Cancer drugs from Bristol-Myers Squibb Co. and Novartis AG, an HIV medicine from GlaxoSmithKline PLC's Viiv Healthcare joint venture and a hepatitis C drug made by Gilead Sciences Inc. are among those added to the World Health Organization's essential medicines list this year.
The organization also said oseltamivir, known commonly as Roche Holding Ltd.'s Tamiflu, should be used only for pandemic influenza and among severely ill populations or those at a high risk of complications, such as pregnant women. WHO had never recommended its use in seasonal flu, but evolving data had led the organization to further limit its recommendation to certain populations, Suzanne Hill, WHO director of essential medicines and health products, said in a press briefing. The first generic contender for Tamiflu, made by India's Natco Pharma Ltd., was approved for the U.S. market in 2016.
This year's list adds 30 medicines for adults and 25 for children, and expands nine already-listed products to new uses, for a total of 433 essential medicines. WHO's list, updated every two years, is designed to be a guide to national and institutional lists of treatments that should be available to address the most important public health needs. For the first time in the 40-year history of the list, the organization also issued advice on the specific use of its 39 recommended antibiotic options.
Antibiotics are now grouped into three classifications ranging from first-use options for common infections, such as the generic drug amoxicillin, to the "last resort" class, such as colistin and some cephalosporins, used against severe infections from multidrug-resistant bacteria. Experts also added 10 antibiotics to the list for adults and 12 for children.
Price, access and biosimilars
A combination of sofosbuvir and velpatasvir — known commonly as Gilead's Epclusa, but also sold generically as Sofosvel by Beacon Pharmaceuticals Ltd. and Velpanat by Natco — is now recommended to treat all six types of hepatitis C. Hill said the drug's ability to treat all types of the disease will remove some burden for countries without sophisticated diagnostic medicine.
Two oral cancer treatments, Bristol-Myers' Sprycel and Novartis' Tasigna, also made the list to treat chronic myeloid leukemia that has become resistant to standard treatment. In clinical trials, 1 in 2 patients taking these medicines achieved a complete and durable remission from the disease, the WHO committee noted.
Hill said that while these and other medicines are often sold at a high price, adding them to the list can influence talks between purchasers and manufacturers.
"When we designate medicine as essential, buyers have some leverage in negotiating the final purchase price," she said, adding that the evidence-based nature of the list could also help countries in deciding universal health coverage.
Looking to further help in these discussions, WHO is also launching a pilot project in September to investigate the efficacy of biosimilars for Roche's Herceptin, the current market leader for breast cancer treatment. The project, launched through the organization's prequalification program, will try to promote access to the drug and its biosimilars at an affordable price.
Shaking up HIV and infections options
Tivicay, a Viiv Healthcare drug recently approved in Europe in a two-pill HIV regimen with a Johnson & Johnson drug, joins the list of recommended anti-retrovirals, as does Merck & Co. Inc.'s Isentress, which is also being recommended for use in children. The committee cited Tivicay's safety, efficacy and high barrier to resistance in their decision.
The panel did not recommend drugs with tenofovir alafenamide, a formulation used by Gilead in anti-retrovirals such as Genvoya and Descovy. It also advised removing 26 anti-retroviral formulations no longer recommended by WHO guidelines.
For prevention, the organization recommended pre-exposure prophylaxis, or PrEP, with tenofovir disoproxil fumarate, alone or in combination with emtricitabine or lamivudine. Tenofovir disoproxil fumarate alone is commonly sold as Viread by Gilead, while a combination with emtricitabine is sold by Bristol-Myers Squibb as Atripla. Lamivudine is manufactured as Epivir or Combivir by Viiv and GSK, respectively.
Delamanid, sold by Otsuka Holdings Co. Ltd. as Deltyba, and clofazimine, sold by Novartis as Lamprene, are both recommended to treat children with multidrug-resistant tuberculosis; Lamprene is also advised an option for adults, joining Deltyba's previous recommendation. Combination formulas of isoniazid, rifampicin, ethambutol and pyrazinamide are recommended to treat pediatric tuberculosis as well.
Experts also recommended fentanyl skin patches and methadone for pain relief in cancer patients, saying in a statement that the medicines would increase access to medicines for end-of-life care.