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Life after AMNOG – German Healthcare Reform Starts to Impact Pharma

21 September 2011 Gaelle Marinoni

A few months back we held a webcast that looked at the potential impact of AMNOG on the pharmaceutical industry. In the webcast we predicted that greater visibility on the German reform would come at the end of October when the German authorities publish their first benefit assessment for cardiovascular medicine ticagrelor.

But in the last month alone two significant stories broke:

  • Novartis pulled Rasilamlo off the German market three months post-launch
  • Boehringer and Eli Lilly chose not to launch linagliptin in Germany

Both decisions have been related to the AMNOG reform. And so, although we always thought AMNOG would have significant negative repercussions on the industry, it would seem that some of the casualties are happening earlier than anticipated.

Germany a no-go market for linagliptin
In the first week of September Boehringer and US partner Eli Lilly decided not to launch their new type 2 diabetes treatment, linagliptin in Germany as the manufacturers fear negative pricing prospects for the medicine.

While linagliptin is the only approved once-daily diabetes treatment that does not require dose adjustments, its clinical benefits are comparable to reimbursed alternative therapies in Germany, namely sitagliptin, sitagliptin + metformin, and saxagliptin.

It doesn't take a rocket scientist to conclude that in Germany linagliptin's dosing advantage alone is unlikely to secure a price premium for the manufacturers. In fact, linagliptin is even at risk of being added to a reference group on the grounds that it was not shown to bring patient-related outcome benefits compared to reimbursed alternatives.

Market withdrawal of Rasilamlo in Germany
On 1st September Novartis pulled hypertensive aliskiren + amlodipine (brand name Rasilamlo) off the German market three months post-launch. We can speculate on the reason behind Novartis' decision, but it is possible the company may not have put together a compelling enough reimbursement dossier for its medicine. The federal joint committee requires this dossier on the day of launch, and it should ideally demonstrate the added therapeutic benefits compared to alternative treatments.

In our recent webcast we highlighted the fact that manufacturers were not given sufficient time to factor AMNOG's clinical data requirements in their product development. However Novartis' decision to enter the German market for three months, take advantage of free pricing, and then pull out is an interesting strategy that we may see replicated by other manufacturers.

More on the way?
Together these cases demonstrate just how much of a step change AMNOG is for the industry. Things are clearly moving fast and the German authorities are likely to close any of the loose ends they have left in the legislation. This looks to be just the beginning - brace yourselves.

Based on research by Anne-Charlotte Honoré, Pharma Research Analyst, IHS

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