Thought Leadership

To chart a clear path to commercialization, a manufacturer must begin with the end in mind. Early market research helps pharma companies understand which clinical endpoints and differentiators an asset will need to succeed at launch.

Today, one-third of pharma companies start market access planning in Phase I, and 80% start by Phase III. Manufacturers were once reluctant to invest in market research during development, when an asset’s future is uncertain. But the questions raised by early access planning are pivotal for your business, as their answers will drive decisions about your asset’s viability.

As the 340B Drug Pricing Program continues to grow in size and importance, its operations are being scrutinized more than ever. Pharma manufacturers, who have long noted issues with this program, have made various attempts at reform.

Their latest strategy — which would move away from up-front discounts to a rebate model — is currently in limbo as the courts weigh in. If drugmakers are successful in their efforts, however, findings from a recent MMIT survey indicate they would be advised to tread carefully.

Over the past decade, health systems have seen a rapid influx of private equity, with a six-fold increase in acquisitions totaling $10 trillion. As private equity firms continue to explore new methods of investment in health care, the recent announcement that Walgreens Boots Alliance will be acquired by Sycamore Partners seems to be a natural progression in strategy.

What does the introduction of private equity into one of the largest pharmacy chains in the U.S. mean for the industry? While this kind of investment is new for retail pharmacy, a review of the impact of private equity on health systems offers a glimpse into what we can expect with a Walgreens acquisition.

To speed patient access to potentially life-saving therapies, the FDA established expedited approval pathways for selected drugs that fill unmet needs or treat serious conditions. For patients in need, these pathways serve an essential purpose. But many payers and providers are concerned that expedited pathways do not require sufficient safety and efficacy data.

The next few weeks are an exciting time for those who monitor insurance market share shifts. This year’s open enrollment season for the public health insurance exchanges (HIE) set another record-breaking high, for the fourth year in a row. According to Kaiser Family Foundation, 24.3 million people signed up for ACA plans in 2025, more than double the number four years ago.

As we wait for the 2025 insurer data to emerge, it’s important to remember why monitoring large-scale enrollment shifts is useful in the first place. For manufacturers, understanding the payer mix for a particular product’s patient population is essential for determining potential access barriers. Providers must also keep an eye on enrollment shifts, making policy changes as necessary to ensure access and maintain care continuity. And for healthcare IT vendors, assessing market fluctuations at the insurer level informs the identification of potential growth areas for their clients.

At the end of April, more than 8,000 attendees visited Las Vegas for the Asembia Specialty Pharmacy Summit, otherwise known as AXS25. If you missed the conference, here’s an overview of some of the key areas covered this year.

The landscape of patient access has become increasingly complex, intensified by evolving channel dynamics, greater biosimilar investment, and legislative reform. As payers evolve their utilization management tactics, manufacturers must also become more sophisticated in their access strategies.

To explore these topics, MMIT and The Dedham Group conducted the second annual State of Patient Access Survey to collect insights from 250+ pharmaceutical and biotech executives focused on market access and brand strategy. Let’s take a look at a few of our findings.

Established by the Inflation Reduction Act in August 2022, the Medicare Drug Price Negotiation Program is still in its infancy, but is expected to impact a wide swath of stakeholders in the U.S. healthcare system. Last year, CMS negotiated prices for the first round of drugs, and in January, the agency revealed its second list of drugs that will be subject to negotiations this year.

All manufacturers — not just those with drugs on the list — should strategize based on the agents to be negotiated. Not only could their therapeutic areas be impacted, but so could those of their competitors, and their mitigation strategies could impact that class. And as these negotiations are conducted annually, drugmakers might someday find themselves in talks with CMS over their own prices.

Pharma companies are increasingly turning to real-world data to answer their commercial business questions, but not all realize that unstructured EMR data is the unsung hero of most queries. Whether a manufacturer is struggling to find a niche patient population, conduct unbiased outcomes research, or generate persuasive proof points, unstructured data can fill in the gaps left by other real-world data sources.

In a recent post on specialty carve-out mechanisms, we examined how payers’ use of specialty benefit managers and alternative funding programs can impact manufacturers’ patient assistance programs (PAPs). Today’s post takes a look at another managed care trend: the rise of copay accumulators and maximizers, also known as copay adjustment programs.

In 2025, copay accumulator and maximizer programs have become one of payers’ primary strategies for mitigating the use of PAPs. While these controversial programs help payers fully leverage the funds that manufacturers deploy to increase patient access, they can often result in exorbitant surprise costs for patients, which can lead to treatment abandonment.