When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. Securing approval but lacking market access results in unrealized revenue and, most importantly, patients left untreated. But how do we price and how do we gain access on the promise of long-term value when we don’t have the long-term data?
In this podcast by Blog Talk Radio, Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel discuss early market access planning, including inclusive data collection, payer models and the impact of new regulations and innovative trial design on data collection and ongoing evidence provision.
RBQM Podcast Series | Episode 1: Getting it Right Upfront - Managing Study Risk from End-to-End
Episode 17: Funding Biotech Innovation: How to Attract Investors
Episode 16: COVID-19 Vaccines and Kids: The Research and Vaccine Explained
Episode 15: Pandemic Preparedness: Investing in the future of infectious disease vaccine development
Episode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical Insights
Episode 13: The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19
Episode 12: ASCO20 Debrief: The latest in cell and gene therapy
Episode 11: Maintaining Clinical Trial Continuity During COVID-19: The Patient Perspective
Episode 10: The emerging role of wearables in clinical trials
Episode 9: Making the Most of Functional Service Provider (FSP) Relationships
Episode 8: Performing clinical trials in a shifting development landscape
Episode 7: International Women’s Day: Insights from Ascending Davos
Episode 6: The opportunity for biotechs in precision medicine: driving value and bringing important new therapies to patients
Episode 5: CAR-T: How far have we come and where are we going?
Episode 3: Bridging the Gap – How Minimizing Patient Barriers Can Improve Clinical Research
Episode 2: Tackling Rare Diseases & Inside the FDA
Episode 1: International Women's Day
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