The pricing of new
treatments for hepatitis C virus (HCV) means they are unaffordable for many
health systems in richer countries, according to an analysis published in PLoS Medicine. The research calculated the potential cost of
providing access to sofosbuvir and ledipasvir/sofosbuvir in 30 Organisation for
Economic Co-operation and Development (OECD) member countries and also four
low- and middle-income countries. In OECD countries, the average cost of a single
course of sofosbuvir therapy was US$42,000. Funding new therapies for all people with HCV infection would account for at least 10% of the total
pharmaceutical budget in every one of the 30 OECD countries. Treatment was also
shown to be unaffordable for individuals, costing over one year’s annual income
in as many as 21 OECD countries.
suggests that sofosbuvir and ledipasvir/sofosbuvir are not ‘affordable’ for
most OECD countries…with Central and Eastern European countries being the most
affected,” comment the authors. “Where patients do not have access to
subsidized treatment, individuals are unlikely to be able to pay for the
medicines out of pocket.”
An estimated 80
million people worldwide have chronic HCV infection. The development of
direct-acting agents (DAAs) has revolutionised the treatment and care of these
people, achieving cure rates (SVR) as high as 99% in clinical trials,
outcomes which have been replicated in “real world” settings.
have approved sofosbuvir and the combination product ledipasvir/sofosbuvir and
other therapies are in development. The cost of these therapies is high. The
initial US list price for 12-week courses of therapy with sofosbuvir and
ledipasvir/sofosbuvir were $84,000 and $94,500, respectively. Health economists
calculated that even at these prices the therapies are cost-effective. However,
the estimated cost of producing a single course of treatment has been estimated to
be between $68 and $136. This has raised questions about the fairness of the
pricing of these drugs.
The high cost of
new HCV therapies has already led to their rationing, even in rich countries
such as the US. Several countries have also succeeded in negotiating discounts
with the manufacturers.
three-quarters of people with chronic HCV live in low- and middle-income
countries, and some have been able to secure tiered pricing deals (Mongolia,
India and Pakistan have published prices of $900 for a 12-week course of
sofosbuvir) whereas other countries have secured voluntary licensing agreements.
A team of Austrian
investigators aimed to systematically compare prices of sofosbuvir and
ledipasvir/sofosbuvir across 30 OECD countries and four low- and middle-income
countries (Brazil, Egypt, India, Mongolia). They assessed the affordability and
budget impact of these treatments, both to health systems and individuals
paying for their own treatment. The authors emphasise that their calculations
did not include the cost of health monitoring, supplementary therapies, or the
additional disbursement associated with the consequences of cirrhosis or
obtained 2015 prices and assumed a 23% discount in all countries. They
estimated how many people in each country had HCV infection. The price
of therapies was analysed and compared between countries, adjusting for
currency differences and the wealth of each country. The likely cost of
treating all people with chronic HCV infection was calculated for each
country, and for each country this was compared to total annual expenditure on
pharmaceuticals. The investigators also calculated how long a person in each
country would need to work to pay for treatment out of their own pocket, based
on the average wage of each country.
In OECD countries,
the median price of a 12-week course of sofosbuvir was $42,017. However,
there was considerable price variation between countries, ranging from $37,729 in
Japan to $64,680 in the US. In low- and middle-income countries, a course of
therapy cost between $6,875 in Brazil and $539 in India.
currency differences showed that richer countries, such as Norway, were paying
significantly less for treatment (adjusted price, $28,092), whereas poorer OECD
countries were paying more in real terms. For instance in Poland the adjusted
cost of a course of therapy was over $100,000. High adjusted costs were also
observed for other countries, including Turkey, Slovakia and Portugal. Adjusted
prices were also significantly higher in low- and middle-income countries
($9708 - $1,861).
The nominal price
of ledipasvir/sofosbuvir was highest in the US ($72,765) and lowest in the UK
($43,215). After adjustment for currency strength, therapy was once again
cheapest in Norway ($31,255) and highest in Poland ($118,754).
budget impact associated with treating everyone in each individual country
varied from $100.9 million in Luxembourg to $166.6 billion in the US. For
Poland, Turkey, Spain and Italy the total budget impact was between $20 billion
and $35 billion.
treating everyone with HCV would entail expenditure 1.6 times the current
total annual pharmaceutical budget. Only treating 10% of people would mean
that Poland, New Zealand, Portugal, Italy and Spain would each spend between
16% and 10% of their total annual drug budget on HCV therapies. The proportion
was even higher if therapy with ledipasvir/sofosbuvir were provided.
payment by individual people was not an option in many countries. In 12
countries, a 12-week course of treatment was equal to at least one year of
average earnings. In Poland, treatment cost the equivalent of 5.55 years of annual
earnings. In 21 countries, a person on average earnings would need at least one
year of average earnings to pay for a course of ledipasvir/sofosbuvir.
could not be achieved in many OECD countries, even if they have price control
systems, which suggests a need for updated pricing systems,” conclude the
authors. “In order for countries to increase investment and to minimise the
burden of hepatitis C, governments and industry stakeholders will need to
jointly develop and implement fairer pricing and frameworks that deliver lower
and more affordable prices.”