Specialty Drugs

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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FTC’s First Shot at PBMs Leaves Many Industry Critics Wanting More

When the Federal Trade Commission (FTC) on July 9 released an interim report based on its yearslong investigation of PBMs, criticism of the document was in no short supply.

The trade group representing major PBMs, the Pharmaceutical Care Management Association (PCMA), said the report “falls far short of being a definitive, fact-based assessment of PBMs or the prescription drug market.” And FTC Commissioner Melissa Holyoak, who voted against issuing the report, said during a House Energy & Commerce Committee hearing on July 9 that the report is not nearly comprehensive enough and “lacks economic and empirical evidence.”

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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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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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Report: Led by Anti-Inflammatories, Specialty Drugs Continue Upward Trend

Specialty drugs are still taken by only a small percentage of people but represent more than half of total drug costs. Anti-inflammatory specialty therapies continue to be a huge driver of those costs, according to the recently released 2023 Drug Trend Report from PBM analytics firm Xevant. The specialty pipeline remains strong, and payers should expect these agents to continue to affect their costs, says one industry expert.

Based on Xevant’s book of business for 2022 and 2023, the company observed an 11% increase in the number of prescriptions filled for specialty drugs. The plan-paid amounts for those agents rose 19%, slightly less than nonspecialty medications’ 22% plan-paid costs. In addition, the average plan cost per specialty prescription rose from $6,100 in 2022 to $6,700 in 2023.

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Report: Led by Anti-Inflammatories, Specialty Drugs Continue Upward Trend

Specialty drugs are still taken by only a small percentage of people but represent more than half of total drug costs. Anti-inflammatory specialty therapies continue to be a huge driver of those costs, according to the recently released 2023 Drug Trend Report from PBM analytics firm Xevant. The specialty pipeline remains strong, and payers should expect these agents to continue to affect their costs, says one industry expert.

Based on Xevant’s book of business for 2022 and 2023, the company observed an 11% increase in the number of prescriptions filled for specialty drugs. The plan-paid amounts for those agents rose 19%, slightly less than nonspecialty medications’ 22% plan-paid costs. In addition, the average plan cost per specialty prescription rose from $6,100 in 2022 to $6,700 in 2023.

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News Briefs: Multiple Developments Around Biosimilar Humiras Occurred

Multiple developments around biosimilar versions of AbbVie Inc.’s Humira (adalimumab) have occurred. Teva Pharmaceuticals, a unit of Teva Pharmaceuticals Industries Ltd., and Alvotech launched Simlandi (adalimumab-ryvk) in the U.S., the companies disclosed on May 20. The FDA approved the interchangeable, high-concentration, citrate-free drug on Feb. 23 for nine of its reference drug’s indications.…Boehringer Ingelheim said on May 13 that it had signed an agreement with Quallent Pharmaceuticals, a private-label pharmaceutical distributor that is a wholly owned subsidiary of The Cigna Group, to offer both high- and low-concentration, citrate-free versions of adalimumab-adbm through a copay assistance program. The tumor necrosis factor (TNF) inhibitor’s interchangeable designation applies to the low-concentration version. Boehringer will continue to commercialize that agent and its branded version, Cyltezo, which has approval for nine of Humira’s indications.…Celltrion USA has made its high-concentration, citrate-free adalimumab-aaty available at a low wholesale acquisition cost that is an 85% discount to Humira’s WAC, the company revealed on May 9. Its branded version, Yuflyma, remains available at a 5% discount to Humira’s WAC. The agent is approved for eight of Humira’s indications.

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How Will Beqvez Fare in Challenging Market for Cell and Gene Therapies?

The FDA recently approved the second gene therapy for hemophilia B, Pfizer Inc.’s Beqvez (fidanacogene elaparvovec-dzkt). While the agent offers an additional treatment option with the potential for freedom from regular infusions of factor therapy, its price — which is equal to that of its competitor — may be too high for many payers, according to a Zitter Insights survey. Industry experts say that it may suffer from some of the challenges other cell and gene therapies have faced in gaining a foothold in the U.S. market.

On April 25, the FDA approved Beqvez for the treatment of adults with moderate to severe hemophilia B who use factor IX (FIX) prophylaxis therapy; have current or historical life-threatening hemorrhage; or have repeated, serious spontaneous bleeding episodes and do not have neutralizing antibodies to adeno-associated virus (AAV) serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. The manufacturer launched a warranty program for the intravenous infusion based on durability of patient response to treatment.

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Companies Should Make Sure Patient Assistance Is Robust, Keep Eye on External Factors

Pharma manufacturers began offering patient assistance programs (PAPs) as a way to help patients afford their medications. And as list prices of drugs continue to rise, so does that assistance. Companies can take a variety of steps to make sure that their offerings are not being hamstrung due to common pitfalls and instead are truly helping patients access and remain adherent to their medicines, say industry sources. In addition, manufacturers should be keeping an eye on copay offset programs, as well as the Inflation Reduction Act (IRA), for their potential impact on PAPs.

In 2023, manufacturer-provided copay assistance in the form of coupons and debit cards offset patient costs of $23 billion, according to the IQVIA Institute for Human Data Science report titled “The Use of Medicines in the U.S. 2024: Usage and Spending Trends and Outlook to 2028. Released in April, the report also found that such assistance offset costs of $84 billon over the last five years.

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