A Look at Reimbursement Issues in Germany

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Market Access & HTA
A PUBLICATION OF UNITED BIOSOURCE CORPORATION OCTOBER 2007 VOLUME XIII ISSUE 4
A Look at Reimbursement Issues the pharmaceutical market is a contentious issue
in Germany. Since the late 1980s, successive
in Germany
Inside this Issue
FOCUS governments ON: have imposed a wide range of costcontainment
measures. However, some observers
By Bernd Brüggenjürgen, MD, MPH, Managing Partner,
Safety, Epidemiology &
Cover Story: Alpha Care GmbH, Cooperating Partner of UBC, and Head
Impact of FDAAA Legislation
believe that the Risk German Management
health care system has not
of the Health Economics Chair at Steinbeis University Berlin,
exploited the full potential of these measures.
Change Blowing Germany. Through Prof. Dr. NICE Brüggenjürgen is an expert on the German
health care system.
Assessing Risk and
CMS’ Compendia Changes
Hospital inpatient services are reimbursed through a
Changes to The the Pricing German of pharmaceutical market still looks system Evaluating of diagnosis related Risk groups (German DRG—
UK Pharmaceuticals inviting to drug manufacturers. Germany has one “G-DRG”). Management For ambulatory care Programs
provided to SHI
PACE Ad Board of the Formed highest levels of health care spending in the members, physicians are reimbursed on a mixture
By Gerald Faich, MD, MPH, FISPE and Annette
world and has the largest pharmaceutical market of pre-paid
Upcoming and Recent Presentations
Stemhagen, capitation, DrPH, FISPE treatment lumps sums, and
in Europe (and the third-largest worldwide). In fee-for-service according to a point-based doctors’
Focus on: 2009, Improving drug spending Data Quality increased by 5.3% compared fee scale, Introduction the so-called German Uniform Evaluation
in Clinical to Trials 2008, which is about 1.5 billion-Euro. 1 Drug Standard Evaluation (Einheitlicher of any program Bewertungsmassstab—EBM
or activity must
Purpose-Platform manufacturers Matching also enjoy a great degree of freedom 2009). begin Each with physician a clear has view a of “capitations the purpose of of service” the
in setting pharmaceutical prices, which are among volume activity, per quarter, a pre-specified which varies statement regionally, of goals between
Communicating Evidence
the highest in Europe. However, pharmaceutical specialties and objectives, and morbidity an understanding of patients. of the steps
with a PRO Evidence Dossier
companies seeking to do business in Germany must involved to achieve the objectives, and a
Placebo Response and Signal Detection
contend with A central plan for body evaluation. for market The access purpose is the of G-BA: evaluation
Non-Inferiority Trials
many costcontainment
The is Joint to determine Federal Committee if the activity on Healthcare is succeeding
Statistical Germany SAS Programmers is Europe’s biggest
(Gemeinsamer and to allow Bundesausschuss) for modification to which make is the the
pharmaceutical market, worth more
In-Study Ratings Surveillance
measures. central activity agency more for effective reimbursement or efficient. decisions In the case
than 30 billion Euro annually, These include in Germany. of risk management Its main task programs, is to determine it is important and
CRF/EDC and GCP Training
and continues to be a major to prescribing recognize that there communicate is a new which language outpatient evolving or for inpatient activities therapies that
NICE Recommendations on
relate guidelines, to risk assessment and drugs versus are part risk of minimization the benefits or catalogue mitigation. of
influence in drug pricing overall
Both
Utility Mapping
of patient these activities the have SHI. been The described G-BA is authorized in regulatory by guidances law to issue and
for the European Union.
A “NICE Design”: Getting
commentary. copayments,
1 This directives, article will which summarize are binding, and discuss on sickness each of funds, these the
the Right Clinical Trial Data
initiatives. reference insured population, panel physicians, and hospitals.
pricing, a negative list of drugs excluded from In the event that the G-BA is indecisive on whether,
Science Policy Corner
Risk Assessment Activities
reimbursement, generic substitution, and
for example, certain therapeutic strategies in
Hospital Products: parallel Commodity import dispensing targets. Moreover, Assessment the of risk indications can be defined would as work, the the systematic Institute and for Quality ongoing and
Pricing to Value
adoption
Pricing
of cost-effectiveness as a requirement measurement of recognized Efficiency in or Health known Care risks. (Institut A key für postmarketing
Qualität und
EXACT-PRO for Initiative reimbursement Update is due to be implemented challenge for is to further Wirtschaftlichkeit determine the im magnitude Gesundheitswesen—“IQWiG”)
and determinants of
UBC at ISPOR selected substances launching in the coming the risk year. in actual practice. could be Much requested risk information to perform a derives health from technology routine
postmarketing collection and analysis of individual spontaneous
Recent Publications
While generics’ pricing is mostly under control, assessment (HTA) process.
patented drugs are the main growth driver, (non-clinical which trial) case reports of adverse events. Tracking of use
News Briefs
explains why current reform trends focus patterns, on medication IQWiG errors, is similar and product to the National quality complaints Institute for should Health
branded drugs.
also be seen as components and Clinical of Excellence risk assessment. (NICE) in These the United activities
are well established Kingdom components and is of an a independent, rigorous pharmacovigilance
scientific institute
Most Germans (about 90%) rely on the program country’s and are expected that provides for every technology approved assessments, and marketed with drug. the
Gesetzliche Krankenversicherung (GKV; statutory major difference being that NICE offers guidance
Going beyond the routine activities, several special considerations
health insurance—SHI) for their health care.
on treatments, while IQWiG only assesses the
for postmarketing risk assessment must be planned and evaluated.
Pharmaceuticals are the third-largest area of GKV health technology without any further guidance
These are driven by concerns or signals remaining at time of
expenditure after hospitalisation and treatment by
approval and are focused on: further defining the magnitude of
physicians. As in other countries, the growth of
continued on page 2
continued on page 2

EVIDENCEMATTERS ONLINE • WWW.UNITEDBIOSOURCE.COM 2
and reimbursement decision on treatment. Their
primary task is to assess (not to appraise) the
benefit of drugs and therapies, as well as cost
analyses for drugs. The IQWiG‘s evaluation frame
is defined by one of its own method papers, 2 as
well as by the G-BA. The usefulness of a method
generally has to be proven with the aid of studies
satisfying Evidence Stage I, measuring patientrelated
outcomes (e.g., mortality, morbidity, quality
of life). If no studies of this quality are available, the
cost-benefit analysis can be based on high-quality
studies of lower evidence stages. However, the
recognition of the medical usefulness of a method
on the basis of lower evidence stage studies
requires special justification, which needs to be
increasingly solid the more a study deviates from
Evidence Stage I. The interaction between G-BA
and IQWiG regarding reimbursement decisions is
quite complex. G-BA can evaluate treatments by
itself through subcommittees, working groups, and
expert hearings.
The reference pricing system, which covers
approximately 60% of medicines reimbursed under
the GKV public insurance system, will be maintained
with drugs priced at least 30% below the reference
price being eligible to have patient co-payments
removed. However, drugs included in the reference
pricing system will be increasingly targeted by
negotiating further discounted contracts. While
this will obtain considerable savings for Germany’s
statutory health insurance funds, patients will still
have the possibility to choose non-discounted
medicines in exchange for additional co-payments.
A rebate system is also in place in Germany.
Collective rebates comprise a manufacturer’s
discount (6%—if not reference price regulated), a
pharmacy discount (€2.30 per pack), and a generics
discount (10% since 4 January, 2006 onward). In
addition, individual rebates (Rabattverträge §130a 3 )
are increasing considerably, where SHI-funds are
allowed to contract directly with pharmacies for
selecting the generic to be substituted, and where
SHI-funds are in a position to reduce or to lift the
co-payments for their insurees.
Current ongoing political changes include the
following:
Assessing value of new drugs: The G-BA
and IQWiG may be the ones running these
analyses, however, recent information
indicates that the Federal Ministry of Health
is setting up the list of evaluation parameters,
hence steering the process, supported
by its own benefit assessment studies.
Drugs without added value compared with
alternative treatments will be directly included
in Germany’s reference pricing system.
Maintaining free market access for
innovative products: Since Germany is a
reference market for drug prices in many
European Union (EU) member states,
manufacturers have been reluctant to reduce
their prices in Germany. To be rebated,
prices of those drugs with added value
will be negotiated between the GKV and
pharmaceutical companies. Official list
prices will be kept.
Introducing the obligation for
manufacturers to negotiate prices with
Germany’s SHI within the first year after
marketing approval: Prices negotiated
within one year of marketing approval will
take effect for all statutory health insurances
funds in Germany. If no agreement is
concluded within three months of benefit
assessment, the GKV will set a price
based on international reference prices.
Pharmaceutical companies might set a price
unilaterally if agreement with the insurers has
not been reached after 15 months.
A further extension of individual contract
negotiations according to §130a: 3 Individual
contracting so far could be based on
quantitative elements like amount- dependent
rebates or compensations when exaggerating
targets. In addition, a qualitative element has
been introduced, which allows the integration
of the development of contracts based on
therapy outcomes.
Germany is Europe’s biggest pharmaceutical
market, worth more than 30 billion Euro annually,
and continues to be a major influence in drug
continued on page 3

ONLINE
ResearchNews
EvidenceMatters
3
Inside this Issue
Cover Story:
Impact of FDAAA Legislation
Change Blowing Through NICE
CMS’ Compendia References Changes
Changes to the Pricing of
UK Pharmaceuticals
PACE Ad Board Formed
Upcoming and Recent Presentations
Focus on: Improving Data Quality
in Clinical Trials
Purpose-Platform Matching
Communicating Evidence
with a PRO Evidence Dossier
Placebo Response and Signal Detection
Non-Inferiority Trials
Statistical SAS Programmers
In-Study Ratings Surveillance
CRF/EDC and GCP Training
NICE Recommendations on
Utility Mapping
A “NICE Design”: Getting
the Right Clinical Trial Data
Science Policy Corner
Hospital Products: Commodity
Pricing to Value Pricing
EXACT-PRO Initiative Update
UBC at ISPOR
Recent Publications
News Briefs
EVIDENCEMATTERS ONLINE • WWW.UNITEDBIOSOURCE.COM
pricing overall for the European Union. While costcontainment
strategies continue to be evaluated
A PUBLICATION OF UNITED BIOSOURCE CORPORATION OCTOBER 2007 VOLUME XIII ISSUE 4
and implemented, the evidence needed for
market access also continues to be reviewed and
updated so all relevant parties are considered in the
final decisions and policies.
For more information, please email
evidence@unitedbiosource.com.
1
http://www.bmg.bund.de/SharedDocs/Pressemitteilungen/
DE/2010/pm-10-03-10-ausgaben-gkv-kv-45.html
2
General Methods for the Assessment of the Relation of
Benefits to Costs, Version 1.0—19/11/2009. Accessible at:
http://www.iqwig.de/index.736.en.html
3
http://www.kbv.de/12909.html
FOCUS ON:
Safety, Epidemiology &
Risk Management
Assessing Risk and
Evaluating Risk
Management Programs
By Gerald Faich, MD, MPH, FISPE and Annette
Stemhagen, DrPH, FISPE
Introduction
Evaluation of any program or activity must
begin with a clear view of the purpose of the
activity, a pre-specified statement of goals
and objectives, an understanding of the steps
involved to achieve the objectives, and a
plan for evaluation. The purpose of evaluation
is to determine if the activity is succeeding
and to allow for modification to make the
activity more effective or efficient. In the case
of risk management programs, it is important
to recognize that there is a new language evolving for activities that
relate to risk assessment versus risk minimization or mitigation. Both
of these activities have been described in regulatory guidances and
commentary. 1 This article will summarize and discuss each of these
initiatives.
Risk Assessment Activities
Assessment of risk can be defined as the systematic and ongoing
measurement of recognized or known risks. A key postmarketing
challenge is to further determine the magnitude and determinants of
the risk in actual practice. Much risk information derives from routine
postmarketing collection and analysis of individual spontaneous
(non-clinical trial) case reports of adverse events. Tracking of use
patterns, medication errors, and product quality complaints should
also be seen as components of risk assessment. These activities
are well established components of a rigorous pharmacovigilance
program and are expected for every approved and marketed drug.
Going beyond the routine activities, several special considerations
for postmarketing risk assessment must be planned and evaluated.
These are driven by concerns or signals remaining at time of
approval and are focused on: further defining the magnitude of
continued on page 2