.
- Because the absorption of alpelisib is affected by food, the patients will be advised to take alpelisib immediately after food and at approximately the same time each day.
- The prescribing clinician is aware of the potentially serious side-effects of alpelisib (e.g. hyperglycaemia, cutaneous reactions, diarrhoea, and pneumonitis) and of the necessary alpelisib dose adjustments for these toxicities, as outlined in alpelisib’s Summary of Product Characteristics.
- The prescribing clinician is aware that patients with a diagnosis of diabetes mellitus require a treatment consultation with a diabetic specialist or a healthcare professional experienced in the management of hyperglycaemia prior to the start of treatment with alpelisib.
- Should the patient develop hyperglycaemia, a consultation with a healthcare professional experienced in the management of hyperglycaemia should be considered for all non-diabetic patients and is recommended for those patients who are any of the following: pre-diabetic or in those with a fasting blood glucose level >250mg/dL or >13.9 mmol/L or those have a BMI ≥30 or those of age ≥75 years.
- The prescribing clinician is aware of the potential drug interactions between alpelisib and human Breast Cancer Resistance protein (BCRP) inhibitors and various cytochrome P450 enzyme systems, as outlined in alpelisib’s Summary of Product Characteristics.
- When a treatment break of up to 6 weeks beyond the expected 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment, including as appropriate if the patient had an extended break on account of Covid-19.
- Alpelisib and fulvestrant will be otherwise used as set out in their respective Summaries of Product Characteristics (SPCs).
NHS funded From: 08 November 2022
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 13 May 2025 at 19:45.
If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.