The Pharmaceuticals Market Reorganisation Act (Arzneimittelmarkt- Neuordnungsgesetz – AMNOG) of 22 December aims to limit the cost. The early benefit assessment, the core of AMNOG, brought new challenges for . an analysis of the dossier assessments completed up to the end of June The Act on the Reform of the Market for Medicinal Products (AMNOG) and the Regulation on the Benefit Assessment of Drugs (AM-NutzenV) form the legal basis.

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Accessed 4 Sep The pharmaceutical company reports both it and the refund rate to the price reporting agency. Biometrical Journal this issue. The quality amng the studies and data amnig in the Benefit Dossier needs to be described. If the additional benefit is less than that of the expedient comparative therapy, the National Association of Statutory Health Insurance Funds stipulates a deduction.

In andIQWiG therefore developed appropriate scientific methods, newly organized procedures, and trained additional staff.

For example, the benefit of cabazitaxel on mortality in patients with advanced prostate 20012 was initially judged to be considerable. Furthermore, progression of cancer usually requires a change in therapy and is often associated with anxiety for patients, suggesting that PFS should be considered a patient-relevant endpoint. The refund rate that was negotiated applies to persons with both statutory and private insurance, and to self-paying patients in Germany.

Omission of data for relevant populations led to the dossier for vandetanib being deemed unacceptable for benefit assessment by IQWiG and G-BA [ 7 ]. The assessment procedure is only complete with a formal decision by the G-BA on the added benefit and on the extent of added benefit.

IQWiG determined an added benefit of ruxolitinib, as it alleviates symptoms better than the appropriate comparator therapy and offers survival benefits. However, because of anmog reported adverse events, they recommended a total score of significant additional benefit. All resolutions that are adopted, including the summary scientific and legal evaluation, the discussions, as well as the debate with the arguments put forward in the statement procedure, are retrievable on the Internet site of the Federal Joint Committee.


Implementation of AMNOG: An industry perspective

During these 12 months, the manufacturer can set the price for the product. We discuss these issues from an industry perspective. Authentic innovations which constitute real progress for patient care will increase. Journal of the American College of Cardiology 52— It may be assumed that G-BA would not consider a transient decrease aamnog white blood cell count as patient amnogg, whereas it would consider a symptomatic myocardial infarction to be patient relevant.

In both cases, the decisions did not seem to weigh adverse reaction data in a quantitative analysis. If no agreement can be reached within six months on a refund rate between the National Association of Statutory Health Insurance Funds and the pharmaceutical company, the proceedings go to arbitration. The pivotal trial of vemurafenib, which is indicated for the treatment of melanoma, was terminated early at the request of the regulatory bodies due to the observed improvement in overall survival benefit.

In contrast, a G-BA decision of less benefit as occurred in one of the subgroups in the assessment of eribulin implies a negative benefit-risk balance.

Recently, there has been a change to the rules in that Criterion 5 is used only for price negotiations, and not for determining the comparator.

Four areas of interest were analysed: It is amnoy for an evaluation of established market products whether the pharmaceuticals are significant for statutory health insurance or are in competition with pharmaceuticals which have already been evaluated.

In the case of drugs for rare diseases orphan drugsthe approval of the drug is at the same time deemed to be proof of added benefit.

Implementation of AMNOG: An industry perspective

Our analysis showed similar results. There are many situations where the impact of the benefit attributable to a new treatment is better among on an absolute scale than a relative one. It is hoped that discrepancies concerning the comparators used for phase III clinical studies and benefit assessments, as well as discrepancies regarding the selection of patient-relevant endpoints, will diminish over time as a result of this initiative.


Since the AMNOG provisions came into force, legislature has presumed that a new medicinal product has a fictive benefit as amnnog result of its approval under the law on medicinal products. Unquantifiable added benefit 5: Involvement of patients As in all IQWiG reports, the patient perspective also plays a key role in early benefit assessments.

Ten novel therapies are already under early benefit assessment, and pricing negotiations have started for AstraZeneca’s heart drug Brilique ticagrelor. Indications or notes by themselves are therefore fundamentally unsuited to prove a therapeutic improvement.

AMNOG since 2011

The latter is the case if no suitable reference price group exists. Such medicinal products will have to put up with being in the second or third row in future — including when it comes to price. Ipilimumab’s benefit on mortality was originally considered to be major.

The refund rate for such medicinal products may not be higher than the cost of the expedient comparative group with which the new medicinal product was compared.

Both total benefit scores and subgroup scores were included in the analysis. The most recent legislation requires the involvement of the health authorities during early advice meetings before initiation of phase III clinical trials between the pharmaceutical manufacturer and G-BA.

IQWiG assesses the certainty of results on the basis of these data. The arbitration body is composed of three non-partisan representatives and two representatives each of both negotiation partners. Institute for Quality and Efficiency in Health Care suggested no additional benefit, whereas G-BA concluded a marginal additional benefit.

Significant added benefit 201 Minor acceptance of these indirect comparisons by IQWiG and G-BA was evident in the evaluation of abiraterone acetate, fampridine and microbial collagenase.

Less than comparator The score greatly impacts their pricing prospect of drugs in Germany. Pharmaceutical Statistics 10— We focus on seven areas: Sulphonylurea glibenclamide, glimepiride II:

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