Blog
Published February 18, 2022
Executive Summary
A new pan-European Health Technology Assessment (HTA) regulation that will redefine the processes for the evaluation of new medicines in the EU entered into force in January 2022
Although it will not become fully active until 2025, the new regulation will require EU member states to give “due consideration” to joint clinical assessment (JCA) reports and provide feedback to the European Commission
These new JCAs will only focus on the clinical domain of HTAs and thus they will…
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Blog
Published February 2, 2022
The National Institute for Health and Care Excellence (NICE) will mark the start of 2022 by implementing changes to health technology assessments (HTAs), demonstrating adaptability of regulatory bodies as medical technologies continue to evolve. The final HTA changes aim to provide earlier and more equitable access to treatments as well as display increased flexibility in the evaluation of new health technologies. As part of NICE’s plan to modernize healthcare, the changes will apply to both digital therapeutics as well as…
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Blog
Published December 6, 2021
Executive Summary
The National Institute for Health and Care Excellence (NICE) is the major reimbursement body and pathway to achieving market access in England, although products that have not been evaluated by NICE or have received a negative NICE outcome can still achieve local access through CCGs (Clinical Commissioning Groups)
In 2017, NHS England announced deals facilitating patient access to two innovative treatments (KADCYLA and STRENSIQ). KADCYLA’s previous negative NICE recommendation in HER2+ breast cancer and strong patient advocacy from…
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Blog
Published September 30, 2021
Written by Caspar Kengeter and Manon Ricard…
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Blog
Published 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 critical illness budgets,…
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Blog
Published 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 targeting the most…
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Blog
Published July 6, 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 the steep average…
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Blog
Published June 2, 2021
Executive Summary
The Medical Fund Bill would increase drug spending up to 4% of the total healthcare spending in Poland
The reimbursement applications can be reviewed as quickly as 180 days, reducing the typical time-to-market of two – three years
The criteria for “innovativeness” that need to be met for inclusion on the list are still not fully fleshed out to date
Only four of the 12 candidates on the list have been approved by the Health Minister to secure reimbursement…
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Case Studies
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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Blog
Published 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 were invited to…
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