Embracing the Change: Revisiting Simon-Kucher 2020 China NRDL Predictions

February 16, 2021

drugs

China’s 2020 NRDL (National Reimbursement Drug List) results are out, marking many firsts in history. In this article, we revisit the three themes and five predictions from our NRDL perspectives last October, and cordially invite you for a quick survey on its future outlook.

China doesn’t take a break over Christmas, which works out well for the NHSA (National Health Security Administration). On December 28 2020, the NHSA released the much-awaited official results of the latest NRDL update.

As expected, the 2020 NRDL marked several firsts in history,

  • For the very first time, there were around 700 drugs going into the process;
  • Subsequently, 162 drugs made it into the shortlist, and 119 of them eventually made the listing, breaking the record for most inclusions in NRDL history;
  • Of the new additions, 17 drugs were recently approved in China between January and August 2020, underscoring the NHSA’s increasing commitment to encouraging innovative drugs that address unmet needs;
  • New mechanisms for NRDL inclusion and negotiation emerged, with VBP (volume based pricing) becoming another path to direct NRDL inclusion;

In October 2020, we shared our perspectives on the 2020 NRDL outlook, identifying three key themes and making five predictions. In this article, we revisit these themes and predictions, building on our ongoing monitoring of the processes and outcomes, as well as first-hand insights from industry players and key stakeholders.

Theme 1: NRDL processes evolve to include more engagements and interactivity

While this was evident and refreshing from the start of the 2020 NRDL process in August, it became clearer as the processes unfolded.

  • The 2020 NRDL marks the first time in history that pharma companies submit applications for formal review;
  • For the drugs shortlisted for negotiation, companies had the opportunity to meet evaluation expert panels and present their data, model, and evidence;
    • The pharmacoeconomics evaluation panel consists of 40 experts nominated by healthcare security authorities and medical associations, headed by Dr. Gordon Liu, an HTA expert from PKU;
    • The budget impact evaluation panel consists of 12 experts nominated by healthcare security authorities and medical associations, headed by Mr. Jie Zheng, head of the Beijing Medical Security Bureau;
  • Subsequently, companies had two rounds of tendering with negotiation experts, and will proceed if tender prices do not exceed the NHSA evaluated price by 15%;

NRDL listing process and engagement opportunities

At the same time, there was limited transparency and visibility on the shortlisting process from around 700 drugs to 162 candidates, underscoring the importance of engaging review experts earlier on, and highlighting the intense competition reflected in theme 2.

Theme 2: Long list of drugs going into the NRDL translated into intense competition

After overcoming the competition to get into the shortlist, the candidates were further evaluated by separate panels on the basis of pharmacoeconomics and budget impact, and were divided into five negotiation groups that went through two rounds of price tendering.

  • While the NHSA highlighted the success rate at 73% from the shortlist to the final list as an encouraging sign for the industry, the actual success rate stood at less than 20% given the long list that passed the formal review; historically the success rates stood at 82%, 94%, and 59% from the 2017-2019 negotiations;

NRDL negotiation outcomes

  • Price concessions averaged at 51% for the drugs that went through negotiations and made it to the 2020 final list, compared to 44%, 57%, and 61% average cuts from 2017 to 2019;

price cut magnitudes

  • Price concessions are more salient in some contested categories and subcategories; for example, the much followed PD-1/PD-L1s saw stiff competitions among the seven players, and the winners walked away with around 80% price cuts;

2020 NRDL negotiation outcomes: PD-1/PD-L1s

Molecule Company China indications 2020 NRDL outcome
Nivolumab BMS NSCLC, head and neck, gastric cancers not included
Pembrolizumab Merck Melanoma, NSCLC, esophageal squamous carcinoma etc. not included
Durvalumab AstraZeneca NSCLC not included
Atezolizumab Roche SCLC not included
Camrelizumab Hengrui Classical Hodgkin’s lymphoma, NSCLC, HCC, esophageal squamous carcinoma etc. 80% price cut
Tislelizumab BeiGene R/R cHL, urothelial carcinoma ~80% price cut
Toriplalimab Junshi Melanoma ~80% price cut

 

  • While the magnitude is still substantial, it is encouraging to see that the NHSA is not pursuing that as the single most important KPI for the negotiations by outdoing the price cuts from previous years;

Theme 3: Strong signal encourages innovations that address unmet needs

The NHSA made an interesting change to the NRDL formal review eligibility on August 17 2020, so all drugs approved by that date were encouraged to submit their applications. Most newly approved drugs seized the opportunity, and many were not disappointed;

  • In fact, 17 drugs approved in 2020 made it to the NRDL final list, accounting for over one sixth of the 96 drugs that made it through the negotiations;
  • Of the 17 newly approved drugs, three are 3 traditional Chinese medicine (TCM) and the rest are western drugs across diverse therapeutic areas, including oncology, cardiovascular, immunology, antivirals, and rare diseases;

NRDL inclusion of drugs newly approved in 2020

Drug Indication Company China approval
date
Coblopasvir HCV Kawin 2020 02
Favipiravir Flu Hisun 2020 02
Almonertinib EGFR T790M NSCLC Hansoh 2020 03
Vedolizumab UC, Crohn’s Disease Takeda 2020 03
Avatrombopag Thrombocytopenia Fosun 2020 04
Tislelizumab R/R cHL, urothelial carcinoma BeiGene 2020 04
Siponimod Multiple sclerosis Novartis 2020 05
Glycopyrolate
/formoterol fumarate
COPD AstraZeneca 2020 05
Deutetrabenazine Huntington’s Teva 2020 05
Dupilumab Atopic dermatitis Sanofi 2020 06
Zanubrutinib MCL, CLL, SLL BeiGene 2020 06
Inetetamab Breast cancer 3S Bio 2020 06
Ertugliflozin Diabetes MSD 2020 07
Edaravone Decanol Stroke Simcere 2020 07
Jingu pain relief gel
筋骨止痛凝胶
Arthritis Kangyuan 2020 04
Lianhua cough tablet
连花清咳片
Bronchitis Yiling 2020 05
Sangzhi total alkaloids
桑枝总生物碱片
T2D Wuhe Boao 2020 03

 

  • This signals a much desired linkage between new drug approval and coverage, and represents the most encouraging gesture so far: dynamic inclusion of innovative drugs intended to address unmet clinical needs for rare diseases, chronic diseases, and critical diseases alike.

Besides the three themes we identified, Simon-Kucher made five bold predictions on the 2020 NRDL in October, and here is the readout of them.

Simon-Kucher NRDL predictions and readout summary

Predictions Readout

1: With around 700 drugs that have made it into the 2020 NRDL process, only a small fraction will make it to the final list

  • Officially success rate was stated at 73% with 119 making final listing out of 162 shortlisted;
    • Taking into account the longest list going into NRDL in history, actual success rate is at lower than 20%, as vs. to 58% in 2019;
2:The seven categories stand to have very different likelihoods of NRDL inclusion reflecting NHSA priorities
  •  2020 NRDL also marks the first time the candidates are grouped in seven categories;
    • Many drugs from Category III are high priced innovative drugs, and 9 out of 28 made it to the final list, translating to 32% success rate;
    • Category VII in contrast are more mature drugs with lowest inclusion percentage at 9%;
3: Price concessions will be substantial, and more so for Category V and VII
  • Price cuts averaged at 51% for the drugs made through negotiations;
    • In contested subcategories like PD1/PD-L1 in Category V and certain TCMs in Category VII, price cut magnitudes were much bigger;
4: Pharmacoeconomics and budget impact considerations are increasingly important in 2020 NRDL
  • Panels for pharmacoeconomics and budget impact evaluations are institutionalized in 2020 NRDL process, and play prominent roles in the price determination;
    • Companies have the opportunities to engage the panels and present evidence for consideration;
5: Innovative contracting models may emerge at the 2020 NRDL
  • 2020 marks the first time for VBP and NRDL coupling, as well as price negotiations for previous inclusions;
    • Value based contracting models are yet to emerge;

 

Please reach out to our experts to receive the full Simon-Kucher NRDL readout for an in-depth revisit of our five predictions, and score us on our hits and misses.

Furthermore, we cordially invite you to participate in our NRDL outlook survey with a few simple clicks here, and we will share with you the in-depth analysis of the aggregated results:

Take the survey now!

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Read more from this series:

Part 1: Embracing the Change: 2020 China NRDL Outlook
Part 3: Embracing the Change: Strategizing on Volume-based Procurement in China
Part 4: Embracing the Change: Accessing Rare Disease Patients in China
Part 5: Embracing the Change: China Commercial Health Insurance Opportunities