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In Cholesterol Drug Price Fight, Real Message Is “Wait Til Next Year”

Xconomy National — 

The authors of a study published Tuesday in the Journal of the American Medical Association argue that the new wave of cholesterol-fighting drugs, hailed as a big medical step forward when they launched last year, should cost 70 percent less than their current list price to be worth the trouble prescribing them.

The drugs’ owners, Amgen (NASDAQ: AMGN) and Regeneron Pharmaceuticals (NASDAQ: REGN), immediately contested the findings, noting, for example, that the list price—over $14,000 per year for each —isn’t actually what anyone pays for the drugs. Regeneron blamed the study and others like it for dampening demand for the drugs. They were approved in the summer of 2015 for high risk patients who can’t lower their dangerous cholesterol levels with the standard of care, drugs called statins, and by other means.

Drug pricing should be top of mind for many Americans in the fall. The issue has come up time and again in the presidential campaign, and California voters will consider a state initiative to control prices. A similar measure in Ohio just suffered a setback at the hands of the state’s Supreme Court.

Statins are seemingly everywhere, but heart disease remains the leading cause of death in the U.S., according to the Centers for Disease Control and Prevention.

Still, early demand for the new drugs, known as PCSK9 inhibitors, is dismal. In the first six months of 2016, evolocumab (Repatha), from Amgen, and alirocumab (Praluent), from Regeneron and its partner Sanofi, have combined for less than $100 million in revenues, a far cry from the blockbuster sales that many analysts predicted the drugs would ring up. (They are called PCSK9 inhibitors because they block a protein, proprotein convertase subtilisin/kexin type 9, which interferes with the body’s ability to clear so-called bad cholesterol from the bloodstream.)

PCSK9 blockers could still prove popular and necessary, but doctors, insurance companies, and their agents will need convincing through long-term studies that show the drugs reduce heart attacks and strokes. Data from those studies, with more than 50,000 patients involved, are expected next year from Amgen, Regeneron-Sanofi, and Pfizer (NYSE: PFE), whose anti-PCSK9 drug bococizumab is still experimental.

In clinical trials, the drugs led to dramatic reductions of so-called bad cholesterol, LDL-c, which was good enough for U.S. and European approval last year, with limitations, because of decades of evidence linking cholesterol levels to heart disease. But there is no direct connection yet between the new drugs and better health.

Even if the upcoming studies make that connection, the JAMA study’s lead author says his study’s message is unlikely to change. “We don’t expect these drugs to magically become cost-effective based on new data,” says Dhruv Kazi, a cardiologist and biostatistician at the University of California, San Francisco. “This conversation is happening because we think these drugs work and are safe. The challenge is not the effectiveness. It’s the cost.”

“Our existing prevention therapies for cardiovascular disease are fairly effective, so it’s unlikely the findings from these studies will change health outcomes so dramatically that these drugs become cost-effective at these price tags,” Kazi says.

The study says the price needs to come down to $4,536 a year to be worth prescribing, based on a complicated formula that measures quality of life, known in shorthand as QALY. (For those who need additional help beyond statins, the drug ezetimibe (Zetia) was more cost effective, according to the study.)

Both drugs must be taken in perpetuity, making their price tags particularly prohibitive. But measuring their cost-effectiveness at those prices and at this time is wrong-headed, say Amgen and Regeneron spokespeople. The list price isn’t the actual price, because of secret discounts and rebates the drug makers negotiate with insurers and their agents, like Express Scripts (NYSE: ESRX).

The spokespeople also criticize the study’s QALY definition, but they also refuse to divulge the real-world price … Next Page »

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