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Priced Out: Generic Therapy Price Competition and Drug Shortages

Published January 29, 2024

Introduction In the summer of 2023, many oncologists and cancer patients faced an impossible choice. Amidst many challenging treatment decisions, they had to determine how to proceed without two mainstays among oncology therapeutics: cisplatin and carboplatin. While it can sometimes be expected that there may be delays for the newest and most innovative treatments to reach patients, both cisplatin and carboplatin have been available for over twenty years, are used frequently in oncology regimens and are not considered particularly expensive.…

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Blog

Key Takeaways and Learnings from ASH 2023

Published January 12, 2024

Introduction The Trinity Life Sciences’ team recently attended the 65th ASH Annual Meeting and Exposition from December 9-12, 2023, in San Diego, California. The conference brought together physicians, scientists and industry experts to share and collaborate on advances in understanding and treating blood cancers and blood disorders. Below are a few of the key insights that the Trinity team observed during the conference: Advances in CAR-T Therapy: Expansion into New Targets and Therapeutic Areas Numerous groups across the industry are…

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White Papers

Empowering Cancer Immunotherapy: Unleashing the Potential of NK Cell Therapies in Oncology

Cell therapies are becoming increasingly incorporated as late-line standards of care across relapsed/refractory oncology indications, with an expanding ability to improve outcomes for a diverse set of tumors and patient subgroups. As the next frontier of personalized and precision medicine continues to grow, Natural Killer (NK) cell therapies offer the potential to penetrate untapped needs across a variety of cancers. However, enthusiasm surrounding the opportunity offered by NK-based technologies has fluctuated over recent years. Several large pharma leaders have made…

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Blog

The Enhancing Oncology Care Model: Where Public Health Meets Oncology Care

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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Scientific Publications

Burden of Cremophor-related Paclitaxel Therapy on Patients with Ovarian Cancer: A Patient Focused Study from the United Kingdom, Germany, and Spain.

Cremophor EL (CrEL) is a solubilizer used in paclitaxel and is associated with side effects (i.e., hypersensitivity reactions, peripheral neuropathy). Current CrEL-containing therapies require long infusion times (2-4 hours) and pre-medication with steroids to manage these side-effects. However, the holistic burden of CrEL on patients is not well studied. This study aimed to characterize the burden associated with CrEL-paclitaxel treatment on patients with ovarian cancer, including clinical, safety, and quality of life (QoL) implications. Authors Diana Brixner, Anke-Peggy Holtorf, Ayesha…

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Blog

AI-Based Software Paige Prostate is Granted FDA Approval Through the De Novo Regulatory Pathway

Published September 27, 2021

Paige Prostate is the first artificial intelligence (AI)-based software designed to identify areas of concern (i.e., high likelihood of containing cancer) on a prostate biopsy image so they can be flagged for further review by a pathologist. The program is intended to be used as an adjunct tool to the review of digital scanner slide images from prostate biopsies. The program was reviewed through the De Novo pathway, a regulatory pathway for low-to-moderate risk novel devices. The FDA authorization is based…

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Blog

What Market Access Opportunities Exist for Oncology Products in China? An Analysis of Oncology Product Inclusion in the 2020 NRDL

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

Poland’s Medical Fund Bill to Improve Access to Oncology Drugs

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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Blog

CAR-Ts: Barriers and Opportunities for the Migration into Earlier Lines of Therapy in the USA

Published September 22, 2020

Executive Summary Although CAR-Ts are on the cutting edge of oncology treatment, they are still only approved for administration following at least two other lines of treatment Key barriers for CAR-T migration into earlier lines include the complex logistics and site of care restrictions, a lack of comparative 3L+ and 2L clinical trial data, and reimbursement uncertainty in fee-for-service (FFS) Medicare New opportunities to overcome these hurdles are being pursued in the form of innovative pricing and contracting strategies to…

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