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


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


Very different funding systems and HTA-requirements – two examples

3. APPROACHES TO HTA

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)


The Coloplast payer landscape – differs across markets

100 %Co-payment

Procurement/ Tenders

Reimbursement/ Value based

Reimbursement/ Fixed categories

Pricing / feature based

Performance/value based

?


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

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



No UTI

Chronic kidney failure



No UTI




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)

No UTI



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

Urinary Tract Infections

Adverse EventsCost Data

Results

Data input Modelling Output




No UTIUTI responding to initial treatment



Output

UTIs

Adverse Events

Mean cost

Mean QALYMean LYG

Data input Modelling Output

ICERCost-effectiveness ratio

depends on local costing data


Limitations in conventional CUAs in relation to effects of medical devices – defining and measuring QOL


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 ?


One way is to base willingness to pay on a discreet choice experiment

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?


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

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

-


Assessment of SAS premium evidence10 May 2013

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

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


mailto:[email protected]

Any questions or comments ?

Jeppe Sørensen

International Health Economist, Coloplast

[email protected]

mailto:[email protected]

dksfjsldkj22 May, 2014

hta-challenges in the medical device industry hta-course, danish society for biopharmaceutical...

Documents

medical devices examples

disposable medical devices

introduction slide

different conditions

uti reduction53

uti reduction21

coloplast revenue

real life uti rates