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Reimbursement of Digital Therapeutics in the U.S.

Digital therapeutics (DTx) are impacting how patients are treated, interact with their providers and think about their own health. DTx have garnered interest from the investment community as well as pharma companies seeking an integrated digital offering. However, payers have not yet established a clear framework for integrating these technologies in their plans. Coverage of DTx to date has been limited and the outlook for it is unclear. We spoke to four medical and pharmacy directors from large payer organizations…

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Brazil’s Latest Updates to Drug Coverage in the Private Sector: Anticipated Impact and Implications

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…

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Valuing an Early-Stage Asset in Pharma and Biotech: Innovative Approaches for Novel Therapies

Now Available On Demand: Secure success in bringing your novel therapies to market with Trinity’s innovative, holistic approach to valuing early-stage assets. Biopharma companies have been experiencing record levels of growth in recent years through M&A, co-developments, joint ventures, licensing agreements and other partnership deals. It is unlikely that this accelerated growth would have been sustained using traditional methodologies that are less able to generate realistic valuations for complex innovative therapies. Using traditional valuation methods, we likely would not have…

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Smarter Commercialization Investment for First Launch Biopharma

With more momentum than ever to bring innovative medicines to market, there is increased pressure on emerging companies to get the launch right. The industry has seen record-breaking funding for therapies in recent years, and many have been commercialized by emerging biopharma companies launching for the first time. For many of these emerging biopharma companies, optimizing commercial launch spend is a critical consideration pre- and post-launch, and with limited funds it can be easy to misjudge the timing of key…

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Measures the Life Sciences Industry Can Take to Facilitate Diversity in Clinical Trials

The importance of ensuring diversity in clinical trials is undisputed, but barriers across the healthcare ecosystem still exist; what can healthcare regulators, policy makers, and manufacturers do to overcome challenges when recruiting clinical trial participants? Host, Matthew Rube, a Senior Consultant at Trinity Life Sciences, joins two of the subject-matter experts that authored Trinity Life Sciences’ cornerstone white paper to discuss why ensuring diversity in clinical trials participation is such a critical issue, the results of the team’s research, and…

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The Next-Generation Commercial Model: Questions You Should Be Asking

Now Available On Demand: Whether you are an emerging, mid-tier or large-tier company preparing for launch, now is the time to challenge conventional thinking. We have all seen the dramatic shifts in scientific innovation in the life sciences industry that have been further accelerated by the COVID-19 pandemic. Despite these shifts, Trinity Life Sciences found that the commercial models employed by companies that launched new products recently were still largely based on traditional sales and marketing approaches. In reaction to…

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IRA Medicare Inflation Penalties: Implications for Manufacturer Pricing and Contract Strategy Decision Making

Now Available On Demand: What do ‘pricing inflation penalties’ actually mean for manufacturers of biopharma products? Explore the impact of the Inflation Reduction Act (IRA) on biopharmaceutical product net prices and contract strategies as manufacturers adapt to new U.S. market conditions. In this webinar, Trinity Life Sciences’ Evidence, Value, Access & Pricing practice experts will provide a high-level review of IRA policy updates before exploring the implications for currently marketed Medicare Part B and Part D therapies, as well as…

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How to Generate Evidence to Drive Differentiation for Your Asset in a Competitive Market

Now Available On Demand: Demonstrating and communicating the value story to clinicians and payers is critical for successful commercialization, but there are many scenarios where new products may struggle to differentiate themselves. If you have a better mousetrap, how do you demonstrate value to support pricing, access, adoption and reimbursement? The HEOR Evidence Strategy team at Trinity Life Sciences will conduct a webinar to explore this important question and share several case studies where we worked with companies facing this…

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Patient Journey: A New Approach To Meet The Demands Of Patient Centricity

Patient Journey is a mainstay of pre-launch commercial insights generation, traditionally sitting beside demand estimation, segmentation and other key inputs to commercial decision-making and launch preparation. Historically, Patient Journey has been used to identify leverage points and opportunities to increase market share for the new product. It has been generated through primary market research (largely qualitative) and presented as a one-time, standalone deliverable. Today, the call to engage on a meaningful level with patients demands a new focus on the…

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Japan’s Latest Drug Pricing Policy Updates: Key Changes and Expected Impact

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 futureThese 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…

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