Radar on Specialty Pharmacy

Amneal Pharmaceuticals, Inc. launched Fylnetra (pegfilgrastim-pbbk), the company said May 16. The granulocyte colony-stimulating factor is the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) to launch in the U.S. The FDA approved the drug on May 26, 2022, to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Its J-code is Q5130. It is the third biosimilar that Amneal has launched in the U.S.

Amgen settled a patent infringement lawsuit (No. 22-cv-1549) with Janssen Biotech Inc., a division of Johnson & Johnson, over a proposed biosimilar of Stelara (ustekinumab), Amgen revealed May 23. Stelara, a human interleukin-12 and -23 antagonist, is indicated for adults with moderate-to-severe plaque psoriasis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis, as well as people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 with active psoriatic arthritis. The FDA first approved it Sept. 25, 2009. Amgen said the settlement will allow its biosimilar to launch “no later than” Jan. 1, 2025.

Issues around so-called alternate funding companies that carve out specialty drugs have existed for several years now, but only recently has a manufacturer taken legal action against such a company. On May 5, AbbVie Inc. filed a lawsuit (1:23-cv-02836) against Payer Matrix, LLC in the U.S. District Court for the Northern District of Illinois Eastern Division over its “fraudulent and deceptive scheme to enrich itself by exploiting AbbVie’s PAP [patient assistance program] through the enrollment of insured patients into a charitable program not intended for them.”

AbbVie states that it is “bring[ing] this action to stop Payer Matrix’s harmful conduct and protect its program so it can continue to serve its intended purpose — providing free drugs to uninsured and underinsured patients who otherwise could not afford their AbbVie medicine.”

On May 5, AbbVie Inc. filed a lawsuit (1:23-cv-02836) against Payer Matrix, LLC in the U.S. District Court for the Northern District of Illinois Eastern Division over its “fraudulent and deceptive scheme to enrich itself by exploiting AbbVie’s PAP [patient assistance program] through the enrollment of insured patients into a charitable program not intended for them.”

Payer Matrix was not able to provide a comment on the lawsuit by press time. But prior to the filing and shortly before AbbVie updated its PAP language earlier this year, AIS Health, a division of MMIT, conducted an interview with Michael Jordan, Payer Matrix’s chief business officer (CBO), to learn more about the company’s practices.

Specialty drug management continues to be of utmost importance to plan sponsors, which are implementing a variety of levers to try to keep spending in check while making sure their beneficiaries are receiving appropriate care. Pharmaceutical Strategies Group (PSG), an EPIC company, recently released its 2023 Trends in Specialty Drug Benefits Report, which examines the use of these strategies and overall trends in managing these costly medications.

The report, released May 3, is the 10th annual report; it previously was published under the Pharmacy Benefit Management Institute (PBMI) brand. Conducted from Sept. 20, 2022, through Oct. 21, 2022, the survey included 182 benefits leaders from employers, unions/Taft-Hartley plans and health plans representing plan sponsors of approximately 86.7 million covered lives. Genentech USA, Inc., a member of the Roche Group, co-sponsored the report with PSG.

The FDA recently expanded the use of BeiGene, Ltd.’s Brukinsa (zanubrutinib) to include its use in the treatment of a hematologic cancer. The agent is already approved for three other rare types of non-Hodgkin lymphoma. Respondents to a Zitter Insights survey said that while its availability will result in a lower level of unmet need in the treatment of chronic lymphocytic leukemia (CLL), there is still moderate or high unmet need for the condition.

On Jan. 1, the FDA expanded the label of Brukinsa to include the treatment of adults with CLL or small lymphocytic lymphoma (SLL). CLL and SLL are the same disease, a type of non-Hodgkin lymphoma, except CLL cancer cells are mostly in the blood and bone marrow, while in SLL, the cells are mainly in the lymph nodes. CLL is the most common adult leukemia.