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PHARMA: Statin drugs may go OTC in UK next year and Crestor update

As you probably know by now, the UK has a national health service (NHS) which pays for prescription drugs. Most Brits pay a small (or if they are over 60 no) co-payment when they get their drugs and the real cost of the drugs are absorbed by the government. The government does indeed bargain down the price of the drugs, but there is still a real cost involved. Just like health plans in the  US, where Wellpoint led the battle to get Claritin forcibly moved to the OTC market, the UK is interested in moving drugs OTC–where of course the cost is absorbed directly by the consumer. 

Now, one of the most significant categories is moving in that direction. Currently the NHS is spending roughly $625 per year for each of the 1.5 million Brits on statins–more proof as if you needed it that we Brits eat too much greasy food!  At over $900m a year, that’s a tempting morsel to get off the government’s budget, and consequently the health minister is looking to move statins to OTC in the UK within 6 months.

Merck is thrilled about this as its main statin Zocor lost its patent in the UK earlier this year–it has patent protection in the US until 2006.  Pfizer has less to worry about in the US as Lipitor is patented until 2010. However, in the UK presumably if Lipitor comes out of the NHS’ (and in some cases out of fundholding GPs’ budgets), and Zocor is availble OTC, this is bad news for Lipitor as physicians there will stop prescribing it, and instead tell patients to get Zocor at the local chemist. Of course, Merck and its OTC competitors will meet stiff price resistance there. At Drugstore.com Liptor is about $1100 a year in the US, but less than half that in Canada, and obviously will cost much less OTC in the UK. So this might be a fore-runner of what happens in the US when Zocor goes off patent in 2 years. And of course if Zocor is operating successfully OTC in the UK by then, why wouldn’t US health plans want to move it and Lipitor OTC here too–just as they did with Claritin?

Crestor Update.  The newest statin Crestor from Astra-Zeneca has had a somewhat rocky start.  In this post I noted that the  research group Friedman, Billings, Ramsey & Co had suggested Crestor wasn’t selling too well and that there were some adverse events being reported in the UK.  Now that same group has reported that according to:

    The Canadian Adverse Drug Reaction Monitoring Program, a database maintained by the Therapeutic Products Directorate of Health Canada (the drug regulatory agency in Canada), between February 1st and September 30th, 30 adverse drug reactions have been reported with Crestor, 24 of which were considered serious. In addition to 10 reports of muscle-related side effects (eight at the 10mg strength and two at 20mg, with eight patients below the age of 60) and one death (myocardial infarction in a 22-year-old patient), we find it notable that kidney-related adverse events have been associated with the drug at lower dosages. Events associated with kidney issues were observed in five patients in Canada and are as follows:

    ? one report of acute renal failure at the 40mg strength;
    ? one report of nephropathy at the 10mg strength;
    ? two reports of proteinuria at 10mg;
    ? three reports of hematuria, one at 10mg and two at the 20mg strength;
    ? two reports of increased blood creatinine, one at 10mg and one at the 40mg strength.

Of course it’s still very early days for Crestor, but between these reports and the suggestions of rushing the research in The Lancet last month, it may be that the FDA starts to consider some action.

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wally
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don smith
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I was diagnosed with type 2 diabetes.My chiolestrol level was very high. I am on crestor medications, my bad cholesterol has come down, what more my good cholestrol has raised up.

Lily
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