Spotlight on Market Access

Patient Groups Laud IRA Provisions but Worry About Access to Prescription Drugs

While a lot of the attention around the Inflation Reduction Act (IRA) has focused on its implications for pharma manufacturers and Medicare Part D plans, much of its focus is on patients and making sure they can access the prescription medications they need at a price they can afford. While aspects such as the out-of-pocket cap for Medicare beneficiaries and the limit on premium increases for plans are welcome developments, some uncertainties still exist around the actual implementation of the law and how patients may be affected. On Oct. 19, life sciences consulting firm Innopiphany, LLC brought together three speakers from patient-advocacy groups to discuss their hopes, concerns and what they have experienced so far.

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MMIT Payer Portrait: Oscar Health, Inc.

Founded in 2012, Oscar Health Inc. bids itself as “the first health insurance company built around a full stack technology platform.” Since its founding, Oscar has grown to serve more than 900,000 members in 19 states (though it will exit California for the 2024 plan year), largely via the Affordable Care Act (ACA) exchanges and off-exchange individual and family plans. The startup also offers Medicare Advantage plans in Florida and partners with Cigna Healthcare on co-branded small group products. For the 2024 plan year, Oscar will expand to 512 counties in its existing state markets, focusing on underserved and rural areas. The insurer is also expanding the availability of its diabetes-focused plan and will launch a new product called Breathe Easy, which offers enhanced services to members with chronic obstructive pulmonary disease (COPD) and asthma.

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Study Suggests Spread Pricing Ban on PBMs Alone May Have Little Impact

Although PBMs are taking increasing heat for spread pricing — or charging payers more for a drug than pharmacies are reimbursed — they aren’t the only players in the drug supply chain that engage in the practice, a new study points out. And one of the study’s authors says its findings suggest that patients may be better off if generic drugs are simply removed from insurance coverage entirely.

The study, published in JAMA Health Forum on Oct. 20, examined data associated with 45 high-utilization Medicare Part D-covered generic drugs.

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Star Ratings Plummet in 2024 for Stand-Alone Medicare Prescription Drug Plans

Only 2% of Medicare beneficiaries who enrolled in a stand-alone Prescription Drug Plan (PDP) in 2024 will be in contracts with 4 or more stars, compared to 42% in the 2022 plan year and 9% in 2023, according to CMS’s recently released estimates. The average Star Rating for PDPs dropped to 3.11 in 2024 from 3.70 in 2022, with two contracts receiving 1.5 stars.

The distribution change is largely fueled by methodology changes in how many of the Star Ratings are calculated. Known as Tukey outlier deletion, the changes center on removing outlier contract scores when determining the cut points for all non-Consumer Assessment of Healthcare Providers and Systems measures.

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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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