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Figure 1
The introduction of a mandatory benefit assessment process in early 2011 the Act
Benefit assessment
Commission
possible
Dossier
Manufacturer
Market launch
on the Reform of the Market for Medicinal Products (AMNOG) radically changed the
Report
Hearing
Federal Joint
Committee (GBA)
Benefit
assessment
(internet
publication)
Additional
benefit
Federal Joint
Committee (GBA)
Benefit
assessment
(Decision)
No additional
benefit
Manufacturers
price
(set freely)
Market launch
FRP
reference
price
3 months
Figure 2
Reference price
not possible
6 months
No
agreement
Manufacturer
Head association
of the
SHI scheme
(GKV)
Arbitration Panel
Rebate negotiations
Agreement
Discounted
net price
Retroactive
market access environment for products with a new active ingredient in Germany. The
Not
accepted
act created new requirements for comparator-driven evidence in clinical trials and
Decision
(e.g. based
on international
prices)
Institute for
Quality
and Efficiency in
Health Care
Cost/benefit
assessment
Decision
Decision
Discounted
net price
although the focus has so far been on new products, the law also covers products
already on the market, opening up the possibility of cuts to the reimbursed prices
of both new and existing products. Following publication of the first early benefit
assessments in January 2012, IMS Consulting Groups Justus Dehnen and Michael
12 months
15 months
No additional benefit
Additional benefit
Schmoeller review the results and present the key learnings to date.
THE AMNOG LAW
three months.
Additional benefit
stays unchanged.
TM
On the basis of the evaluations to date, it is possible to draw seven early learnings on
the implications of AMNOG on strategic market access decisions for companies planning
Benefit dossier
EVALUATIONS TO DATE
IMPLICATION
treatment.
Figure 3
GBA procedures
(status of 11th May 2012)
Early benefit assessment procedure
started
Exemption from early benefit assessment
BRILIQUE
HALAVEN
ESBRIET
RASILAMLO
GILENYA
TRAJENTA
an additional benefit.
Soon after the AMNOG law was passed, and long before
an additional benefit.
JEVTANA
XIAPEX
EDARBI
Total
29
YELLOX
Restricted add.
benefit granted
No additional
benefit granted
No dossier
submitted
TROBALT
ZYTIGA
INCIVO
16
VICTRELIS
No status
Xiapex).
TM
Indication
MNF dossier
Patient population
Comparator
Patient population(s)
IQWiG assessment
Comparator choice
(Additional) benefit
No additional benefit
No additional benefit
IMPLICATION
IMPLICATION
Manufacturers are advised in the current
environment not to be over-reliant on quality of life
endpoints in their benefit assessments but to work
(Additional) benefit
GBA decision
methodologies.
Indication
MNF dossier
Patient population
Comparator
Clopidogrel + ASA
Patient population(s)
MI with ST elevation
(STEMI) in patients on
medication
MI with STEMI in
patients with previous Coronary Artery
Bypass Graft (CABG)
Comparator choice
Clopidogrel + ASA
Clopidogrel + ASA
Prasugrel + ASA
ASA monotherapy
(Additional) benefit
No additional benefit
No additional benefit
No additional
benefit
No additional benefit
No additional benefit
Exception: Weak indicator for not
quantifiable additional benefit for
(1) patients >75 inappropriate for
Prasugrel (2) patients with transitoric ischemic attacks/stroke
No additional
benefit
IQWiG
assessment
IMPLICATION
Manufacturers should identify and consider all
potential sub-populations in a risk assessment prior
to the submission of the dossier ideally in the
GBA
decision
(Additional) benefit
TM
IQWiG and the GBA (see Figure 4). The main elements
patient population.
(Lesson 5).
IMPLICATION
Germany.
In all cases, IQWiG and the GBA explained their
Figure 4
IMPLICATION
For manufacturers, the best predictors of benefit
assessments are AMNOGs own defined procedures,
as German pricing and reimbursement decisions do
not automatically follow the label, HTA or market
access decisions of other European countries.
Figure 5
71%
63%
IQwiG
GBA
19%
13%
Level of additional
benefit
Major additional benefit
Important additional
benefit
Slight additional benefit
Quality of additional
benefit
Evidence for additional
benefit
Indicator for additional
benefit
Weak indicator for
additional benefit
Not quantifiable
additional benefit
No additional benefit
Smaller benefit than
comparator
7% 6%
major additional benefit
important additional
benefit
14%
7%
slight additional
benefit
not quantifiable
additional benefit
no additional benefit
IMPLICATION
TM
CONCLUSION
Although the pricing and market access environment
has become more regulated and more evidence-based
Figure 6
GBA follows
IQWiG
(n=10)
Figure 7
Learning
Commentary
Implication
2: F OCUS ON HARD
ENDPOINTS
3: A NTICIPATE PATIENT
SEGMENTATION BY
IQWiG/GBA
4: P
REPARE WITHOUT
RELYING ON QUALITY
OF LIFE OUTCOMES
6: CLARIFY WHAT IS
MEANT BY ADDITIONAL
BENEFIT
7: N
EGOTIATE WITH
THE GBA AFTER
PUBLICATION OF
IQWiGs RESULTS
internationally.
REFERENCES
Federal Joint Committee (G-BA). Frhe Nutzenbewertung (35 a SGB V), in:
http://www.g-ba.de/informationen/nutzenbewertung/
Institute for Quality and Efficacy in the Health care system (IQWiG). Projekte, in:
https://www.iqwig.de/projekte-ergebnisse.915.html
10
11
TM
GERMANY
Justus Dehnen, Engagement Manager
jdehnen@imscg.com
+49 89 457912 6418