Monday, July 28, 2014

Rating New Hepattits Drugs: What Standard?

There seem to be two problems with the newest drugs for hepatitis C,  simeprevir (Olysio) and sofosbuvir (Sovaldi). The problem most discussed these days is "miracle drugs cost too much." For example, guru David Blumenthal, MD, holds forth on the Commonwealth Fund website--
--that Sovaldi is "dramatically effective and extraordinarily expensive." Robert Steinbrook and Rita F. Redberg, in an editorial in JAMA Internal Medicine, declare the new drugs "a scientific triumph". They then go on to note the problem--that Sovaldi can cost $1000 per tablet for 12 weeks' treatment, putting the cost at $84,000 ($168,000 for 24 weeks).

Our old friend Dr. Roy Poses at Health Care Renewal seems to be one of the few who's discussing a radically different problem--"maybe the drugs that cost so much are not miracle drugs at all." In his latest post:
he highlights the most recent article in JAMA, which is fawned over in an accompanying editorial despite the fact that it's non-randomized and non-controlled. Dr. Poses points out that the FDA decided to approve Sovaldi as a "breakthrough drug" which seems to have undercut the requirements that it be documented by something akin to science.

The article that accompanied the editorial in JAMA Internal Medicine addressed an evidence report by the Institute for Clinical and Economic Review, Boston, prepared for a meeting of the California Technology Assessment Forum. They concluded a need for caution regarding the two newest drugs:
"First, the evidence base on the comparative clinical effectiveness of these 2 new drugs remained thin in most areas and notably incomplete in others. For example, in some subgroups, such as patients who have failed earlier treatments, there were little or no data available. There were no long term data demonstrating the durability of short-term sustained virologic response rates for either drug; nor had either drug been compared head-to-head in a randomized clinical trial with each other or with a first-generation direct-acting antiviral drug. Finally, the evidence necessary for sofosbuvir to gain marketing approval through the FDA’s breakthrough designation was particularly sparse and did not include requirements for controlled trials." They noted that as a result of this presentation, the California forum voted the use of these drugs a "low value" for the health system.

Steinbrook and Redberg noted that Sovaldi had grossed $2.3B in the first quarter of 2014. So "low value" by one standard seems to be pretty high value by another. If the past is any indication, it will be some years before we find out which standard is the correct one; and meanwhile, the profiteers at the makers of the two drugs can expect a killing.

Steinbrook R, Redberg RF. The high price of the new hepatitis C virus drugs. JAMA Internal Medicine 174:1172, 2014.

Ollendorf DA, Tice JA, Pearson SD. The comparative clinical effectiveness and value of simeprevir and sofosbuvir for chronic hepatitis C infection. JAMA Internal Medicine 174:1170-71, 2014.


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