Dive Brief:
- The National Institute for Health and Care Excellence, a U.K. drug cost watchdog, has dealt Pfizer a setback, provisionally judging its important breast cancer drug Ibrance (palbociclib) as too expensive to cover.
- In a draft guidance which has yet to be confirmed, NICE states Ibrance's cost is too high in relation to its potential benefits. According to the agency, a full course of therapy with Ibrance costs £79,650, or about $99,500.
- NICE is known for slapping back costly drugs, even if initial trials have shown clinical benefit for patients. Pfizer's Ibrance is an important oncology asset for the pharma giant, but almost all of its sales to date have come from the U.S. market.
Dive Insight:
Pfizer has a lot riding on Ibrance, which has become its top-selling cancer treatment in short order. But competition from Novartis and Eli Lilly is looming as their respective drugs inch toward markets.
Winning over physicians in the U.S. and rolling out the drug in Europe will help build up Pfizer's first mover advantage in the drug class, Pfizer executives suggested on an investor call last month.
Ibrance is the first CDK 4/6 inhibitor to win approval in Europe, securing an okay for treatment of HR+, HER2- locally advanced or metastatic breast cancer last November.
In a statement on its decision, NICE noted data which showed Ibrance extended progression-free survival by an average of 10 months, but wanted to see more evidence on potential overall survival benefits.
"The committee needs more evidence of the drug’s impact on overall survival of people with breast cancer," said Carole Longson, director of the Centre for Health Technology Assessment at NICE, "However, even when allowing for these potential benefits, it was still not enough to make palbociclib cost effective at its current price."
NICE's recommendation remains a draft version for now. Comments on the guidance are due Feb. 24 and a second appraisal committee meeting is set for Apr. 6. Pfizer could still negotiate an agreement with NICE to secure coverage for Ibrance.
Besides Pfizer, other groups were disappointed in the judgment.
"It is very disappointing that palbociclib is not being made available to patients, but cost is the limiting factor. If the manufacturer, NICE and NHS England can find a way of making this treatment available for patients, they will substantially improve the lives of patients with breast cancer," said Nicholas Turner, team leader in molecular oncology at the Institute of Cancer Research, a U.K.-based organization.