In September, the FDA made the controversial decision to give Exondys 51 (eteplirsen, Sarepta Therapeutics) accelerated approval for the treatment of patients with Duchenne muscular dystrophy (DMD). The drug is priced at approximately $300,000 for one year’s treatment. So far, most large insurers appear to be willing to cover the medication. Leading the parade is Humana, which has posted a pharmacy coverage policy document for Exondys 51 on its website.
Humana said it will consider Exondys 51 medically necessary provided the DMD patient has a confirmed genetic mutation amenable to exon 51 skipping and is ambulatory, the document said. Initial approval will cover six months of treatment. The company will cover the next six months if the patient continues to be ambulatory.
“Humana’s Pharmacy and Therapeutics Committee determined that Exondys 51 meets an unmet medical need as there is a lack of effective alternative therapy for the treatment of Duchenne muscular dystrophy,” a company spokesperson said in a statement. “The drug requires an approval on a member-by-member basis where we look for appropriateness of the treatment per FDA label.”
Anthem, on the other hand, has given the drug “thumbs down.” In a position statement, the company concluded that the use of eteplirsen was “investigational and not medically necessary” for all indications.
“Ultimately, eteplirsen secured the FDA’s approval based on an increase in dystrophin seen in the skeletal muscle of some boys treated with the drug; however, uncertainty exists regarding whether the small observed increase in dystrophin will confer a clinically meaningful benefit,” Anthem said in its notice.