New HCV therapies unaffordable to health systems and individuals

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.

“Our analysis 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.

Glossary

middle income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. There are around 50 lower-middle income countries (mostly in Africa and Asia) and around 60 upper-middle income countries (in Africa, Eastern Europe, Asia, Latin America and the Caribbean).

low income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. While the majority of the approximately 30 countries that are ranked as low income are in sub-Saharan Africa, many African countries including Kenya, Nigeria, South Africa and Zambia are in the middle-income brackets. 

sustained virological response (SVR)

The continued, long-term suppression of a virus as a result of treatment. In hepatitis C, refers to undetectable hepatitis C RNA after treatment has come to an end. Usually SVR refers to RNA remaining undetectable for 12 or 24 weeks after ending treatment and is considered to be a cure (SVR12 or SVR24).

reinfection

In HIV, synonym for superinfection. In hepatitis C, used when someone who has been cured of the virus is infected with hepatitis C again.

cure

To eliminate a disease or a condition in an individual, or to fully restore health. A cure for HIV infection is one of the ultimate long-term goals of research today. It refers to a strategy or strategies that would eliminate HIV from a person’s body, or permanently control the virus and render it unable to cause disease. A ‘sterilising’ cure would completely eliminate the virus. A ‘functional’ cure would suppress HIV viral load, keeping it below the level of detection without the use of ART. The virus would not be eliminated from the body but would be effectively controlled and prevented from causing any illness. 

US authorities 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, 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.

Approximately 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 treating reinfection.

The investigators 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 everyone 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 $6875 in Brazil and $539 in India.

Adjustment for 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-$1861).

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).

Adjusted total budget impact associated with treating all people in each individual country varied from $100.9 million in Luxemburg to $166.6 billion in the US. For Poland, Turkey, Spain and Italy the total budget impact was between $20 billion and $35 billion.

In Poland, 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.

Out-of-pocket payment by individuals 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.

“Affordable prices 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.”

References

Iyengar S et al. Prices, costs and affordability of new medicines for hepatitis C in 30 countries: an economic analysis. PLoS Medicine, DOI: 10.1371/journal.pmed.1002032, 2016.

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