NHS England announced this week that it aims to eliminate hepatitis C by 2025 – if it can negotiate 'best value for money' deals with the pharmaceutical industry in a new round of tendering for direct-acting antivirals due to take place in February.
NHS England already operates a 'no cure, no fee' deal with pharmaceutical companies. The money saved has allowed more people to be treated, including re-treatment of people with advanced or decompensated cirrhosis who were not cured by a previous course of direct-acting antiviral treatment.
Approximately 160,000 people are estimated to have hepatitis C in England. To achieve elimination by 2025 NHS England will need to increase the number of people treated each year. The World Health Organization defines elimination of hepatitis C as a 65% reduction in HCV-related deaths and a 90% reduction in new infections by 2030, with 80% of eligible people treated by 2030.
Achieving this target by 2025 implies either that more money will be made available, which is highly unlikely, or that NHS England is looking for a very substantial cut in the price of direct-acting antivirals.
Public Health England says that approximately half of all people with hepatitis C may have been diagnosed in England and Wales, but according to Charles Gore, chief executive of the Hepatitis C Trust, “We have at least 100,000 people to find.” According to estimates released by the Polaris Observatory at the World Hepatitis Summit in November 2017, at least 10,000 people will need to be treated each year to achieve elimination by 2030. This number would need to rise to at least 16,000-17,000 a year to achieve elimination in 2025. But the Polaris Observatory warns that unless rates of diagnosis improve the number of people treated could fall to 5000 a year by 2020.
NHS England plans to increase the number of people treated for hepatitis C to 13,000 in the year beginning April 2018, Professor Graham Foster announced earlier this month. A review of Operational Delivery Networks for hepatitis C treatment in England, published by the Hepatitis C Coalition in December 2017, indicated growing concern among healthcare professionals about how to identify new people in need of treatment.
NHS England says that it wants to collaborate with the pharmaceutical industry to identify more people living with hepatitis C in need of treatment. If the treatment budget is not elastic, this implies that what NHS England hopes to secure is an agreement similar to the one obtained by the Australian government in 2016.
The Australian deal committed the government to spend AUS$1 billion on direct-acting antivirals up to 2020, specified a heavily discounted price per treatment course, and placed a maximum cap on expenditure each year but no cap on the number of people who could be treated. The expenditure cap effectively allows free treatment for each additional patient once the annual budget is spent. As a result of the high enrolment on treatment, the deal has resulted in a cost per treatment of around £3100 to £3700 (5400 to 6500 euros) in 2016 in Australia, compared to a cost between £15,000 and £20,000 per treatment course in the United Kingdom.
Calculations of the cost of production of generic versions of direct-acting antivirals presented at recent international scientific meetings show that a 12-week course of treatment with sofosbuvir/ledipasvir can be manufactured for $79, suggesting the scope for reductions in the cost of branded products.
The Australian deal incentivises new diagnoses and new treatment starts. A recent inquiry conducted in Scotland, led by the Hepatitis C Trust, shows that numerous parts of the health system will need to be encouraged to improve hepatitis C diagnosis, including substance misuse services, prison, general practitioners, pharmacies and accident and emergency departments.