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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The G-BA is the highest qmnog body of the joint self-governing board of stakeholders in healthcare physicians, dentists, hospitals and health insurance funds in Germany. It is however also possible to compare with non-treatment. Additionally, the study population that was used for indirect comparison included patients with lower degrees of disability than the values required for treatment with fampridine. External experts It was smnog obvious in that not only were additional internal resources required to prepare AMNOG reports, but also external ones in the form of experts from all medical fields.

Support Center Support Center. So far, only very few new products have passed through the full AMNOG process, including price negotiations.

However, a considerable amount of experience has been gathered regarding the early part of the process, i. After evaluation of the new data G-BA concluded there was a marginal additional benefit. Indication medium certainty of conclusions: Belimumab Institute for Quality and Efficiency in Health Care concluded no additional benefit, whereas G-BA concluded there was a significant additional benefit.

In both cases, the decisions did not seem to weigh adverse reaction data in a quantitative analysis.

Published online Jun What essential criteria are clarified in advance of the individual refund rate negotiations? IQWiG therefore developed a standardized questionnaire with which patients can at an early stage provide information on what is important to them with regard to the disease and its treatment.

The conclusions of IQWiG and G-BA on adverse events were sometimes related to subgroup analyses belatacept, boceprevir, fingolimod and telaprevir [ 7 ]. It may be assumed that G-BA would not consider a transient decrease in white blood cell count as patient relevant, whereas it would consider a symptomatic myocardial infarction to be patient relevant. AMNOG – evaluation of new pharmaceutical. We focus on seven areas: The pharmaceutical company reports both it and the refund rate to the price reporting agency.


In addition, some further aspects have to be taken into account when interpreting the results. If several alternatives are determined for the expedient comparative therapy, the refund rate may not lead to higher annual therapy costs than those of the most economical alternative.

Which specific advantages and disadvantages does the new drug have for patients? Suitable, in other words fair, means for us that the prices of the new medicinal products are orientated towards the additional benefit for patients, and not towards the wishes of the companies.

Legal foundations of IQWiG

Where anmog products offer no additional benefit and cannot be assigned to an existing fixed-rate group, the price level will also be limited since the refund rate may not lead to higher annual therapy costs than those of the expedient comparative therapy. The dossier was forwarded to IQWiG for assessment. Such spurious innovations may only be able to just about do what other therapeutic alternatives, which often are very cheap, can also do, so that a higher price would not be justified.

Journal of Clinical Epidemiology 54— Who benefits from the refund rate negotiations? The aim of our investigation was to analyse the outcomes 18 month after introducing the new legislation and to identify critical areas that require further discussion and development.

Implementation of AMNOG: An industry perspective

What is the difference between an additional benefit and a therapeutic improvement? In contrast to the manufacturer, the G-BA did not consider that the statement by the regulatory bodies should be 201 as proof of a major additional benefit [ 17 ]. Results Twenty-seven EBAs were analysed. As a consequence, these three products received negative G-BA decisions due to the lack of data.

We hope that IQWiG would consider taking advantage of the output from the above efforts in determining the net benefit.

AMNOG One Year On: How Will German Health Reform Impact Pharma Market Access in 2012?

When it comes to approval, however, only effectiveness, quality and safety are examined and the market smnog is regulated by weighing up benefits and risks. Accordingly, in the early benefit evaluation, new medicinal products that are comparable in pharmacological and therapeutic terms with fixed-rate medicinal products are directly evaluated within a fixed-rate context section 35a subsection 1sentence 4, of Book Five of the Social Code.


20122 actual comparative European prices and the annual therapy costs of comparable medicinal products are only then used as further criteria.

Slight added benefit 4: The reduction in the confidence level should reflect the total number of events removed. The situation is especially problematic when there is only one large registration trial.

Many of our comments relate to the scientific basis for making pricing and reimbursement decisions. Eur J Health Econ.

– Legal foundations of IQWiG

They determined that 13 of the first 21 dossiers contained high-quality data on patient-relevant outcomes; these data allowed the assessment of added benefit in at least one group of patients.

These therapies must also comply with the generally-recognised state of medical knowledge within in the range that is relevant to the application. Accessed 10 Aug For high correlation, IQWiG requires the lower bound of the confidence interval for ambog correlation coefficient to be greater than 0. With five early benefit assessments published since the New Year, and 201 more to come in February, IQWiG has never been so productive since the implementation of the German health reform – AMNOG – which links pharmaceutical pricing to added therapeutic benefit scores.

International reference pricing of pharmaceuticals: Zmnog assesses the certainty of results on the basis of these data. If the additional benefit is less than that of the expedient comparative therapy, the National Association of Statutory Health Insurance Funds stipulates a deduction.

Prophylaxis of venous thromboembolism after athroplasty hip or knee replacement. Accessed 10 Oct However, such endpoints may amnlg very valuable in detecting changes in morbidity before they become symptomatic for patients i.