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China updates drug reimbursement list, agrees price cuts

Drugs added include AbbVie's Humira and Roche's Perjeta

China

Chinese regulators have added 70 new medicines to the country’s National Reimbursement Drug List (NRDL), and has agreed an average of 61% in price cuts with pharma companies. 

The key drugs which have been added to the list include AbbVie’s blockbuster drug Humira (adalimumab), Novartis’ dermatitis drug Xolair (omalizumab) and Roche’s HER2 breast cancer treatment Perjeta (petuzumab).

These companies have agreed with China’s National Healthcare Security Administration (NHSA) to discount the prices of these drugs for access to the country’s booming market, with average price cuts of 61%.

According the NHSA, Chinese citizens can use their state medical insurance to cover a significant amount of the cost of the drugs addd to the list. The administration also said that the drugs included in this update had the ‘lowest prices globally’.

Drugmakers hoping to edge into the Chinese pharma market are faced with significant discounts of drug costs, as China is steadily increasing its attention to the price of in-patent drugs.

However, this most recent update shows a willingness from Western pharma companies to comply with the country’s regulatory authorities – in large part thanks to the promise of huge volumes to more than make up for the offset of price cuts.

Also included on the updated list is the PD-1 inhibitor Tyvyt (sintilimab) – jointly developed by Innovent Biologics and Eli Lilly – for the treatment of relapsed/refractory Hodgkin’s lymphoma.

It is the first and only PD-1 inhibitor to be included on the NRDL – Merck’s Keytruda (pembrolizumab) and BMS’ Opdivo (nivolumab) are not present on the updated list.

Merck’s Keytruda recently won approval as a first-line treatment for NSCLC in China, and was also the first PD-1 inhibitor to be approved in the country for the treatment of advanced melanoma.

However, BMS’ Opdivo claimed the first PD-1 approval in China, when it was approved by national regulators in NSCLC in 2018.

Meanwhile, China’s pharma industry is also making headway in the immunotherapy market, with drugmaker BeiGene recently claiming the first approval for a Chinese-developed drug in the US for its mantle cell lymphoma therapy Brukinsa.

This therapy is also under regulatory review in China and Europe for the same indication, and the company is also developing its own PD-1 inhibitor – tislelizumab – which has been filed for approval in China for classic Hodgkin’s lymphoma. If approved, it could directly rival Innovent/Lilly’s Tyvyt.

Article by
Lucy Parsons

29th November 2019

From: Regulatory

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