Devil in the Details

Comparing How Germany and France Evaluate the Benefit of a Drug

With the passing of the cost-limiting Act on the Reform of the Market for Medical Products (AMNOG), new medications in Germany must now demonstrate an added benefit compared with the Federal Joint Committee (G-BA) approved comparator to attain a price premium. Comparator therapies (existing standard therapies) form reference price groups, to which new medicines are automatically allocated if they fail to prove an additional benefit.

Orphan drugs are eligible for a simplified submission process if anticipated peak sales stay below a threshold of €50 million each year. In the simplified submission process, the Institute for Quality and Efficiency in Health Care (IQWiG) does not evaluate dossiers. The G-BA alone decides the extent of additional benefit because the existence of an overall additional benefit is assumed proven by the drug’s market authorization.

The French National Authority for Health (HAS) has a similar practice — “improvement in actual benefit.” The agency decides how much additional benefit a drug provides compared with other drugs already on the market. HAS is an independent public authority that contributes to the regulation of the country’s healthcare system by evaluating all health products and practices, according to its website. HAS uses a five-point scale, ASMR I signifying the best (major), and ASMR V the worst (no improvement).

How Germany and France Compare in Evaluating Kalydeco

We wanted to explore how Germany and France compare when evaluating additional benefit for Kalydeco. The analysis below, generated from our database platform, provides a snapshot of the agencies’ behavior. Germany and France have similarly sized, big markets, and operate on a similar scale: For drug manufacturers, there is certainly value in knowing how the score in one country might relate to, or influence, the other.

Kalydeco (ivacaftor) is an orphan drug, approved by the European Medicines Agency (EMA) for the treatment of Cystic Fibrosis. Because Kalydeco was approved by the EMA, G-BA assumes it has an added benefit, and it is under their jurisdiction to assess the level of benefit.

The graph below shows Germany on the Y-axis, and France on the X-axis. It illustrates that GBA split their indication in two, based on patient age. For 6- to 11-year-olds, GBA determined the drug had Major additional benefit, and for children older than 12 years, considerable benefit. Conversely, HAS did not splice the indication by age. Our experience shows that it is common for Germany to subdivide, and for France to look at its group as one unit. HAS’ review shows the entire Cystic Fibrosis patient population was examined without specific breakdown, and the drug indicated important improvement (ASMR II).

Drug: Kalydeco (ivacaftor) Indication: For treatment of patients with G551D mutation in Cystic Fibrosis


The Devil, the Details, and the Context

We are not the first ones to examine the distribution and frequency of scores from GBA and HAS, but we like to think that Context Matters brings a uniquely data-driven perspective to the debate. We have invested heavily in building the resources to analyze policies like these both quantitatively and on a individual drug-indication level. We have standardized thousands of HTA decisions by drug and indication across a variety of agencies, letting us and our customers keep an eye on relationships like this very quickly.  What market access policy relationships are you watching?