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Transcript of HTA-challenges in the Medical Device Industry HTA-course, Danish Society for Biopharmaceutical...
HTA-challenges in the Medical Device IndustryHTA-course, Danish Society for Biopharmaceutical Statistics, May 26 2014Jeppe Sørensen, International Health Economist
Agenda1. Introduction to Coloplast
2. HTA challenges for medical devices – same or different?• Product characteristics• Licensing requirements
3. Country specific approaches to HTAs and medical devices – examples and implications for evidence
4. How does Coloplast respond to the challenges? Value based argumentation• “Traditional” cost-effectiveness analysis• Disease specific PROMs• Discreet choice experiments
Coloplast’s business areas, typical users and products
SenSura® MioLaunchedin 2011
SpeediCath®Compact SetLaunched in 2012
Altis®Single Incision slingLaunched in 2012
New Biatain®SiliconeLaunched in 2013
UrologyCare
People with dysfunctional urinary and reproductive systems
Wound & SkinCare
People with difficult-to-healwounds
ContinenceCare
People in need of bladderor bowel management
OstomyCare
People who have had their intestine redirected to an opening in the abdominal wall
1. INTRODUCTION
Business areas 2012/13
Ostomy Care #1globalposition
35-40%global marketshare
42%of Coloplastrevenue
4.8billion DKKannual revenue
7%organic growthrate
Innovative solutions
1. INTRODUCTION
Business areas 2012/13
Continence Care #1globalposition
40-45%global marketshare
35%of Coloplastrevenue
4.1 billion DKKannual revenue
7%organic growthrate
Award winning Products
1. INTRODUCTION
Product characteristics of medical devices influence conditions for establishing evidenceReasons why devices are different in relation to RCTs
1. Difficult/impossible to do blinded studies with devices
2. No “steady state” period: Frequent product modifications and
3. Device-Operator Interactions: Efficacy depends on how it is used and RCT risks demonstrating experience rather than differences
2. MEDICAL DEVICES – SAME OR DIFFERENT?
Source: Drummond, M., Griffin, A. and Tarricone, R. (2009), Economic Evaluation for Devices and Drugs—Same or Different?. Value in Health, 12: 402–404
Different licensing requirements compared to drugs mean different conditions for producing evidence
Pharma • 10-15 years development and clinical trials aiming at a strong regulatory file for
FDA/EMA approval
Medical devices • Often a CE-mark is the only licensing requirement for disposable medical
devices• 2-3 years from idea to market• Fewer and smaller trials
2. MEDICAL DEVICES – SAME OR DIFFERENT?
Example: Evidence on hydrophilic coated vs. uncoated catheters and occurrence of UTIs
Patients UTI rates in community is the most relevant measure for real life picture of the UTI rate.
Number of patients UTI / yr
Uncoated HCIC Uncoated HCIC
Cardenas 2009 23 22 1.65 0.77
UTI reduction 53 %
Low patient number
Institutional data is the best measure for a difference in UTI rates, however it overestimates the real life UTI rates.
Number of patients UTI / yr
Uncoated HCIC Uncoated HCIC
De Ridder 2005 61 60 6.60 5.28
Cardenas 2011 114 105 8.18 6.47
UTI reduction 21 %
Independently, both studies
indicate a 21 % UTI reduction
2. MEDICAL DEVICES – SAME OR DIFFERENT?
ECONOMICAL EVALUATION
Committee 2 (CEPS)
Example: France – reimbursement system & characteristics
Key characteristicsCommunity Reimbursement system
MEDICAL SERVICE : YES/ NO MEDICAL SERVICE IMPROVEMENT (MSI):
5 gradesI. Major improvement → high price
II. Important improvement → premium price
III. Moderate improvement → price level ?
IV. Minor improvement → parity/ low price
V. No improvement → No reimbursement / low price
Decision-makers = physicians
Spotlight clinical data
HAS: The French National Authority for Health evaluates reimbursement in 2 steps (outside category)
1st step: Medical evaluation
REIMBURSEMENT PRICE -> LPPR
Cost-minimisation politic for Healthcare
Spotlight budget impact and
EU prices/ reimbursement
2nd step: Economic evaluation
• National categories with fixed prices: OC: 17 sub-categories IC: 3 sub-categories (CD: 8 sub-categories) WC: sub-categories based on size Application time in category: < 1 week
(only need safety registration in Afssaps)
Clinical data not required No international reference pricing Review every 5th year (longer in reality)
• Brand specific reimbursement possible Application time: 6 – 12+ months Clinical data required International reference pricing Review every 5th year (incl reference price)
• Co-payment: none for chronic care (OC/ CC)
35% non Chronics (but 90% insured)
TECHNICAL & MEDICAL EVALUATION
Committee 1 (CEPP/ CNEDiMTS)
3. APPROACHES TO HTA
The Coloplast payer landscape – differs across markets
Page 11
100 %Co-payment
Procurement/ Tenders
Reimbursement/ Value based
Reimbursement/ Fixed categories
Pricing / feature based
Performance/value based
?
3. APPROACHES TO HTA
Example on how health economics is used for value argumentation in relation to intermittent catheterization
Page 12
Published article show that by using a hydrophilic coated catheter, a UTI reduction of 21 % can be obtained
Urologist and rehab specialist panel
Consolidated possible
adverse events
Health economic analysis
Findings
Hydrophilic coated catheters are
4% more expensive than uncoated catheters
HCIC increase QALY by 5%, increase additional life years by
4% and decrease the risk of UTI
by 16 % with a lifetime perspective
4. VALUE BASED ARGUMENTATION
Chronic Urinary Retention – HCIC vs. uncoated
No/minor renal impairment
UTI not responding to initial treatment
UTI responding to initial treatment
No UTI
Major renal impairment
UTI not responding to initial treatment
UTI responding to initial treatment
No UTI
Chronic kidney failure
UTI not responding to initial treatment
UTI responding to initial treatment
No UTI
No/minor renal impairment
Chronic kidney failure
Major renal impairment
No or minor renal impairment requiring dietary changes only
Careful monitoring is needed.
• Monthly risk : 0,020% (1/4 of upper tract abnormalities, Weld
2000)
Dialysis or renal replacement therapy needed.
• Monthly risk : 0,0035% (UK renal registry, Lawrenson 2001)
Page 13
No UTI
UTI not responding to initial treatment
UTI responding to initial treatment
Presence of treatment-requiring urinary tract infections that responds well to initial treatment - including 7% multiple drug resistance. • Monthly risk at IC: 32,6% (Cindolo 2004, Cardenas
2009 + 2011, De Ridder 2005, Giannantoni 2001, Duffy 1995 & King 1992)
• Risk reductions HCIC vs. uncoated: 10% (meta analysis) 21% (Cardenas 2011 – controlled part), 53% (Cardenas 2009)
Including cases leading to epididymitis, pyelonephritis and urosepsis. • Monthly risk: 0,320% (Chai 1995, Perrouin-Verbe 1995,
Weld 2000)• Risk reduction HCIC vs. uncoated: 10% (Expert
assumption)
No presence of treatment-requiring urinary tract infections
Bladder stones 0.117% (Perrouin-Verbe 1995, Chai 1995) Kidney stones 0.117% (assumed the same as bladder stones)Urethral damage 0.189% (Perrouin-Verbe 1995, Chai 1995 and Weld 2000)
Background adverse events
Full overview of the CEM CUR Model
Page 14
Urinary Tract Infections
Adverse EventsCost Data
Results
Data input Modelling Output
No/minor renal impairment
Major renal impairment
Chronic kidney failure
No UTIUTI responding to initial treatment
UTI not responding to initial treatment
4. VALUE BASED ARGUMENTATION
Output
Page 15
UTIs
Adverse Events
Mean cost
Mean QALYMean LYG
Data input Modelling Output
ICERCost-effectiveness ratio
depends on local costing data
4. VALUE BASED ARGUMENTATION
Limitations in conventional CUAs in relation to effects of medical devices – defining and measuring QOL
Page 16
4. VALUE BASED ARGUMENTATION
Page 17
Example: SpeediCath Compact and quality of life
QoL
HRQoL
Disease QoLQualiveen
C-IQoL
SF-36
EQ-5D
ISC-Q
• Validated instrument accepted for publication (Pinder 2013)• Total score 0-100 based on 24 questions in 4 domains:• Ease of use, convenience, discreteness and psychosocial
wellbeing
Intermittent Self-Catherisation Questionnaire (ISC-Q)
Compact: 17 point improvement out of 100Randomised controlled trial of 118 neurogenic users from 5 countries using Compact 6 weeks vs. non-Compact for 6 weeks (Chartier-Kastler 2013).
Compact trial results on quality of life (ISC-Q)
But what is better quality of life worth ?
4. VALUE BASED ARGUMENTATION
One way is to base willingness to pay on a discreet choice experiment
Page 18
Attribute Catheter A Catheter B
Convenience
Catheter coating Apply gel to the catheter to lubricate it The catheter is pre-coated with lubricant
and needs no preparation
Risk of infection No urinary tract infections You will have 1 urinary tract infection
Ease of insertion Moderately easy to insert Difficult to insert
Willingness to pay £XX per month £XX per month
Which catheter do you prefer?
4. VALUE BASED ARGUMENTATION
Example of WTP results for specific catheter attributes
Page 19
• WTP puts a value on the benefit of certain features to the users
• Can be used to link an improvement in quality of life to monetary units
• In Coloplast WTP is used to describe user-perceived value of various aspects (i.e. coating, risk of infection, convenience etc.)
• A regular cost-minimisation analysis only counts costs – WTP counts the value for the users
Attribute Level £/Cath.
Convenience Small and compact.Moderately sized. Not compact and can be bulky.
XXXX
-
Catheter coating
Pre-coated, needs no preparation. Add water and wait ~30 seconds. Apply gel.
XXXX
-
Risk of infection
UTI next 12 months: No urinary tract infections 1 urinary tract infection 3 urinary tract infections
XXXX
-
Ease of insertion
Easy Moderately easy Difficult
XXXX
-
4. VALUE BASED ARGUMENTATION
Assessment of SAS premium evidence10 May 2013
Existence of evidence within the field of stoma care is very limited
Page 20
Stoma appliance trials registered at ClinicalTrials.gov
Sponsor Trials RCT Blinded Finished
Coloplast 15 13 0 14
ConvaTec 7 1 0 5
Hollister 2 0 0 2
Independent 1 1 0 1
Total trials 25 15 0 22
Subjects in trials: <6,000 in total – 2 trials accounts for ~5,000
Use of less valid study designs
The DialogueStudy
Details:
25 trials registered – 15 by Coloplast
15 RCTs registered – 13 by Coloplast
0 blinded trials registered – Not possible to blind stoma appliance trials
- >3,000 subjects included- Improved Quality of Life
- Improved leakage level- Improved skin condition
Half of all patient ever studied in stoma care
Use of Willingness-to-pay study
Combining willingness-to-pay study with cost-minimisation analysis ([email protected])
International perspective on evidence gap
4. VALUE BASED ARGUMENTATION
Jeppe Sørensen
International Health Economist, Coloplast
Page 22