Specialty Drugs

PBM Moves Spur Humira Biosimilar Uptake but Raise Questions

The FDA has approved 10 biosimilars of AbbVie Inc.’s Humira (adalimumab), with nine of them launching in the U.S. since last year, but uptake of them has been relatively slow. Recently, though, a formulary change by CVS Health Corp. seems to have spurred uptake of the agents, and an upcoming change by The Cigna Group should increase their use again. However, some industry experts question whether those changes were made with an eye on increasing biosimilar access — or boosting their own profits.

On April 25, Evernorth Health Services, a subsidiary of Cigna, revealed that it will have a high- and low-concentration interchangeable Humira biosimilar for zero out-of-pocket costs for “eligible patients” of its specialty pharmacy, Accredo, starting in June. The product, according to a press release, “will be produced for Evernorth’s affiliate private label pharmaceutical distributor, Quallent Pharmaceuticals, through agreements with multiple manufacturers.”

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Older Drug Gets New Indication for Use in Aggressive Cancer

A drug that the FDA first approved more than a decade ago was recently approved for the first-line treatment of an aggressive blood cancer. One clinical trial showed that people on the agent experienced complete remission more than twice as often as those on a comparator therapy.

On March 19, the FDA gave accelerated approval to Takeda Pharmaceuticals U.S.A., Inc.’s Iclusig (ponatinib) in combination with chemotherapy for the treatment of adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The newest application had priority review and orphan drug designation, and its review used the Real-Time Oncology Review and the Assessment Aid.

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News Briefs: Amylyx Is Withdrawing ALS Drug Relyvrio in U.S., Canada

Amylyx Pharmaceuticals, Inc. said on April 4 that it was voluntarily discontinuing the marketing authorization for Relyvrio (sodium phenylbutyrate and taurursodiol) in the U.S. and in Canada, where it is known as Albrioza. As part of a restructuring, the company also is laying off about 70% of its workforce. The FDA approved the agent for the treatment of amyotrophic lateral sclerosis (ALS) on Sept. 29, 2022, based on data from a Phase II trial involving 137 people. But on March 8, the company revealed that its Phase III PHOENIX trial did not meet the prespecified primary or secondary endpoints. Prior to the drug’s approval, the FDA’s Peripheral and Central Nervous System Drugs Advisory committee found that the study did not provide substantial evidence that the therapy was effective, but during a second meeting in September reversed course in favor of approval. At the time of Relyvrio’s approval, Amylyx co-founder and co-CEO Justin Klee declared that “if the PHOENIX trial is not successful, we will do what's right for patients, which includes taking the drug voluntarily off the market.” The company will not allow any new prescriptions for the drug, but it will transition current patients who wish to remain on treatment with Relyvrio to a free drug program. Amylyx will present topline data from the PHOENIX trial at the American Academy of Neurology Annual Meeting in Denver on April 16.

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New FDA Approvals: FDA Approves BeiGene’s Tevimbra

March 13: The FDA approved BeiGene, Ltd.’s Tevimbra (tislelizumab-jsgr) for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a programmed death receptor-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor. Recommended dosing for the PD-1 inhibitor is 200 mg via intravenous infusion once every three weeks. The initial dose is administered over 60 minutes; if it is tolerated, subsequent doses can be administered over 30 minutes. The drug will be available in the second half of 2024.

March 13: The FDA gave an additional indication to Mirum Pharmaceuticals, Inc.’s Livmarli (maralixibat) for the treatment of cholestatic pruritus in people at least 5 years old with progressive familial intrahepatic cholestasis (PFIC). The agency first approved the ileal bile acid transporter inhibitor on Sept. 29, 2021. The new indication has orphan drug designation, as well as breakthrough therapy designation for PFIC type 2. The starting dose for the newest use of the oral solution is 285 mcg/kg once daily in the morning, increasing to 285 mcg/kg twice daily, then 428 mcg/kg twice daily and then 570 mcg/kg twice daily. Drugs.com lists the price of 9.5 mg/mL for 30 milliliters as more than $56,239.

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Final 2025 NBPP Addresses Copay Maximizers, Is Silent on Accumulators

While CMS has thus far declined to take action on companies using copayment accumulators, the agency is moving forward to prohibit the use of a similar type of program, it revealed in the final 2025 Notice of Benefit and Payment Parameters (NBPP). Still, the rule — at least at this point — applies only to certain plan sponsors, and it is unclear how manufacturer patient assistance ultimately will be treated.

Several years ago, health plans and PBMs began implementing copay accumulators to counter manufacturer copay assistance programs. A next-generation version of these tools known as copay maximizers soon followed.

Before these tools, manufacturer assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year.

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CarelonRx Gains Scale, Limited-Distribution Contracts Via Kroger Specialty Pharmacy

The Kroger Company recently revealed that it had entered into a definitive agreement to sell Kroger Specialty Pharmacy to CarelonRx, a subsidiary of Elevance Health, Inc, formerly known as Anthem, Inc. The deal, say industry experts, allows Kroger to focus on retail pharmacy while bringing scale and coveted limited-distribution contracts to CarelonRx as it seeks to establish a stronger footing within the specialty space.

Unveiled March 18, the deal is expected to close in the second half of this year. It does not include Kroger’s in-store retail pharmacies and The Little Clinics. CarelonRx, formerly known as IngenioRx, operates within Carelon, Elevance’s health care services brand that serves one in three people across 50 states.

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Budgets Propose Eliminating Interchangeability Status for Biosimilars

When then-President Barack Obama signed the Affordable Care Act (ACA) into law on March 23, 2010, he established the 351(k) biosimilar pathway via the Biologics Price Competition and Innovation Act (BPCIA), which amended the Public Health Service (PHS) Act. Since then, the FDA has approved almost 50 biosimilars, with nearly one fifth of those gaining interchangeable status. That distinction, however, has been increasingly under fire, most recently in President Biden’s fiscal year (FY) 2025 budget, which proposes eliminating the interchangeability designation entirely. That could help boost uptake of biosimilars, resulting in prescription drug savings, say some industry experts.

In contrast to the EU, whose European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) clarified in September 2022 that all biosimilars approved in the EU are interchangeable, the FDA has created two levels of biosimilars: biosimilars and interchangeable biosimilars.

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Pharma Takes Aim at New Legal Foe: State Drug Affordability Boards

Prescription drug affordability boards (PDABs) have been rising in popularity as a way for states to tamp down on soaring drug prices. But a recent lawsuit filed by one drugmaker and public remarks from the industry’s main trade group make it clear that the pharma sector sees such boards — and the price caps some are authorized to set — as a major threat.

In a suit filed on March 22, Amgen Inc. takes aim at Colorado’s Prescription Drug Affordability Review Board, which is the closest to becoming the first state board to set an upper payment limit (UPL) on a drug. The state in late February initiated formal rulemaking to set a UPL for Enbrel (etanercept), Amgen’s rheumatoid arthritis treatment, after determining it was unaffordable.

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Pharma Takes Aim at New Legal Foe: State Drug Affordability Boards

Prescription drug affordability boards (PDABs) have been rising in popularity as a way for states to tamp down on soaring drug prices. But a recent lawsuit filed by one drugmaker and public remarks from the industry’s main trade group make it clear that the pharma sector sees such boards — and the price caps some are authorized to set — as a major threat.

In a suit filed on March 22, Amgen Inc. takes aim at Colorado’s Prescription Drug Affordability Review Board, which is the closest to becoming the first state board to set an upper payment limit (UPL) on a drug. The state in late February initiated formal rulemaking to set a UPL for Enbrel (etanercept), Amgen’s rheumatoid arthritis treatment, after determining it was unaffordable.

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With Kroger Specialty Purchase, Elevance Closes Gap in Race With Health Service Giants

Elevance Health Inc. plans to buy Kroger Co.’s specialty pharmacy division, the firms revealed on March 18, in a deal that closely follows Elevance’s purchase off Paragon Healthcare, Inc., an infusion center provider. Health care insiders say that the Kroger deal is a shrewd play for Elevance, which in recent years has sought to expand its Carelon health services arm, particularly the CarelonRx PBM.

The deal could help Elevance catch up with other major insurers. Elevance, a for-profit Blue Cross and Blue Shield affiliate, lags behind its publicly traded managed care competitors, such as The Cigna Group, CVS Health Corp. and UnitedHealth Group, in health services revenue. All three health services divisions, respectively Evernorth, Caremark and Optum, include a major PBM and lucrative specialty pharmacy divisions that serve both their own plans and payers outside their own enterprise. Cigna and CVS's care management divisions had higher revenues and earnings than their insurance divisions in the fourth quarter of 2023, which is often the case for those firms.

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