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 oncologists have indicated that they are willing to prescribe it in place of other neutropenia agents, according to Zitter Insights.
On Sept. 9, 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 company developed the drug with South Korea’s Hanmi Pharmaceutical Co. The recommended dose is 13.2 mg administered subcutaneously once per chemotherapy cycle. The company says it expects the product to be available in fourth-quarter 2022. It has not revealed the agent’s price yet.
Other neutropenia treatments include Amgen Inc.’s Neupogen (filgrastim), first approved in 1991, and Neulasta (pegfilgrastim), its longer-acting formulation approved in 2002, as well as biosimilars of both agents. As of mid-October 2022, the FDA had approved three Neupogen biosimilars and six of Neulasta, although not all of them had launched by AIS Health press time.
For the Managed Care Oncology Index: Q2 2020, from June 1, 2020, to June 30, 2020, Zitter Insights polled 51 commercial payers covering 129.6 million lives about their management of neutropenia. Once Rolvedon — which previously was known as Rolontis — launches, payers with 51% of lives said they expect to manage the new agent at parity with branded Neulasta.
Zitter Insights and AIS Health are both MMIT companies.
However, respondents with more than three-quarters of lives said it was unlikely that they would prefer the new G-CSF over all other pegfilgrastim agents. Similarly, those covering 83% of lives said it was doubtful that they would prefer Rolvedon over all other neutropenia agents, while those representing 85% of lives said they were not likely to prefer the new product over some pegfilgrastim therapies. Payers covering 20% of lives said that after Rolvedon launches, they likely would not cover Neulasta. Those with 12% of lives said it was possible that they would not cover the new agent.
During the same time frame, Zitter Insights polled 51 oncologists. While many of them were undecided in how they would prescribe Rolvedon and the other neutropenia agents after the new G-CSF launches, 31% said they were likely to prescribe the new agent over Neulasta (see chart). About a quarter of the respondents said it was possible that they would prescribe the new drug in place of all pegfilgrastim biosimilars, as well as in place of all other neutropenia agents.
For more information on the Zitter Insights data, contact Jill Brown Kettler at email@example.com.