News Alert: China’s 2021 NRDL Welcomes 67 New Additions at an Average 62% Price Reduction

PRICENTRIC BRIEF:

• The National Healthcare Security Administration (NHSA) of China has published the 2021 National Reimbursement Drug List (NRDL), which takes effect on January 1, 2022.
• The 2021 NRDL includes a total of 2,869 drug varieties – 1,486 western medicines and 1,374 traditional Chinese medicines (TCMs) – with 74 new listings covering 21 clinical groups; specifically, 20 drugs for chronic diseases, 18 for cancer, and the rest for hepatitis C and HIV, rare diseases and COVID-19, among other disease areas.
• Sixty-seven drugs were included through negotiations that resulted in an average price reduction of 61.71%. Of these, 27 medicines come from western drugmakers, with Johnson & Johnson seeing four additions to the list: Darzalex (daratumumab), Erleada (apalutamide) and two indications for Stelara (ustekinumab).

THE DETAILS 

BEIJING, China – The National Healthcare Security Administration (NHSA) of China has published the 2021 National Reimbursement Drug List (NRDL), which takes effect on January 1, 2022.

The relevant notices from NHSA can be found here and here.

The 2021 NRDL includes a total of 2,869 drug varieties – 1,486 western medicines and 1,374 traditional Chinese medicines (TCMs) – with 74 new listings covering 21 clinical groups; specifically, 20 drugs for chronic diseases, 18 for cancer, and the rest for hepatitis C and HIV, rare diseases and COVID-19, among other disease areas.

67 Drugs Make NRDL Debut

Sixty-seven new drugs (or indications for already listed products) were included through negotiations that resulted in an average price reduction of 61.71%. Of these, 27 medicines come from western drugmakers, with Johnson & Johnson seeing four additions to the list: Darzalex (daratumumab), Erleada (apalutamide), and two indications for Stelara (ustekinumab).

Notable additions from both domestic and foreign manufacturers to the list include:

• BeiGene’s Baize’an (tislelizumab) in three new indications, meaning all five NMPA-approved indications are now reimbursed; BTK inhibitor Brukinsa (zanubrutinib) in one new indication, meaning all three NMPA-approved indications are reimbursed; and PARP inhibitor pamiparib for the first time
• Junshi’s anti-PD-1 Tuoyi (toripalimab) in two new indications, NPC and urothelial carcinoma
• HUTCHMED’s Elunate (fruquitinib) in CRC and Sulanda (Surufatinib) in pancreatic NETs
• Ascletis’ Asclevir (raviclasvir)/Ganovo (danoprevir) for hepatitis C
• Innovent and Eli Lilly’s PD-1 inhibitor sintilimab in three new indications – squamous and non-squamous NSCLC and HCC in combination with Byvasda (bevacizumab biosimilar) – meaning all NMPA-approved indications are reimbursed
• RemeGen’s telitacicept (RC18) for lupus and disitamab vedotin (RC48) for gastric cancer
• Zai Lab’s Zejula (niraparib) in ovarian cancer
• Luye’s Rykindo (risperidone microspheres for inhalation) for schizophrenia
• Amgen’s and Sanofi’s respective PCSK9 inhibitors Repatha (evolocumab) and Praluent (alirocumab) in CVD
• ViiV’s (through GlaxoSmithKline) Dovato (dolutegravir/lamivudine) for HIV
• Roche’s Xofluza/Sufuda (baloxavir marboxil) for influenza
• Novartis’ Entresto (sacubitril/valsartan) for hypertension
• Mengke’s Uxitai (Contizolamide) for drug-resistant bacterial infections
• Eli Lilly’s Taltz (ixekizumab) for autoimmune disorders

China scored a handful of medicines for rare diseases as well; with each update to the NRDL, the government has sought to include a greater variety of medicines to provide to patients, not only as part of the medical insurance “basic guarantee”, but also to achieve goals outlined in the “Healthy China 2030” plan.

Orphan drugs added to this year’s NRDL include Takeda’s Replagal (Agalsidase alfa) for Fabry disease and Firazyr (icatibant) for HAE attacks, as well as Biogen’s Spinraza (nusinersen) for spinal muscular atrophy (SMA) and Accord’s Ampyra/Fampyra (fampridine tablets) for multiple sclerosis (MS).

Price cuts are always necessary for inclusion on the NRDL. For example, through NRDL negotiations, the cost of Spinraza 5 ml injection was reduced from 550,000 yuan to 460,000 yuan, with medical insurance covering 400,000 yuan and patients responsible for the remainder.

NRDL Renewals – Domestic PD-1/L1 Inhibitors Back Again

There were also 67 renewals granted through further price reductions. Among western drugmakers, Johnson & Johnson and Novartis won big, with seven and six renewals, respectively.

Other renewals include BeiGene’s Brukinsa (zanubrutinib) and China’s domestic PD-1 inhibitors, Baize’an and Tuoyi, which were already offered up at significant price cuts in exchange for inclusion over foreign PD-1/PD-L1 inhibitors.

Last year’s NRDL update, PD-1 inhibitors were the hot issue between multinational corporations (MNCs) and China. 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 Junshi Biosciences, BeiGene, and Jiangsu Hengrui took the coveted spots, with the three China-based companies offering 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.

The updated NRDL takes effect come January, and NHSA outlined a list of mandates for provincial governments to follow and execute, including payment and insurance fund management. Essentially, provincial governments must implement the new listings, putting these negotiated drugs online for procurement before the year’s end and ensuring uptake of new products by June 30, 2022.

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