Blog
Published April 21, 2023
Executive Summary
Biosimilar versions of adalimumab have launched in the U.S., ending blockbuster therapy Humira’s lengthy market exclusivity and long-running commercial success.
In parallel, in the creation of the Inflation Reduction Act (IRA), the U.S. joins Europe and other major markets in constraining the opportunity for medicines during their market exclusivity window.
Trinity’s Take
These events usher in a new era for the life sciences industry, necessitating new thinking around development and commercialization strategy.
Historic reliance on the U.S. market…
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Blog
Published March 10, 2023
Executive summary
83 non-traditional Chinese medicines successfully entered the National Reimbursement Drug List (NRDL) for the first time. This is a >20% increase from the 2021 and 2020 NRDL updates, indicating the growing interest of both manufacturers and payers to ensure reimbursement for novel therapies in China.
The percentage of products achieving NRDL inclusion within one year of regulatory approval continues to increase steadily, from 24% in 2020 to 53% in the 2022 update, keeping up the strong momentum of…
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Blog
Published March 2, 2023
Meet Melissa Leonhauser:
Melissa has over 20 years of experience managing analytic solutions that support pharmaceutical brand teams. She has helped introduce and shape how pharmaceutical manufacturers use Real World Data to understand the patient journey and inform their decision making.
I’m not sure if ‘multi-experience engagements’ is just the newest buzz phrase, but I like it.
It’s similar to ‘omnichannel marketing’ but with a focus on the customer instead of your efforts, and I appreciate that nuance. Let’s break…
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Blog
Published 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 to foster and…
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Blog
Published December 12, 2022
Last month, Trinity attended the ISPOR Europe 2022 conference in Vienna. The main theme of the conference was “Collaborating Across Borders: Building & Using Evidence to Enable Access”, which facilitated many interesting discussions amongst different stakeholders in life sciences, including manufacturers, regulatory leaders and health economists. Among the myriad of topics covered, digital health emerged as a hot topic for podium sessions, poster presentations and group discussions.
A highlight for Trinity Life Sciences was presenting two posters, and one podium…
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Blog
Published November 7, 2022
Executive Summary
The Oncology Care Model (OCM) was designed to test whether financial incentives can improve care and lower Medicare (U.S. federal health insurance program) spending, emphasizing value-based care within oncology treatment. This model supported a wide range of services such as high-cost emergency room visits, 24/7 access to clinicians and specialized, patient-specific coordinated care plans.
The Enhancing Oncology Model (EOM) builds on the structure of OCM with an increased focus on managing provider risk, promoting patient-centric care and addressing…
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Blog
Published October 31, 2022
Executive Summary:
Germany’s ‘Financial Stabilization of Statutory Health Insurance System’ Act (GKV-Finanzstabilisierungsgesetz) was first proposed in March 2022 by Health Minister Professor Karl Lauterbach to help tackle the country’s economic deficit
Updated (January 13, 2023): The act was adopted by the Bundestag (German Federal Parliament) in October 2022. Most reforms have entered into force in November 2022, with the exception of the reduced sales threshold for orphan drugs (December 2022), the increased manufacturer rebate (January 2023) and the additional rebate…
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Blog
Published October 14, 2022
Executive Summary
The “ANS rol” defines the minimum mandatory coverage of services (diagnostics, procedures, and treatments) in the private sector. While private providers could opt to provide coverage beyond this list, in practice, the “ANS rol” has traditionally been seen as the maximum coverage that would be provided with anything beyond the “ANS Rol” being typically rejected
Law 14.454/2022 published in September 2022 establishes that the “ANS Rol” will dictate the minimum coverage that private payers need to provide, but…
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Blog
Published September 6, 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.
Summary of Japan’s…
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Blog
Published August 12, 2022
Long-awaited Medicare price negotiations look more like statutory discounts than the value-based negotiations seen in global healthcare systems; combined with expanded price increase rebates and out of pocket limits, new regulation may drive prices for new drugs up more than down. Trinity explores the impact and implications for manufacturers of innovative medicines.
Headline Summary:
After over a year of drafting, Congress recently passed the Inflation Reduction Act, and on August 16th President Biden formally signed the act into law
The…
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