How Germany’s Reimbursement System Evaluates Evidence and Cost

Why the G-BA Matters

In Germany, reimbursement decisions begin and end with the Gemeinsamer Bundesausschuss (G-BA) — the Federal Joint Committee responsible for determining which diagnostics, digital health applications (DiGA), medical devices, and pharmaceuticals are funded by the statutory health insurance system (GKV). No new treatment can enter routine care without passing through this highly structured and evidence-driven process. As a result, understanding how the G-BA, IQWiG, and InEK operate is essential for any company seeking reimbursement in Germany.

The G-BA’s influence is visible across all major innovation pathways. The DiGA Fast-Track has already enabled digital therapeutics such as Deprexis (depression) and Vivira (musculoskeletal pain) to achieve national reimbursement within months. Under the AMNOG framework, IQWiG’s assessments of breakthrough oncology medicines like Keytruda and Kymriah directly determine the level of “added benefit” and the pricing corridor available to manufacturers. High-risk medical technologies such as HeartMate 3 and TAVI have reached German patients only after structured evaluation through §137h and NUB routes, aligning clinical benefit with hospital financing under InEK’s DRG system.

At Odelle Technology, we help innovators translate strong clinical science into reimbursable economic value. Our team designs HTA-ready studies and cost-effectiveness models that meet IQWiG and InEK standards, prepares AMNOG, §137h, and NUB submissions, facilitates early G-BA consultations, and develops real-world evidence programmes that demonstrate both patient benefit and system-level cost impact.

This explainer outlines how reimbursement decisions are made in Germany, how the G-BA, IQWiG, and InEK share responsibility for evidence appraisal, and how manufacturers can position their technologies for successful and sustainable market access.

Germany has introduced the most significant hospital reform in two decades. Beginning 1 January 2025, the Krankenhausreform restructures hospitals into service levels and Leistungsgruppen, meaning that reimbursement is no longer determined solely by DRGs or G-BA benefit decisions. Hospitals must now demonstrate structural capability—minimum specialist staffing, equipment, network integration and case volumes—to qualify for specific DRGs. This reform fundamentally reshapes how innovations enter the German market.

A positive G-BA decision is no longer the sole determinant of whether a service can be billed. Under the new service-level and Leistungsgruppen framework, only hospitals that fulfil structural, staffing and volume criteria may perform certain procedures or operate certain specialties. Market access therefore depends on both scientific benefit assessment and hospital qualification.

The structure of the G-BA Plenum and its subcommittees is outlined here.
Named Individuals and Functions (2025)
G-BA Subcommittees & Decision Tracks
IQWiG’s Role and Evidence Standards
Patient Representatives
Reimbursement Pathways & Legal Basis
Consultation & Manufacturer Engagement
Real-World Examples
Comparison with Other EU HTA Bodies
Odelle Technology in the German Ecosystem
FAQ
Glossary
Bibliography & References
Work with Odelle Technology

Structure of the G-BA Plenum and Subcommittees

Nine permanent subcommittees support the G-BA Plenum, which consists of 13 voting members. Together they assess benefit, implementation feasibility, and economic impact within the legal framework of SGB V. The Federal Ministry of Health (BMG) has legal oversight but no vote. The Gemeinsamer Bundesausschuss (G-BA) is Germany’s highest decision-making body for reimbursement and health technology assessment (HTA) under the Social Code Book V (SGB V). Its Plenum consists of 13 voting members, supported by nine permanent subcommittees that evaluate the clinical benefit, implementation feasibility, and economic impact of new medical technologies, diagnostics, and pharmaceuticals.

These subcommittees cover areas such as medical devices, pharmaceuticals, quality assurance, disease management programmes (DMPs), and digital health applications (DiGAs). Their recommendations guide national coverage and pricing decisions across the statutory health insurance (GKV) system.

Although the Federal Ministry of Health (BMG) exercises legal supervision, it holds no voting rights, ensuring that the G-BA remains an independent body representing physicians, hospitals, and statutory insurers.

Voting Members of the Plenum

Stakeholder Group	Members	Votes
Impartial Members	Chair + 2	3
GKV-Spitzenverband (Payers)	5 representatives	5
KBV (Outpatient Physicians)	2 representatives	2
DKG (Hospitals)	2 representatives	2
KZBV (Dentists)	1 representative	1
Patient Representatives	Recognised bodies	No vote

Governance practices include rotating chairs, dual roles across policy/scientific review, and frequent participation by alternates to support rapid appraisals.

Named Individuals and Their Functions (as of 2025)

The Gemeinsamer Bundesausschuss (G-BA) operates under the leadership of experienced healthcare policymakers and representatives from statutory insurers, physicians, hospitals, and dental organisations. These individuals guide the reimbursement and health technology assessment (HTA) process for medical devices, diagnostics, pharmaceuticals, and digital health applications in Germany.

Leadership

Professor Josef Hecken – Chair of the G-BA.
Leads decision-making across key committees, including Arzneimittel (pharmaceuticals), Bedarfsplanung (healthcare planning), and Dental Care. Under his leadership, the G-BA has overseen pivotal AMNOG appraisals, DiGA listings, and high-impact reforms shaping patient access.
Karin Maag is the chair of DMP, ASV, and quality assurance.
Karin Maag is in charge of the Disease Management Programmes (DMPs), Ambulant Specialist Care (ASV), and quality assurance initiatives, which ensure uniform care and performance standards throughout the GKV (statutory health insurance) system.
Dr. med. Bernhard van Treeck – Chair of Methodenbewertung and Psychotherapy.
Dr. med. Bernhard van Treeck oversees the Method Assessment Committee, which assesses the clinical benefit and evidence of new diagnostic and therapeutic procedures, including those submitted under the137h and NUB pathways.

The representatives of the Statutory Health Insurance Funds (GKV-SV) are involved in decision-making processes.)

Oliver Blatt, Stefanie Stoff-Ahnis, Dr. Martin Krasney, Dr. Elke Schöne-Plaumann, and Torsten Wendt.
These payer representatives play a central role in evaluating economic feasibility, cost-effectiveness, and budget impact, ensuring that innovations deliver value within SGB V reimbursement structures.

Physicians and Hospital Representatives

The KBV, or National Association of Statutory Health Insurance Physicians, is responsible for overseeing healthcare decisions.
Dr. Sybille Steiner and Dr. Stephan Hofmeister – represent ambulatory physicians and general practitioners in national reimbursement negotiations.
DKG (German Hospital Federation):
Dr. Gerald Gaß and Professor Dr. Henriette Neumeyer – advocate for hospital inclusion and funding under InEK’s DRG system and NUB evaluations.
KZBV (National Association of Statutory Health Insurance Dentists):
Martin Hendges – represents the dental sector, particularly in quality assurance and service reimbursement frameworks.

Influential Experts and Policy Advisors

Dr. Regina Klakow-Franck – consultant to G-BA and IQWiG, recognised for her leadership in methodological evaluation and quality measurement in healthcare.
Dr. Thomas Müller – liaison from BfArM (Federal Institute for Drugs and Medical Devices) on DiGA approvals and §137h innovations, bridging regulatory and reimbursement processes.
Dr. Matthias Mieves – Member of the Bundestag and noted advocate for digital reimbursement reform, AI integration, and accelerated HTA pathways in Germany.

Together, these leaders form the core network of decision-makers shaping reimbursement, digital health policy, and HTA evaluation in Germany’s healthcare system.

Professor Josef Hecken—Chair—leads decisions in Arzneimittel, Bedarfsplanung, and Dental.
Karin Maag — Chairs DMP, ASV, and Quality Assurance.
Dr med. Bernhard van Treeck — Chairs Methodenbewertung, Psychotherapy.
GKV-SV (payers): Oliver Blatt, Stefanie Stoff-Ahnis, Dr Martin Krasney, Dr Elke Schöne-Plaumann, Torsten Wendt.
KBV: Dr Sybille Steiner, Dr Stephan Hofmeister.
DKG: Dr Gerald Gaß, Professor Dr Henriette Neumeyer.
KZBV: Martin Hendges.
Influential experts: Dr Regina Klakow-Franck (consultant to G-BA/IQWiG), Dr Thomas Müller (BfArM liaison on DiGA/§137h), and Dr Matthias Mieves (Bundestag) (digital reimbursement reform advocate).

G-BA Subcommittees: Domains and Decision Tracks

Subcommittee	Focus	Typical Use
Arzneimittel	AMNOG drug assessments	Added benefit, post-launch price
Methodenbewertung	Non-drug technologies & diagnostics	Imaging, AI tools, biomarkers
Quality Assurance	Clinical performance indicators	Hospitals & specialty clinics
DMP	Disease management programmes	Diabetes, COPD, cancer
ASV	Specialised outpatient care	Oncology, rheumatology
Ordered Services	Tests & referrals	Lab diagnostics, CT/MRI
Needs Planning	Regional workforce planning	GP/specialist ratios
Psychotherapy	Access and models of care	Session length, eligibility
Dental	Dental procedures	Fillings, implants, orthodontics

Learn about the Role of IQWiG — Evidence Authority Under G-BA

The Institute for Quality and Efficiency in Health Care (IQWiG) is Germany’s central evidence-assessment authority supporting the Gemeinsamer Bundesausschuss (G-BA) in decisions on reimbursement and health technology assessment (HTA). IQWiG independently evaluates the benefits of medicines, medical devices, tests, and digital health tools (DiGA) to make sure that only those with clear health benefits and good value for money are paid for by the public health insurance (GKV).

IQWiG applies internationally recognised methods, such as systematic reviews, meta-analyses, and GRADE frameworks, to assess the quality of evidence. For non-drug technologies, the institute often prioritises cost-consequence analysis (CCA) and budget impact analysis (BIA) over full cost-utility analysis (CUA), aligning evaluations with real-world healthcare decision-making.

A key innovation is IQWiG’s “Versorgungsnahe Daten” (real-world data) workstream, which integrates real-world evidence (RWE) into benefit assessments. This approach allows early-stage data from registries, hospital studies, and digital platforms to inform national reimbursement discussions – an increasingly important factor for MedTech and digital health innovators seeking access under §137h, or NUB routes.

IQWiG’s recommendations form the evidence base for G-BA coverage decisions, shaping pricing negotiations and InEK’s hospital reimbursement calculations. Understanding IQWiG’s evaluation principles is therefore essential for any company pursuing reimbursement and market access in Germany.

Patient Representatives: Influence Without Voting Power

How the Patientenvertretung Influences Reimbursement Decisions within the G-BA

In Germany, patient representatives (Patientenvertretung) play a pivotal role in shaping health policy and reimbursement decisions within the Gemeinsamer Bundesausschuss (G-BA)—the federal body governing coverage for medicines, medical devices, and procedures under SGB V §140f.
Supported by BAG SELBSTHILFE, DBR, BAGP, VdK, and vzbv, these representatives participate in G-BA committees with Mitberatungsrecht (advisory rights) but no formal vote.
Through evidence review and agenda proposals, they influence Erstattungsentscheidungen and HTA evaluations, ensuring that patient perspectives inform Germany’s highly structured reimbursement and market-access pathways.

Overview

In Germany, patient representatives (Patientenvertreterinnen und -vertreter) form a legally embedded and highly influential part of the Gemeinsamer Bundesausschuss (G-BA) — the federal body that determines which medical services, pharmaceuticals, diagnostics, medical devices, and digital health applications are reimbursed under SGB V. Although they do not hold formal voting rights, their consultative mandate (Mitberatungsrecht) gives them structured power over agenda setting, evidence interpretation, and benefit-assessment priorities across the entire reimbursement process.

Patient representatives participate directly in AMNOG benefit assessments, §137h medical-device evaluations, DiGA policy discussions, quality-assurance programmes, and care-pathway decisions. Their role is not symbolic: they can propose issues for formal evaluation, request modifications to evidence requirements, highlight unmet needs, and shape the definition of patient-relevant outcomes. This influence is particularly important in rare diseases, oncology, chronic conditions, and digital health, where patient experience and real-world impact often inform the interpretation of clinical data.

By bringing structured patient-centred insights into a highly technical HTA environment, the Patientenvertretung ensures that Germany’s reimbursement decisions balance scientific evidence with lived experience. Their participation strengthens legitimacy, improves the relevance of benefit assessments, and helps align reimbursement policy with the real clinical pathways encountered by patients and caregivers.

Legal Basis and Structure

The role of patient representatives is legally anchored in SGB V § 140f and the Patientenbeteiligungsverordnung (PatBeteiligungsV – Patient Involvement Ordinance), which formalise patient participation in federal health-care governance.
Under these provisions, recognised national advocacy organisations—including BAG SELBSTHILFE, DBR, BAGP, VdK, and vzbv—are authorised to nominate representatives (Patientenvertreterinnen und -vertreter) to the Gemeinsamer Bundesausschuss (G-BA).

These representatives may

Attend G-BA plenary and committee meetings,
Submit petitions and agenda items (Antragsrecht), and
Contribute to deliberations (Mitberatungsrecht).

Although they do not possess voting rights, the G-BA is legally required to record their written and oral positions in the official reasoning of its decisions (G-BA-Beschlüsse).
This ensures that the patient perspective is systematically reflected in every benefit assessment and reimbursement ruling made within Germany’s statutory health-insurance framework.

Recognised National Patient Organisations

Four major umbrella organisations hold official nomination rights and coordinate patient representation at the federal level:

Organisation	Full Name & Description	Website
BAG SELBSTHILFE e.V.	Bundesarbeitsgemeinschaft Selbsthilfe von Menschen mit Behinderung, chronischer Erkrankung und ihren Angehörigen — Represents more than 120 national self-help groups for people with disabilities and chronic illnesses.	bag-selbsthilfe.de
BAGP	Bundesarbeitsgemeinschaft der PatientInnenstellen und -Initiativen — Umbrella association for patient advice and representation groups in Germany.	de.wikipedia.org/wiki/BAGP
DBR	Deutscher Behindertenrat — The German Disability Council, representing people with disabilities and chronic diseases.	g-ba.de
vzbv	Verbraucherzentrale Bundesverband — The Federation of German Consumer Organisations, representing consumer and patient interests.	patientenvertretung.g-ba.de

Additional representation often comes from Sozialverband VdK Deutschland (VdK) and the Sozialverband Deutschland (SoVD), both active in social and health policy advocacy.

How Patient Representation Works in Practice

Nomination and Coordination

Representatives are nominated by their umbrella organisations and coordinated through the Koordinierungsausschuss der Patientenvertretung, a central committee that manages representation across all G-BA working groups.

The Stabsstelle Patientenbeteiligung (Patient Involvement Support Office) at the G-BA provides administrative and technical support to ensure continuity, expertise, and training.

Rights and Responsibilities

Although they cannot vote, patient representatives have several formal rights:

Mitberatungsrecht — the right to speak, deliberate, and influence discussions.
Antragsrecht—the right to propose topics, such as the inclusion of rare diseases, digital diagnostics, or new care pathways.
Stellungnahmerecht — the right to submit formal written opinions, which must be summarised in the G-BA’s final documentation.

Their active involvement spans areas such as benefit assessments (Nutzenbewertung), quality assurance, disease management programmes, and hospital planning decisions.

Influence Without a Vote

Even without formal voting power, patient representatives play a decisive agenda-setting and framing role. They:

Propose new issues for discussion, e.g., access to rare disease treatments, inclusion of new IVDs, or chronic illness pathways.
Shape deliberations by introducing patient-relevant outcomes such as quality of life, adherence, or burden of disease.
Ensure transparency by requiring that their perspectives are reflected in G-BA documentation.
Build alliances with scientific societies, advocacy networks, and self-help groups to generate supporting evidence or petitions.
Mobilise public awareness, particularly in cases where G-BA decisions affect vulnerable or under-represented patient groups.

A practical example includes patient groups’ contribution to prostate cancer early-detection discussions and the inclusion of rare diseases in care pathway evaluations.

Key Limitations

No Voting Rights: They cannot influence final votes in the G-BA plenum or subcommittees.
Limited Resources: Patient advocacy organisations often lack the research capacity of statutory insurers or medical associations.
Procedural Restrictions: Their role focuses on consultation rather than negotiation of tariffs or reimbursement rates.
Dependency on Coordination: The efficiency of representation depends on collaboration between multiple umbrella bodies and the support office.

Milestones in German Patient Representation

Year	Event
2004	Formal introduction of patient representation in the G-BA following reforms to SGB V.
2008	Establishment of the Stabsstelle Patientenbeteiligung at the G-BA.
2012–2015	Patient representatives participate in early benefit assessments (Nutzenbewertung) for medical devices under §137h.
2020–2025	Growing role in digital health evaluation (DiGA), AMR policy, and rare disease access discussions.

Collaboration Opportunities for Industry and Stakeholders

For MedTech, diagnostics, and digital health innovators aiming to enter the German market, patient representation is a strategic partner rather than a barrier.

Practical collaboration strategies:

Engage early with BAG SELBSTHILFE or DBR to ensure patient-centred evidence.
Include patient perspectives in submissions to the G-BA or IQWiG.
Align clinical and real-world evidence with patient-relevant outcomes.
Support patient organisations in data collection, awareness, and health literacy initiatives.
Co-develop educational material for patients and carers on new technologies.

These partnerships not only enhance acceptance but can strengthen dossiers for reimbursement, NUB applications, or §137e coverage-with-evidence-development pathways.

Deliberative Democracy and Patient Influence in the G-BA

Germany’s patient representation framework (Patientenvertretung im G-BA) exemplifies deliberative democracy in healthcare decision-making.
Although patient representatives lack formal voting rights, they wield substantive influence through agenda-setting, evidence interpretation, and coalition-building with clinicians, payers, and policymakers.
Their involvement ensures that patient-centred values and lived experience inform an otherwise highly technical, evidence-driven reimbursement system governed by the Gemeinsamer Bundesausschuss (G-BA).

For innovators and policymakers, engagement with the Patientenvertretung is critical for understanding Germany’s reimbursement and health-technology-assessment (HTA) landscape, from AMNOG drug appraisals to § 137h SGB V medical-device evaluations and DiGA digital-health listings.

Reimbursement Pathways and the G-BA’s Legal Role

Pathway	G-BA Function	Key Legal Basis (SGB V / KHEntgG)
AMNOG (Arzneimittel-Nutzenbewertung)	Conducts benefit assessment after EMA approval and issues guidance on added benefit (Zusatznutzen)	§ 35a SGB V
§ 137h HTA (MedTech)	Performs early evaluation of high-risk medical devices used in hospitals	§ 137h SGB V
NUB Payments (Neue Untersuchungs- und Behandlungsmethoden)	Enables temporary inpatient reimbursement through DRG add-on payments	§ 6 KHEntgG
DiGA Apps (Digitale Gesundheitsanwendungen)	Provides indirect oversight; BfArM lists the app, while the GKV-Spitzenverband negotiates reimbursement	§ 139e SGB V

Clarifying DiGA Pricing and Coverage

The G-BA does not determine DiGA prices — responsibility lies with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds).
After a BfArM listing, reimbursement depends on evidence of population-level benefit and sustained clinical effect.
Several apps have faced €0 reimbursement decisions where insurers judged benefits insufficient — notably HelloBetter Stress and M-Sense Migraine — while others, such as Zanadio, achieved partial or conditional coverage.
This underscores how robust real-world evidence (RWE) and economic durability are now decisive for digital-health market access in Germany. Why It Matters

Germany’s patient representation framework embodies deliberative democracy in healthcare. While patient representatives lack formal votes, they hold substantive power through agenda control, moral authority, and alliance-building with policymakers and clinicians.

For innovators and policymakers alike, the Patientenvertretung im G-BA remains a vital forum for embedding patient-centred values into an evidence-driven reimbursement system.

Public Consultation and Manufacturer Interaction

Submit formal dossiers (AMNOG, §137h, method assessments).
Participate in oral hearings, and respond to draft consultations.
Request early scientific advice with IQWiG (Beratungsgespräche).
Engage G-BA subcommittees during evidence planning to align outcomes and comparators early.

Real-World Examples

✅ PET oncology tracer integrated into DMPs following positive benefit rationale and payer alignment.
❌ The AI ECG triage tool was rejected under Methodenbewertung for lack of comparative effectiveness.
⚖️ BfArM-listed DiGAs are assigned €0 value where payer thresholds are unmet (effect size/durability, system impact).

Comparison with Other EU HTA Bodies

Country	HTA Body	Leadership	Binding?	Scope
Germany	G-BA	Payer + clinical stakeholders	✅ Yes	Full system
France	HAS + CEESP	State-led	✅ Yes	HTA + pricing
UK	NICE	Independent + NHS input	⚪ Partial	Guidance
Netherlands	ZIN	State body	✅ Yes	Cost-effectiveness driven

Odelle Technology in the German Healthcare Ecosystem

The new Leistungsgruppen model reshapes the adoption pathway for innovative technologies. Hospitals will increasingly invest in tools that strengthen their structural capability and help them secure their service-level designation. Smaller hospitals may lose access to higher-complexity DRGs, while tertiary centres consolidate specialised care. For innovators, market access strategies must now identify which service levels will deliver the relevant procedures in future, and position the technology as a means of supporting structural qualification—staff efficiency, clinical quality, diagnostic accuracy, or minimum volume attainment.

Odelle Technology supports MedTech, diagnostic, and digital-health innovators in Germany through structured reimbursement and evidence-generation programmes aligned with the G-BA, IQWiG, InEK, GKV-Spitzenverband, and regional provider and payer networks. Our approach integrates scientific methodology, policy literacy, and health-economic analysis to meet the expectations of Germany’s evidence-based healthcare system.

Reimbursement Pathway Analysis

Odelle maps the complete regulatory and reimbursement continuum from AMNOG and §137h early-benefit assessments to NUB, OPS/EBM coding, and selective contracting (§140a). We also analyse hybrid-DRG and outpatient-care integration pathways in collaboration with university hospitals and Kassenärztliche Vereinigungen (KV) to identify where innovations can be adopted under current SGB V frameworks.

Health-Economic Modelling

Our teams design IQWiG-conformant cost-consequence and budget-impact analyses, supported by scenario-based sensitivity modelling. Where appropriate, real-world utilisation data from hospital DRG records, claims databases, and disease-specific registries (e.g., AOK, InGef, BARMER, DZIF, and RKI) is incorporated to contextualise national budget implications.

Evidence Generation and RWE Integration

We structure real-world evidence (RWE) studies and post-introduction monitoring programs that complement G-BA expectations for Versorgungsnahe Data. Designs include prospective registry studies, patient-reported outcome (PRO) and experience (PREM) assessments, and observational pilots conducted with academic research networks such as DZHK, DZIF, and leading university hospitals (Charité, LMU, and Heidelberg).

Digital Health and DiGA Evaluation

For digital technologies, Odelle develops DiGA and DiPA dossiers, combining usage analytics, adherence data, and quality-of-life outcomes to support evidence-based price negotiations with the GKV-Spitzenverband. Our methodology aligns with BfArM evidence requirements and IQWiG’s digital-health appraisal standards.

Stakeholder and Patient-Centred Collaboration

Odelle facilitates structured dialogue with payer representatives, clinical societies, and patient organisations to ensure that outcome measures and endpoints reflect patient relevance and societal value. Engagement spans early scientific advice meetings, hearing preparations, and multi-stakeholder evidence workshops integrating clinicians, economists, and patient advocates.

Selected partners and institutions we collaborate with:

InEK – Institut für das Entgeltsystem im Krankenhaus (NUB/DRG and costing guidance)
BVMed (MedTech policy & reimbursement workstreams)
Charité – Universitätsmedizin Berlin (clinical and RWE collaboration)
Universitätsklinikum Freiburg (pilot implementation & evidence)
Regional Kassenärztliche Vereinigungen (KV) for outpatient integration and coding

Internal resources you may find helpful:

Contact Odelle Technology to discuss your Germany market-access plan.

FAQ – G-BA, IQWiG, and Market Access in Germany

What is the G-BA?

The Gemeinsamer Bundesausschuss (G-BA) is Germany’s Federal Joint Committee, the highest decision-making body in healthcare. It determines which medical devices, diagnostics, pharmaceuticals, and digital health applications (DiGA) are reimbursed by the statutory health insurance (GKV) under Social Code Book V (SGB V). Its resolutions are legally binding for all sickness funds and shape national coverage, coding, and tariff inclusion.

🔹 How does IQWiG influence G-BA decisions?

The Institute for Quality and Efficiency in Health Care (IQWiG) provides independent scientific assessments that underpin most G-BA reimbursement decisions. Using systematic reviews, GRADE methodology, and health-economic analyses, IQWiG evaluates clinical benefit, patient relevance, and economic impact. For non-drug technologies, IQWiG often emphasises cost-consequence analysis (CCA) and budget-impact analysis (BIA) rather than full cost-utility analysis (CUA). Its findings directly inform G-BA benefit appraisals, AMNOG pricing negotiations, and InEK DRG adjustments.

🔹 Can DiGA apps be reimbursed automatically after BfArM listing?

Not automatically. A BfArM listing on the DiGA directory is a prerequisite for national access, but reimbursement depends on demonstrated benefit. After listing, the GKV-Spitzenverband (GKV-SV) negotiates pricing based on evidence of improved health outcomes, usability, and data protection. Without sufficient evidence, DiGA products may receive a temporary listing or a €0 tariff, pending new data from real-world evidence (RWE) studies.

🔹 What role does InEK play in reimbursement?

The Institut für das Entgeltsystem im Krankenhaus (InEK) defines Diagnosis-Related Groups (DRG) and supplementary payments (ZE/NUB) for hospital-based innovations. Manufacturers must apply for a NUB (Neue Untersuchungs- und Behandlungsmethoden) to obtain temporary reimbursement while evidence is generated. InEK’s calculations integrate clinical cost data, length-of-stay metrics, and coding structures (OPS) to ensure new technologies are appropriately financed within the hospital system.

🔹 What are §137h and §140a pathways?

Under §137h SGB V, new high-risk medical devices must undergo an early benefit assessment before routine reimbursement. Evidence demonstrating patient benefit and safety is essential.
The §140a framework allows selective contracts between manufacturers, insurers, and hospitals or regional Kassenärztliche Vereinigungen (KV) for innovative care models. These pathways can accelerate access while real-world data and patient-reported outcomes (PROs) are collected.

🔹 How can Odelle Technology help with G-BA submissions?

Odelle Technology supports innovators through the full German HTA and reimbursement lifecycle.
We:

Align clinical and economic evidence with IQWiG’s Methodenpapier and G-BA procedural rules.
Design RWE and PRO endpoints relevant to patient benefit and cost-effectiveness.
Prepare AMNOG, §137h, NUB, and DiGA dossiers that meet methodological and payer expectations.
Facilitate early scientific advice with G-BA, IQWiG, and InEK.
Model budget-impact and cost-consequence analyses to inform negotiations with the GKV-SV.

🔹 Does Odelle work with German partners?

Yes. We collaborate with InEK, BVMed, Charité Universitätsmedizin Berlin, Universitätsklinikum Freiburg, LMU Munich, and regional KVs to align outpatient and inpatient evidence generation. Odelle also engages with patient organisations, real-world data consortia (InGef, AOK, RKI, DZIF), and clinical research networks (DZHK, NAPKON) to ensure that real-world evidence (RWE) and patient-reported outcomes (PROs) meet both scientific and payer standards.

🔹 How important is real-world evidence (RWE) for reimbursement in Germany?

Increasingly crucial. The G-BA and IQWiG now recognise Versorgungsnahe Daten (real-world data) as complementary to clinical trial evidence. RWE can demonstrate long-term effectiveness, adherence, cost savings, and quality-of-life improvements — key criteria for ongoing reimbursement and price renegotiation.

🔹 How do patient organisations influence G-BA decisions?

Patient representatives participate in G-BA subcommittees and contribute to defining patient-relevant endpoints and quality-of-life metrics. Their input strengthens the social and ethical legitimacy of reimbursement decisions, especially for chronic diseases, rare conditions, and digital self-management tools.

🔹 How does Odelle integrate patient and payer perspectives?

Our evidence frameworks combine clinical trial data, RWE, and PRO/PREM instruments to demonstrate both clinical utility and societal value. We align analyses with GKV budget priorities, ensuring that technologies deliver measurable improvements in outcomes, resource use, and workforce efficiency.

SEO Meta Description (155 chars)

Germany HTA FAQs: Learn how G-BA, IQWiG, and InEK decide reimbursement, how DiGA apps qualify, and how Odelle supports RWE and evidence generation.

Glossary of Key Terms

G-BA — Gemeinsamer Bundesausschuss (Federal Joint Committee)

The G-BA is Germany’s highest decision-making body in healthcare. It decides which medical treatments—like medicines, tests, digital health apps, and medical devices—are paid for by the public health insurance under Social Code Book V.
The G-BA comprises representatives from physicians (KBV), hospitals (DKG), insurers (GKV-SV), and dentists (KZBV), with oversight from the Federal Ministry of Health (BMG). Its resolutions on benefit, quality, and efficiency are legally binding and shape national reimbursement, coding, and care-delivery frameworks.

IQWiG — Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen

The Institute for Quality and Efficiency in Health Care (IQWiG) performs independent evidence assessments that underpin G-BA decisions. Using systematic reviews, meta-analyses, GRADE methodology, and health-economic modelling, IQWiG evaluates clinical benefits, patient relevance, and cost-effectiveness.
For non-drug technologies and digital health, IQWiG frequently applies cost-consequence analysis (CCA) and budget-impact analysis (BIA) instead of full cost-utility analysis (CUA). Its dedicated “Versorgungsnahe Daten” workstream enables integration of real-world evidence (RWE) and patient-reported outcomes (PROs) into national assessments.

AMNOG — Arzneimittelmarkt-Neuordnungsgesetz (Pharmaceutical Market Reorganisation Act)

The AMNOG framework governs the early benefit assessment and pricing of pharmaceuticals in Germany. IQWiG assesses newly approved drugs for added clinical benefit compared to standard therapy.
The G-BA assigns a final benefit rating that guides the price negotiations between the manufacturer and the GKV-Spitzenverband. Drugs without demonstrated additional benefit revert to reference pricing. The process ensures that pharmaceutical expenditure aligns with patient benefit and economic sustainability.

§137h: SGB V— Early Evaluation of High-Risk Medical Devices

Section 137h of SGB V requires an early benefit assessment of high-risk Class III medical devices and implantable devices before they can be reimbursed in hospitals.
Manufacturers must submit clinical and economic evidence showing measurable patient benefit. The G-BA, with support from IQWiG, decides whether provisional or full reimbursement is justified. This pathway parallels AMNOG for MedTech innovations and helps control clinical and financial risk while evidence matures.

NUB — Neue Untersuchungs- und Behandlungsmethoden (New Diagnostic and Treatment Methods)

The NUB process, managed by InEK, allows hospitals to apply for temporary DRG supplements (Zusatzentgelte, ZE) for innovative procedures not yet reflected in the DRG catalogue.
Manufacturers and hospitals submit annual NUB Anträge describing clinical benefits, costs, and utilisation. Approved NUB codes enable temporary reimbursement while data collection continues, often forming the bridge to permanent DRG integration or §137h evaluation.

InEK— Institut für das Entgeltsystem im Krankenhaus (Institute for the Hospital Reimbursement System)

InEK develops and maintains the German DRG (Diagnosis-Related Group) system and evaluates hospital cost data for new medical procedures. It reviews NUB applications, sets supplementary payment levels (ZE), and determines OPS coding alignment for novel diagnostics and implants.
InEK collaborates with G-BA and IQWiG to ensure that reimbursement reflects both clinical evidence and economic transparency, making it a key authority in hospital-based market access.

DiGA — Digitale Gesundheitsanwendungen (Digital Health Applications)

DiGA are certified digital medical apps listed by the Federal Institute for Drugs and Medical Devices (BfArM) under the Digital Healthcare Act (DVG).
To qualify, a DiGA must demonstrate positive healthcare effects—either medical benefit or structural/care improvements—through clinical studies or real-world data.
Once listed, statutory insurers (GKV-SV) negotiate pricing with the manufacturer. Lack of proven benefit can result in temporary listing or €0 reimbursement, pending further evidence generation.

SGB V—Socialgesetzbuch V (Social Code Book V)

SGB V provides the legal foundation for statutory health insurance (GKV) in Germany. It defines coverage principles, reimbursement procedures, and cost-containment rules for pharmaceuticals, medical devices, and healthcare services.
Sections such as §137h (device evaluation), §140a (selective contracts), and §35a (AMNOG) form the core legal basis for HTA and evidence-based reimbursement within the German healthcare system.

GKV-Spitzenverband—National Association of Statutory Health Insurance Funds.

The GKV-Spitzenverband (GKV-SV) represents all statutory health insurers at the federal level. It negotiates prices, contracts, and reimbursement terms with manufacturers following G-BA assessments.
For pharmaceuticals (AMNOG) and digital health (DiGA/DiPA), the GKV-SV plays a pivotal role in value-based pricing discussions, determining whether new technologies are funded within national insurance budgets.

EBM / OPS — Einheitlicher Bewertungsmaßstab / Operationen- und Prozedurenschlüssel

The EBM is the outpatient fee schedule defining how physicians are reimbursed by the GKV for ambulatory services.
The OPS coding system, managed by InEK and DIMDI/BfArM, classifies inpatient procedures and serves as the basis for DRG cost calculations.
Proper alignment of new technologies within EBM (ambulatory) and OPS (inpatient) coding is essential for obtaining sustainable reimbursement and accurate hospital funding.

§140a SGB V — Selective Contracting and Integrated Care

Section 140a enables direct reimbursement agreements between insurers, hospitals, and providers for innovative treatments or integrated-care models.
These selective contracts can bypass national HTA delays, allowing faster patient access while collecting real-world evidence (RWE) and patient-reported outcomes (PROs) for later G-BA revi

Bibliography & References

Key References and Official Resources – German HTA and Reimbursement

1. Gemeinsamer Bundesausschuss (G-BA) – Federal Joint Committee

Official website: https://www.g-ba.de
Germany’s highest decision-making body for healthcare reimbursement under the statutory insurance system (GKV). Contains current benefit assessments, subcommittee minutes, and resolutions related to pharmaceuticals, MedTech, and DiGA applications.
Keywords: G-BA reimbursement decisions, HTA Germany, SGB V, benefit assessment, AMNOG.

2. IQWiG – Institute for Quality and Efficiency in Health Care

Official website: https://www.iqwig.de
The evidence authority supporting the G-BA through systematic reviews, meta-analyses, and health-economic evaluations. Publishes scientific dossiers, methodological updates, and current benefit assessment reports for drugs and non-drug interventions.
Keywords: IQWiG methods, health economic modelling, cost-consequence analysis, GRADE, RWE Germany.

3. IQWiG Methodenpapier Version 6.1 (2024)

Full text (German): IQWiG Methods Paper v6.1 – 2024
Defines IQWiG’s methodological framework for evidence appraisal and economic evaluation, including requirements for real-world evidence (Versorgungsnahe Daten) and patient-relevant endpoints. Essential reference for dossier preparation aligned with G-BA expectations.
Keywords: IQWiG Methodenpapier 6.1, HTA methodology Germany, RWE inclusion, PRO standards.

4. IQWiG – Real-World Evidence (RWE) Position Paper

Title: Versorgungsnahe Daten: Nutzenbewertung auf Basis realer Versorgungsdaten
Outlines how IQWiG integrates real-world data (RWD) and registry-based evidence into benefit assessments. Explains data quality criteria, bias control, and linkage to German healthcare data sources (InGef, AOK, RKI, DZIF).
Keywords: real-world evidence Germany, IQWiG RWE guidance, Versorgungsnahe Daten, registry studies.

5. Sozialgesetzbuch V (SGB V) – Social Code Book V

Official legal text: https://www.gesetze-im-internet.de/sgb_5
The legal foundation of statutory health insurance in Germany. Key sections:

§35a – AMNOG pharmaceutical assessment
§137h – Early evaluation of high-risk medical devices
§140a – Selective contracting for integrated care models
Keywords: SGB V reimbursement law, German HTA regulation, statutory health insurance framework.

6. BfArM – Federal Institute for Drugs and Medical Devices / DiGA Directory

Official DiGA Directory: https://diga.bfarm.de
Managed by BfArM, this directory lists all approved Digitale Gesundheitsanwendungen (DiGA), including clinical evidence, indication, and pricing status. Includes guidance on DiGA and DiPA dossier preparation under the Digital Healthcare Act (DVG).
Keywords: DiGA Germany, BfArM listing, digital health reimbursement, DVG, digital therapeutics.

7. GKV-Spitzenverband – National Association of Statutory Health Insurance Funds

Website: https://www.gkv-spitzenverband.de
Represents all statutory insurers at the national level and conducts price negotiations with manufacturers following G-BA assessments. Publishes frameworks for value-based pricing, contract templates, and DiGA/AMNOG negotiations.
Keywords: GKV-SV price negotiation, AMNOG framework, DiGA pricing Germany, value-based healthcare.

8. InEK – Institut für das Entgeltsystem im Krankenhaus (DRG / NUB)

Website: https://www.g-drg.de
Responsible for the German DRG reimbursement system and NUB (Neue Untersuchungs- und Behandlungsmethoden) evaluations. Provides tools for DRG cost calculations, ZE (Zusatzentgelt) listings, and OPS code updates.
Keywords: InEK Germany, DRG costing, NUB application, hospital reimbursement, health economics.

9. AMNOG – Early Benefit Assessment Resources

Overview: https://www.bfarm.de/EN/Drugs/benefitAssessment/_node.html
Explains the AMNOG process for evaluating new pharmaceuticals. Includes timelines, dossier structure, IQWiG/G-BA assessment interaction, and guidance for evidence submission.
Keywords: AMNOG Germany, pharmaceutical pricing, HTA process, added benefit evaluation.

10. BVMed – Bundesverband Medizintechnologie e.V.

Website: https://www.bvmed.de
Industry association providing guidance on MedTech reimbursement, NUB submissions, §137h pathways, and DiGA integration. BVMed also hosts policy updates on EU HTA Regulation 2021/2282 and German digital-health adoption.
Keywords: MedTech Germany, BVMed, device reimbursement, §137h, HTA regulation.

11. Deutsches Netzwerk Versorgungsforschung (DNVF)

Website: https://www.dnvf.de
National network promoting real-world evidence (RWE), patient-centred outcomes research, and registry integration in Germany. Their frameworks inform IQWiG and G-BA expectations for Versorgungsnahe Daten.
Keywords: RWE Germany, outcomes research, DNVF, PRO integration, evidence generation.

12. European HTA Regulation (EU 2021/2282) – Cross-Border Alignment

Official Text: https://eur-lex.europa.eu/eli/reg/2021/2282/oj
Sets the foundation for Joint Clinical Assessments (JCA) across EU Member States from 2025 onward. Defines data submission formats, evidence requirements, and interaction between EU HTA bodies and national authorities such as G-BA and IQWiG.
Keywords: EU HTA Regulation, JCA 2025, cross-border reimbursement, evidence submission, European HTA.

How to Influence Reimbursement Decision-making