Top US cardiologists push to limit PCSK9 drug patient pool
- During a panel titled "Rethinking Cholesterol" at the Harvard T.H. Chan School of Public Health, physicans' views synced with those of some health insurers. The goal is to limit use in order to control costs. The estimated cost of Sanofi/Regeneron's Praluent (alirocumab) and Amgen's Repatha (evolocumab) before discounts is roughly $14,000 per year.
- Several large pharmacy benefits managers (PBMs) and insurance companies, including CVS Health, Aetna, and United Healthcare, have been trying limit which patients can be treated with PCSK9 inhibitors. Not only are they adhering strictly to the label, but PCSK9 inhibitors are being reserved as second- or third-line treatment after high-potency statin therapy has failed, in addition to ezetimbe.
- With respect to controlling costs, the goal is not only to be selective about which patients are treated with PCSK9 inhibitors, but also to win as many discounts as possible from Amgen and Regeneron/Sanofi.
In February, well before the approval of Praluent, the first FDA-approved PSCK9 inhibitor, in July, CVS Health published an alarming report estimating that the costs of PCSK9 inhibitors would be in the $7,000 to $12,000 range per year and that total costs could reach $150 billion per year. As it turned out, CVS Health underestimated the actual cost of these drugs.
Now, top cardiologists who have years of experience treating patients with hypercholesterolemia with statins are agreeing with payers instead of fighting to get reimbursement for as many patients as possible. In fact, during the panel, participants discussed ways to determine which patients—out of the possible 3.5 million to 15 million Americans who might be eligible for treatment—should receive PCSK9 inhibitors.
One issue that came up is that many people might consider themselves 'statin intolerant' without really fulfilling the criteria for this condition. This is just one way that too many patients could end up on drugs that they don't really need, especially if their hypercholesterolemia is controlled with statins, according to the panel.
It's becoming increasinly clear that payers are going to flex their muscles with Amgen and Sanofi/Regeneron to make PCSK9 inhibitors a more affordable therapy, and at the same time, they will limit who can receive the therapy.