Market Access for Medical Apps

We get your medical app into reimbursement

The German healthcare system offers a great commercial opportunity for digital health companies: Since the introduction of the Digital Care Act (DVG) and the Digital Care and Nursing Modernisation Act (DVPMG) in 2020, digital health and nursing applications can be reimbursed by the statutory health insurance for the first time in Germany. This regulatory framework provides digital health companies access to 73 million people with statutory health insurance. Like regular medications Digital Health Application (DiGA) are prescribed by doctors and costs are covered by the insurance.

For this purpose, manufacturers must submit an application to the Federal Institute for Drugs and Medical Devices (BfArM). The BfArM then examines, among other things, safety, performance, data protection, medical quality and interoperability as well as the positive effects on care or the benefits for nursing.

co.value supports you in getting your medical app approved as a Digital Health Application (DiGA) or Digital Care Application (DiPA). We combine many years of experience in market access for pharmaceutical and medical technology companies with hands-on experience from the DiGA world. In order to position your product optimally on the market, we advise you holistically. Starting with the evaluation concept and the clinical trial, to accompanying the fast-track procedure at the BfArM as well as the price negotiation with the Federal Institute for Drugs and Medical Devices. (GKV-SV), we are at your side. In addition, we support you in the strategic cooperation with doctors, patients, payers, distribution partners and the search for investors.

Start-up sparring

You have just started to deal with the market access process of your DiGA or DiPA? Feel free to contact us at short notice. We will enter into an uncomplicated exchange with you and answer all your questions about the market access of DiGA and DiPA unbureaucratically and free of charge.

Your benefit from our services:

  • Ad-hoc counselling with immediate availability
  • Free initial assessment
  • Experienced sparring partner at your disposal

Evidence generation: Showing positive health care effects and medical benefits

In order to be reimbursed, your DiGA/DiPA must be convincing in terms of medical evidence, i.e. show a positive health care effect and a medical benefit or nursing benefit. Our physicians and medical statisticians are experts in clinical trials and will advise you on which studies you need to set up in order to generate the necessary medical evidence.

Your benefit from our services:

  • Evidence-based design development and statistics for the clinical trial
  • Agile project management and regulatory support
  • Professional preparation of the final report by our medical writers

DiGA listing - application and inclusion in the directory

The path to reimbursement of a DiGA/DiPA is full of regulatory hurdles, which we overcome together with you. We support you with the application to the BfArM and the preparation of all necessary documents, and make sure you avoid typical pitfalls. We give you a valid assessment of whether your product qualifies as a DiGA or DiPA and which requirements you have to fulfil, e.g. with regard to data protection, robustness, interoperability and proof of a positive supply effect. In addition, we advise you on other ways beyond standard care to get your Digital Health Application reimbursed, e.g. through selective contracts with health insurers.

Your benefit from our services:

  • Highly competent support for the DiGA/DiPA consultation at the Innovation Office of the BfArM
  • Comprehensive preparation for the application procedure and checking the application requirements
  • Skillful development of an application strategy and submission of the application

Price negotiation: We maximise the remuneration amount of your Medical APP

For the DiGA/DiPA to be a lasting economic success, the price negotiation with the GKV-SV is the most critical success factor. The negotiators of the GKV-SV have an experience advantage over you. Therefore, you should not go into the negotiation unprepared. We develop a value story for you that highlights the value of your product and convinces in the negotiation.

The communicative strategy must also be right in order to achieve an optimal negotiation result. Here, co.value relies on solution-oriented communication based on Marshall B. Rosenberg's concept, which we have optimised specifically for remuneration amount negotiations. With this method, we have achieved excellent negotiation results, especially in difficult constellations.

Your benefit from our services:

  • Development of a convincing pricing strategy
  • Development of a compelling value story to support price negotiation
  • Comprehensive preparation and competent support of the price negotiations with the GKV-SV based on the concept of solution-oriented communication

Our specialised solutions for marketing and sales

Once your product has reached the reimbursement stage, you can expect comprehensive marketing and sales support from us. For marketing to physicians, we support you with the vast expertise of our partner agency specialising in medical communications

Just as important as marketing to doctors is marketing to patients. For this, we support you together with our partner agency specialised in patient communication

Your benefit from our services:

  • Comprehensive support for marketing and sales to physicians through our specialised partner agency co.medical
  • Comprehensive support for patient marketing through our specialised partner agency co.patient

Insights and cooperation

Benefit from our excellent network to payers and pharmaceutical companies.

Early contact with payers is essential for your start-up to incorporate the perspective of health insurers into your market access strategy. We advise you on which payers are particularly relevant for your Digital Health Application and connect you with them. For this we make use of our network of current and former health insurer employees. Cooperation with payers in advisory board meetings, which we are happy to organise for you, is particularly productive.

In many cases, you can take the distribution of your Digital Health Application to the next level through a distribution partnership or cooperation with a pharmaceutical company. We advise you on possible cooperation partners with pharmaceutical companies, share insights and establish contacts – also with possible investors and exit partners.

Your benefit from our services:

  • Insightful research on the Payer landscape
  • High-quality insights through payer interviews
  • Advisory Board Meetings with Payers
  • Establishing collaborations with pharmaceutical companies for distribution partnerships
  • Finding exit partners
Hans Hirsch

Your contact

Hans Hirsch, Digital Health Consultant
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