Spark sets off gene therapy debate with $850K sticker on Luxturna

Spark sets off gene therapy debate with $850K sticker on Luxturna

Maybe if Spark focused its attention on developing a gene-therapy treatment for a disease less rare than the blindness Luxturna is supposed to treat, the company wouldn't have to charge such an exuberant price.

Luxturna is still significantly more expensive than almost every other medicine on the global market, including two other gene therapies approved earlier past year in the U.S. Approved last month, Luxturna, is the nation's first gene therapy for an inherited disease.

Spark reached an agreement in principle with nonprofit health plan Harvard Pilgrim, which insures 1.2 million people across New England, for the first outcomes-based rebate arrangement. It can improve the vision of those with a rare form of blindness that affects just a few thousand people in the U.S. But gene therapies are given only once, with potentially permanent effects. Luxturna will be distributed through just six to eight treatment centers in the USA initially and is expected to be available later in the first quarter.

To avoid putting hospitals in a fix over the "buy and bill" reimbursement model, which leaves them on the hook for the initial cost of the treatment, Spark is contracting directly with payers on the price, leaving the providers to charge for their end of the procedure. Luxturna, approved in December by the FDA, is created to be given just once. Similar to Luxturna, Kymriah is a one-time treatment, and its price tag is $475,000.

When the US Food and Drug Administration (FDA) last month approved Luxturna, the first-ever therapy for a genetic disease, excitement abounded.

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"Spark CEO Jeffrey Marrazzo's comments, implying that $850,000 represents something other than greed, are absurd and obscene", Maybarduk said.

The group said it would share the risk of the treatment failing by paying some health insurers a rebate linked to whether the treatment worked in the first 30 to 90 days, and also to whether it was still effective after 30 months. It says it may give insurers a rebate if patients' vision gets worse within two and a half years, and it is working with Medicare and Medicaid so that the USA government can pay in installments. The therapy will cost $425,000 per injection.

It's clear that Spark is working hard to get the treatment to market - but the headline price is still likely to cause controversy in a country where the patient pays some, and sometimes all of the costs of drugs from their own pocket.

Spark's Luxturna, for instance, involves inserting a functioning copy of a missing gene directly into a patient's eye, where it encourages the body to produce a protein essential for sight. "We're at the infancy of what I think could be a lot of innovations in how we pay for these really expensive drugs", Express Scripts' Chief Medical Officer Steve Miller told CNBC. "Gene therapy is also being used to correct deficiencies in the production of dopamine, such as in Parkinson's disease, correct some immune system problems, and restore components needed for normal blood cell function in those with certain blood diseases, such hemophilia and beta-Thalassemia". "But the question that must be asked is this: What is a fair price that will maximize affordability and accessibility and provide a reasonable return for the drug?"

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