Demonstrating Value of Medicines Through Health Economic and Outcomes Evidence

Transcription

1 Demonstrating Value of Medicines Through Health Economic and Outcomes Evidence Eleni Samaras Allen, PharmD March 22, 2016 Kissimmee, FL Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 1

2 Objectives Describe the external regulatory and healthcare landscape Describe the scope of health pharmacoeconomic research and the differences from clinical trials Evolving External Landscape Poses A Challenge for Approval and Access to Healthcare Products Uncertainty regarding: Global economy US Healthcare Regulatory approvals Market Access Areas of increased concern: Rising healthcare costs & shrinking budgets Healthcare reimbursement restrictions Need to show overall value in terms of cost and efficacy/safety for a new product vs existing therapies 2

3 Federal Legislation The American Recovery and Reinvestment Act of 2009 Provided funding of $1.1 billion for Comparative Effectiveness Research (CER) Mandated Institute of Medicine (IOM) study to establish National Priorities Patient Protection and Affordable Care Act of 2010 Outlined how the federal government will focus on and shape CER Created and funded Patient-Centered Outcomes Research Institute (PCORI) Preserved Agency for Healthcare Research and Quality s (ARHQ) role Value & Access is the Fourth Hurdle of Drug Development Value & Access Quality Safe Efficacious 3

4 Payers Want to Know How a Technology Works Under Routine Practice Can it work? (Efficacy) Does it work? (Effectiveness) Is it worth it? (Value) Demonstration of Added Therapeutic Value Assessed By Multiple Decisions-Makers Drives Market/Patient Access Decision- Makers Regulatory Agency Payer Prescriber Patient as Payer Drug/biologic Candidate Road to Market/Patient Access Market Access Assessment Questions Does the drug/biologic do more good than harm in a defined patient group in a controlled experimental setting? What are the health and cost consequences associated with drug/biologic relative to other interventions in specific payerdefined group of patients? How does the drug/biologic perform relative to other interventions in this patient? Am I willing to pay out-of-pocket or higher premiums for this treatment? Figure adopted from: Eichler GH et al. Nat Rev Drug Discov. 2010;9:

5 Health Technology Assessments Are Conducted to Inform Policy Making and Access/Reimbursement Decisions How reimbursement/healthcare agencies perceive the value of a healthcare product in terms of cost and efficacy/safety impacts: What treatments hospitals and pharmacy services will place on their formularies (ie, impacts access of patients/healthcare professionals to the treatment) What treatments insurance companies* and government agencies** will cover (or reimburse) for patients and healthcare providers Outside of US, the cost-effectiveness of a product relative to a standard of care or to no treatment are also the basis for many decisions (eg, NICE) * eg, WellPoint, US insurance company **eg, Medicare in the US or the National Health Service in the UK Comprehensive Value Propositions Highlight the Value of a Product Health Technology Assessments Often Include: Efficacy data (RCTs) Safety data (RCTs) Patient-reported outcomes Real-world effectiveness data Cost data (eg, budget impact models) Cost-effectiveness comparative research 5

6 Academy of Managed Care Pharmacy (AMCP) Format For Formulary Submissions AMCP is a US national society of managed-care pharmacists and other healthcare professionals. In 2000, AMCP endorsed a Format for the Submission of Clinical and Economic Information of Pharmaceutical Products Guidance intended to improve the quality of formulary-decision making by standardizing the content of information submitted to US payers & formulary decision-makers Provides US payers & formulary decision-makers with a process to proactively request specific clinical & economic information from manufacturers Value-based Drug Assessment Landscape Is Rapidly Transitioning in the US Produces Health Technology Assessment reports Links price to patient benefit Calculates value-based price benchmarks Developed ASCO Value Framework, a tool for physicians to discuss with patients the relative value of new cancer therapies as compared with established treatments Developed DrugAbacus, an interactive cancer drug pricing tool to explore different ways to weigh various components of value and compare the resulting price with actual market price 6

7 Ask 7