Innovation Isn’t Enough: Navigating Market Access, Pricing, and Patient Success.

This week in pharma and biotech underscores the complex landscape commercial and market access teams face: evolving government pricing schemes, new regulatory approvals in Europe, and payer decisions that impact patient access. For teams responsible for strategy, launch planning, and market access, staying ahead of these developments is critical to ensure both business success and patient impact.

UK NHS Drug Pricing Rebate Scheme Negotiations—Accelerated review of VPAG concludes without agreement

The accelerated review of the UK’s Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) concluded without an agreement between the government and the pharmaceutical industry. Negotiations focused on the scheme’s future rebate levels, which determine how much companies pay back to the NHS if spending exceeds the agreed cap. The lack of consensus highlights ongoing tension between the government’s goal of controlling NHS drug costs and the industry’s concerns about maintaining incentives for innovation. Both sides indicated a willingness to continue discussions, but no immediate changes to VPAG have been finalized.

TruView: The stalled VPAG negotiations underscore the growing complexity of managing drug pricing in the UK and the broader European context. For commercial and market access teams, this highlights the importance of proactive engagement with government payers, scenario planning for rebate obligations, and modeling financial impact under varying VPAG terms. Teams must balance the need to demonstrate value and support NHS sustainability while ensuring that innovation incentives and launch economics remain viable. Anticipating shifts in pricing frameworks and maintaining flexibility in market access strategies will be critical to navigating this evolving landscape.

Madrigal Receives European Commission Approval for Rezdiffratm—Madrigal Receives European Commission Approval for Rezdiffra™ (resmetirom) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis

Madrigal Pharmaceuticals announced that the European Commission (EC) has granted conditional marketing authorization for Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Madrigal estimates that approximately 370,000 patients with MASH with moderate to advanced fibrosis are currently diagnosed and under the care of a liver specialist across Europe.

Rezdiffra is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. At one year, 91% of patients treated with Rezdiffra 100 mg achieved improvement or stabilization of liver stiffness as measured by vibrational-controlled transient elastography (VCTE), a test that is frequently used to monitor treatment response in clinical practice. This decision not only provides patients with access to a new therapeutic option in a disease area with high unmet need but also strengthens Madrigal’s strategic position in the European market.

TruView: The Rezdiffratm milestone highlights the importance of coordinated cross-functional planning in biotech. Regulatory approval is only one step; reimbursement and provider adoption are equally critical. Teams should leverage clinical trial data to build a strong value narrative on patient and healthcare system impact. Early and proactive engagement with stakeholders can accelerate uptake and optimize commercial outcomes across diverse European markets.

CVS Declines Coverage for Gilead’s Twice-Yearly HIV PrEP Treatment Yeztugo—For now, CVS declines to cover Gilead's long-acting HIV PrEP treatment Yeztugo

CVS Health has decided not to cover Gilead’s twice-yearly HIV pre-exposure prophylaxis (PrEP) treatment, Yeztugo, citing concerns over cost and comparative value. This decision highlights ongoing payer scrutiny of high-cost therapies, even when clinical benefit is clear. While other payers may take different approaches, CVS’s decision signals that novel dosing regimens or delivery methods do not guarantee coverage without compelling economic evidence.

TruView: Payer decisions like this underscore the importance of strong value proposition and evidence package to support coverage discussions. Market access teams must anticipate payer concerns and develop multi-channel engagement strategies that clearly communicate both clinical and economic benefits. Launch success increasingly depends on proactive collaboration with payers, providers, and patient advocacy groups to ensure access while maintaining commercial viability.

This week’s developments illustrate the multifaceted challenges pharma and biotech teams face—from navigating complex pricing schemes and regulatory approvals to securing payer coverage for innovative therapies. Commercial and market access leaders must adopt a proactive, integrated approach, combining clinical, economic, and patient-focused insights to drive sustainable growth and patient access across global markets.

The headlines this week are more than news—they’re signals. The organizations that interpret them well and act decisively will shape the next phase of biopharma leadership. TruBio Consulting helps biotech and pharma teams translate market shifts into smart, strategic action.

TruView - What Matters This Week. Tru & Simple.