Radar on Specialty Pharmacy
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New FDA Approvals: FDA Approves First Abraxane Generic
Oct. 8: The FDA approved Sandoz Inc.’s paclitaxel for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. It is the first FDA-approved generic of Abraxane from Abraxis BioScience LLC, a division of Bristol Myers Squibb. The agent is available as a 100 mg single-dose vial of lyophilized powder. Recommended dosing is 260 mg/m2 via a 30-minute intravenous infusion every three weeks. Drugs.com lists the price of one 100 mg vial of Abraxane as more than $1,673. -
News Briefs: Gilead Withdraws Trodelvy in Urothelial Cancer
Gilead Sciences Inc. is voluntarily withdrawing the U.S. accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, the company said on Oct. 18. Other indications for the Trop-2-directed antibody-drug conjugate are not affected. The FDA granted the accelerated approval on April 13, 2021, based on tumor response rate and duration of response in a Phase II single-arm trial. Earlier this year, the company revealed that a Phase III confirmatory trial did not meet the primary endpoint of overall survival in the intention-to-treat population. -
PBM Private-Label Units Bring Promise of Biosimilar Competition, Scrutiny
At the beginning of next year, the last of the Big Three PBMs will join the others in offering a new private-label subsidiary. Those units, which are largely focused on biosimilars and generics, have the potential to boost biosimilar competition and improve pricing, but such arrangements also are drawing scrutiny, most recently from the Senate Finance Committee.
On Jan. 1, 2025, UnitedHealth Group’s Optum Rx will place Nuvaila-labeled biosimilars of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine and AbbVie Inc.’s Humira (adalimumab) on various tiers of three of its commercial formularies for a zero-dollar copay. In partnership with Amgen Inc. for its interchangeable Wezlana (ustekinumab-auub), Wezlana for Nuvaila will be available in both high-wholesale acquisition cost and low-WAC versions.
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CMS Places All No-Cost PrEP Coverage in Medicare Part B
After taking several steps to prepare — including releasing a fact sheet, posting a technical frequently asked questions for pharmacies and launching an informational website for health care providers — CMS on Sept. 30 issued a final National Coverage Determination on Medicare coverage of HIV pre-exposure prophylaxis (PrEP). Effective immediately, coverage for PrEP will be under Medicare Part B — including oral agents previously covered under Part D — where it will be available at no cost to beneficiaries, a move that should increase adherence to treatment, industry experts say.
“At face value, moving coverage to Part B helps ensure that all Medicare recipients will have access to the HIV PrEP, as opposed to depending upon patients with stand-alone or carved-out prescription benefits to access PrEP through their prescription benefit,” observes Winston Wong, Pharm.D., president of the W-Squared Group. “I don’t believe there is any question of coverage since CMS issued an NCD, which mandates all Part D plans meet the minimum coverage requirements; however, I don’t believe carve-out prescription benefits for retirees are required to provide comparable coverage to CMS.”
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Flexible CAR-T Monitoring Period Could Help With Post-Treatment Barriers
In the seven years since the approval of the first chimeric antigen receptor T-cell (CAR-T) therapy, the agents have proved to be effective in the treatment of non-Hodgkin lymphoma. But the one-time-use agents come with risks, including the potentially fatal cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), so the FDA requires patients remain near their treatment center for four weeks after administration, which can be onerous for patients. But a recent study finds that side effects were rare after the first two weeks post-infusion, perhaps helping lead to less of a burden for patients.
An article in Blood Advances, a journal of the American Society of Hematology, revealed the findings of a retrospective study of 475 patients who received three CD19-directed CAR-Ts at nine different centers: Yescarta (axicabtagene ciloleucel) from Gilead Sciences Inc. subsidiary Kite Pharma, Inc., Novartis Pharmaceuticals Corp.’s Kymriah (tisagenlecleucel) and Breyanzi (lisocabtagene maraleucel) from Juno Therapeutics, Inc., a Bristol Myers Squibb company.