Changes to the rules of procedure of the Federal Joint Committee are planned
18.11.2010 16:50
Transfer of the AMNOG into a detailed procedural code by the G-BA
Just as diligent as the officials who worked on the Drug Benefit Assessment Ordinance were the employees of the Federal Joint Committee (G-BA), who have been working for months to bring the AMNOG guidelines into a more detailed procedural code; a project that was and is not entirely easy because the relevant BMG legal regulation has only been passed recently (see message “AM-NutzenV – Drug Benefit Assessment Ordinance") and will not undergo some changes until the public hearing on November 25th. This is what the G-BA chairman Dr. Rainer Hess, who gave insights into the G-BA's new procedural rules at his institution's legal symposium, can only be understood as the current status of the discussion; However, one that shows in great detail where the journey is headed. Especially at a time when the concept of benefit as such is defined much more harshly than before.
So far the valid one says Rules of Procedure of the Federal Joint Committee (in the version dated December 18, 2008, published in the Federal Gazette 2009, p. 2050 (supplement), came into force on April 1, 2009 and amended on December 17, 2009, published in the Federal Gazette 2010, p. 968 came into force on February 12th .2010) in chapter 4 § 6 on the “assessment of benefit and medical necessity” the following:
(1) The benefits and medical necessity of the services or treatments under consideration are deemed to be sufficiently proven if
a) an assessment in accordance with Sections 135, 138 or 137c SGB V has shown that the benefit and medical necessity of a method underlying the service has been sufficiently proven, or if
b) the service or treatment is part of the statutory health care.
In case of doubt, the subcommittee should obtain the opinion of another subcommittee or the evaluation committee in accordance with Section 87 SGB V.
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If an assessment of the benefit and medical necessity is not available or there are reasonable doubts that this still corresponds to the generally accepted state of medical knowledge, this can be done Plenum trigger a cross-sectoral assessment according to Chapter 2.
In the new Chapter 4 § However, at least according to the current state of discussion, 6 should say:
(1) The assessment of the therapeutic benefit of a medicinal product is carried out on the basis of documents either for Extent of therapeutic benefit of the drug for a specific indication or by comparison with other drugs or forms of treatment Consideration of the additional therapeutic benefit for the patients.
(2) Is decisive for the assessment of the therapeutic benefit the extent of the influence on patient-relevant endpoints, particularly morbidity, mortality and quality of life.
This does nothing other than define the previously rather vague concept of benefit even more precisely, as is also attempted in the BMG legal regulation. There it says under § 2 Definitions in the third paragraph that “the benefit of a medicinal product within the meaning of this regulation is the patient-relevant therapeutic effect”. – in particular with regard to improving the state of health, shortening the duration of the disease, extending survival, reducing side effects or improving quality of life.
18.11.2010