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France Access to Innovation: Stakeholder Reality Pr Robert LAUNOIS 28, rue d’Assas 75006 Paris France Tel . 01 44 39 16 90 Fax 01 44 39 16 92 E-mail : [email protected] - Web : www.rees-france.com Eurocomed DRG Technical Forum 2006 FRANKFURT November 20-21, 2006

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Page 1: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

France – Access to Innovation:

Stakeholder Reality

Pr Robert LAUNOIS

28, rue d’Assas

75006 Paris – France

Tel . 01 44 39 16 90 – Fax 01 44 39 16 92

E-mail : [email protected] - Web : www.rees-france.com

Eurocomed DRG Technical Forum 2006

FRANKFURT November 20-21, 2006

Page 2: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 2

Historical Background

Until 2004 the fundings of « public hospitals »

depended exclusively on global budgets which

were mainly fixed on a historical basis.The private

for profit sector had its own reinbursement system

until 2005.

The PPS was introduced in the public sector in

2004 covering 10 % of acute public hospital care.

Currently, about 35 % of its activity is covered.

Private for profit hospital, have been funded

entirely by the PPS since 1 st march 2005.

Page 3: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

The New Hospital

Reimbursement

Schemes

Page 4: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 4

T2A – 3 modes of Hospital Reimbursement

Tariffs per hospital stay : DRG Tariffs

and daily supplements added to DRG

Tariffs per medical procedures:

outpatient care activities: imaging, lab

tests(CCAM),Sessions, Consultations

Real cost payments: Onerous drugs

and medical devices

Activity based

reimbursement

Not Activity based

reimbursement (block grant)

Annual Lump sum funding:

Emergency treatment, organ

retrieval and transplants

Public utility missions and

contractual activities

(MIGAC)

Mix Funding

Page 5: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 5

T2A – Prospective Payment Systeme

DRG + Day-outliers

When the length of stay (LOS) falls outside the limit set

per DRG by the Technical Agency for Hospital

Information (ATIH) then, a financial adjustment is made :

If the LOS > upper bound of the DRG:

activity above the high outlier point is only reimbursed in addition

to the DRG at 0,75 of the DRG daily average tariff

Hospitalisation cost = DRG + 0,75 x n days x (DRG/ALOS)

If the LOS < lower bound of the DRG:

activity below the low outlier point is only reimbursed on the top of

the DRG at 0,50 of the DRG daily average tariff

Page 6: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 6

T2A - Prospective Payment System DRG + Daily Supplements [2006]

DRG 1682

10 Days in ICU under mecanical ventilation

4 533,22 €

+

824,91 €

X 10

Hospitalisation

Cost

12 774,22 €

Transfert into intensive care unit

PTCA and AMI with co morbidities :

Page 7: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 7

T2A - Prospective Payment System

DRG + DAILY SUPPLEMENTS + EXPENSIVE MEDICAL DEVICES [2006]

DRG 1682

10 Days in ICU with

mecanical ventilation

Drug Eluting Stent

4 533,22 €

+

+

824,91 €

X 10

DES : 1632 €

Hospitalisation

Cost

12 774,22 € Overall

Cost

14 407,18 €

Medical device

Transfert into reanimation

PTCA and AMI with co morbidities :

Page 8: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 8

T2A – Internal Audit

DRG Hospital

analytical

Accounting

Tariffs

comparison

Costs

Convergency ?

Page 9: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 9

Hospital Stakeholder : Financial Manager , Pharmacist, Medical Information Chief

The orchestra chief is the head of the financial department . He can’t do anything without its two faithful lieutenants: the hospital pharmacist and the Medical Information manager (DIM).

The phamacist manages the medical devices purchasing policy : he negociates prices and discounts, he references the products, signs contract with the ARH for the proper use of expensive drugs and medical devices…

The DIM Manages the interactions between purchasers and payers. He is at the origin of the income flows for the hospital and figures out the costs of the treatments. He has essential links with the medical team…

HFD

Pharmacist

DIM

Page 10: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

Get More Bang

For The Buck

Page 11: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 11

Conventional treatment or innovative treatment?

Where should we put our money

to lighten the burden of illness?

The Economic Question

Page 12: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 12

The Answer

Choose the treatment which has the

highest rate of return on the

therapeutic, human and financial

aspects per invested monetary unit.

Page 13: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 13

HTA: The Bridge Between Science and

Decision

Economics

Health Economics

Heath Care Reforms

Health Technology

Assesment

Cost/Effectiveness

Analysis Statistics

Page 14: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 14

What Amount of Money Has to Be Invested to Get The Expected Benefits?

To

tal In

ve

stm

en

t (e

uro

pe

r patient)

Effectiveness of Treatment (YOL)

Usual care

0

Effectiveness ^

Inves

YOL = year of life saved

Statines.in Secondary

prevention

(20,000 €/ YOL)

Osteoporosis prevention (>100,000 € /YOL)

Antihypertensive treatment

in type II diabetes (500 €/ YOL)

B

DIALYSIS (50,000 € /YOL)

A

The ratio additional Investment / induced health outcomes :

Page 15: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 15

How Much are the Fit Willing to Pay?

C

E Treatment

acceptability

zone

K : Willingness to pay

Dominated strategies

Page 16: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 16

A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game

The value (K) allocated by the Society to an amount of additional effect is a socio-political value which the evaluator cannot judge.

The results must be analysed in light of the results of the different possible willingness to pay from the purchaser by constructing an acceptability curve for the treatment by the statutory authorities.

This curve shows the probability that this treatment will considered to be efficient by the authorities for all possible values of K.

Estimation procedure: generation of ΔE, ΔC couples by bootstrap – Selection of the points beneath the line for all values of K.

Page 17: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 17

$(600.00)

$(400.00)

$(200.00)

$-

$200.00

$400.00

$600.00

-0.50 -0.40 -0.30 -0.20 -0.10 0.00 0.10 0.20 0.30 0.40 0.50

K1

K0

K2

Proportion of Cost /Effective Samples for The Willingness to Pay K0 , K1 , K2

Page 18: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 18

Probability of Making the Right Choice when Xigris is

Preferred to Conventional Treatments [STIC 2002-2005]

Willingness to Pay per Life Year gained ( €2004)

Pro

bab

ilit

y f

or

the

new

tech

nolo

gy

to b

e co

st e

ffec

tive

( p

errc

en

tage)

85,92 %

Page 19: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

Statistical Analysis

Page 20: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 20

Observational Studies : Pros & Cons

Randomised Trials (RCTs) “Gold standard”

Populations comparable (except for the treatment given)

Simple analyses

Good internal validity → relevant for adoption decisions

Observational Studies (OSs) Sometimes, randomisation infeasible, unethical or too

costly

Pre-existent non-randomised data available (e.g. registries)

Real life practice ≠ Strict protocol-driven conditions

Good external validity → relevant for policy decisions

Page 21: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 21

Recruitment Bias

Patient population

RCT

Treatment

Randomisation

Observational studies can’t assure patient comparability :

Allocation procedure Patient sample

Non randomisation

OS

Selection bias : patients selected according to some characteristics correlated with outcome

Page 22: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 22

Identification of Recruitment Bias

Question: Are the baseline characteristics

balanced between the two phases ?

Standardised difference d:

d > 10% => Indicate serious unbalance

Page 23: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 23

Reduction of Recruitment Bias

Propensity Score (PS): Probability that a person of given characteristics is exposed to the treatment

Total comparibility between the two phases if PSAfter = PSBefore

Simulation of a RCT with PS matching: Match a treated subject to the unexposed subject with

the nearest PS

Comparability of patients is guaranted on the observed covariates

The Use of PS Matching

Page 24: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 24

Deviation of Treatment Costs from Normality

Non normal distribution

The Student t-test use is questionable

The mean cost is the only relevant variable for

decision-making

Non parametric tests (Mann Whitney) and

logarithmic transformation of costs are rejected

Cost comparison with the bootstrap technic

Cost

Nu

mb

ers

0 10000 20000 30000 40000

050

100

150

200

250

Cost

Nu

mb

ers

0 10000 20000 30000 40000

050

100

150

200

250

The majority of patients incur low costs

Few patients incur very high costs

The Non Parametric Bootstrap Method

Page 25: France Access to Innovation: Stakeholder Reality · ICU under mecanical ventilation ... A Need: To Take Hold of the Uncertainty Which Presides Over the Rules of the Game The value

SL-6212/06 Eurocomed DRG Technical Forum 2006 25

Conclusion

New endpoints are introduced Uncertainty

QoL assessment

Estimates of the additional investments required to obtain the expected or actual clinical benefits

A new ethic of our duties arises:

The implementation of databases fed by

professionals based on individual data, changes

deeply the assessment methods.

« prodigate the best » per euro invested