The role of Health Technology Assessment and current developments in Ireland

The role of Health Technology Assessment (HTA) and current

developments in Ireland

Dr. Michael BarryDr. Michael Barry

November 25th 2010

The role of Health Technology Assessment

“ “ensuring the best health outcomes for Irish ensuring the best health outcomes for Irish patients while securing value for money”patients while securing value for money”

Health Strategy 2001

The fundamental economic problem The fundamental economic problem – Scarcity !– Scarcity !

Expenditure on medicines in Ireland (Community Drugs Schemes 1991 - 2009)

0

500

1000

1500

2000

2500

Mill

ions

(€)

?

“€ 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 studies the medical, social, ethical, and economic implications of development, economic implications of development, diffusion and use of health technology”diffusion and use of health technology”

INAHTA: 1998INAHTA: 1998

“rationing”

or

“priority setting”

Pharmacoeconomic Assessment

HTA in Europe 2010Norway: Norwegian Knowledge Centre for Health ( NOKC )

Finland:Finish Office for HTA( Finohta )

Sweden:Swedish Council for Technology Assessment in Health Care ( SBU ).

Denmark:Danish Centre for Evaluation and HTA ( DACEHTA )

England & Wales: Scotland: National Institute of Clinical ScottishExcellence (NICE) & All Medicines Wales Medicines Strategy ConsortiumGroup (AWMSG) ( SMC )

Germany:Institute for Quality and Efficiency in the Health Service ( IQUiG ) .

France:Haute Authorite deSante ( HAS )Spain:Health technology assessment at a regional level.e.g. CAHTA

Italy:Italian Network for HTA ( NI-HTA )

Austria; Ludwig Boltzmann Institute of HTA ( LBI@HTA )

Switzerland: Swiss Network for HTA ( SNHTA )

Belgium: Belgian Health Care Knowledge Centre ( KCE ) .

Netherlands:Health Insurance Board ( CVZ ) .

Poland:Polish agency for HTA

Ireland: National Centre for Pharmacoeconomics (NCPE ) & Health Information and Quality Authority (HIQA)

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 IrelandRecent developments in HTA in Ireland

The cost-effectiveness of all new products is considered The cost-effectiveness of all new products is considered prior to reimbursement under the Community Drugs prior to reimbursement under the Community Drugs Schemes Schemes

The ‘Rapid Review’ processThe ‘Rapid Review’ process Incremental cost-effectiveness ratio (ICER) and the Incremental cost-effectiveness ratio (ICER) and the

reimbursement recommendationreimbursement recommendation Probability of being cost effective at different thresholdsProbability of being cost effective at different thresholds Methodological developments Methodological developments Recent decisions and the use of PEA results Recent decisions and the use of PEA results Updated HTA & Budget Impact guidelines Updated HTA & Budget Impact guidelines

Pharmacoeconomic assessment Pharmacoeconomic assessment (HTA) (HTA)

HTA not required Full HTA

Rapid Review

A two – four week process to determine whether a full HTA is required

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 If the rapid review process suggests that the new product is suggests that the new product is unlikely to prove cost effectiveunlikely to prove cost effective

oror

we cannot be surewe cannot be sure

Formal HTA

Incremental cost-effectiveness ratio (ICER) and the reimbursement recommendation

1. Incremental Cost Effectiveness ratio (ICER)

Cost A – Cost BCost A – Cost BEffect A – Effect BEffect A – Effect B

CostEffect

e.g. € 10,000/QALY

Cost effectiveness and probability of Cost effectiveness and probability of

rejectionrejection

Probability of rejection

Increasing Cost per QALY (log scale)

€ 5,000

€ 30,000

“there is no fixed cost-effectiveness threshold above or below which technologies are guaranteed to be rejected or accepted for reimbursement”

Relationship between cost Relationship between cost effectiveness and probability of effectiveness and probability of

rejectionrejection

Probability of rejection

Increasing Cost per QALY (log scale)

€ 5,000

€ 30,000

Cost-effectiveness and the probability of rejection

Relationship between cost effectiveness and probability of rejection

0

5000

10000

15000

20000

25000

30000

35000

YES NO

ICER values €/QALY for 2010 assessments

Probability of being cost-effectiveProbability of being cost-effective

Probability of being cost effective

Cost effectiveness threshold

100%

50%

€ 20,000/QALY

€ 45,000/QALY

“the probability that a technology is cost effective at a range of threshold levels should be presented”

Probability of being cost-effectiveProbability of being cost-effective

Probability of being cost effective

Cost effectiveness threshold

100%

50%

€ 20,000/QALY

€ 45,000/QALY

Methodological developments Methodological developments in pharmacoeconomic in pharmacoeconomic

assessment (PEA) at the NCPEassessment (PEA) at the NCPE

Mixed treatment comparisons Mixed treatment comparisons – a Bayesian approach – a Bayesian approach

The expected value of perfect The expected value of perfect information (EVPI)information (EVPI)

Recommendations following evaluation of individual products and price modulations

Jan 2005 – November 2010

• 32 submissions were accepted without modification.32 submissions were accepted without modification.

• 8 submissions were accepted with modifications.8 submissions were accepted with modifications.

• 25 submissions were rejected.25 submissions were rejected.

NCPE 2010NCPE 2010

A total of 65 evaluations were conducted

‘A tale of four countries’

Rycroft et al 2010 ISPOR

Recent pharmacoeconomic evaluations

ProductProduct IndicationIndication

Eculizumab (Soliris)Eculizumab (Soliris) PNHPNH

Golimumab (Simponi) Golimumab (Simponi) Rheumatoid ArthritisRheumatoid Arthritis

Oxycodone/naloxone (Targin)Oxycodone/naloxone (Targin) AnalgesiaAnalgesia

Denosumab (Prolia)Denosumab (Prolia) OsteoporosisOsteoporosis

Certolizumab pegol (Cimzia) Certolizumab pegol (Cimzia) Rheumatoid ArthritisRheumatoid Arthritis

Roflumilast (Daxas)Roflumilast (Daxas) COPDCOPD

Eltrombopag (Revolade)Eltrombopag (Revolade) Immune thrombocytopenic purpuraImmune thrombocytopenic purpura

Gefitinib (Iressa)Gefitinib (Iressa) Non small cell lung cancerNon small cell lung cancer

Negative PEA – what next ?

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

2010www.ncpe.ie

Example - Cimzia

Negative PEA Reimbursement

Pricing threshold analysis

&/or

Performance based risk sharing scheme

ICER

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

Pricing threshold analysis

Price (€) per patient/year

€45,000/

QALY

€20,000/QALY

€15,000€10,000

Q1

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 cost-effectiveness”

Performance based models - terminology

DEAL !

Typical DealTypical Deal

• The payer (HSE) funds the drug for a The payer (HSE) funds the drug for a defined period of time, with defined period of time, with manufacturers refunding the cost of the manufacturers refunding the cost of the drug in patients who did not achieve the drug in patients who did not achieve the targeted health outcome (e.g. targeted health outcome (e.g. bortezomib for MM)bortezomib for MM)

• The HSE would purchase the drug at The HSE would purchase the drug at 50% of the regular price for the first 50% of the regular price for the first treatment cycle and then purchase at treatment cycle and then purchase at the full price for those who achieved the the full price for those who achieved the targeted outcome and continued on targeted outcome and continued on therapy (e.g. sorafenib for mRCC)therapy (e.g. sorafenib for mRCC)

Barry & Tilson IMJ 2010;103(5):133

Recent pharmacoeconomic evaluations










Recent reimbursement decisions










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 ?The HTA future ?• Increased scrutiny of expenditure on Increased scrutiny of expenditure on

medicines as decision makers medicines as decision makers become more risk aversebecome more risk averse

• All new products considered for HTA All new products considered for HTA with HTA submissions becoming with HTA submissions becoming increasingly sophisticated e.g. increasingly sophisticated e.g. probabilistic sensitivity analysis, EVPI.probabilistic sensitivity analysis, EVPI.

• An increased use of HTA in price An increased use of HTA in price negotiation & guiding performance negotiation & guiding performance based risk sharing schemes for high based risk sharing schemes for high cost drugs cost drugs

• In addition to single technology In addition to single technology assessment it is likely that multiple assessment it is likely that multiple technology assessment will be technology assessment will be consideredconsidered

• Hospital HTAHospital HTA

• HTA guided disinvestmentHTA 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

The role of Health Technology Assessment and current developments in Ireland

Health & Medicine

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