2025 access trends

The fast-paced access landscape potentially means someone, somehow is going to run into a law, regulation or patient access factor that they might not even be aware of

A regular staple at the Informa Access and Channel events are presentations related to compliance and enforcement from the Department of Justice (DOJ). As they say, “the wheels of justice turn slowly, but grind exceedingly fine,” so while it may appear that you hear about legal issues related to access that seem similar every year, to be sure these cases build to precedents and ultimately laws that could lead to both civil or criminal charges against pharmaceutical manufacturers.

For example, Charlene Fullmer, Assistant United States Attorney at US Attorney’s Office, Eastern District of Pennsylvania in Philadelphia, noted at the November Copay, Reimbursement and Access event, the history of off-label promotion in the industry. Ten to 15 years ago, the way that drugs were marketed and how sales representatives interacted with doctors and providers led to costly fines paid by individual pharma companies. This, in turn, led to Corporate Integrity Agreements (CIA) between the companies and the DOJ. “[This is an example] of how that space was changed because of the interaction with compliance, by having compliance be separate and independent, by having training in each of your respective wheelhouses within the company.”Charlene Fullmer, Assistant United States Attorney at US Attorney’s Office, Eastern District of Pennsylvania

Below are some areas in 2025 that access professionals should keep an eye on. Not all rise to the level of the DOJ. Some issues remain at the state-level, others are policy, others are rising to red flags, and some are just awareness and education for the professional and the public. Further, this is a mix of private insurer issues, as well as Medicare and Medicaid.

Patient Assistance Programs

Yellow Flag. Patient assistance programs will always be a yellow flag because of the inherent guardrails in place between manufacturers and the public. There are many examples of great patient assistance programs, and other examples of programs that have gone awry. According to Fullmer, patient assistance programs exist based on the premise that money should be funneled from a number of different manufacturers into a foundation, with independence from manufacturers. Examples of violations include phone calls directly from the manufacturer to the foundation; funneling specific patients into a program; large amounts being paid to the foundation that is not on a regular basis but potentially based on a certain number of patients or narrow disease states. “We want beneficiaries to be able to have access to drugs, but it just has to be done in the appropriate way,” said Fullmer. Companies should make note of the independence that these programs have and tread accordingly.

Alternative Funding Programs (AFPs)

Red Flag. Alternative funding programs (AFPs) or third-party, for-profit vendors are programs designed by companies and offered to private health insurance plans to save the insurance company money. According to our conference producer in this area, the companies often change names. Examples of AFP companies from Google include PaydHealth, RxFree4Me, SHARx and Matrix Payer Group. Matrix was sued by AbbVie in May 2023 and subsequently denied any person working with an AFP to qualify for the company’s own assistance plan.

Both the PAN Foundation and the Immune Deficiency Organization offer explanations for how the AFPs carve outs work, by basically taking over the specialty medicines patient access. It’s complex and according to Jason Harris, Vice President of Government Relations & Advocacy with the National Psoriasis Foundation said at the Patient Support Services Congress, “I just couldn't believe something like this was legal.” Harris said that it would be ideal if on the federal level these companies were made redundant, but one way to get ahead of this is through information sharing and education.Jason Harris, Vice President of Government Relations & Advocacy, National Psoriasis Foundation

If AFPs go the way of copay accumulators, it could come down to state legislation that begins to impact patient threats to access. There are currently 21 states, including Puerto Rico and Washington, DC that have banned copay accumulators.

Medicare Prescription Payment Plan (MPP)

Blue Flag. Falling under the category of education and awareness is the Part D benefit with $2,000 out-of-pocket cap, which includes an optional or voluntary “smoothing” of out-of-pocket costs over the year. Mark Gooding, Managing Director, Market Access at Avalere Health, summed up during his Copay, Reimbursement and Access presentation focusing on legislation. Open enrollment for this program started in October, and in effect means that instead of paying large sums upfront when filling prescriptions, enrollees can spread their costs evenly across 12 monthly payments. For example, a $2,000 out-of-pocket expense would be divided into monthly installments of about $167. This program allows patients to pay nothing at the pharmacy counter, receiving a bill later for their monthly portion.Mark Gooding, Managing Director, Market Access at Avalere Health

While a great idea on paper, patient advocates and industry watchers are concerned that education and understanding is lacking. First off, the voluntary piece and the fact that patients don’t enroll at the point of sale, it happens after a pharmacy visit and takes 24 hours (if they didn’t enroll in the open period). Patients might enroll during open enrollment in October, not pay anything for their January prescription, and then forget about the subsequent monthly bills. Then what happens if they miss a payment? And speaking of pharmacy....

Retail Pharmacy

Orange Flag. Retail pharmacy has been trying to reinvent itself for the past few years. Who can help clinical trial recruitment? Who can offer low-risk healthcare services? Who can educate hard to reach populations? Pharmacies have tried in one way or another to diversify their services, but the fact is more “brick and mortar” pharmacies are closing. Bill Roth, Senior Vice President & Managing Partner, Consulting for Blue Fin, an IntegriChain company, noted at the Trade and Channel Strategies conference that the time has come to innovate pharmacy, not break it down.Bill Roth, Senior Vice President & Managing Partner, Consulting for Blue Fin, an IntegriChain company

Roth pointed to the trend of the growth of cash pharmacy, especially in the generic medicine space, where there is no data or tracking of spend. Roth told the audience, “Pharmacy is my pet project at the moment. I am fixated on this and I think Good RX…[they] have a great front door there…and direct distribution is coming on strong.”

Another factor to warrant innovation is what Roth noted about the average pharmacy abandonment rate in the retail model, which is 50%. Keeping mind that most people don’t want to go back to the PBM mail-order model of drug delivery, the time is right for channel innovation. Speaking of PBMs....

PBM Vertical Integration

Orange Flag. Instead of labeling this trend just PBMs (because there’s a lot going on in the news with PBMs right now and who can narrow it down?), the trend is being tied to what Nancy Bell, Vice President, Head of US Patient Value & Access for Takeda Oncology, said at the end of her panel session at Hub and Specialty Pharmacy Models West in September.

Bell said, “The biosimilar market recently just got 10-times more complicated with the private labels out now by PBMs...where they’re taking biosimilars and slapping their own manufacturing labels on it. That just made our life a whole lot more complicated on a whole different level.”Nancy Bell, Vice President, Head of US Patient Value & Access for Takeda Oncology

For a more detailed look at what Bell was referring to, see the observations from industry watcher Brian Reed. Here, he privately-labels the effort of PBMs to expand vertical integration vis a vis biosimilar spin-off companies as “one of the most undertold stories,” further comparing this vertical integration to what happened with Merck and its PBM Medco in 1998.

“Are they steering-not-steering patients to the drugs that go away from your services? PBMs are taking 60% of all Medicare right now…and they are going to keep finding ways to still grow and innovate,” Bell told the audience. “We are going to have to find ways to react to that. We have to evolve our thinking because the old plug and play doesn’t work anymore.”

This list is in no way exhaustive of the access issues facing industry on the precipice of 2025. Check back regularly for updates and information from the Access Insider team and coverage from our Access and Channel events...next up is ACCESS USA.

Quotes lightly edited for clarity.