In January of this year, we summarized the key trends that our market access experts anticipated would dominate 2024. It is now time to review our predictions and examine their impact.
For a detailed outlook of the 2024 trends. Click here
Trend 1: Enhanced Patient Access to Digital Therapeutics on a Global Scale
The global landscape for digital therapeutics is evolving, with notable progress in national pricing and reimbursement frameworks in countries like the UK, Germany, and France. However, challenges remain in ensuring widespread patient access, as regulatory processes and reimbursement structures continue to evolve.
Progress in the EU:
- Significant strides in implementing national pricing and reimbursement frameworks in the UK, Germany, and France.
- Germany’s BfArM reported 219 applications for DiGA by April 2024, with 56 positive decisions.
- The most prescribed DiGAs in Germany focus on mental health, diabetes, obesity management, and orthopedic complaints like knee and back pain.
Cost and Remuneration:
- Average remuneration for DiGAs in Germany is EUR 221, which is around 60% lower than the average manufacturer price of EUR 552.
Developments in the UK:
- NICE published guidance in October 2024 recommending two remote monitoring tools for heart failure patients.
- NHS England has expanded virtual wards for heart failure patients.
Challenges in France:
- The PECAN scheme, intended to fast-track access to digital therapeutics, has faced lukewarm feedback.
- One of the first applicants under PECAN received a negative opinion from the HAS, with no opportunity for appeal or additional data submissions.
Ongoing Barriers:
- National evaluation processes for digital therapeutics remain slow and complex.
- Widespread patient access is still constrained by regulatory hurdles, reimbursement challenges, and the need for strong evidence of clinical efficacy and cost offsets.
This trend highlights the growing global interest in digital therapeutics but also emphasizes the ongoing hurdles that must be overcome to ensure broader access for patients.
Trend 2: The Road Ahead for EU HTA
The implementation of the EU Health Technology Assessment (HTA) regulation, set for January 2025, marks a significant shift toward centralized health technology evaluations in the EU. While substantial progress has been made, challenges persist, particularly in harmonizing national and EU-wide systems. Below is an overview of key updates and concerns as the regulation moves closer to implementation:
EU HTA Regulation Implementation:
- Official start date: January 2025.
- Significant groundwork laid for joint clinical assessment and regulatory frameworks.
Key Developments in 2023:
European Commission released its fourth implementing act in October: “Health Technology Assessment – Joint Scientific Consultations on Medicinal Products for Human Use.”
Key provisions include:
- Process for requesting Joint Scientific Consultations (JSCs).
- Parallel Consultation with the European Medicines Agency.
- Deadlines and procedures for various stages of JSCs (e.g., briefing packages, issue lists, and outcomes).
- Expert and stakeholder involvement processes.
- Correspondence protocols and IT platform usage.
- Data protection and confidentiality measures.
2025 EU HTA Work Plan Highlights:
- 17 Joint Clinical Assessments (JCAs) for cancer therapeutics and 8 for ATMPs planned.
- 5–7 JSCs for medicinal products and 1–3 for medical devices.
Industry Criticism:
- EUCOPE, EFPIA, EuropaBio, and Vaccines Europe criticized limited JSC capacity, urging fee-paying systems to support more consultations.
Ongoing Challenges:
- Uncertainty over integrating EU HTA outcomes into national pricing and reimbursement frameworks.
- Countries like Italy and Spain are slow to adapt; Germany resists centralized control.
- Concerns about managing multiple PICO frameworks and overlapping assessments for single products.
Outlook for 2025:
- Teething problems are expected as countries transition to the new system.
- EU-wide coordination on HTA is anticipated to gain momentum, albeit slower than initially expected.
Trend 3: Navigating Demand, Ethical Access, and Future Challenges of Obesity
The rising demand for novel obesity treatments, particularly GLP-1 agonists, has underscored significant challenges in supply, affordability, and equitable access. Medications like Wegovy and Ozempic have gained widespread popularity, but their high costs and limited availability are sparking ethical and financial debates. As manufacturers explore expanded indications and new market opportunities, healthcare systems face mounting pressure to balance innovation with cost and equity concerns.
Surging Demand for GLP-1 Agonists:
- Wegovy (Novo Nordisk) and Zepbound (Eli Lilly) experienced significant uptake in 2024.
- Demand for these drugs exceeded supply in several regions, creating access challenges.
Ethical and Financial Concerns:
- High costs raise questions about insurance coverage and equitable access.
- Ethical dilemmas over prioritizing obesity treatments over other healthcare interventions.
Healthcare System Challenges:
- Systems struggle to balance the costs of these treatments with broader healthcare equity.
- Ongoing debates about how to prioritize expensive obesity therapies within limited budgets.
Expanding Applications:
- Trials are underway to expand indications to conditions like heart disease.
- Concerns grow over long-term affordability as these drugs are approved for broader use.
Future Outlook:
- Novo Nordisk and Eli Lilly are preparing to launch these treatments in China.
- Flexible pricing strategies may be introduced to increase accessibility and market reach.
- This trend is expected to remain a focal point through 2025 as healthcare systems and manufacturers navigate these complex challenges.
Trend 4: Does Value Drive Price?
In 2024, the pharmaceutical landscape in the EU saw a marked shift from focusing on the value of treatments to controlling their price. This trend reflects economic pressures stemming from the COVID-19 pandemic and the Ukraine conflict, driving cost-containment efforts across healthcare systems. Below are the key highlights of this ongoing shift.
This trend underscores the growing tension between affordability and innovation, requiring careful navigation by healthcare systems and the pharmaceutical industry alike.
Increased Focus on Cost Containment:
- Cost reduction and price control became a dominant theme in the EU healthcare sector in 2024.
- Economic aftershocks of COVID-19 and the Ukraine conflict have made healthcare expenditure a critical concern.
Policy Shifts Toward Price Control:
- Significant increases in discounts and clawbacks were observed in markets like the UK and Germany.
- Expanded efforts to promote generics and biosimilars are further driving price-focused policies.
Disparity Between Drug Prices and Patient Access:
- A review of EU pharmaceutical expenditure revealed rising net costs despite cost-containment measures.
- Higher drug prices have not consistently translated to increased patient access.
Pressure on Pharmaceutical Industry:
- Companies face growing pressure to innovate pricing schemes, including discounts and value-based contracts.
- Emphasis is returning to robust value propositions and early payer engagement for evidence generation.
Trend 5: US and Medicare Price Negotiations
The implementation of the Inflation Reduction Act (IRA) in the US has created significant uncertainty in the pharmaceutical industry, with widespread implications for drug pricing, innovation, and patient access. As the IRA’s price-setting mechanisms take effect, the industry faces challenges and debates that are reshaping the landscape of drug development and reimbursement.
Inflation Reduction Act (IRA) Implementation:
- Introduced Medicare’s ability to negotiate maximum fair prices for selected drugs.
- Small-molecule drugs are subject to negotiation nine years post-approval, while biologics have a thirteen-year timeframe, leading to industry criticism.
Litigation and Legislative Revisions:
- Pharmaceutical manufacturers are increasingly litigating against the IRA’s price-setting processes.
- Several legislative bills in 2024 aimed to address discrepancies in the IRA legislation.
Impact on Innovation:
- Industry earnings calls in Q3 2024 highlighted concerns about negative effects on R&D investment.
- Reduced incentives for small-molecule drug development compared to biologics.
Research Findings:
- Clinical and cost data analyses show that biologics and small-molecule drugs deliver similar health gains on average.
- Industry stakeholders question whether the IRA’s timelines unfairly disadvantage small-molecule therapies.
Benefits for Patients:
- Medicare beneficiaries now benefit from capped out-of-pocket costs at USD 2,000 per year.
- This change has been widely acknowledged as a positive step for improving patient affordability.
As discussions around the IRA continue into 2025, the pharmaceutical industry must navigate a complex mix of regulatory challenges and opportunities while balancing innovation and affordability.
For a detailed outlook of the 2024 trends. Click here