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Market Access with IQWiG: Your Guide to Germany’s Health Technology Assessment

The Institute for Quality and Efficiency in Health Care (IQWiG) is an independent German agency responsible for evaluating the benefits and harms of medical interventions for patients. Established in 2004, IQWiG plays a crucial role in assessing medical treatments, including drugs, non-drug interventions, diagnostic tests, and screening methods. Its evaluations inform decisions on which services are covered by statutory health insurance, directly impacting market access for healthcare products in Germany.

Core Functions of IQWiG

IQWiG’s primary responsibilities include:
  •     Assessment of Medical Interventions: Evaluating the benefits and harms of medical interventions, such as drugs and surgical procedures, to determine their efficacy and safety for patients.
  •     Health Information Dissemination: Providing easily understandable health information to the public, helping patients make informed decisions about examination and treatment methods.
  •     Evidence-Based Reporting: Producing independent, evidence-based reports on various medical topics, including diagnostic tests and disease management programs.

Leadership and Key Contacts

As of January 2025, IQWiG is led by Director Dr. Thomas Kaiser, who oversees the organization’s strategic initiatives and operations. Deputy Director is Dr. Michaela Eikermann. The Drug Assessment Department is led by Dr. Beate Wieseler.

Contact Details for IQWiG

Website: https://www.iqwig.de/ Address: Institute for Quality and Efficiency in Health Care (IQWiG) Siegburger Str. 237 50679 Cologne, Germany

Challenges in Working with IQWiG

Engaging with IQWiG involves:
  •     Understanding Assessment Processes: Familiarity with IQWiG’s evaluation criteria and submission requirements is crucial for successful market access. This includes the IQWiG General Methods (Allgemeine Methoden).
  •     Timely and Accurate Submissions: Ensuring that all necessary documentation is complete and submitted promptly to facilitate the evaluation process.
  •     Stakeholder Collaboration: Working effectively with various healthcare stakeholders in Germany to align with IQWiG’s guidelines and recommendations.
Successful collaboration with IQWiG can lead to efficient market entry and favorable reimbursement outcomes in Germany.

Opportunities / Solutions with Justin Stindt Consultants

Justin Stindt IQWiG expertise ensures:
  •     Expert Consultant IQWiG Submissions: Creating high-quality submissions for assessments and evaluations.
  •     Market Access IQWiG Strategies: Proven methods for optimizing reimbursement outcomes.
  •     Specialist IQWiG Processes: In-depth knowledge of German health technology assessment procedures to accelerate approvals.
  •     IQWiG Consultants Support: Our team provides expert guidance on navigating the complexities of IQWiG assessments and market access strategies.
Justin Stindt Consultants specializes in helping clients prepare effective submissions and engage confidently with IQWiG evaluations.

Case Study: A Pharmaceutical Company’s Success with IQWiG

A pharmaceutical company sought our assistance to obtain a favorable assessment for a novel therapy in Germany. We guided them in preparing a comprehensive AMNOG dossier that addressed IQWiG’s and G-BA’s evaluation criteria. Our strategic approach led to a positive IQWIG opinion, enabling the therapy’s favourable assessment by the G-BA and subsequent pricing negotiations.

Case Studies

A Pharmaceutical Company’s Success with IQWiG

Challenge:
A pharmaceutical company sought our assistance to obtain a favorable assessment for a novel therapy in Germany.

Solution:
We guided them in preparing a comprehensive AMNOG dossier that addressed IQWiG’s and G-BA’s evaluation criteria.

Outcome:
Our strategic approach led to a positive IQWIG opinion, enabling the therapy’s favourable assessment by the G-BA and subsequent pricing negotiations.

Need support with IQWiG market access? Justin Stindt Consultants has the expertise to help you succeed.

Contact us today to discuss your market access strategy and ensure your success with IQWiG.