This is really messed up.
U.K. Panel Balks at Drug Payments
Agency says government shouldn't pay for higher-priced Novartis, Bristol-Myers medications
In another sign of growing opposition to high drug prices, an arm of the U.K.'s health-care system said Britain shouldn't pay for a group of expensive leukemia drugs for certain patients, saying their cost outweighs their benefits.
The decision is preliminary and applies only to a limited group of patients with chronic myeloid leukemia, or CML. But it is a blow to the drugs' makers—Novartis AG and Bristol-Myers SquibbCo.—and a sign of the increasingly frugal environment they face for drugs that cost tens of thousands of dollars a year. The U.K. is considered a leader in the scrutiny of health-care costs, and its decisions are closely watched by other health systems and insurers around the world.
The ruling applies to three drugs: Tasigna, Sprycel and high doses of an older drug called Glivec, which is known as Gleevec in the U.S. These treatments are typically prescribed to patients who haven't responded well to a standard dose of Glivec.
Patients who don't respond to standard doses of Glivec shouldn't be given the other treatments, because the evidence for their effectiveness is "very weak," the National Institute for Health and Clinical Excellence, or NICE, said in a statement.
"When we recommend the use of very expensive treatments, we need to be confident that they bring sufficient additional benefit to justify their cost," the NICE statement said. The agency's rulings apply to England and Wales only.
Sprycel, made by Bristol-Myers, and Tasigna, made by Novartis, both cost over £30,000 ($49,500) per patient a year, NICE said. Novartis also makes Glivec and recently raised the price, so that a high dose now costs more than £40,000 a year, NICE said.
U.K. patients currently using the drugs in this way will be able to continue, but no new patients will be offered the treatments. The decision doesn't apply to patients taking standard-dose Glivec as an initial, or "first-line," treatment. NICE, which regularly reviews all classes of drugs, said it is currently reviewing the clinical and cost effectiveness of standard-dose Glivec as a first-line treatment.
NICE has rejected a number of pricey drugs for cancer and other diseases in the past, including Nexavar from Bayer AG and Onyx Pharmaceuticals Inc.; Tyverb from GlaxoSmithKline PLC; and the kidney-cancer treatments Sutent and Torisel, both from Pfizer Inc. Sometimes NICE rejects drugs for all patients with the disease, and sometimes just for patients with a specific form of the disease, where the efficacy doesn't appear to justify the price.
NICE's decisions often anger patients, their families and drug companies. After issuing preliminary guidance, the agency gives patients and companies time to submit responses before making a final decision. NICE doesn't have the authority to ask companies to lower their prices, but companies sometimes cut deals with the agency in order to get their drugs approved, such as offering a certain number of doses for free. Companies are often reluctant to lower their prices, saying that other countries and insurers would then also demand price reductions.
In a statement, Bristol-Myers said the ruling "may significantly set back the treatment of CML." In the same statement, a patient group called CML Support called the ruling "very disappointing" and urged NICE to reconsider.
In a statement, Novartis said it was "concerned" that the decision could leave patients "with a potentially poor prognosis due to a lack of effective treatment options." It added that it hopes to persuade NICE to overturn the ruling.
Bristol-Myers and Novartis launched Sprycel and Tasigna several years ago as successor products to Glivec, which was first launched in the U.S. in 2001. Glivec is considered one of the great successes of cancer treatment, and has extended many patients' lives by many years. Glivec last year had global sales of $4.3 billion.
But some patients don't respond well to Glivec; Sprycel and Tasigna were approved to treat these patients. In a 58-page decision, NICE said it is "clear" that the drugs "provide clinical benefit for people" with Glivec-resistant CML, but that "the paucity of the evidence base means that the magnitude of the benefit is uncertain."
Sprycel and Tasigna have so far rung up healthy sales. Sprycel had global sales of $576 million last year, while Tasigna had $399 million in global sales.