What’s Ahead for Market Access in 2025?
As the pharma industry continues to adjust to the provisions of the Inflation Reduction Act (IRA), the country will soon be ushering in a new presidential administration—leaving the future of the IRA in question. Despite ongoing regulatory uncertainty, manufacturers will still be focused on the same concerns: drug development, pipeline performance and ensuring patient access to their therapies.
To better understand what 2025 might bring, I asked three of my colleagues to share their perspectives on upcoming market shifts. Their answers provide key insights into the year ahead.
Q: What’s the biggest challenge for manufacturers launching new products this year?
Kala Bala, SVP, Enterprise Access and Data Expertise: One of the top challenges being flagged by our clients is the impact of the Inflation Reduction Act’s various provisions, especially on formulary changes, including the addition of newly launched brands to Medicare formularies. Due to the increased focus on being cost-effective, payers are expected to be very cautious in the drugs they cover, which could potentially have a negative impact on newly launched brands.
The IRA’s Medicare Drug Price Negotiation Program could significantly lower the price of newer brands, forcing companies to carefully consider their pricing strategies to remain competitive. When you couple those pricing pressures with the prevalence of cheaper alternatives, such as biosimilars, it’s clear that pharma companies will need to leverage real-world data and analytics to monitor these market dynamics and adjust their launch strategies as needed.
On the other hand, companies launching a new drug in indications with lower price pressures and unmet medical needs may witness an uptick in launch success, because of the IRA incentivizing innovation in these therapeutic areas.
Jayne Hornung, Chief Clinical Officer: I can’t remember the last time there was a traditional small molecule launch. The pharma industry is producing targeted precision therapeutics and personalized medicine. This change will force organizations to rethink key elements of their launch strategies, reimbursement models, and patient services to cater to these more specialized treatments and their long-term outcomes.
Andrew Rouff, Senior Consultant, Advisory Services: In addition to greater competition in more therapeutic areas, we also expect quite a few changes to payers’ books-of-business, as payers will be impacted by the ongoing Medicaid redetermination process, the resulting increase in health insurance exchange members and the uncertain future of the ARP’s income-based premiums. As Kala discussed, they’ll also be impacted by Medicare changes due to the IRA.
All of these shifts can influence new brands’ channel exposure, payer mix, and messaging strategies. Manufacturers launching new products will also need to carefully monitor payers’ new-to-market blocks to understand what coverage will look like prior to P&T decisions, as payers have become more restrictive with these blocks in recent years.
Q: Do you anticipate any movement in PBM reform this year?
Andrew Rouff: PBM changes are likely to take place further along in the future. However, recent House Oversight committee meetings on PBMs highlighted likely focuses of this reform. There might eventually be changes to how PBMs reimburse their own pharmacies vs independent ones. Potential federal regulation to incentivize competition among an increased number of PBMs would also focus on improving transparency, with a particular focus on overseas group purchasing organizations.
Jayne Hornung: While nobody knows what’s going to happen with either the IRA or PBM reform, the next administration has shown signs of appreciating change. The incoming administration’s desire to clear unnecessary regulation and reduce government (D.O.G.E.), as well as its emphasis on transparency, signal that it may be time for a complete overhaul. But they must do more than simply cut red tape; they must create an environment where reform is encouraged and incentivized. They should encourage a healthcare environment that rewards innovation, promotes transparency, and delivers real value to patients.
Currently, several drug pricing and supply chain transparency and accountability policies have been proposed in various bills. Clearly, healthcare transparency has significant bipartisan support right now. Having Trump in the White House and having a Republican-controlled Congress means we can certainly expect more PBM reforms to come.
Trump previously tried to enact significant PBM reforms using his regulatory authority with the OIG rebate rule, but the Democrats repealed the OIG rebate rule with the Inflation Reduction Act. However, in general, PBM reform is a bigger issue for Republicans than Democrats. So, the fact that Republicans are now in control puts even greater scrutiny on PBMs and increases the likelihood of more legislative movement next year.
Q: Are there any trends in pharma/payer contracting that we should expect?
Andrew Rouff: The shift from traditional volume-based contracts to outcome-based agreements will certainly continue. As more expensive therapies come to market, such as cell and gene therapies, CAR-T therapies, and monoclonal antibodies, the demand for contracting will increase. Competition from biosimilars and/or novel MoAs will also contribute to contracting pressures.
Notably, warranty-based agreements are on the rise for certain high-cost brands like Hemgenix, Roctavian and Beqvez. I’m looking forward to seeing if these warranties help these products increase their utilization or continue to show lackluster results despite their innovative MoAs. It will be interesting to see how innovative contracting evolves in the future.
Q: What is likely to happen in the biosimilar space this year, and how will biosimilar white-labeling impact the market?
Andrew Rouff: There will likely continue to be increased competition in biosimilars. Humira competition is already well under way, while payers and manufacturers are currently in active discussions regarding Stelara biosimilar entrants in 2025. Topics like interchangeability, contracting, therapeutic areas and route of administration continue to be important considerations for payers evaluating formulary decisions.
While PBM white-labeling initiatives are brand new, they have already resulted in a drastic change in the biosimilar landscape. Humira biosimilars have had historically low uptake due to strong AbbVie contracting, but recent efforts by CVS and its subsidiary Cordavis have been successful in taking market share from Humira. Recent payer/manufacturer discussions regarding Stelara biosimilars are pointing to similar strategies by Cigna’s Quallent and Optum’s Nuvaila.
Jayne Hornung: Additionally, we will see several denosumab (Prolia) biosimilars, as well as omalizumab (Xolair); these will be the first biosimilars for these reference drugs.
Q: Which TAs will become more competitive this year?
Andrew Rouff: This year will bring increased competition in many therapeutic areas in the form of biosimilars and/or drugs with novel mechanisms of action. More than half of the 66 drugs likely to undergo FDA review in 2025 have been deemed practice-changing, such as gene therapies Upstaza and Zolgensma, RNA-based drugs for hemophilia and FCS, and new antibodies (Vyloy, Dato-DXd, Blrenrep, Enhertu).
Numerous biologics are expanding into chronic obstructive pulmonary disease (COPD), which will result in increased competition, new options for patients, and enhanced portfolio contracting opportunities for manufacturers. I’m also excited about the continued growth of GLP-1s and their impact on obesity, diabetes, cardiovascular disease and potentially other indications as well.
We’ll be keeping an eye on direct-to-consumer programs like LillyDirect and PfizerForAll, which help patients gain access to therapies in therapeutic areas like obesity, diabetes, migraine, and vaccines. Industry disruptors like Mark Cuban’s Cost+ and Amazon One Medical are also gaining traction and may continue to impact various areas as they grow.
Jayne Hornung: Pharma companies will also be waiting to see which drugs are chosen for the second round of Medicare Drug Price Medication Negotiation in February this year. This list has the potential to upend the landscape in some therapeutic areas, most notably oncology, pulmonology, diabetes and gastroenterology. Most of the drugs targeted for price negotiations have significant market share in their respective TAs, due to multiple indications and continued patent protections.
While speculation runs rampant, Novo Nordisk’s immensely popular GLP-1 agonist to treat type II diabetes, Ozempic, is likely to be on the list (potentially alongside its obesity counterpart, Wegovy). Oncology therapies Ibrance and Xtandi are also potential contenders, along with COPD treatments Trelegy Ellipta and Breo Ellipta.
Q: How do you expect AI and data science to impact the industry this year?
Kala Bala: As more payers, manufacturers, and providers begin using AI and data science, we’ll see a growth in our data-sharing capabilities and data integration/interoperability. In turn, greater connectivity will allow for more hyper-personalized care for individuals, and better clinical decision-making through advanced analytics. One example that comes to mind is leveraging AI on genomic data to better understand patient outcomes, refine care protocols, and improve future care. Of course, data privacy and cyber security concerns will need to be addressed alongside the rise of these new technologies.
Another example is the potential of AI and data science to significantly minimize the administrative burden of the entire prior authorization process. While I don’t believe that prior authorizations will ever go away entirely, we can certainly improve efficiencies over today’s status quo, which fax machines and land line calls back and forth between payers, providers and patients. The more transactional aspects of prior authorization will likely be automated, streamlining the process towards better overall utilization and resource management.
Andrew Rouff: Many payers are still only in preliminary discussions for how to utilize AI, so 2025 is likely still too soon for major changes on that side. Despite this, our research shows that payers are anticipating using AI for automated data retrieval for research and competitive analysis. They are also planning on using AI to provide initial screenings for prior authorization reviews, and to support HCPs with clinical decision-making.
Jayne Hornung: AI and machine learning are quickly changing the pharma market and how manufacturers approach it. The greatest impact of AI has been in drug discovery, clinical trials, diagnostic engagement, personalized patient engagement, and remote monitoring, making it a critical factor in the delivery of healthcare. Manufacturers need to think about AI across the drug life cycle from finding new patients for clinical trials to keeping patients adherent to medications once they are prescribed.
Q: What’s should pharma companies should focus on to prepare for the future?
Andrew Rouff: Biosimilars will soon become relevant for all therapeutic areas. These therapies are becoming today what generics were previously. Trends within this topic, like PBM white-labeling and dual pricing strategies, will continue to be important. Pharma companies need to factor in these market disruptors into their pre-launch research. In a constantly changing landscape, timely insights can make the difference between success and failure!
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