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HTAQ Summer 2024

In this edition, we continue the series on preparations for European Union (EU) HTA now that the draft implementing act on procedural rules for Joint Clinical Assessment (JCA) of medicinal products has been published. Additionally, two country-specific analyses consider the impact of AMNOG benefit assessment on drug pricing in Germany, and the impact of participation in the UK’s Early Access to Medicines Scheme (EAMS) on recommendations from the National Institute for Health and Care Excellence (NICE).

Embarking on the EU HTAR realization journey: Key insights from the first of six implementing acts 

Less than one year before the implementation of the European Union Health Technology Assessment Regulation (EU HTAR), industry and national HTA bodies are still missing clarity on the Joint Scientific Consultation (JSC) and Joint Clinical Assessment (JCA) procedures. The first implementing act of JCA has now been published, but does it address the stakeholders’ concerns?

Benefit-driven pricing: How AMNOG strikes a balance between the financial burden on statutory health insurance and reimbursement of innovative medications in Germany

The German health technology assessment of newly approved drugs aims to relate the declared added benefit with the pricing of pharmaceutical products. How does the outcome of the AMNOG benefit assessment affect the reimbursement negotiations?

EAMS evidence: A key player in drug value proposition and NICE approval?

The United Kingdom (UK) Medicines and Healthcare Regulatory Agency (MHRA) established the Early Access to Medicines Scheme (EAMS) in 2014 with the intention of providing patients with life-threatening or seriously debilitating conditions access to medicines that have not yet been granted marketing authorisation but address a clear unmet medical need. A decade later, we consider EAMS’ influence on corresponding National Institute of Health and Care Excellence (NICE) recommendations.

Heard on the street

 “Gene therapies have the possibility to transform thousands of lives, but only if we ensure sustainable access to them for all patients … It is incumbent upon the entire health care system to focus on innovative payment solutions that can address the challenges of paying for high-cost, one-time treatments … [considering the] options available to move beyond responding to the high costs with reduced access, while meaningfully addressing the concerns around clinical uncertainty and budget impact.”

  Sarah K. Emond, MPP, President and CEO of The Institute for Clinical and Economic Review (ICER) on publication of a new white paper developed by ICER in collaboration with New Drug Development Paradigms (NEWDIGS) at Tufts Medical Center.

HTA by the numbers

#1

Real-world evidence (RWE) appears again as the #1 trend in ISPOR’s 2024-2025 Top 10 HEOR Trends report. RWE has made the trends list for 4 of 5 reports and has appeared as #1 in the 3 most recent reports.

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