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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77

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