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HTA-challenges in the Medical Device Industry. HTA-course, Danish Society for Biopharmaceutical Statistics, May 26 2014 Jeppe Sørensen, International Health Economist. Agenda. Introduction to Coloplast HTA challenges for medical devices – same or different? Product characteristics

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hta challenges in the medical device industry

HTA-challenges in the Medical Device Industry

HTA-course, Danish Society for Biopharmaceutical Statistics, May 26 2014

Jeppe Sørensen, International Health Economist

agenda
Agenda
  • Introduction to Coloplast
  • HTA challenges for medical devices – same or different?
    • Product characteristics
    • Licensing requirements
  • Country specific approaches to HTAs and medical devices – examples and implications for evidence
  • 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

1. INTRODUCTION

Coloplast’s business areas, typical users and products

Ostomy

Care

Continence

Care

Urology

Care

Wound & Skin

Care

People in need of bladderor bowel management

People who have had their intestine redirected to an opening in the abdominal wall

People with dysfunctional urinary and reproductive systems

People with difficult-to-healwounds

SenSura® Mio

Launchedin 2011

SpeediCath®

Compact Set

Launched in 2012

New Biatain®

Silicone

Launched in 2013

Altis®

Single Incision sling

Launched in 2012

business areas 2012 13 ostomy care

1. INTRODUCTION

#1global

position

35-40%

global market

share

Business areas 2012/13Ostomy Care

42%of Coloplast

revenue

7%organic growth

rate

4.8

billion DKKannual revenue

Innovative solutions

business areas 2012 13 continence care

1. INTRODUCTION

#1globalposition

40-45%

global marketshare

Business areas 2012/13Continence Care

35%

of Coloplast

revenue

7%organic growth

rate

4.1 billion DKKannual revenue

  • Award winning Products
product characteristics of medical devices influence conditions for establishing evidence

2. MEDICAL DEVICES – SAME OR DIFFERENT?

Product characteristics of medical devices influence conditions for establishing evidence

Reasons why devices are different in relation to RCTs

  • Difficult/impossible to do blinded studies with devices
  • No “steady state” period: Frequent product modifications and
  • Device-Operator Interactions: Efficacy depends on how it is used and RCT risks demonstrating experience rather than differences

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

2. MEDICAL DEVICES – SAME OR DIFFERENT?

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
example evidence on hydrophilic coated vs uncoated catheters and occurrence of utis

2. MEDICAL DEVICES – SAME OR DIFFERENT?

Example: Evidence on hydrophilic coated vs. uncoated catheters and occurrence of UTIs

Independently, both studies indicate a 21 % UTI reduction

Institutional data is the best measure for a difference in UTI rates, however it overestimates the real life UTI rates.

Low patient number

Patients UTI rates in community is the most relevant measure for real life picture of the UTI rate.

example france reimbursement system characteristics

3. APPROACHES TO HTA

Example: France – reimbursement system & characteristics

CommunityReimbursement system

Key characteristics

HAS: The French National Authority for Health

evaluatesreimbursement in 2 steps (outsidecategory)

  • Nationalcategorieswithfixedprices:
  • OC: 17 sub-categories
  • IC: 3 sub-categories(CD: 8 sub-categories)
  • WC: sub-categoriesbasedonsize
  • 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 specificreimbursementpossible
  • Application time: 6 – 12+ months
  • Clinical data required
  • International reference pricing
  • Review every 5th year (incl reference price)
  • Co-payment: none for chroniccare(OC/ CC)
  • 35% non Chronics (but 90% insured)

1st step: Medical evaluation

2nd step: Economic evaluation

ECONOMICAL EVALUATION

Committee2 (CEPS)

TECHNICAL & MEDICAL EVALUATION

Committee 1 (CEPP/ CNEDiMTS)

  • MEDICAL SERVICE : YES/ NO
  • MEDICAL SERVICE IMPROVEMENT (MSI):
  • 5 grades
  • REIMBURSEMENT PRICE -> LPPR
  • Major improvement → high price
  • Important improvement → premium price
  • Moderateimprovement → price level ?
  • Minorimprovement → parity/ low price
  • No improvement → No reimbursement / low price

Decision-makers = physicians

Spotlight clinical data

Cost-minimisation politic for Healthcare

Spotlight budget impact and

EU prices/ reimbursement

the coloplast payer landscape differs across markets

3. APPROACHES TO HTA

The Coloplast payer landscape – differs across markets

?

Reimbursement/

Value based

Reimbursement/

Fixed categories

Procurement/

Tenders

100 %Co-payment

Pricing / feature based

Performance/value based

Page 11

slide12

4. VALUE BASED ARGUMENTATION

Example on how health economics is used for value argumentation in relation to intermittent catheterization

Published article show that by using a hydrophilic coated catheter, a UTI reduction of 21 % can be obtained

Urologist and rehab specialist panel

Health economic analysis

Findings

Hydrophilic coated catheters are 4% more expensivethan uncoated catheters

HCIC increase QALY by 5%, increase additional life years by4%and decrease the risk of UTI by16 %with a lifetime perspective

Consolidated possible adverse events

chronic urinary retention hcic vs uncoated
Chronic Urinary Retention – HCIC vs. uncoated

No/minor renal impairment

Major renal impairment

Chronic kidney failure

No UTI

UTI responding to initial treatment

No UTI

UTI responding to initial treatment

No UTI

UTI responding to initial treatment

UTI not responding to initial treatment

UTI not responding to initial treatment

UTI not responding to initial treatment

No UTI

No presence of treatment-requiring urinary tract infections

No/minor renal impairment

No or minor renal impairment requiring dietary changes only

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)

Major renal impairment

  • Careful monitoring is needed.
  • Monthly risk : 0,020% (1/4 of upper tract abnormalities, Weld 2000)

UTI not responding to initial treatment

Chronic kidney failure

  • Dialysis or renal replacement therapy needed.
  • Monthly risk : 0,0035% (UK renal registry, Lawrenson 2001)
  • 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)

Background adverse events

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)

full overview of the cem cur model

4. VALUE BASED ARGUMENTATION

Fulloverview of the CEM CUR Model

No/minorrenalimpairment

Major renalimpairment

Chronickidneyfailure

No UTI

UTI responding to initial treatment

UTI not responding to initial treatment

Data input

Modelling

Output

Urinary Tract Infections

Results

Adverse Events

Cost Data

output

4. VALUE BASED ARGUMENTATION

Output

Data input

Modelling

Output

Mean cost

Mean QALY

Mean LYG

UTIs

ICER

Cost-effectiveness ratio depends on local costing data

Adverse Events

example speedicath compact and quality of life

4. VALUE BASED ARGUMENTATION

Example: SpeediCath Compact and quality of life

Intermittent Self-Catherisation Questionnaire (ISC-Q)

QoL

HRQoL

  • 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

SF-36

EQ-5D

Disease QoL

Qualiveen

C-IQoL

Compact trial results on quality of life (ISC-Q)

Compact: 17 point improvement out of 100

Randomised controlled trial of 118 neurogenic users from 5 countries using Compact 6 weeks vs. non-Compact for 6 weeks (Chartier-Kastler 2013).

ISC-Q

But what is better quality of life worth ?

Page 17

example of wtp results for specific catheter attributes

4. VALUE BASED ARGUMENTATION

Example of WTP results for specific catheter attributes
  • 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
existence of evidence within the field of stoma care is very limited

4. VALUE BASED ARGUMENTATION

Existence of evidence within the field of stoma care is very limited

Details:

Subjects in trials: <6,000 in total – 2 trials accounts for ~5,000

25 trials registered – 15 by Coloplast

15 RCTs registered – 13 by Coloplast

0 blinded trials registered – Not possible to blind stoma appliance trials

International perspective on evidence gap

Use of Willingness-to-pay study

Use of less valid study designs

The DialogueStudy

  • >3,000 subjects included
  • Improved Quality of Life
  • Improved leakage level
  • Improved skin condition

Combining willingness-to-pay study with cost-minimisation analysis (niklas.hedberg@tlv.se)

Half of all patient ever studied in stoma care