Even though a NICE committee considered Merck’s ($MRK) Keytruda a “life-extending, end-of-life treatment,” certain lung cancer patients in the U.K. won’t have access to the med because the agency isn't sure the drug is cost effective.
In an initial appraisal, NICE turned away the Merck med after concluding that a majority of patients would opt to continue treatment after two years. Merck had assumed a two-year treatment duration in its submission to NICE, and extending would obviously cost more.
The drug's list price is £1,315.00 per 2 mg/kg dose, administered every three weeks, NICE said. The company had offered a confidential patient access scheme--typically some sort of discount--but apparently it was not enough to win NICE over. Often, an initial rejection from NICE prompts drugmakers to come back with a better deal.
It sounds as if NICE could use more information from Merck as well. With most patients expected to extend treatment, not only expenses, but uncertainties about Keytruda's long-term cost effectiveness would increase, the agency said. Therefore NICE couldn’t approve it, according to appraisal documents.
"The committee noted the uncertainty around the optimal duration of treatment and was aware that it had not been presented with compelling evidence that a two-year stopping rule would be applied in clinical practice," according to the appraisal.
Though it’s only an initial review, Merck’s managing director in the U.K., Louise Houson, said the decision was “very disappointing.” As the process unfolds, the company will to work with the cost watchdog to “find a solution to get back on track and make sure this much-needed treatment option is made available to people with previously treated advanced NSCLC as quickly as possible,” she added.
The issue is “particularly important” because of the prognosis of advanced lung cancer patients, Houson said.
Before its EU approval in August, Keytruda had been available through the U.K.’s Early Access to Medicines Scheme for about 140 patients. The initial decision by NICE won’t affect patients who are already on Keytruda.
While it’s unhappy with the development, Merck can take solace in the fact that it’s not alone in being turned away by NICE. In recent months, numerous pharma companies have seen coverage for effective new treatments declined due to cost effectiveness concerns and uncertainties.
AstraZeneca ($AZN), which was unhappy with a delay over lung cancer med Tagrisso, just this week won coverage for the new med on the revamped CDF. It’ll be covered by NHS England as investigators seek to learn more about its long-term effectiveness.
Eisai and Roche ($RHHBY) have each been turned away in recent months for thyroid cancer med Lenvima and breast cancer med Perjeta, respectively, drawing negative reactions from each company.
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