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ESMO 2018: Variations Between European Countries in Time to Reimbursement Decisions for New Cancer Treatments Approved by the EMA

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Key Points

  • The median time from EMA approval to health technology assessment decisions was two to three times longer in England (405 days) and Scotland (384 days) compared to Germany (209 days) and France (118 days).
  • The study found that health authorities generally made decisions much more quickly for treatments ranked as being of “highest benefit” on the ESMO Magnitude of Clinical Benefit Scale compared to those with less clinical benefit.
  • However, the variation in time from EMA approval to health technology assessment decisions remained between different countries for these “highest benefit” treatments.

Some European countries take more than twice as long as others to reach health technology assessment (HTA) decisions to reimburse new cancer treatments following their approval by the European Medicines Agency (EMA). The average decision time is longer than 1 year in some countries, according to a study reported by Hwang et al at the European Society for Medical Oncology (ESMO) 2018 Congress (Abstract 1555O_PR).

Once the EMA has approved a new treatment, many countries evaluate its benefit and cost-effectiveness through a systematic HTA process as part of making a decision on whether to reimburse use of the treatment for routine patient care.

Study Methods

In this study, researchers identified all new cancer treatments approved for solid tumors by the EMA between January 2007 and December 2016. They then tracked the time between EMA approval for each of the treatments and HTA decisions being taken by health authorities in four European countries: England, France, Germany, and Scotland.

Results for 47 treatments in 77 solid tumor indications revealed that the median time from EMA approval to HTA decisions was 2 to 3 times longer in England (405 days) and Scotland (384 days) compared to Germany (209 days) and France (118 days).

“In contrast to the centralized approval of anticancer [treatments] by the EMA, the time to HTA decisions remains a national responsibility,” explained study coauthor Kerstin Vokinger, MD, JD, PhD, LLM, Senior Research Scientist at the University Hospital of Zurich, Switzerland, and affiliated researcher at Harvard Medical School. She added: “Among other things, the different amount of resources invested in such assessments and different national regulations regarding HTA systems may lead to variation in the time from EMA approval to HTA decisions in different countries.” 

The study found that health authorities generally made decisions much more quickly for treatments ranked as being of “highest benefit” on the ESMO Magnitude of Clinical Benefit Scale (MCBS) compared to those with less clinical benefit. However, the variation in time from EMA approval to HTA decisions remained between different countries for these highest-benefit treatments.

The ESMO-MCBS grades the magnitude of clinical benefit that can be expected from anticancer treatments. “Lowest benefit” refers, for example, to treatments increasing median progression-free survival by a few weeks, whereas the category of “highest benefit” is given to treatments improving long-term survival in the neoadjuvant/adjuvant setting. For more on the approach used to grade the clinical benefit in the ESMO-MBCS, see a report by Cherny et al in Annals of Oncology.

In France, the median time to an HTA decision on highest-benefit treatments was 154 days compared to 198 days for treatments of less benefit. Faster HTA decisions for highest-benefit cancer treatments were also made in Germany and England, but the time to HTA decisions was much longer in England (median 302 days) than in France or Germany (203 days).

Further analysis showed that nearly all cancer treatments ranked as being of highest benefit on the ESMO-MCBS were approved for reimbursement by all four countries: Germany (100%), Scotland (95%), England (92%) and France (90%). In addition, the researchers found high concordance between ESMO-MCBS and scores health regulators gave in HTA procedures for cancer treatments of highest benefit.

Commentary

Commenting on the findings for ESMO, Elisabeth de Vries, MD, PhD, a medical oncologist at the University Medical Center Groningen, Groningen, the Netherlands, and Chair of the ESMO-MCBS Working Group, said, “It is reassuring that in the countries studied, anticancer treatments with greatest clinical benefit on ESMO-MCBS (version 1.1) are associated with faster times to HTA decisions, and nearly all are approved for reimbursement.”

Noting the variation in times to final decisions, Dr. de Vries suggested, “Hopefully, this information can be helpful to raise the interest of HTA agencies in their performance and time frames.” She added, “Data were analyzed only for England, France, Germany, and Scotland. This means data for HTA procedures and reimbursement decisions were reported for only part of Europe, with no countries included from Southern or Eastern Europe. Insights into these procedures in other European countries might be of interest.”

Dr. Vokinger shared that the group now plans to expand research in this area. “Among other things, we plan to include more countries for assessing HTA decisions and to explore access to new cancer medicines by individual patients,” she concluded.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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