>> Maria Huber, a cancer patient in Mecklenburg-Western Pomerania, doesn't understand her treating oncologist. She has been being treated by him for a few months now for her life-threatening disease, cutaneous squamous cell carcinoma (cSCC) - with great success. She receives a new product, cemiplimab, which gives her immune system the ability to recognize and destroy the cancer cells in her body. The skin lesions have recently been healing, she no longer hides at home and goes out in public again. Today she learns from her doctor that a national benefit assessment has determined that her new therapy, which brings her back to life from the imminent death, has no additional benefit compared to purely palliative end-of-life care. How can experts come to such a conclusion and virtually disregard their newfound life and their new perspective on life?
Is the individual patient fate of Maria Huber tending to be found in the reports on the AMNOG birthday or is it the national statements of the G-BA, for example from Prof. Josef Hecken, the independent chairman of the G-BA, on the anniversary or are about it Are other aspects relevant to the implementation of AMNOG assessments as part of a regional flashlight to mark AMNOG's 10th birthday?
In the UCEF workshop, participants quickly found a consensus on the positive effects of AMNOG. There was affirmative agreement primarily on the following aspects:
(1) A transparent, generally accepted and adaptable procedure has been established.
(2) In the reviews you will find all relevant information from the e.g. T. unpublished studies on the respective active ingredient.
(3) The market access of new medicinal products was not hindered.
(4) Substantial savings have now been achieved through the agreed reimbursement amounts.
Despite the last-mentioned positive experiences, representatives from the health insurance sector pointed out that pharmaceutical expenditure had increased significantly in recent years, even under the AMNOG. In addition to the morbidity structure of the insured, the reasons for this increase are, above all, innovations and the associated price effects.
The price reductions achieved in AMNOG would correspond to the increase in expenditure, for example. B. from the areas of immunology and oncology counteract this, but the savings achieved could be expanded. Possibilities for this would be, for example: B. an orientation towards a “pay for performance” or re-evaluations based on more recent study data. The annual savings in drug costs achieved by the G-BA, which recently averaged 3 billion euros, can be further increased from this purely monetary cost perspective (source of the savings: letter from Prof. Josef Hecken, G-BA dated September 14, 2020).
The continued increase in spending on pharmaceuticals despite the drug evaluations is also reflected in the therapeutic areas and the orphan drug status. Of the 581 benefit assessment procedures, 233 concerned drugs for oncological diseases and 106 for metabolic diseases. For these two therapeutic areas, the proportion of orphan drugs was also quite high at 71 and 47 procedures, respectively. Therefore, although the AMNOG fulfills its function as a cost containment law, it will not be able to prevent the disproportionate increases in the share of the generally more expensive biologicals/biosimilars and orphan drugs in drug costs (Fig. 1).
Maria Huber, the cancer patient in Mecklenburg-Western Pomerania, can understand this perspective of the health insurance companies, but cannot understand it. Rather, the question for them is what responsibility payers assume for the treatment of their illness. How can it be that the therapy that was successful for them has no additional benefit? When you ask your doctor, you get the following information: For formal reasons, your therapeutic drug cemiplimab was not considered to have any additional benefit. In its assessment on February 6, 2020, the G-BA determined that it could not assess the additional benefit based on the available data. For this reason, the additional benefit is not proven. Ms. Huber notes that her therapy and, above all, her therapy success are apparently not relevant for the data analysis in AMNOG. The question of responsibility for patients formulated by the G-BA seems unanswered to her - for herself.
According to the discussion participants, Ms. Huber's situation is of a general nature. In the AMNOG Data 2020 study, the BDI (Federal Association of Industry) states that for the majority of benefit assessments in AMNOG between 2011 and 2019, an additional benefit was not identified for formal reasons. The data to be evaluated was – as Figure 2 below shows – either insufficient or not suitable.
In its analysis, the BDI further states that a lack of additional benefit for formal reasons cannot be equated with the fact that the corresponding preparations do not actually have an additional benefit. Participants in the UCEF workshop also adopted this perspective. Demands from the discussion were to limit benefit assessments in the event of a lack of formal data requirements and to give manufacturers the general opportunity or even to require them to initiate a new benefit assessment with new or additional data. A step in the right direction is the possibility of data collection during the application. However, according to the health insurance representatives, the pharmaceutical industry would also have to contribute to this by submitting applications for the establishment of appropriate registers in advance of approval in order to possibly be able to start this process with accompanying clinical studies upon approval. This allows new findings in the medical context of a therapy or developments in the area of guidelines to be taken into account.
Another point of discussion was the question of how positive benefit assessments should be viewed in their implementation by the prescribing doctor. Do these assessments reach doctors and can they be passed on directly to patients according to the AMNOG results, without doctors having to worry about recourse?
On this question, the IGES Institute determined in 2017 as part of an empirical analysis that the market penetration of new active ingredients in Germany is generally low. According to this, new active ingredients with or without a benefit assessment generally rarely achieve more than ten percent of their expected consumption in the affected patient group within two years; a positive additional benefit is not necessarily accompanied by increased consumption. Own reports from the pharmaceutical industry and the medical profession using the example of new antibodies in the field of immunomodulation confirmed the IGES report. For example, in the case of the antibody dupilumab in the treatment of “chronic rhinusitis with nasal polyps”, a disease under the responsibility of ear, nose and throat doctors. The G-BA has pronounced evidence of considerable additional benefit for the product in the indication just mentioned in the AMNOG procedure (G-BA decision of May 14, 2020). This assessment applies to ENT doctors in many regions where prescription volumes are rather low in accordance with the local drug agreements. When prescribing antibodies such as dupilumab, ENT doctors exceed their specific prescription volumes and become “conspicuous”. A report from the University of Duisburg-Essen (Professor Wasem and colleagues) has already been devoted to this topic. The experts there identified a regulatory conflict between the economic concepts of AMNOG versus the regional drug agreement (see Fig. 3).
In their regulatory analysis they concluded:
“There is no longer any need for further analysis to determine that the concepts of economic efficiency described are incompatible with one another in a large number of concrete cases. ... nevertheless, the individual doctor is confronted with both legally valid concepts in his daily practice, so that he can come into the personal dilemma of not being able to take both perspectives into account at the same time ... Efficient and evidence-based care for patients and a factual meaning of the However, regulation for the innovation incentive requires that the results of the benefit assessment are actually reflected in medical care behavior in the way originally intended.”

The implementation of AMNOG results in prescribing practice can therefore be carried out in accordance with the additional benefit if the doctors know this... and know that they do not have any conflicts with regional drug agreements and therefore do not have to be afraid of audits or recourse. From the participants' point of view, there is a need for communicative implementation aids for the AMNOG: The G-BA's authority to interpret the AMNOG assessments compared to regional drug regulations should be communicated more strongly, especially to practicing physicians. Ultimately, it is the doctors who decide how high the costs actually are when prescribing medicines.
For this reason, it is somewhat surprising that the results of the benefit assessment by the G-BA will only be displayed in the practice management software programs from October 1, 2020. The extent of the additional benefit of an active ingredient should be displayed using graphic elements and assigned to ICD10 GM diagnoses. However, the legislature has hardly given any guidelines as to what information should be accessible where, how and with how many clicks. Therefore, the implementation by the different software programs will be very different. It remains to be hoped that this implementation of the AMNOG assessment will lead to faster penetration of new drugs with a positive additional benefit assessment.
The situation of orphan drugs has already been pointed out. For these preparations and most other medicines for oncological diseases, the initial prescription of the medication is often made by clinicians. If patients continue to be treated on an outpatient basis, the practicing doctor may not only face a dilemma due to the regional drug agreement, as already described. And for many preparations (approx. 60%) it is indicated that an additional benefit has not been proven (see above).
Should the resident doctor now take a medication that, according to the advertisement
could not prove any additional benefit of his PVS according to the G-BA decision and is probably expensive, so do not prescribe it or continue the therapy as started by the clinician? This shows that the same standards for prescribing medicines should apply to both hospital doctors and general practitioners.
Overall, the approaches mentioned in the discussion did not contain any fundamental criticism of AMNOG, but rather starting points for detailed improvements. The AMNOG has achieved its goals stated in 2010 that “the best and most effective medicines must be available to people in the event of illness, the prices and prescriptions of medicines must be economical and cost-efficient and there must be a reliable framework for innovations, the care of the insured and there must be security for jobs” (from: Bundestag printed matter 17/2413 draft law by the CDU/CSU and FDP factions July 6, 2010). However, the general goal of patient orientation should be the focus of all evaluations. Patients like Maria Huber, the cancer patient in Mecklenburg-Western Pomerania, would benefit greatly from this. <<

from: Dr. Günter Jost (1) and Dr. Thomas Kehl (2)

1 = Independent Center for Empirical Market and Social Research GmbH (UCEF); 2 = Sanofi

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