Title: A comprehensive model and economic evaluation of HCV elimination amongst people who inject drugs in England to guide testing and treatment intervention policy and implementation
Funder: Department of Health and Social Care

Abstract: Hepatitis C Virus (HCV) infection is a common cause of liver-disease in the UK. In England, about 150,000 people have HCV and 5,000 new infections occur every year. HCV is estimated to cost the UK £280-470 million per year._x000D_ _x000D_ New treatments for HCV cure nearly all patients but are expensive so the number of treatments allowed each year has been restricted in England._x000D_ _x000D_ The World Health Organization has set targets for reducing the number of new HCV infections by 80% and HCV-related deaths by 65% by 2030. Many countries have started increasing levels of HCV testing and treatment to reach these targets. NHS-England aims to reach the World Health Organization targets by 2025. To do this, NHS-England plans to rapidly increase the availability of treatments through bulk buying and improving approaches for finding patients to treat._x000D_ _x000D_ In the UK, most new HCV-infections are due to injecting drug use. Providing people who inject drugs with new needles and syringes or medically prescribed replacements for illegal drugs (e.g. daily methadone) can reduce the risk of infection. However, these approaches alone cannot reduce the number of new infections enough to meet the World Health Organization targets. The number of people receiving HCV treatment must also increase._x000D_ _x000D_ Limited numbers of people who inject drugs and who are infected with HCV receive treatment. To change this, new approaches to diagnosis, referral and treatment are being tested. These approaches are called HCV case-finding interventions. These interventions focus on different locations where people who inject drugs can be tested, including prison and drug treatment services. They also use people with experience of injecting drug use or nurses to improve referral to treatment. It is unclear which combination of approaches could increase treatment enough to achieve the NHS-England elimination goal._x000D_ _x000D_ This project aims to improve HCV case-finding efforts in England. The findings will provide locally tailored guidance on the best value approaches to eliminating HCV in England._x000D_ _x000D_ We will review information on the costs and results of case-finding interventions for people who inject drugs in England and other similar countries. We will develop a model that estimates how HCV spreads among people who inject drugs in different English regions. We will use this model to decide whether on-going efforts are enough to achieve the NHS-England elimination goal in each region. If they are not, then the model for each region will be used to compare the healthcare costs and reduction in new HCV infections for different approaches to improve case-finding and referral to treatment. This will make it easier to decide what changes are needed to meet the elimination goals for the lowest possible cost._x000D_ _x000D_ Managers of relevant services and patient groups will be involved in each stage of this research. An early discussion group held with people who inject drugs highlighted the preferences and needs of patients in relation to diagnosis and treatment. To ensure that patients are central to our work and to ensure the practicality of our suggested approaches, we will form advisory groups in each region, which includes patient representatives and people who manage relevant services. These groups will guide our work, so we only evaluate options that are practical and meet people’s needs. This will increase the chances of our findings being used in practice.

Lay abstract: Hepatitis C (HCV) is a chronic infection with high burden in the UK that is primarily transmitted through injecting drug use. New direct acting antiviral treatments have dramatically increased cure rates, with NHS-England aiming to eliminate HCV as a public health threat ahead of the World Health Organization (WHO) global elimination goal of 2030. To do this, it has recently announced it will bulk purchase direct acting antivirals, in contracts with pharmaceutical companies worth £1.0 billion. HCV case-finding, linkage to care and treatment, especially among People Who Inject Drugs (PWID) will be critical for ensuring these resources are used effectively. There are many potential interventions and alternative HCV care-pathways but there is little understanding on the most cost-effective strategies. This project will provide evidence-based guidance on optimal strategies to eliminate HCV in England._x000D_ _x000D_ AIM 1: Review and synthesise data on the costs and effects of HCV case-finding, linkage to care and treatment interventions for PWID_x000D_ We will update existing systematic reviews of case-finding and treatment interventions among PWID using PRISMA guidelines, including searches of published/grey literature and contacting key authors/stakeholders. We will focus on UK relevant interventions with a comparison group. Cost and outcome data will be extracted from studies. When cost data is unavailable, it will be estimated through requesting information on the intervention’s care pathway and resource use data. When data from multiple similar interventions are available, outcome estimates will be synthesised using meta-analysis techniques, otherwise best practise interventions will be selected based on methodological quality and UK relevance._x000D_ _x000D_ AIM 2: Determine the most cost-effective case-finding and treatment strategies for achieving HCV elimination among PWID_x000D_ A dynamic model of HCV transmission will be used to project the impact of existing prevention, case-finding and treatment services in 4 England regions (defined by NHS-England operational delivery networks responsible for delivering HCV treatment). Detailed data will be used to calibrate the model to each region. The model will evaluate the cost-effectiveness of different scenarios of either scaling up existing case-finding and treatment strategies and/or initiating alternative strategies, using results from AIM 1. Intervention scenarios will be compared to determine the most cost-effective strategy for different budget levels and least costly strategies for achieving the elimination goal. Through undertaking sensitivity analyses, we will determine the optimum strategies for other regions._x000D_ _x000D_ Timeline: The work will be performed over 3 years with the evidence synthesis occurring in year 1, detailed modelling for 4 England regions in years 1/2, and generalising modelling to other regions in years 2/3._x000D_ _x000D_ Impact and Dissemination: The project will help NHS-England maximise the impact achieved from an estimated £1.0 billion investment in achieving HCV elimination. Through partnering with regional and national stakeholders (providers, commissioners, public health agencies, patient representatives), we will ensure the relevance and influence of our modelling in their decision-making. Results will be published in peer review journals and shared at key national and regional stakeholder committees and meetings concerned with decision-making and recommending strategies for elimination.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: INFECTION