Spotlight on Market Access
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More MA Enrollees Are Facing Step Therapy Requirements for Part B Drugs
Over half of Medicare Advantage enrollees were in plans that applied step therapy to the 10 most commonly used rheumatoid arthritis (RA) medications covered by Medicare Part B in 2023, according to a recent Avalere analysis.
Since 2019, CMS has given MA plans the ability to use step therapy protocols — meaning a patient may be required to try a less expensive drug before moving to the more expensive one — for physician-administered and other Part B medications. Avalere analyzed MA plans’ annual medical policy and formulary restrictions for 22 RA drugs from 2018 to 2023 and found that the percentage of MA beneficiaries in plans that use step therapy has increased steadily since 2019. For two of the drugs studied, 78% of enrollees were in MA plans that applied step therapy in 2023.
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FDA Moves Bring Total Biosimilar Approvals to 54
With the FDA’s approval of three biosimilars in May, that brings the total number of these drugs to 54 since the agency’s green lighting of Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. With all three agents also gaining interchangeability status, that brings the count to 14 biosimilars with this designation. Payer and provider respondents to a Zitter Insights survey said they expect to see increased use in rheumatoid arthritis (RA) and ophthalmic biosimilars, among others, this year, while oncologists cited agents for non-small cell lung cancer (NSCLC) as the area in which they expected to see the most increase.
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).
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With IRA Impacts Looming, Manufacturers Should Focus on Providing Patient Support
Most industry experts likely would agree that certain provisions in the Inflation Reduction Act (IRA), such as a $2,000 out-of-pocket spending cap for Medicare Part D beneficiaries and copay smoothing — known as the Medicare Prescription Payment Plan (M3P) — are no-doubt wins for patients. But other aspects of the law, particularly Medicare drug price negotiations and inflation-based rebates, have prompted disagreements over their ultimate outcomes, with some experts claiming that they will hurt drug development and will prompt more restrictive utilization management among payers. Ultimately, said pharma industry experts during a recent webinar, stakeholders should keep patient support top of mind as they navigate these changes. -
Remote Physiologic Monitoring Use Among Medicaid Enrollees Skyrocketed From 2019 to 2021
Between 2019 and 2021, the use of remote physiologic monitoring (RPM) via wearable devices and mobile applications soared by more than 1,300% among Medicaid enrollees, which was driven by a small number of providers, according to a recent Health Affairs study.
Based on Transformed Medicaid Statistical Information System Analytic Files data from Jan. 1, 2019, to Dec. 31, 2021, the study found that the number of RPM recipients per 100,000 Medicaid enrollees increased from 2.1 recipients in 2019 to 29.6 recipients in 2021 and started to accelerate with the March 2020 onset of the COVID-19 public health emergency. Among over 5,600 distinct providers who billed RPM claims for Medicaid enrollees in 2021, more than half of the claims were from 5% of providers.
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MMIT Payer Portrait: The Lifetime Healthcare Cos.
The Lifetime Healthcare Companies are the parent organization of New York-based Blues insurer Excellus Blue Cross Blue Shield and Univera Healthcare. Combined, the companies are the sixth-largest insurer in New York, largely focusing on the Western and upstate New York markets. Lifetime on May 22 unveiled plans to acquire Capital District Physicians' Health Plan, Inc. — better known as CDPHP — a physician-founded nonprofit payer based in Albany, N.Y., that serves about 375,000 members. It offers employer group products and Medicare Advantage plans, and holds a New York Medicaid contract. CDPHP also operates ConnectRx, a community-based full-service pharmacy.
