Why Rare Disease Therapeutics Need Early Market Access Planning

About The Episode 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? Join Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel, to 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. About the Speakers: Sangeeta Budhia is VP and Global Head, Pricing and Market Access, at Parexel. Her role is to ensure that global strategies including pivotal clinical trials, long-term data collection studies, real world evidence generation plans and HEOR strategies are prepared for the reimbursement challenges that each product will face. Wyatt Gotbetter is SVP & WW Head of Access Consulting, leading all facets of Parexel's Access Consulting business with a focus on helping customers position products for market success. With more than 25 years of industry experience, he brings unique insights to guide Parexel's strategy as we invest in this segment of the business to further our patients-first focus. Sangeeta and Wyatt can be contacted at Sangeeta.Budhia@parexel.com & Wyatt.Gotbetter@parexel.com.