ISPOR US 2023 Research Posters

Health Equity Frameworks – Healthcare System Actions and Priorities

Gulaid A¹, Goldman E², Skaar J¹, Dehipawala S³

¹Trinity Life Sciences, New York, NY, USA, ²Trinity Life Sciences, Waltham, MA, USA, ³Trinity Life Sciences, Bellerose, NY, USA

Health equity has been defined as attainment of the highest level of health for all people, regardless of race, ethnicity, disability, and/or other factors affecting access to care and health outcomes in healthcare delivery. Health equity is becoming a priority for payers and hospitals looking to improve patient outcomes. The objective of this research was to evaluate health equity frameworks currently used by payer and hospital organizations.

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The Inflation Reduction Act Exclusion Effect: An Analysis of Inflation Reduction Act Minimum-Discount Negotiation Rules

Mock G, Frois C, Oden D

Trinity Life Sciences, New York, NY, USA

The 2022 Inflation Reduction Act (IRA) was introduced to contain Medicare spending. A key feature of the Act was the introduction of mandated price discount/negotiations of at least 25% for selected therapies that have been on the market at least 9-13 years. However, the IRA includes several exemptions excluding therapies from these discounts/negotiations e.g., therapies with less than $200M in annual Medicare spending, biosimilar or generic entrants available, only a single orphan indication, and those that are vaccines or plasma-derived.The present research seeks to assess how much these exemptions may impact the law’s ability to contain Medicare spending.

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Demodex Blepharitis Patient Journey: A Medical Chart Audit Study

Ho A¹, Mun J², Chan A², Doshi R², Periman L³, Maiti S³, Whitley W⁴, Skaar J⁵, Hadker N⁶, Athavale A⁷

¹Tarsus Pharmaceuticals, Mountlake Terrace, WA, USA, ²Tarsus Pharmaceuticals, Irvine, CA, USA, ³Periman Eye Institute, Seattle, WA, USA, ⁴Virginia Eye Consultants, Norfolk, VA, USA, ⁵Trinity Life Sciences, New York, NY, USA, ⁶Trinity Life Sciences, Waltham, MA, USA, ⁷Kiniksa Pharmaceuticals, Waltham, MA, USA

Demodex blepharitis (Db) is an under-diagnosed disease caused by an overgrowth of Demodex mites. Db results in a chronic inflammation of the eyelid margin and has no FDA-approved treatments. This study aimed to understand how the disease is diagnosed and the patient journey in Db.

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The Past, Present and an Outlook on the Future of Evidence Development for Digital Therapeutics

Acosta Luis S¹, Varshni C², Silber A³, O’Hara M⁴, Monahan M³, Stockton K², Martin De Bustamante M⁵

¹Trinity Partners, LLC, London, UK, ²Trinity Partners, LLC, New York, NY, USA, ³Trinity Life Sciences, Waltham, MA, USA, ⁴Trinity Life Sciences, HINGHAM, MA, USA, ⁵Trinity Life Sciences, Waltham , MA, USA

Digital Therapeutics (DTx) are medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.

Randomized clinical trials are a source of DTx evidence, similar to pharmaceuticals or medical devices. In addition, the use of real-world evidence (RWE) has been increasingly explored for DTx value demonstration. Key concerns around the use of RWE in DTx, has thus far limited its acceptance and applicability, including the robustness of data, and a lack of consensus over an evaluation framework for DTx.

This study aims to understand the current trends in evidence development for DTx, and to evaluate how this may impact the assessment of these therapies. The analysis will describe the strength and influence that different types of evidence and endpoints have had in the value assessment, coverage, reimbursement, and adoption of DTx.

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Humanistic Burden of Illness in Demodex Blepharitis and Its Impact on Patients Lives Beyond the Presenting Symptoms

Ho A¹, Mun J², Chan A², Doshi R², Gupta P³, O’Dell L⁴, Thompson V⁵, Skaar J⁶, Hadker N⁷, Green O⁶

¹Tarsus Pharmaceuticals, Mountlake Terrace, WA, USA, ²Tarsus Pharmaceuticals, Irvine, CA, USA, ³Triangle Eye Consultant, Durham, NC, USA, ⁴Medical Optometry America, New Freedom, PA, USA, ⁵Vance Thompson Vision, Sioux Falls, SD, USA, ⁶Trinity Life Sciences, New York, NY, USA, ⁷Trinity Life Sciences, Waltham, MA, USA

Demodex blepharitis (Db) is a chronic inflammation of the eyelid margin caused by an overgrowth of Demodex mites and has no FDA-approved treatments. This study assessed the humanistic burden of Db on patients’ daily lives.

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The Inflation Reduction Act in Effect: Implications for Pharmaceutical Research and Development (R&D)

Mock G¹, Frois C¹, Bryan A²

¹Trinity Life Sciences, New York, NY, USA, ²Trinity Life Sciences, New York, MA, USA

The Inflation Reduction Act (IRA) seeks to limit Medicare spending, although the indirect effects remain unclear. This research aims to understand how the IRA will impact pharmaceutical R&D investment.

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Medical Chart Audit Study to Demonstrate Shortcomings of Corticosteroids in Treatment of Duchenne Muscular Dystrophy

White T¹, Wasson L², Hadker N³, Francis A³, Athavale A³, Green O³, Mulrooney M³, Gulaid A³

¹Santhera Pharmaceuticals, Downingtown, PA, USA, ²Santhera Pharmaceuticals, Burlington, MA, USA, ³Trinity Life Sciences, Waltham, MA, USA

This study aims to understand the holistic disease burden and treatment experiences for Duchenne muscular dystrophy (DMD) patients despite the use of pharmacotherapy, with a focus on corticosteroid (CS) use.

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Evolving Payer Perception on Patient Centricity and Real-World Evidence: Insights from A Quantitative Survey

Oak B¹, Kulkarni A², Alonso A³, Bechini M³, Pikus J⁴, Hadker N⁵

¹Trinity Partners, LLC, Waltham, MA, USA, ²Trinity Life Sciences, Malden, MA, USA, ³Trinity Life Sciences, London, UK, ⁴Trinity, New York, NY, USA, ⁵Trinity Life Sciences, Waltham, MA, USA

Regulatory bodies, including the FDA and EMA, endorse real-world evidence (RWE) as a part of patient-focused drug development, encouraging manufacturers to conduct RWE research. Despite the potential for RWE to strengthen randomized clinical trial (RCT) data, there is notable divergence in how HTA and payer organizations incorporate RWE into their decision-making. This research aimed to understand payer perception and evolution of patient-centric approaches in clinical trials and RWE in health technology assessment (HTA) submissions and payer decision-making.

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Real-World Treatment Preferences Among People Living with ALS: A Discrete Choice Experiment

Stenson K¹, Belviso N², Taylor L², Fecteau T², Alvarez P², Hadker N³, O’Hara M³, Athavale A³, Green O³, Abilash V³, Monserrat L³, Orsulak C⁴, Norel R⁵, Gandhi M⁵

¹Biogen, Weymouth, MA, USA, ²Biogen, Cambridge, MA, USA, ³Trinity Life Sciences, Waltham, MA, USA, ⁴ALS Therapy Development Institute, Watertown, MA, USA, ⁵EverythingALS, Seattle, WA, USA

The objective was to quantitatively assess treatment attributes that are most important to people living with ALS (pALS) in the United States.

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The Pharmaceutical Industry’s Carbon Footprint and Current Mitigation Strategies: A Literature Review

Dehipawala S¹, Goldman E², Hwang E², Shah P², Shroff A², O’Hara M³

¹Trinity Life Sciences, Bellerose, NY, USA, ²Trinity Life Sciences, Waltham, MA, USA, ³Trinity Life Sciences, HINGHAM, MA, USA

The pharmaceutical industry develops and discovers new treatments to improve patient outcomes. However, improper disposal of unused and expired medicines, as well as pollutants from manufacturing, contribute to a sizeable carbon footprint. This research reports on the pharmaceutical industry’s carbon footprint and mitigation measures they are taking to tackle climate change.

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What Does Healthcare Resource Utilization Look Like in the General Population of the US? A Real-World Analysis Using Claims Data

Silber A, Oak B, Bryan A, Xue Y, Gallivan M, Francis K, Hadker N

Trinity Life Sciences, Waltham, MA, USA

Quantifying healthcare resource utilization (HCRU) is key for health economics and outcomes research. This study aims to establish HCRU benchmarks for the general US population (GP) to facilitate comparisons between patients and GPs to quantify disease burden.

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Use of Novel Qualitative Research Methods for Evidence Generation

Silber A¹, Kulkarni A², Mahadik B¹, Goswami L³, Oak B¹, O’Hara M¹, Hadker N¹

¹Trinity Life Sciences, Waltham, MA, USA, ²Trinity Life Sciences, Malden, MA, USA, ³Trinity Life Sciences, Gurgaon, India

In the field of health economics and outcomes research, qualitative research is often conducted with key stakeholders to gain insights into the patients’ journey, experiences, and disease burden beyond quantitative research methods. The purpose of this review was to identify and evaluate qualitative research methods used for evidence generation.