Spotlight on Market Access

While plenty of telehealth and online drug dispensing companies have rolled out direct-to-consumer (DTC) offerings, two pharma manufacturers have unveiled their own digital platforms this year in a bid to streamline and simplify consumers’ experience with the U.S. health care system. Other drugmakers are likely to launch similar offerings, say industry experts, as they offer benefits to various stakeholders. Still, certain challenges exist for those stakeholders, and manufacturers will need to ensure that they take certain steps — both pre- and post-launch — to set themselves up for success while remaining compliant with various regulations.

On Aug. 27, Pfizer Inc. launched PfizerForAll, a “user-friendly digital platform designed to make access to healthcare and managing health and wellness more seamless for people across the U.S.” It is aimed at Americans with migraine, COVID-19 or flu and offers adult vaccinations for conditions such as COVID-19, flu, respiratory syncytial virus (RSV) and pneumococcal pneumonia.

L.A. Care Health Plan is the largest publicly operated health plan in the United States, serving more than 2.5 million members in Los Angeles County. It largely serves Medi-Cal, the state's managed Medicaid program, but also offers products on California's state-based health insurance exchange, Covered California. In 2022, the insurer launched a Dual Eligible Special Needs Plan (D-SNP) that coordinates both Medicare and Medi-Cal benefits. Additionally, its PASC-SEIU Homecare Workers Health Care Plan is specifically designed for Los Angeles residents working as in-home caregivers. Most recently, L.A. Care in August 2024 cut 24% of its prior authorization codes to help avoid delays in member care and speed up inpatient discharge requests.

Now that CMS has revealed the prices of the first 10 drugs subject to Medicare price negotiation, all eyes are on how Part D plans will cover those drugs on their formularies in 2026, when the new prices go into effect.

To that end, a recent poll from Zitter Insights offers some clues about how payers and PBMs are thinking about this thorny question.

If Medicare Part D covered GLP-1 drugs for obesity, rather than just Type 2 diabetes, it could increase annual spending by $3.1 billion to $6.1 billion, according to a recent Health Affairs study.

The introduction of GLP-1 medications for treatment of diabetes and obesity has reignited the debate over Medicare’s prohibition on covering weight loss medications. In June, the House Ways & Means Committee advanced legislation that would provide a limited pathway for adults 65 and older to get anti-obesity GLP-1s covered by Medicare. The bill has not yet passed the full House.

Integrated delivery networks (IDNs) are becoming an increasingly larger stakeholder within the U.S. health care system. As of January 2024, almost 80% of physicians were employees of hospitals/health systems and other corporate entities such as private-equity firms, according to an April report prepared by Avalere Health and commissioned by the Physicians Advocacy Institute. Pharma manufacturers can take steps to enhance their partnerships with these entities, said industry experts at a recent webinar.

While the Inflation Reduction Act (IRA) had multiple provisions affecting a variety of industries, including energy, agriculture and manufacturing, the prescription drug aspects of the law have arguably gotten the most attention, both positive and negative. Those provisions impact several industry stakeholders, with pharmaceutical manufacturers and health insurance plans in particular shouldering new responsibilities. In response, Medicare plans are expecting to take various actions, such as increasing premiums, and even commercial plans have begun to modify their drug management approach, according to research from Zitter Insights.

With the Medicare Part D national average monthly bid amount (NAMBA) set to spike 180% next year, CMS late last month unveiled a new demonstration program aimed at stabilizing a market that is experiencing unprecedented volatility.

However, some Republicans in Congress are up in arms over the demonstration, arguing that it contains “extra-statutory, eleventh-hour policy changes” aimed at cleaning up a problem created by the Biden administration’s most-touted health policy achievement.

With policymakers and industry stakeholders increasingly focused on the cost savings opportunities tied to biosimilars, a new Health Affairs study sheds light on some of the factors that influence uptake of these near-copies of pricey biologic medications.

Among almost 200,000 commercial and Medicare Advantage enrollees who newly initiated one of seven biologic drugs with available biosimilar versions — filgrastim, bevacizumab, epoetin alfa, trastuzumab, pegfilgrastim, infliximab and rituximab — the share of people initiating a biosimilar increased from 1% in 2013 to 34% in 2022. Patients who were younger than 18 years were less likely to initiate a biosimilar than other age groups. Meanwhile, enrollees in commercial high-deductible health plans were more likely to use a biosimilar, compared with those in MA plans.

As U.S. tensions with China rise, federal legislation is proposing limiting federal agencies’ contracting with certain biotech companies. But the efforts have the potential to affect a large swath of the U.S. biotech and pharmaceutical industries, say experts, who recommend that firms should start assessing their potential exposure in order to mitigate any impact on their operations.

On Dec. 20, 2023, Sen. Gary Peters (D-Mich.) introduced S. 3558; on Jan. 25, Rep. Mike Gallagher (R-Wis.) introduced the House version, H.R. 7085. Known as the BIOSECURE Act, the legislation would ban federal contracting with a “biotechnology company of concern,” and it specifically mentioned Chinese companies BGI (formerly known as Beijing Genomics Institute), MGI, Complete Genomics, WuXi AppTec and any of their patent companies, subsidiaries or successor of these entities. It also includes any entity that

UPMC Health Plan is the health insurance unit wholly owned by the University of Pittsburgh Medical Center. UPMC operates a large health system of 40 hospitals throughout Pennsylvania and Appalachian regions of New York and Maryland, as well as several international locations. Its health plans serve members across the spectrum of insurance products, including Pennsylvania’s managed Medicaid program and the Affordable Care Act exchanges. It is currently the third-largest insurer in its home state and the fourth-largest integrated insurer in the U.S. UPMC also operates a Program of All-Inclusive Care for the Elderly, Community LIFE, and is a joint owner of Maryland Physicians Care, a provider-sponsored managed Medicaid plan.