Is Global Variability in HTAs Limiting Patient Access to Important Medicines?

On June 17th we attended the HTAi conference in Washington, DC. At the conference we presented research on three topics, including one that was a collaboration with PhRMA (The Pharmaceutical Research and Manufacturers of America). Our collaboration focused on clinical variability across Heath Technology Agencies (HTAs), and highlighted some of the challenges for countries that may be considering utilizing technology assessment as a budgetary tool, but which may have consequences on patient access to important medicines. We examined trends in global HTA, with a specific focus on established global HTA models that are often referenced in U.S. policy conversations regarding access and reimbursement. To that end, we paid particular attention to The United Kingdom’s (UK) National Institute for Health and Care Excellence (NICE), given their high level of activity and amplified presence in global HTA.

The Background

In recent years, technology appraisals and reimbursement recommendations from established HTA organizations around the globe have taken on an increasingly prominent role in cost-containment strategies and health policies. It appears that these HTA appraisals have become more restrictive over time. In fact, as HTAs have become a prominent element of health care decision-making in many countries, attention is turning to whether they assess outcomes and measures that are most meaningful to patients and their physicians. Perhaps more importantly, the main question that has arisen is whether current models are flexible enough to recognize the way value emerges over time, as the science advances and understanding of the underlying disease grows.

For example, many models make decisions based on an average response, which does not take into account patient heterogeneity, the current standard of care, or a change in the evidence base over time. There is concern that these types of determinations may limit patient access to important medicines and, more generally, might not provide sufficient incentives for continued biomedical innovation.

In addition to achieving market access through stringent regulatory processes, research and drug development companies must also seek reimbursement approval from many countries around the world in order to reach patients. In navigating this complex process, it is important to understand whether the evaluations and decisions of agencies in different countries are aligned around the same key clinical and economic components.

A Few Key Questions

  • Do HTA agencies make similar decisions to NICE when they evaluate the same drug for the same indication?
  • Are there certain disease conditions where agencies are more or less aligned on reimbursement decisions?
  • How aligned is NICE with other global HTA agencies regarding their clinical conclusions in HTA assessments?
  • How does variability in HTA clinical assessments affect the manufacturers and HTA agencies?
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A DAY IN THE LIFE: INCORPORATING HTA INTO INNOVATION

Panel session featuring our CEO Yin Ho, Randy Burkholder (PhRMA), Tanisha Carino (Avalere), Bill Chin (PhRMA), Scott Gottlieb (American Enterprise Institute), Iñaki Gutiérrez-Ibarluzea (Basque), and Richard Lieblich (MedImpact).