This may be a bad break for drugmakers. Wellpoint is using comparative effectiveness to make it more difficult for its members to use the Boniva osteoporosis drug after its own research found greater fractures, lower compliance and higher costs than other meds, according toDow Jones.
The insurer studied 26,000 members on osteo meds, comparing Boniva, which is marketed by Roche and GlaxoSmithKline with Actonel, which is sold by Sanofi-Aventis and Warner Chilcott, and Merck's Fosamax. Although randomized clinical trials suggest the drugs should be equivalent, WellPoint data found differences. Now, WellPoint other drugs must be tried before Boniva is approved.
The drug remains where on Tier 3, or non-preferred level, on the formulary. WellPoint actually made the change last year, Dow Jones writes, although last month, WellPoint announced it had developed standardized comparative effectiveness guidelines to evaluate a drug's ability to improve outcomes. Another approach is taken by RegenceRx, the not-for-profit arm of the Regence Group that includes several BlueCrossBlueShield insurers, by analyzing the quality of clinical trials promulated by pharma (see this).
Three months ago, by the way, the FDA determined there is no link between these drugs and thigh-bone fractures, even though a warning had been issued two years ago (background here). Nonetheless, the agency is continuing to work with outside experts to analyze more info.
10 Comments
Ed,
Thanks for posting this. So, you wrote the piece on RegenceRx.
Blame this one on the abject failure of the pharmaceutical industry to conduct its own prospective clinical trials on comparative effectiveness. Every such protocol that I proposed was shot down as either too expensive or two risky. The Marketing mentality is that they would rather protect a smaller market share by not doing such study than risk losing share altogether should the study not come out in the company's favor.
This may be a bad break for drugmakers????----what a SERIOUS joke---it is a an act. RegenceRx, Wellpoint, FDA are all connected, Comparative Effictive Research is a gimmick---to protect the medical profession, pharma, hospitals and all associated with medicine. iNSTEAD OF cOMPARATIVE RESEARCH--- stop PHARMACEUTICALS from using toxic chemicals---like anti-freeze in medicines. Comparative Effective Research is not for the patient---it is a protection act for industries and professionals within the medical profession. Wellpoint is associated with Acdemy of Managed Care Pharmacy---of which AMCP is part of the most corrupt group Insititute of Medicine-- RegenceRx is selling medicine. MEDICINE IS SUPPOSED TO HEAL NOT LIE AND CORRUPT.
Lilly...just out of curiosity, which pharmaceuticals are using anti-freeze?
I guess I am confused by the whole rant.....nvm.
Josh, in the distant past some companies used ethylene glycol as a preservative in some of the drugs used in animal studies. That was discontinued long ago.
I haven't heard about that in the past 10-15 years...so just curious. Wonder if some people need to clean out their medicine cabinets....
What about elixir of sulfanilamide which used ethylene glycol (1932). Plus it's very common to used methanol in the synthesis of drugs and since you can't totally remove it you have to test to make sure the residual levels aren't excessive. Of course I know certain products that have problems with this. Plus in general some companies don't seem to have very good GMP nowadays.
Salmon
Correction 1937 and diethylene glycol. I guess my memory isn't what it was.
Plus there's been a whole bunch of other meds with DEG since then. With the latest DEG problem in the US being only a couple of years ago when it was found in toothpaste manufactured China. (Gave it a sweet taste).
See
http://en.wikipedia.org/wiki/Diethylene_glycol
for a nice list of incidents of DEG in meds over the years.
Salmon
The recent ones seem to happen in the 3rd world nations. I have yet to hear about any real recent incidences for drugs in the US...