BERLIN, Sep 6 (APM) - Germany's lower health technology assessment (HTA) body IQWiG has said that the current practice of exempting orphan drugs from the full assessment required of most new drugs under the AMNOG law is "not successful" and should be changed.
In IQWiG's annual report 2015, the institute's director Juergen Windeler said orphan drugs should receive a standard assessment.
"Exempting orphan drugs from added benefit assessment has not proven its worth," said Windeler in the report released on Wednesday.
Non-orphan drugs new to the German market must be accompanied by a dossier from the manufacturer that is submitted to Germany's higher HTA body, the G-BA, for assessment. IQWiG is normally commissioned by the G-BA to give a recommendation.
The G-BA takes IQWiG's proposal into consideration when making its final decision on whether or not the new drug offers any additional benefit over current therapies.
Orphan drugs are exempt from a review by IQWiG if their estimated annual sales are below 50 million euros, because their additional benefit is considered already proven by their marketing authorisation.
However, IQWiG does provide the G-BA with an estimate of the number of eligible patients and the costs of treatment. IQWiG performed a greater number of estimates for orphan drugs in 2015, with 14 files completed compared to 10 in 2014, the annual report said.
Giving an advantage to orphan drugs provides the wrong incentive for research, suggested Windeler. The result is drugs marketed on less reliable data, posing a greater risk for patients.
Changing the assessment of orphan drugs was not part of the pharma dialogue which concluded in April (APMMA 47326) and served as a precursor to the AM-VSG draft law, IQWiG said.
It added that while it supports the conclusion of the dialogue that no substantial changes to the AMNOG assessment procedure are necessary, IQWiG does see a need for reform in the law's approach to orphan drug assessment.
This position puts IQWiG in line with the German medical association (BÄK) which, in its criticisms of the draft drugs law AM-VSG currently being revised to amend AMNOG, demanded that orphan drugs undergo the standard HTA process rather than a simplified assessment (APMMA 49193).
Windeler said IQWiG has observed with "concern" the falling standards of market access for drugs on the European level. Through a less rigorous assessment process, manufacturers might reduce development costs but patients are paying the price of uncertainty, he said.
The adaptive pathways pilot programme, supported by the European Medicines Agency (EMA), is headed in the same direction of lower standards, he added.
The practice of introducing approved drugs with only very limited use and close monitoring, in order to generate further evidence, is "inconceivable" in Germany, said Windeler.
For the same safety reasons, Windeler advocates that paediatric drugs and antibiotics should undergo a full assessment. A principle of no deviations from standard assessment should be adopted. Contrary to that view, the draft drugs law AM-VSG would introduce specific criteria for both categories of drugs.
IQWiG also supports an assessment of all drugs launched before 2011 and which are currently not undergoing HTA evaluation while being part of the so-called "established market" (Bestandsmarkt).
"Incentives for manufacturers should be created to carry out studies on long-term effects after marketing authorisation", IQWiG said.
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