WHO adds new hepatitis C, cancer drugs to essential medicines list

The World Health Organization on Friday said it added a number of new treatments for hepatitis C virus (HCV) infection to its essential medicines list, although the agency noted that their "high prices currently make them unaffordable, and thus inaccessible, to most people who need them." The list was also updated to include new drugs for various cancers, including breast cancer and leukaemia, as well as multi-drug resistant tuberculosis (TB).

The agency noted that five direct-acting oral antivirals recently introduced to the HCV market, including Gilead Sciences' Sovaldi (sofosbuvir) and Bristol-Myers Squibb's Daklinza (daclatasvir), have transformed chronic hepatitis C from "a barely manageable, to a curable condition." Marie-Paule Kieny, WHO assistant director-general for health systems and innovation, said HCV therapies "are evolving rapidly," with several making their way through the development pipeline. However, she pointed out that "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."

Gilead, which reported first-quarter sales of $972 million for Sovaldi, has faced criticism from various quarters over the drug's pricing, including from lawmakers in the US, where a standard course of treatment costs $84 000. Earlier this year, the company announced steeper US discounts for Sovaldi, as well as for Harvoni (ledipasvir/sofosbuvir), its combination hepatitis C treatment (for related analysis, see ViewPoints: Medicare spending on HCV drugs jumps in 2014 – was it money well spent?). Gilead has also signed licensing agreements authorising multiple drugmakers to make Sovaldi for distribution in 91 developing countries, such as India, where a typical 24-week course of therapy would cost less than $1800.

Meanwhile, the WHO said recent breakthroughs have prompted the agency to revise the full cancer segment of the essential medicines list, to which 16 new drugs have been added. Kees De Joncheere, the WHO's director of essential medicines, noted that "some of these [drugs] produce relevant survival benefits for cancers with high incidence," citing Roche's Herceptin (trastuzumab) as an example. De Joncheere said "other treatment regimens for rare cancers, such as leukaemia and lymphoma, which can cure up to 90 percent of patients, were added to set a global standard."

The agency also stated that after decades of "scarce innovation" in TB drug development, the list now contains five new therapies, including Johnson & Johnson's Sirturo (bedaquiline) and Otsuka's Deltyba (delamanid), both of which target multi-drug-resistant TB. In addition, De Joncheere said the expert committee agreed to maintain Roche's Avastin (bevacizumab) as the preferred medicine for eye diseases such as macular degeneration, and rejected an application to include Roche and Novartis' Lucentis (ranibizumab) on the list, noting that the panel evaluated evidence for safety and efficacy, as well as price differences between the drugs. The committee also recommended supporting off-label uses "in cases where there is clear evidence of major health benefits, though no licensed indication, such as for many medicines for children."

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