HEPICC GmbH

HEPICC GmbH is a consultancy that supports start-ups, small and medium-sized enterprises (SMEs) as well as pharmaceutical and medical technology companies in digital health and digital therapeutics (DTx).

Company profile

We are your competent partner for the German healthcare market. We have an in-depth understanding of the healthcare system, its mechanisms and stakeholders, and have built an extensive network of reliable partners. Our focus is on the strategic and operational support of projects, from the initial idea to successful implementation and reimbursement by statutory and private health insurers and other payers in the German healthcare system. Together with our clients, we shape the strategy, implementation and marketing of digital health innovations: reliably, to a high standard and with a focus on results. HEPICC has been a supporting member of the SVDGV from the very beginning. Since the DVG came into force, the company has supported DiGA manufacturers in assessing the DiGA eligibility of their products, designing DiGA-eligible products, product development and generating clinical evidence. In addition, HEPICC supports manufacturers throughout the entire Fast Track procedure.

HEPICC services at a glance

• Strategic advice on reimbursement (DiGA, selective contracts, statutory optional benefits, digital aids, G-BA Innovation Fund, etc.) • Analysis of the suitability of the DiGA idea and/or product concept • Preparation and support for BfArM consultations • Support with product design and development • Support with clinical evidence generation: from study planning through conduct to analysis • Pricing strategy • Preparation of, or assistance with, the BfArM DiGA application • Support throughout the entire Fast Track procedure & assistance with deficiency notices • Preparation for reimbursement price negotiations with the GKV

Long-standing expertise in market access & reimbursement

HEPICC has solid experience from DiGA projects across all process steps. In addition, HEPICC continuously monitors the development of the DiGA market and all DiGA prices and derives recommendations for its clients. Alongside the DiGA Fast Track, HEPICC supports companies with in-depth knowledge from more than five years of experience in market access and reimbursement of medical devices and digital health solutions.

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