The global payer landscape is continuously evolving and undergoing significant transformation, influenced by the escalating burden of diseases and surging healthcare expenditures. As the complexity of new pharmaceutical products increases, payer evidence expectations are becoming stringent, impacting pharmaceutical companies’ strategies concerning clinical development, product launches, portfolio management, pricing, and market access. Consequently, it is crucial for manufacturers to monitor and adapt the dynamics of pricing and market access (P&MA) policies to effectively navigate this evolving environment.
Recently, various payer policies have been introduced worldwide that emphasise on the patient access, cost-containment strategies, and adaptations to Health Technology Assessment (HTA) frameworks. These developments reflect a broader trend towards more rigorous evaluation processes aimed at ensuring that new therapies deliver substantial value to both patients and the healthcare system.
Access Infinity closely analysed three key payer policies from the perspective of P&MA implications for pharmaceutical manufacturers, focusing on how they can strategize to seize opportunities and address challenges.
Trend #1. GERMANY: Updates to the drug list subject to the mandatory brand-brand combination discount
Almost two years ago, the government introduced a 20% discount on drugs used in free combinations unless the combination has considerable or major added benefit rating. However, its implementation was difficult given the GKV-SV (National Association of Statutory Health Insurance Funds) and industry associations could not agree on how the rebate should be applied. Thus, the Federal Ministry of Health intervened, resulting in publishing new regulations recently.
Trend #2. Italy's 2025 budget proposals: impact on innovative drug access and pharmaceutical spending
The Italian government’s newly approved 2025 budget proposes significant reforms to the Innovative Medicines Fund (IMF) and the broader pharmaceutical spending structure, impacting access to innovative drugs, especially those addressing critical conditions such as antimicrobial resistance (AMR). With the aim of improving access to novel therapies for serious diseases, these changes are poised to impact both the pharmaceutical industry and the healthcare system in Italy.
Trend #3. Australian government publishes the final HTA review report
The federal government released the long-awaited final report of the HTA policy and methods review. The report outlined fifty recommendations with aim to improve access to new technologies, address disparity in access and simplify HTA process to boost participation from consumers and clinicians.
Proactive Planning & Agile Adaptation: Pharma Strategy for Market Access and Pricing with Changing Payer Policy Dynamics
Pharma companies must prioritize proactive planning and adopt a forward-thinking strategy to navigate the complex and dynamic market access and pricing landscape evolving with payer policy environment. Agility and flexibility are crucial in responding to evolving payer landscapes, reimbursement policies, and competitive pressures.
Access Infinity advises global/ local market access and pricing teams within pharma organizations to initiate early planning. This proactive approach allows for a deeper understanding and identification of early market access and pricing opportunities. Access Infinity acts as a key enabler, guiding pharma companies through the complexities of the payer landscape. By fostering cross-functional synergies, Access Infinity helps navigate the challenges and ensure successful market entry and sustained access for innovative therapies.
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
Samrudhi Mansukh, Analyst, Data, Access Infinity
Brett Gardiner, Senior Partner, Access Infinity
