Our leading subject matter experts share their insightful analysis and points of view to help you stay abreast of industry trends
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.
Excess body weight is a real problem in this country, as more than two-thirds of American adults are either overweight or have obesity. Despite efforts to diet and…
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).
Manufacturers with LAIs in the pipeline will need to be mindful about the persistent barriers to access faced by drugs with this formulation. Manufacturers with…
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.
The steady increase of drug prices has…
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%.
Supplemental prescription drug plan (PDP) enrollment for traditional Medicare has also shifted, with the number of beneficiaries…
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.
But just because the agency approves these vaccines doesn’t mean that many people will immediately have access to them. The process of gaining…
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.
Detrimental Impact on Patients Normally, when a manufacturer provides copay assistance for a drug, that dollar amount of that…
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.
To prepare for the impact of increased biosimilar competition in immunology indications in 2023, it is important to understand not only…
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…
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.
As biosimilar manufacturers face a huge barrier to market entry, they will need to incentivize payers across all lives to gain market share. They will offer either…
