The widely anticipated release of negotiated additions to the National Reimbursement Drug List by China’s National Medical Insurance Administration came on Nov. 28, with Innovent’s Tyvyt the lone anti-PD-1 mAb to make the cut. In all, 97 drugs were added to the list, including 74 drugs that aren’t traditional Chinese medicines.
Across the 52 newly-added innovative molecules to the NRDL, the average price cut was nearly 61%, higher than the 45% and 57% discounts negotiated for new drugs added to the NRDL in 2017 and 2018, respectively (see “China Releases Preliminary Reimbursement List”).
Of the 52 therapies, 14 are from domestic biopharmas.
For the 22 innovative medicines that were re-negotiated and remain on the NRDL -- nine of which came from Chinese companies -- the average price cut was about 25%.
Tyvyt sintilimab from Innovent Biologics Inc. (HKEX:1801) and Eli Lilly and Co. (NYSE:LLY) beat out competing anti-PD-1 mAbs Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK), Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) and domestic competitor Tuoyi toripalimab from Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877).
Tyvyt is approved in China for relapsed or refractory classical Hodgkin’s lymphoma, while Tuoyi is approved to treat melanoma. While the NRDL addition will reimburse Tyvyt only for its approved indication, the broader access to the drug could increase its off-label use in other indications such as non-small cell lung cancer (NSCLC), for which it is in Phase III testing.
Innovent agreed to a 64% discount. According to a Bernstein analyst report, the Chinese biotech is expected to cancel its patient benefit program, which would mean the discount would be about a 40% cut from the pre-reimbursed price.
For the therapies that didn’t make the cut, many companies may look forward to the next NRDL update, which is expected in two years. But it doesn’t mean the therapies are shut out from the market in the interim.
Sheng Yao, Junshi’s SVP of oncology and cellular therapy, told BioCentury that Tuoyi can still be competitive in the Chinese market because it has the lowest cost of any PD-1 inhibitor, with an annual price of RMB94,000 ($13,350). Yao added that as Tuoyi, which is offered via a patient assistance program, adds larger indications to its label, “Junshi will engage actively to enter the NRDL in the next round of negotiations.”
Tuoyi is in Phase III testing for third-line nasopharyngeal carcinoma and second-line urothelial carcinoma.
In a statement sent to BioCentury, Merck said that it will continue to provide access to Keytruda on the private market while offering a patient assistance program.
Yet missing out on the NRDL could limit Merck’s growth strategy in China. In July, the pharma had said the potential addition of Keytruda to the NRDL could substantially expand access to the PD-1 inhibitor for lung cancer patients in China (see “Keytruda Sales Show How Merck can Compete in China”).
Keytruda had $8 billion in sales through the first nine months of 2019, with $3.4 billion coming from outside the U.S. -- an increase of 63% over the same period in 2018. Merck does not break out the drug’s sales from China alone.
The news came two days after China’s National Medical Products Administration (NMPA) approved Keytruda for first-line treatment of metastatic squamous NSCLC in combination with chemotherapy.
Other notable additions to the NRDL include HCV drugs Epclusa sofosbuvir/velpatasvir and Harvoni sofosbuvir/ledipasvir from Gilead Sciences Inc. (NASDAQ:GILD) and Merck’s Zepatier elbasvir/grazoprevir; colorectal cancer therapy Elunate fruquintinib from Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM); and cancer therapies Lynparza olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Perjeta pertuzumab from Roche (SIX:ROG; OTCQX:RHHBY).
AiRuiZhuo roxadustat from AZ and FibroGen Inc. (NASDAQ:FGEN) also made the cut; the drug was first approved in China last year to treat anemia in chronic kidney disease patients (see “When a First-in-China Regulatory Strategy Makes Sense”).
Orphan therapies approved for broad reimbursement included a trio of pulmonary arterial hypertension (PAH) drugs that Johnson & Johnson (NYSE:JNJ) gained through its 2017 acquisition of Actelion Ltd.: Opsumit macitentan, Uptravi selexipag and Tracleer bosentan.