Our review of the 2024 pricing and market access revealed key challenges facing the pharmaceutical industry, including: access to digital therapeutics, the EU HTA, Obesity challenges: balancing demand with ethics, value vs. price and US Medicaid negotiations.
Let’s look ahead to 2025 and examine our five key pricing and market access trends set to shape the industry
Trend 1: EU HTA Implementation: JCA Takes Centre Stage!
The long-anticipated implementation of the EU HTA legislation (EU Regulation 2021/2282) is finally here, set to take effect on January 12, 2025, for oncology products and advanced therapy medicinal products (ATMPs). This follows extensive groundwork by European Network for Health Technology Assessment (EUnetHTA) and the Member State Coordination Group on HTA (HTACG).
Implementing the JCA process will require meticulous cross-functional coordination, the JCA dossier will largely follow the same structure as previous EUnetHTA relative efficacy assessments and G-BA dossiers. However, evidence requirements are unlikely to relax, necessitating a robust strategy aligned with PICO scenarios and evidence needs.
Companies undergoing early JCA, should already have systems and processes in place to accommodate the increase in workload and changes in ways of working, we anticipate that although larger companies may have prepared for this smaller companies will face resource and capability challenges.
Although the much talked about JCA is finally upon us, we anticipate 2025 to be a year of uncertainty and anxiety for companies having to submit early JCAs (no one likes to be the first!), a great deal of hype and anticipation for the first JCA report (expected in November 2025), followed by deliberation on how countries will embed the JCA report into their local decision making.
Given these factors, the path to JCA adoption may appear lengthy and uncertain. However, thorough early cross-functional planning and preparation will be crucial in building a strong foundation for successful JCAs and ensuring a seamless transition into this new process.
To support our clients through this complex journey, we have developed the Remap JCA Advisor, an AI-powered tool designed to help you better understand the European Union Health Technology Assessment (EU HTA) processes.
This tool aims to simplify the complexities of the JCA and Joint Scientific Consultation (JSC) processes; for more information on the JCA advisor or to discuss how we can support you, email: contact@remapconsulting.com
Trend 2: RWE – More Tangible as a Complementary Source of Evidence
Real-World Evidence (RWE) is becoming an increasingly valuable tool in the healthcare sector, particularly in supporting regulatory, reimbursement, and market access decisions. Unlike traditional clinical trials, which are often limited by strict inclusion criteria, RWE captures data from everyday clinical practice. This includes patient registries, patient-reported outcomes (PROs), electronic health records (EHRs), administrative claims data, wearables and mobile data, social media and health care forums, observational studies, healthcare databases, post marketing surveillance studies and public health databases, offering insights into how treatments work across broader and more diverse patient populations.
The growing acceptance of RWE by regulatory authorities and health technology assessment (HTA) bodies is helping bridge the gap between clinical trial data and real-world evidence, making it a more tangible and recognised source of evidence and with initiatives like DARWIN-EU, the European Health Data Space (EHDS) and growing support from the GetReal Institute as well as NICE and the EMA demonstrating the value of RWE, 2025 is set to be a pivotal year for RWE.
It would be remiss not to mention AI in the context of RWE, and we anticipate this partnership will grow in 2025 as AI empowers users to derive valuable insights from RWE by analysing large, complex datasets. Through AI, you can uncover patterns and trends in real-world data, guiding clinical decisions, enhancing drug development, and improving patient outcomes.
Trend 3: The growth of the GLP-1s
In 2024, GLP-1s were propelled into the spotlight mainly due to the success of weight loss and diabetes drugs from Novo Nordisk and Eli Lilly. In 2025, we see this trend continuing, with several manufacturers pursuing oral GLP-1 medications in the clinic to secure a competitive edge over the once-weekly injectables currently available.
The potential of GLP-1 therapies extends beyond obesity and diabetes. Novo Nordisk’s Wegovy was approved by the FDA to reduce the risk of cardiovascular disease in 2024. Two clinical trials investigating Semaglutide, the drug in Ozempic and Wegovy, as a therapy for early Alzheimer’s are expected to conclude in 2025. If the results are positive, it could mark a breakthrough in Alzheimer’s treatment and re-ignite the GLP-1 cost debate!
Trend 4: AI is here to stay
In 2024, as in previous years, you could not attend a conference or pick up an industry magazine without seeing the words Artificial Intelligence. However, we predict 2025 to be a year where AI tools will be adopted more broadly in the healthcare sector to improve efficiency and quality. The value of using AI tools to analyse large volumes of data has never been debated, manufacturers like BMS have been leading the charge when it comes to using AI to reduce costs and improve study designs since they announced their partnership with Owkin back in 2022. With more use cases, including drug discovery, data analysis as well as draft guidance from the FDA and NICEs statement of intent for the use of AI in evidence generation, confidence is increasing.
Trend 5: High-Cost Therapies for rare diseases
Several factors position 2025 as a year for advancements in rare disease treatment. Remote participation in clinical trials will expand access for more patients, while precise identification of genes responsible for monogenic diseases will open the door to exploring life-saving therapies. In April 2023, the European Commission introduced a proposed regulation for EU pharmaceutical reform, prompting the Committee on the Environment, Public Health and Food Safety (ENVI) to suggest several amendments. These amendments were adopted unchanged by the European Parliament in April 2024. The reform brings notable updates to the criteria for orphan medicinal product designation, including maintaining the prevalence threshold of five affected persons per 10,000 and introducing specific criteria for conditions with high mortality and short duration. It removes the return-on-investment criterion, limits orphan designation validity to seven years with possible extensions and revises the market exclusivity framework. The continued advantages of Orphan Drug Designation will remain a strong incentive for pharmaceutical companies developing these treatments. Innovations like base editors, capable of correcting point mutations, will enable companies to make significant progress toward effective therapies from the outset. Coupled with one-time, curative treatments, these advancements set the stage for a healthy rare diseases pipeline, however we expect to see increased use of alternative reimbursement pathways.
Pharmaceutical manufacturers and the broader healthcare industry must prepare for a potentially transformative 2025. The pricing and market access trends discussed underscore the constantly evolving nature of the healthcare landscape and point to the JCA and AI disrupting the status quo, whilst demonstrating the value of a product is crucial for high-cost therapies to ensure successful reimbursement is still imperative.