Spotlight on Market Access

2028 Global Medicine Spending Is Expected to Reach $2.3 Trillion

Global spending on medications is expected to hit $2.3 trillion by 2028, as not only more therapies become available but also more people have access to them. That’s one of the findings of the IQVIA Institute for Human Data Science’s recent report titled The Global Use of Medicines 2024: Outlook to 2028. Oncology and obesity, among other therapeutic classes, are expected to be among the top areas in global spending over the next five years, estimated researchers.

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MMIT Payer Portrait: Point32Health

Canton, Mass.-based Point32Health was established Jan. 1, 2021, following the successful merger of Harvard Pilgrim Health Care and Tufts Health Plan, two major players in the New England health insurance markets. With more than 1.5 million members, Point32Health is one of the largest insurers in New England, serving members across the spectrum of insurance products. The org’s top state market is Massachusetts, where it is the second-largest insurer overall, behind UnitedHealthcare. The insurer in February 2024 unveiled plans to acquire Baystate Health's insurance subsidiary, Health New England. The deal would grow Point32Health’s membership by 11%, to more than 1.7 million lives, according to AIS's Directory of Health Plans.

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PBM Industry Could Face Major Challenges From ERISA Suits

A lawsuit filed by an employee against Johnson & Johnson could signal that significant changes in the legal obligations of commercial plan sponsors and PBMs around drug pricing are coming, experts say. The suit alleges that J&J violated its fiduciary obligations as a health plan sponsor under the Employee Retirement Income Security Act (ERISA) of 1974 by overpaying the plan’s PBM for employees’ medications.

If it’s successful, the suit could expose plans, plan sponsors and PBMs to significant, ongoing legal risk, experts say. However, they add that the opacity and complexity of drug pricing dynamics mean that the suit’s success is far from certain.

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Prescription Drugs, Home Care Drove Health Spending in 2023

With respective increases of 10.8% and 10.7% in 2023, health care spending on prescription drugs and home health care rose the fastest out of seven health care categories analyzed in a recent Altarum report.

Total national health care expenditures grew by 6.2% last year, while gross domestic product (GDP) increased by 6.3% year over year. In December 2023, health care spending accounted for 17.2% of GDP and has remained below 17.5% since January 2022. About 84% of health spending was attributed to personal health care, half of which was spent on hospital care and physician and clinical services.

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All Eyes Are on Novel New Therapies, Impact of IRA, AI

The FDA approved the highest number of novel therapies in years in 2023, and multiple potential blockbusters are slated for decisions in 2024. In addition, the Inflation Reduction Act looms large over the pharma industry as HHS negotiates the prices of the initial 10 Medicare Part D agents and lawsuits over the legality of the IRA play out. And while life sciences dealmaking was down a bit in 2023, the new year already looks to be more promising. AIS Health, a division of MMIT, spoke with some industry experts about their outlook for 2024.

AIS Health: What are some pharma issues to keep an eye on in 2024, and why?

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FDA Approves Game-Changing Regimen for Urothelial Cancer, but Will Cost Pose Issue?

In late 2023, the FDA approved a new treatment regimen for urothelial cancer that represents a “paradigm change,” according to one industry expert. The cost of the therapy, however, could pose a barrier to its uptake.

On Dec. 15, 2023, the FDA approved Pfizer Inc. and Astellas Pharma Inc.’s Padcev (enfortumab vedotin-ejfv) in combination with Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with locally advanced or metastatic urothelial cancer (la/mUC). The agency gave accelerated approval to this combination for people with la/mUC who are not eligible for cisplatin-containing chemotherapy on April 3, 2023. The newest approval converts that accelerated approval to full and expands the labeled indication to include the treatment of people eligible for cisplatin chemotherapy. The application had priority review and breakthrough therapy designation.

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Copay Accumulator Lawsuit Comes to an End; Will Ruling Be Enforced?

An ongoing lawsuit over the use of copay accumulators is drawing to a close following the defendants’ and plaintiffs’ motions to dismiss their appeals. The ball is now in the federal government’s and state insurance commissioners’ courts to enforce a district court judge’s ruling, which states that manufacturer assistance must be counted toward patients’ out-of-pocket responsibility unless a brand-name drug has a medically appropriate generic equivalent.

Health plans and PBMs several years ago began implementing copay accumulators — and then a new iteration known as copay maximizers that declare certain drugs non-essential health benefits to avoid covering them per the Affordable Care Act (ACA) — to counter manufacturer copay assistance programs. Before these tools, that 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. With accumulators and maximizers, patients can still use that assistance, but it does not help reduce their out-of-pocket costs.

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As Reform Efforts Persisted, PBM Trade Association Set Its Lobbying Record in 2023

The pharmaceutical and health products industry, which has consistently outspent all other industries on federal campaign contributions and lobbying, spent nearly $378.6 million in 2023 to further policy goals, according to data compiled by OpenSecrets.

With the 2024 presidential election around the corner, the pharma/health products industry nearly evenly distributed their donated campaign funds to Democratic and Republican lawmakers during the 2023-2024 election cycle. Among the 20 lawmakers who received the most contributions from the industry, nine are Democrats. President Joe Biden, who is running for re-election this year, topped the list, receiving over $232,000.

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Number of FDA Approvals Increased in 2023, With Notable Agents Including Cell and Gene Therapies

In 2023, the FDA continued to rebound from a drop in approvals, marking the highest number in years. The agency’s Center for Drug Evaluation and Research (CDER) approved 55 novel drugs last year, and its Center for Biologics Evaluation and Research (CBER) approved 17 agents. That’s up from 37 CDER-approved therapies in 2022 and 51 in 2011. In 2022, CBER OK’d 13 agents, up from 10 in 2021. Specialty agents, such as cell and gene therapies, continued to make up a large portion of those new approvals, while the FDA approved several biosimilars, including a handful that were the first versions of their reference drugs. AIS Health, a division of MMIT, spoke with industry experts about what they view as the most notable FDA approvals of 2023.

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MMIT Payer Portrait: Blue Shield of California

Founded in 1938 as the California Physicians' Service, Blue Shield of California is now the fifth-largest insurer in its home state. While nearly 70% of its members are enrolled in employer-based insurance products, Blue Shield of California also offers Medicare Advantage and Affordable Care Act exchange plans. It acquired the Medicaid insurer Care1st Health Plan in 2015, which now operates as Blue Shield of California Promise Health Plan. In August 2023, the insurer made headlines for breaking with its longtime pharmacy benefits manager CVS Caremark in favor of a transparency-focused model in partnership with Amazon Pharmacy and Mark Cuban Cost Plus Drug Company, among others.

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