Pfizer's Ibrance faces tough review at NICE, U.K. exec worries

Pfizer is worried that NICE's review methodology might hurt its breast cancer med Ibrance.

Many drugmakers have voiced displeasure after England’s cost watchdog gave negative assessments for their promising but costly new meds. Now, though, Pfizer is voicing concerns about its Ibrance review ahead of a ruling by NICE.

NICE’s methodology puts Ibrance in a poor position to gain coverage, oncology exec David Montgomery told pharmaphorum, because the breast cancer med is used in combo with other drugs. In its reviews, NICE looks at costs for such “add on” meds in addition to the other components in a regimen, giving little ability for new combos to show cost-effectiveness.

Case in point, Roche’s Perjeta. Used in combo with Herceptin and chemo, the cancer-fighting cocktail didn’t fare well at the agency, at least at first. The drug won EU approval in 2013, but it was not until this month that it secured NICE’s backing to treat early-stage breast cancer.

Ibrance won its EU approval earlier this month for breast cancer in combination with an aromatase inhibitor or, in women who’ve received prior endocrine therapy, with AstraZeneca’s Faslodex.

Since its U.S. approval last year, Ibrance has shot out of the gate to deliver blockbuster sales for the New York pharma. The med hauled in third-quarter sales of $550 million, more than double last year’s $230 million. In the second quarter, Ibrance contributed $514 million to Pfizer’s top line.

Despite the strong U.S. launch, Montgomery said he believes the med might struggle in the U.K. based on NICE’s review methodology. The company will price Ibrance “sensitively in a way that is socially responsible” in the country, he told pharmaphorum.

In recent months, as NICE works to take over the burdened Cancer Drugs Fund, companies including Merck and Eisai have seen pricey new cancer meds turned away on cost concerns. But Pfizer’s Bosulif was the first drug to see its previous coverage decision reversed by the agency when it won backing in June based on a new discount offer.

NICE decisions only directly affect patients in the U.K., but other countries use the agency’s assessments to shape their own coverage, giving added gravity to judgments by the U.K. agency.