New rules for prescribing statin drugs could double the number of people taking them--or not. They could help AstraZeneca ($AZN) pump up sales of its high-powered Crestor--or not. What they will do--most likely--is undercut Merck's ($MRK) cholesterol drugs Vytorin and Zetia, along with AbbVie's ($ABBV) fenofibrate-based lipid meds TriCor and Trilipix.
The new American Heart Association guidelines throw out the numbers-oriented approach to statin use in favor of a risk-based analysis. Rather than prescribing based on levels of so-called "bad" cholesterol, or LDL, and tailoring drug and dosage to lowering LDL past a specific threshold, the new guidelines look at those figures as part of a broader calculation of heart-disease risk.
Patients whose age, family history, history of smoking, and cholesterol numbers--among other factors--put them at higher risk of heart disease should take the drugs, the AHA says. Those whose cardiovascular risk is highest, including patients with diabetes and those with LDL cholesterol over 190, should take high doses or higher-powered statins. Follow-up cholesterol testing? Not required.
According to Bloomberg, the new rules will put 33 million people in line for statin therapy, about twice as many as the number covered by current guidelines. Forbes, however, says experts who've advocated a similar approach figure the number of statin patients would decline. Either way, a change in statin use all depends on whether doctors a. get the message, and b. follow the new rules.
Some drugmakers, namely AstraZeneca, will want physicians to hop on the bandwagon, particularly when it comes to the recommendation for potent drugs for the riskiest patients. Already a $5 billion drug, Crestor has long been seen as a high-powered solution for the hardest-to-treat patients, but the new rules give Crestor a shortcut to doctors' prescription pads. High risk? Take the most potent drug; end of story. The other option for these vulnerable patients would be high doses of Pfizer's ($PFE) Lipitor (atorvastatin)--or its generics--but some patients can't tolerate them. With Crestor losing market exclusivity in 2016, you can bet AstraZeneca will be touting these new guidelines, and quickly, to boost sales as much as possible before generic competition hits.
Other companies, however, have much to lose. In favoring statin drugs--and excluding other cholesterol-lowering meds from the rules--the organization puts Vytorin, Zetia, TriCor and Trilipix at risk. Vytorin and Zetia, with combined sales of $4.3 billion last year, have been marketed as higher-powered drugs to help force LDL levels down to the magic-number level. If doctors no longer shoot for that magic number, then there's little case for adding Zetia to statin therapy. Same goes for TriCor and Trilipix, also used as add-ons to statins.
Some studies have cast doubts on the benefits of these four drugs, but the new risk-based calculation leaves them out in the cold almost entirely. Indeed, as Bloomberg points out, the guidelines specifically say that there's no evidence that these meds help cardiovascular health enough to outweigh their potential side effects. The rules allow that they may be considered for some high-risk patients, but not for routine use even in that group of people.
One question raised by the new guidelines: How might they affect the PCSK9 drugs now racing to market? These drugs fight cholesterol via a new mechanism, and most of the late-stage research now focuses on lowering LDL numbers. But there's been some worry that lowering LDL--traditionally seen as a surrogate endpoint to prove cardiovascular benefit--may not be enough to win the FDA's blessing. Two weeks ago, Pfizer said its bococizumab development program includes massive outcomes trials, both to persuade payers of its worth, and as a back-up plan if regulators grow skeptical of LDL as a basis for approval.
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