Versorgungsforschung: Klinik, Patient, Arzt und Daten im vernetzten Versorgungspfad

ValueDemonstration

We make the value of your product visible to payers and HTA authorities – from strategy and evidence preparation to communication. Our strength is the pluralism of methods and sources, paired with the experience of knowing which presentation suits which audience. We work scientifically state of the art, in publication quality and backed by two decades of project practice, prepared for the respective audience – payers and authorities.

Value Demonstration

  • Our Capabilities
  • EU HTA
  • Our Quality Promise
  • Our Offer
  • Your Added Value

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Patient Access & Reimbursement Evidence Generation

Our Capabilities

From HTA strategy through dossier and indirect comparisons to value communication: the full spectrum to show the value of your product.

At the analytical and documentary steps we deploy AI deliberately where it adds speed; methodological judgement and ultimate responsibility remain with senior HTA experts.

Early planning of the assessment pathway: gap analysis, value proposition, comparator and endpoint strategy, and an HTA roadmap that brings national and European requirements together from the start.

Preparation of the benefit dossier for early benefit assessment: for medicinal products modules 1–5 under §35a SGB V, for methods and high-risk medical devices the assessment under §137h SGB V. Derivation of the appropriate comparator therapy, patient-relevant endpoints, evidence preparation, and support through the consultation and commenting procedure. AI-assisted templates and cross-module consistency checks accelerate preparation and quality assurance.

Systematic evidence synthesis to international standards (PRISMA, Cochrane) as a basis for HTA dossiers, guidelines and publications. We accelerate screening, deduplication and data extraction with AI support and human verification – faster reviews with fully documented, reproducible methodology.

Adjusted indirect comparisons (Bucher), network meta-analyses (NMA) and population-adjusted methods (MAIC, STC) where no direct head-to-head evidence is available – central to the missing comparator-therapy comparisons in the dossier and the consolidated PICOs in the JCA.

Cost-of-illness analyses, cost-effectiveness studies and budget-impact analyses, methodologically robust and tailored to the requirements of HTA authorities.

Decision-analytic models (discrete-event simulations, Markov models, decision trees, partitioned-survival models) to assess long-term cost-effectiveness where long-term data are not available. We generate and check model code and sensitivity analyses partly automatically – more tested scenarios in less time, fully traceable.

Translating the evidence into a compelling value story: value dossiers, lines of argument and stakeholder-appropriate materials for payers, authorities and sales, including scientific publications and conference contributions.

EU HTA

Since January 2025 the EU HTA Regulation has introduced a joint European assessment procedure – we prepare you for JCA and JSC.

With the EU HTA Regulation (Regulation (EU) 2021/2282), a completely new procedure has applied since January 2025: the clinical assessment is, for the first time, carried out jointly at European level – initially for oncology products and ATMPs, from 2028 for orphans, and from 2030 for all other newly authorised medicinal products. We already gained experience in the predecessor process EUnetHTA and bring it directly into your preparation for JCA and JSC.

Preparation for the joint clinical assessment: PICO strategy, indirect comparisons and evidence synthesis for the consolidated PICOs, plus preparation of the clinical dossier, aligned with the subsequent national benefit assessment by the G-BA and IQWiG. We manage the large number of consolidated PICOs with tool support – automated feasibility checks and tracking across all PICOs, so that no comparator and no subgroup cut is lost.

Preparation for the joint scientific consultation at EU level: we align evidence and study strategy so that they serve the later JCA, and coordinate them with the expectations of the HTA bodies.

Our Quality Promise

Publication-ready analyses, transparently documented – including AI-assisted steps.

  • Publication Quality

    Every analysis is set up to withstand peer review, whether it is ultimately published, submitted to authorities or used as an internal data source.

  • Transparent Methodology

    Clear analysis protocols, traceable assumptions and open documentation of all data sources and limitations. We document AI-assisted steps transparently and reproducibly – efficiency without compromising auditability.

  • Scientific Standards

    Adherence to the relevant guidelines (Good Epidemiological Practice, CHEERS, PRISMA) and health-economic methodological standards.

Our Offer

The complete evidence and communication package for dossier, negotiation and publication.

We build the clinical and health-economic evidence for your value demonstration, nationally and across Europe. Whether HTA strategy, benefit dossier, indirect comparison, cost-effectiveness model or JCA preparation: we deliver the analyses for your value story, the communication with the G-BA, IQWiG and authorities, and your publications. Through the targeted use of AI we deliver dossiers and assessments faster and more resource-efficiently – with consistent methodological rigour.

Your Added Value

Analyses that land with the G-BA, IQWiG and EU bodies – and can be reused directly.

  • Robust Value Story

    Our analyses give you the benefit values and cost arguments you need for reimbursement dossiers, price negotiations and sales argumentation.

  • Direct Usability

    The results are tailored to your stakeholders, whether the G-BA, IQWiG, EU assessment bodies, health insurers or your own market access department.

  • From Analysis to Publication

    We accompany the entire journey, from analysis planning through evaluation to the finished paper or conference contribution.

From practice

Health economic modelling for NHS market access

For the NHS market entry of a new cartilage cell therapy, LinkCare developed a Markov model over the patient lifetime and proved the cost-effectiveness despite the lack of long-term studies.

View case