2/22/2013 7:36:49 AM
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.
comments powered by