Restrictions on free DAA access in many European countries contrary to guidelines and undermine HCV elimination targets, say researchers

The restrictions which many European countries impose on free/reimbursed access to hepatitis C virus (HCV) direct-acting antivirals (DAAs) are contrary to guidelines and undermine the World Health Organization (WHO) goal to eliminate HCV as a major public health concern, new research suggests.

In a study published in The Lancet Gastroenterology and Hepatology, investigators found that 46% of countries restricted free or reimbursable access to DAAs according to fibrosis stage. Approximately a fifth of countries imposed additional criteria relating to drug and alcohol abuse.

“These restrictions are not in agreement with the 2016 European Association for the Study of the Liver (EASL) recommendations on the treatment of hepatitis C, which state that all patients without contradictions to therapy should be offered treatment,” comment the authors. “Successful treatment of HCV infection reduces progression of liver disease and decreases all-cause mortality in people with advanced liver disease. Treatment of those with the greatest risk of transmission…helps to prevent onward transmission. As such, increasing access to DAA therapy will yield both individual and public health benefits.”

An estimated 3.2 million people in Europe have chronic HCV infection. The proportion of people with HCV-related cirrhosis and liver cancer is projected to increase by between a fifth and a third by 2030.

All oral DAA regimens can cure HCV in almost all people. WHO has set the target of eliminating HCV as a global public health concern. For this to be achieved, it will be necessary to reduce incidence by 80%, increase diagnosis rates to 90% and to treat 80% of all diagnosed individuals. To meet these targets, it is essential that countries maximise the use of DAAs, minimising restrictions on people who are eligible for free/reimbursed access.

Between November 2016 and August 2017, a team of investigators reviewed the criteria for free/reimbursed access to DAAs across the European Union, European Economic Area and Switzerland. They especially wanted to see if there were restrictions according to fibrosis stage, drug and alcohol use, type of healthcare provider and HCV/HIV co-infection status.

All 35 European countries provided information.

The most commonly prescribed free/reimbursed DAA regimen was ombitasvir, paritaprevir and ritonavir, with dasabuvir, and with or without ribavirin (94% of countries).

Sofosbuvir and daclatasvir with or without ribavirin were the least likely to be reimbursed (63% of countries).

Most countries provided access to sofosbuvir and ledipasvir with or without ribavirin (31 countries – 89%). Three-quarters reimbursed sofosbuvir and velpatasvir and 83% provided access to sofosbuvir with ribavirin.

Approximately half (46%) restricted access to people with fibrosis stage F2 or higher. Moreover, five countries required a minimum of F3 and Malta demanded F4. There were no fibrosis restrictions in 13 countries (37%). Genotype and age restrictions were in place in Norway, whereas in some countries, the type of DAA regimen was dependent on fibrosis stage.

The investigators suggest that the fibrosis restrictions are likely to be interim while countries await declines in DAA pricing. “Restrictions regarding stage of liver disease will probably be removed in many countries in the near future, as happened in Spain in June 2017,” they suggest.

The majority of countries (89%) had no restrictions for drug and/or alcohol use. However, six (17%) demanded abstinence for six months before initiation of treatment.

Prescribing DAAs was restricted to a specialist in 94% of countries. In England, GPs could prescribe but only with input from a local multi-disciplinary committee. Germany permitted all GPs to prescribe. In France, GPs with special training were allowed to monitor HCV once DAA therapy had been started.

Only one country placed restrictions on the prescription of DAAs to people with HIV co-infection. In Romania, people with co-infection needed to provide evidence of a negative drug test, a restriction not placed on people with HCV mono-infection.

“Broad access to DAAs requires negotiations to decrease DAA prices (or discounts to list prices) to facilitate removal of restrictions,” conclude the authors. “WHO mortality and incidence elimination targets are achievable and cost-effective in many countries but will require collective efforts of researchers, health-care providers, policy makers, the affected community, and the pharmaceutical industry, to succeed.”