BMS, Roche, AZ Lose Out as China Favors Domestic Companies in 2020 NRDL PD-1 Bid

PRICENTRIC BRIEF:

• The finalized 2020 NRDL, which comes into effect on March 1, 2021, contains 119 additional drugs across 31 therapeutic classes compared to the 2017 list – when the NHSA took hold of procurement – but has also removed 29
• Following three-day negotiations that started on December 17, 2020 in Beijing, MSD’s Keytruda (pembrolizumab), Bristol Myers Squibb’s Opdivo (nivolumab), AstraZeneca’s Imfinzi (durvalumab) and Roche’s Tecentriq (atezolizumab) all failed to make their way into the finalized 2020 list
• Instead, home-grown PD-1 efforts from Shanghai Junshi Biosciences, Beigene Ltd and Jiangsu Hengrui Medicine took the coveted spots

THE DETAILS

BEIJING, China – In the days before 2020 came to a close, China’s National Healthcare Security Administration (NHSA) and Ministry of Human Resources and Social Security (MOHRSS) issued the 2020 Edition of the National Reimbursement Drug List (NRDL).

The finalized 2020 NRDL, which comes into effect on March 1, 2021, contains 119 additional drugs across 31 therapeutic classes compared to the 2017 list – when the NHSA took hold of procurement – but has also removed 29. On average, pharma companies agreed to cut drug prices by 51% in order to gain access to the list.

This year, PD-1 inhibitors – a category of drugs which are often costly yet highly effective – were the hot issue between multinational corporations (MNCs). The group of checkpoint inhibitor anticancer drugs work by blocking the activity of PD-1 and PDL1 immune checkpoint proteins present on the surface of cells.

Following three-day negotiations that started on December 17, 2020 in Beijing, MSD’s Keytruda (pembrolizumab), Bristol Myers Squibb’s Opdivo (nivolumab), AstraZeneca’s Imfinzi (durvalumab) and Roche’s Tecentriq (atezolizumab) all failed to make their way into the finalized 2020 list.

Instead, home-grown PD-1 efforts from Shanghai Junshi Biosciences, Beigene Ltd and Jiangsu Hengrui Medicine took the coveted spots. The three China-based companies offered up to a hefty 80% off the drugs’ prices to win their places on the list, significantly more than the already staggering 64% that Eli Lilly offered to slash Tyvyt (sintilimab) by in the previous year’s NRDL.

In 2019, Tyvyt – which is co-developed by Innovent and Lilly in China – was the only PD-1 to make the list, under the indication of relapsed/refractory classical Hodgkin’s lymphoma after at least two lines of chemo.

The 2020 price reductions won Jiangsu’s camrelizumab coverage for four indications, BeiGene’s Baizean (tislelizumab) two indications and Junshi Biosciences’ Tuoyi (toripalimab) reimbursement in one indication.

At the time of the list’s release, the prices were not officially disclosed, but Chinese media has since clarified them as the below:

• Hengrui Medicine’s Camrelizumab (200 mg): CNY 3,000
• BeiGene’s Tislelizumab (100 mg): CNY 1,500
• Junshi’s Teriprizumab (80 mg): CNY 906

China has always been favorable of national drugmakers when choosing drugs for reimbursement. As such, it has an ongoing aim to ramp up production capabilities of domestic manufacturers, issuing guidance on which now off-patent medicines should be the focus of production and passing domestic manufacturers though generic quality and clinical equivalence evaluation (GQCE) to ensure their products are safe to market.

Pricentric is in the process of releasing the full list with an accompanying evaluation, but more information on the 2020 NRDL can already be found in the Pricentric Insights Newsfeed.