Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Case Study: An In-Market Drug Approved for Several Indications - AMNOG and Its Impacts

Dr. Sven Enders (Abschlußjahr: 2012)

Summary

Language: English

The price setting procedure in Germany for drugs changed on 1st January 2011 with the introduction of AMNOG (Arzneimittelmarkt-Neuordnungsgesetz). An evaluation of the clinical benefit provided by the manufacturer is mandatory for any new patentprotected drug for that market access is intended. This evaluation requirement is not exclusively true for new drugs but also for products of special interest that have been on the market already before 1st January 2011 by request of the Federal Joint Committee (G-BA). At latest 12 months after starting a benefit evaluation, the reimbursed price will be set based on discount negotiations and reference pricing. The reimbursed price of products with no additional benefit is set based on a reference price while manufacturers with products with additional benefit enter price negotiations with the umbrella organization for the statutory health care insurance (GKV-Spitzenverband). In case that negotiations fail, the reimbursed price is set by an arbitration panel based on prices in 15 EU countries.

For the evaluation and negotiation process, the benefit dossier compiled by the manufacturer is of high relevance. The dossiers core element is a presentation of evidence for the drugs additional benefit over the comparator. For its compilation, it is important to work closely with the G-BA as early as possible. It provides the opportunity for choosing the appropriate comparator in the right patient population with endpoints of most interest for the G-BA. For an in-market product with a risk to be evaluated in the near future, an early consultation of the G-BA is recommended as well. Their recommendations can be essential for a successful evaluation outcome.

Beyond the benefit evaluation, first price negotiations between manufacturers and the GKV-Spitzenverband for new drugs have been completed. These first negotiations ended without any consultation of the arbitration panel. It will take more time to be able to evaluate the final outcome of the first wave of products going through these negotiations.

As a consequence of the AMNOG changes, manufacturers should think thoroughly when considering the G-BA-driven approach internationally. There are concerns that if a therapeutic benefit cannot be shown this may result in a low price that other countries could reference. At this point, AMNOG is already changing the way manufacturers have to consider their launch strategy in Germany and shows how that is having impact internationally.

One and a half years after introduction of the AMNOG law, this master thesis discusses the statutory health care insurance in Germany and existing instruments of cost limitations before 2011 as well as the status quo of the changes that came along with AMNOG. So far, there have been several benefit evaluations of new drugs but no single benefit evaluation of any in-market product. Using the example of a patentprotected drug with a prominent market position, this master thesis addresses current and future companywide impacts of AMNOG based on the first experiences of the new drugs benefit evaluations.

Pages: 49