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WHO analysis: Cost of new HCV meds unaffordable globally

The cost of new medicines for patients infected with hepatitis C virus vary widely around the globe, especially when adjusted for national wealth, results from an economic analysis led by World Health Organization officials suggest.

“These prices threaten the sustainability of health systems in many countries and prevent large-scale provision of treatment,” Suzanne Hill, PhD, of the World Health Organization, Geneva, and her associates wrote (PLoS Med. 2016 May 31;[5]:e1002032. doi:10.1371/journal.pmed.1002032).

“Stakeholders should implement a fairer pricing framework to deliver lower prices that take account of affordability. Without lower prices, countries are unlikely to be able to increase investment to minimize the burden of hepatitis C.”

In an effort to calculate the potential total cost of sofosbuvir and ledipasvir/sofosbuvir for different national health systems and individual patients in 30 countries, the researchers obtained 2015 prices for a 12-week course of treatment with the medications for as many countries as possible. Sources of reference were the Pharma Price Information service of the Austrian public health institute Gesundheit Österreich GmbH, national government and drug reimbursement authority website, and press releases.

Using data compiled between July 17, 2015, and Jan. 25, 2016, medication prices in Organisation for Economic Co-operation and Development (OECD) member countries and certain low- and middle-income countries were converted to U.S. dollars using period average exchange rates and were adjusted for purchasing power parity (PPP). “We analyzed prices compared to national economic performance and estimated market size and the cost of these drugs in terms of countries’ annual total pharmaceutical expenditure (TPE) and in terms of the duration of time an individual would need to work to pay for treatment out of pocket,” the researchers explained. “Patient affordability was calculated using 2014 OECD average annual wages, supplemented International Labour Organization median wages where necessary.”

Dr. Sullivan and her associates found that HCV medication prices varied significantly across countries, especially when adjusted for national wealth. For example, the median price of a 12-week course of sofosbuvir across 26 OECD countries was $42,017 in U.S. dollars, ranging from $37,729 in Japan to $64,680 in the United States. At the same time, countries in central and eastern Europe had higher PPP-adjusted prices, compared with other countries. For example, the PPP-adjusted prices of sofosbuvir in Poland and Turkey were $101,063 and $70,331, respectively, compared with a price of $64,680 in the Unite States. At the same time, the PPP-adjusted price of ledipasvir/sofosbuvir in Poland was $118,754, compared with a price of $72,765 in the United States.

The researchers also found that the PPP-adjusted price of a full course of sofosbuvir alone would be equivalent to at least 1 year of the PPP-adjusted average earnings for individuals in 12 of the 30 countries analyzed. In Poland, Slovakia, Portugal, and Turkey, a course of sofosbuvir alone would cost at least 2 years’ of average annual wages. “This analysis is conservative because prices were ex-factory prices with an assumed 23% price reduction, and did not include supply chain mark-ups and other costs such as the cost of diagnosis, daclatasvir, ribavirin, and health service costs,” they wrote.

They characterized the costs of sofosbuvir and ledipasvir/sofosbuvir as “not ‘affordable’ for most OECD countries at the nominal and PPP-adjusted prices, with Central and Eastern European countries being the most affected. While determining what is affordable or not is a value judgment, funding these treatments in these national health systems would consume large proportions of their TPE and increase pressure on existing budgets.”

They acknowledged certain limitations of the analysis, including the accuracy of the estimates of the numbers of people infected and of the price information that was accessible. “We have also not included all likely costs, such as the costs of combination treatment with ribavirin, other health care services, and increases in the duration of treatment in patients with cirrhosis; thus, our budget impact estimates are underestimates of the cost of treatment. We are also aware that in some countries, the prices are probably lower than the publicly accessible prices because of confidential discounts or rebates negotiated with the manufacturer.”

Dr. Hill disclosed that she is a member of the PLoS Medicine editorial board.

[email protected]

References

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The savings to the medical system in averted future costs of liver complications were excluded from the assessment developed by Suzanne Hill, PhD, and her colleagues. However, studies of the cost-effectiveness of HCV therapies in the United States suggest that these benefits are substantial and can help finance HCV treatment.

Despite the discounts offered in both LMICs (low- and middle-income countries) and OECD (Organisation for Economic Cooperation and Development) countries, the short-term impact of HCV treatment on budgets of health care payers and individuals may limit access. However, there are two mitigating factors. First, once the backlog of prevalent cases is treated, the budgetary impact drops dramatically, as only the relatively few incident cases need be treated. Thus, while fiscally disruptive if all HCV-infected persons were immediately put on treatment, that disruption would last only 1 year. Second, treating everyone in year 1 is implausible. The process of identifying cases, limits to health care system capacity, and patient preferences all suggest a multi-year catch-up process. For those reasons, the fiscal burden expressed as a percent of TPE (total pharmaceutical expenditure) or as a portion of the average annual wage would be much less than the maximum burden as presented in Dr. Hill’s article.

One solution, then, is to spread the upfront cost of treatment over several years. Not everyone is eager to be treated, especially the asymptomatic for whom delay may be less harmful. Beyond this, there are options for phasing in treatment gradually by equity concerns, i.e., treating those with lower access to care first, or by disease stage. Our U.S.-based analysis found that while treating all patients in fibrosis stages 1–4 was cost-effective, initiating treatment in stages 3 and 4 was more cost-effective and would reduce total net treatment costs in the United States by about one-third per individual with chronic hepatitis C. A combination of equity and disease stage criteria can match phase-in plans to different countries’ budgets and political will.

It is in each country’s capacity, and without disruptive budgetary impact, to start treating many of those most in need of care now and to extend coverage to all over the succeeding few years.

These comments were extracted from an accompanying editorial (PLoS Med. 2016 May 31;[5]:e1002031. doi:10.1371/journal.pmed.1002031) by Elliot Marseille, DrPH, and James G. Kahn, MD, MPH. Dr. Marseille is with the Oakland, Calif.-based Health Strategies International. Dr. Kahn is with the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. The authors reported having no relevant financial disclosures.

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Body

The savings to the medical system in averted future costs of liver complications were excluded from the assessment developed by Suzanne Hill, PhD, and her colleagues. However, studies of the cost-effectiveness of HCV therapies in the United States suggest that these benefits are substantial and can help finance HCV treatment.

Despite the discounts offered in both LMICs (low- and middle-income countries) and OECD (Organisation for Economic Cooperation and Development) countries, the short-term impact of HCV treatment on budgets of health care payers and individuals may limit access. However, there are two mitigating factors. First, once the backlog of prevalent cases is treated, the budgetary impact drops dramatically, as only the relatively few incident cases need be treated. Thus, while fiscally disruptive if all HCV-infected persons were immediately put on treatment, that disruption would last only 1 year. Second, treating everyone in year 1 is implausible. The process of identifying cases, limits to health care system capacity, and patient preferences all suggest a multi-year catch-up process. For those reasons, the fiscal burden expressed as a percent of TPE (total pharmaceutical expenditure) or as a portion of the average annual wage would be much less than the maximum burden as presented in Dr. Hill’s article.

One solution, then, is to spread the upfront cost of treatment over several years. Not everyone is eager to be treated, especially the asymptomatic for whom delay may be less harmful. Beyond this, there are options for phasing in treatment gradually by equity concerns, i.e., treating those with lower access to care first, or by disease stage. Our U.S.-based analysis found that while treating all patients in fibrosis stages 1–4 was cost-effective, initiating treatment in stages 3 and 4 was more cost-effective and would reduce total net treatment costs in the United States by about one-third per individual with chronic hepatitis C. A combination of equity and disease stage criteria can match phase-in plans to different countries’ budgets and political will.

It is in each country’s capacity, and without disruptive budgetary impact, to start treating many of those most in need of care now and to extend coverage to all over the succeeding few years.

These comments were extracted from an accompanying editorial (PLoS Med. 2016 May 31;[5]:e1002031. doi:10.1371/journal.pmed.1002031) by Elliot Marseille, DrPH, and James G. Kahn, MD, MPH. Dr. Marseille is with the Oakland, Calif.-based Health Strategies International. Dr. Kahn is with the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. The authors reported having no relevant financial disclosures.

Body

The savings to the medical system in averted future costs of liver complications were excluded from the assessment developed by Suzanne Hill, PhD, and her colleagues. However, studies of the cost-effectiveness of HCV therapies in the United States suggest that these benefits are substantial and can help finance HCV treatment.

Despite the discounts offered in both LMICs (low- and middle-income countries) and OECD (Organisation for Economic Cooperation and Development) countries, the short-term impact of HCV treatment on budgets of health care payers and individuals may limit access. However, there are two mitigating factors. First, once the backlog of prevalent cases is treated, the budgetary impact drops dramatically, as only the relatively few incident cases need be treated. Thus, while fiscally disruptive if all HCV-infected persons were immediately put on treatment, that disruption would last only 1 year. Second, treating everyone in year 1 is implausible. The process of identifying cases, limits to health care system capacity, and patient preferences all suggest a multi-year catch-up process. For those reasons, the fiscal burden expressed as a percent of TPE (total pharmaceutical expenditure) or as a portion of the average annual wage would be much less than the maximum burden as presented in Dr. Hill’s article.

One solution, then, is to spread the upfront cost of treatment over several years. Not everyone is eager to be treated, especially the asymptomatic for whom delay may be less harmful. Beyond this, there are options for phasing in treatment gradually by equity concerns, i.e., treating those with lower access to care first, or by disease stage. Our U.S.-based analysis found that while treating all patients in fibrosis stages 1–4 was cost-effective, initiating treatment in stages 3 and 4 was more cost-effective and would reduce total net treatment costs in the United States by about one-third per individual with chronic hepatitis C. A combination of equity and disease stage criteria can match phase-in plans to different countries’ budgets and political will.

It is in each country’s capacity, and without disruptive budgetary impact, to start treating many of those most in need of care now and to extend coverage to all over the succeeding few years.

These comments were extracted from an accompanying editorial (PLoS Med. 2016 May 31;[5]:e1002031. doi:10.1371/journal.pmed.1002031) by Elliot Marseille, DrPH, and James G. Kahn, MD, MPH. Dr. Marseille is with the Oakland, Calif.-based Health Strategies International. Dr. Kahn is with the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. The authors reported having no relevant financial disclosures.

Title
Treating those in need now leads to savings downstream
Treating those in need now leads to savings downstream

The cost of new medicines for patients infected with hepatitis C virus vary widely around the globe, especially when adjusted for national wealth, results from an economic analysis led by World Health Organization officials suggest.

“These prices threaten the sustainability of health systems in many countries and prevent large-scale provision of treatment,” Suzanne Hill, PhD, of the World Health Organization, Geneva, and her associates wrote (PLoS Med. 2016 May 31;[5]:e1002032. doi:10.1371/journal.pmed.1002032).

“Stakeholders should implement a fairer pricing framework to deliver lower prices that take account of affordability. Without lower prices, countries are unlikely to be able to increase investment to minimize the burden of hepatitis C.”

In an effort to calculate the potential total cost of sofosbuvir and ledipasvir/sofosbuvir for different national health systems and individual patients in 30 countries, the researchers obtained 2015 prices for a 12-week course of treatment with the medications for as many countries as possible. Sources of reference were the Pharma Price Information service of the Austrian public health institute Gesundheit Österreich GmbH, national government and drug reimbursement authority website, and press releases.

Using data compiled between July 17, 2015, and Jan. 25, 2016, medication prices in Organisation for Economic Co-operation and Development (OECD) member countries and certain low- and middle-income countries were converted to U.S. dollars using period average exchange rates and were adjusted for purchasing power parity (PPP). “We analyzed prices compared to national economic performance and estimated market size and the cost of these drugs in terms of countries’ annual total pharmaceutical expenditure (TPE) and in terms of the duration of time an individual would need to work to pay for treatment out of pocket,” the researchers explained. “Patient affordability was calculated using 2014 OECD average annual wages, supplemented International Labour Organization median wages where necessary.”

Dr. Sullivan and her associates found that HCV medication prices varied significantly across countries, especially when adjusted for national wealth. For example, the median price of a 12-week course of sofosbuvir across 26 OECD countries was $42,017 in U.S. dollars, ranging from $37,729 in Japan to $64,680 in the United States. At the same time, countries in central and eastern Europe had higher PPP-adjusted prices, compared with other countries. For example, the PPP-adjusted prices of sofosbuvir in Poland and Turkey were $101,063 and $70,331, respectively, compared with a price of $64,680 in the Unite States. At the same time, the PPP-adjusted price of ledipasvir/sofosbuvir in Poland was $118,754, compared with a price of $72,765 in the United States.

The researchers also found that the PPP-adjusted price of a full course of sofosbuvir alone would be equivalent to at least 1 year of the PPP-adjusted average earnings for individuals in 12 of the 30 countries analyzed. In Poland, Slovakia, Portugal, and Turkey, a course of sofosbuvir alone would cost at least 2 years’ of average annual wages. “This analysis is conservative because prices were ex-factory prices with an assumed 23% price reduction, and did not include supply chain mark-ups and other costs such as the cost of diagnosis, daclatasvir, ribavirin, and health service costs,” they wrote.

They characterized the costs of sofosbuvir and ledipasvir/sofosbuvir as “not ‘affordable’ for most OECD countries at the nominal and PPP-adjusted prices, with Central and Eastern European countries being the most affected. While determining what is affordable or not is a value judgment, funding these treatments in these national health systems would consume large proportions of their TPE and increase pressure on existing budgets.”

They acknowledged certain limitations of the analysis, including the accuracy of the estimates of the numbers of people infected and of the price information that was accessible. “We have also not included all likely costs, such as the costs of combination treatment with ribavirin, other health care services, and increases in the duration of treatment in patients with cirrhosis; thus, our budget impact estimates are underestimates of the cost of treatment. We are also aware that in some countries, the prices are probably lower than the publicly accessible prices because of confidential discounts or rebates negotiated with the manufacturer.”

Dr. Hill disclosed that she is a member of the PLoS Medicine editorial board.

[email protected]

The cost of new medicines for patients infected with hepatitis C virus vary widely around the globe, especially when adjusted for national wealth, results from an economic analysis led by World Health Organization officials suggest.

“These prices threaten the sustainability of health systems in many countries and prevent large-scale provision of treatment,” Suzanne Hill, PhD, of the World Health Organization, Geneva, and her associates wrote (PLoS Med. 2016 May 31;[5]:e1002032. doi:10.1371/journal.pmed.1002032).

“Stakeholders should implement a fairer pricing framework to deliver lower prices that take account of affordability. Without lower prices, countries are unlikely to be able to increase investment to minimize the burden of hepatitis C.”

In an effort to calculate the potential total cost of sofosbuvir and ledipasvir/sofosbuvir for different national health systems and individual patients in 30 countries, the researchers obtained 2015 prices for a 12-week course of treatment with the medications for as many countries as possible. Sources of reference were the Pharma Price Information service of the Austrian public health institute Gesundheit Österreich GmbH, national government and drug reimbursement authority website, and press releases.

Using data compiled between July 17, 2015, and Jan. 25, 2016, medication prices in Organisation for Economic Co-operation and Development (OECD) member countries and certain low- and middle-income countries were converted to U.S. dollars using period average exchange rates and were adjusted for purchasing power parity (PPP). “We analyzed prices compared to national economic performance and estimated market size and the cost of these drugs in terms of countries’ annual total pharmaceutical expenditure (TPE) and in terms of the duration of time an individual would need to work to pay for treatment out of pocket,” the researchers explained. “Patient affordability was calculated using 2014 OECD average annual wages, supplemented International Labour Organization median wages where necessary.”

Dr. Sullivan and her associates found that HCV medication prices varied significantly across countries, especially when adjusted for national wealth. For example, the median price of a 12-week course of sofosbuvir across 26 OECD countries was $42,017 in U.S. dollars, ranging from $37,729 in Japan to $64,680 in the United States. At the same time, countries in central and eastern Europe had higher PPP-adjusted prices, compared with other countries. For example, the PPP-adjusted prices of sofosbuvir in Poland and Turkey were $101,063 and $70,331, respectively, compared with a price of $64,680 in the Unite States. At the same time, the PPP-adjusted price of ledipasvir/sofosbuvir in Poland was $118,754, compared with a price of $72,765 in the United States.

The researchers also found that the PPP-adjusted price of a full course of sofosbuvir alone would be equivalent to at least 1 year of the PPP-adjusted average earnings for individuals in 12 of the 30 countries analyzed. In Poland, Slovakia, Portugal, and Turkey, a course of sofosbuvir alone would cost at least 2 years’ of average annual wages. “This analysis is conservative because prices were ex-factory prices with an assumed 23% price reduction, and did not include supply chain mark-ups and other costs such as the cost of diagnosis, daclatasvir, ribavirin, and health service costs,” they wrote.

They characterized the costs of sofosbuvir and ledipasvir/sofosbuvir as “not ‘affordable’ for most OECD countries at the nominal and PPP-adjusted prices, with Central and Eastern European countries being the most affected. While determining what is affordable or not is a value judgment, funding these treatments in these national health systems would consume large proportions of their TPE and increase pressure on existing budgets.”

They acknowledged certain limitations of the analysis, including the accuracy of the estimates of the numbers of people infected and of the price information that was accessible. “We have also not included all likely costs, such as the costs of combination treatment with ribavirin, other health care services, and increases in the duration of treatment in patients with cirrhosis; thus, our budget impact estimates are underestimates of the cost of treatment. We are also aware that in some countries, the prices are probably lower than the publicly accessible prices because of confidential discounts or rebates negotiated with the manufacturer.”

Dr. Hill disclosed that she is a member of the PLoS Medicine editorial board.

[email protected]

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WHO analysis: Cost of new HCV meds unaffordable globally
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WHO analysis: Cost of new HCV meds unaffordable globally
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Key clinical point: Current prices of new medicines for hepatitis C virus are variable and unaffordable globally.

Major finding: The median price of a 12-week course of sofosbuvir across 26 OECD countries was $42,017 in U.S. dollars, ranging from $37,729 in Japan to $64,680 in the United States.

Data source: An economic analysis of prices, costs, and affordability of new medicines for HCV in 30 countries .

Disclosures: Dr. Hill disclosed that she is a member of the PLoS Medicine editorial board.