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Inflation Reduction Act of 2022: No Room for Negotiation

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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Insulin Approval Pathways USA vs. EU

Published November 2, 2021

Executive Summary In March 2020, the FDA amended its classification of add-on insulin products, changing the approval pathway from that of a chemical drug follow-on to a biosimilar and more closely aligning with the EMA’s longstanding biosimilar insulin approval pathway The FDA approved the Semglee Pen (insulin glargine) as the first product through the new biosimilar insulin approval pathway in July 2021; the Semglee was priced as almost three times less costly in the USA than the previously approved biosimilar…

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Exploring the Impact of COVID-Driven Trends on the US Healthcare Landscape

Published September 1, 2021

Executive Summary The COVID-19 pandemic has called into question many elements of the US healthcare system across key stakeholders, resulting in changes across patients, providers, payers, researchers, and manufacturers The pandemic has required many healthcare providers and patients to provide telemedicine options, which for many specialties has proved to be an effective way to dispense and receive care For payers at the national level, CMS has implemented reimbursable telehealth codes for all medical services that may be provided remotely, while…

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Case Studies

Assessment of the Impact of National Guidelines on Uptake of a Biomarker Among HCPs and Payers

Trinity designed staggered quantitative research to assess the impact of national guidelines on uptake of a biomarker among HCPs and payers. Geographic Scope: Client Situation The client wanted to understand the impact of national physician society guidelines on uptake / acceptance of an innovative biomarker based on developed patient vignettes, and expectations for updates to payer diagnostic testing polices. Trinity’s Solution Trinity conducted qualitative research, fielding a survey with physicians and payers, to determine current physician utilization and payer coverage of biomarker diagnostic test and track evolution in payer policies and…

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Case Studies

Early P&MA Forecasting Support for a Pipeline Asset

Trinity provided early P&MA forecasting support for a pipeline asset in development for several inflammatory conditions via secondary research. Geographic Scope: Client Situation The client wanted to uncover the optimal launch strategy for their pipeline asset by understanding the current and future landscape across several inflammatory diseases to support indication prioritization. Trinity’s Solution Trinity conducted secondary research into the clinical treatment algorithms and current pricing and market access (P&MA) landscape of 19 inflammatory diseases to understand the unmet need, level of competition, payer management, contracting…

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Blog

CMS Hospital Pricing Transparency: One Price Fits All?

Published August 2, 2021

Executive Summary: A CMS regulation from the Trump Administration requiring hospitals to post lists containing the list price, negotiated private payer prices, and self-pay rates for up to 300 shoppable services took effect in January 2021 but is still widely ignored by hospitals A lack of enforcement coupled with minor penalties decreases the efficacy of the requirement, resulting in low incentive for hospitals to comply with the rule The data posted by compliant hospitals shows large variation in pricing for…

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Case Studies

Mapping Payer & Employer Perceptions of Novel Migraine Therapies to Support Access Strategy Development

Trinity conducted a payer and employer advisory board to understand current perceptions of novel migraine therapies and potential strategies to improve access. Geographic Scope: Client Situation The client wanted to gather the payer and employer perspective on how the migraine landscape is evolving, and pressure test key strategic options as well as messages that they had developed. The employers included:  Coca-Cola Company, Metro Nashville Public Schools, St. Louis Community College, and Vibra Healthcare. Trinity’s Solution Trinity conducted an unblinded advisory board with a diverse…

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