Control of Pharmaceutic Costs
in France
Prof. Jean-Luc Harousseau
Chair of the Board
Haute Autorité de Santé, France
Washington DC, 7th November 2011
The French Healthcare system in a
nutshell
•
•
Universal care coverage
National Health Insurance (NHI)
–
–
–
•
Supplementary Health Insurance:
–
•
Statutory, coverage > 90% of the population
Three major funds: salarees, rural workers, self-employed
Universal Medical Coverage (CMU) since 2000: for
uninsured patients and supplementary coverage under
threshold income
92 percent of the population subscribe to supplementary
health insurance
Which medical services are covered ?
–
–
Hospital care, ambulatory care, prescription drugs
For prescription drugs:Coinsurance level depends on the
therapeutic value
2
General rules for drug reimbursement
and pricing
1. All drugs have to be assessed by HAS
 before inclusion on the positive list of reimbursed products
2. Role of the HAS Commission (CT) : advice for
reimbursement and pricing
 Reimbursement based on the Actual Benefit (SMR)
- insufficient : 0% reimbursement ( to be confirmed by the law)
- weak : 15% reimbursement ( currently debated)
- moderate: 30% reimbursement
- important: 60% reimbursement
 Pricing based on the Added Value (ASMR)
- 5 levels
3. For 30 chronic diseases (ALD) 100% coverage by SHI of
drugs on the positive list
 13% of patients , 68% of spendings
4. Review every 5 year
 or when significant new information is available.
3
Access to innovative and expensive
agents
•
•
•
•
•
•
In addition to the positive list,
Specific list for coverage of innovative drugs and devices
(inpatient care)
Fully covered by SHI outside the hospital activity-based
financing system (T2A linked to DRG type information
system)
Mostly cancer and biotherapy drugs
Off label use authorized (and reimbursed) if « good
clinical use » according to available literature: to be
restricted by the law currently discussed at the Parliament
Annual Budget fied by the Parliament (ONDAM)
Parliament : National Health Spending Objective (ONDAM)
Parliament adopts every year a national health spending objective (ONDAM)
► sets targets to the spending made by the mandatory basic schemes
► indicative, not compulsory.
HTA, Pricing and reimbursement procedures
CEPS
Economic Committee for
Healthcare Products
HAS
Guidance
Decision
Ministry of Health,
M. of Social Security
NHI Union
February 2011
Price
L
I
S
T
I
N
G
Copayment
Level
5
Initial assessment: From HTA to decision
making on price and reimbursement
Dimensions
Criteria
Clinical aspects
• clinical efficacy
• clinical effectiveness
Results
Insufficient
Actual
Benefit
No reimbursement
Sufficient
• relative effectiveness
Other aspects
• disease characteristics
• target population
• impact on public health
Clinical
added
value
• impact on healthcare
organisation (qualitative)
HTA: HAS Guidance
No added
value
Reimbursement
only if price inferior
to comparators
Added
value
Price may be
higher than
comparators
P
R
I
C
I
N
G
Decision: Ministry
Pricing:
Economic Committee
6
The pricing committee
CEPS (Comité économique des produits de santé) 1999
Membership
•
Drug and medical devices industry trade unions
•
Representatives from ministries ( health, industry, finance)
•
Mandatory and voluntary sickness funds representatives
Remit
–
Five year agreement with industry trade-unions (provisions for
data access, good use and expenditure growth control)
–
Decision on drug pricing and annual individual price/volumes
agreements with companies
–
monitoring trends in spending on drugs in relation to the annual
budget targets (sanctions if overshooting volume targets)
–
Risk sharing agreements other than price/volumes agreement
possible but very rarely used
7
Reforms on the drug market side
•
Incentives to participate in negotiations through a default clause
for non participating firms
•
Incentives for generic prescribing by physicians and substitution
right for pharmacists
•
Regular increases in advertising tax set up in 94.
•
Limits on the number of drugs reimbursed (around 600 drugs
removed from the positive list)
•
As of 2011 decrease in the drug reimbursement rate (from 65 to 60
and from 35 to 30%)
•
As of 2001 severe HTA excluded from the ALD list (no longer
100% covered)
Reforms in the ambulatory care sector:
Professionals
• Agreements on good use of care ( AcBus) defined by NHI
• HPST Law: Evaluation of health care professionals’ competence
(Continuous professional development)
• NHI individual contracting with physicians: beyond collective
negotiation of fees, introduction of NHI Individual contracting
with physicians (CAPI -Contrat d’amélioration des pratiques
individuelles), on a voluntary basis, starting in 2009
• To be extended with the recent contracting between NHI and
GP: « French » P4P introcucing a list of « quality indicators »
including generics prescription
Patients
• Slow introduction of gate-keeping : after several attempts,
setting up of the ‘médecin traitant’ option (treating doctor !)
reform in 2004.
• Development of disease management and patient education
Sales of reimbursable drugs - 2010
•
•
Total sales 2010: Euros 25.5 billion.
1.3% increase / 2009 (3% in average for the
previous 5 years)
–
–
•
community pharmacies +0.5%
Hospitals +6%
Slowing down of growth due to :
–
–
–
–
–
lapsing of patents
growing generic substitution
Reduced number of new innovative drugs,
impact of price management
promotion of rational prescribing (“maîtrise médicalisée”)
June 2009
10
HAS specialist Committees
Chairman of the Board : Prof. Jean-Luc HAROUSSEAU
Managing Director : Dominique Maigne
Pharmaceuticals (Transparency Committee)
Medical Devices, interventional and diagnostic procedures
Economic and Public Health Evaluation (CEESP)
Healthcare cover for long-term conditions
Medical information quality and dissemination
Accreditation of healthcare organisations
Clinical Guidelines
October 2010
11
From clinical relative effectiveness
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
12
HAS adoption of health economics
• New remit by Law in 2008
• For HTAs and for public health and good practice
guidelines
• No cost-effectiveness analysis for new technologies:
– 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
 Statins, Drug eluting stents, ..
• For some technologies, full HTAs (inc. ethics and social
values)
 Growth hormones for non-deficient children
• Increasingly, financial impact included for first listing
13
Future changes to be expected at HAS
• Recently, 6 independent official reports from various
auditing boards recommended that HAS advice be
more oriented towards documenting the collective
added value of drugs/technologies, leaving the
assessment of the individual clinical benefit/risk ratios
to the French licensing body
• HAS may have to carry out mini HTAs with economics
for some new technologies, with a potential impact on
prices
• Reeavaluation after 2-3 years with post-inscription
studies and real-life prescriptions
• Currently debated in Parliamnet
14
8.7
8.5
8.5
8.4
8.1
7.8
United Kingdom
Australia
Norway
Finland
Japan
Slovak Republic
6.0
5.9
Mexico
6.5
Turkey
Korea
6.9
8.7
Ireland
Chile
9.0
OECD
7.0
9.0
Spain
Poland
9.1
Italy
7.1
9.1
Iceland
Czech Republic
9.4
Sweden
7.2
9.7
Greece
Luxembourg
9.7
Denmark
7.3
9.8
New Zealand 1
Public expenditure on health
Hungary
9.9
Portugal
10.2
Belgium 1
9.9
1. Current expenditure. Source: OECD Health Data 2010.
Netherlands
10.4
Canada
0
10.5
2
Germany
4
10.5
6
Austria
8
10.7
10
Switzerland
11.2
12
France
16.0
16
United States
Health expenditure as a share of GDP,
2008 (or latest year available)
% GDP
18
Private expenditure on health
14
15
Pharma expenditure per capita (USD)
France
Germany
UK
HAS : an independent scientific public body
Broad scope of missions and an integrated global approach to
improve quality and safety of healthcare:
– assessment of health technologies (drugs, devices,
diagnostic and interventional procedures) for pricing and
reimbursement,
– clinical practice guidelines,
– public health guidance,
– chronic disease management models and guidance,
– guidance and recommendations on the most effective
strategies (prescriptions, care pathways...)
– Certification and continuing professional development,
– hospital accreditation,
– labeling of patient information websites.
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 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
October 2010
18
HTA and prices: are
we changing our
minds?
19
CEPS pricing rules
Decision tree / Clinical added value (CAV)
•
High 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
•
Competitors’ prices in same therapeutic indication
•
Forecast or recorded sales volumes
•
Expected and/or actual conditions of use
Price review
•
« automatic » at the end of a « price stability period » for innovative
drugs
•
« Volumes clauses » (higher volumes than expected)
•
« Daily treatement cost » clause (e.g. higher dosages used)
20
Thank you for your attention
http://www.has-sante.fr
21