Cholesterol Wars: The Reimbursement Battle Begins

(Updated)

The next stage of the cholesterol wars has officially started. With the recent approval of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Sanofi and Regeneron) the big immediate question everybody wanted answered was how the battle to pay for these expensive drugs (the wholesale acquisition cost is more than $14,000/year for both drugs) would shape up.

Now one major insurance company has unveiled a key part of its strategy to manage the problem. Aetna has published precertification criteria to determine for which members Praluent is “medically necessary.” To obtain reimbursement patients will need to have a documented diagnosis of one of the two FDA-approved indications: heterozygous hypercholesterolemia or existing cardiovascular disease. In addition– and here is where the rubber meets the road– Aetna will require that patients have elevated LDL levels (>70mg/dl) after treatment at the maximum tolerated dose of a high-potency statin and treatment with ezetimibe. Patients must continue to take the maximum tolerated dose of a statin.

Aetna defines high-potency statins as:

• rosuvastatin 20mg or higher, or
• atorvastatin 40mg or higher, or
• simvastatin 40mg or higher.

But high-potency statins will not be required for people with these conditions:

• Adverse effects occurred at higher doses,
• Age over 65,
• Body Mass Index < 18.5,
• Impaired glucose tolerance or elevated fasting glucose exists, or
• Concomitant use of medications such as cyclosporine, protease inhibitors, ritonavir, clarithromycin, itraconazole, ketoconazole,  erythromycin, nefazodone, ritonavir, simeprevir, verapamil, diltiazem, dronedarone, amiodarone, amlodipine, or ranolazine

For the diagnosis of heterozygous familial hypercholesterolemia Aetna will require one of the following:

• Cholesterol level is higher than 190 mg/dl (age > 18 years) either pre-treatment or highest on treatment plus tendon xanthomas, or evidence of these signs in a first or second-degree relative, or
• DNA-based evidence of an LDL- receptor mutation, apo-B100 or a PCSK9 mutation, or
• Other genetic typing indicating the presence of heterozygous familial hypercholesterolemia

Click here to download a PDF of the Aetna Precertification form.

Update–

The criteria for United Healthcare has also become available. The Aetna and United criteria have several differences. United doesn’t require patients to be taking ezetimibe and allows treatment for cholesterol levels above 160 mg/dl in patients without cardiovascular disease and above 130 mg/dl in patients with CV disease. Click here to download a PDF of the United HealthCare Criteria.

Hat tip: Thanks, once again, to Marilyn Mann