Long-term Impact

Given the large degree of uncertainty with regard to getting a feasible price in Germany, the consensus within industry is it will not be able to plan effectively for a German launch under AMNOG. Companies have to deal with an already fragmented environment, between national and regional market access requirements in various large markets around the world. Uncertainty in one or more of these markets creates an even more daunting task, particularly since development decisions typically have to be made three to five years before launch.

If companies have a muddied view of payer requirements, their propositions are likely to be off target—and all stakeholders pay the price for that in some way or other. Given the timing of development decisions that impact the ability to negotiate price, it will take about five years before AMNOG will see dossier submissions that have taken the new requirements into consideration (that is, if companies decide to base their decisions on specific German requirements rather than that of all other, and many larger, countries). And it is fair to say that the German government will probably have changed its system again by then. It is true, however, that as G-BA expands its review process, which now is likely to include the 27 new drugs approved by the EMA so far this year, precedents will be set that in an informal way—over time—will help fix the parameters for engagement.

Johann Meyer-Christian is a Consultant at ZS Associates in Zurich