2025 Market Access Predictions: Hic Sunt Dracones

In medieval times, cartographers often marked the unknown territories on their maps with dragons and other scary creatures to warn the arrogant and foolhardy: hic sunt dracones, they noted (though for all those mapmakers knew, the dragons could just as well have been winged ponies – hic sunt manni alites?). As 2025 dawns, there are any number of unknowns awaiting the biopharmaceutical industry. Here are the top dragons – or maybe winged ponies -- from the Real Endpoints team.

1. PBM reform: not. The legislative rhetoric around PBM reform reaches a fever pitch, but remains more heat than light. A much meeker FTC retreats, looking for easier targets. The challenges around PBM transparency, specialty pharmacy consolidation, fee expansion, and the disruption of co-pay assistance will only be met when customers say “enough” – and turn to new models. To whit – prediction #2.

2. New-style disaggregated pharmacy benefit: possible. As anti-Big-3-PBM anger grows, the Blue Shield of California “Pharmacy Care Reimagined” approach gains adherents among the Blues and self-insured employers. Some plans sign up directly for BSCA’s model – which it markets—others go their own way towards philosophically similar disaggregated and apparently transparent vendor mixes of non-PBM affiliated specialty pharmacies, mail order, claims adjudication, and contracting (even if they’re still accessing the rebates of the Big 3). Amazon, via mail order, finally gets a firm toehold into the pharmacy business. If the BSCA or similar models work, pharma contracting could grow more complicated (more important customers to deal with) – but with each contract growing a little less existential.

3. DTC expansion: The success of Lilly Direct in delivering GLP-1s, coupled with increasing supply-chain rebates and provider shortages, sparks a number of pharma companies to start selling direct to consumers. By avoiding traditional distribution, the pharmas reach a new market – consumers who, blocked by PBMs and payers, otherwise wouldn’t get their brands. And if companies follow the Lilly model, the consumer discount would simply approximate (or perhaps be even less than) what PBMs and the rest of the supply chain require for covered access. The most obvious candidates for the model are products in the specialty-lite arena where competition and contracting are already fierce. Think migraine and dermatology (especially eczema and psoriasis) to start, with an expansion to other inflammatory conditions if successful. The DTC movement is yet another hit to community pharmacy.

4. Ugly Q1 for patient support: Number of hub program calls skyrocket as patients, caregivers, providers, pharmacies and payers struggle to understand and implement the Medicare Prescription Payment Plan (M3P or “smoothing”). Every January is generally a “blizzard” (as hubs call it) but 2025 should bring white-out conditions as Medicare Part D patients begin to receive extraordinarily complex bills. Pharmas will spend a lot of extra money on hub transaction fees and FTE costs.

5. AI tools ... still dream, not reality: The possibilities with artificial intelligence are virtually endless. Most obviously: helping with the physician shortage (a growing challenge) and back-office admin, but in plenty of other ways too. Maybe helping biosimilar companies (including the specialty pharmacies and PBMs) develop the base-case requisite patient support tools biosimilar margins haven’t so far allowed. In creating and adjudicating formulary decisions. In supporting or just as often debunking specific real-world evidence arguments. Maybe even playing scorekeeper on value-based agreements among pharmas and payers. But despite its enormous potential to lower healthcare costs and improve delivery, our cynical bet is that AI is most likely to be used to maximize, not resolve, the competing stakeholder interests which are the root causes of our dysfunctional healthcare system.

6. Continued 340b costs: The 340b program expands – or at least doesn’t shrink. With the support of the Trump administration and DOGE, which assume that the program could reduce government spending (with Medicare extracting a portion of the discount), the 340B program remains as big as ever. Bigger in fact: states enact new laws to allow hospitals to expand their network of 340b pharmacies. The duplicate discount problem for pharma only grows.

7. Payers restrict fast-tracked drugs: The FDA will continue its liberal approval policies on drugs they consider important new medicines – but payers will clamp down. They’ll introduce next-gen new-to-market blocks for drugs approved through an accelerated pathway (especially those approved with surrogate endpoints) – some with time-defined exclusions (e.g., no coverage for 18 months), some even more draconian: no coverage until either further confirmatory trial with clinical outcomes and/or FDA grants full approval.

8. Value-based deals...finally. Some will stay between pharmas and payers, as they have in the past. But a new form emerges. Under growing pressure from employers to moderate their specialty drug spend, provider groups (particularly in oncology, retinal medicine, and immunology) sign on to contracts not unlike the risk-sharing programs they’ve signed on the medical side, but around pharmaceutical spend – and turn to pharma to help them meet these new obligations, often in partnership with the national distributors.

Jeff Berkowitz Susan Raiola Ryan Walsh Rob O'Brien Ellen Licking Julia Murphy Alec Doherty Jane F. Barlow, MD, MPH, MBA