Pfizer sales and marketing update

The U.K.’s NICE issued a final appraisal determination (FAD) recommending the use of Bosulif bosutinib from Pfizer to treat chronic, accelerated and blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adults who have been treated with at least one tyrosine kinase inhibitor (TKI) and for whom Gleevec imatinib, Tasigna nilotinib and Sprycel dasatinib are not appropriate -- Bosulif’s approved indication.

The recommendation is the first reappraisal of a drug that was covered by the U.K.’s Cancer Drugs Fund since NICE integrated the fund into its appraisal process. NICE issued a FAD recommending against Bosulif in 2013, and the dual inhibitor of BCR-ABL and Src kinase subsequently was made available by the CDF. NICE began reassessing drugs covered in the fund in April. As part of Bosulif’s reappraisal, Pfizer submitted revised cost-effectiveness analyses that included an additional discount for the drug under a patient access scheme. According to the new FAD, NICE “on balance” found Bosulif a cost-effective use of NHS resources. The recommended dose for Bosulif is 500 mg once daily, which can be increased up to 600 mg based on complete hematologic and cytogenetic response. The annual cost for Bosulif excluding VAT is L44,799 ($60,058). The agency noted the most plausible incremental cost-effectiveness ratio (ICER) for Bosulif was L40,000-L50,000 ($53,625-$67,031); L58,000 ($77,755); and L60,000 ($80,437) per quality-adjusted life year (QALY) gained for chronic, accelerated and blast phase CML, respectively. ...