Spotlight on Market Access

Would Proposed Changes on Interchangeability Diminish Designation?

By Angela Maas

When the Affordable Care Act (ACA) became law on March 23, 2010, it 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 more than 40 biosimilars, with only a handful of those gaining interchangeable status. That designation, however, may not carry quite the distinction it historically has had if proposed guidance from the agency — which would replace previous guidance — on labeling for interchangeable biosimilars is finalized. Various stakeholders, including manufacturers, pharmacies, patients and providers, stand to be affected, stakeholders say.

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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Newly Approved Tofidence, First Actemra Biosimilar, Expected to Have Some Impact for Payers, Rheumatologists

The FDA recently approved the first biosimilar of Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group, for multiple indications. Both payers and rheumatologists responding to a Zitter Insights survey said they expected the new drug to have some impact on their management of and prescribing for rheumatoid arthritis (RA).

On Sept. 29, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) intravenous formulation for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to at least one disease-modifying antirheumatic drug, people at least 2 years old with active polyarticular juvenile idiopathic arthritis and people at least 2 years old with active systemic juvenile idiopathic arthritis. Dosing of the intravenous infusion is based on the indication.

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OTC Birth Control Is Coming Soon — But Coverage Could Be Tricky

This summer, Opill (norgestrel) became the first over-the-counter (OTC) daily contraceptive pill approved by the FDA, and it’s slated to hit the U.S. market in early 2024. However, Opill’s OTC designation — which on the surface would seem to increase access to birth control — may have the opposite effect for patients seeking reimbursement from their health plans, experts said during a recent KFF web event.

“Having over-the-counter contraceptives is definitely a positive step,” said Christine Gilroy, M.D., chief medical officer of The Cigna Group’s PBM, Express Scripts. “I am concerned, though, that while it removes the barrier of needing to pay for a physician visit and get a prescription from the physician…in order to be processed against a pharmacy benefit, it does need to be entered into a system that essentially turns it into a prescription.”

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Enrollees Will Face Fewer Medicare PDP Options, Higher Average Premiums in 2024

During the 2024 Medicare Annual Election Period that starts on Oct. 15, a total of 708 stand-alone Prescription Drug Plans will be available for beneficiaries in 2024 nationwide, a 12% drop from 2023. Only 126 PDPs will be offered without a premium to enrollees receiving the Low-Income Subsidy (LIS) in 2024, compared with 191 PDPs in 2023.

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Commercial Forecasting Is Changing Rapidly but Still Needs Some Improvements

Life sciences companies need to be agile in an often-changing market, and forecasting plays a crucial role in being able to do this. The increasing focus on the use of machine learning (ML) and artificial intelligence (AI) can make parts of forecasters’ jobs easier, but there is room for improvement in these and other areas. A recent IQVIA webinar discussed trends in commercial forecasting based on the company’s second annual survey, which was conducted earlier this year.

“This is a very exciting time to be in forecasting,” declared David Wolter, a vice president in IQVIA’s commercial consulting group. And while forecasting is critical to making business decisions, multiple challenges exist within the process.

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MMIT Payer Portrait: Kaiser Permanente

Kaiser Permanente, founded in 1945 as a consolidation effort between local hospitals in California and an insurance group for construction employees, has since become one of the largest integrated delivery networks in the U.S. The company operates 39 hospitals, employs more than 23,000 physicians in its medical groups and offers health insurance products in both the private and public sector markets. Kaiser’s seven regional managed care plans enroll more than 11 million lives in eight states and Washington, D.C. The company will expand to Pennsylvania with its planned acquisition of Geisinger Health, a health system that operates the fourth-largest public-sector health insurer in the state. The deal also marks the advent of Kaiser's Risant Health, a new nonprofit subsidiary that aims to expand the adoption of value-based care nationwide.

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CVS Steps Into Biosimilar Space With New Subsidiary Cordavis

CVS Health is getting into the biosimilars business, the company said in late August, and will officially enter the market on Jan. 1 in partnership with a Humira biosimilar. CVS stressed the importance of driving use of biosimilars and ensuring their supply, which sources say is a positive development. But one industry source questions whether the new company raises potential conflict-of-interest issues.

On Aug. 23, CVS revealed that it had launched the wholly owned subsidiary Cordavis to commercialize and/or co-produce biosimilars in collaboration with drug manufacturers. “Through Cordavis, CVS Health intends to develop a portfolio of products that it expects will facilitate broader access to biosimilars in the U.S. — creating more competition that drives down prices — while encouraging investment in future products,” said the company in a press release.

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Retail Prescription Drug Spending Growth May Slow Down in Next Decade

Retail prescription drug spending is expected to grow moderately throughout the next decade. But per capita out-of-pocket retail drug costs may decrease starting in 2024 due to the Inflation Reduction Act (IRA), a recent Peterson-KFF Health System Tracker study predicted.

Using National Health Expenditures Accounts historical and projection data from 2021, researchers found that per capita spending on retail prescription drugs has skyrocketed over the past three decades— from $101 in 1960 to $1,147 in 2021. Meanwhile, out-of-pocket prescription drug spending has been declining since the mid-2000s and is anticipated to drop by 8% by 2031.

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McClellan: IRA Price Negotiations May Have Broader Impact Beyond Drugs on List

Although CMS has released its list of the first drugs to be negotiated under the Inflation Reduction Act (IRA), questions surrounding the process, as well as other provisions of the law, still exist. During a recent webinar, Mark McClellan, M.D., Ph.D., the Robert J. Margolis Professor of Business, Medicine, and Policy, and founding director of the Duke-Margolis Center for Health Policy at Duke University, addressed some of those issues, including the real-world evidence that CMS is looking for and how the redesign of Medicare Part D will play out.

The Sept. 18 webinar was the second in a series presented by Innopiphany on navigating the IRA, following the initial one held June 20.

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FDA Approves First Multiple Sclerosis Biosimilar, Sandoz’s Tyruko

The FDA recently approved the first biosimilar for the treatment of multiple sclerosis (MS): Tyruko (natalizumab-sztn) from Novartis Pharmaceutical Corp. subsidiary Sandoz Inc. The drug is entering a fairly crowded class, and payers have said they expect it to have a moderate impact on their management of the other agents available to treat the condition.

On Aug. 24, the FDA approved Tyruko for the treatment of two indications: (1) adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and (2) adults with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s therapies and tumor necrosis factor (TNF) inhibitors.

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