Pace of cancer drug reimbursement varies wildly across Europe

Researchers have found that some European countries take more than twice as long as others to reach health technology assessment (HTA) decisions about reimbursing cancer drugs following European Medicines Agency (EMA) approval.

The team looked at the new cancer drugs approved for solid tumours by the EMA between January 2007 and December 2017, which totalled 47 drugs for 77 indications. They then tracked the length of time from approval to HTA decisions in England, France, Germany and Scotland.

They found that the median from approval to reimbursement decision was two to three times longer in England and Scotland, compared to Germany and France.

The average length was 405 days for England, 384 days for Scotland, 209 days for Germany and 118 days for France.

Study co-author, University Hospital of Zurich, Switzerland senior research scientist at the, and affiliated researcher at Harvard Medical School Dr Kerstin Vokinger said: “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 researchers also found that health authorities in all four countries generally made decisions more quickly about drugs ranked as of the highest benefit by the European Society of Medical Oncology’s (ESMO) Magnitude of Clinical Benefit (ESMO-MCBS), compared to those with less clinical benefit.

In France, the median time to HTA decision on highest benefit drugs was 154 days, compared to 198 for less benefit.

However, similar time variations, in which England and Scotland were significantly slower than Germany and France, existed for the so-called highest benefit drugs.

The median for highest benefit drugs was 302 days in England, compared to 203 days for Germany.

University Medical Centre Groningen medical oncologist and chair of the ESMO-MCBS Working Group Professor Elisabeth de Vries said: “It is reassuring that in the countries studied, anticancer drugs with greatest clinical benefit on ESMO-MCBS are associated with faster times to HTA decisions and nearly all are approved for reimbursement.”

In addition, the ESMO research found that in all four countries nearly all the highest benefit cancer drugs approved by the EMA passed the HTA reimbursement process. In Germany, this was the case 100% of the time, 95% in Scotland, 92% in England and 90% in France.

The institutions responsible for HTA decisions are the National Institute of Care Excellence (NICE) for England, the Scottish Medicines Consortium for Scotland, the National Authority for Health (HAS) for France and the Institute of Medical of Medical Documentation and Information’s Agency of Health Technology Assessment for Germany.

These findings will be presented at the ESMO’s 2018 Congress in Munich between 19 and 23 October.

The researchers are planning to expand their research and compare their findings with Southern and Eastern Europe.