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The onus is on the drug developer to paint that picture on behalf of its therapy, says Walsh.

“If we went to [payers] with a product that had incremental value, we wouldn’t be having the same dialogue,” says Walsh.

Uniqure has six-year follow-up data showing a 50% reduction in pancreatitis in Glybera-treated patients, he said, and dividing that up-front price by six years “you get to a [per-year] price that’s actually lower than [typical] orphan drug pricing,” he said.

Pricing gene therapies might follow one of three general schemes.

Now that insurers can’t reject patients based on pre-existing conditions, or limit lifetime benefits, and may be required to offer gene therapies that become standards of care as parts of minimum essential benefits packages (all of which came into law as part of the Patient Protection and Affordable Care Act in 2010), the environment for annuity-style payments for gene therapies is in place, he says (Nat. And at the same time, “companies can make a bunch of money without gouging the system,” he says.

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Spreading out the cost of therapy is likely to be important to insurance providers, especially private payers in the US who may have a patient for only a few years.“If I was working for a carrier right now, I’d be very eager to be pushing for some solutions that are not going to entail bearing the entire cost, just because I have a particular patient’s beta thalassemia this year,” says CVS’s Brennan. And for diseases with very clear cost off-sets—in beta-thalassemia, for example, the cost of chronic blood transfusions and disease complications—payers will be more likely to see gene therapies as being cost effective, says Roger Longman, CEO of Real Endpoints, a New York–based information and analytics company focused on pharmaceutical reimbursement.Glybera is used to treat adults with lipoprotein lipase (LPL) deficiency, an orphan disease which results in abnormally large particles of fat in the blood and causes inflammation of the pancreas.The therapy consists of LPL, encoded by an adeno-associated virus vector, administered through a series of intra-muscular injections.“Ultimately, where industry needs to go is true pay for performance,” says Bluebird COO Jeff Walsh.But for such a model to work, the product would have to have “transformative data” and endpoints that can both be measured and have a direct correlation with disease.




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