Prior to any costing taking place it is important to establish the current epidemiological baseline and determine future projections. This will help you to understand the overall disease burden and will set measures for both the disease progression and transmission models for HBV and HCV. Both the prevalence, which is the amount of disease in a population at a given time, and incidence, which is the number of new cases of a disease in a population over a given period of time, will need to be measured and understood. To determine the prevalence and incidence the following will be needed and used as a basis for modelling future estimates:
- Serological surveys
- Systematic review of previous national studies
- Demographics of the population
- Disease progression states: these are based on international literature and so are not country specific.
In the absence of good data sources, a reasonable approximation may be possible by extrapolating from neighbouring or similar countries. Lack of data should not be a barrier to costing a viral hepatitis programme. Sub populations, especially those at high risk, will also need to be differentiated as there may be different costs to reaching them for diagnosis, treatment and prevention activities. For each of the sub populations you will need to determine population size, disease prevalence and incidence. Sub populations include:
- Indigenous peoples
- People who inject drugs
- People in prison
- Men who have sex with men
- Sex workers
- Transgender persons
Costing a hepatitis programme
The national hepatitis programme should be fully costed with the objective to reach the 2020 and 2030 WHO targets. The outcome of this will give countries an overall cost for elimination.
What to cost
Ideally each country will have a national hepatitis action plan. This should clearly set out the interventions that will be needed to eliminate viral hepatitis by 2030. To ensure a fully costed programme both commodity and infrastructure costs must be accounted for. A “bottom up” approach to costing (figure 1) is recommended to ensure the programme is comprehensively costed. This is where the total cost per activity is calculated by breaking down and estimating the specific cost drivers for each activity. The realistic country budget will be completed at a later stage but using this approach will aid with strategic decision making at the financing stage as it is likely that different areas of the hepatitis programme will require different sources of financing and a good understanding of costs will be required to drive these decisions. The inputs to be considered when costing the programme will include:
- National strategic plan and WHO elimination targets
- Key activities
- Epidemiological estimates
- Unit costs
The unit costs are multiplied by the frequency/quantity of an activity to arrive at the total annual cost of the activity. The assumptions for each activity will vary in complexity.
Areas that you may wish to include as part of this costing exercise are below.
|Item||Things to consider|
|Committee and working group meetings|
|Hepatitis programme operating costs||Office costs, vehicles for the federal and district level teams|
|Awareness raising activities||A variety of different activities including support to community-based organisations, as well as media campaigns may be required|
|Access to condoms|
|HBV vaccination||This should include contact tracing after a positive diagnosis for HBV|
|Blood safety||This may already be in place as part of the health system|
|Injection safety||This may already be in place as part of the health system|
|Infection control||For both hospital and informal setting based transmission|
|HBV and HCV diagnostic tests||
|Procurement systems for tests and treatment||Costs may vary depending on the supply chain selected in countries with parallel supply chains for different types of commodities.|
|Ongoing prevalence studies|
|Monitoring and evaluation system||WHO has a Monitoring and Evaluation framework against which countries will be asked to report and so this is a useful tool to use when determining the indicators to be monitored.|
|Hepatitis surveillance system||Integration of hepatitis into existing surveillance systems may be effective.|
Costs relating to the training of existing healthcare workers around the prevention, treatment and care of viral hepatitis or the recruitment of additional staff have not been included in the above table but it may be useful to undertake a separate costing exercise for this.
The World Health Organization (WHO) has set the below elimination targets and countries may want to do the costing with the objective of reaching these targets. WHO has set out targets for 2020 and 2030 but intermediate targets can be set for each of the hepatitis programme areas to increase the accuracy of annual costing.
|Target area||2020 Targets||2030 Targets|
|Incidence: New cases of chronic viral hepatitis B and C infections||30% reduction||HBV: 95% reduction|
|HCV: 80% reduction|
|Mortality: Viral hepatitis B and C deaths||10% reduction||65% reduction|
|Service coverage targets|
|Hepatitis B vaccination: childhood vaccine coverage (third dose coverage)||90%||90%|
|Prevention of hepatitis B virus mother-to-child transmission: hepatitis B virus birth-dose vaccination coverage or other approach to prevent mother-to-child transmission||50%||90%|
|Blood safety||95% of donations screened in a quality-assured manner||100% of donations screened in a quality-assured manner|
|Safe injections: percentage of injections administered with safety-engineered devices in and out of health facilities||50%||90%|
|Harm reduction: number of sterile needles and syringes provided per person who injects drugs per year||200||300|
|Viral hepatitis B and C diagnosis||30%||90%|
|Viral hepatitis B and C treatment||80% of eligible persons with chronic hepatitis B virus infection treated 80% of eligible persons with chronic hepatitis C virus infection treated|
Each WHO region also has an action plan or framework, agreed by all countries in that region. Some of these contain more ambitious targets than set out in the GHSS and links to these can be found below.
A costing tool has been developed to help countries with this process. It follows the “bottom up” approach to costing by breaking down what needs to be costed under each of the cost categories detailed in Table 1. It also breaks down the cost by year to enable you to set annual targets to help reach the overall elimination targets.
Areas where costs can be minimised will need to be determined as this will ensure the true cost to the health system is measured. Different ways of minimising costs are noted below.
Price variation over time
In an environment where, for example, the prices of commodities such as drugs and tests are expected to fall this could be captured by entering different prices to produce a range of overall costs. Conversely, other prices may be expected to increase over time due to inflation.
Integration explores how to use and link current systems, including infrastructure, and existing programmes to increase efficiency. This is underpinned by the concept that it is more efficient to share resources rather than devote them to one disease and it is more effective to deal with a person as a whole rather than each of their health issues separately. When considering integration you may want to involve people from other departments or organisations, such as:
- HIV, TB and cancer programmes
- NCD programmes if they include cancer and/or liver disease
- Primary care
- Supply chain
Pooled procurement is the process of a group of countries, or organisations within a country, coming together to improve the outcome of procurement for each of the individual members. It works by increasing the purchasing power of the individual countries by pooling demand. It can be used for vaccines, diagnostics or medicines and, when successfully implemented, can ensure that countries have access to a sustainable and affordable supply of commodities. WHO has identified that countries that are likely to benefit from pooled procurement usually have at least one of the following characteristics:
- Geographic isolation or small population
- Existing regional or inter-country body
- Limited negotiating capacity
- Internal difficulties establishing demand
This strategy can also work within a single country if the procurement is currently fragmented or facility driven. Current mechanisms within hepatitis which utilise the concept of pooled procurement at the country level are detailed below.
|Name of the mechanism||Pan American Health Organization (PAHO) revolving fund||Pan American Health Organization (PAHO) strategic fund||Global Procurement Fund (GPRO)|
|Who can access the mechanism||PAHO region||PAHO region||All low and middle income countries|
|Purpose of the mechanism||The fund enables 41 countries and territories in the PAHO region to improve their purchasing power by pooling their resources to procure high-quality vaccines, syringes and related supplies at the lowest price.||The fund is open to all PAHO Member States who are able to improve their purchasing power by pooling their resources to procure essential medicines and strategic health supplies at the lowest price.||The fund pools orders for medicines and diagnostics from member countries and provides competitive prices through economies of scale, assured quality, and access to more products.|
|Hepatitis commodities that can be procured using the fund||Hepatitis A and hepatitis B vaccines||Hepatitis C medicines||Hepatitis B and C medicines|
|How the mechanism works||In addition to the price of the vaccine members are charged a 3.5% recapitalisation fee||In addition to the price of the medicine members are charged an additional 3% to contribute towards funding the Capital Account and a 1.25% administration fee||In addition to the price of the medicines members are charged a mark-up of 5% which is added to the price of the products plus the shipping cost and importation tax.|
Direct negotiation with suppliers
Direct negotiations with suppliers of diagnostics and medicines is a useful tool in securing better prices and so reducing costs. This can be greatly aided by knowing what other countries are paying. Close links between hepatitis programme managers in different countries that facilitate information sharing can be developed during meetings like the World Hepatitis Summit.
Australia has been able to achieve universal access to hepatitis C treatment by driving down drug prices through direct negotiation with pharmaceutical companies. The government agreed to commit AUD $1 billion over 5 years in a risk-sharing arrangement with the pharmaceutical companies which gave them a major discount on drug prices, a maximum expenditure per year but with no cap on treatment numbers. This has resulted in Australia starting almost 40,000 people on treatment since March 2016 and placing it on track to eliminate hepatitis C by 2026. Source: Negotiating better discounts for DAA therapy is critical to achieve HCV elimination by 2030, Gregory J Dore, Jason Grebely, Journal of Hepatology, Volume 67, Issue 2, August 2017 Monitoring hepatitis C treatment uptake in Australia, Issue 7, July 2017, Kirby Institute