Gilead confirms China talks on pricing for Sovaldi as country works on serious illness coverage

Gilead Sciences ($GILD) is in talks with China on pricing for Sovaldi as the country stands outside of an access program by the U.S. drugmaker that relies heavily on manufacturing and sales licensing to mostly India-based companies. The discussions are also held against a backdrop of China seeking to expand insurance access for serious illness coverage.

"We are in discussions with the Chinese authorities regarding access to Sovaldi, yes," Gilead spokesman Nick Francis said in an email to FiercePharmaAsia. "But (we) cannot comment further than that though."

Gilead earlier this year negotiated to expand market access for the drug, priced at around $1,000 per pill, or $84,000 for a 12-week course, in the U.S., and agreed to slash the cost to $300 a bottle, or roughly $10 per pill, through manufacturing and sales licenses that would cover India and many emerging markets at similar costs.

But there were notable exclusions from the deal, including some large emerging markets with high hepatitis C infection rates such as China, Russia, Brazil, Mexico and Ukraine.

The talks follow a June decision by China's State Intellectual Property Office, or SPIO, to reject a portion of an application by Gilead Sciences related to hepatitis C drug Sovaldi (sofosbuvir) for a prodrug, or a catalyst, that activates sofosbuvir in vivo.

China in particular has a large hepatitis C population, with nearly 30 million people living with the chronic viral infection, the highest number worldwide. The case has attracted widespread attention from civil society groups such as New York-based Initiative for Medicines, Access & Knowledge (I-MAK) that say pricing for the drug remains too high for poor patients around the world.

However, as Francis noted in the email, Sovaldi is "not approved yet" in China and the company is "still working though the regulatory pathway."

Liang Wannian, vice-director of China's medical reform office

A reimbursement pathway may be opening in China as well. China recently approved the rollout of medical insurance on serious illness nationwide, said Liang Wannian, vice-director of the medical reform office under the State Council and a senior official with China's National Health and Family Planning Commission, at a July 24 policy briefing.

Access to innovative medicines in China have lagged on a combination of a slow approval process and cost--though cost-benefit assessments in cases like Sovaldi which offer a cure appear to be a growing focus of healthcare policymakers in China. 

Though Gilead retains the patent on the API, the focus is now on whether it pursues the same actions as a similar China case two years ago with HIV treatment Viread (tenofovir) that saw the company release its patent to a pool that led to generic versions one year later in China and India.

Competition may also be a driver, with China-based Ascletis Pharmaceuticals in June announcing plans for Phase III trials of danoprevir (ASC08) and ASC16 (PPI-668) to treat chronic hepatitis C in China and Taiwan.

Applications were made with the China FDA and Taiwan FDA for the candidates, with danoprevir licenses from Roche ($RHHBY)--which halted work in 2013--and ASC16 licensed from Presidio Pharmaceuticals. An Ascletis spokesman told FiercePharmaAsia in June that the Taiwan approval is expected within three months and that China's Center for Drug Evaluation could take as long as the first quarter of 2016.

The World Health Organization in May added Sovaldi to its essential medicines list and urged lower prices, especially in middle income countries.

- here's a story from Xinhua
and a notice from the State Council on China's serious illness insurance push