How to navigate in the new world of price cuts in Europe?
- Where did the money disappear?
Prepared for:
From:
Mattias Kyhlstedt
CEO
[email protected]
SYNERGUS
1
May 9, 2013
Agenda
Intro to Synergus
Common issues across Europe
Financial realities
DRG s
Health Economics
HTA s
Country specific examples:
France
Germany
2
Synergus Services
The toolbox
Planning &
Strategy
For reimbursement and health
economics professionals who
know how to use the tools and
knowledge.
Services that help to plan and to
develop a strategy for your specific
situation; providing a blueprint for
what needs to be done.
3
Execution
Where the rubber hits the road
and we do the hands-on work to
create the change.
Synergus - Pan European Market Access Support
Reimbursement
& Health
Economics
4
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Synergus
Global Regulatory Support
Regulatory
Quality Systems
(specialist in SW)
5
Historical view...
Procedure code
application
DRG
change
Optimally
adapted DRG
Interim funding
Develop
market
access
strategy?
Willingness to
treat
Willingness to
endorse
Sales
Willingness to
Champion
Time
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Today s reality
Procedure code
application
DRG
change
Optimally
adapted DRG
Interim funding
Conditional
willingness to pay
Develop
market
access
strategy?
Willingness to
pay
Sales
AND
Willingness to
treat
Clinically and
economically
accepted
treatment
Willingness to
endorse
Willingness to
champion
Time
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1, Who is willing to pay for my product?
2, How will I get there?
8
What Activities are Needed to create funding and reimbursement?
Initial Period of No or
Insufficient Funding
Transitory Period of
Temporary Funding
No of Procedures
80
70
60
50
40
30
20
10
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Established
Sustainable Funding
Make smart products that reduce cost in health care and
improve outcomes with meaningful difference !?
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The challenge of funding & reimbursement
11
Who Is Going Broke?
Healthcare Cost as a
% of GDP
Healthcare Cost Pressure
Source: Authors calculations based on Laurence Kotlikoff and Christian Hagist, Who s Going
Broke? National Bureau of Economic Research, Working Paper No. 11833, December 2005, p.29.
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Most medical devices do not have any reimbursement issue!
13
European Reimbursement:
A Snapshot of Some Healthcare Systems
UK
Belgium
Denmark
152 Primary Care Trusts
1 centralized system
5 Counties
105 Foundation Trusts
Device specific
reimbursement
High decision making at hospital
level (global budget)
10 Strategic Health Authorities
(England)
HRG (DRG) Prospective payment
system
Germany
16 counties 134 public & 43
private sickness funds
France
Public & Private
decision making
High decision making power at
hospital level
centralized
G-DRG prospective payment
system
DRG (T2A) system prospective
payment system
Device specific reimbursement
Italy
Spain
21 local health authorities
17 autonomous regions
High decision power at regional
level
High decision making
power at hospital level
(global budget)
DRG prospective payment
system
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DRG
A system to distribute healthcare funds
Demands on
healthcare are
increasing (e.g.
with age)
Amount is fixed
Good distribution from a healthcare/payer
perspective:
- is fair for small and big hospitals
- does support efficiency gains => less
costs for produced healthcare
- has the ability to introduce innovations
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Reimbursement vs. Funding
Reimbursement
Funding
vs.
The system through which hospitals are
The willingness to pay for the activities in
being paid for performance (activities
the hospital
DRGs)
Example:
Example:
Gastric Banding
Guidelines state that patients with BMI
Either there is a DRG that describes this
above 40 should receive gastric banding.
activity with corresponding value or not.
However local decisions-makers in UK only
If not, the hospitals will not receive payment
want to fund for patients with BMI above
for their activities.
BMI 60
Depending on the country, for the product, one or both issues might be a challenge.
(In this presentation the word Reimbursement will represent both dimensions.)
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DRG Systems
Can be used for budgeting or financing
Purpose is to provide relevant clinical description of activities that are
carried out with appropriate reimbursement of cost
Does not care about the technology utilised
Updates of the system will occur if new methods (from a DRG-perspective)
are introduced
Typical timeframe to change DRG-system is 3-5 years
Reimbursement levels are based on historical cost data
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DRG Systems cont.
DRG Systems
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Is the Reimbursement System Likely to be Adapted to
Accommodate Your Technology?
Interim funding
System-change
possible
Understanding
pathway for change
Implementation
of system-change
Favourable tariff
System-change
not possible
Unfavourable tariff
Market
Opportunity?
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Market access
hurdles &
opportunities?
Required
Tools &
Actions?
Recognise the Opportunities
and Limitations in the
Reimbursement Systems
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Main types of reimbursement routes / challenges
Change DRG-system
Reported volume in system, difference in procedure, costdifference
Product registrations
Require evidence about comparative effectiveness
HTA
evaluations
No change in system
Work within exisiting system.
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Who Cares?
22
Stakeholder Mapping
Who are the relevant stakeholders and their influence on decision-making?
Conceptual example
How to establish
a provisional
budget?
Department
Head
What is the hospital
purchasing
Purchas
process?
-ing
What does the
physician need
to justify his
case?
Physicians
What is required to
convince the
management?
Market
Access
Action
Plan?
Hospital
Managament
HTA
XXXXXXXXXXXXXX
XXX
Clinical
Society
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Opportunity or
threat?
Hurdles for New Innovative Technology
Affordability
Cost-Effectiveness
Quality
Efficacy
Economic and Budgetary issues
Safety
Clinical
Methodological
Design issues
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Economic and Budgetary Issues
Value for Money
Cost-Effectiveness
Impact on Budget
Affordability
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Economic Evaluation: Basic Principle
The comparative analysis of alternative courses of action in terms of both their
costs and consequences in order to assist policy decisions (Drummond et al)
Always comparative analysis
Comparison of both costs and Consequences
Consequence A
Cost A
Intervention A
Choices
Pain free
hours
Consequence B
Cost B
Intervention B
Pain free
hours
Cost B - Cost A
Comparison*
=
Incremental Cost Effectiveness Ratio (ICER)
Effect B - Effect A
ICER should be below the Willingness-To-Pay of each payer (e.g. in UK it is 30,000 £ / QALY)
*Assuming B as a new intervention and having more costs and effects
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Reimbursement Potential: Which Quadrant?
WTP £35 000
Cost
Reimbursed but may
require alternative
funding
Reject
WTP £25 000
Higher cost
lower benefit
(High Likelihood of
Rejection)
High certainty of
Reimbursement
Benefit (QALY)
Lower cost & Lower
benefit
(may or may not be
reimbursed, depends on
clinical endorsement)
Highest certainty
of Reimbursement
WTP = Willingness To Pay or Cost Effectiveness Threshold (e.g. In UK £25 000
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£35 000)
From Back of the Envelope to Rigid Support Documentation
Market Access Strategy
Market-Need Evaluation
Comparator Evaluation
Value Proposition Strategy
Evidence Evaluation & Strategy
Value Communication Strategy
Clinical Landscape (Guidelines, etc) Review
Stakeholder Perception Analysis
Budgetholder Implications
Budget-Impact Analysis
Funding Pathways Analysis
Reimbursement Evaluation
Value-Based Pricing Analysis
Reimbursement & Pricing Strategy
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Value Proposition - Starting At the Back of The Envelope
Current clinical
pathway
Biomarker
New clinical
pathway
New
Biomarker
10
CT-Scan
Ultrasound
Ultrasound
Surgery
Surgery
Cost: 3000
Cost: 2500
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210
HTA
In EU Decision Making Model
Topic Selection
Decision makers
Ministry, Autonomous
bodies, Providers,
Payers etc.
Appraisal / Review
e.g. IQWiG, HAS, NICE,
DACHETA or by
independent reviewers
research groups,
universities etc.
Manufacturer s
submission
with some exceptions,
assessment and
appraisal are
conducted following a
manufacturer s
application.
- European Observatory
for Health Policy
Supervision
Policy
recommendation
bodies
Government
Parliament
Politicians
Final Decision
Dotted box = HTA in Decision making process
Ref.
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Health Technology Assessment and Health Policy-Making in Europe, Marcial Velasco Garrido, Observatory studies Series no. 14, European Observatory
for Health Policy Publication, ISBN 978 92 890 4293 2
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What Health Technology Assessment organizations
(HTA) look for?
What HTA
Authorities look for?
Cost effectiveness
Clinical / Therapeutic Value
Budget Impact
Available Alternatives
Public Health Impact
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All based
on highlevel
published
evidence
High quality evidence is required
Typical threshold for
inclusion in evaluation
32
Oxford Centre for Evidence-Based Medicine
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Country specific examples
Germany
France
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changing the DRG-system
Regsitration of a product
Reimbursement Pathways - Inpatient
Covered sufficiently
by G-DRG
Yes
No
OPS-change
(DIMDI)
No
DRG with fixed
cost-weight
Has cost data
been reported
Innovation
Funding
Yes
DRG-change
(InEK)
Uneven distribution
Additional funding
ZE
Even distribution
Regrouping of
DRG
InEK Evaluation
(NUB)
New/split
DRG
Negotiation
Sickness
fund
Negotiation
Healthcare
provider
Sickness
fund
Healthcare
provider
Reimbursement
(1 year)
Reimbursement
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Reimbursement
Funding System - Inpatient
Activity based financing system for hospitals
Diagnosis Code
ICD-10-GM Version 2013
(~13400 in 2013)
Indications e.g.
age, LOS, sex,
type of admission.
DRGs include:
Medical treatment
Nursing care
Board and accommodation
Provision of pharmaceuticals and medical devices
Therapeutic appliances including all overhead
Procedure Code
OPS (~28300 in 2013)
Grouping
(+ indications)
In addition to DRGs there is the option to apply for
innovation funding, called NUB.
For certain specific procedures and treatment there
may be established supplementary payment called
Zusatzentgelt (ZE).
DRG
G-DRG (1187 in 2013)
Tariff;
Base-rate is
negotiated
regionally and
updated every year.
Calculated as the DRG cost
weight multiplied by the
regional base-rate
Reimbursement
The national base-rate for
2013 is set at 3068.37 .
Until 2014 the regional
base-rates must move
closer to the national rate
and deviate no more than
+2,5 % or -1,25 %.
DRGs list which treatments (including medical devices) that can be provided to patients.
DRGs are meant to cover all costs that arise from a certain medical procedure
costs are instead financed by the regions (states/länder).
apart from investment costs (capital equipment). Those
Medical device prices are negotiated between the hospital and the respective medical device manufacturer.
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Adaptation of G-DRG System
Observe
outcome
end of
January
Market Access
Request for DRGregrouping /
ZE 31st March
NUB
NUB
Apply for
NUB until
31st
October,
annually
NUB
Procedure Code (OPS)
Report: New OPS
Apply for
OPS
until 28th
February
2013
2014
Observe
outcome
end of
August
2015
Data Analysis
DRG / ZE
2016
2017
If procedure codes, DRGs and ZEs will be granted, they will be usable from the 1st January on (therefore the gradient colouring).
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Innovation Funding - Inpatient
Neue Untersuchungs- und Behandlungsmethoden (NUB)
Alternative pathway for
Only initiated by
Manufacturer
Healthcare provider
InEK
Re-application
possible
next year
Deadline: October 31st
Decision: January 31st
review application
Approval
No
Facts of NUB Arrangements
Re-application needed each year
Only applicable for those hospitals that apply
Only ~15%
in 2013
Yes
Healthcare
Provider
Local Sickness Funds
Negotiation
Reimbursement for 1 year
Hospital specific; additional to the existing tariff
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Some Success Factors for NUB Arrangements
Understanding the criteria for approval
Ability to appropriately answer the questions
Submitting hospitals
Criteria for NUB Arrangements
Novelty (< 5 years)
Suitable patient group
Significantly higher costs (labor and material costs)
NUB is an Add-On to Existing Payment in DRG-System
NUB
DRG
NUB
ZE
DRG
DRG
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Understanding the German NUB Solution
The objective is to provide an interim funding solution until the DRG-system
has adapted
The application is submitted by individual hospitals in October
The decision is based on the review of the group of applications by InEK
If the group of applications is granted status 1 , it gives the applying
hospitals the possibility to negotiate with the insurance companies
The NUB status is valid for one year
Until there is an established solution in the DRG-system, a new application
should be submitted annually
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NUB Process
Preparation
Submission
Approval/Rejection
Development of application
master document based on a
set of questions that have been
defined by InEK (Institute for the
Hospital Remuneration System),
concerning the
technology/treatment, patient
population, costs etc.
Applications are submitted to
InEK using a computer
program.
NUB Status 1
Criteria fulfilled. Hospitals that
applied for the NUB are allowed to
negotiate reimbursement with
sickness funds.
Only hospitals/physicians can
submit the applications. An
application may be
collaborative, so that one
hospital submits the application
on behalf of other hospitals of
the same hospital network.
NUB Status 2
Criteria not fulfilled.
NUB Status 3
InEK was unable to process the
application.
NUB Status 4
Insufficient information/description
of treatment.
October 31st
January 31st
Note:
NUB Status 1 only gives hospitals the possibility to negotiate reimbursement with the sickness funds and does not mean that it will be
reimbursed automatically without effort.
If an NUB is approved (status 1), for which hospitals does it apply?
If a technology is granted NUB status 1, all hospitals that have applied for that particular technology (and only those) are allowed to negotiate
reimbursement with the sickness funds.
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French example
41
Device Funding & Reimbursement Mainly Organized at a
National Level with a Focus on Clinical Effectiveness
The T2A (La Tarification à l Activité) is the French activity-based hospital financing system which is
similar to other DRG (Diagnosis-Related Group) systems.
Covered sufficiently
by GHM?
Medical Procedure HTA (SEAPCNEDiMTS)
No
Yes
Covered by
GHM, but has
to be on
LPPR
CCAM-change
(Ministry of Health)
LPPR
GHM-change
(Ministry of Health)
Professionals
Unions
New/split GHM
PHRC
STIC
Medical Device HTA (SED-CNEDiMTS)
Price negotiation
Price negotiation
UNCAM
Innovation Funding
CEPS
Medical Device
Manufacturer
Ministry of Health Coverage (LPPR)
Fast Track Procedure
(Ministry of Health decision,
no direct application
possible)
Ministry of Health Art.
L165-1-1 CSS
Reimbursement
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CCAM, Classification Commune des Actes Médicaux (procedure code classification); GHM, Groupe homogène de malades (DRG); GHS,
Groupe Homogène de Séjour (DRG tariff); UNCAM, Union nationale des caisses d'assurance maladie; CNEDiMTS, Commission Nationale
d'Evaluation des Dispositifs Médicaux et des Technologies de Santé; SEAP
SED
LPPR, Liste de Produits et Prestations
Remboursables; PHRC, Programme hospitalier de recherche Clinique; STIC, Soutien aux techniques innovantes et coûteuses
Criteria for eligibility for
LPPR inclusion:
Statistical
criteria
(degree of heterogeneity
within the cost distribution
that would result from the
integration of the product
within the GHM).
Medical criteria (strong
innovation supported by
clinical evidence).
Economic criteria (highcost devices supported
by
cost-effectiveness
(CE); new rule: CE-study
should be done in order
to aim towards ASA
[expected
benefit
improvement or added
clinical value] 1, 2 or 3)
New
Fast
procedure:
Track
Grant reimbursement for
whole package (medical
device + procedure +
medical fees)
Limited period and in a
restricted area (set by
Health Ministry)
Applicable since March
1st of 2010
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Hospital Reimbursement System
Hospitals are reimbursed by T2A, an activity-based financing system consisting of GHMs (Patient Homogeneous Groups,
equivalent to DRGs). Each GHM code could correspond to one or more GHS codes (Hospital Stay Related Group) based on
clinical intervention profiles. Each GHS has a fixed GHS Tariff which allows for the reimbursement in form of lump sum payment
for both in-patient care, and out-patient care (day-hospitalization).
ICD-10 (CIM-10)
(Diagnosis code ~14400)
Grouping
(+ indications)
GHM
Code
GHS
Code
Fully implemented in;
2005 for the private for-profit
hospitals
2008 for the public hospitals
and private non-profit
hospitals
CCAM
(Procedure code ~8000)
DRG
GHM (~900)
Tariff
GHS (~2300)
Select Patient
characteristics:
Associated
Comorbidities or
Complications
(CMA)
Age
Lenght of stay
Others i.e. sex,
type of admission
Salaries are
excluded for the
private market
Potentially
Additional
reimbursement for
some implantable
devices via LPPR
Total
Reimbursement
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Public hospitals are
harmonized with the private
sector, in terms of similar
financing systems (e.g.
procedures, services and
products). Adjustments of the
tariffs occur every year.
Main differences between inpatient and out-patient care
would be in the length of stay
(LOS). The reimbursement
tariff varies according the
severity of the case and the
LOS.
Going through LPPR to Gain Reimbursement Implies
both a Clinical and Budget Impact Evaluation
Clinical and
technical dossier
Any similar device
on LPPR
Can be
given by
any
European
Notified
Body
CEmark
1
Required for
the monitoring
of MD market
Communication
ANSM (former
AFSSaPS)
Simultaneous
submission to
HAS and CEPS
Only for brand
name pathway
Submission to
HAS
Evaluation by the
CNEDIMTS/SED
4
Brand
name
pathway
SA
sufficient
Submission to
CEPS
Reimbursement
Application
3
2
~398 days (vs. 180 days in theory)
1. Notification about launch of
medical device on French market
2. Declaration of the LPPR codes intended to be
used (after inclusion in ANSM list)
Generic
description
pathway
Application
ANSM
* CEPS activity report 2009
Sources: CEPS, ANSM, HAS
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Evaluation by
CEPS
Based on the advisory
opinion of CNEDIMTS
(takes ~90 days)
Based both on the
evaluation by the
CNEDIMTS and by the
CEPS
SA not
sufficient
STOP
Economic dossier
If some similar
device already
exists on the LPPR
Average period in 2009 between
Submission and Publication in the JORF*
44
Evaluation of the expected public
health benefit (takes ~90 days)
5
Manufacturer
Decision by the
Ministry of health
Publication in the
JORF then
Registration on LPPR
6
7
Application for Inclusion on the LPPR List
LPPR: Generic Code or Brand Specific Code?
In order for the product to be reimbursed separately, the product must be listed on the LPPR List.
For listing on the positive reimbursement list, LPPR, manufacturers have the following alternatives:
3
Generic
LPPR Code
Brand Specific
LPPR Code
or
This option applies if:
1) There is an existing generic LPPR code that
is appropriate for the device
2) The existing generic LPPR code renders
reimbursement that is enough to cover the
cost of the device.
This option applies if:
1) No existing generic LPPR codes are
appropriate for the device
2) The product is innovative or specific:
monitoring of the product is required
3) A higher price is requested; in this case the
device must show substantial clinical and
economic value to justify a higher price
Application for a Brand Specific LPPR code is more extensive than an application for a Generic LPPR code.
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LPPR Application
Brand Specific LPPR Code (1/3)
Reimbursement Pathway
When no existing generic LPPR code adequately describes the device, manufacturers may apply for a new LPPR
code. In order to achieve superior reimbursement, the product must show substantial clinical and economic
benefits.
Process
Dossier should be prepared based on an LPPR template.
Once the dossier has been prepared, it should be sent to:
Manufacturer file (clinical and technical part) must be provided to the CNEDiMTS1 directly or by post mail
Clinical and economic part of the application file must be sent at the same time to CEPS 2
Fee
Registration fee: 3220
Renewing inscription fee: 644
Modification of inscription conditions fee: 644
1 CNEDiMTS
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= Commission nationale d évaluation des dispositifs médicaux et des technologies de santé visés à
l'article L.165-1 du code de la sécurité sociale 2 CEPS = Comité Economique des Produits de Santé
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LPPR Application
Brand Specific LPPR Code (2/3)
Content for LPPR application dossier (1/2)
1. Clinical and technical dossier
Administrative data
History of development, marketing, and reimbursement of the product
Associated procedure codes, if applicable
Proof of the Actual Benefit (SA1), claimed by the applicant (description of the product benefit and of the
current strategy, impact on the public health, risks and adverse effects); can result in
SA
No SA
Level of scientific evidence for published data
Level 1
Randomised controlled trials of high power (low alpha and beta risks) / Meta-analyses
Level 2
Randomised controlled trials of low power (high alpha and beta risks)
Level 3
Non randomised prospective comparative studies or Cohort or prospective studies
Level 4
Comparative studies with historical series or studies containing bias
Level 5
Case series or retrospective studies
Demonstration of the Improvement in Added Clinical Value (ASA2) claimed by the applicant
Proposed comparator
Level of Added Clinical Value (ASA)
Description of endpoints used to assess ASA
I.
Major improvement
Level of ASA with justifications
II.
Substantial improvement
Demonstrations of ASA
III.
Moderate improvement
Target population
IV.
Minor improvement
Recommendation on conditions of prescription and use
V
No improvement
1
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2
SA: service attendu (expected actual benefit)
ASA: amélioration du service rendu (expected benefit improvement or added clinical value)
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LPPR Application
Brand Specific LPPR Code (3/3)
Content for LPPR application dossier (2/2)
2. Summary sheet for the clinical and technical dossier (must be attached in appendix).
3. Summary tables for key studies and summary of medical device vigilance data (must be attached in
appendix)
3. Other documents that need to be provided:
Statement of compliance with European Directive 93/42/EEC for all medical devices
CE marking certificate
Leaflet and instruction for use of the medical device
Technical sheet for the product
Any certificates that confirm the compliance with standards, specifications, tests or analyses.
5. Copy of publications mentioned in the dossier
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Evaluation Process
LPPR Application (1/2)
Once the dossier has been submitted, the following steps apply:
4
Evaluation by CNEDiMTS (normally within 90 days)
The significance of the product or service with regards to: therapeutic or diagnostic effect or compensation
for a disability as well as undesirable effects or risks linked to its use; the role of the product or service in
therapeutic or diagnostic strategy or compensation for a disability, taking other available therapeutic or diagnostic
methods or means to compensate for the disability into account
Its expected public health benefit: impact on the health of the population (mortality, morbidity and quality of
life, its ability to fulfill a therapeutic or diagnostic need or to compensate for a disability), impact on the health
service and impact on public health policies and programs.
CNEDiMTS gives a final advisory opinion if Actual Benefit (SA) is sufficient or not.
If Actual benefit is NOT sufficient = End of the reimbursement application. A new application is possible when the
manufacturer brings further evidence.
If the Actual Benefit is sufficient, there follows an evaluation of the Added Clinical Value (ASA) in relation to a
comparable product, procedure or service, considered to be the current gold standard according to available
scientific data. The ASA is rated on a scale of 1-5 (with 1 being the highest). Although the Ministry of Health makes
the final decision on reimbursement, the CEPS makes tariff proposals based on the recommendations by
CNEDiMTS, taking the SA and ASA into account as well as tariffs/prices of comparable products, procedures and
services on the list and anticipated volumes.
For products with an ASA rating of 5 in particular (i.e. no ASA), the Social Security Code specifies that products
that do not provide any improvement in actual benefit or economy related to the cost of the treatment, or which is
likely to involve unjustifiable expenditure to the national health insurance, cannot be included in the LPPR.
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Evaluation Process
5
LPPR Application (2/2)
Evaluation by CEPS (normally within 90 days)
CEPS is the governmental body responsible for the pricing of health products on the LPPR before registration
The price of the device in other markets and economic studies (budget impact analysis) will be taken into
consideration
A correlation between price and sale volume will be agreed with the manufacturer (price reduction if the forecast
sale volume is exceeded)
Pricing of Medical Devices
The price will be set after negotiation between manufacturers (or their representatives) and the CEPS according
to:
The actual benefit and level of ASA
Tariffs of similar products or services registered in the LPPR
The forecast number of devices sold each year
The real conditions of use will be taken into consideration
European prices should not be taken into consideration because of constraints linked with different distributors
6
7
Decision by the Ministry of Health
Based both on the advice opinion of CNEDMITS and the evaluation by CEPS
Registration on LPPR and Publication in the Official Journal of the French Republic
Publication date = start of the reimbursement
Registration valid for 5 years maximum: every five years, CNEDIMTS evaluates again the public health benefit
(SA) of the device and its added clinical value (ASA) to decide whether the device should be removed from the
LPPR or not
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Reimbursement and market access is challenge is an art
that requires:
- Understanding of how to introduce new therapies
- Knowledge and understanding about
- the different national process to establish
reimbursement
- Health Economics
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Therapy Development & Reimbursement
A multi-disciplinary approach
Physicians /
Providers
Payers /
Government
Clinical evidence
Clinical guidelines
Budget Impact Analysis
Cost & Cost Minimization
Referring Physicians
Health Technology Assessment
Comparative Effectiveness
Health Economics
Incremental Cost-Effectiveness
Implanting physicians
Key Opinion Leaders
Department Heads
Hospital Management
Procurement
Commissioner
Payer / Insurance
Policy Maker
Therapy Selling
Customer Relationship Management
Value Added Selling
Economic Outcome Selling
Health Economics knowledge
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