Making the Jump from “Coverage assumed” to “Access proven”: The New Equity Imperative in Market Access

The Academy of Managed Care Pharmacy (AMCP) meeting in Nashville, TN, raised important questions about health equity, novel therapies and payer strategies that have long-term implications for manufacturers and how patients access treatment.

At the Academy of Managed Care Pharmacy meeting in Nashville, TN (AMCP 2026), session after session confirmed one important message: health equity is increasingly being determined not by whether a medicine works, but by payer policy design – the coverage and reimbursement decisions payers make – and how those policies are implemented day to day. Payers are tightening access in high-spend categories such as obesity/GLP-1s; they are expanding beyond-label criteria in complex categories such as gene therapy; and they are maintaining high evidence bars that patient experience data and patient reported outcomes (PED/PRO) must meet in order to influence coverage.

For manufacturers, this signals a strategic shift – a move away from the old mindset of “coverage assumed” to a new mindset of “access proven”. This brings with it the need to show, with data, where access barriers occur and what is being done to reduce these barriers. Patients need to be tracked for “pathway drop-off measurement” which considers where patients fall off the path somewhere between receiving a prescription and actually receiving the treatment they need. Key questions include: Do patient drop-offs differ by payer, site of care, geography, race/ethnicity, language, socioeconomics, Medicaid vs commercial?  Solutions to the issues may include building patient support or navigation capabilities that are designed to reduce unequal access – not accidentally reinforce it. Such strategies may help shape health equity in the future.

Implications for Biotech/Pharma

For Biotech/Pharma this suggests that launch planning needs to be built around quantifying and fixing access barriers and not just securing coverage decisions. Issues to consider include:

• Rejections: what percent of patients get stuck at their health plan’s prior authorization gate
• Abandonment: what percent abandon pursuit of treatment due to the out-of-pocket costs they must pay in order to receive the treatment
• Non-fill: What percentage fail, for whatever reason, to actually collect their prescriptions

Equity risk will show up as variability: by payer type, geography, plan policy, site of care, and operational capability (e.g. qualified centers, monitoring).

Evidence strategies must be designed for payer credibility thresholds – especially Patient-reported outcomes (PROs) and Patient experience data (PED), which payers will not treat as decision-grade unless they are quantitative and statistically defensible.

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2025–2026 Health Care and Pharmaceutical Marketplace Trends

At a session titled:“2025–2026 Health Care and Pharmaceutical Marketplace Trends” speakers discussed health equity seen through payer restriction patterns and real-world patient access drop-off. The key points and takeaways raised were that access to obesity treatment is becoming harder to obtain at a time when overall spending is rapidly increasing, and this is creating a growing inequality in which some patient populations can get effective treatment while others are locked out and denied care.

• Anti-obesity spend has seen rapid and significant increases – anti-obesity preps $42.0B, +82.7% year on year (YoY) – but payers are actively restricting coverage for obesity GLP-1s
• Examples shared included notable market events in late 2024-early 2025 which included BCBS/IBX removing coverage for obesity GLP-1s, MassHealth preferring Zepbound and Wegovy non-covered for obesity; meantime multiple US states are tightening Medicaid eligibility
• Equity risk implication: access will increasingly diverge by payer type and geography – creating uneven real-world outcomes for the same clinical need

Moreover, access to novel therapies is difficult given extreme patient drop-off for novel medicines. This story is clear from the data:

• 56% of new-to-brand prescriptions are written but unfilled
• 39% are rejected by the original payer
• The equity risk implication is that even when clinicians prescribe, patients may not start therapy – making access attrition a core equity metric, not a secondary operational issue

From a market context: pipeline/launch dynamics are shifting:

•  “With no new GLP-1s since 2023, immunology and oncology take the lead in sales and new launches (Alyftrek, Wezlana, and Journavx emerge as the top products in 2025)”
• The practical implication is that as payer focus rotates across categories, manufacturers should anticipate new restriction patterns following budget pressure – especially in large-population indications
• “Late 2024–Early 2025 Payers remove coverage for GLP-1s used for weight loss.”

For manufacturers takeaway messages may be that they should look to:

• Shift launch planning from “coverage assumed” to “access proven”: build a payer-by-payer strategy that anticipates tighter obesity/GLP-1 restrictions and quantifies where patients drop off (rejections, unfilled scripts, abandonment)
• Build interventions targeted to the highest-friction segments (not generic “access support”): align solutions to specific payer controls (prior authorization rules, exclusions, step therapy, diagnosis requirements, refill requirements)

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Beyond the Breakthrough: Practical Insights for the Complex Gene Therapy Market

At an AMCP 2026 session titled: Beyond the Breakthrough: Practical Insights for the Complex Gene Therapy Market, speakers discussed equity risk from coverage variability, beyond-label criteria, and operational delivery constraints. The top takeaways from this session were:

• Equity risk is emerging from “coverage variability + criteria creep,” with many plans adding clinical requirements beyond the Food and Drug Administration (FDA) label (including Medicaid policies) that are largely derived from clinical-trial subgroup criteria – creating a real risk of uneven access across plan types and geographies if trial populations do not reflect underrepresented groups. Beyond-label criteria are increasingly common:

1. Commercial/Exchange: 52% of policies included clinical criteria beyond the FDA label
2. Medicaid: 68% of policies included requirements beyond FDA label
3. 72% of payers think that managing financial risk is a challenge

Payers’ practical “equity framework” for gene therapy access is increasingly operational (not just clinical): eligibility often hinges on treatment at qualified centers plus comprehensive care coordination and long-term monitoring, while real-world barriers like travel/lodging and cultural/psychosocial factors show up as explicit stakeholder concerns.

Evidence expectations are shifting toward “prove it and track it,” because payers’ preferred affordability approaches (utilization management + risk transfer + outcomes-based contracts/warranties) depend on durable, real-world outcomes monitoring – and plans are signalling that care coordination is a key gap, with case management and financial assistance among the most common solutions.

Speakers noted that coverage variability + “criteria creep” are creating uneven access risks.  

“Gene therapy coverage remains highly variable across plans.”

Patient Experience Data in Managed Care Pharmacy Decision Making: Barriers, Opportunities, and Practical Strategies for Managed Care Pharmacists was another AMCP 2026 session which took the health equity argument further with a discussion of outcomes research. Focus points included making PED/PRO credible and usable in payer decision making.

From the discussion we concluded that Pharma/Biotech should stop treating PED/PRO as “nice-to-have” and instead design them to clear payer credibility thresholds: make them quantitative and statistically defensible (primary or pre-specified alpha-controlled secondary endpoints) and have them ready at/near launch (not delayed to post-marketing).

Three main points were raised at the session: 

• Payer signal: Traditional “hard” evidence still dominates; clinician-reported outcomes (83%) and biomarkers (73%) outrank real-world evidence (RWE) (57%), while patient stories (85%) and patient preference (77%) are most often viewed as least important decision inputs in formulary decisions
• Evidence expectation: If Pharma wants PROs/PED to influence coverage, payers are explicitly signaling they need them structured like “real endpoints” – quantitative and statistically credible (primary or pre-specified, alpha-controlled secondary), not exploratory add-ons
• Framework shift (outcomes research +value-based care readiness): PED/PROs are increasingly being operationalized as performance measures (PRO-PMs) with clinical, operational, and financial/regulatory value – explicitly tying patient-relevant outcomes to longitudinal tracking and value-based payment models aligned with Centers for Medicare & Medicaid (CMS) / National Committee for Quality Assurance (NCQA)
  
  

“While formulary decisions currently rely heavily on traditional clinical trial data, these data alone may not fully capture the diverse range of patient experiences, and the impacts disease and treatments have on everyday life. PED should more routinely be incorporated into decision making, along with other relevant disease and treatment information.”

Conclusion

With three days spent at AMCP 2026 we left with plenty to reflect on. Managed care organizations are making faster, higher-stakes decisions in an environment of accelerating specialty spend, disruptive pipeline innovation in terms of gene therapies, GLP‑1s, etc., and growing expectations for transparent, decision-relevant evidence. Success increasingly depends on (1) fit-for-purpose data and research practices, (2) medical–pharmacy benefit integration with actionable analytics, and (3) practical operating models that connect clinical strategy, member experience, and financial risk management. Meantime, manufacturers, must move away from the old mindset of “coverage assumed” to a new mindset of “access proven”.

Across obesity, gene therapy, and outcomes research, the market signal is consistent:

• Payers are tightening policies fastest in categories with high budget exposure (e.g. obesity)
• Payers are expanding criteria beyond label where uncertainty and risk are high (e.g. gene therapy)
• Payers are open to broader evidence types, but only if they meet methodological standards (e.g. PED/PRO)
• Patients are falling out of the pathway at rates that can no longer be treated as noise.

Health equity in this environment is a performance outcome of the access system – visible in rejection rates, fill rates, eligibility criteria, center requirements, and monitoring infrastructure.

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