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China Publishes Final PD-1 Agreed Prices as NRDL Takes Effect

Date: March 3, 2021 | Country: CHINA | Region: ASIA & SOUTH PACIFIC | Type: Pricing & Reimbursement | Keywords: #bmi #china #mohrss #nhsa #nrdl #pd1 #reimbursement 
#volumebasedprocurement

PRICENTRIC BRIEF:

  • 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), which came into effect at the beginning of March 2021
  • The 2020 list is ultimately made up of a total of 2,800 products, including 1,426 Western medicines and 1,374 proprietary Chinese medicines, and these products experienced price cuts, on average, of 51%
  • This year, PD-1 inhibitors – a category of drugs which are often costly yet highly effective – were the hot issue between multinational corporations (MNCs) and domestic businesses, with home-grown PD-1 efforts from Shanghai Junshi Biosciences, Beigene Ltd and Jiangsu Hengrui Medicine securing coveted spots on the NRDL

 

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), which came into effect at the beginning of March 2021.

The scope of the 2020 NRDL considers what basic medical service (BMI) funds can afford considering clinical demands for drugs. Eligible drugs had to meet provisions outlined in Articles 7 and 8 of the Interim Measures for the Administration of BMI Medicines.

2020 NRDL Outcomes

The finalized 2020 NRDL 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%, on average, in order to gain access to the list. The Chinese market’s promise of quantity is supposed to ultimately make up for the offset of the price cuts required to be on the NRDL

On the release of the list, the NHSA noted that a total of 704 non-2017 NRDL-listed drugs passed the initial application and review process for the 2020 list, among them 23 drugs (non-exclusive) were added to it directly and a further 138 exclusive drugs were eligible for negotiation towards addition.

The organization also confirmed that the 2020 list is ultimately made up of a total of 2,800 products, including 1,426 Western medicines and 1,374 proprietary Chinese medicines.

Some key Western drugs that made the list include Novartis’ Cosentyx (secukinumab), Teva Pharmaceutical’s Austedo (deutetrabenazine) for Huntington’s disease; AstraZeneca’s oncology drug Zoladex (goserelin) and GlaxoSmithKline’s Benlysta (belimumab) and Volibris (ambrisentan), for lupus and high blood pressure in the lungs, respectively.

A full list of the 28 drugs by 10 multinational corporations (MNC) included in the list can be found below:

  • Fingolimod Hydrochloride
  • Siponimod
  • Brinzolamide and Timolol Maleate
  • Brinzolamide and Brimonidine
  • Dabrafenib
  • Trametinib
  • Ceritinib (new indication)
  • Nilotinib
  • Octreotide Microspheres
  • Pazopanib
  • Ceritinib (original indication)
  • Etanercept
  • Axitinib
  • Crizotinib
  • Sunitinib
  • Trelegy Ellipta (Fluticasone Furoate, Umeclidinium, and Vilanterol)
  • Belimumab
  • Ambrisentan
  • Vonoprazan Fumarate
  • Vedolizumab
  • Ibrutinib
  • Paliperidone Palmitate
  • Dulaglutide
  • Baricitinib
  • Dupilumab
  • Regorafenib Tablets
  • Ryzodeg (Insulin Degludec/Insulin Aspart)
  • Nintedanib

*Source: Saibailan via Pharma China Online

Of note, Novartis’ two multiple sclerosis drugs Gilenya (fingolimod) and Mayzent (siponimod) were included in the list, with capped payment prices through China’s medical insurance scheme. Additionally this year, a number of COVID-19 therapy recommendations also secured spots on the 2020 NRDL, including Arbidol and Ribavirin, which can be used to treat COVID-19 in China.

The Battle for PD-1 Placement

This year, PD-1 inhibitors – a category of drugs which are often costly yet highly effective – were the hot issue between 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 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.

Comp.Drug NamePriceIndicationValidity Period
BeiGeneBaizean (tislelizumab)– 2,180 yuan/100 mg

– 74,100 yuan annual treatment cost

(80% discount)

 

– Classical Hodgkin’s lymphoma treated with at least two prior therapies

– Some locally advanced or metastatic urothelial carcinoma patients with PD-L1 high expression*

March 1, 2021 to December 31, 2022
Junshi Tuoyi (toripalimab)– 906.80 yuan/ bottle (80 mg/2 mL)

– 1,074.87 yuan/bottle (100 mg/2.5 mL)

– 2,100.97 yuan/bottle (240 mg/6 mL)

– 54,900 yuan annual treatment cost

(70+% discount)

– Unresectable or converted patients with previously failed systemic treatment of metastatic melanomaMarch 1, 2021 to December 31, 2022
Hengrui camrelizumab– 2,928 yuan/200 mg

– 49,800 yuan annual treatment cost

(85% discount)

– Third-line treatment of recurrent or refractory classical Hodgkin’s lymphoma

– First-line treatment of non-squamous NSCLC

– Hepatocellular carcinoma before Sorafenib treatment

– Post-treatment disease progression in locally advanced or metastatic esophageal squamous cell carcinoma

March 1, 2021 to December 31, 2022

Whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

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.

After 2019 NRDL inclusion negotiations wrapped, NHSA’s Xiong Xianjun forecasted that price negotiations for PD-1 cancer drugs would likely see intense competition next year (2020), given that medicines that find a place on the list are typically sold at the “lowest prices worldwide,” said Xianjun.

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.

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.

Looking to the future, the global market for PD-1/PD-L1 immunotherapy has been predicted to grow at a compound annual growth rate (CAGR) of 10.72% from 2020 to 2030, with a chance for the technology to become a prominent player in the cancer treatment landscape. However, as is the issue with many innovative drugs with a high price tag, PD-1s have various cost-related issues surrounding their market access pathways that need to be tackled.

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