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How to assess the value of a new drug in a
changing environment?
The example of lung cancer
Pr A Vergnenègre, CHU Limoges (France)
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Summary

• The French health care system
• What do we know?
• What we would like to know

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?
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Background

• France top five in terms of health care
  expenditures

Background

• France third place for female life expectancy
• seventh place for male with a high early
• mortality rate.
• Only 99.9 of insured patients.
• Health care system is very specific, with high
• reimbursement rates and high hospitalization fees.

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The French health care system

• Budgets yearly fixed by the Parliament
• Global envelopes for each care category
• Price volume regulation
• But unable to control our health care expenditures

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The French health care system

• Ambulatory care assessed by specific scale
  Classification Commune des Actes Médicaux
• To each procedure correspond fees for the
  physicians with a specific evaluation for
  consultations
• In and Outpatients for hospitals and clinics
• payment by Costs per DRGs
• Tarification à lActivité (T2A).
• Only one payer !!!

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The French health care systemin and outpatients,
T2A
5 FINANCING MODALITIES
Other financing (dotation)
Fees per DRGs
Clinical research Teaching activities Public
health programs
PAYMENT IN ADDITION (MEDICATIONS, PROCEDURES)
Contractual yearly financing emergency
services, transplantation
Fees for consultations and ambulatory care
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The French health care systemin and outpatients,
T2A

• (T2A)
• Codification
• Transmission
• Payment

DRGs fees national, induce financing for
hospitals
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The French health care systemin and outpatients,
T2A
DRGs fees
424.17 for outpatient chemotherapy infusion

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The French health care systemin and outpatients,
T2A

• Reimbursement for drugs published on a listing
  by Ministry of Health
• Reimbursement at 100 par French social security
• If prescription in conformity to practice
  guidelines.
• If no conformity, reimbursement between 70 and
  100 of drug prices.

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The French health care systemin and outpatients,
T2A

• The selection of administration type had
  consequences on global costs.
• Any drug easy to use and whose administration is
  possible as an outpatient or at home could be
  efficient for french health care system (with
  high hospitalisation costs)

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Summary

• The French health care system
• What do we know?
• What we would we like to know

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Health care expenditures for tumors
5.6
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Overall costs comparison
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French study markov model

1st Line

Survey
2d Line


Death

Chouaid c, Vergnenegre A Br J Cancer 2004
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French study average 2 year costs

• mean IC95
• LC 25 643 10 631-46 191
• Extensive SCLC 22 420 7 748-37 584
• Limited SCLC 27 098 16 653-37 719
• Surgical I,II,III NSCLC 30 424 15 298-62
  430
• Non surgical I,II NSCLC 19 543 6 423-25
  390
• Non surgical III NSCLC 26 982 2 868-45
  756
• Metastatic NSCLC 24 383 12 107-48 931

1999
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French study components of cost

• Diagnosis
• Initial treatment
• Adverse events 1
• 2nd intention treatment
• Adverse events 2
• Follow-up
• Terminal care
• Transportation

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French study Markov model stage IV
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French studycost distribution
Surgical stage I,II,III NSCLC (2-year cost
distribution)
7
7
16
5
0
2
4
59
Diagnosis
Initial ttt
Adverse events1
2d intention Ttt
Adverse events2
Follow up
Terminal care
Transportation
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French studycost distribution
Non surgical stage I,II NSCLC (2-year cost
distribution)
11
14
31
33
4
7
0
0
Diagnosis
Initial ttt
Adverse events1
2d intention Ttt
Adverse events 2
Follow up
Terminal care
Transportation
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French studycost distribution
Stage IV NSCLC (2-year cost distribution)
5
13
23
2
0
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6
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Diagnosis
Initial ttt
Adverse events1
2d intention Ttt
Adverse events 2
Follow up
Terminal care
Transportation
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French studycost distribution
Distribution of initial treatment cost (stage IV
NSCLC)
4
3
7
6
40
40
Chemotherapy drugs
Drug administration
radiotherapy dose
radiotherapy administration
partial-complete surgery
metastatical surgery
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Economic analysis of drug

• Health economic assessment of second line
  chemotherapy for IIIB and IV NSCLC
• Cost- minimization analysis

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Economic analysis of drug
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Economic analysis of drug

• Impact on the average costs of several drug types
  of administration and adverse event valorisation
• Minimization of cost analysis
• cost of the drug,
• cost of drug and administration,
• cost of drugs, administration and
  hospitalisation for adverse events.

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Economic analysis of drug
Pemetrexed is 86 more costly.
Pemetrexed is 42 more costly.
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Economic analysis of drug
Costs of drugs with home based chemotherapy for
pemetrexed
Pemetrexed is 30.2 more costly
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Economic analysis of drug
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• The cost of drugs
• The costs
• of the use
• of drugs

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Summary

• French health care system
• What do we know?
• What we would like to know

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Discussion
Toxicity
Effectiveness
Quality of life
Decision
Costs
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What we would like to know

• The impact on average cost strategy
• The impact on the cost sequence first, second or
  terminal care
• The consequences in terms of
• Cost per LYS or DFS
• Cost per Qaly or Daily
• Cost per adverse event avoided

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What we would like to know
Costs
Direct costs (DC)
Intangible costs
Indirect costs (IC)
Out of work
Human and psychological costs
Medical
Non medical
Hospitalization, Medical and paramedical,
procedures
Transports, Home care, social supports
Prevention, rehabilitation, equipments, drugs
Recurrent adverse events
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What we would like to know

• The impact on average cost strategy
• The impact on the cost sequence first, second or
  terminal care
• The consequences in terms of
• Cost per LYS or DFS
• Cost per Qaly or Daily
• Cost per adverse event avoided

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What we would like to know
Pemetrexed
Docetaxel
Grade 4
Grade 2
Grade 3
Percent of patients
Grade 2
Grade 1
Grade 1
No adverse events
265
239
153
136
100
276
238
160
139
102
88
90
No. of cycles Number of patients for whom data
are available
In general, adverse events were of lower severity
inpemetrexed patients than in docetaxel patients
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Proportion of time on chemotherapy spent with
each toxicity grade( ITT population)
What we would like to know
p 0.0049
p 0.0063
p 0.0002
p lt 0.0001
p lt 0.0001
Pemetrexed patients spent a smaller proportion of
their time on chemotherapy experiencing higher
grade drug-related adverse events
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Discussion

• Has health resource assessment some consequences
  on individual decision ?
• environment
• health care system
• technology
• expensive, accessibility of procedures
• patients preferences impact of QoL or trial
  participation

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Discussion

• Has health resource assessment some consequences
  on collective decision (public health) ?
• To know costs of disease or costs of management
  strategy like first line regimen
• To know costs of clinical management a new
  drug, RHE .

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The economic threshold
50 000/ QALY ??
20 000/QALY 2 GNP/p
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Discussion

• The last two questions
• would my own patients have the same outcome ?
• would my own patients have the same health
  resource assessment ?

Trials
Real life
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Conclusion

• global economic evaluation is unavoidable
• major role of perspective of economic assessment
• finally more information is required,
  particularly with comparison between costs and
  outcomes
• economic studies have to be included in clinical
  trials

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Perspective
Decider Clinician
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Conclusion

• global economic evaluation is unavoidable
• major role of perspective of economic assessment
• finally more information is required,
  particularly with comparison between costs and
  outcomes
• economic studies have to be included in clinical
  trials