Spark Therapeutics announces programs to improve patient access to Luxturna
Spark Therapeutics (ONCE) announced three new payer programs:
- an outcomes-based rebate arrangement with a long-term durability measure,
- an innovative contracting model
- and a proposal to CMS under which payments for Luxturna would be made over time.
Together, these initiatives aim to help ensure eligible U.S. patients have access to Luxturna, a one-time gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
Luxturna should only be administered to patients who have viable retinal cells as determined by their treating physicians.
Spark Therapeutics has reached agreement in principle with Harvard Pilgrim to make Luxturna available under the outcomes-based rebate arrangement and the innovative contracting model that aims to reduce risk and financial burden for payers and treatment centers.
Spark Therapeutics also has reached an agreement in principle with affiliates of Express Scripts (ESRX) to enable the innovative contracting model. Luxturna and other potential one-time therapies face unique health insurance challenges given current practices and regulations in the U.S. health care system.
Barriers to offering alternate models include the system’s focus on short-term value, largely because most patients switch health insurance companies on average every three years; government price reporting requirements that are not designed to reflect certain outcomes-based arrangements, therefore limiting a manufacturer’s ability to offer significant performance-based rebates, particularly for diseases with small patient populations; and complicated distribution models, which add costs and financial risk to parties involved in the delivery and reimbursement of specialty drugs and specialized medical care.
“Over these past few months, we have been working with health insurers to create innovative pathways for access to Luxturna that may serve as models for other one-time administered gene therapies in the future,” said Marrazzo.
“Our work is not done, but we believe that the offerings we are announcing today will help ensure that eligible U.S. patients have the coverage and financial support they need to gain access to both Luxturna and the specialized medical care required to deliver the product at treatment centers.”
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