The FDA's December approval of lomitapide (brand-name Juxtapid) to treat extremely high cholesterol will give patients a once-a-day capsule to take as opposed to a complicated blood filtering procedure that some need on a weekly basis.
This was also good news for Dr. Dan Rader, the University of Pennsylvania and Aegerion Pharmaceuticals, all of whom collaborated in different ways to produce the drug.
An Inquirer story on the long journey from idea to approval is here.
There are medical concerns about the drug, especially those related to liver toxicity. The FDA approval came with a black box warning and Risk Evaluation and Mitigation Strategy requirement.
The other issue is the cost.
This is Aegerion's first product and it has a lot of debt to pay off. It is planning to charge a yearly rate of $235,000 for the initiation doses of the drug and then a yearly rate of $295,000 for maintenance doses.
The company projects 3,000 patients in the U.S. and the same in five major European countries, though it's still awaiting European approval. Others do the genetic math on this genetically-induced condition called Homozygous Familial Hypercholesterolemia (HoFH) and come up with fewer people in the patient population. Either way, because of that size, the company plans to have more contact with individual patients to help with use and secure payments. When all else fails, that might include discounts from the company.
Insurance companies are a bit wary.
Generally, insurers, pharmacy benefits management companies and self-insured companies all negotiate drugs prices. Those results vary, meaning different people might pay a different price for the same drug, depending on their plan.
Dr. Don Liss, vice president for clinical programs and policy for Independence Blue Cross, said some pharmacy plans have a fixed limit per month (say $50 or $75), but others are based on a percentage of the drug’s cost, often 20 percent or 50 percent. Most plans have an out-of-pocket maximum, such as $2,000 or $2500 for an individual.
The rest of the bill?
“The remainder would be the responsibility of the health plan or the insured company, if they are self-funded,” Liss said, adding the drug will be on IBC’s third tier of drugs, meaning the least affordable.
Aetna spokesman Walt Cherniak said in an e-mail on Tuesday that, "Lomitapide (Juxtapid) was approved by the FDA on Dec. 24, but it has not yet been launched in the market. Aetna has not yet reviewed the drug (we have 90 days from date of launch). Given the restrictive indication for a small number of patients, and the significant chance for liver toxicity, which resulted in a restrictive REMS program (limited to prescribers who have been certified), we will cover for members with HoFH, but with restrictions. Until we’ve reviewed the drug, we cannot say what tier or co-pay level it will occupy."