By Kellie Rademacher – Director, Strategy at Inizio Evoke
Executive Summary
The U.S. healthcare market is undergoing a fundamental restructuring of how patients access, pay for, and receive prescription medications. Long-standing payer-centric market access models are being challenged by two concurrent developments: the rise of provider-led direct contracting, in which health systems assume both clinical and financial responsibility for defined populations, and the emergence of direct-to-patient (DTP) purchasing pathways, enabled by evolving federal policy and manufacturer innovation. Together, these shifts are reducing the centrality of traditional insurers and pharmacy benefit managers (PBMs) as the sole arbiters of access and forcing pharmaceutical manufacturers to rethink how access, affordability, and value are designed and communicated across the healthcare ecosystem [1-4].
Redefining the Gatekeepers: From Payers to Multi-Channel Access
For decades, market access strategy in biopharmaceuticals has centered on negotiating coverage and formulary placement with insurers and PBMs. That model is now being challenged on multiple fronts.
First, health systems are increasingly entering direct contracting arrangements with self-insured employers, effectively bypassing traditional insurers to manage care delivery, utilization, and cost risk. The recent expansion of Northwell Direct, including its agreement with the 32BJ Health Fund, represents one of the largest direct healthcare contracts in the United States and underscores employers’ willingness to pursue alternative purchasing models when insurers are perceived as insufficiently controlling costs [1,2,3].
Second, federal policy is beginning to enable new direct-to-patient purchasing pathways, allowing manufacturers to sell medications directly to patients under defined conditions. Recent guidance from the U.S. Department of Health and Human Services (HHS) and the Office of Inspector General (OIG) has clarified how manufacturers may offer discounted cash-pay options without violating federal fraud and abuse statutes, while public reporting suggests the federal government is exploring platforms that connect patients to lower-cost, manufacturer-led purchasing channels. Most notably, the federal government recently launched TrumpRx.gov, a government-operated portal designed to help patients identify discounted prescription drugs and route them to manufacturer direct-to-consumer purchasing or coupon channels, making a concrete step in operationalizing this pathway under broader drug pricing initiatives [7,8,11].
Together, these developments signal a critical shift: access is no longer routed exclusively through third-party payers, but instead through a growing set of payer, provider, and patient-managed channels.
Implications for Market Access Strategy
From Coverage Optimization to Channel Orchestration
Historically, securing favorable coverage terms with payers and PBMs was synonymous with achieving patient access. As provider-led contracting and patient-driven purchasing expand, that assumption no longer holds. Manufacturers must now manage access as a portfolio of channels, each with distinct gatekeepers, incentives, and frictions [10].
These channels include:
Provider-managed access, where health systems at risk define pathways and preferred therapies;
Traditional payer-managed access is still relevant for large insured populations, and
Patient-managed access, where individuals make purchasing decisions based on transparent pricing and affordability.
In this environment, access strategy becomes less about winning a single negotiation and more about orchestrating coherence across channels.
Affordability Is No Longer a Backstop — It Is Core to the Value Proposition
Traditionally, affordability was addressed downstream through copay assistance and patient support programs layered on top of payer coverage. In contrast, direct-to-patient purchasing makes affordability visible, immediate, and reputational.
Industry analyses suggest that direct purchase programs may reduce out-of-pocket costs for some patients, particularly those with high deductibles or limited insurance coverage [4,8]. At the same time, these models raise new questions about equity, sustainability, and how pricing logic is perceived by payers and providers.
As a result, affordability can no longer be treated as a tactical afterthought. It must be intentionally designed, clearly explained, and aligned with how different access channels are meant to function.
Clinical Appropriateness and Utilization Oversight Must Be Reimagined
One concern raised in the literature is that direct-to-patient purchasing may weaken utilization management mechanisms that have historically been enforced by payers, such as prior authorization and step therapy [5]. Without careful design, this could contribute to fragmented care or inappropriate utilization.
To mitigate these risks, manufacturers pursuing DTP strategies must embed clinical guardrails, including patient education, decision support tools, and coordination with providers, to ensure access expansion does not come at the expense of evidence-based use [5,9].
Strategic Implications for Market Access and Communications
Integrating Market Access Messaging Across Stakeholders
As access decision-making fragments, market access communications must evolve beyond payer-centric narratives. Manufacturers must be able to articulate a coherent value story to:
Health systems managing population risk,
Patients evaluating direct purchase options, and
Payers concerned with cost containment and precedent.
Critically, these narratives must be internally consistent, even as they are tailored to different audiences. In a more transparent access environment, contradictions between patient-facing and payer-facing messages are likely to surface quickly.
Aligning Value Demonstration with Health System Priorities
In direct contracting arrangements, health systems are accountable for total cost of care and outcomes across populations. Manufacturers must therefore shift value demonstration away from narrow pharmacy budget impact toward system-level outcomes, including avoided downstream utilization, operational feasibility, and pathway efficiency [3,10].
This requires translating traditional HEOR evidence into health-system-relevant insights, rather than relying solely on payer-oriented economic models.
Conclusion: The New Access Landscape
The convergence of provider-led direct contracting and consumer-driven purchasing represents a meaningful dilution of the payer’s historical centrality in market access. Rather than eliminating intermediaries altogether, these trends redistribute access control across providers, employers, and patients.
In this evolving landscape, a successful pharmaceutical market access strategy will depend on:
Designing access across multiple channels rather than optimizing a single gatekeeper,
Treating affordability as a core component of value, not a downstream fix, and
Communicating access strategy with clarity, coherence, and intent.
Manufacturers that proactively adapt to this reality will be better positioned to support appropriate use, sustain adoption, and maintain credibility in a healthcare system defined by increasing transparency and accountability.
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References (AMA Style)
[1] Tong L. Northwell’s direct contracting deal with 32BJ Health Fund threatens insurers. Modern Healthcare. January 28, 2026.
[2] Northwell Health. Northwell Direct and 32BJ Health Fund announce largest direct health care contract of its kind. December 2025.
[3] Fierce Healthcare. Direct contracting, real savings? Northwell thinks so. 2025.
[4] Avalere Health. Direct-to-Consumer Drug Purchasing: What Comes Next. October 2025.
[5] Lalani HS, Rome BN, Kesselheim AS. Benefits and limitations of direct-to-consumer pharmacies in the United States. JAMA Netw Open. 2025;8(9):e2527484. doi:10.1001/jamanetworkopen.2025.27484.
[6] Dunne C. Direct purchase programs can lower costs for patients. PhRMA Blog. October 2025.
[7] U.S. Department of Health and Human Services, Office of Inspector General. OIG advisory opinion on manufacturer direct-to-consumer prescription drug sales. January 2026.
[8] Becker’s Hospital Review. HHS outlines path for lower-cost drugs via direct sales. January 27, 2026.
[9] Debevoise & Plimpton LLP. “Pharm-to-Table”: The Impact of Direct-to-Consumer Pharmaceutical Sales. September 2025.
[10] Kaiser Family Foundation. Employer-sponsored insurance and the rise of alternative purchasing models. 2025.
[11] The White House. Fact Sheet: President Donald J. Trump Launches TrumpRx.gov to Bring Lower Drug Prices to American Patients. The White House; February 5, 2026. Available at: https://www.whitehouse.gov/fact-sheets/2026/02/fact-sheet-president-donald-j-trump-launches-trumprx-gov-to-bring-lower-drug-prices-to-american-patients/. Accessed February 6, 2026