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Spark divides opinion with $850000 gene therapy

Spark divides opinion with $850000 gene therapy

The FDA in December approved Luxturna, a new gene therapy that can treat the progressive blindness, and on Wednesday, its maker revealed the staggering cost: $425,000 per eye.

Last month, the FDA approved a gene therapy called Luxturna, which can treat a rare eye disease that causes blindness.

Spark announced it will ease the cost burden of Luxturna (vertigene neparvovec-rzyl) with an outcomes-based rebate scheme with a long-term durability measure, a contracting model that aims to reduce risk, and allowing taxpayer-funded payment schemes to make payments over time.

Gene Therapy: The Future Of Medicine?

"Our work is not done, but we believe that the offerings we are announcing today will help ensure that eligible USA 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". However, "there are very few such patients, and the price of every treatment matters a great deal".

"We wanted to balance the value and the affordability concerns with a responsible price that would ensure access to patients", CEO Jeffrey Marrazzo told the AP.

Bankrupt Westinghouse bought for $4.6B - is U.S. nuclear making a comeback?
The Japanese company later announced in November that it was exploring alternatives to sell the US -based company. Limited Partnership Units now has a consensus rating of "Buy" and a consensus price target of $29.66.

A proposal to CMS under which payments for Luxturna would be made over time, which is not now available "due to current government price reporting requirements", according to Spark. Lucky for patients, the brunt of this will go to insurers and not to the individual, but that's still a pretty tough pill to swallow, especially if it results in insurance rate hikes for the patients.

These therapies are generally meant to be taken once, a fact which drug developers argue sets them apart from traditional drugs taken for months or years. The cost dilemma presented by gene therapies stems from the fact they are one-time treatments.

In doing this, Marrazzo is also acutely aware that the first payment model will likely heavily influence what and how he charges for a gene therapy for hemophilia, now well down the clinical path. 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 US government can pay in installments.

One insurer, Harvard Pilgrim Health Care, which covers 2.7 million people in New England, has already signed on to pay for Spark's therapy. But the Spark pricing team has worked it out so that under one model Spark can offer payers unspecified rebates at 30 days and 30 months - which is about the average amount of time a patient stays in a commercial plan - if Luxturna falls short of established efficacy goals on vision. And the company is also working on covering patients' out of pocket costs as part of the overall price. Having said that, the price is still a bit hard to come to terms with.

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.

However, even though the cost is lower than the $1 million price tag that analysts were expecting, there remain concerns that the drug is overpriced.


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