Download Michael Barry - Irish Pharmaceutical Healthcare Association

The role of Health Technology
Assessment (HTA) and current
developments in Ireland
Dr. Michael Barry
November 25th 2010
The role of Health Technology Assessment
“ensuring the best health outcomes for Irish
patients while securing value for money”
Health Strategy 2001
The fundamental economic problem – Scarcity !
?
Expenditure on medicines in Ireland
(Community Drugs Schemes 1991 - 2009)
2500
Millions (€)
2000
1500
1000
500
0
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“€ 746 million saving required in the Health area”
For decision makers when considering
reimbursement of a pharmaceutical
product there are two questions
(a) Is it value for money ?
(b) Can we afford it ?
Health Technology
Assessment
“studies the medical, social, ethical, and
economic
implications
of
development,
diffusion and use of health technology”
INAHTA: 1998
Pharmacoeconomic Assessment
“rationing”
or
“priority setting”
HTA in Europe 2010
England & Wales:
National Institute of Clinical
Excellence (NICE) & All
Wales Medicines Strategy
Group (AWMSG)
Scotland:
Scottish
Medicines
Consortium
( SMC )
Ireland: National Centre
for Pharmacoeconomics
(NCPE ) & Health
Information and Quality
Authority (HIQA)
Finland:
Finish Office for HTA
( Finohta )
Sweden:
Swedish Council for Technology
Assessment in Health Care ( SBU ).
Denmark:
Danish Centre for Evaluation and
HTA ( DACEHTA )
Belgium:
Belgian Health Care
Knowledge Centre ( KCE ) .
France:
Haute Authorite de
Sante ( HAS )
Spain:
Health technology
assessment at a
regional level.
e.g. CAHTA
Norway:
Norwegian Knowledge
Centre for Health ( NOKC )
Netherlands:
Health Insurance Board ( CVZ ) .
Poland:
Polish agency for HTA
Germany:
Institute for Quality and
Efficiency in the Health
Service ( IQUiG ) .
Italy:
Italian Network for
HTA ( NI-HTA )
Austria;
Ludwig Boltzmann Institute of HTA ( LBI@HTA )
Switzerland:
Swiss Network for HTA ( SNHTA )
Pharmacoeconomic assessment prior to
reimbursement
“The HSE reserves the right to assess new and existing
technologies (pharmaceuticals, diagnostics and devices)
that may be high cost or have a significant budget impact on
the Irish healthcare system.”
IPHA/HSE agreement
2006
Recent developments in HTA in Ireland

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
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The cost-effectiveness of all new products is considered
prior to reimbursement under the Community Drugs
Schemes
The ‘Rapid Review’ process
Incremental cost-effectiveness ratio (ICER) and the
reimbursement recommendation
Probability of being cost effective at different thresholds
Methodological developments
Recent decisions and the use of PEA results
Updated HTA & Budget Impact guidelines
Pharmacoeconomic assessment (HTA)
A two – four
week process
to determine
whether a full
HTA is
required
Rapid Review
HTA not required
Full HTA
Rapid reviews not leading to a formal HTA
• Adenuric (Febuxostat)
• Cholesevelan (Cholestagel)
• Corifollitropin Alfa (Elonva)
• Dronedarone (Multaq)
• Degarelix (Fimagon)
• Indacaterol (Onbrez)
• Liraglutide (Victoza)
• Ranolazine (Ranexa)
• Silodosin (Urorec)
• Tobramycin (TOBI Podhaler)
If the rapid review process suggests that the
new product is unlikely to prove cost effective
or
we cannot be sure
Formal HTA
Incremental cost-effectiveness ratio (ICER)
and the reimbursement recommendation
1. Incremental Cost Effectiveness ratio
(ICER)
Cost A – Cost B
Effect A – Effect B
Cost
Effect
e.g. € 10,000/QALY
Cost effectiveness and probability of rejection
“there is no fixed cost-effectiveness threshold above or below which
technologies are guaranteed to be rejected or accepted for reimbursement”
€ 30,000
Probability
of rejection
€ 5,000
Increasing Cost per QALY (log scale)
Relationship between cost effectiveness and
probability of rejection
€ 30,000
Probability
of rejection
€ 5,000
Increasing Cost per QALY (log scale)
Cost-effectiveness and the probability of rejection
Relationship between cost effectiveness and
probability of rejection
35000
30000
25000
ICER values
€/QALY
for 2010
assessments
20000
15000
10000
5000
0
YES
NO
Probability of being cost-effective
“the probability that a technology is cost effective at a range
of threshold levels should be presented”
100%
Probability
of being
cost
50%
effective
€ 20,000/QALY
€ 45,000/QALY
Cost effectiveness threshold
Probability of being cost-effective
100%
Probability
of being
cost
50%
effective
€ 20,000/QALY
€ 45,000/QALY
Cost effectiveness threshold
Probability of being cost-effective
100%
Probability
of being
cost
50%
effective
€ 20,000/QALY
€ 45,000/QALY
Cost effectiveness threshold
Methodological developments in
pharmacoeconomic assessment (PEA) at
the NCPE

Mixed treatment comparisons
– a Bayesian approach

The expected value of perfect
information (EVPI)
Recommendations following evaluation of
individual products and price modulations
Jan 2005 – November 2010
A total of 65 evaluations were conducted
•
32 submissions were accepted without modification.
•
8 submissions were accepted with modifications.
•
25 submissions were rejected.
NCPE 2010
‘A tale of four countries’
Rycroft et al 2010 ISPOR
Recent pharmacoeconomic evaluations
Product
Indication
Eculizumab (Soliris)
PNH
Golimumab (Simponi)
Rheumatoid Arthritis
Oxycodone/naloxone (Targin)
Analgesia
Denosumab (Prolia)
Osteoporosis
Certolizumab pegol (Cimzia)
Rheumatoid Arthritis
Roflumilast (Daxas)
COPD
Eltrombopag (Revolade)
Immune thrombocytopenic purpura
Gefitinib (Iressa)
Non small cell lung cancer
Recent pharmacoeconomic evaluations
Product
Indication
Eculizumab (Soliris)
PNH
Golimumab (Simponi)
Rheumatoid Arthritis
Oxycodone/naloxone (Targin)
Analgesia
Denosumab (Prolia)
Osteoporosis
Certolizumab pegol (Cimzia)
Rheumatoid Arthritis
Roflumilast (Daxas)
COPD
Eltrombopag (Revolade)
Immune thrombocytopenic purpura
Gefitinib (Iressa)
Non small cell lung cancer
Negative PEA – what next ?
Example - Cimzia
Cost-effectiveness of certolizumab pegol
(Cimzia) in the treatment of moderate to
severe rheumatoid arthritis
“The review group was not convinced of the cost
effectiveness of certolizumab for the treatment of
rheumatoid arthritis in patients who have failed MTX”
“Consequently we do not recommend reimbursement of
certolizumab pegol at the submitted price”
1st September 2010
www.ncpe.ie
Negative PEA
Reimbursement
Pricing threshold analysis
&/or
Performance based risk sharing scheme
Pricing threshold analysis
The cost-effectiveness analysis usually includes a price/ICER assessment i.e.
pricing threshold analysis
This indicates the price of the product where the decision maker considers it
cost-effective or value for money
Q1
€45,000/ QALY
ICER
€20,000/QALY
€10,000
€15,000
Price (€) per patient/year
Performance Based Risk
Sharing Schemes
These are contracts between payers and
manufacturers that link reimbursement to a
products performance (e.g. clinical outcomes or
utilisation) in the post marketing setting.
Performance based models - terminology
Performance based schemes
Risk sharing schemes
Performance based risk sharing
schemes
Patient access schemes
“special ways pharmaceutical companies can propose to enable
patients to gain access to high cost drugs”
“innovative pricing arrangements designed to improve costeffectiveness”
Performance based models - terminology
DEAL !
Typical Deal
•
The payer (HSE) funds the drug for a
defined period of time, with
manufacturers refunding the cost of the
drug in patients who did not achieve the
targeted health outcome (e.g.
bortezomib for MM)
•
The HSE would purchase the drug at
50% of the regular price for the first
treatment cycle and then purchase at
the full price for those who achieved the
targeted outcome and continued on
therapy (e.g. sorafenib for mRCC)
Barry & Tilson IMJ 2010;103(5):133
Recent pharmacoeconomic evaluations
Product
Indication
Eculizumab (Soliris)
PNH
Golimumab (Simponi)
Rheumatoid Arthritis
Oxycodone/naloxone (Targin)
Analgesia
Denosumab (Prolia)
Osteoporosis
Certolizumab pegol (Cimzia)
Rheumatoid Arthritis
Roflumilast (Daxas)
COPD
Eltrombopag (Revolade)
Immune thrombocytopenic purpura
Gefitinib (Iressa)
Non small cell lung cancer
Recent reimbursement decisions
Product
Indication
Eculizumab (Soliris)
PNH
Golimumab (Simponi)
Rheumatoid Arthritis
Oxycodone/naloxone (Targin)
Analgesia
Denosumab (Prolia)
Osteoporosis
Certolizumab pegol (Cimzia)
Rheumatoid Arthritis
Roflumilast (Daxas)
COPD
Eltrombopag (Revolade)
Immune thrombocytopenic purpura
Gefitinib (Iressa)
Non small cell lung cancer
Recent NCPE website developments
for PEA submissions
Pharmacoeconomic guidelines (www.ncpe.ie)
• Template for rapid review assessment submissions from manufacturers
• Recommendations on the reporting format and layout of PEA
submissions
• Guidelines for inclusion of drug costs in pharmacoeconomic evaluations
• Critical assessment of economic evaluations
• Irish Healthcare Technology Assessment Guidelines
• Guidelines for the Budget Impact Analysis of Health Technologies in
Ireland
Irish healthcare technology assessment (HTA)
guidelines
‘methodological guidance on the conduct of economic evaluation’
8th November 2010 www.hiqa.ie
Guidelines for Budget Impact Analysis
‘methodological guidance on the conduct of budget impact
analysis’
23rd November 2010 www.hiqa.ie
The HTA future ?
•
Increased scrutiny of expenditure on
medicines as decision makers
become more risk averse
•
All new products considered for HTA
with HTA submissions becoming
increasingly sophisticated e.g.
probabilistic sensitivity analysis, EVPI.
•
An increased use of HTA in price
negotiation & guiding performance
based risk sharing schemes for high
cost drugs
•
In addition to single technology
assessment it is likely that multiple
technology assessment will be
considered
•
Hospital HTA
•
HTA guided disinvestment
“Delphi the shrine of Apollo and site of the famous
Oracle whose often inscrutable advice was sought
down through historical times”
“to date assessments in Ireland have been
conducted in a pragmatic, timely, transparent
and flexible manner and it is important that
these features continue to characterise the
conduct of future assessments”
Thank you
NCPE www.ncpe.ie