In practice, a number of withdrawals of products, for which an additional therapeutic benefit could not be established, has occurred. Since its implementation, the AMNOG process has been labelled as a learning system by political representatives and other stakeholders. 1 and Art. If no agreement can be reached, the reimbursement price will be determined by an arbitration committee and will be equally applicable as of the 13th month after product launch. Remicade, according to Cigna, saw $4.2 billion in global sales in 2020, but the cost of infusion varies based on patient, indication and site of care. Found insideThe internationally recognized response to AMR advocates for a ‘One Health’ approach, which requires policies to be developed and implemented across human, animal, and environmental health. For example, the joint clinical assessment report at the EU level, which was an essential part of the initial proposal of the EU Commission and which aimed at standardising and unifying HTAs in the European market, is proposed to be ultimately downgraded to a non-binding assessment with a restricted scope. In this light, the draft bill was subject to consultation with the European Commission. Its main responsibility is to conduct the marketing authorisation process for pharmaceuticals in national proceedings. This lack of evidence has triggered criticism from the pharmaceutical industry with regard to the G-BA’s practice of possibly ‘slicing’ patient populations into sub-groups and demanding data which cannot be available at the early stages of market entry of an innovative product. The Federal Administrative Court deemed the pricing regime for RX products compatible with the German Constitution, stating that it pursues legitimate interests of public health. In 2021, the legislative process is still ongoing. It should be noted, however, that SHIs continue to lobby for the possibility of an indication-specific pricing as an alternative model to the established mechanism of blended pricing. 5 Book of the German Social Code, which defines and specifies the competences of the G-BA. A first step was made in 2019 when a new law paved the way for consideration of data collections accompanying the use of the pharmaceutical in defined end exceptional constellations (e.g. Even in the absence of a fourth hurdle, successful market access by pharmaceutical companies in Germany requires careful preparation and a well-structured approach. Hence, the EU Parliament mitigated the draft in several points; it shall, for example, be possible for Member States to conduct additional HTAs, and the HTA shall not be exclusive. Access to treatment with pharmaceuticals: no fourth hurdle. The GKV-SV is the federal level association of all SHIs. Framework agreement on the supply of medicinal products. The actual derivation and determination of the reimbursement price, as such, however, is only subject to limited judicial review, given that such decision is discretionary in nature and must be based on a subjective assessment of all relevant facts and circumstances of the individual case. The G-BA has assessed the threshold in this context to €1 million. In 2018, 81% of all prescriptions issued for treatments with pharmaceuticals referred to products regulated by the reference price system, thereby covering 37% of the overall expenditures by the SHIs for pharmaceuticals. Only a blended threshold combining annual costs of treatment for different comparators across different indications can ensure an adequate mapping of the different indications of the new pharmaceutical and its future prescription across these indications. The legal basis of G-BA operations is the No. Based on an ordinance enacted by the German Federal Ministry of Health, all insured (whether privately or publicly) and uninsured persons are granted the right to a free COVID-19 vaccination. Moreover, the G-BA also states the level of evidence by which such benefit is established. Therefore, in most cases, pharmaceutical companies lower their market prices to the respective reference price to avoid this substitution by prescription of competing products. In general, this means that CMS will group biosimilar products that rely on a common reference product’s biologics license application into the same payment calculation, and these products will share a common payment limit and HCPCS code. Given the ‘bottom-up’ nature of the price negotiation process, the determination of the appropriate comparator can substantially influence the potential for agreeing the ultimate reimbursement price. Such scenarios can create conflicts with the general principle that the negotiated reimbursement price must generally not exceed the annual costs of treatment of the cheapest comparator. €44 billion, €21 billion of which were spent on patent-protected products, which covered only 6.5% of the prescriptions. Please see our terms and conditions page for further details. Germany currently has 83.2 million residents, who have access to free healthcare services based on a statutorily funded system, currently operating around 103 SHIs, which cover approx. The Federal Ministry of Health (‘BMG’) is the competent federal authority for all health-related policy issues. Thus, if a different pharmaceutical company launches another product with the same new API after the first launch, the reimbursement price agreed with the pharmaceutical company having launched the first product containing this API applies to this other product (and all subsequent products) too. In the absence of a fourth hurdle, pharmaceutical companies may, in general, freely determine market prices when launching their products. Please note that the determination of the payment amount for biosimilars is not affected by the use of a modifier. Finally, legal proceedings have no automatic suspensive effect so that the reimbursement price set by the arbitration committee will apply with effect from the 13th month after the initial product launch unless suspensive effect is exceptionally granted at the request of either party. Against this background, successful market access in Germany requires careful preparation, which should be initiated as early as possible. In her late twenties, Helen received a diagnosis for stage four non-Hodgkin lymphoma. Register today ➡️ https://www.grxbiosims.org/ Note, that in general the UK prohibits generic or biosimilar substitution in pharmacies for a brand-name prescription. In practice, however, the SHI pursues a ‘bottom-up’ approach based on the costs of the defined comparator and a ‘premium’ for the innovative product reflecting its additional therapeutic benefit. Against this background, the SHI is still lobbying for a restriction of the right for free pricing in year one. It remains to be seen whether additional data (e.g. While level 1 reflects an extensive additional benefit over the defined comparator, level 6 is equal to a ‘negative additional benefit’. There are various players in the market that participate in self-governing decision-making processes, while the legislator sets out the overall conditions and criteria for healthcare services. Furthermore, the rebate agreements were criticised due to the lack of transparent selection criteria with which pharmaceutical companies contract negotiations are initiated. To address some of these concerns, the Act on Fair Competition between Statutory Health Insurance Funds (‘GKV-FKG’), in force since February 2020, particularly loosened the binding effect of the rebate contracts for the pharmacies. With the end of the pandemic situation, COVID-19 vaccines are likely to become part of the usual set of vaccination required and indicated for all or certain groups of the German population. Its assessments are non-binding on the G-BA, but are presumed to be scientifically correct by the German social courts. Moreover, when assessing the therapeutic benefit and medical necessity of a pharmaceutical, the G-BA must not contradict the findings and assessments made by the competent regulatory authority, which has granted the marketing authorisation (i.e. As a general rule, all patients covered by the SHI are entitled to adequate treatment of diseases, including the administration of pharmaceuticals. Although it remains currently unclear when an agreement between the relevant EU institutions can be expected, some stakeholders hope that the regulation might come into force during 2022, allowing application as of 2025. As such, it is expected that they will become subject of the usual pricing and reimbursement scheme applicable for all vaccines covered by the statutory health insurance (e.g. While statutory health insurance funds (‘SHIs’) and the German government regard the AMNOG system as successful overall, the pharmaceutical industry is still raising numerous concerns pertaining to: (i) a relatively high number of negative assessments; (ii) data requirements which cannot be fulfilled in the early stages of product launch; (iii) undue pressure on prices by choosing generic comparators as a reference point for ‘bottom-up’ price negotiations; and (iv) an unbalanced governance structure which gives the GKV-SV the combined power of first influencing the additional benefit assessment conducted by the G-BA, and then negotiating reimbursement price negotiations with the respective pharmaceutical company. By this notion, it is acknowledged that there is no expectation that the system will work perfectly and smoothly from day one, but that it may need to be adjusted and modified as it evolves in its daily practice. Medicaid Services. Data on file, Amgen [#1 Trastuzumab Biosimilar]; 2021. The AMNOG process does not change the general principle that pharmaceutical companies remain free to determine the launch price for innovative pharmaceuticals. Hence, adherence to the framework agreement is a prerequisite for the pharmacists to be permitted to provide services in the SHI system and thus to receive reimbursement. However, there are various mechanisms which directly or indirectly regulate prices or contribute to cost-savings in the healthcare system. As a matter of fact, the GKV-SV is able to significantly influence decisions of the G-BA by its own representatives. Even Better + Together! As in most countries, the costs related to coronavirus vaccination is borne by the German Federal Government, outside the usual and established regime of pricing and reimbursements of vaccines. Once the IQWiG has completed its scientific assessment, the G-BA takes a final decision within six months. Rebate agreements were criticised in many ways, especially with increased political discussions ongoing in 2019. First, non-prescription pharmaceuticals are generally excluded from reimbursement. Quite the contrary, there are a number of mechanisms which directly or indirectly regulate prices or contribute to cost savings in the healthcare system. The book is also strong on analysis of those facts as well." Jerry Avorn, Harvard Medical School. "This book offers a comprehensive examination of approaches to manage pharmaceutical expenditures in Europe. Global Legal Group Ltd. and the contributors accept no responsibility for losses that may arise from reliance upon information contained herein. Special problems: Blended pricing in case of a mixed HTA. In the 2016 Physician Fee Schedule Final Rule, CMS updated the regulation text found at 42 CFR 414.904(j) to make clear that effective January 1, 2016, the payment amount for a biosimilar biological drug product is based on the average sales price of all NDCs assigned to the biosimilar biological products included within the same billing and payment code. These groups can be established on the basis of: (i) products having the same API; (ii) products having pharmacological or therapeutically comparable APIs; or (iii) products having comparable therapeutic effects, including combination products consisting of more than one API. To this end, the design of the pivotal trials should be discussed and structured not only with respect to regulatory and clinical aspects but also anticipating requirements for a successful additional benefit assessment under the AMNOG process. If the parties cannot reach an agreement, an arbitration process is triggered. Beyond that, since 2017 a marketing authorisation has also been granted for those pharmaceuticals subject to the AMNOG process which consist of established APIs enjoying the protection of clinical data. 17-08-2021. The directives enacted by the G-BA are legally binding on third parties as subordinate regulations. flu vaccines). Finally, restrictions or exclusions of reimbursement are considered an ‘ultima ratio’ tool, and can only be determined if cost-effectiveness cannot be established by other price regulation mechanisms. 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