Service planning OPERATIONAL AND IMPLEMENTATION ISSUES

10. OPERATIONAL AND IMPLEMENTATION ISSUES

Scaling up access to treatment for people infected with HCV in low- and middle- income countries requires careful consideration of resource availability in individual settings. A high-income model of specialist care with a high physician- to-patient ratio and availability of advanced laboratory monitoring is not feasible in many countries and therefore service delivery plans need to be adapted accordingly. A public health care-based approach to improve access to health care for people infected with TB and HIV has been promoted by WHO and has resulted in improved health care in many resource-limited settings. 219 The roll-out of screening, care and treatment for HCV in low- and middle-income countries will require an assessment of many of the same issues already addressed by TB and HIV treatment programmes, and similar approaches are likely to be effective.

10.1 Service planning

Service planning requires an estimation of the local burden of disease, and an assessment of the availability of resources and infrastructure for rolling out treatment. National programmes are required to plan screening and treatment strategies. At present, many countries have poor documentation of the prevalence of infection; this is particularly the case in low-income countries. The Global policy report on the prevention and control of viral hepatitis, 2013 provides country-speciic information on policies and structures already in place to combat viral hepatitis. 107 Building on these policies and structures will be necessary to increase the availability of treatment for those infected. Estimates of how many people are likely to be affected may be made by assessing populations at high risk as well as previously documented prevalence and incidence rates. Regular sentinel screening of targeted populations using serology and NAT is therefore required to facilitate service planning and is the irst step in increasing access to care and treatment for HCV. Improvements in molecular tools for rapid screening, including dried blood spot and oral luid testing, as well as polyvalent PCR platforms, would increase the numbers of infected patients identiied. They would also allow the expansion of screening services into the ield as well as among dificult-to-access populations such as PWID. Integration of HCV screening with HIV, HBV and TB screening services may be suitable in many settings as the routes of transmission are common. A central barrier to treatment roll-out is cost – this includes the cost of medicines, taxes, import charges, appropriate medical facilities and staff, as well as diagnostic and monitoring facilities. Negotiation on drug costs is required and prioritization of particular groups, for example, patients with advanced liver disease ≥F2 disease or, in more constrained settings, F4 may be required. Integration of services, for example, diagnostic and treatment facilities, may help to minimize costs and is likely to facilitate treatment delivery. Task-shifting is the process of sharing clinical management responsibilities with trained personnel such as nurses, clinical oficers and pharmacists. Such personnel should have access to consultations with specialized team members as necessary and are likely to require training in order to facilitate adequate health-care delivery. Sourcing of medication and negotiation on pricing at a central level using pooled procurement may also minimize costs. Patent coverage and the availability of prequaliied biosimilar agents or generic formulations is another central consideration – this is likely to be of key importance as new DAAs are licensed. Clinical and laboratory facilities for screening and monitoring patients on treatment are an essential component of health-care provision. The development and implementation of simpler methods to assess HCV viral load and genotype as well as for the tests needed to monitor drug toxicity are important to increase accessibility of treatment in less well-resourced settings. Point-of-care HCV viral load testing may be required in some settings in order to facilitate appropriate treatment. Pharmacy facilities and drug storage space, including refrigeration space for IFN, should be included in the planning of new treatment centres. Sourcing and distribution planning is also required. The registration of new drugs in individual Member States may be time consuming and will require adequate planning.

10.2 Service delivery