Thought Leadership

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.

Across indications, biosimilar uptake is rapidly accelerating, with the number of biologics facing biosimilar competition more than doubling by 2026. This year’s impending launch of adalimumab biosimilars will serve as a case study for manufacturers, who will be studying the market’s response. Humira biosimilars have great potential to disrupt immunology market baskets, especially if multiple competitors employ aggressive discounting strategies.

Welcome back to MMIT’s Market Access 101 series, in which we unpack the complexities of market access via a series of blog posts. In our first post, Understanding the Basics, we covered the difference between the pharmacy and medical benefit structure, the typical timeline for drug review, and why it’s critical to determine which entity makes formulary and coverage decisions.

In this post, we’ll address how to research and articulate your drug’s value proposition, how to overcome access barriers like prior authorization, and how to engage controllers during formulary decision-making.

Given the growth of specialty pharmaceuticals, manufacturers will need to develop more aggressive contracting strategies to secure optimal market access for their medical benefit drugs. Shifting market dynamics, driven in part by the influx of lower cost biosimilars on the pharmacy benefit, will require pharma companies to focus more on rebating and cost minimization.

Many manufacturers are interested in which factors can give them an edge on obtaining preferred coverage with payers. This is especially true given the increasing competition in saturated categories such as immunology, diabetes care and breast cancer.

We scoured recent MMIT research to gain a better grasp on the factors that are top of mind for payers—those that will truly move the needle in terms of coverage determination.