MMIT Reality Check on Neutropenia (1Q2023)

Payer Coverage:

A review of market access for neutropenia treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions. Around 56% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 69% of the lives under commercial policies are covered with utilization management restrictions. Almost 54% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 79% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 51% require multiple steps. Around 69% of payer-controlled pharmacy benefit covered lives require prior authorization, with 37% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

Oncologists May Prescribe New Neutropenia Agent Over Others in Class, but Therapy Faces Another Challenge

The FDA recently approved the first novel long-acting granulocyte colony-stimulating factor (G-CSF) in more than 20 years. Payers say they are likely to manage the new agent similar to existing ones, but some oncologists have indicated that they are willing to prescribe it in place of other neutropenia agents, according to Zitter Insights. Still, the leader in the space has a unique quality that has allowed it to continue to retain market share, which may prove challenging for the new drug — at least for the time being.

FDA Approves Rolvedon

In September 2022, the FDA approved Spectrum Pharmaceuticals, Inc.’s Rolvedon (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. The manufacturer says it is the first novel long-acting granulocyte colony-stimulating factor (G-CSF) approved in more than 20 years. The recommended dose is 13.2 mg administered subcutaneously once per chemotherapy cycle.

FDA Approves Stimufend

In September 2022, the FDA approved Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk) to decrease the incidence of infection, as manifested by febrile neutropenia, in people with nonmyeloid malignancies who are receiving anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) that the agency has approved. Recommended dosing of the subcutaneous injection is 6 mg once per chemotherapy cycle.

Key Findings:

Market Events Drive Changes

In September 2022, the FDA approved Spectrum Pharmaceuticals, Inc.’s Rolvedon (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. In the same month, the agency also approved Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk) to decrease the incidence of infection, as manifested by febrile neutropenia, in people with nonmyeloid malignancies who are receiving anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) that the agency has approved.

Competitive Market Landscape

This is becoming a crowded market, with 14 approved filgrastim/pegfilgrastim products and two additional pegfilgrastim biosimilars from Lupin and Tanvex BioPharma, Inc. expected to be reviewed in 2023. Multiple other companies have filed applications with the FDA, and more treatments are in the pipeline. The surge of pipeline biosimilars will mean increased competition.

Pharmacy, Medical Benefit Implications

Coverage can span the pharmacy and medical benefits with self- and provider administration options. The majority of prior authorizations (PAs) will require diagnosis, risk factors for developing febrile neutropenia and dose requirements. As the market grows and competition increases, a preferred product and step restrictions policies are emerging.

Key Players in Market:

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