The role of Health Technology Assessment and current developments in Ireland
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The document discusses the role of health technology assessment (HTA) in Ireland, emphasizing its importance for ensuring optimal health outcomes while managing costs. It highlights recent developments in HTA processes, including cost-effectiveness evaluations for new pharmaceutical products, and the increasing sophistication of assessment methods. Furthermore, it addresses challenges like budget constraints and the need for innovative pricing and risk-sharing agreements for high-cost drugs.
The role of Health Technology Assessment and current developments in Ireland
- 1. The role of Health Technology Assessment (HTA) and current developments in Ireland Dr. Michael BarryDr. Michael Barry November 25th 2010
- 2. The role of Health Technology Assessment ““ensuring the best health outcomes for Irishensuring the best health outcomes for Irish patients while securing value for money”patients while securing value for money” Health Strategy 2001
- 3. The fundamental economic problem – Scarcity !The fundamental economic problem – Scarcity ! Expenditure on medicines in Ireland (Community Drugs Schemes 1991 - 2009) 0 500 1000 1500 2000 2500 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Millions(€) ? “€ 746 million saving required in the Health area”
- 4. 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 ?
- 5. Health Technology Assessment ““studies the medical, social, ethical, andstudies 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
- 7. HTA in Europe 2010 Norway: 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 Scottish Excellence (NICE) & All Medicines Wales Medicines Strategy Consortium Group (AWMSG) ( SMC ) Germany: Institute for Quality and Efficiency in the Health Service ( IQUiG ) . France: Haute Authorite de Sante ( 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)
- 8. 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
- 9. Recent developments in HTA in IrelandRecent developments in HTA in Ireland The cost-effectiveness of all new products is consideredThe cost-effectiveness of all new products is considered prior to reimbursement under the Community Drugsprior to reimbursement under the Community Drugs SchemesSchemes The ‘Rapid Review’ processThe ‘Rapid Review’ process Incremental cost-effectiveness ratio (ICER) and theIncremental 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 developmentsMethodological developments Recent decisions and the use of PEA resultsRecent decisions and the use of PEA results Updated HTA & Budget Impact guidelinesUpdated HTA & Budget Impact guidelines
- 10. Pharmacoeconomic assessment (HTA)Pharmacoeconomic assessment (HTA) HTA not required Full HTA Rapid Review A two – four week process to determine whether a full HTA is required
- 11. 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)
- 12. If the rapid review process suggests that theIf the rapid review process suggests that the new product is unlikely to prove cost effectivenew product is unlikely to prove cost effective oror we cannot be surewe cannot be sure Formal HTA
- 13. Incremental cost-effectiveness ratio (ICER) and the reimbursement recommendation
- 14. 1. Incremental Cost Effectiveness ratio (ICER) Cost A – Cost BCost A – Cost B Effect A – Effect BEffect A – Effect B Cost Effect e.g. € 10,000/QALY
- 15. Cost effectiveness and probability of rejectionCost effectiveness and probability of rejection 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”
- 16. Relationship between cost effectiveness andRelationship between cost effectiveness and probability of rejectionprobability of rejection Probability of rejection Increasing Cost per QALY (log scale) € 5,000 € 30,000
- 17. 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
- 18. 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”
- 19. 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
- 20. 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
- 21. Methodological developments inMethodological developments in pharmacoeconomic assessment (PEA) atpharmacoeconomic assessment (PEA) at the NCPEthe NCPE Mixed treatment comparisonsMixed treatment comparisons – a Bayesian approach– a Bayesian approach The expected value of perfectThe expected value of perfect information (EVPI)information (EVPI)
- 22. 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
- 23. ‘A tale of four countries’ Rycroft et al 2010 ISPOR
- 24. 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
- 25. 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
- 26. Negative PEA – what next ?
- 27. 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 Example - Cimzia
- 28. Negative PEA Reimbursement Pricing threshold analysis &/or Performance based risk sharing scheme
- 29. 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
- 30. 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.
- 31. 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”
- 32. Performance based models - terminology DEAL !
- 33. Typical DealTypical Deal • The payer (HSE) funds the drug for aThe payer (HSE) funds the drug for a defined period of time, withdefined period of time, with manufacturers refunding the cost of themanufacturers refunding the cost of the drug in patients who did not achieve thedrug 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 atThe HSE would purchase the drug at 50% of the regular price for the first50% of the regular price for the first treatment cycle and then purchase attreatment cycle and then purchase at the full price for those who achieved thethe full price for those who achieved the targeted outcome and continued ontargeted outcome and continued on therapy (e.g. sorafenib for mRCC)therapy (e.g. sorafenib for mRCC) Barry & Tilson IMJ 2010;103(5):133
- 34. 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
- 35. Recent reimbursement decisions 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
- 36. Recent NCPE website developments for PEA submissions
- 37. 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
- 38. Irish healthcare technology assessment (HTA) guidelines ‘methodological guidance on the conduct of economic evaluation’ 8th November 2010 www.hiqa.ie
- 39. Guidelines for Budget Impact Analysis ‘methodological guidance on the conduct of budget impact analysis’ 23rd November 2010 www.hiqa.ie
- 40. The HTA future ?The HTA future ? • Increased scrutiny of expenditure onIncreased scrutiny of expenditure on medicines as decision makersmedicines as decision makers become more risk aversebecome more risk averse • All new products considered for HTAAll new products considered for HTA with HTA submissions becomingwith 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 priceAn increased use of HTA in price negotiation & guiding performancenegotiation & guiding performance based risk sharing schemes for highbased risk sharing schemes for high cost drugscost drugs • In addition to single technologyIn addition to single technology assessment it is likely that multipleassessment it is likely that multiple technology assessment will betechnology 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”
- 41. “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”