Here's some good news for Lundbeck in an otherwise bleak week: The U.K.'s cost watchdog has endorsed its alcohol-dependence treatment, Selincro.
The U.K.'s cost gatekeeper is notoriously strict when it comes to approving drugs, shooting down meds based on strict cost-effectiveness standards or saddling them with restrictions. But cancer drugs could face the toughest road ahead, as a new report shows that the National Institute of Health and Care Excellence is less likely to green-light the meds compared to other classes of drugs.
The U.K.'s cost-effectiveness gatekeepers have flip-flopped on Novartis' Xolair before, withdrawing support for the drug in 2012 before expanding its approval for asthma the following year. Now, the National Institute for Health and Clinical is asking the drugmaker to pony up more information about the product before recommending it to treat chronic spontaneous urticarial (CSU), or psoriasis.
Bayer's Xarelto, which has been cruising along since it joined a new class of warfarin replacement therapies on the market, has faced a rare stumbling block in acute coronary syndrome--an indication the FDA has denied it on three separate occasions. But across the pond, it's picked up a nod in some ACS patients from the U.K.'s cost-effectiveness gatekeeper.
Drugmakers are accustomed to grappling with government payers and PBMs over prices. But a pricing fight directly with patients? That's not your everyday occurrence.
The U.K.'s cost-effectiveness watchdog has recently sounded a bit like a broken record when it comes to its cancer drug rejections. The latest to get a "no-go" from the gatekeeper? Celgene's Imnovid.
Gilead Sciences' hepatitis C drug Sovaldi may be worth the sticker price. But it's too expensive for the U.K.'s health system to bear. That's the assessment in some National Health Service documents obtained by the Health Service Journal.
Roche just can't win with the U.K.'s drug price watchdog, the National Institute for Health and Care Excellence (NICE). In August, the agency decided the company's heralded breast cancer drug Kadcyla was too expensive for the country's health system to cover. Now NICE has slapped Roche with a preliminary thumbs-down on Gazyvaro, its new drug to treat chronic lymphocytic leukemia (CLL).
Johnson & Johnson pessimists are already worried that Olysio will end up like a mayfly, with a short, happy, busy life and an all-too-sudden end. If the U.K.'s cost-effectiveness gatekeepers offer any indication, they may be correct.
Britain's drug price watchdog, the National Institute for Health and Care Excellence (NICE), has given the go-ahead to GlaxoSmithKline's Tafinlar, which is among the new class of melanoma drugs that target tumor mutations. Not surprisingly, though, there's a catch: GSK must provide the drug at an undisclosed discount, according to NICE's guidance document announcing the decision.