Seven PD-(L)1 players could be vying for a place on China's drug reimbursement list. How far will they go?
New updates to the process of assembling China’s latest National Drug Reimbursement List could mean that seven additional PD-(L)1 drugs will be covered by government-sponsored insurance schemes — but likely not without significant discounts.
Developers of therapies approved by the National Medical Products Administration before August 17 will be eligible to apply for inclusion on the list. The deadline also applies to any drug that scored new indications.
A spot on the NDRL is a sought-after prize for biopharma companies trying to tap into the Chinese market. But given the intense negotiation, it remains a balancing act and analysts have predicted some multinational players may decide it’s not worth the cost.
Under new rules, Covid-19 therapies currently recommended by China’s National Health Commission may also be reimbursed, as may BeiGene’s BTK inhibitor Brukinsa.
But the brightest spotlight remains on the PD-(L)1 market, where it’s long been speculated that the deluge of new entrants would crowd out any space for any one brand to charge premium prices. And as Eli Lilly’s recent $1 billion deal with Innovent underscored, US commoditization may not be far behind.
The question now in China is how much lower they might go.
Tyvyt, which Lilly grabbed US rights to, is currently the only checkpoint drug on the NDRL. It’s approved for third-line classical Hodgkin’s lymphoma and sells for RMB2843 ($403) per 100mg, about 64% less than the original price of RMB7838/100mg ($1117.96) prior to inclusion.
Roche’s Tecentriq, which nabbed the greenlight in February and would therefore not have been eligible under a previous plan, can now join Merck (Keytruda), Bristol Myers Squibb (Opdivo), AstraZeneca (Imfinzi), Shanghai Junshi (Tuoyi), Jiangsu Hengrui (camrelizumab) and BeiGene (tislelizumab) in potentially placing a bid. Hengrui may seek reimbursement for non-small cell lung cancer, hepatocellular carcinoma and esophageal squamous cell carcinoma, having added these indications to the label after an initial OK in classical Hodgkin lymphoma.
Looking beyond PD-1, BeiGene could also be seeking NRDL inclusion for Brukinsa, according to Goldman Sachs analyst Ziyi Chen. In a note quoted by BioCentury, she noted that the BTK inhibitor was approved by the NMPA in June, six months after the FDA did, making it a beneficiary of the updated guidance. Securing reimbursement could give it more footing against rivals at AbbVie and J&J, whose Imbruvica is up for price re-negotiation.
Meanwhile, with Covid-19 treatments, Roche’s Actemra, the malaria drug chloroquine phosphate, ribavirin and alpha-interferon are the better-known drugs featured on the most up-to-date version of the national protocol. Nonetheless, the commercial prospects are likely minimal given the low caseloads in China.
Per the guidance issued by the National Healthcare Security Administration this Monday, companies have until the end of August to apply for inclusion. Expert review will take place in September and October; negotiation and price-setting will then follow. The latest version of the NDRL will be made public by the end of December.