example of health technology assessment (hta) of a therapy for the reduction of alcohol consumption...
TRANSCRIPT
Example of Health Technology Assessment (HTA)
of a therapy for the reduction of alcohol
consumption
David TyasGlobal HEOR - Lundbeck
Contents
• Introduction into a HTA process• Use SMC as an example but equally
could be from many other countries
• Summary of our submission• Main argument• Types of analysis• Clarification question stage
• Summary of questions (what sort)• Final recommendation
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Economic Evaluations in EuropeNorway: Pharmacoeconomic data required for reimbursement; official guidelines in operation.
Finland:Pharmacoeconomic evidence mandatory for evaluating newtherapies for reimbursement and may also be requested for existing therapies.
Sweden:Cost-effectiveness data required for reimbursement.
Denmark:Cost-effectiveness data may be requested for reimbursement decisions.
UK:NICE, SMC, and AWMSG evaluates the cost effectiveness of medicines.
Germany:Guidelines prepared. Institute for Quality and Efficiency in the Health Service established in 2004.
France:Not a formal requirement but increasingly used in reimbursement decisions. Guidelines prepared.
Spain:Health technology assessment at a regional level.
Portugal:Cost-effectiveness data incorporated into reimbursement decisions.
Italy:Cost-effectiveness considered in pricing and reimbursement decisions.
Greece: Guidelines for pharmacoeconomic studies prepared; cost-effectiveness data may be requested.
Belgium: Formal requirement for economic evaluation.
Netherlands:Pharmacoeconomic evidence explicitly required for reimbursement of new products.
Ireland: Guidelines for pharmacoeconomic studies prepared; cost-effectiveness data may be requested.
Poland: C/E and BIA may be requested. HTA agency.
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Manufacturers submission
Clarification questions
Draft advice
Final recommendati
on
SMC process
4
Example of a HTA submission dossier- SMC requirements
Chapter 1 Registration Details
Chapter 2 Overview and Positioning
Chapter 3 Comparative Efficacy
Chapter 4 Comparative Safety
Chapter 5 Clinical Effectiveness
Chapter 6 Pharmaco-Economic
Evaluation
Chapter 7 Resource Implications
Total ~ 100 pages
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NalmefeneMain arguments and data
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Indication
Nalmefene is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification.
WHO categoryTotal Alcohol Consumption
(g/day)
Women Men
Very high-risk consumption > 60 > 100
High-risk consumption 40–60 60–100
Medium-risk consumption 20–40 40–60
Low-risk consumption 1–20 1–407
Relative risk for all-cause mortality by average daily intake of alcohol
8
9
Place in therapy
Stages of alcohol abuse/ dependence
Early Middle Late
Brief intervention
Reduction
Abstinence
Tre
atm
ent
inte
nsity
10
Clinical efficacy
Study name Study duration Patients enrolled High drinking risk
ESENSE 1(Mann 2013; Wim van den Brink 2013)
24-week604
(306+298)350
180+170
ESENSE 2(Gual 2013; Wim van den Brink 2013)
24-week718
(358+360)317
(155+162)
SENSE(Wim van den Brink 2014)
52-week675
(509+166)187
3 RCTs in patients with alcohol dependence
Mann et al. 2013. Biol Psychiatry 73(8) 706-713Gual et al. 2013. Eur Neuropsychopharmacol 23(11) 1432-42Wim van den Brink et al. 2014. J PsychopharmacolWim van den Brink et al. 2013. Alcohol and Alcoholism. 1–9 11
Pharmaco Economic analysis
Objective:• To show nalmefene is cost-
effective
Treatment alternatives:• Nalmefene + psychosocial
support• Psychosocial support alone
Perspective:• Healthcare system
Time horizon:• 1 year: period covered by RCTs• 5 years
Population:• nalmefene indication as informed
by phase III clinical programme
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General concept of the model
Decreasecosts
IncreaseQALYs
Reduction of alcohol intake
Quality-Adjusted Life Year (QALY)
QALY=patient quality of life * patient survival
Reduction of alcohol-attributable harms and mortality
Severe morbidities and injuries considered:
• Transport injuries• Injuries other than
transport• Ischaemic heart
disease• Ischaemic stroke• Liver cirrhosis• Pancreatitis• lower respiratory
infections
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Clarification questions
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1. Patient discontinuation
2. Calculation of number of days taking therapy
3. Application of utility in the model
4. Proportion who receive care at a specialist level
5. Real world discussion of relapse rate
Final recommendation
16
17
Questions….