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Radar On Market Access: FDA's Approval of Sogroya May Change GH Class Management

Posted by Angela Maas on Nov 5, 2020


When the FDA approved Novo Nordisk, Inc.'s Sogroya (somapacitan-beco) for the replacement of growth hormone in adults with growth hormone deficiency on Aug. 28, it became the only long-acting agent on the market, AIS Health reported.

There are seven short-acting growth hormones currently available to treat adults with growth hormone deficiency, all of them branded forms of somatropin. Differences among the products, all of which are self-administered, include the strengths available and the type of device to deliver the treatment. But all of them must be administered daily. Sogroya, which also is self-administered, is the only FDA-approved product with weekly dosing.

Mesfin Tegenu, R.Ph., president of PerformRx, LLC, points out that Sogroya "is a human growth hormone (hGH) analog — an hGH with an added albumin-binding moiety. Up until this point, all hGH products have been a recombinant product, identical copies of hGH (rhGH). The half-life of somapacitan is measured in days (two to three days) while the half-life of rhGH (somatropin) is measured in hours (approximately two-and-a-half hours). The extended half-life of somapacitan allows less frequent (weekly) dosing."

He says that payers typically have prior authorization on somatropin, with "controls including diagnostic and lab values as prerequisites." A prescription from an endocrinologist is also a "common practice."
"Somapacitan is likely to be managed similar to all the other rhGH class of drugs," Tegenu says, adding that "it is reasonable to classify it as a second-line or nonpreferred agent whose use is allowed only after a trial and failure of or other medical reason for not using a preferred daily rhGH."

For the Managed Care Biologics and Injectables Index: Q1 2020, Zitter Insights surveyed between Feb. 25 and April 1 51 commercial payers with 138.1 million covered lives, and respondents with 55% of the lives said they expect to cover at least one long-acting therapy at parity with a preferred short-acting one. Payers with 11% of the covered lives said they expected to prefer a long-acting agent over all other products.

Zitter also polled 25 endocrinologists about their anticipated reaction to the availability of a long-acting growth hormone. Three-fourths of them said they were somewhat likely and highly likely to prescribe it to patients new to therapy, and 68% said they were somewhat likely and highly likely to shift current patients to it.

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Topics: Specialty, Industry Trends, Product Release, Data & Analytics