prmaconsulting™
Pricing, reimbursement and market access consulting
AMNOG
The German healthcare market is the largest in Europe and one of the biggest worldwide – and it is one of the most multilayered and complicated. The new AMNOG legislation has dramatically increased market access hurdles and uncertainties for pharmaceutical companies. Furthermore, for many companies, there is a significant language barrier, as little reliable information is available in English.
The German drug regulation pathway under AMNOG
G-BA scientific advice
The manufacturer can ask for an advice meeting with the G-BA to discuss:
- the code of practice in general
- documents that are acceptable for submission
- studies relevant to assess the benefit of the pharmaceutical
- compilation of dossier documents The "appropriate comparative therapy" (ACT).
This advice meeting can take place any time (e.g. before start of Phase 2 clinical development).
The meeting will take place within 8 weeks of the application document being submitted. (The application form and details of the literature/evidence that will be essential to the discussion can be downloaded from the G-BA website.
The cost for these advice meetings is generally €2,000–10,000; depending on the level of detail required, up to a maximum of €20,000 for extensive advice.
- The application form for the advice meeting needs to specifically state the questions that the manufacturer wants to discuss – in German.
- The G-BA provides a protocol for the meeting.
- The meeting will not involve analysis of the data to be included in the dossier!
- The advice given is not legally binding; however, the manufacturer can negotiate individual agreements with the G-BA.
- The meeting will be held in German. A professional interpreter can be present but must be paid for by the manufacturer.
- The manufacturer can request attendance of representatives of the BfArM and PEI. Any fees charged for these attendees by their respective organizations are charged to the manufacturer.
The AMNOG dossier
Must be written in German (with the exception of Module 5).
Must contain the following information:
- registered indication
- medical benefit
- additional medical benefit vs ACT (the technical term "additional" benefit does not apply because of differences in the aim of and techniques applying to assessment)
- number of patients and patient subgroups for which there is a meaningful additional therapeutic benefit
- cost of therapy to the SHI
- requirement for quality-assured implementation.
Separate chapters are required for each indication included on the label. First- and second-line treatments require separated lines of argument.
Must show that the new drug or new indication demonstrates specific additional benefits vs the ACT.
- Does it treat a disease comparatively better than current treatments?
- Can an accelerated healing process be expected?
- Can adverse events be prevented?
- Will the new drug significantly improve patients' quality of life?
The dossier must also included:
- Requirements for quality-assured use (specialist care only, second opinion, etc.) must be presented.
- All clinical trials from Phase 1 onwards conducted with the drug for this indication must be included, irrespective of sponsorship!
- For a drug that has been marketed anywhere in the world for 12 months or more before the date of dossier submission, a mandatory systematic literature review (Embase/Medline/Cochrane databases) is required. This is also required when indirect comparisons are used in the dossier.
- Mandatory forms are to be used for all evidence and argumentations.
- Formatting and electronic file name formats are predefined.
- In the case of indirect comparisons for a new oncology product, a meta-analysis has to be performed in accordance with IQWiG's publication dated 28 February 2011.
The AMNOG dossier modules
Module 1
- Administrative information
- Summary of statements in the dossier
Module 2
- General information on the drug
- Approved indications in the label
Module 3
- ACT
- Number of patients where additional benefit would be relevant
- Cost of therapy to the SHI
- Requirements for quality-assured use
Module 4
- Systematic overview of clinical benefit and additional clinical benefit (description of methodology and results)
- Description of patient groups where additional benefit would be therapeutically relevant
Module 5
- Full-text version of referenced sources
- Reference list of all quoted sources in Research Information System format (RIS file)
- All manufacturer's study reports
- Essential clinical submission files (Common Technical Document)
- Assessment report of the Clinical Review Board
- Checklist to assess completeness
Assessment of additional benefit
| Extent of additional benefit | Therapeutic significance in terms of §5 (7) Verfahrensordung | Definition of therapy-relevant benefit [§3 (1) Verfahrens-ordnung] |
| Major | Lasting major improvement in therapy-relevant benefit compared with the ACT, particularly:
|
The benefit of a pharmaceutical is the patient-relevant, therapeutic effect, particularly with regard to:
|
| Important | Significant improvement in the therapy-relevant benefit compared with the ACT, particularly:
|
|
| Slight | Moderate and not just minor improvement in the therapy-relevant benefit compared with ACT, particularly:
|
|
| Additional but not quantifiable | Scientific data basis does not allow such quantification | |
| None proven | ||
| Less than with ACT |
The PRMA Consulting team includes native German experts with in-depth knowledge of the German healthcare system who have already run successful workshops on AMNOG for national and international audiences.
For more information email our AMNOG experts or call +44 (0) 1252 786284.
Are you prepared for the new market access regulations in Germany?
Join our webinar
PRMA Consulting is delighted to announce a three-part modular webinar, to be presented in English, covering the German healthcare system and the impact of the AMNOG legislation.
Each session consists of a 1 hour presentation followed by 30 minutes for questions and discussion. The sessions are presented by native German experts with in-depth knowledge of the German healthcare system who have already run successful workshops on AMNOG for national and international audiences.
Find out more about the AMNOG webinar
Rheinischer Kongress für Versorgungsforschung
am 28. und 29.09.2011 in Düsseldorf
PRMA Director, Dr Andreas Guhl will be leading a conference workshop on AMNOG with Germany's top payors on 28 and 29 September 2011 in Düsseldorf.
Download the program of events
