When novelty is not enough: Assuring adoption, access, as well as - - PowerPoint PPT Presentation
When novelty is not enough: Assuring adoption, access, as well as approval within the clinical development process Michael F . Murphy M.D. Ph.D. Chief Medical and Scientific Officer, Worldwide Clinical Trials Research and Development Editor,
Chief Medical and Scientific Officer, Worldwide Clinical Trials
Research and Development Editor, American Health and Drug Benefits™ Teaching Faculty, Center for Experimental Pharmacology and Therapeutics Harvard-MIT Division of Health Sciences and Technology
Acadia Coronis GB Sciences Neumentum RMJH Rx AgeneBio Cortexyme Gideon Richter Neuralstem Roche Amygdala Cristcot Global Blood Therapeutics NeuroRx R-Pharm Aptinyx Curadim Immunova Neurotrope Rubius ARC Cytogel Incys Novus Sanofi Genzyme Argenx Diurnal Isothrive Orchard Sinopia ArQule Dynacure Medivir PanX Spruce AudioCure Eisai Momenta Philip Morris Int. Suven Aurin EMS Navinta Praxis X4 BioXcel Frequency Therapeutics NeoTrope Rhythm
Chief Medical and Scientific Officer, Worldwide Clinical Trials
Research and Development Editor, American Health and Drug Benefits™ Teaching Faculty, Center for Experimental Pharmacology and Therapeutics Harvard-MIT Division of Health Sciences and Technology
“I have time to ask three questions– how’s your gallbladder, how’s your teeth, and do you have good outpatient pharmacy coverage” Interventional Cardiologist Birmingham, AL Prior to PCI
Care Providers Academia
Physicians Labs
Products & Services
Intermediaries
Consumers Governments Devices
States
Disease Management Insurers Global Regulation Regional Variation Medicare -Medicaid Basic Researchers
Employers
Insured Seniors Women Children Unions
Uninsured Nurses
Neither orderly nor rational, multiple stakeholders impact R&D with conflicting data needs
Financial Markets
Assisted Living
Nursing Homes
Med Tech
Bio Tech Patients
Pharma
CMS, State Medicaid
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Michael F. Murphy M.D., Ph.D. Research & Development Editor
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David B. Nash M.D., MBA Editor-In Chief, Dean Jefferson School
“Rarity, Disease Heterogeneity, and A Pathw ay for Estim ating Econom ic Burden
Risk stratification Personalized Medicine Orphan Disease Indications Raises questions about validity of drug formularies and reimbursement mechanisms to control access to therapeutics Can this inform a development program?
Intellectual Property Position Cost of Goods Advantage Improved Features & Benefits Quality
Innovation Value
Ability to Leverage Core Competencies Market Attractiveness Fit Within Company Strategic Initiatives
Evidence-based Value Clinical Impact Economic Impact
Improved patient
Reduces downstream costs
Result
? ?
How Impact
Data during development creates a “value” proposition to inform technology investment decisions
Confidential - Used with Permission, Boston Healthcare Associates
Used with permission of Boston Healthcare Associates, Inc.
“W hat don’t they w ant?” “Current stum bling blocks?” “W hat they are w illing to consider?” “W hat’s prom ising given current perspectives?” “How diverse are data needs?”
Diverse Policies Specialist Rx Only Prior Authorization (+ Re-authorization) Tier Placement (~ 60% ) Require affirming benefit before and after therapy (~ 40% )
Strattera will face low reimbursement from
2003 JUN 9 - (NewsRx.com & NewsRx.net) -- Decision Resources finds that Eli Lilly's Strattera will face low or nonexistent reimbursement from HMO pharmacy directors…
“Out of pocket expenses range from $40-$230/ month across a range of possible medications…and can substitute a generic without physician permission” PA Pharmacist
High Interest
Fatigue impact on cost drivers uncertain (Reimer et al, 2007; Wu et al, 2007; Leibson et al, 2001) “Interaction effects” (Page et al,2016) Many Tools Control Utilization (Fail-First strategy, Preferred List, Co-insurance, Co-pay)
Opportunities
Mild cognitive impairment (Zhu et al, 2013) Informal care (Jönsson et al, 2006; Deb et al, 2017) Depression, resilience, distress in caregivers (Lavretsky et al, 2010; Abreu et al, 2018)
“Off the radar” for Some Stakeholders, Many Questions by Others Fatigue entwined with Cognitive Impairment, Reduced Physical Activity? Contribution to metabolic syndrome (CV
Poor compliance (institutionalization)? Episodes of care (utilization)?
High Interest Commercial Plans Non-Psychiatric Utilization (minor somatic complaints including fatigue; Katon et al, 2001; Greenberg et al, 2015) Employers Absenteeism, Presenteeism (Druss et al, 2000; Cocker et al, 2014; Evans-Lacko and Knapp, 2016)
No (minimal) Additional Expenditures
Additional Expense