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Drugs evaluation, pricing and
reimbursement in France
Mira Pavlovic MD
Moscou, May 21st , 2012
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The author declares
having no conflicts of interest
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01The current
French system
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HAS specialist Committees
Pharmaceuticals (Transparency Committee)
Medical Devices, interventional and diagnostic procedures
Economic and Public Health Evaluation (CEESP)
Health care for chronic conditions, disease management
Medical information quality and dissemination
Accreditation of healthcare organisations
Clinical Guidelines
Improvement of Professional practices and Patient safety
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1. All drugs have to be assessed by HAS
before inclusion on the positive list of reimbursed products
2. Regulated prices.
Negotiating committee = CEPS (Economic Committee for
Health Products) CEPS and HAS are separate entities.
3. Link between HAS opinion and drug prices
Assessment of clinical added value
4. Review every 5 year
or when significant new information is available.
Assessment of added value can be revised
General rules
HAS Guidance
CEPSEconomic Committee for
Healthcare Products
NHI Union
Ministry of Health, M. of Social
Security
LISTING
Decision
Price
Copayment
Level
HTA, pricing and reimbursement:
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HAS Guidance Content for a new drug
1. Eligibility to reimbursement (SMR)– Full indication or restricted to situations or subpopulations
2. Assessment of clinical added value (ASMR)
– What is the clinical added value and for what population?
3. Target population– Quantitative estimate
4. Uncertainty – and need for additional data collection
5. Recommendations – for use in clinical practice
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Clinical aspects
• clinical efficacy
• clinical effectiveness
• relative effectiveness
Other aspects
• disease characteristics
• target population
• impact on public health
• impact on healthcare
organisation (qualitative)
Actual
BenefitSufficient
Insufficient
Clinical
added
value
No added
value
Added
value
No reimbursement
Reimbursement
only if price inferior
to comparators
Price may be
higher than
comparators
Dimensions Criteria Results
P
R
I
C
I
N
G
HTA: HAS Guidance Decision: Ministry
Pricing:
Economic Committee
Initial assessment: From HTA to decision
making on price and reimbursement
Drugs with ASMR I, II or III
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3134
39
13
1715
0
10
20
30
40
50
2005 2006 2007 2008 2009 2010
% of new products* with
moderate to major
added value
(ASMR I, II or III)
* or new indication
Rules governing price setting
• The retail price of drugs:
– shall be set by means of a contract between the company
selling the drug and the CEPS, or by decree
• Primary considerations when setting prices:
– clinical added value (CAV, ASMR),
– prices of comparators,
– forecast or recorded sales volumes,
– foreseeable and actual circumstances surrounding use of
the medicine
• Link between CAV (ASMR) and price
– drugs that provide no „ASMR‟ as assessed by HAS and no
savings on medical treatment costs‟ cannot be put on the
list of reimbursed products
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02Ongoing and
expected changes
What changes?
• New laws on assessment of drugs and medical
devices
– More focus on efficiency
• Possible changes in the criteria
– From 2 criteria (SMR- ASMR) to one single criterion?
• International and European collaboration
– Concrete pilot actions on early dialogue
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European collaboration:
Some of the challenges
• Influence of HTA on initial data production:
– Engagement of HTA bodies in early dialogue / scientific
advice
– Production of HTA-oriented guidelines?
• How to make the best use of available data?
– HTA methodological guidelines (choice of comparators,
use of indirect comparisons….)
• Post launch data
– Relative importance of global and local data?
– Cooperation within EUnetHTA, and between EUnetHTA
and EMA.
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Concrete actions in European
collaboration
• Some of EUnetHTA achievements
– Tools and databases (POP, EVIDENT)
– Core HTA information model and pilots
– Methodological guidelines
• New field of activity: Early Dialogue
– Will be part of EUnetHTA Joint Action 2 program, starting
October 2012.
– Immediate launch ot pilots, to be realised in May and June
2012
– Action approved by EUnetHTA Executive Committee and
supported by European Commission.
– Coordinated by HAS, 6 HTA bodies volunteered to join.
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Changes in France : Towards one
single integrated criterion?
• ASMR and SMR are both comparative
– SMR has to be evaluated „in consideration with
other existing therapies‟
• Advantage of a single criterion
– Simpler
– Possibility to introduce some standardised way of
assessment/judgement (see AMNOG approach)
– Better reproducibility
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Changes in France: New legislative
measures
Law on Social Security Financing for 2012 (LFSS 2012)
Voted 29 November 2011
• For that purpose [HTA mission], HAS produce
guidance on the conditions of prescription,
realization or use of health products, procedures
or services as well as on their efficiency.
• In particular, HAS performs or validates the
“medico-economic” studies that are deemed
necessary for the purpose of Health Technology
Assessment.
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LFSS 2012 Voted Nov. 29 (Cont.)
Health economics Committee
• A Specialist Committee at the HAS in charge of establishing
recommendations and health-economic guidance on the most
efficient prescriptions and strategies of care.
• Naming, composition and procedural rules of this Committee
are specified and decided by HAS.
• A decree will specify the cases in which “medico-economic”
evaluation is required, e.g. for technologies that bring added
clinical benefit, or considering the foreseen expenses, or the
conditions of use.
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Concrete changes
• Initial assessment, at the time of Marketing
autorisation
– CEESP (HAS) will analyse the methodological quality of
the economic part of the application submitted by
companies, when available.
– This analysis will be transmitted to CEPS to better inform to
the price setting process
• Full economic analysis at the time of re-
assessment
– Together with other non clinical aspects
– Based on additional data collection
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The value assessment process
• HAS guidance comprises an evaluation of the
clinical added value (CAV = ASMR)
• Consequence on price settting : 3 situations arise :
– Major to moderate CAV (I, II, III): eligible for faster access at a
European price (Price notification instead of negotiation)
– No CAV (Level V): price lower than comparators (by Law)
– Minor CAV (IV): negotiation
• Additional criteria in the CEPS pricing decision :
– Competitors‟ prices in same therapeutic indication
– Forecast or recorded sales volumes
– Expected and/or actual conditions of use
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The French pricing system does rely on a partial
assessment of value: the assessment of clinical
added value undertaken by the transparency
committee at HAS (predominantly based on
individual clinical benefit)
– The therapeutic added value to society is not addressed per se
at first listing
– The other price determinants (public health or industrial
considerations) are balanced by the pricing committee (CEPS)
but there is no decision traceability
From clinical added value …
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… to collective added value
Value based pricing has to rely on the explicit and
quantitative assessment of all the individual and collective
value determinants
For the French pricing system to qualify as „value based
pricing‟, additional issues must be addressed, beyond the
measurement of clinical added value (relative
effectiveness):
• efficiency
• organization of care
• Social values
=> HAS may increasingly contribute to this assessement
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• New remit by Law in 2008
• No cost-effectiveness analysis for first listing
– Short time frame for CAV assessment
– Price proposed by the firm not known at time of assessment
• Mostly at time of reassessment (every five years) with
possible impact on CEPS price revision
Statines, stents, ..
• For some technologies, full HTAs (inc. ethics and social
values)
Growth hormones for non deficient children
• Increasingly, financial impact included for first listing
HAS progressive use of health
economics
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• HAS‟ experience with quantifying the individual magnitude
of the technology benefit is of high relevance … but it only
constitutes the first step
• The more recent contribution of non-medical disciplines
(economics, sociology, ..) to assessing the collective added
benefit of a technology, compared to other strategies, is
also relevant and needs to be developed
• Strengthening the link between HAS guidance (based on
both dimensions) and CEPS pricing policy will contribute
towards a more transparent and collective assessment of
value in the near future.
Challenges ahead
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Thank you for your attention
http://www.has-sante.fr