Access to hepatitis C treatment: France, Ireland and India

France will provide access to hepatitis C treatment with direct-acting antivirals to everyone diagnosed with hepatitis C from September 2016, and will begin to provide treatment to everyone with stage 2 fibrosis immediately, health minister Marisol Touraine announced at the end of May.

Up to 230,000 people in France with hepatitis C could be treated under the new rules, the French health ministry has said, but Marisol Touraine said that the prices paid by the French health system for direct-acting antivirals must be renegotiated.

She pointed out that the indications for prescribing of drugs has expanded, increasing the size of the market, and competitor products are becoming available. She also noted that other European countries had been able to use the French price negotiations to achieve favourable deals for high-volume prescribing. In Spain and Portugal prices of 13,000 euros are believed to have been achieved in confidential deals, in which governments pay nothing for people who are not cured and the cost of treatment is the same regardless of duration.

The Irish health minister has also announced an increase in the number of people who will receive treatment for hepatitis C. A further 1500 people will be able to receive treatment as a result of widening the criteria for treatment. Previously, Ireland’s national plan for treatment prioritised people with end-stage liver disease, or compensated cirrhosis at higher risk for decompensation, and people falling outside these groups at high risk of progression including people with high HCV RNA or with HIV co-infection. Treatment criteria will be further expanded until Ireland has provided treatment to somewhere between 20,000 and 50,000 people with hepatitis C, with the aim of eliminating the infection in Ireland by 2026.

Indian’s Punjab state government has announced it will be the first to provide free treatment for hepatitis C in state hospitals, through a special fund launched last week.

Hepatitis C treatment rationing

Funding new therapies for all people with hepatitis C virus (HCV) infection would account for at least 10% of the total pharmaceutical budget in every one of the 30 Organisation for Economic Co-operation and Development (OECD) member countries, according to an analysis published this month in the journal PLOS Medicine. Treatment was also shown to be unaffordable for individuals, costing over one year’s annual income in as many as 21 OECD countries.

In an attempt to contain the costs of direct-acting antiviral treatment, some countries are choosing to ration treatment. Other countries have adopted a more ambitious approach, negotiating volume-based agreements which create incentives for governments and health systems to maximise the number of people who are diagnosed and treated.

One country which has negotiated a volume-based agreement is Australia. The government has negotiated a unique volume-based price agreement with pharmaceutical companies to treat 62,000 people at a cost of AUS$1 billion over five years – an average price per treatment of AUS$16,129 (US$11,715 / £8234) if all 62,000 people are treated. This deal creates an incentive for Australia to diagnose and treat as many people as possible.

Although the details of the agreement have not been made public, there has been speculation that the deal includes a risk-sharing arrangement. If expenditure exceeds a certain level in any year, the cost of any extra treatment courses is believed to fall in a stepwise fashion until drugs are being supplied at virtually no profit to the manufacturer – or free of charge, those with insight into the process have told infohep.

In contrast, hepatitis C treatment is being strictly rationed in England to people with cirrhosis, despite a decision by the health technology appraisal body that direct-acting antiviral treatment with sofosbuvir/ledipasvir (Harvoni) is cost-effective for all people with genotype 1 infection. NHS England says it can only afford to treat 10,000 people per year for the next two years. The Hepatitis C Trust is planning to seek a judicial review of this decision, arguing that it is not legal for NHS England to put a cap on the number of people treated if NICE (the National Institute for Health and Care Excellence) has determined that the treatment is cost-effective.

The numbers of people with hepatitis C in Australia and England are fairly similar although the prevalence of hepatitis C is higher in Australia. In March 2016, 1811 people started treatment for hepatitis C in Australia and this number is likely to be exceeded in subsequent months. In England, 2000 people will be permitted to start hepatitis C treatment in the three-month period from April 1 to June 30. Meanwhile, the Scottish government plans to treat 1500 people each year up to 2020, out of an estimated population of 37,000 people who have hepatitis C.

Modelling of the impact of treatment on the HCV epidemic in England published this month shows that restricting treatment to 3500 people with cirrhosis each year would nevertheless quickly reduce the burden of end-stage liver disease and liver cancer, averting around 6000 cases over ten years. Expanding treatment to cover those with moderate fibrosis would have a modest additional impact on cases of liver cancer and the development of end-stage liver disease. To reduce new infections and reduce the prevalence of hepatitis C among people who inject drugs by two-thirds by 2030 would require treatment to be made available to people with mild or moderate fibrosis, the study authors concluded.

Global targets for the elimination of viral hepatitis

Achieving global targets for the elimination of viral hepatitis will require a greater focus on addressing the structural and legal factors which impede access to services, a blog published by the International AIDS Society has argued.

The first-ever global targets on viral hepatitis were adopted at the 69th World Health Assembly last month. These targets include:

  • Reduce the incidence of viral hepatitis from 6-10 million new cases in 2015 to <1 million in 2030, achieving a 30% reduction in new cases by 2020 and a 90% reduction by 2030.
  • Reduce deaths from viral hepatitis from 1.4 million deaths in 2015 to <500,000 deaths in 2030, achieving a 10% reduction in mortality by 2020 and a 90% reduction by 2030.

In settings where sharing of injecting equipment continues to be a major route of hepatitis C transmission, the authors argue that provision of harm reduction services, including needle and syringe programmes and opioid substitution therapy, is an essential step in engaging people who inject drugs in care. Legal barriers to harm reduction, punitive policing of drug users and requirements for people to cease using drugs before beginning hepatitis treatment represent major obstacles to engaging and retaining people who inject drugs in care. Harm reduction services need to be integrated with care for viral hepatitis, HIV and tuberculosis.

A recently-published systematic review of studies of interventions to improve access to hepatitis care for people who inject drugs found that:

  • Diagnosis of hepatitis C among people who inject drugs is improved when testing is offered through harm reduction services, clinics providing opioid substitution therapy and community settings where medical services for people who inject drugs are provided.
  • Linkage to care can be improved by interventions in primary care settings, such as medical services for homeless people, and in substance use treatment centres. All interventions used multidisciplinary teams that addressed both medical and social needs.
  • Peer-based support programmes to help people stop injecting as a qualification for treatment and to help people adhere to treatment were found to be effective, but more research is needed to identify peer-led mechanisms that can improve linkage to and retention in care.
  • Directly-observed therapy to provide interferon-based treatment was effective in a variety of settings; other adherence support measures such as electronic pill bottle monitoring and pharmacy refill measurements were also found to be effective.

Making hepatitis C diagnosis easier

Testing for hepatitis C virus (HCV) core antigen could eventually replace the current two-step procedure for diagnosing chronic hepatitis C infection in lower- and middle-income countries, speeding up access to treatment and improving retention in care, a systematic review designed to inform World Health Organization hepatitis C testing guidelines has found.

Chronic hepatitis C infection is currently diagnosed by antibody testing followed by a confirmatory nucleic acid test to detect HCV RNA, which indicates active viral infection. The second step is essential because between 15 and 50% of people with HCV antibodies will have spontaneously cleared HCV infection during the first six months after exposure and are not chronically infected. Nucleic acid testing must be done by a laboratory equipped to carry out molecular testing. Nucleic acid testing is costly and inaccessible in many places. As a result, an unknown proportion of people who test positive for HCV receive no confirmatory testing and are lost to follow-up, resulting in a lack of monitoring and treatment.

The two-step diagnostic process is seen as a major obstacle to diagnosis and treatment of hepatitis C on the scale needed to achieve ambitious targets for reducing the burden of the disease and eliminating hepatitis C as a public health problem.

The study found two assays – the Abbott ARCHITECT HCV Ag assay and the Ortho HCV Ag ELISA – almost matched nucleic acid testing in sensitivity and specificity where HCV viral load was above 3000 i.u./ml.

A rapid point-of-care test for HCV antigen that could be used by health care workers in the same way as point-of-care tests for HIV or HCV antibodies was viewed as the highest priority for improving HCV diagnosis, and a feasible target for product development, by a recent stakeholder consultation convened by the Forum for Collaborative HIV Research and the Foundation for Innovative Diagnostics (FIND).

The World Health Organization will issue new guidance on viral hepatitis testing at the 21st International AIDS Conference (AIDS 2016) in Durban, South Africa in July.

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