Costeffectiveness analyses in relapsed advanced NSCLC

1
Cost-effectiveness analyses in relapsed advanced
NSCLC

• Pieter Postmus
• Vrije Universiteit, Amsterdam, The Netherlands

2
NSCLC and Tarceva in The Netherlands

• Approximately 9,000 new cases of lung cancer each
  year inThe Netherlands
• about 80 NSCLC
• Tarceva approved in 2005 for treatment of
  relapsed advanced NSCLC as part of EU-wide
  approval based on BR.21 study results
• first oral drug with proven efficacy in this
  setting
• similar efficacy to other approved drugs
  (chemotherapy) but with benefits in terms of
  tolerability and convenience
• Health economic (HE) analyses performed to
  determine whether these benefits provide value
  for money to healthcare systems

3
The Netherlands reimbursement system

• Different reimbursement systems for hospital and
  ambulatory drugs
• For ambulatory drugs

Non-unique products
Unique products with clinically proven added
therapeutic value
No HE analysis necessary Reimbursement limit
applies
Mandatory HE analysis No reimbursement limit
4
Reimbursement for unique ambulatory drugs

• Dossiers evaluated by national reimbursement
  committee
• Minister takes final decision based on committee
  advice
• Comparators to be used in the dossier are defined
  by the reimbursement committee
• standard care
• usual care
• HE analysis was mandatory for Tarceva

5
HE analysis for Tarceva in relapsed advanced NSCLC

• Cost-effectiveness analysis
• assesses both costs and clinical outcomes
• results expressed as cost per life-year gained
  (LYG)
• Comparators defined for Tarceva dossier
• docetaxel standard of care according to
  guidelines
• BSC usual care in daily practice

6
Characteristics of HE analysis

• Markov cost-effectiveness model
• 3-year time horizon
• Cycle length of 1 month
• Costs based on official 2004 list prices for both
  drug and hospital expenditures
• Discounting at 4 for both costs and effects
• Assumptions verified by an expert panel

Pompen M, et al. Value Health 20069A203 (Abs.
CN3)
7
HE analysis efficacy

• No head-to-head data for Tarceva versus
  docetaxelavailable at the time of this analysis
• available data suggest equivalent efficacy
• BR.21 study data
• overall survival and progression-free survival
  availablefor 2 years
• extrapolated to 3 years using Weibull
  distribution
• equivalent efficacy for Tarceva and docetaxel
  assumedin this analysis

8
Phase III studies efficacy outcomes
1Shepherd FA, et al. N Engl J Med
200535312332 2OSI and Roche data on
file3Shepherd FA, et al. J Clin Oncol
2000182095103 4Fossella FV, et al. J Clin
Oncol 2000182354625Hanna N, et al. J Clin
Oncol 200422158997
Results cannot be compared directly because of
different patient populations Includes
third-line patients
9
HE analysis costs

• Overall costs comprised
• drug acquisition costs
• administration costs
• general management costs (e.g. outpatient visits,
  hospitalisation, diagnostic procedures,
  laboratory tests)
• No published data available for resource use with
  BSC
• Therefore, retrospective medical chart review
  performed to substantiate resource utilisation by
  patients on BSC and docetaxel, from diagnosis
  until death
• first time that resource utilisation data
  collected for patients with NSCLC in The
  Netherlands

10
HE analysis costs (medical chart review)

• Collected by single, independent investigator
• five hospitals (one academic, four general)
• 96 charts reviewed (72 BSC 24 docetaxel)
• To correct for differences in overall survival,
  data expressed as amount of resource used per
  month
• All data confirmed by a panel of 10 Dutch lung
  cancer clinical experts
• Expert panel also provided overview of possible
  medical treatments for various AEs
• no data available for outpatient visits or
  hospitalisation in relation to treatment of AEs
• costs for managing docetaxel AEs expected to be
  higher than those for Tarceva

11
Results efficacy
Tarceva/docetaxel overall survival Tarceva/docetax
el PFS BSC overall survival BSC PFS
1.0 0.8 0.6 0.4 0.2 0
Proportion
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 3
6
Months
12
Results costs

• Tarceva offers cost savings versus docetaxel
• same efficacy, lower costs

Total for 3-year period Tarceva 2,184 for 30
tabletsDocetaxel 144mg/3 weeks 2,153.95 for 3.3
cycles/patient Weekly administration of 1/3 doses
of docetaxel would increase treatment costs to
27,596
13
Results breakdown of treatment costs

• Drug costs are main cost driver for both active
  treatments (38)
• Hospitalisation is main cost driver for BSC
  (58) double that for active treatments (25)
• 30 of cost with both active treatments and BSC
  is for laboratory tests and diagnostic
  procedures
• Costs due to AEs are very low because reliable
  data on hospitalisation were not available only
  drug costs are included

Average total treatment cost( per patient for 3
years 2004)
14
Results cost-effectiveness

• Tarceva is cost-saving versus docetaxel (lower
  costs, equivalent efficacy)
• Incremental cost-effectiveness ratio (ICER)
  difference in costs/difference in effects
• ICER37,551 (12,62172,960) per LYG for Tarceva
  versus BSC
• Tarceva is cost-effective versus BSC
  (willingness-to-pay threshold of 50,000/LYG)

PSA probabilistic sensitivity analyses
conducted on both outcomes and resource use
15
Results sensitivity analyses

• Hospitalisation for Tarceva BSC instead of
  docetaxel
• Length of hospitalisation (active 0.59.7, BSC
  0.416)
• Median instead of mean for resource use
• Number of outpatient visits (active 0.74.3,
  BSC 0.125)
• Frequency of hospitalisation (active
  0.11.7, BSC 0.13)
• Shorter treatment duration with Tarceva (2.2
  months)

Tarceva versus BSC

• Tarceva remained cost-saving versus docetaxel in
  all scenarios, unless 110mg/cycle docetaxel used
  (8 patients), which made Tarceva 854 more
  expensive

16
Conclusions The Netherlands

• Tarceva is cost-saving versus docetaxel
• Tarceva is cost-effective versus BSC
• Reimbursement committee conclusion
• positive reimbursement decision resulted in
  unrestricted access to Tarceva in The Netherlands

17
Other HE analyses of Tarceva in relapsed advanced
NSCLC

• Canada
• cost-effective versus BSC1
• Germany
• cost-saving versus docetaxel and pemetrexed2
• Spain
• cost-saving versus docetaxel and pemetrexed3
• Poland
• cost-saving versus docetaxel and pemetrexed4
• UK
• cost-saving versus docetaxel5

1Côté I, et al. Value Health 20069A279 (Abs.
PCN11) 2Gabriel A, et al. Value Health
20069A278 (Abs. PCN9) 3Rubio Terres C, et al.
Value Health 20069A2834 (Abs. PCN26)
4Orlewska E, et al. Value Health 20069A279
(Abs. PCN12) 5Lewis G, et al. Value Health
20069A2034 (Abs. CN4)
18
European countries in which Tarceva is reimbursed
19
Summary

• Tarceva is the first oral drug with proven
  efficacy in relapsed advanced NSCLC
• HE analyses in several countries suggest that
  Tarceva is
• cost-saving versus docetaxel
• cost-saving versus pemetrexed
• cost-effective versus BSC
• Therefore, Tarceva delivers both clinical and
  economic benefits in the treatment of relapsed
  advanced NSCLC