FDA Expands Patient Population for Long-Acting Growth Hormone

The FDA recently expanded the patient population for Novo Nordisk’s Sogroya (somapacitan-beco), a long-acting growth hormone requiring weekly administration, as opposed to daily administration of short-acting agents. Payers and endocrinologists have expressed a willingness to manage and prescribe the new long-acting agents, according to Zitter Insights.

On April 28, the FDA expanded the patient population for Sogroya to include the treatment of people at least 2 1/2 years old who have growth failure due to inadequate secretion of endogenous growth hormone. The agency initially approved the drug on Aug. 28, 2020, for the replacement of growth hormone in adults with growth hormone deficiency. With the newest approval, the therapy becomes the first and only once-weekly growth hormone treatment for both children and adults.

Although the drug was approved almost three years ago, Novo Nordisk has not launched it yet. However, the company now says it will be available in June.

The agency has approved another long-acting growth hormone, but it’s indicated only for pediatric use: On Aug. 25, 2021, the FDA approved Ascendis Pharma A/S’s Skytrofa (lonapegsomatropin-tcgd) to treat people 1 year and older who weigh at least 11.5 kg and have short stature due to inadequate secretion of endogenous growth hormone.

There are seven short-acting growth hormones available — all of them branded forms of somatropin — but those must be administered daily.

For the Managed Care Biologics and Injectables Index: Q1 2023, from Feb. 27, 2023, to March 27, 2023, Zitter Insights polled 35 commercial payers covering 116.1 million lives, 25 Medicare payers representing 42.3 million lives and 25 endocrinologists about their management and prescribing of growth hormones, as well as long-acting vs. short-acting growth hormones.

Payers covering 56% of commercial lives said that managing branded growth hormone treatments was an average priority for them, while those with only 1% of lives said it was a very high priority. Those representing 45% of Medicare lives gave the therapies an average management priority, but those with 19% of Medicare beneficiaries said it was a very high priority.

Both AIS Health and Zitter Insights are divisions of MMIT.

Respondents with 45% of commercial lives expressed high satisfaction with available treatments, while those with 71% of Medicare lives rated their level of satisfaction similarly. Sixty percent of endocrinologists ranked their level of satisfaction as average.

When it comes to the long-acting growth hormones, payers with 74% of commercial lives and 53% of Medicare ones said that net price is significantly influential in their choice to prefer those agents over short-acting growth hormones. Respondents with 54% of commercial lives and 35% of Medicare lives said that once-weekly dosing was influential in preferring the long-acting agents.

When asked about potential strategies to manage long-acting agents, payers with the most beneficiaries said they would prefer at least one long-acting agent at parity with preferred short-acting treatments (see chart).

Only 4% of endocrinologists said they were not at all comfortable prescribing long-acting growth hormones. Around one-third of the respondents said they were somewhat likely to prescribe those therapies to new patients, as well as to switch over patients on short-acting agents to them. Endocrinologists said that once-weekly dosing and efficacy of the long-acting agents were the top factors that could persuade them to prescribe those treatments.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jkettler@mmitnetwork.com.

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