Is your company prepared for the new changes in the drug industry? There are currently 20 new drugs in the gene therapy pipeline, and Luxturna, approved by the FDA in December 2017, has an estimated price tag of $425,000 per eye, as a one-time treatment.
Luxturna is a new gene therapy for the treatment of a rare, inherited form of blindness affecting 1,000-2,000 people in the United States. It is administered via subretinal injection by a surgeon experienced in performing intraocular surgery into the eye for biallelic RPE65 mutation-associated retinal dystrophy. Patients should be treated first with a short course of oral prednisone to limit the potential reaction to Luxturna.
On January 3, 2018, Spark Therapeutics announced three new payer programs: an outcomes-based rebate arrangement with a long-term durability measure; an innovative contracting model that aims to reduce risk and financial burden for payers and treatment centers; and a proposal to CMS under which payments for Luxturna would be made over time. “We believe that access to therapy is a shared responsibility among Spark Therapeutics, payers, health benefit providers, physicians and treatment centers.”
Luxturna was originally intended to only be administered at approved Ocular Gene Therapy Treatment Centers, which have retinal specialists, nurses and genetic counselors with experience treating patients with inherited retinal diseases. “Spark Therapeutics is working with affiliates of Express Scripts to enable the innovative contracting model by leveraging their specialty distribution and specialty pharmacy capabilities” and they are in active discussions with other national and regional payers to enter into similar agreements allowing them to purchase Luxturna, rather than the treatment centers. “Luxturna and other potential one-time therapies face unique health insurance challenges given current practices and regulations in the U.S. healthcare system.”
For the outcomes-based pricing, Spark Therapeutics has an agreement with Harvard Pilgrim to pay rebates if patient outcomes fail to meet a specified threshold, thereby linking the payment for Luxturna to both short-term efficacy (30-90 days) and longer-term durability (30 months). These measures are unique to this one-time gene therapy.
Luxturna might only be the start of a whole new way that insurance companies pay for medications in the United States. Be sure to talk to your PBM or medical company and consultants now so that you can be proactive in your approach to implement recommended prior authorization and coverage of these high priced gene therapies.
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