Back HCV Policy & Advocacy Sofosbuvir/Daclatasvir Combination Could Be Produced for $200 per Hepatitis C Cure

Sofosbuvir/Daclatasvir Combination Could Be Produced for $200 per Hepatitis C Cure

alt

Month-by-month tracking of the prices paid in India for the chemicals used to make direct-acting antivirals to treat hepatitis C shows that it is now possible to make and sell a combination of drugs to cure hepatitis C virus (HCV) infection for less than $200, Andrew Hill of Liverpool University said at the Second European HIV Hepatitis Co-infection Conference in London last week.

[Produced in collaboration with Aidsmap.com]

If those drugs were bought at list price in the U.S. they would cost approximately $147,000 for a 12-week course of treatment -- $84,000 for sofosbuvir (Sovaldi), manufactured by Gilead Sciences, and $63,000 for daclatasvir (Daklinza), manufactured by Bristol-Myers Squibb.

Tracking shipments of active pharmaceutical ingredients (API) by indiainfodrive.com, a reporting mechanism for importers and exporters, shows that the value of shipments of the APIs used to make sofosbuvir -- the world’s the most frequently-prescribed hepatitis C direct-acting antiviral -- has fallen from around $8000 per kilogram in January 2015 to around $2000 per kg in September 2015.

Active pharmaceutical ingredients are manufactured in India and China and shipped to other parts of the world for final manufacture of a drug. The website tracks shipments in and out of India for a wide range of commodities by analyzing customs data, which must declare the weight and value of items passing through customs.

By crunching these data, Hill and colleagues were able to track changes in the value of shipments of the APIs used in the manufacture of sofosbuvir and daclatasvir. Using these prices, they went on to calculate how much it would cost to manufacture a finished product, using methods of calculation already validated for the estimation of antiretroviral drug costs.

In the case of sofosbuvir, they found that even assuming a 50% profit margin for the manufacturer to cover capital investment and return to shareholders, it would now be possible to sell a 12-week course of the drug for $178.

"The supplies in 2015 are sufficient to treat 150,000 people with sofosbuvir for 12 weeks. Even at these quite low volumes the prices have fallen by 70% in one year, and there is no sign of a leveling off in prices, Hill told Aidsmap by email.

Indian manufacturers are already making generic versions of sofosbuvir under voluntary licensing agreements with Gilead, selling for around $483 for a 12-week course of treatment in India. In comparison, a generic version of sofosbuvir -- again, manufactured under voluntary license -- is sold for $900 in Egypt. The branded product Sovaldi, manufactured by Gilead, costs $27,921 in Spain and $53,010 in the United Kingdom, although prices paid might be considerably lower due to negotiations regarding volume.

Daclatasvir would be even cheaper. The cost of its active ingredients have fallen from around $10,000 per kg in January 2015 to $2000 per kg in September 2015, implying a generic cost of $22 for a 12-week course of treatment, compared to the $63,000 list price currently charged in the U.S. This low price may be achievable imminently, Hill believes, as a result of the licensing of daclatasvir to the Medicines Patent Pool for lower-income countries.

These costs suggest that it would be possible to market a pangenotypic (effective against all HCV genotypes) combination of sofosbuvir and daclatasvir for no more than $200.

But many of the middle-income countries with a high burden of hepatitis C, such as China, Brazil, Ukraine, and Latin America, will continue to be excluded by the terms of voluntary licensing agreements from obtaining Indian generics -- unless they pursue compulsory licensing. Hill reminded conference participants that the South African government’s threat to use compulsory licensing had been critical in opening the way to lower antiretroviral drug prices in the early 2000s.

In the case of hepatitis C treatment, people could take matters into their own hands without waiting for governments. In Australia the FixhepC buyers club is working to assist individuals in buying generic drugs, carrying out quality testing to ensure that they contain active pharmaceuticals, and importing the drugs for personal use. (The FixhepC website contains details about import regulations regarding medication for personal use for Australia, New Zealand, the U.K. and the U.S., as well as details about how people can purchase medication from generic manufacturers).

Hill also challenged the claim that current U.S. pricing of Sovaldi and Harvoni (Gilead's coformulation of sofosbuvir and ledipasvir) makes the drugs cost-effective. He pointed out that at current prices, the use of these drugs is only cost-effective when set against a lifetime of medical costs, and calculations of cost-effectiveness ignore the propensity of drug prices to fall over time.

Similarly, claims that treatment at current prices is cost saving are misleading, Hill argued, pointing to recent projections published in Annals of Internal Medicine. Jagpreet Chhatwal and colleagues found that treating all eligible patients with hepatitis C in the U.S. over the next 5 years would cost $65 billion, but would save only $16 billion in medical costs over the same period.

The current levels of pricing are only sustainable, Hill believes, for as long as Gilead lacks price competition in developed world markets and faces no serious threat of compulsory licensing in middle-income markets.

"It only takes one company to be brave and say 'we aren’t going to charge £30,000, we’re going to charge £10,000', and they will make a lot of money," Hill concluded, to prolonged applause.

12/15/15

Reference

A Hill. Second European HIV Hepatitis Co-infection Conference. London, December 10-11, 2015.