Biosimilars

Co-Branding Could Offer Better Formulary Placement, Shift From Rebating

All of the Big Three PBMs have added private-label subsidiaries into their fold that are working closely with some manufacturers. And while industry experts say that the companies offer certain benefits to the U.S. health care system overall, questions about them remain. Still, the entities could offer benefits to their pharma partners, including better formulary positioning and potentially even moving away from rebates.

Two of the companies, both based in Ireland, seem to be mainly, if not exclusively, focused on biosimilars, starting with those of AbbVie Inc.’s best-selling Humira (adalimumab).

0 Comments
© 2024 MMIT

News Briefs: Blue Shield of California Will Offer $0 Co-Pay Humira Biosimilar

Starting on Jan. 1, 2025, most Blue Shield of California commercial plan enrollees will have access to a Humira (adalimumab) biosimilar with a $0 copay as part of the insurer’s Pharmacy Care Reimagined model. Blue Shield announced the initiative on Oct. 1 and said it would partner with Fresenius Kabi, which manufactures a Humira biosimilar, and Evio Pharmacy Solutions, a company that Blue Shield and other Blues plans founded in 2021. As part of the agreement, Blue Shield will purchase the Humira biosimilar for a monthly price of $525, significantly below the net price of $2,100 per month for branded Humira. Blue Shield revealed the Pharmacy Care Reimagined model in August 2023 and noted it would shift from a traditional PBM contract with CVS Health Corp.’s Caremark to a pharmacy benefits arrangement with five different vendors.

0 Comments
© 2024 MMIT

PBM Private-Label Units Are Drawing Pharma Contracting, Scrutiny

The last of the so-called Big Three PBMs recently joined the others in offering a new private-label subsidiary when it unveiled upcoming changes to its commercial formularies. Those units, which are largely focused on biosimilars and generics, may offer benefits to pharma companies partnering with them, but such arrangements also pose potential risks as the offerings are already drawing scrutiny.

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.

0 Comments
© 2024 MMIT

Comments on FDA Interchangeability Draft Guidance Run the Gamut

Over the last few years, the FDA has taken multiple steps to level the playing field between biosimilars and interchangeable biosimilars. More recently, it proposed draft guidance that would do away with switching studies for interchangeability status. Commenters on that guidance were mostly supportive — with some even backing interchangeability for all biosimilars — and others asked for clarification on a range of issues, including what information the FDA needed to make a determination of interchangeability. Meanwhile, one group derided the guidance as an “ill-advised and inappropriate move.”

0 Comments
© 2024 MMIT

Study Finds Promising Impact of Health Plans Warming Up to Biosimilars

In recent years, commercial health plans have increasingly opted to place both biosimilars and their reference biologics on preferred tiers in their formularies, according to a recent Health Affairs study.

The researchers analyzed coverage and market share for seven biologics — also known as “originator products” — and 20 corresponding biosimilars from the Tufts Medical Center Specialty Drug Evidence and Coverage Database and the IQVIA Longitudinal Access and Adjudicated Data Set from August 2017 to August 2022. The study categorized the payers’ coverage policies as:

0 Comments
© 2024 MMIT

New FDA Approvals: FDA Approved Citius’ Lymphir for CTCL

Aug. 7: The FDA approved Citius Pharmaceuticals, Inc.’s Lymphir (denileukin diftitox-cxdl) for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one systemic therapy. The immunotherapy is the only CTCL treatment that targets the interleukin-2 (IL-2) receptor found in T-cell lymphomas and regulatory T cells (Tregs). The rare disease is a chronic non-Hodkin lymphoma that primarily affects the skin. The drug is a reformulation of Ontak (denileukin diftitox), which was on the U.S. market from 2008 to 2014, when it was voluntarily withdrawn “to enable manufacturing improvements.” The FDA gave the therapy orphan drug designation. The recommended dose is 9 mcg/kg per day based on actual body weight via a 60-minute intravenous infusion on days one through five of a 21-day cycle. The company says it expects to launch the agent within the next five months.

0 Comments
© 2024 MMIT

News Briefs: CVS Challenges Lawmaker’s Claim of False Testimony

After the chairman of a key House committee accused three top PBM executives of giving “fraudulent testimony,” one of those companies is hitting back. The heads of CVS Health Corp.’s Caremark, The Cigna Group’s Express Scripts and UnitedHealth’s Optum Rx testified before the House Committee on Oversight and Accountability on July 23 to defend their companies against skeptical lawmakers. In late August, committee Chairman James Comer (R-Ky.) sent letters to CVS’s David Joyner, Express Scripts’ Adam Kautzner and Optum Rx’s Patrick Conway, M.D., offering them an opportunity to “correct the record” regarding statements they made, such as Joyner’s assertion that Caremark pays CVS-affiliated pharmacies less than other pharmacies in its network. In a Sept. 10 letter, Caremark responded by asserting that Joyner’s testimony was “accurate and supported by comprehensive analyses of CVS Caremark’s data by an outside economist.”

0 Comments
© 2024 MMIT

Evernorth Reveals Stelara Biosimilar Strategy, but Will Others Get Same Discount?

Ahead of the much-anticipated launch of the next wave of biosimilars for a high-cost specialty drug, The Cigna Group’s Evernorth Health Services has said that it will roll out a program to manage the drugs that is similar to one it first began offering this summer. But several aspects of the upcoming launch remain unclear, including whether the discount provided for the new drug will be available to all payers.

Evernorth revealed on Sept. 5 that it will offer an interchangeable biosimilar of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine for $0 for “eligible patients” of Accredo starting “early next year.” The agent will be produced by Quallent Pharmaceuticals, Cigna’s private-label subsidiary.

The new agent’s price will be more than 80% less than Stelara’s list price. “For many employers, unions, municipalities and other health plan sponsors that choose to work with Accredo as part of their specialty pharmacy network offering, this represents an opportunity for significant savings,” said Evernorth in a press release.

0 Comments
© 2024 MMIT

Study Finds Promising Impact of Health Plans Warming Up to Biosimilars

In recent years, commercial health plans have increasingly opted to place both biosimilars and their reference biologics on preferred tiers in their formularies, according to a recent Health Affairs study.

The researchers analyzed coverage and market share for seven biologics — also known as “originator products” — and 20 corresponding biosimilars from the Tufts Medical Center Specialty Drug Evidence and Coverage Database and the IQVIA Longitudinal Access and Adjudicated Data Set from August 2017 to August 2022.

0 Comments
© 2024 MMIT

News Briefs: Otezla for Pediatric Use Is Now Available

Otezla (apremilast) is available in the U.S. for the treatment of pediatric patients 6 to 17 years of age and weighing at least 20kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, Amgen Inc. said Aug. 20. The FDA approved the agent for that use on April 25 while also registering an additional packaging facility to support new packaging configurations for the pediatric population.

0 Comments
© 2024 MMIT