As we enter 2024, the global healthcare landscape is experiencing fundamental changes ushered in by major policy shifts and challenging payer decisions. While groundbreaking legislative changes and increasing global pricing pressures may be the clear headliners, there are other changes — state-of-the-art technological and medical innovations, the growth of potentially curative therapies — swirling against a backdrop of uncertainty across different geographies. In the United States, the Inflation Reduction Act will not only accelerate pricing pressures on high-cost, highly utilized products, but it will also lead to downstream patient access impacts. Globally, payers continue to expect that manufacturers demonstrate the value of their products to the healthcare system and patients.  

In light of this ever-changing environment, Cencora’s market access team offers insights on the top trends that are changing the face of market access. In 2024, all stakeholders will need a clearer understanding of how these dynamic trends will affect patient access to innovative therapies across global markets.

Key focus areas for 2024:

• The Inflation Reduction Act (IRA) is ushering in a new era of government price scrutiny, negotiations, and pressures for manufacturers.
• Negotiations in Medicare are likely to have future impact on innovation throughout industry.
• Medicare Part D redesign will cap out-of-pocket costs for patients, but manufacturers and Part D plans must share in the cost burden.
• Higher financial liability for Part D plans is likely to lead to narrower formularies, greater utilization management, higher premiums, and less plan availability in 2025.

Similarly, in Europe, the European Commission published its proposal in April 2023 to reform the EU's pharmaceutical legislation.

• A key objective of this legislation is to reduce drug prices by enabling earlier market entries of biosimilar products and facilitating exchanges of best practices on pricing and reimbursement between member states.¹
  
  

Key focus areas for 2024:

• In Spain, a Royal Decree aims to revamp HTA regulation by introducing changes to governance bodies' structures and processes, in addition to implementing health economic assessments inspired by the UK's National Institute for Health and Care Excellence (NICE) approach.²
• In Italy, there have been significant reforms to the Italian Medicines Agency (AIFA), including merging the Technical and Scientific Committee (CTS) and the Pricing and Reimbursement Committee (CPR) into a single entity called the Scientific and Economic Commission for Medicines (CSE). This unified body will have the responsibility for conducting scientific assessments as well as making pricing and reimbursement decisions.³
• The objective for both is to ensure equal access to innovative medicines and new medical devices within individual countries and across the EU, specifically the following:
  • Reducing bureaucracy and redundancy across member states
  • Speeding up access to innovative medicines
  • Easing patient affordability challenges with greater price transparency, innovative payment schemes, population health models, and outcomes-based agreements.
    
    

Key focus areas for 2024:

The CGT landscape is shifting from rare/ultra-rare indications to more common conditions.

• Manufacturers in the CGT space must consider the extensive ways in which this shift will impact global healthcare systems, patient access, long-term data collection, manufacturing capacity, and payer, provider, and patient education.
• Given the growth of CGTs, the US Food and Drug Administration (FDA) is ramping up its reviewer resources to support Biologics License Applications (BLAs), necessitating enhanced market access strategies focused on breaking down access barriers and attaining appropriate reimbursement.
• In the EU, advanced therapeutic medicinal products (ATMPs) will be submitted through the Joint Clinical Assessment (JCA) from 12 January 2025. 
  
  

Key focus areas for 2024: 

• Stakeholders are increasingly recognizing the value of RWE to inform regulatory decision-making, optimize healthcare delivery, and enhance patient outcomes.  
• As an example, the FDA does accept RWE to support decision-making in some cases. In 2018, the FDA established a framework to evaluate the potential use of RWE to support expanded indications of approved products⁴.
• Equally, access to outcomes-focused RWE will enable payers to better determine the value of the product. The utilization of RWE in decision-making will continue to expand as data sources expand and improve and as new methodologies for leveraging RWE are introduced. 
  
  

Key focus areas for 2024:

Value-based partnerships are expected to:

• Gain prominence, mainly between manufacturers, hospitals, and often payers. 
• Focus on integrating and improving care and increasing transparency of care, rather than on specific outcomes measurement (which is seen as a lagging indicator).
• Increase in importance amid a greater focus on new personalized medicine, rare disease, and curative therapies, all of which potentially impact the patient profiling process, care delivery path, supply chain, reimbursement decisions, and/or financing methods needed.  
  
  

Key focus areas for 2024:

• Developing and providing evidence of improved patient outcomes and cost-effectiveness of the drug-device combination. 
• Building convincing cases via collecting and utilizing real-world data to address payer concerns for gaining market access.  
• Collaborate (pharmaceutical and medical-device manufacturers) to bridge the knowledge gap between these sectors in order to develop comprehensive market access strategies. 

Key focus areas for 2024:

• By leveraging AI technologies, biopharma companies can analyze vast amounts of data more efficiently, identify key insights, and make data-driven decisions to support their market access strategies.
• Importantly, AI could revolutionize forecasting and pricing strategies by analyzing RWE, patient outcomes, and health economic data, enabling biopharma companies to demonstrate the value of their products during a HTA and negotiate favorable reimbursement agreements with payers. 
  

  
  

¹European Commission. Reform of the EU pharmaceutical legislation. Accessed December 19, 2023. https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-way-life/european-health-union/reform-eu-pharmaceutical-legislation_en 

²PharmaTech.com. Changes Afoot in Pharmaceutical Laws and Regulations in Spain. Accessed December 13, 2023.  https://www.pharmtech.com/view/changes-afoot-in-pharmaceutical-laws-and-regulations-in-spain 

³NAVLIN DAILY. Italian State-Regions Conference Approves AIFA Reform. Accessed December 13, 2023.  https://www.navlindaily.com/article/19512/italian-state-regions-conference-approves-aifa-reform 

⁴U.S. Food & Drug Administration, Real-World Evidence. Accessed December 19, 2023. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence 

The contents of this article are speculatory in nature and any predicted trends may ultimately not occur. Cencora strongly encourages readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto.