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Health Technology Assessment of Birth Cohort Testing for Hepatitis C

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Health Technology Assessment of Birth Cohort Testing for Hepatitis C Draft report for public consultation Health Technology Assessment of Birth Cohort Testing for Hepatitis C March 2021 Draft: Health technology assessment of birth cohort testing for hepatitis C Health Information and Quality Authority About the Health Information and Quality Authority The Health Information and Quality Authority (HIQA) is an independent statutory authority established to promote safety and quality in the provision of health and social care services for the benefit of the health and welfare of the public. HIQA’s mandate to date extends across a wide range of public, private and voluntary sector services. Reporting to the Minister for Health and engaging with the Minister for Children, Equality, Disability, Integration and Youth, HIQA has responsibility for the following: . Setting standards for health and social care services — Developing person-centred standards and guidance, based on evidence and international best practice, for health and social care services in Ireland. Regulating social care services — The Chief Inspector within HIQA is responsible for registering and inspecting residential services for older people and people with a disability, and children’s special care units. Regulating health services — Regulating medical exposure to ionising radiation. Monitoring services — Monitoring the safety and quality of health services and children’s social services, and investigating as necessary serious concerns about the health and welfare of people who use these services. Health technology assessment — Evaluating the clinical and cost- effectiveness of health programmes, policies, medicines, medical equipment, diagnostic and surgical techniques, health promotion and protection activities, and providing advice to enable the best use of resources and the best outcomes for people who use our health service. Health information — Advising on the efficient and secure collection and sharing of health information, setting standards, evaluating information resources and publishing information on the delivery and performance of Ireland’s health and social care services. National Care Experience Programme — Carrying out national service- user experience surveys across a range of health services, in conjunction with the Department of Health and the HSE. Page 1 of 295 Draft: Health technology assessment of birth cohort testing for hepatitis C Health Information and Quality Authority Table of Contents 1 Introduction ............................................................................................ 5 1.1 Background to the request ........................................................................... 9 1.2 Terms of reference .................................................................................... 10 1.3 Overall approach ....................................................................................... 11 2 Description of technology ..................................................................... 13 2.1 Introduction .......................................................................................... 15 2.2 Viral hepatitis ........................................................................................ 15 2.3 Hepatitis C ............................................................................................ 15 2.4 HCV Genotypes ..................................................................................... 17 2.5 Immune response after HCV infection ..................................................... 18 2.6 Birth cohort testing ................................................................................ 19 2.7 Principles of a birth cohort testing programme......................................... 20 2.8 Screening for HCV in Ireland .................................................................. 25 2.9 International practice ............................................................................. 30 2.10 Diagnosis and treatment of chronic HCV infection .................................... 33 2.11 Discussion ............................................................................................. 37 3 Epidemiology ........................................................................................ 39 3.1 Introduction .......................................................................................... 40 3.2 Natural history of HCV ........................................................................... 40 3.3 HCV notifications in Ireland .................................................................... 46 3.4 Infection ............................................................................................... 53 3.5 Prevalence ............................................................................................ 60 3.6 Morbidity and Mortality .......................................................................... 63 3.7 Discussion ............................................................................................. 73 4 Clinical effectiveness of testing and treatment ................................... 74 4.1 Introduction .......................................................................................... 75 4.2 Laboratory testing.................................................................................. 77 4.3 Treatment effectiveness and safety......................................................... 86 Page 2 of 295 Draft: Health technology assessment of birth cohort testing for hepatitis C Health Information and Quality Authority 4.4 Harms and consequences of testing and treatment .................................. 96 4.5 Validity of SVR, a surrogate outcome measure ......................................... 98 4.6 Outcomes of US-based birth cohort testing.............................................. 99 4.7 Discussion ........................................................................................... 101 5 Systematic review of economic evaluations ...................................... 103 5.1 Introduction ........................................................................................ 104 5.2 Review methodology ............................................................................ 104 5.3 Results ................................................................................................ 108 5.4 Discussion ........................................................................................... 143 5.5 Conclusion ........................................................................................... 144 6 Economic evaluation and budget impact analysis ............................. 146 6.1 Introduction ........................................................................................ 148 6.2 Health economic analysis ..................................................................... 148 6.3 Model parameters ................................................................................ 155 6.4 Handling of uncertainty and model verification ...................................... 174 6.5 Results ................................................................................................ 180 6.6 Discussion ........................................................................................... 210 7 Organisational issues .......................................................................... 217 7.1 Introduction ........................................................................................ 219 7.2 A birth cohort testing programme for HCV ............................................. 219 7.3 Clinical pathway ................................................................................... 226 7.4 Capacity implications ............................................................................ 229 7.5 Information and awareness .................................................................. 234 7.6 Alternative testing options and settings for birth cohort testing for HCV .. 236 7.7 Pilot programme of birth cohort testing for HCV .................................... 240 7.8 Discussion ........................................................................................... 241 8 Ethical Considerations ........................................................................ 243 8.1 Terminology ........................................................................................ 244 8.2 Overview of population testing ............................................................. 244 Page 3 of 295 Draft: Health technology assessment of birth cohort testing for hepatitis C Health Information and Quality Authority 8.3 Benefit-harm balance ........................................................................... 246 8.4 Acceptability ........................................................................................ 250 8.5 Justice and equity ................................................................................ 254 8.6 Ethical consequences of HTA ................................................................ 259 8.7 Discussion ........................................................................................... 261 9 Discussion ........................................................................................... 262 9.1 Background to the assessment ............................................................. 262 9.2 Description of the technology ............................................................... 263 9.3 Epidemiology ......................................................................................
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