News Briefs: GoodRx Offers Adalimumab-adbm for $550

GoodRx will offer Boehringer Ingelheim’s adalimumab-adbm, a biosimilar of AbbVie Inc.’s Humira (adalimumab), at a cash price of $550 per two-pack, revealed the companies on July 18. The price for the citrate-free biosimilar is 92% off that of its reference drug. It is available in both high-concentration and low-concentration formulations. The FDA has approved the 50 mg/mL version as interchangeable with Humira. Consumers may purchase the lower-cost tumor necrosis factor (TNF) inhibitor — which also is available as brand drug Cyltezo — at more than 70,000 retail pharmacies across the U.S.

Walmart is opening 25 new autoimmune-focused Specialty Pharmacies of the Community (SPOC) across five states, said Kevin Host, Pharm.D., senior vice president of pharmacy at Walmart Health and Wellness Pharmacy, on July 25. In October 2023, the company launched six SPOC, which are now available in nine states: Alabama, Idaho, Louisiana, New York, Oregon, Pennsylvania, Rhode Island, Texas and Wisconsin.

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PSG Report: Cost Per Claim Played Bigger Role; Rebates Had Smaller Impact

Some findings from the new report by Pharmaceutical Strategies Group (PSG), an EPIC company, may have seemed like old news: AbbVie Inc.’s Humira (adalimumab) was the top specialty drug in terms of spend. Inflammatory treatments dominated the top 10 of those agents. But the 2024 Artemetrx State of Specialty Spend and Trend Report, released July 25, also revealed some new findings, including that rebates had a smaller impact in 2023 than they did the previous year and that cost per claim played a bigger role in the 2023 specialty drug trend than it did in the prior time frame.

PSG based the report — which is sponsored by Walmart Specialty Pharmacy — on integrated pharmacy and medical claims data from the book of business for its proprietary SaaS platform Artemetrx. In its eighth year, the newest report is based on 138 million medical claims and 136 million pharmacy claims. The findings are based mainly on commercial health plans.

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Employer Panel Stresses Specialty Drug Management, PBM Bidding

When benefits managers from a range of employers gathered at the Midwest Business Group on Health’s (MBGH) recent forum in Chicago, the final session of the day revealed that specialty drugs were some of their top concerns. And it appears employers are getting savvier about managing them.

A big focus of the conference was benefits managers’ fiduciary duty to their employees — and how shirking that duty could land them in hot water.

“If you haven't done a market check, do a market check,” recommended Dan Dentzer, manager of health and wellness design for United Airlines, at the June 26 MBGH Employer Forum on Pharmacy Benefits, Specialty and Biopharma Therapies. “I do market checks like I change my socks because you have to know what's going on out there. You have to know what others are doing. You have to know you're getting the best deal possible. If you haven't done that, please do.”

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Report Reveals Plan Sponsor Uncertainty Around CGTs’ Impact

With more than 4,000 cell and gene therapies (CGTs) in development, plan sponsors should not be ignoring or underestimating the potential impact of these agents, not only on their beneficiaries’ health but also on their own bottom lines. A recent report by Pharmaceutical Strategies Group (PSG), an EPIC company, found that some improvement is needed in this area.

Sponsored by Prescryptive Health and published June 11, “2024 Trends in Drug Benefit Design Report” examines trends among traditional — or nonspecialty — drug benefits, as well as gene therapies.

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Collaborative Launches Employer Guide for Oncology Management

Cancer has become the top condition driving costs for employers, and a recent report found that most of them expect their annual spend on the condition will increase by up to 9% each year over the next three years. Last fall, the Midwest Business Group on Health and the Florida Alliance for Healthcare Value, in collaboration with MBGH employer members, shared information around the management of oncology benefits with an eye on making sure that the right care is given to the right person at the right place, right time and right price, for both the employer and the member.

Among the topics of discussion for the Oncology Learning Collaborative were prevention, including screening and early identification; navigation, including psychosocial support and return to work; and diagnosis, including a second opinion, biomarkers and treatment.

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Shot and Chaser: FTC Issues PBM Report, Reportedly Plans Lawsuit

When the Federal Trade Commission on July 9 released an interim report based on its yearslong investigation of PBMs, criticism of the document abounded, with even an FTC Commissioner saying it wasn't nearly comprehensive enough to publish. However, one day later the FTC appeared to prove its critics wrong, with the Wall Street Journal reporting that it plans to sue the three largest PBMs over their business practices related to the rebates they negotiate with drug manufacturers for products like insulin.

The FTC has not yet confirmed the WSJ report, which cited a person familiar with the matter. But it would not be the first time the federal government attempted to reform how PBMs treat drug rebates. The Trump administration proposed a rule in 2019 that would have effectively forced PBMs to pass negotiated rebates on to consumers at the point of sale in Medicare Part D and managed Medicaid, but it later tabled the regulation.

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New FDA Approvals: FDA Expanded Almirall’s Klisyri Treatment Area

June 7: The FDA expanded the treatment area of Almirall, LLC’s Klisyri (tirbanibulin) from up to 25 cm2 of the face or scalp to up to 100 cm2 for the treatment of adults with actinic keratosis. The agency first approved the microtubule inhibitor on Dec. 14, 2020. Dosing is one unit-dose packet on the face or scalp once daily for five consecutive days. Drugs.com lists the price of five packets of the ointment as more than $1,179.

June 10: The FDA gave another indication to Sanofi and Regeneron Pharmaceuticals, Inc.’s Kevzara (sarilumab) for the treatment of people weighing at least 63 kg with active polyarticular juvenile idiopathic arthritis. The agency initially approved the interleukin-6 (IL-6) receptor antagonist on May 22, 2017. The recommended dose is 200 mg via subcutaneous injection every two weeks. Drugs.com lists the price of both the 150 mg/1.14 mL and 200 mg/1.14 mL as more than $4,582.

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Biosimilars Market Is Becoming More Active but Still Faces Issues

In May, the FDA approved three interchangeable biosimilars that were the first for their reference drugs. With an additional three approvals in June, that brings the total number of biosimilars to 57 since the agency’s green lighting of Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. With the three agents approved in May also gaining interchangeability status, that brings the count of interchangeable biosimilars to 15. While the market is certainly heating up, it still is grappling with issues such as expected rebates, maintains one industry expert.

On May 20, the FDA approved the first biosimilars of Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept): Biocon Ltd. subsidiary Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf) and Samsung Bioepis Co., Ltd. and Biogen Inc.’s Opuviz (aflibercept-yszy). On June 28, the FDA approved a third Eylea biosimilar, Formycon AG and Klinge Biopharma GmbH’s Ahzantive (aflibercept-mrbb) for the same indications as the first two agents, but it does not have interchangeable status.

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FDA Proposes Doing Away With Biosimilar Switching Studies for Interchangeability

When the biosimilar pathway was first established, it created a two-tier system of biosimilars and interchangeable biosimilars, but multiple attempts have been made recently to level the playing field. In the latest move, the FDA proposed doing away with switching studies for interchangeables. But while the move could bring biosimilars onto the U.S. market faster and result in more competition, industry efforts are divided about whether it could prompt broader payer uptake.

As part of the Affordable Care Act (ACA), the Biologics Price Competition and Innovation Act of 2009 (BPCIA) amended the Public Health Service (PHS) Act and established section 351(k), which outlines the requirements for a proposed biosimilar product and a proposed interchangeable biosimilar product. Physicians must specifically prescribe biosimilars without interchangeable status, but when a biosimilar is approved as interchangeable, that drug may be substituted at the site of care or dispensing for its reference product by a dispensing pharmacist or practitioner without the involvement of the prescribing physician.

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News Briefs: BCS Financial Unveils Gene Therapy Rider

BCS Financial Corp. unveiled the Gene Therapy Rider on its EssentialCare Critical Illness insurance policy, the company said on June 18. The offering by the insurance and financial services company, which is owned by all 34 Blues plans, can pay the entire policy face value amount when a beneficiary is diagnosed with a covered disease and chooses to undergo treatment with an FDA-approved gene therapy. “The payments, which are based on the policy's face value, are made directly to the insured to use how they see fit,” says the company.

Prime Therapeutics LLC and Magellan Rx Management launched the technology-enabled specialty pharmacy solution Pharmacy Match, the companies said June 19. The offering, which is powered by Free Market Health’s cloud-based technology platform, is designed to drive competition by comparing prices across the market for specialty drugs and identifying the specialty pharmacy “best suited to meet their needs.” It also tracks each claim through fulfillment.

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