- Newly approved PCSK9 inhibiting, cholesterol-lowering drugs are, to put it lightly, expensive. The estimated cost of Sanofi/Regeneron's Praluent and Amgen's Repatha (approved last week) before discounts is more than $14,000 per year.
- As Cardio Brief's Larry Husten flags, two major insurers are already drawing lines in the sand when it comes to which parts of the cholesterol market will have access to the drugs.
- For instance, Aetna plan holders will have to meet strict guidelines, including having CVD disease or heterozygous hypercholsterolemia, in addition to failing treatment with a high-potency statins and ezetimbe in order to qualify for reimbursements. Many patients must also continue taking the "maximum tolerated dose of statins." United Healthcare has also released its PCSK9 coverage criteria and it is slightly less stringent than Aetna's.
The by-the-book guidelines from Aetna are designed to eliminate usage of PCSK9 inhibitors among patients for whom it is not "medically necessary." In addition, Aetna will require that patients have elevated LDL-C levels of 70 mg/dL or higher after treatment with the maximum dose of a high-potency statin and ezetimbe. According to Aetna, high-potency statins include rosuvastatin (20 mg or higher), or atorvastatin (40 mg or higher), or simvastatin (40 mg or higher).
However, according to the guidelines, high-potency statins will not be needed if the patient suffers adverse events at higher doses, is over the age of 65, has a body mass index of less than 18.5, has impaired glucose tolerance or elevated fasting blood glucose or is using certain medications, such as cyclosporin, as well as other drugs, which are listed in the guidelines.
In addition to Aetna's criteria, United Healthcare has issued criteria for coverage of the PCSK9 inhibitors, and while the guidance is slightly more lenient (for instance, patients will not have to be taking ezetimibe), it's still strict.
These guidelines come in addition to pronouncements from massive benefits managers Express Scripts and CVS Health that PCSK9 coverage and prices will be heavily negotiated and scrutinized. The age of payer activism is alive and well.