MMIT Reality Check on Neutropenia
A review of market access for neutropenia treatments shows that under the pharmacy benefit, about 45% 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 74% of the lives under commercial policies are covered with utilization management restrictions. Almost 57% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.
For about 85% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about half require multiple steps. Around 67% of payer-controlled pharmacy benefit covered lives require prior authorization, with 27% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
FDA Rejects Plinabulin
In a move that demonstrates just how quickly things can change in the prescription drug world, one of the five drugs featured in OptumRx’s latest quarterly Drug Pipeline Insights Report was rejected by the FDA not long after the report went live in late November 2021.
The rejected drug in question is plinabulin, which was being developed to prevent chemotherapy-induced neutropenia (CIN) — a condition in which patients have an abnormally low amount of a certain type of white blood cell. The FDA sent a response letter to plinabulin’s manufacturer, BeyondSpring Pharmaceuticals, on Dec. 1, stating that the results of a single registrational trial conducted by the company was not sufficiently robust to demonstrate the drug’s benefit and that a second, well-controlled trial “would be required to satisfy the substantial evidence requirement to support the CIN indication,” according to the drugmaker.
FDA Approves Nyvepria
In June 2020, the FDA approved Pfizer Inc.’s Nyvepria (pegfilgrastim-apgf) to decrease the incidence of infection, as manifested by febrile neutropenia, in people with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It was the fourth approved biosimilar of Amgen, Inc.’s Neulasta (pegfilgrastim).
FDA Approves Ziextenzo
In November 2019, the FDA approved Novartis Pharmaceuticals Corp. unit Sandoz’s Ziextenzo (pegfilgrastim-bmez) to decrease the incidence of infection, as manifested by febrile neutropenia, in people with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It is a biosimilar of Amgen’s Neulasta (pegfilgrastim).
Market Events Drive Changes
In June 2020, the FDA approved Pfizer Inc’s Nyvepria (pegfilgrastim-apgf) to decrease the incidence of infection, as manifested by febrile neutropenia, in people with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. In November 2019, the agency approved Ziextenzo (pegfilgrastim-bmez) from Novartis unit Sandoz Inc. as a treatment for this condition. These biosimilars of Amgen, Inc.’s Neulasta (pegfilgrastim) joined two other biosimilars of the drug on the U.S. market. Multiple biosimilars of Amgen’s Neupogen (filgrastim) are also available.
Competitive Market Landscape
This is becoming a crowded market. 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. Neupogen competitor Granix (tbo-filgrastim) from Teva Pharmaceutical Industries Ltd. and biosimilar Zarxio (filgrastim-sndz) from Sandoz are doing very well in terms of coverage and are taking market share from Neulasta and Neupogen.
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. While PAs are common, step edits are limited.
Key Players in Market: