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NICE Recommends Pfizer's Talzenna for BRCA-Mutant, HER2-Negative Breast Cancer After Discount

NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Friday reversed a prior decision and recommended Pfizer's Talzenna PARP inhibitor (talazoparib) for the treatment of advanced or metastatic BRCA1/2-mutated, HER2-negative breast cancer.

The regulator initially declined to recommend Talzenna in July due to the cost of the drug. In a draft guidance from July, NICE concluded that the cost-effectiveness estimates for Talzenna in this indication were above what it considers an acceptable use of National Health Service (NHS) resources. The cost of the drug was £4,965 ($6,296) for a 30 pack of 1 mg capsules and £1,655 ($2,098) for a 30 pack of 0.25 mg capsules.

However, Pfizer has since offered an increased discount to the NHS on the price of Talzenna, which was not disclosed. With the discount, NICE concluded in a final draft guidance released on Friday that Talzenna's cost-effectiveness estimates did fall within an acceptable range.

NICE is recommending the drug for patients who have had prior lines of treatment with an anthracycline, or a taxane, or both, and with endocrine therapy, if appropriate. The regulator noted that Talzenna would replace chemotherapy in this indication and the approval would benefit about 300 patients per year.

The recommendation was based on results from the Phase III EMBRACA trial, which evaluated Talzenna against physician's choice of treatment. Talzenna demonstrated improvement in progression-free survival in the study, but overall survival was similar between the two arms. The median progression-free survival was 8.6 months with Talzenna and 5.6 months with the physician's choice treatment. NICE noted in its guidance that there was uncertainty in the overall survival and certain subgroup analyses.

"Although some uncertainty in the clinical evidence remains, when considering the impact of advanced breast cancer and its effect on quality and length of life, the improved discount from the company means we can now recommend talazoparib for use in the NHS," Helen Knight, director of medicines evaluation at NICE, said in a statement.