1. A multi-center evaluation of clinical pathways cost and time using real-life data in patients treated for their breast cancer in day sessions
Comparison between two modes of administration of trastuzumab: IntraVeinous (IV) versus SubCutaneous (SC)
Nadia Bahmad, ROCHE
2nd World Congress on Health Economics Policy & Outcomes Research - June 29-30, 2017 Madrid, Spain 1

2. 1 2 3 4 Contents Context and objectives Real-life data collection
Comparative analyses : IV versus SC 4
Discussions

3. 1. Context and objectives

4. The 2 objectives of the study
Assess the organizational impacts of IV versus SC
Evaluate the difference in pharmacy preparation time between the 2 forms
Evaluate the difference in patient’s admission duration between the two forms
(B) Assess the economic impact of IV versus SC
Evaluate the differences in consumables costs for the preparation and the administration between the two forms
Note: The economic perspective is from the health facility point of view.

5. 2. Real-life data collection

6. Data collection methodology
An observational and multicenter study with 2 forms
9 facilities
Facility form: the organizational model
1 form by facility
Number of patients
Opening hours
Pharmacy organization
Herceptin® preparation
2) Patient form: the care management
1 form by patient
All stages of cancer
Treated with Herceptin® SC or IV
Anonymous forms
Details of the care process
Validation by a board of medical experts: September 2016
Collection period: from mid-Nov to mid-December 2016 (= 1 month)
Patient selection: non-random method in incoming patients
Theoretical minimum number of patients per facility: 15 IV and 15 SC

7. Data collection results
An observational and multicentric study
417 patient forms were obtained
411 patients*
248 patient forms
with SC
245 SC patients
169 patient forms
with IV
167 IV patients**
PATIENTS
IV form
* 6 patients came twice for a drug administration
** 1 patient received Herceptin® in a IV form, then in SC form
THE 9 FACILITIES
8 out of 9 : more than 30 patient forms collected
3 out of 9 : less than 15 IV patient forms (including 1 facility with none)
2 out of 9 : less than 10 IV patient forms

8. A precision about cost evaluation
Each medical facility performs a detailed cost analysis of consumables
Illustration : most commonly used consomables
For each item : unit cost and used quantity
Advantages of this cost evaluation : a robust comparison (compared to “times”)
 Robustness, since not influenced by factors (organization, size)
 No bias of data collection among the facilities
 Easily repeatable in new facilities
Type of consumables for the administration of Herceptin® (SC or IV)
Drip set
Site Y perfuser
Syringe 30 ml luer lock for preparation 0,408
Secure Hubert needle
Rinse aid of 50 ml NaCl 0.9%
10 ml luer lock syringe for preparation
Needle for SC 23g
Disconnection set
NaCl 250 ml
Needle 18g for preparation
3 way luer lock faucet
Secure administration device (Duoperf)

9. 3. Comparative analyses : IV versus SC

10. Patient characteristics
1/6
Patient characteristics
60 (± 13)
58 (± 14)
59 (± 13)
Age
66 kg (± 13)
68 kg (± 16)
67 kg (± 14)
Weight (kg)
Weight

11. Analyses of treatment combinations
2/6
Analyses of treatment combinations
Monotherapy or in combination?
Monotherapy
in combination with
another IV treatment
Conclusion :
The proportion of Herceptin® alone in monotherapy is significantly higher for the SC form than for the IV form.

12. Analyses of treatment preparation
3/6
Analyses of treatment preparation
Level of anticipation (= early preparation)
Anticipated
Partially anticipated
No anticipation
Conclusion :
The anticipation of Herceptin® preparation is significantly associated with the form of administration of Herceptin® (SC / IV) at the 5% threshold.
Early preparation rate (before arrival of the patient) is more important for the IV form than the SC form.

13. Analyses of treatment preparation
4/6
Analyses of treatment preparation
Preparation time
1 min (± 1)
14 min (± 12)
Time (minutes)
Conclusion :
Average preparation times were significantly different at the 5% threshold between the SC and IV groups (p <0.0001).
The mean time for pharmaceutical preparation was significantly higher of 13 minutes (± 7 minutes) for the IV form.

14. Analysis of total session time
5/6
Analysis of total session time
Elapsed time between start and end of
Herceptin® administration: IV versus SC
87% of IV patients spend more than 2 hours
Probability
26% of SC patients spend more than 2 hours
Time (hours)
Conclusion :
Average difference in administration time is 107 minutes (± 8 minutes).
SC form: 74% of sessions last less than 2 hours versus 13% for IV form.

15. Cost of consumables : a robust comparison
6/6
Cost of consumables : a robust comparison
12.42€ (± 2.20€)
Total cost (euros)
1.35€ (± 0.47€)
Costs not incl. VAT
Note: For 121 sessions out of 417 (29%), no consumable cost could be calculated
Conclusions :
A significant difference between the two forms :
differential of 11.07€ (± 1.36 € VAT not included).

16. 4. Discussions

17. Review of this study on the administration of trastuzumab
A multicenter study: 9 facilities
411 patients were included: 60% SC and 40% IV
Mean time of care admission is significantly higher by 1h47 minutes (± 1h20) for the IV form compared to SC
Average time is 8 minutes higher for the installation step in SC.
Average time is 40 minutes higher for the administration step in IV.
Consumables cost analyses:
A strong significant difference between the two forms
Cost is 1.35€ for SC versus for IV : 11.07€ of difference

18. Discussions Bias and limits
Bias of data collection: the major role of “forms“
The matching of post-confounding factors: recruitment using a non-random method:
 Strong impact of the treatment combinations (monotherapy, adjuvant, associated): 89% of SC sessions are monotherapy versus 39% of IV sessions
 Unbalanced distribution of the number of patients in each group (1 month of data collection)
Still, a robust and repeatable cost analysis.

19. Thank you for your attention.
Any question?