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

Description of the technology

Palbociclib (Ibrance, Pfizer) is a selective, small-molecule inhibitor of cyclin-dependent kinases 4 and 6, which prevents DNA synthesis by stopping cell cycle progression from the G1 to S phase.

Marketing authorisation

Palbociclib is indicated for treating 'hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:

In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone agonist'.

This appraisal only considers the use of palbociclib in combination with an aromatase inhibitor.

Adverse reactions

The most common (20% or more) adverse reactions of any grade reported in patients having palbociclib in randomised clinical studies were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anaemia, alopecia and diarrhoea. The most common (2% or more) adverse reactions of grade 3 or over to palbociclib were neutropenia, leukopenia, anaemia, fatigue and infections. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

The recommended dose is 125 mg of palbociclib, taken orally, once daily for 21 consecutive days followed by 7 days off treatment (schedule 3/1) to make up a complete cycle of 28 days. Treatment with palbociclib should be continued as long as the patient is having a clinical benefit from therapy or until unacceptable toxicity occurs. Some adverse reactions may need to be managed by temporary dose interruptions or delays, dose reductions, or permanently stopping the treatment. For full details of dose reduction schedules, see the summary of product characteristics.

Price

£2,950 for a 21‑capsule pack of 125‑mg capsules (excluding VAT; MIMS online, accessed January 2017).

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of palbociclib, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.