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of the drugs that the authors should instead have used in their calculations. (It’s unlikely that the real-world prices are anywhere close to the 70 percent reduction recommended in the study.)
Another point of contention: it’s premature to calculate the drugs’ value before data arrive from the massive outcome studies. It’s because of “misleading analyses” like Kazi’s that payers have put “unprecedented restrictions” on the PCSK9 drugs, says Regeneron spokeswoman Hala Mirza. Three quarters of patients who have been prescribed alirocumab have been denied coverage, she says.
Amgen spokeswoman Kristen Davis sent a statement to Xconomy that read, in part, “We remain concerned that these types of assessments are focused on ringing alarm bells from a payer perspective, rather than focusing on a rigorous analysis that fully reflects the patient perspective of value.” (Davis offered an alternative: a study funded and conducted by Amgen that concluded evolocumab “may be” cost effective.)
Alirocumab and evolocumab are approved for people at high risk of heart attack or stroke who can’t reduce their dangerous cholesterol levels with statins, or who can’t tolerate statins. There are roughly 9 million Americans who fit those criteria.
One restriction: Insurers are demanding proof that patients seeking anti-PCSK9 medication in fact have bad reactions, such as muscle pain, to statins. “When our clients have denied coverage, it is most frequently due to a lack of documentation and lab results from a physician demonstrating that the patient does in fact meet the clinical criteria for this drug,” says Express Scripts spokesman David Whitrap. His company’s insurance-industry clients cover 25 million Americans.
Whitrap declined to say how many people have been denied coverage for a PCSK9-blocking drug. He did not comment on Regeneron’s claim that 75 percent of alirocumab prescriptions are denied coverage.
The drug companies can’t complain about all the restrictions. In fact, since it launched alirocumab Regeneron has advocated patients on statins should first explore higher doses before turning to a prescription of the new drugs. “We definitely believe that patients should be evaluated” for a maximum statin dose, says Mirza.
The new JAMA study also estimated that the drugs at current list prices, if prescribed to everyone eligible, would run up health care costs of more than half a trillion dollars the next five years. (Total U.S. retail prescription sales were $287 billion in 2015.)
Given that roughly half of all people eligible for statins—which have gone generic, are easy-to-take pills rather than injectable antibody drugs, and are widely available—are not on statins, it’s hard to imagine everyone eligible for PCSK9 inhibitors taking PCSK9 inhibitors. Kazi acknowledges that real-world costs will be lower, but he argues that even with fewer people taking the drugs, the cost effectiveness, at current prices, would remain unacceptable.
One twist that bears watching as part of the larger drug-price debate: Some insurers, such as Cigna and Harvard Pilgrim, have agreed to pay on a sliding scale for the drugs’ performance. If they don’t lower cholesterol as much as they did in clinical trials—a fairly high bar—the price goes down. (Express Scripts has not negotiated pay-for-performance, says Witrap, “because there is very little question that these drugs effectively lower LDL.”)
The formulas for performance pricing are as secret as the list-price discounts. So it’s unclear if these pay-for-performance arrangements are significant or just window dressing. Either way, UCSF’s Kazi dismisses them as a “bad idea.” “It has to be linked to real performance, that is, fewer heart attacks and strokes,” he says.