When a new class of cholesterol-lowering medications called PCSK9 inhibitors hit the market in 2015, they were instantly controversial because of their price. Amgen’s version, called Repatha, and a rival drug from Regeneron and Sanofi, Praluent, sell on average for $14,300 a year. Still, the drugs can help patients who cannot lower their cholesterol with traditional statins and therefore face a high risk of developing heart disease.
Yet 53% of those patients were unable to get insurance coverage for PCSK9 inhibitors in the year ended in August 2016, according to a study published today in the journal Circulation. Of the people who were turned down for the drugs, 57% already had a history of atherosclerotic cardiovascular disease, or the dangerous buildup of plaque in the arteries.
The problem, of course, is the price. PCSK9 inhibitors are far more expensive than statins like Pfizer’s once-blockbuster Lipitor (atorvastatin), which went generic long ago and sells for pennies a pill. Patients who are prescribed PCSK9 inhibitors must get prior authorization from their insurance companies before they fill those prescriptions—a tough hurdle at a time when high drug prices still dominate the national conversation on health care.
The study investigators discovered that the biggest predictor of a PCSK9 prescription getting approved was not the health of the patient, but rather the type of insurance he or she carried. Medicare patients received the most approvals, while people with private insurance were more likely to be turned down, they reported. Researchers from Harvard and the Leonard Davis Institute of Health Economics at the University of Pennsylvania led the study, which they completed without funding from any PCSK9 manufacturer.
Because of the high cost associated with newfangled cholesterol-lowering drugs, private insurers are demanding onerous pre-authorization procedures from patients and doctors, the authors note. This can include filling out long forms, which can differ widely among the 10,000 or so insurance plans in the U.S. “The forms require substantial time and create a direct cost for healthcare providers, and an indirect cost for patients repeatedly attempting to receive the prescribed medication, as well,” the authors wrote in the paper.
The pre-authorization hassle has also been a headache for Amgen, Sanofi and Regeneron, as they struggle to sell their products. Sales of Praluent in the second quarter of this year came in at just $24 million. Repatha sales in the U.S. were $62 million in the third quarter, Amgen reported last week. Repatha demand has been going up, the company said. But neither drug is anywhere close to the $4 billion in peak sales analysts once predicted each would reach.
Repatha and Praluent hit the market at a challenging time for drugs with high price tags. It had been less than two years since Gilead introduced its groundbreaking hepatitis C drug Sovaldi at a staggering price of $84,000 per 12-week treatment course. The drug was effectively a cure, but that didn’t stop insurers and pharmacy benefits managers (PBMs) from beating up Gilead until it granted them significant discounts, particularly after competitors hit the market.
Steve Miller, the chief medical officer of PBM Express Scripts, harkened back to the Sovaldi controversy after Repatha and Praluent were approved.
“Although the clinical trials for both Praluent and Repatha have been successful, it should be noted that these trials have been short-term, and little has been proven about the long-term effect of lowering LDL in this manner,” he wrote in a blog post at the time. “For both patient safety and payer affordability, it will be important that the healthcare industry ensure that this class of drugs is managed appropriately.”
Since then, the pricing debate has only become more heated. First there was the outcry over huge price increases on old drugs, like Turing Pharmaceuticals’ Daraprim and Mylan’s EpiPen.
Now there are cost concerns about newly approved gene therapies to treat cancer. Novartis’ Kymriah to treat some leukemia patients was priced at $475,000, while Gilead’s Yescarta for B-cell lymphoma debuted at $373,000. Spark Therapeutics, which is awaiting an FDA decision on its gene therapy for a rare form of blindness, hasn’t disclosed pricing plans, but some analysts predict the treatment could sell for as much as $1 million.
The authors of the new study on PCSK9 inhibitors say they understand the cost concerns. But they were surprised by how high the rejection rate was for patients with documented artery disease, said lead author Robert Yeh, M.D., director of the Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center in Boston, in a statement.
“Whether or not we can agree on the cost-effectiveness of these drugs, I believe most would agree that one’s access to medications should be driven primarily by the strength of the indications for the prescription as opposed to what drug plan you happen to carry,” Yeh said.