IHS Global Insight Perspective
The new criteria, which still need to be officially approved by the federal ministry of health and published in the official gazette, define the framework of the early assessment of new drugs, introduced as part of the Act for the Restructuring of the Pharmaceutical Market in Statutory Health Insurance (AMNOG).
The early benefit assessment will mainly be conducted on newly approved medicines and combination therapies, the first on the list being AstraZeneca's (U.K.) blood thinner Brilique (ticagrelor), approved in December 2010 by the European Commission.
While some major figures of the German healthcare system have expressed their fear to see patients be put at risk by this early benefit assessment, this reform is a real step forward in terms of access to innovative drugs.
The Joint Committee on Healthcare (Gemeinsamer Bundesausschuss; G-BA) yesterday unveiled the details of the new criteria which will regulate the early benefit assessment of new drugs under the AMNOG law. The regulation, available here, details what is required to demonstrate an added value, which comparative therapy should be chosen and what should be included in the submission dossier.
The early benefit assessment will be conducted on all new reimbursable drugs and combination therapies launched after 1 January 2011, on drugs for which a new indication is approved after 1 January 2011 and on any other drugs when required by the G-BA or at the request of the manufacturer. Based on the decree AM-NutzenV (Arzneimittel-Nutzenbewertungsverordnung) compiled by the federal ministry of health in November, the G-BA defines a benefit as any "additional patient-related outcome", such as an improvement of health conditions, a shortening of the duration of the disease, an improvement in overall survival, a reduction in side effects and an improved quality of life. An added value will be recognised when the new active ingredient is shown to bring a qualitative or/and quantitative improvement compared to the benefit gained with an appropriate alternative.
When possible, the manufacturer will choose a reference-priced drug to conduct direct comparison study. If no appropriate alternative is currently included in the reference pricing system, the new drug will be compared to a drug with the same approved indication. When several alternatives exist, the less expensive one will be chosen.
The added benefit will have to be proven by the drug manufacturer, whose dossier will be composed of the following features:
- Approved indications;
- Clinical benefit;
- Therapeutic improvement compared with alternative therapies;
- Cost of treatment;
- Number of patients for whom the treatment would bring an added value.
The following level of innovation will be granted by the G-BA, whose decision will greatly affect drug makers' ability to negotiate prices:
- Major added benefit: When a sustainable and unprecedented greater therapeutic improvement is demonstrated over an appropriate alternative (especially if the treatment is shown to cure the disease, to bring a significant extension in overall survival or a long-term reduction in symptoms and prevention from serious relevant side-effects);.
- Significant added benefit: When a significant therapeutic improvement is demonstrated over an appropriate alternative such as a significant reduction of symptoms, a moderate improvement in overall survival or/and the avoidance of serious relevant side effects.
- Small added benefit: When a slight (but not minor) therapeutic improvement is demonstrated over an appropriate alternative (e.g.: a reduction of non-severe symptoms or prevention of a relevant side effect).
- An additional benefit exists but is not quantifiable because of irrelevant scientific data;
- No added benefit demonstrated;
- The benefits of the new drug are below those brought by the alternative therapy.
Outlook and Implications
The regulation unveiled yesterday by the G-BA follows the guideline set by the decree AM-NutzenV adopted by the federal ministry of health at the end of 2010 (see Germany: 2 December 2010: Germany's Federal Government Sets Methodology for Benefit Assessment of Drugs). The approval of the federal ministry of health is therefore set to be a formality and should not bring any amendment to the present directive. The first manufacturer to undergo the new assessment process which came into force on 1 January 2011 will be AstraZeneca with its new blood-thinner drug Brilique (ticagrelor). A decision on Brilique, which will focus on determining whether the drug brings an added value compared with alternative products, should be published in the first half of 2011 as the early benefit assessment of new drugs is to be conducted within three months of commercialisation. The G-BA's verdict will be determinant for the commercial prospect of the drug. In fact, if Brilique is deemed as of no added value, the drug will be automatically included in Germany's reference pricing system. On the contrary, if the drug is shown to bring an improvement in terms of patient-related outcomes, it will qualify for price negotiations with the GKV. The discounted price agreed via price negotiation is to be applied from the 13th month of commercialisation, which means that manufacturers are still free to set prices during the first year of commercialisation (see Germany: 12 November 2010: Adoption of German Austerity Package Weakens G-BA Independence, Strengthens IQWiG Role).
The introduction of an early benefit assessment is a real "step forward" in terms of access to innovative drugs according to Rainer Hess, head of the G-BA. But Rainer Hess and other major figures of the German healthcare system have expressed their fear to see patients be put at risk by this early benefit assessment. The head of the G-BA criticised the fact that a drug can remain on the market even if an added value is not scientifically proven, in an interview to the news agency dpa. He also admitted that such early assessment cannot give a proper idea of how much a drug can offer to patients. He finally recognised the fact that "a drug can be assessed seven or eight years after market entry and be excluded from reimbursement". The fact that there is no obligation on the part of manufacturers to conduct studies after this early assessment has also been pointed out. In a meeting in Berlin, Wolf-Dieter Ludwig, chairman of the German Medical Association's medicines commission, called for a broader reform, such as for very expensive cancer drugs for which a "proper and independent evaluation of the benefits after two or three years" is needed, reports the German newspaper Sueddeutsche. He also said that patient care was "suboptimal".
- Germany: 2 December 2010: Germany's Federal Government Sets Methodology for Benefit Assessment of Drugs
- Germany: 12 November 2010: Adoption of German Austerity Package Weakens G-BA Independence, Strengthens IQWiG Role
- Germany: 4 October 2010: Germany's Structural Reform: The End of a Pharma Paradise?
- Germany: 30 June 2010: German Government on Track to Shatter Pharma Market with Major P&R Reform Ready for Parliament
- Germany: 14 June 2010: Germany's Coalition Government Plans 4-Bil.-Euro Savings on Healthcare