Price discussion on new drugs in Germany

The availability of Zolgensma in the USA has also fuelled the price discussion for new drugs in Germany. Zolgensma is approved in the USA for the treatment of children with spinal muscular atrophy (SMA) and can (potentially) cure the disease. The drug has not yet been approved in Germany – European approval is expected next year.

Now there are two big discussions in Germany: On the one hand the handling of drugs that have not yet been approved in Germany and on the other hand the pricing of these drugs.

The handling of drugs prior to approval is clearly regulated in the Drug Hardness Ordinance (AMHV) on the so-called Compassionate Use Programme and provides for a cohort programme care of German patients. The drug is made available free of charge! The individual case regulation, which is now also criticized by the health insurance companies, is also clearly regulated by the so-called “Nikolaus” judgment from the year 2005 and is especially made for life-threatening diseases.

As far as the price is concerned, it should be noted that 1) SMA only affects 500 patients throughout Europe, i.e. approx. 80 patients in Germany (!) – so with 100 insurances on average 1 patient per insurance – and 2) without an expectation for high profit in such ultra orphan diseases, no new therapies and medicines will be available in the future either, as the research and investment incentives are then no more given.

Press article on the issue available in German, e.g. in the Badische Zeitung as of November 20 2019: Hoffnung, Leid und viel Geld as well as a comment.

MArS supports you with the optimal reimbursement strategy, pricing for the D-A-CH market and, of course, in a possible early contact and discussion with the statutory health insurance funds.

Communication with cost carriers

Incidence of acquired thrombotic thrombocytopenic purpura in Germany

Acquired thrombotic thrombocytopenic Purpura (aTTP) is a life-threatening ultra-orphan disease with a reported annual incidence between 1.5 and 6.0 cases per million in Europe and mainly affecting otherwise young and healthy adults aged 40 years on average. The goal of this study was to assess the incidence of aTTP in Germany. A systematic review was performed to determine the published evidence on the aTTP epidemiology in Germany. To obtain additional evidence on the proportion of aTTP cases within the national Thrombotic Microangiopathy (TMA) population a hospital-level study was performed, using a retrospective data collection approach. Diagnosis of aTTP was confirmed if ADAMTS13 level were < 10% and/or the medical records explicitly mentioned aTTP diagnosis. The aggregated hospital data were then projected to the national level using logistic regression techniques.
The determined annual incidence of newly diagnosed aTTP cases and the overall annual incidence of aTTP episodes in Germany confirm the ultra-orphan character of aTTP.

Download the full article here:

Miesbach, W., Menne, J., Bommer, M. et al. Incidence of acquired thrombotic thrombocytopenic purpura in Germany: a hospital level study. Orphanet J Rare Dis 14, 260 (2019) doi:10.1186/s13023-019-1240-0

Ever wanted to understand game theory?

Ever wanted to understand game theory?

Perfect timing with the availability of infocomix. Within „game theory“ the authors were able to transfer the basic concepts of game theory in an easy and non-mathematical way! Fun to read also for experienced game theorists!!

We at MArS apply game theory in our MArS negotiation boot camp to prepare clients optimally for the negotiations with payers! Contact us!!!

The book is available also on Amazon.

MArS supporting the reform of the Egyptian health care system

Great honor to have been invited to a Pharmacoeconomics workshop in November to Cairo, Egypt. Dr. Walzer presented the situation on evidence-based medicine, HTA and reference pricing in Europe as well as the introduction into value-based pricing in the context of health economics.

The course was well organized by Accsight and their team with a very open-minded Egyptian payer audience.

Big discussions paving the way for a new Egyptian health care system by 2030!!!

Risk share agreements and application in global reimbursement decisions

Which risk share agreements are available and are those applied in global reimbursement decisions?

Risk Share Agreements (RSAs) are defined as agreements between a payer and a manufacturer where the price level is related to the actual future performance of the product. In the last years RSAs were introduced and applied in various jurisdictions. RSAs in Australia, Canada, Italy, Spain, UK and the US were systematically searched for. They were clustered into the type of RSA per country and compared to each other.

Download the poster including all results: Walzer_et_al._Risk_Share_Agreements_ISPOR_2015

A systematic comparison of AMNOG decisions

On January 1st 2011 Act on the Reform of the Market for Medicinal Products (AMNOG) came into force in Germany. The aim of AMNOG is to curb the rapidly rising expenditure for pharmaceutical products by the statutory health insurance funds.

Since the introduction of AMNOG, more than 100 IQWiG recommendations and G-BA decisions on the early benefit assessment have been published. In various assessments, the IQWiG recommendation and the related G-BA decision differed in terms of decision argumentation and actual result.

In this study, these differences were systematically analyzed in order to draw conclusions for future proceedings and optimization of the process.

Download the poster: Vollmer_et_al._IQWiG_vs_G-BA_ISPOR_2015