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7:14 PM
 | 
Aug 09, 2019
 |  BioCentury  |  Product Development

Payers’ view of reimbursement when gene therapy isn’t enough

SMA will be a testing ground for when and if payers reimburse for combinations involving a gene therapy

Spinal muscular atrophy is giving payers a new conundrum, and the indication is poised to become a testing ground with implications for many if not all gene therapies.

The issue is whether, and how, payers will reimburse for both a one-time gene therapy and a chronic therapy for the same setting.

The problem is the lack of long-term data at launch for gene therapies that demonstrates whether or not they provide a cure. The uncertainty means clinicians and patients might seek to add a chronic therapy if a gene therapy isn’t showing results fast enough, to improve the odds of achieving a functional cure. Conversely, they might add a gene therapy to patients already on a chronic therapy for the same reason.

How payers handle reimbursement for follow-on treatment after gene therapy could set the stage for other diseases, with hemophilia or β thalassemia the next settings likely to be confronted with the issue.

The cost paradigm is complex. The most recent market entrant, approved by FDA on May 24, is gene therapy Zolgensma onasemnogene abeparvovec-xioi from the AveXis unit of Novartis AG. The drug has a wholesale acquisition cost of $2.125 million per patient. The other marketed option is the antisense oligo Spinraza nusinersen from Biogen Inc. and Ionis Pharmaceuticals Inc., which costs $750,000 in the first year and $375,000 each subsequent year.

According to one payer, there needs to be clear clinical evidence of a material benefit before payers would be willing to reimburse a combination approach -- that evidence does not yet exist.

How to reimburse the therapies sequentially will require some work. The simpler scenario is for patients on chronic therapy to switch to gene therapy, which they should not be prevented from doing since it could provide a cure. But moving patients in the other direction, from a gene therapy onto chronic therapy -- essentially combination therapy -- will require either a change in how gene therapies are priced, or more creative contracting than can currently be achieved under the Medicaid Best Price rule.

Harvard Pilgrim Health Care Inc.’s SVP and CMO Michael Sherman noted that in any setting where a potential cure with gene therapy is possible, the value of that...

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