Spotlight on Market Access

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.

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FDA Moves Bring Total Biosimilar Approvals to 53

With the FDA’s approval of three biosimilars in May, that brings the total number of these drugs to 53 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 13 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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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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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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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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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.

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Part D Plans Get Ready for Potentially ‘Messy’ Rollout of M3P Program

For the first time ever, Medicare Part D beneficiaries in 2025 will have the opportunity to spread their prescription drug expenses over the course of the plan year. While Part D sponsors must offer the option to enrollees effective Jan. 1, 2025, plans face multiple considerations and tasks prior to then. One of their most immediate concerns, industry experts say, is factoring in potential administrative costs and/or financial losses associated with the new Medicare Prescription Payment Plan (M3P, as many are calling it) into bids due next month.

Created under the Inflation Reduction Act, the M3P requires stand-alone Prescription Drug Plans and Medicare Advantage Prescription Drug plans to give enrollees the option to pay out-of-pocket prescription drug costs in the form of capped monthly payments versus paying the full amount at the pharmacy. Program participants will pay $0 at the pharmacy but receive a monthly bill from their Part D carrier, which must reimburse the pharmacies in full.

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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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Balancing Technology, Human Touch Can Improve Therapy Access, Adherence

Emerging technologies such as artificial intelligence (AI) are being incorporated into numerous processes within the health care system with an eye on improving a wide range of results. But rather than applying them across the board, a balance must be struck between what tasks are best suited for automation and what work best when provided with a human touch.

When it comes to patient onboarding, for instance, automated solutions may help fulfill certain requirements quickly, allowing patients to start needed therapies soon. But adherence to those treatments may be better achieved with a human touch that can help personalize approaches.

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FDA Approves Another Hemophilia Gene Therapy, but Will Price Prove to Be Too High?

The FDA recently approved the second gene therapy for hemophilia B, Pfizer Inc.’s Beqvez (fidanacogene elaparvovec-dzkt). But while the manufacturer priced the agent at parity to the other treatment, that price may still be too high for many payers, according to a Zitter Insights survey.

On April 25, the FDA approved Beqvez for the treatment of adults with moderate to severe hemophilia B who use factor IX 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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