Gilead Taps New Talent In China Hepatitis Drug Access Drive

In signs of a strategy shift, Gilead Sciences appears to be independently pursuing opportunities in China's rapidly growing hepatitis market by appointing a top market access executive.

Having had to rely on partners to tap into China's vast hepatitis market, Gilead Sciences Inc.now appears to be looking more to insider talent in a bid to bring its operations in China to the next level, perhaps with an eye on new market access schemes.

The US firm has announced the hiring of Rogers Luo as its new vice president and general manager of commercial operations in China. Luo has been a VP for Roche in China since 2012, and before that was the senior vice president in charge of Northern China operations for another Swiss multinational, Novartis AG.

While Luo's experience in China operations is valuable, the biggest attraction for Gilead may be his latest stint as Roche’s VP for market access and corporate affairs, a role in which he helped the Swiss company expand local market access to its high-cost innovative products in China's private pay market.

"In this new role, Rogers will lead the build out of the Commercial team across China to support the anticipated launches of Gilead's HCV therapies Sovaldi, Harvoni, Epclusa and single agent TAF for HBV over the next several years," a Gilead spokesperson told Scrip.

Slow Access Prompts Strategy Shift?

Gilead has so far chosen partnerships over building its own commercial presence in China. In 2009, the company teamed up with GlaxoSmithKline PLC to market the hepatitis B treatment Viread (tenofovir) in five Asian countries including China.

But like many innovative new drugs launched in China after 2009, when the National Reimbursement Drug List was last updated, Viread is not included in this and thus has no reimbursement coverage. To expand patient access, GSK participated in China's first-ever national drug price negotiation and agreed to a deep 67% cut for the drug.

However, the negotiations have not meant automatic adoption of the drug by provincial reimbursement authorities, which in effect has been slow so far. Three months after May 20, when the National Health Commission released the price cut results, only around half of China’s 31 provinces had started partially covering the drug.

As of Aug. 20, 17 provinces had listed the drug for reimbursement, of which 12 are covering it via new rural cooperation insurance schemes and seven via critical disease coverage plans. Only one province, Xinjiang, offers coverage through all four basic insurance schemes, providing wider access.

Without this type of coverage, the uptake of Viread is expected to remain muted despite the big price cut. Experience with this system and the slow adoption pace might be factors behind Gilead apparently now deciding to build its own on-the-ground commercial expertise in China, and the choice of a local veteran to tackle access hurdles.

New Access Programs?

Gilead's best-selling hepatitis C virus (HCV) drugs, Sovaldi (sofosbuvir) and its combination therapy with ledipasvir Harvoni, made headlines for their prices of up to $1,000 per tablet in the US, and pricing concerns have also prompted calls by Chinese officials to lower their eventual market prices upon launch.

Roche introduced novel market access programs in China under Luo's watch, which Forest City, California-based Gilead may be looking to adopt and adapt.

For instance, Roche's oncology drug Herceptin (trastuzumab) costs CNY20,000 ($3,003) for a treatment cycle and is not covered for reimbursement by most of China's 31 provinces.

To help patients gain access, Roche launched patient access programs (PAP) offering the drug free of charge if a patient had purchased a certain amount and continued showing a response. This proved successful and within a few years more than 100 million people were using the PAP.

Roche has also been working with re-insurance giant SwissRe and other multinational companies to help develop supplementary insurance coverage for cancer patients in China.

Newer Therapies Coming

Gilead’s China ambitions may also be helped by the fact that hepatitis cases are rising in the country - which has the highest hepatitis population in the world - and because the government is striving to reduce this disease burden through a newer generation of treatments.

All-oral HCV regimens are particularly lacking in China, where interferon-based therapies still dominate despite their side effects, and many patients also seek alternatives such as traditional Chinese medicines.

Against this background, foreign companies including Gilead are actively seeking Chinese regulatory approvals for their novel therapies. Several months ago, the China FDA's drug review arm designated fast-track approval reviews for products including Gilead's Sovaldi and Harvoni, Bristol-Myers Squibb Co.'s Daklinza (daclatasvir) and asunaprevir, and AbbVie Inc.'s Exviera (dasabuvir) and Viekira Pak (ombitasvir, paritaprevir and ritonavir) (Also see "China Fast-Tracks Multiple HCV Drugs With Access In Mind" - Scrip, 28 Apr, 2016.).

Additionally, Gilead is looking to commercialize its single agent TAF (tenofovir alafenamide) for hepatitis B in China. Compared to HCV, this form of hepatitis affects even more people and comes with an even heavier disease burden. There are an estimated 120 million carriers, accounting for close to 10% of the country’s total population and making it the top infectious disease.

Treatment cycles with traditional drugs can be long, and Gilead hopes TAF will have an improved safety profile over standard tenofovir, and an approval filing has already been made in Europe.

From the editors of PharmAsia News.