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NICE Recommends Pfizer's Ibrance Combination for HER2-Negative Breast Cancer

NEW YORK – The National Institute for Health and Care Excellence in a final draft guidance on Friday recommended Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) with fulvestrant for routine use in patients with hormone receptor-positive, HER2-negative breast cancer who have already had hormone therapy.

NICE specified in its guidance that it is recommending the National Health Service England provide Ibrance-fulvestrant when the combination of Novartis' Afinitor (everolimus) and exemestane is the most appropriate alternative to a CDK4/6 inhibitor. Approximately 2,400 advanced breast cancer patients in England who have had endocrine treatment will be eligible for this treatment once the decision is final.

NHS England has provided Ibrance through the Cancer Drugs Fund since 2020. Data collected while the drug was available to patients through the CDF and within the PALOMA-3 trial showed that Ibrance-fulvestrant extended median overall survival by 6.8 months compared to placebo-fulvestrant, 34.8 months versus 28 months, respectively.

NICE also reviewed data on Ibrance-fulvestrant from PALOMA-3 against data from pivotal studies of two other CDK4/6 inhibitors, Eli Lilly's Verzenio (abemaciclib) and Novartis' Kisqali (ribociclib), in combination with fulvestrant, and determined that these three drug regimens are likely to provide similar health benefits for breast cancer patients.

NICE further concluded that the three regimens would have similar costs but still recommended that doctors consider factors that can increase healthcare spending. "If patients and their clinicians consider palbociclib plus fulvestrant and abemaciclib plus fulvestrant or ribociclib plus fulvestrant to be suitable options, use the least expensive treatment," NICE said in the guidance. "Take account of the monitoring and adverse event costs, dosage, price per dose and commercial arrangements."

Ibrance's list price is £2,950 ($3,211) per 21-pack of 75 mg, 100 mg, or 125 mg capsules, and the average cost for a course of Ibrance-fulvestrant at the list price is £6,170.70 for the loading dose and £5,126.42 for subsequent cycles. However, Pfizer is making the drug available to NHS at an undisclosed discount.

"As our evaluation of palbociclib shows, this process works well when companies engage with NICE and NHS England to price their medicines reasonably and present a clear case for additional evidence to be gathered while they’re in the CDF," Helen Knight, interim director of medicines evaluation at NICE, said in a statement.