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The pharmaceutical market in China has experienced tremendous growth over the past several decades and is becoming increasingly important. While many life sciences organizations consider China to be a ‘must win’ market, commercial success can be elusive. Despite the large patient base and recent economic and political tailwinds driving the advancement of the healthcare industry, sales for innovative drugs in China are often only a fraction of those in the U.S. The complex and rapidly evolving…
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February 27, 2023
Executive Summary:
The 2023 off-year Drug Price Revisions are the second implementation of the off-year re-pricing approach by the Japanese Ministry of Health, Labor and Welfare (MHLW) and are predicted to result in additional price cuts to 48% of listed products across multiple therapeutic areas.
Although the MHLW continues to maintain a stance of leveraging price revisions to achieve budget savings, other policies (i.e., expansion of Orphan Drug Designation and Price Maintenance Premium revisions) signal an intent…
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As the market becomes increasingly crowded and budget constraints continue in China, downward pricing pressure to secure National Reimbursement Drug List (NRDL) inclusion remains the top challenge for multinational pharma companies in this market. However, the significant uptake post-NRDL inclusion and broad access offer substantial opportunities for innovative products with clinical differentiation.
In this white paper, Trinity Life Sciences explores the highlights of the 2021 NRDL negotiation; including trends within the oncology, rare disease and chronic disease therapeutic areas…
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September 7, 2022
Executive Summary
A series of new drug pricing reforms came into effect in Japan in April 2022, to encourage innovation and ensure the transparency and predictability of drug pricing in the future
These include updates to the cost-accounting pricing methodology, an expansion of the scope of the Price Maintenance Premium (PMP), an update to the spillover rule for drug re-pricing and an addition of a new “specific use” premium. Further details are outlined in the graphic below.…
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Now Available On Demand:
What do pharmaceutical manufacturers need to know to successfully navigate the market access landscape in China through the latest NRDL update?
The access landscape in China is rapidly evolving with important implications for novel medicines. The most recent update of China’s National Reimbursement Drug List (NRDL) in 2021 focused on the expansion of new and high-cost innovative therapies and highlighted the improving access environment for these drugs.
In this webinar, Trinity Life Sciences’ Value, Access and…
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August 19, 2021
Executive Summary
While 7 additional rare disease drugs were included on the 2020 NRDL in China, this development comes amid a backdrop of rare disease policy development signaling a move towards multi-channel funding mechanism to support more widespread patient access and maintain sustainability of the NRDL
As such, manufacturers cannot solely rely on NRDL inclusion for their rare disease product market access strategy in China and should consider alternative funding opportunities outside of the NRDL (e.g., provincial…
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August 16, 2021
Executive Summary
Recent updates in the National Drug Reimbursement List (NRDL) have increasingly focused on the expansion of oncology products and highlighted the improving market access environment for innovative oncology therapies in China
This effort first came under the spotlight in 2018 as the National Health Security Administration (NHSA) announced the inclusion of 17 novel oncology agents on the NRDL with discounts averaging ~60%. Subsequent NRDL updates saw comparable levels of price discounts and selection of products…
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July 06, 2021
Executive Summary
The Chinese National Reimbursement Drug List (NRDL) is managed and negotiated by the National Healthcare Security Administration (NHSA) and drugs listed on the NRDL are reimbursed by the public insurance
Since 2017, on average, a significant price discount of 44-61% was required for products to achieve a positive listing on the NRDL
Based on average 2018 sales data, products included on the 2017 NRDL were able to achieve an increase in sales revenue (188%) despite…
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Trinity organized a full day on-site workshop to bring together key cross functional client teams to align on a final launch strategy for their mNSCLC asset in Japan.
Geographic Scope:
Client Situation:
The client wanted to build alignment on the launch pricing & market access assumptions for their asset in metastatic non-small cell lung cancer (mNSCLC) and metastatic colorectal cancer (mCRC) in Japan, including consideration of all forecasting assumptions and pricing and market access (P&MA) risks.
Trinity’s Solution:
Trinity conducted targeted secondary research to determine the existing mNSCLC…
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June 2, 2020
Executive Summary
China’s 2019 National Reimbursement Drug List (NRDL) update offers manufacturers key learnings and insights for future NRDL negotiations, particularly with respect to the negotiation tactics used in different disease areas; although in most disease areas the comparative negotiation rule was employed during the 2019 NRDL, the use of a new competitive negotiation rule employed in the hepatitis C disease area characterized the 2019 NRDL negotiations; under this rule, no base price was set and manufacturers…
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