Amnog Process Research Articles

PHP167 - Analysis of the IQWIG Comments on the Evidence Searches of Dossiers in the German Amnog Process

The benefit assessment of new drugs in Germany requires the submission of a value dossier including systematic searches. The majority of dossiers are methodically inspected and assessed by the German Institute for Quality and Efficiency in Healthcare (IQWiG). The study’s objective was the analysis of common deficiencies in systematic searches and their consequences for the IQWiG assessment. A total of 37 IQWiG assessment reports were analysed with regard to all comments made on the presented systematic searches in the dossier of the pharmaceutical company. A distinction was made between literature and study searches. The respective IQWiG comments were categorized and listed. Inadequate searches were examined in terms of consequences for the assessment by the IQWiG. Consequences were divided into those affecting the search required for the substance itself and those carried out for indirect comparisons/ further investigations. A total of 4 of the 37 dossiers passed the IQWiG assessment without deficiencies. Out of all analysed searches a total of 104 deficiencies were found, of which the most frequent ones referred to the search strings (32%) and the documentation of the search (25%). In the consistency check on the number of hits deviations were found by the IQWiG in 13%; 92% of the inconsistencies occurred in study-registry versus 8% in literature searches. There were no consequences in 62% (23/37) for the substance-search and in 22% (8/37) for indirect comparisons/ further investigations. Non-consideration of study results, which was the most frequent consequence of an inadequate search, occurred in 24% for the substance-search and in 32% for indirect comparisons/further analyses. The methodological requirements for systematic searches to be accepted by the IQWiG are not achieved in the majority of dossiers. An adequate design and a careful documentation of the searches is crucial to ensure the best possible acceptance of evidence in the AMNOG process.

PHP22 - Is Drug Innovation Still Rewarded in the Top 5 European Pharmaceutial Markets?

To assess how drug innovation is rewarded and how it is impacted by cost-containment policies. Manufacturer prices per unit of package and strengths were compared and assessed in a basket of 97 innovative drugs approved by the European Medicines Agency (EMA) since 2000. The products were still patent protected, and available in each of the top 5 European pharmaceutical markets. Prices of innovative drugs in Germany were still the highest and had a benchmark price index of 100. In France, when drugs were deemed innovative, premium prices were granted – resulting in a price index of 94 – but significantly decreased over time. While prices at launch in Italy, Spain and the UK were commonly lower – with price indexes of 89, 88 and 86 respectively - they tended to remain constant over time. Despite the fact that governments in developed markets are attempting to lower prices, differences still exist across the largest markets, enabling pharmaceutical companies to implement differential and protective pricing strategies. In Germany, time to market is comparatively fast and premium prices at launch have been granted. In future, the AMNOG reform will complicate this picture, although pricing premiums have still been achieved for drugs deemed innovative that have gone through the full AMNOG process. In France, although prices are relatively high at launch, they drop at time of renewal and innovation is granted to a limited number of drugs. Prices have been comparatively low at launch but remain constant in Italy and Spain, reflecting the fact that price cuts in those countries have often been directed towards generics, although these are still considered high-risk markets. In the UK, it remains to be seen how the value-based pricing reform will impact prices.

PRS61 - European ex-factory price development for global pharmaceutical companies in the context of the international price reference (ipr) framework. Impact of the german health care reform (amnog) on the european price development for innovative pharmaceuticals

To evaluate pharmaceutical pricing in the EU with a focus of cost-containment due to International Price Reference (IPR) in the context of the German AMNOG on pricing in Europe. Qualitative research identified guidelines for international price reference from each national reimbursement body (focusing on 10 major EU countries). Reimbursement submissions and results of price negotiations per country were also reviewed to gain insight into the application of pricing guidelines. Findings are based on review of the guidelines, selected appraisals and interviews with national payers in Germany, France and UK. In consideration of existing European price differences, high-price countries have so far increasingly attempted to also lower their pharmaceutical prices: preferably with different cost containment policies and measurements and in addition referencing low-price countries in international price reference (IPR). In both situations, an international downward effect on pricing threatens to happen for global pharmaceutical companies investing in Europe. This creates a European pricing and reimbursement network of connections of countries referencing each other with the tendency to develop a standard price across European countries. Germany is directly price referenced by more than 15 countries and indirectly referenced by around 5 countries. What impact on European pricing the change from the previously free pricing and full reimbursement of patented drug prices in Germany really has, after the implementation of the AMNOG, is quantitatively hard to assess. If Germany will follow more strictly the international price referencing in the future for innovative drugs based on the AMNOG process, it will lose anchor function in European pricing with an overall international downward effect on the European pricing for innovative pharmaceuticals.

Drei Jahre frühe Nutzenbewertung nach §35a SGB V – kritische Würdigung und Lösungsvorschlag

BackgroundAgainst the background of increasing cost pressure in the German Health Care system German health policy introduced several law changes to increase competition within German health care system for both, payers and health care providers. At the same time law changes included centralization of decisions—counteracting a real competition. Both approaches are part of an austerity plan. The latest example for this approach is the new drug law (AMNOG) in 2011 with the core element of centralized early benefit assessment (§ 35a SGB V) for new drugs and therapies and price negotiations between federal association of health insurances and pharmaceutical company.In this review we examine the implementation of the new drug law with respect to the achievement of political objectives: Ensure sustainable financing of innovations in the German health care system, provide innovations early to the patient, decrease overregulation and establish a transparent environment in which efforts of the pharmaceutical industry are being honored by fair prices.MethodsWe reviewed the new AMNOG process since its implementation on 1st January 2011 and first 64 values dossiers from pharmaceutical companies that have been evaluated by G-BA (Federal Joint Committee) between January 2011 and December 2013 with respect to the above mentioned political objectives. Parameters such as added value, determination of an adequate competitor, patient relevant endpoint surrogate parameter and subgroup analysis are being discussed.ResultsAMNOG process has been implemented as a learning system and indeed several issues have already been addressed, such as the determination of the adequate comparator by G-BA as well as the treatment of orphan drugs in this process. Basically implementation of AMNOG and early benefit assessment is a necessary step on the way to transparent priorisation of health care benefits. But the AMNOG process is one step further towards centralization of the German health care system and therefore contradicts a healthy and fair competition within the system. As a consequence the development of high quality solutions for patients might be hampered.The analysis of the first 64 value dossiers shows that less of half of the affected patient populations (40 %) have access to new therapies being reimbursed by health insurances with a premium price. There is a major inbalance in assessment of drugs in different therapeutic areas. In combination with increased uncertainty for the pharmaceutical companies the AMNOG process on the middle and long-term might jeopardize the commitment of pharmaceutical industry in the German market. This in turn endagers the political objective to ensure patients early access to innovative therapies.Besides this, centralization of the subjective parameter “added value” seems to be problematic, since value decisions should be taken by democratic processes.We therefore suggest a model in which only objectively measurable value decisions are being taken centrally and subjective value decisions are as much as possible decentralized. This results in both a stronger competition of qualitatively best solutions for patients and in a higher fault tolerance. Instruments such as health care research and conditional reimbursement can help to enhance a fair competition for more quality in regionally organized health care and more economical allocation of short resources.

PHP203 How to Optimise Chances for Successful AMNOG Assessments – Best Practice Approach for German Market Access

Since the introduction of AMNOG in January 2011, manufacturers in Germany are required to submit a “benefit dossier” and show additional benefit in relation to a so-called appropriate comparative therapy to the Federal Joint Committee for every NCE in order to gain access to price negotiations. If an additional benefit is shown, the new reimbursed price will be a surplus on the reimbursed comparator price. Market access in Germany changed significantly due to AMNOG and requires early preparation, an interdisciplinary approach and clearly defined internal processes. Market access strategies and processes have to be reviewed in light of the new framework and adapted in order to optimize the chance to be successful in the AMNOG process. Preparation for AMNOG should start as early as in the planning of clinical studies to implement the right questions into the study and not to rely on surrogate drivers. The FJC will respond best to data providing the most credible scientific clinical evidence. Building RCTs powered to capture such information does present important issues for pharmaceutical companies to address. Early planning of clinical studies should be part of an early strategy development for the NCE that can be informed by early phase modeling of the likely outcome of the benefit assessment. Early identification of the patient groups that are most likely to benefit is vital in order to plan for patient (sub-) populations big enough to achieve statistical significant results and positive outcomes in the AMNOG process. An interdisciplinary approach is required at a stage in the product development where there are no common processes and communication paths established between headquarter and affiliates. A best practice approach requires a well defined process including road maps and checklists per stage of product development in form of standard operating procedures in order to optimize market access.