2 Information about acalabrutinib

Marketing authorisation indication

2.1 Acalabrutinib (Calquence, AstraZeneca) is indicated:

as monotherapy or in combination with obinutuzumab for the 'treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)', and
as monotherapy for the 'treatment of adult patients with CLL who have received at least one prior therapy.'

The company did not submit evidence to support reimbursement for acalabrutinib in combination with obinutuzumab. It also did not provide evidence for adults with previously untreated CLL that is suitable for fludarabine, cyclophosphamide and rituximab (FCR) or bendamustine plus rituximab (BR) therapy (see section 3.5).

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics.

Price

2.3 A 30-day pack of acalabrutinib 100-mg tablets costs £5,059. The company has a commercial arrangement (simple discount patient access scheme). This makes acalabrutinib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.