WHO Puts Hep C, TB, Cancer Drugs on Essential List
The World Health Organization has added new treatments for hepatitis C to its essential medicines list, including Gilead Sciences’ Sovaldi and Harvoni, but says prices must come down before most people will be able to access them.
The new hepatitis C medications are important because the disease affects 150 million people throughout the world and kills about 500,000 annually. Five direct acting oral antivirals, including Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir), have entered the market, transforming the disease from barely manageable to curable.
But that promise has come with a high price. Sovaldi currently costs about $84,000 for a full treatment in the U.S. — or $1,000 a pill.
“While some efforts have been made to reduce their price for low-income countries, without uniform strategies to make these medicines more affordable globally the potential for public health gains will be reduced considerably,” said Marie-Paule Kieny, WHO assistant director-general for health systems and innovation.
Updated every two years, the essential medicines list serves as a model for nations developing their own similar lists because every medicine has been vetted for efficacy, safety and quality.
After about 45 years of little advancement in tuberculosis treatment, WHO also added five new TB products to the list this year. Four of these, including Janssen’s Sirturo (bedaquiline) and Pfizer’s Zyvox (linezolid) target multidrug-resistant TB, WHO notes. TB remains one of the world’s deadliest infectious diseases, killing 1.5 million people in 2013.
WHO also added 16 new cancer drugs to the list. Included are such pricey items as Novartis’ Gleevec (imatinib), Genentech’s Herceptin (trastuzumab) and Rituxan (rituximab).
Along with approving new medications, WHO recommends supporting off-label uses of medications in cases where there is clear evidence of major health benefits, such as treating children where there is no licensed indication for treatment.
Read the Essential Medicines List at www.fdanews.com/05-12-15-essentialmedicines.pdf. — John Bechtel