Thought Leadership

Welcome back to our Market Access 101 blog series, which began with the basics of market access and covered how to improve formulary placement and secure coverage under the medical benefit. In this post, we’ll dive deeper into the medical benefit, explaining how payer/PBM contracting works—and why it’s increasingly necessary.

While the Inflation Reduction Act (IRA) may best be known for mandating Medicare drug price negotiation, the act did much more than that. Among its other accomplishments are the elimination of cost sharing for vaccines under Medicare Part D, as well as improved access to adult vaccines for Medicaid and Children’s Health Insurance Program (CHIP) enrollees.

The rising cost of specialty pharmaceuticals has motivated payers to implement tighter restrictions and seek both traditional and value-based contracts. As manufacturers are already contracting with GPOs, distribution networks and medical practices, most would prefer to avoid contracting with payers and PBMs for their medical benefit products.

In 2021, Novo Nordisk’s Wegovy (semaglutide) gained FDA approval for chronic weight management in overweight or obese adults, hitting the market in June 2022 at a list price of $1,349 per 28-day supply. In clinical trials, patients achieved an astounding mean weight loss of nearly 15% after 68 weeks of treatment with Wegovy.

The past few years have seen an increase in the number of long-acting injectable (LAI) therapies for a variety of disorders and diseases, including schizophrenia, bipolar disorder, and HIV. These LAI antipsychotics and antiretroviral therapies include brand-name drugs such as Invega Sustenna (paliperidone palmitate by Jannsen), Abilify Maintena (aripirazole by Otsuka), and Cabenuva (cabotegravir/rilpirivine by ViiV).

The Inflation Reduction Act (IRA), signed into law in August 2022, was intended in part to lower healthcare costs for families and small businesses. The IRA contains several provisions aimed at prescription drug costs which will roll out over the next few years, with the earliest taking effect this year. As of 2023, CMS will require pharmaceutical manufacturers to pay rebates to Medicare if their drugs’ prices increase at a rate which outpaces inflation.

Over the past year, the health plan landscape has seen significant enrollment shifts, especially within government-sponsored plans. According to MMIT’s Directory of Health Plans, the top 10 Medicare Advantage insurers accounted for 77.2% of the national market at the close of 2022. Nine of the top 10 organizations reported year-over-year growth ranging from 2.8% to 56.8%, with a cumulative average growth rate of 13.4%.

Welcome back to MMIT’s Market Access 101 blog series. Our first post, Understanding the Basics, covered the difference between the pharmacy and medical benefit structure, while our second, Improving Your Drug’s Formulary Placement, discussed how to overcome access barriers.

In this post, we’ll discuss what manufacturers should know about drugs covered under the medical benefit. We’ll cover pre-certification requirements, components of a medical policy, and distribution methods, and address the importance of aligning clinical pathways and policies to smooth patient access.

Following a severe season of respiratory syncytial virus, or RSV, in the U.S., multiple companies have reported that they have promising vaccine candidates for various patient populations in the late-stage clinical trial pipeline. The FDA could approve some of them as early as this year, for what is estimated to be a market worth more than $10 billion.

Payers’ use of copay adjustment programs has exploded over the past few years, and interest in them remains high. In addition, payers are now looking to bring down their drug spend by adopting newer strategies offered by companies with alternate funding programs. While many manufacturers are pushing back against these copay adjustment and specialty carve-out programs, patients remain caught in the middle.