MMIT Reality Check on Growth Hormone Deficiency (2Q2023)

Payer Coverage:

A review of market access for treatments for people with growth hormone deficiency shows that under the pharmacy benefit, about 49% of the lives under commercial formularies are covered with utilization management restrictions. Around 42% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 37% of the lives under commercial policies are covered with utilization management restrictions. Only 7% of the lives under health exchange policies have access to at least one of the drugs without utilization management restrictions.

For about 67% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 34% of the lives require multiple steps. Around 81% of payer-controlled pharmacy benefit covered lives require prior authorization, with 46% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Skytrofa

In August 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. It is the first long-acting growth hormone that the agency has approved for this indication. The recommended dose is 0.24 mg/kg body weight once weekly.

FDA Approves Sogroya

In August 2020, the FDA approved Novo Nordisk, Inc.’s Sogroya (somapacitan-beco) for the replacement of growth hormone in adults with growth hormone deficiency. The FDA says it is the first human growth hormone to be dosed weekly instead of daily. Dosing starts at 1.5 mg once weekly via subcutaneous injection; dosing is to be increased 0.5 mg to 1.5 mg for a maximum dose of 8 mg until a desired response is achieved.

Sogroya May Change Prescribing in GH Class

When the FDA approved Novo Nordisk, Inc.’s Sogroya (somapacitan-beco) for the replacement of growth hormone in adults with growth hormone deficiency in August, it became the only long-acting agent with that distinction. A survey by Zitter Insights shows that many endocrinologists expect to shift prescribing to such agents from the short-acting growth hormones. And many payers say they expect to manage at least one long-acting agent at parity with short-acting growth hormones.

Key Findings:

Market Events Drive Changes

In August 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. It is the first human growth hormone (hGH) for children to be dosed weekly instead of daily. In August 2020, the agency approved Novo Nordisk, Inc.’s Sogroya (somapacitan-beco) for the replacement of growth hormone in adults with growth hormone deficiency (GHD). The FDA says it is the first hGH for adults to be dosed weekly instead of daily. The company has submitted the drug for approval in pediatric GHD as well. The PDUFA review is expected to happen in April 2023, which means Sogroya will likely be available on the market in the second quarter of 2023. Sogroya will represent direct competition for Skytrofa but will also have the benefit of being the only long-acting agent available for adult patients.

Competitive Market Landscape

Pediatric and adult GHD represents the largest market for recombinant growth hormones. The competitive landscape is driven largely by contracting, with most payers having preferred product(s). Patient choice is primarily driven by these treatments, as many payers require step through of the preferred product(s) before accessing any nonpreferred agents. Skytrofa, the first long-acting agent to hit the market, may see the same broad coverage as the short-acting therapies, or it may require a step through short-acting agent(s).

Pharmacy Benefit Implications

Drugs in this class are generally covered under the pharmacy and medical benefits with prior authorization (PA). Many products in this class are considered specialty drugs. Nearly all plans have a PA policy in place, with specific diagnosis requirements.

Key Players in Market:

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