BERLIN, Mar 19 (APM) - Germany's Association of Scientific Medical Societies (AWMF) has told APM it is proposing several changes to AMNOG that would make early added benefit assessments more transparent but could worsen pharma’s position in price negotiations.
One significant change would require pharmas to provide data on the cost of the entire treatment inclusive of therapy for side effects and hospital stays. Under Germany’s drug law AMNOG, pharmas are required to provide data on the costs of the drug therapy only.
“The idea is to base the price negotiations between health insurers and pharmas on scientific evidence to complement early added benefit assessment ratings", Reiner Leidl, professor at the Ludwig Maximilian University in Munich and co-author of the AWMF statement, told APM on Wednesday.
In a statement released on Monday, the AWMF also called for the introduction of cost benefit analyses, such as piggy back studies of clinical trials and cost-effectiveness data or calculations including the quality-adjusted life-year measure, saying it is standard across other European countries such as the United Kingdom, Sweden and the Netherlands.
This proposed change would lead to more transparency in cost-benefit analyses but could mean pharmas lose power in price negotiations with health insurers, one industry official told APM, asking not to be named.
The AWMF wants early added benefit assessments under AMNOG to promote “medical and cost effectiveness in the health care industry”, the association said in the statement, but says more transparency and input from independent experts is needed with regards to orphan drugs, comparator therapies and sub-group tests.
Once an orphan drug is approved by the European Medicines Agency (EMA), the added benefit of it is regarded as confirmed under AMNOG. The early added benefit assessment of orphan drugs by health technology assessment (HTA) authorities then only quantifies the added benefit.
But the manner in which the higher HTA body, G-BA, and the junior authority, IQWiG, assess the dossiers is not transparent as they don’t contain any categorization of the added benefit, said the AWMF in the statement.
It points to situations when the dossiers of a new orphan drug in the same rare disease were rated differently by the G-BA and the IQWiG depending on the status. Therefore, HTA authorities should check if and how the assessment could be methodically adapted, said the association.
In general, the G-BA assessment and the independent evidence-based report of a scientific institute should include transparent research and comments to justify and explain when the early added benefit assessment rating goes against the recommendations of the latest national and international evidence-based guidelines, the AWMF added.
The stipulation of a comparator therapy has been “problematic” in a “considerable amount of cases” as some assessments used comparators that were not recommended by other national and international guidelines because of missing evidence, the AWMF said.
The decision over which comparator is used has to be “transparent” and “to the highest scientific level”. This is why the AWMF called for independent clinical experts to have a say in determining the comparator.
Finally, the AWMF said it is “surprising” that the G-BA and IQWiG draw conclusions from the results of sub-group tests although these results only “create hypotheses but don’t confirm them”.
The association therefore called on the HTA authorities to “critically reflect” the division in sub groups with regards to evidence, statistical significance and clinical applicability. Results of sub-groups should be taken into account of the benefit assessment but more results should be called for until the final patient group is determined, the AWMF said.
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