Mainland China has gone through a series of regulatory and reimbursement reforms in recent years in an effort to keep pace with its dynamic economic and demographic landscape. Clarivate market assessment expert Karan Verma discusses the role of these reforms in Mainland China’s type 2 diabetes market and how they could broaden access to innovative medicines.
Type 2 diabetes in Mainland China continues to grow at a fast rate
An estimated one in 10 people in Mainland China — around 140 million1,4 – now suffers from type 2 diabetes (T2D), reflecting in part the rapid urbanization of the country over the last few decades. Several anti-diabetic therapies are available to patients to control blood sugar adequately by decreasing intestinal absorption of glucose and improving insulin sensitivity4.
A fragmented regulatory landscape has hampered the uptake of efficacious T2D therapies
Traditionally, most T2D patients in Mainland China have received standard anti-diabetic therapies, such as metformin in first line treatment, and acarbose, sulfonylureas and thiazolidinediones in second line treatment, due to ease of access, the availability of cost-effective generics, and their perceived efficacy in reducing HbA1c levels. Despite adverse attributes associated with these therapies, including weight gain, cardiovascular safety concerns, and high rates of hypoglycemia, their blood glucose lowering benefits kept use high.
Lack of reimbursement meant limited access to better-performing therapies, such as SGLT-2 inhibitors and GLP-1 receptor agonists, which offered weight loss and cardiovascular (CV) benefits over traditionally used drugs, in second-line treatment. As a result, most patients continued to receive traditional therapy choices with complete reimbursement through Category A of the National Reimbursement Drug List (NRDL), and thus, suffered from poor control rate and compliance.
Why does T2D remain the focus for authorities steering access and reimbursement reforms?
The surge in prevalence of diabetes and diabetic complications over the last decade in Mainland China has prompted the country’s authorities to more clinically efficacious improve patient access to therapies for T2D.
Key factors that continue to drive authorities’ attention towards T2D include:
- Substantial forecast growth of the diabetic population over the next two decades,4 owing to growing adaptation of Western dietary patterns and a trend towards sedentary lifestyles and lack of physical activity.
- Relatively low diagnosis rates and prescription treatment uptake compared to other countries with sizeable diabetic populations.3
- Poor glycemic control rates (<49%)4 due to inadequate access to efficacious T2D therapies.
- Persistent financial burdens on the healthcare system as direct and indirect medical costs associated with T2D grow.
In 2018, Mainland China introduced a volume-based procurement (VBP) program for key generic drugs, through which the National Healthcare Security Administration (NHSA) granted volume sales to those generic manufacturers that adhered to Generic Quality and Consistency Evaluation (GQCE)-standards while offering lower-price therapies to patients in Mainland China. Since then, five successful rounds of the VBP program have streamlined prices of several generic T2D drugs (Table 1).
Table 1: List of T2D therapies included in VBP rounds in Mainland China
|VBP round||Month/year||Therapy||Mechanism of action (MOA)||Originator||No. of tender winners||Originator tender winner||Price cut|
|Round 2||January 2020||Acarbose||Alpha-glucosidase inhibitors||Bayer||2||Yes||92.1%5 (brand)77.198 (generic)|
|Round 3||August 2020||Metformin||Biguanides||Bristol Myers Squibb||8||No||84.11%6 (generic)|
|Metformin sustained release||Biguanides||Merck||8||No||71.06%6 (generic)|
|Vildagliptin||DPP-IV inhibitors||Novartis||6||No||78.86%6 (generic)|
|Round 4||February 2021||Empagliflozin||SGLT-2 inhibitors||Boehringer Ingelheim||4||No||55.93%7 (generic)|
|Canagliflozin||SGLT-2 inhibitors||J&J||2||No||56.14%7 (generic)|
|Repaglinide||Meglitinides||Novo Nordisk||2||No||65.55%7 (generic)|
|Round 54||June 2021||Saxagliptin||DPP-IV inhibitors||AstraZeneca||TBC||TBC||TBC|
Source: GBI analysis, Clarivate analysis
Physicians and patients have started to realize benefits of VBP rounds conducted so far. Medical costs associated with T2D care have decreased considerably, patient access to generic SGLT-2 inhibitors and DPP-IV inhibitors has improved, and medical insurance funds have remained sustainable.
The recent access and reimbursement reforms continue to augment T2D market sales by encouraging innovation
Although relatively expensive compared with traditional drug classes for T2D, SGLT-2 inhibitors and GLP-1 receptor agonists have a favorable clinical profile in terms of reducing blood glucose levels and offering cardiovascular and weight loss advantages to patients. The recent inclusion of all GLP-1 receptor agonists in the NRDL, as well as the inclusion of empagliflozin and canagliflozin generics in the fourth round of the VBP program, has generated positive momentum in the T2D therapy market. Depending on their glycemic levels and their treatment history, patients can now choose to switch to better-performing drug classes in their subsequent line of treatment without having to pay high out-of-pocket costs.
Table 2: List of T2D therapies included in the 2019 and 2020 NRDL update in Mainland China
|Therapy||Originator||Year of NRDL inclusion||Price cut||Increase in sales before NRDL inclusion (YoY)||Increase in sales post NRDL inclusion (YoY)|
|Insulin degludec (Tresiba)||Novo Nordisk||2019||8.48%10||443.75%4||380.45%4|
|Empagliflozin (Jardiance)||Boehringer Ingelheim||2019||57%10||94.63%4||341.92%4|
|Canagliflozin (Invokana)||J&J||2019||58%10||556.52%4||34.73%4 (generic entry)|
|Insulin degludec / insulin aspart (Ryzodeg)||Novo Nordisk||2020||47.4%11||875%4||76.28%4|
|Dulaglutide (Trulicity)||Eli Lilly||2020||64.52%11||140.82%4||370.9%4|
|Benaglutide (Yishengtai)||Shanghai Benemae Pharma||2020||54.52%11||68.53%4||122.2%4|
|PEG loxenatide (Fu Lai Mei)||Jiangsu Hansoh Pharmaceuticals||2020||58.68%11||–||66.59%4|
Source: GBI analysis, Clarivate analysis
Clarivate China In-Depth analysis indicates that the yearly NRDL updates have acted as a catalyst to the evolving innovation ecosystem in Mainland China. Multinational companies (MNCs) that have not previously participated in VBP programs have shifted their focus towards specialty drug portfolios and developing innovative products that can demonstrate clinical benefit in order to secure NRDL listing.
Several T2D therapies that successfully negotiated to enter the 2019 and 2020 NRDL updates (Category B) have posted strong year-over-year sales (Table 2), suggesting favorable patient uptake due to lower prices and partial reimbursement.
Rural Mainland China poses a sizeable opportunity to drug developers as access expands
Rural areas see higher diabetes-related mortality rates than do urban ones, suggesting high unmet need in these areas for therapies that are more efficacious, better tolerated and more cost-effective to help improve glycemic control rate.
With the National Healthcare Security Administration aiming to expand VBP coverage to include most existing and emerging generics/biosimilars in Mainland China, including insulins prescribed for T2D, patients in rural areas can expect improved access to more efficacious T2D therapies over the next decade.
Clarivate forecasts suggest that, given several other therapies having posted positive clinical data lined up for launch in Mainland China (e.g., semaglutide and dorzagliatin), the T2D treatment paradigm will likely shift substantially in the next 10 years.
Insights provided in this article were developed by Clarivate analysts using data and analysis from China In-Depth, which covers patient populations, access and reimbursement environment, treatment paradigms, pipelines and drug-level forecasts.
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China In-Depth clients can access the author’s full report on T2D therapy market in Mainland China here.
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2 China (2020). International Diabetes Federation, [online]. Available at: https://idf.org/our-network/regions-members/western-pacific/members/101-china.html (Accessed 22 June 2021)
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4Clarivate China In-Depth analysis
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11 GBI analysis