The UK National Institute for Health and Care Excellence issued draft guidance Friday not recommending Pfizer's Ibrance (palbociclib) "because its cost is too high in relation to its potential benefits." Ibrance is prescribed for HR-positive, HER2-negative locally advanced or metastatic breast cancer, and can be used either before or after other treatments have been tried, although NICE said the draft guidance looks at the drug for patients who have not had any treatments for their disease.
In its analysis, NICE found that Ibrance on average delayed disease progression by 10 months. The agency noted that even though the delay in tumour growth is likely to have some benefit on overall survival, "this could not be quantified from clinical trials."
Carole Longson, director of the centre for health technology assessment at NICE, explained "the committee needs more evidence of the drug's impact on overall survival of people with breast cancer," adding that "even when allowing for these potential benefits, it was still not enough to make [Ibrance] cost effective at its current price." NICE stated that a full course of the therapy costs 79 650 pounds ($99 585).
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Commenting on the decision, Pfizer UK's medical director for oncology David Montgomery noted that NICE's guidance is not yet final and that the company is committed to working to find a solution to make the drug available.
Meanwhile, Breast Cancer Now CEO Delyth Morgan said "this is the clearest illustration to date that the drug appraisal system is totally unfit for purpose in assessing first-in-class breast cancer medicines." Morgan urged Pfizer to "reconsider their decision not to offer the NHS any form of discount on the list price."
Ibrance was approved in Europe last November for use in combination with an aromatase inhibitor to treat women with HR-positive, HER2-negative locally advanced or metastatic breast cancer. US regulators cleared  the CDK 4/6 inhibitor in 2015.