The global payer landscape is rapidly evolving, driven by increasing disease burden and rising healthcare costs worldwide. The payer demands are becoming more stringent in response to the growing complexity of new products which in a higher likelihood significantly influence pharmaceutical manufacturers’ decisions regarding clinical development, new product launches, portfolio management, pricing and market access strategy. As a result, it is imperative for manufacturers to understand the payer and market access (P&MA) policy dynamics to navigate this shifting terrain.
Globally, multiple payer policies have been introduced and implemented recently focused on patient access, cost-containment measures and adaptations in Health Technology Assessment (HTA) or regulatory frameworks.
Access Infinity closely analysed three key payer policies from the perspective of P&MA implications for pharmaceutical manufacturers, focusing on how they can strategise to seize opportunities and address challenges.
Trend #1. EU HTA update: Procedures for joint scientific consultation (JSC) - A Call for Pharma in Early Preparation and Action for Market Access Strategies
The EU’s new HTA rules (Regulation 2021/2282) mark a transformative step in how member countries evaluate new health technologies. They have been designed to foster cooperation across the EU and to optimise the use of health system resources while acknowledging national competencies. A key focus of this initiative is joint scientific consultations (JSC) for medicines wherein the European Commission has now released a draft regulation (set to apply from 12 January 2025) aiming to streamline the JSC process and provide a clear framework for health technology detailing the procedures for JSC on medicinal products for human use. For pharmaceutical companies, engaging with this process is not just an opportunity—it’s essential for navigating the complex landscape of HTA in Europe.
Trend #2. Commission de la Transparence (TC) Relaxes HTA Evidentiary Requirements under New Doctrine in France
In a significant shift aimed at accelerating patient access to new therapies, France’s Transparency Commission (TC) has introduced a new policy framework, as detailed in its latest annual report (2023-24). This “new doctrine” will allow a reduction in the level of evidence required for the reimbursement of health products in cases where traditional randomised controlled trials (RCTs) are not feasible. Previously, RCTs were upheld as the gold standard for safety and efficacy, but the TC will now accept indirect comparisons under specific conditions.
Trend #3. New pricing regulations in Germany
The Medical Research Act was passed by the German parliament on 4th July 2024. This act is a pivotal step in Germany’s National Pharma Strategy and has introduced several key changes to country’s dur pricing and reimbursement that are dependent on manufacturers carrying out R&D activities in Germany.
It is imperative to monitor any further developments since the bill is pending for approval by the German Federal Council (Bundesrat). Once approved, different provisions will come into force at different times however, confidential reimbursement price and the new connection between drug pricing and local clinical trials will apply as from 1 January 2025.
Plan ahead, adopt a forward-thinking strategy and stay agile
Access Infinity advice global/ local market access and pricing teams within pharma organisations is to initiate planning in advance by adapting and adopting a forward-thinking strategy coupled with agility and flexibility. It is imperative for the pharma manufacturers to understand and unlock the opportunities while Access Infinity can act as the enabler to guide through the unchartered and dynamically evolving payer landscape, fostering cross-functional synergies to successfully navigate the wave of challenges.
Authored by
Nikhil Taxak, Ph. D, APAC Head, Pricing and Market Access Data and Analytics, Access Infinity.
Mahesh Jaju, Associate Manager, Data, Access Infinity
Anupama Somu, Associate Manager, Data, Access Infinity.
Srikanth Utukuri, Analyst, Data, Access Infinity.
Brett Gardiner, Senior Partner, Access Infinity.
