In Germany, innovative medicinal products are subject to the early benefit assessment according to AMNOG. Long-term strategic planning and preparation for the benefit assessment is useful in order to negotiate the best possible reimbursement amount. Ideally, this should start with the planning of the pivotal trial(s) and continue throughout the benefit assessment and up to the price negotiations. We are happy to support you in mastering these challenges and will prepare an appropriate market entry strategy as well as a target-oriented benefit dossier. In addition, we will prepare you in a specific and targeted manner for the price negotiations.
Innovative, patented medicinal products can be placed on the market in Germany immediately after receiving European or national marketing authorisation. In Germany, there is a special situation whereby the pharmaceutical company is free to set the price for a new, patented medicinal product when it enters the market and the medicinal product is also reimbursed by the health insurance funds. Upon market entry, the pharmaceutical company must submit a dossier to the Federal Joint Committee (G-BA) within the process of the early benefit assessment according to AMNOG. The benefit dossier must meet the formal criteria of the G-BA – in particular with respect to completeness – and must be prepared on the basis of the formats specified by the G-BA.
Early benefit Assessment according to AMNOG
The essential criterion for the preparation of an AMNOG benefit dossier is the comparison of a new medicinal product with an appropriate comparator therapy (ACT) determined by the G-BA. The additional benefit of a medicinal product is determined in comparison with an ACT. It is advisable to seek advice from the G-BA before preparing a benefit dossier, in particular for clarification of the ACT in the respective indication. If several ACTs exist, the pharmaceutical company may select one of the predefined ACTs for the early benefit assessment. The benefit assessment for innovative medicinal products is carried out by the Institute for Quality and Efficiency in Health Care (IQWiG) on behalf of the G-BA; the decision on benefit and additional benefit is made by the G-BA.
The G-BA assesses the patient-relevant benefit and additional benefit of an innovative medicinal product with regard to the endpoint categories mortality, morbidity, quality of life and side effects. The basis of the assessment is the methodology of evidence-based medicine, generally requiring randomised controlled trials (evidence level 1b) for medicinal products. If the ACT cannot be covered by the marketing authorisation studies, this poses a particular challenge. In this case, indirect comparisons must be conducted to describe the additional benefit. Apart from the additional benefit assessment, the G-BA decides on the number of patients in the indication / subpopulation, i.e. the prevalence of the disease in Germany. In addition, the costs of the new, innovative therapy are compared to the costs of the ACT.
The benefit assessment procedure is structured in terms of time and content. The early benefit assessment is published on the homepage of the G-BA within 3 months of submission of the AMNOG dossier by IQWiG. Subsequently, a hearing phase takes place which consists first of all of a written statement that must be submitted within 3 weeks. Then, an oral hearing takes place before the G-BA approximately 2 weeks after submission of the written statement. The decision of the G-BA regarding the additional benefit of an innovative medicinal product is published 6 months after market entry / dossier submission. The G-BA decides on the degree of likelyhood and the extent of the additional benefit of a new medicinal product compared to the appropriate comparator therapy. The result of the benefit assessment is an essential factor for the subsequent price negotiations with the National Association of Statutory Health Insurance Funds (GKV-SV).
The result of the benefit assessment by the G-BA has an impact on the price negotiations for the reimbursement amount. Following the benefit assessment, the price negotiations are conducted between the pharmaceutical company and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) within 6 months. For this purpose, the GKV-Spitzenverband specifies 4-5 negotiation dates in order to reach an agreement on the reimbursement amount within this period. Price negotiations above the price of the most cost-effective appropriate comparator therapy (ACT) are only possible for medicinal products with additional benefits. The price for innovative medicinal products with no additional benefit or an unproven additional benefit is agreed at the level of the most cost-effective ACT. The law (§ 130b SGB V) stipulates that deviations from this requirement are only permissible in exceptional cases.
For new medicinal products that can be assigned to a fixed-amount group, the benefit assessment is carried out on the basis of the fixed-amount system. If no additional benefit can be established, these medicinal products are directly assigned to the existing fixed-amount group. The fixed amount is considered the maximum reimbursement amount.
The reimbursement amount takes effect 12 months after market entry. If no agreement can be reached on the reimbursement amount, an arbitration procedure will be conducted within 3 months. The reimbursement amount will then be determined retroactively.
For medicinal products that are assessed for a new indication, the reimbursement amount already negotiated will initially apply – for a period of 12 months. The existing price applies for medicinal products that were placed on the market before the introduction of the AMNOG. The reimbursement amount/price can be adjusted in the course of the negotiations.
Market Access and Reimbursement in Inpatient Care
The benefit assessment according to AMNOG also includes medicinal products used in inpatient care. While uniform prices apply in pharmacies in outpatient care, prices in inpatient care can be negotiated between pharmaceutical companies and hospitals. The reimbursement amount serves as the upper price limit for the negotiations.
Reimbursement in inpatient care between hospitals and health insurance funds is based on the inpatient reimbursement system. For the reimbursement of new medicinal products, hospitals can submit a so-called NUB (new examination and treatment methods) application to the Institute for the Hospital Remuneration System (InEK). If the assessment is positive, the new drug is reimbursed in addition to the DRG flat rates per case. NUB applications can only be submitted once a year with a deadline of 31 October; the decision of the InEK is made by the end of January of the following year.