NICE to bypass drugmakers in search of data to support pricey drugs

NICE's Carole Longson

Pharma companies devote a lot of resources trying to get on the good side of the U.K.'s drug price watchdog, the National Institute for Health and Care Excellence (NICE). They compile data to prove the benefits of new products justify their high prices, prepare detailed rebuttals when NICE says a drug is too expensive, and the like.

Now NICE says it's going to start looking beyond pharma companies to get a more complete picture of whether all the new drugs the U.K.'s health system is being asked to cover are really worth their high costs. The agency says that from now on, NICE will request clinical trial data directly from European regulatory authorities whenever it feels a company isn't providing adequate information to make sound coverage decisions, according to a statement.

"We strongly believe that all clinical trial data should be made available so that those with responsibility for developing guidance and making treatment decisions have all the necessary information … to … do so safely and efficiently," said NICE's director of health technology evaluation, Carole Longson, in the statement.

NICE has also updated its guidance document laying out what companies must do when they submit new drugs for appraisal. The agency added a clause saying submitters will need to sign a document "declaring that they have identified all clinical trial data," NICE says in its statement.

NICE's push for more transparency isn't surprising. The agency is a participant in the AllTrials campaign, which was established last year after Roche ($RHHBY) was widely criticized for failing to release all the clinical trial data on its flu-fighting drug Tamiflu. Under pressure, Roche ultimately released reams of clinical trials, prompting some of its critics to contend that the data proves the benefits of the drug don't actually justify the billions of dollars governments have spent stockpiling it to combat a possible pandemic.

The Roche debacle spotlighted an ongoing image problem in the pharmaceutical industry, namely that payers and the public have lost trust in the ability of pharma companies to prove the true value of new products. In May, Ernst & Young released a report revealing that less than half of insurance companies believe data put out by the pharmaceutical industry is credible.

Whether or not NICE's actions will push the industry to be more transparent remains to be seen. But there's little doubt the new policy will likely set up an even more adversarial relationship between Big Pharma and NICE. The marriage has already been rocky enough, with NICE coming down hard on drugmakers that charge high prices for new products. Among the companies that have recently faced NICE's ire is Alexion ($ALXN), which won the agency's recommendation for its $569,000-a-year-drug Soliris, but only on the condition that it submit to extensive, ongoing cost-vs.-benefit reviews. New cancer drugs from Roche and Johnson & Johnson ($JNJ) were rejected altogether.

- here's NICE's statement
- access NICE's updated guidance here
- read more at Pharmaphorum