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WHO Guidelines Call for Pricey Hepatitis C Drugs

Sofosbuvir costs $1,000 per pill

According to a report from the Kaiser Family Foundation, the first-ever global guidelines for the treatment of hepatitis C virus (HCV) infection have advocated worldwide use of two of the most expensive specialty drugs in the world.

The new guidelines, issued by the World Health Organization (WHO), endorse the two newest HCV medications — sofosbuvir (Sovaldi, Gilead Sciences) and simeprevir (Olysio, Janssen Pharmaceuticals).

The WHO gives a “strong” recommendation to treatment with sofosbuvir, in combination with ribavirin with or without pegylated interferon (peg-IFN) (depending on the HCV genotype), in genotypes 1, 2, 3, and 4 HCV infection rather than peg-IFN and ribavirin alone (or no treatment for persons who cannot tolerate IFN).

The WHO also gives a “strong” recommendation to treatment with simeprevir in combination with peg-IFN and ribavirin for persons with genotype 1b HCV infection and for persons with genotype 1a HCV infection without the Q80K polymorphism rather than peg-IFN and ribavirin alone.

The problem is, sofosbuvir (Sovaldi) costs $1,000 per pill or $84,000 for a 12-week course of treatment, and simeprevir (Olysio) costs $66,360 for a 3-month course.

In its guidelines, the WHO concedes that it made its recommendations without taking resource use into consideration, as pricing information was not available for any country other than the U.S. at the time the recommendations were formulated.

The high prices have ignited a storm of criticism. In the U.S., doctors and insurers argue that the cost of the drugs will make their widespread use impossible. And critics say that even if the prices are heavily discounted in other countries, the drugs will still be unaffordable in most of the world.

The controversy over the cost is apparently beginning to have an effect on pricing. Egypt, which has the world’s highest infection rates (around 20% of the population), has negotiated a 99% discount on sofosbuvir, to $900 for a 12-week course.

Gilead is tiering prices for the drug in other countries as well: $55,000 in Canada, $66,000 in Germany, and reportedly around $2,000 for a generic version that may be licensed to Indian companies.

But those discounts don’t impress some critics. “When you’re starting from such an exorbitant price in the U.S., the price Gilead will offer middle-income countries like Thailand and Indonesia may seem like a good discount,” said Rohit Malpani of Doctors Without Borders. “But it will still be too expensive for many of these countries to scale up treatment.”

Other forces may drive prices lower, however. “A number of other medicines are coming down the pike — at least 20,” said Dr. Stefan Wiktor, chief architect of the WHO guidelines. “That in itself will provide competition as companies try to assure market share.”

Sources: Kaiser Health News; April 9, 2014; and WHO Guidelines; April 2014.

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