Early Advice Meeting Germany – HTA scientific advice by the German G-BA to optimize your trial design and chances for reimbursement
In Germany, the Gemeinsamer Bundesausschuss (G-BA) offers paid early scientific advice on evidence-generation plans for new pharmaceuticals, medical devices, or diagnostic/interventional procedures and advice on the evidence to be submitted in the AMNOG dossier. The early advice meetings are optional, paid, non-binding (both for G-BA and the applicant), and confidential between the applicant and the G-BA.
Germany represents an attractive market where premium pricing is possible, but, if G-BA requirements are not met, payers request significant discounts which can in the worst-case lead manufacturers to withdraw from the German market. Therefore, it is important to engage with the G-BA at an early stage to ensure that their requirements can be taken into account.
The goal of the early advice consultation with the G-BA is to allow you to gain crucial insights, in particular to gain feedback on the relevant comparator, your planned studies and quality of evidence that will resonate with the G-BA. Ultimately, the consultation is meant to help avoid the lower categories of the benefit assessment scale such as ‘No added benefit’. With Justin Stindt Consultants you can hire an agency which has helped many companies obtain scientific advice from G-BA.
As a true service provider, we can offer full-service support including development of materials, translations, submissions and moderation of the meeting. Many of our international clients prefer to write the advice request in English first to allow input and sign-off by a global team and our experts then translate the advice request into German for submission via the G-BA AMNOG portal.
Streamlining Market Access in Germany: The ‘Trial upon Application’ Pathway for Innovative Medical Technologies
‘Trial upon application’ (Antragsgesteuerte Erprobung), holds the promise of streamlining market access for innovative medical technologies in Germany. Manufacturers can leverage this pathway to submit applications, which are evaluated by the G-BA. Successful applications then pave the way for the G-BA to design and execute tailored clinical trials.
Through this pathway, the innovative medical technologies can be made available ahead of regular reimbursement decisions which can take many years. Therefore, it allows patients to benefit from the medical technologies’ potential therapeutic advantages sooner. Also, generating positive data through this pathway enhances companies’ chances of obtaining reimbursement for their products, increasing market access and adoption potential. In addition to this, the authorities co-fund the cost of the clinical trial.
Justin Stindt Consultants is your agency to support you with engaging in Early Advice Meetings with the Gemeinsamer Bundesausschuss (G-BA) in Germany
Justin Stindt Consultants is your international consulting firm with experts who have extensive experience in engaging with the G-BA, including facilitating early advice meetings for the development of optimal clinical development and evidence-generation plans.
Our consultancy has helped many clients by engaging the G-BA at an early stage of product development, by developing briefing books, study short descriptions and guideline searches for G-BA meetings. Our consultants not only prepare the materials for you but also attend the meetings upon your request. Our agency also writes meeting minutes and executive summaries and our consultancy supports you with embedding the advice into your pivotal trial design and further evidence generation plans.
Many of our consulting firm’s clients have found the Early Advice Meetings with the G-BA very insightful and have adapted clinical trial protocols and statistical analysis plans to better meet the evidence needs of the G-BA to maximize the chances of successful HTA endorsement.
Are you looking for a vendor to support you with Early Advice Meetings with the G-BA? Then pick a supplier with a proven track record of developing and delivering advice requests for the G-BA and accompanying clients to these scientific advice meetings. Contact our experts today to learn how our agency can tailor our market access service to meet your unique needs and enable you to leverage the G-BA Early Advice Meeting scientific advice pathway.
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