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WEBINAR: Developing Payer Evidence: The Role of Post Approval Programs
 

WEBINAR: Developing Payer Evidence: The Role of Post Approval Programs

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    WEBINAR: Developing Payer Evidence: The Role of Post Approval Programs WEBINAR: Developing Payer Evidence: The Role of Post Approval Programs Presentation Transcript

    • Developing Payer-Focused Evidence: The Role Of Post-Approval Programs September 13, 2011 Compliments ofWE’RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH WE THE WAY IN HEALTHCARE.™
    • Today’s Panel Nathan White, CPC Executive Director Access & Reimbursement Jeff Trotter Executive Vice President Phase IV Development Lujing Wang, MD, MPH Practice Area Lead Pricing & Market Access2 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • The Global Payer Market: Programs To Support Managed Market Strategies Nathan White, CPCWE’RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH WE THE WAY IN HEALTHCARE.™
    • European Landscape • Coverage largely through government sponsored/managed insurance • Well-defined health technology assessment (HTA) process • HTA/Payer relationship is strong (i.e. UK‟s NHS & NICE) • Emphasis on medical innovation: “me too” products are not favored in HTA process • HIT is a critical part of coverage and reimbursement systems4 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • US Landscape • Complex evidence development and utilization • Many national payers and PBMs have developed in-house HTA‟s › Research could be viewed as subjective › Rely heavily on claims data and chart review • CMS coordinates to some degree with AHRQ on evidence needs › AHRQ-sponsored review of evidence for colorectal screenings › NCD for treatment of actinic keratoses • “Me-too” products still have market potential • National HIT standards implementation still has room for improvement5 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • US Payers Likely To Use PRO’s In Future Decisions How likely are you to use PROs to make coverage and reimbursement policy decisions in the future? (on a scale of 1 to 7 where 1=Not likely, 7= Very likely) # of lives = 4,353,435 Mean 4.5 5% # of lives = 19,701,655 26% Very Likely Likely Not Likely 68% n=22 # of lives = 51,127,435 Source: 2011 inVentiv Health Payer Study6 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • US Payers Likely To Follow CMS Lead If CMS publicly leverages the results of these studies, how likely are you to follow CMS’s lead in utilizing PRO’s to guide your coverage decisions? (on a scale of 1 to 7 where 1=Not likely, 7= Very likely) 1% 14% Very Likely Likely Not Likely 86% Source: 2011 inVentiv Health Payer Study7 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Evidence Development: Pre- and Post-Approval • Prospective › Clinical study data • May include PRO endpoints and cost-benefit analysis › FDA approved label • Retrospective › Pharmacy claims analysis › Chart review › Budget impact modeling › Cost effectiveness analysis (limited use in US) › Registry › Phase IV outcomes study with PRO › Commercial marketing programs8 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • What Is This Evidence Used For? • Determining relevant “access barrier” criteria › Step therapy › Prior authorization › Quantity limits • Deciding which benefit the therapy is placed in (medical v. pharmacy v. specialty) • Reimbursing at an appropriate rate9 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Reimbursement Support Programs TODAY TOMORROW? Focused on helping patients  Managed markets data couldwith reimbursement access be used to better guide NAMbarriers and assisting the tacticsunderinsured  Could this program type be Used primarily as marketing integrated into a Phase IV studyinitiative to reduce sponsor cost? Captures some data which  CHALLENGE: How do we getcould be valuable to managed all the stakeholders (vendor,markets and brand teams brand teams, managed markets, etc) to share the same vision? Typically doesn‟t capture PRO WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Patient Assistance Programs TODAY TOMORROW? Focused on assisting the  PAPs could begin to collectuninsured (PAP) adherence/compliance data (especially IPAPs) Used primarily as corporateawareness to the public  What confounding factors would inhibit such an evolution Captures some data which (ex. IRS, study population bias,could be valuable to managed misclassification)?markets teams  Would patient advocates Typically doesn‟t capture PRO object to muddying the waters of a free drug program? WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Adherence Programs TODAY TOMORROW? Focused on changing patient  Would patients be willing tobehavior and improving patient respond to PRO questionnaireshealth outcomes in an opt-out program? Opt-out programs typically  How can manufacturersadministered through 3rd party partner with payers andand use claims data to manufacturers to utilize PROintelligently message patients more effectively? High touch programs use aclinical case managementapproach WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Patient Support Programs: The “Package” Approach • Post-approval RCT sought to demonstrate superior effectiveness of buprenorphine medication-assisted therapy paired with interventional coaching (in opioid dependent patients) • CAC and trained registered nurses conducted telephonic interventions designed to encourage appropriate compliance & persistency • The study concluded that patients were more likely to take their therapy every day and less likely to abuse, compared to controls What can we learn from this example? • Better patient support leads to better patient outcomes, reducing overall payer spend • Additional messaging to payers on total value of package (product + program) Source: Supplement to Journal of Managed Care Pharmacy, Feb 201013 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Role of Commercial Programs In Evidence Development • The primary direct link to patients after approval • Types of programs: › Reimbursement › Patient assistance › Adherence • Control arms could be added with a non-interventional survey or interventional care coordination to demonstrate therapy or therapy/program effectiveness to payers14 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Observational Studies & Registries: Strategic & Operational Considerations Jeff TrotterWE’RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH WE THE WAY IN HEALTHCARE.™
    • Post-approval Research Today – Safety & Value • Requirement › In some countries, „real world‟ post-approval experience data must be submitted to maintain market approval. › Increasingly, some form of safety surveillance / risk management program will be mandated and enforced. • Responsibility › Corporate accountability for post-approval safety is increasingly expected by various constituencies. › Documentation of clinical / economic / humanistic value is critical for commercial acceptance and accelerated product uptake. • Opportunity › If managed proactively, safety surveillance obligation can be controlled. › An observational study can be a cost-effective, high ROI mechanism for fulfilling the post-approval obligation for both safety and effectiveness data.16 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Real World Perspectives, Real World Research “The conditions under which products are examined for regulatory approval are generally not the conditions under which they are actually used…”17 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Who Needs Real World Data? • Health authorities WellPoints CER Guide Describes How It Will Determine Usefulness Of Studies • Pricing commissions Observational Studies Of "Real-World" Questions The guidelines state that, "while randomized, controlled clinical trials remain the gold • Payers standard for producing reliable efficacy and safety data, WellPoint recognizes that there are circumstances in which RCTs alone may not be sufficient for decision-making. Accordingly, a well-conducted CER or observational study may complement RCT- • Regulatory based information by providing effectiveness data, or data on outcomes achieved in a real-world setting.“ authorities • Physicians / German Pharma Law Require Firms to Prove Drugs Value providers Within a Year / Germanys Comparative Effectiveness Debate Concludes; Dossier Refinement Begins • Policy makers The holder of the marketing authorization will be required to hand in a comprehensive • Patients dossier to the G-BA, which needs to contain information on: • the authorized indications; • the actual medical benefit of the product; • the additional medical benefit of the product compared with existing therapies; • the number of patients and patient groups for which the product is relevant; • the cost of the therapy to the statutory health insurance funds; and • requirements for quality-assured use of the product.18 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Real World Studies & Registries Are Needed Because… ►…RCTs can be too artificial in intent and design, and therefore poorly reflective of actual medical practice ► Tight inclusion criteria ► Experimental protocol ► Tight procedural control ► Randomization, blinding, placebo, etc. ► Short in duration ► Homogeneous sites ►We need to know how a product is used and how it “performs” under real world conditions ► Safety ► Clinical outcomes (CER) ► Economic value ► Humanistic value19 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • But The Real World Can Be Really Messy! ►What are we trying to prove? ►What can we prove? ►Should we be trying to “prove” anything? ►Considering… ►Not typically testing a hypothesis ►Potentially shaky statistical foundation ►Inexperienced research sites ►Liberal inclusion criteria ►Strong likelihood of various biases ►Imperfect ability to identify all confounders ►Hawthorne effect ►Inconsistent understanding of observational research …is there a “perfect” observational study? Probably not…20 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Different Conditions Require Different Processes21 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Key Components RCT Component Observational Study Support for approval Strategic Goal Support for “real world” data Efficacy Measures Safety, effectiveness, value Randomization, Controls Inclusion/exclusion inclusion/exclusion criteria, protocol, monitored Sample size based on Statistical Power Possibly, based on expected hypothesis event rate, but often lacking Investigators, subjects Participants Practitioners, patients Consent, EC/IRB, privacy Approval Consent, EC/IRB, privacy (notification) As short as necessary Timeframe Longer-term (“sustain and maintain”)22 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Operational Issues & Challenges • Site selection • Data management • Site training and start-up › Accommodating multiple measures • Site “interaction” › EDC issues (monitoring) and management › Data quality • SDV › Site motivation › Protocol “adherence” • Analysis • Inclusion › Biases, etc. • Procedures › Findings › Reporting (communications23 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Observational Studies Are A Different Animal So, who “owns” it…? • HEOR • Epidemiology • Medical Affairs • Marketing / Product Management • Clinical Operations • Development • Safety / PV24 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Highlights From Study On Observational Research • Motivation: “Schizophrenic” RFPs › i.e., uncertainty, inconsistency, imprecision, over-engineering, etc. • Many functional areas have some involvement in observational research studies • Many different purposes underlie these studies • “Observational research” goes by many names • Sponsors have varying levels of “comfort” with observational research • Most sponsors do not have defined processes for observational studies › Design, Procurement, Operational, Analytical, etc. • Sponsors have varying expectations for the “conclusiveness” of findings from observational studies • Sponsors are concerned that regulatory/health authorities “don‟t get it” • Sponsors plan to become increasingly involved in observational research25 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Operational Planning: Building The Study From The Ground Up PUBLICATIONS ABSTRACTS, PRESENTATIONS• What are the strategic REPORTS goals underlying the ANALYSES study? SITE › Direct impact on how the SUPPORT MEETINGS PATIENT ENROLLMENT, project/study should be OUTCOMES TRACKING, „operationalized‟ DATA COLLECTION NEWSLETTERS • Direct impact on budget and ROI• Work backwards from MATERIALS PRODUCTION AND DISTRIBUTION SITE RECRUITMENT AND TRAINING the deliverable LEGAL, REGULATORY, IRB REVIEW• Don‟t consider any DATA COLLECTION FORMS, SCIENTIFIC ADVISORY PANEL SITE IDENTIFICATION (FIELD PROCESSES, AND LOGISTICS INVOLVEMENT) individual component in a vacuum ANALYSIS PLAN COMMUNICATIONS PLAN STRATEGY26 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Observational Research & Registries: Best Practices • Be realistic in study planning • Set appropriate expectations (internally and externally) › Observational study as part of overall “portfolio” • Strive for organizational inclusiveness and consensus • Develop guidelines addressing study design and SOPs addressing unique operational requirements • Interact with stakeholders during planning stages (and concurrently) • Maintain a collaborative stance with research partners › Minimize operational constraints • Expect change: “shift” happens27 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Payer Utilization Of Value Evidence Lujing Wang, MD, MPHWE’RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH WE THE WAY IN HEALTHCARE.™
    • Pros and Cons of Late Stage Evidence Generation Late-stage evidence generation should aim to demonstrate how a product can provide meaningful benefits to fulfill a justifiable need, at a reasonable and predictable cost Evidence Analysis Very Evidence X Generation Relevance Slight Very Pros Cons  Real-world data with  Intuitive suspicion of balanced demographics manufacturer- Y  Long-term outcomes sponsored studies Slight Repositioning in a large population  Lack of credible  Ability to address adjudication of Credibility payers‟ concerns methodology  Ability to define specific  Perceived subjectivity What to generate: patient (sub)population of patient-reported study endpoints outcomes measures  Partnership to boost credibility of results  Limited actionability of How to generate: study results study design29 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Payer Communication of Value Evidence Successful communication with payers requires following three principles. Principles of Payer Communication I Simplicity II Transparency III Credibility  A complete story that  Avoidance of “black  Well-accepted can be told in a box” design and methodology and definite time window subjective validated design assumptions  Concise and crisp  Third-party takeaways that can  Key foundations for endorsement and stay in memory audience to interpret KOL partnership study results30 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Stakeholder Engagement The right value evidence needs to be delivered to the right audience at the right time by the right people. Stakeholder mapping and engagement is pivotal in rolling out the study outputs efficiently and effectively. Potential Access Stakeholder Groups Stakeholder Profiles Engagement Plan PULL THROUGH Pharmacy Stakeholders Roles and What messages to responsibilities communicate Provider Stakeholders Evolving interests How to deliver the and incentives messages Financial Stakeholders Interaction and Who to own the Operational influence relationship Stakeholders Attitudes and When to engage Key Opinion Leaders perceptions PUSH the stakeholders THROUGH Societies and Advocacies31 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Organizational Requirements The right value evidence needs to be delivered to the right audience at the right time by the right people. Stakeholder mapping and engagement is pivotal in rolling out the study outputs efficiently and effectively. Hypothesis Evidence Value Validation Generation Communication Strategic Visionary Rigorous Scientist Credible Ambassador32 WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH
    • Panel Discussion Nathan White, CPC Jeff Trotter Lujing Wang, MD, MPHWE’RE WAITING FOR YOU AT THE GLOBAL CROSSROADS. WE KNOW KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH WE THE WAY IN HEALTHCARE.™
    • Panel Contact InformationNathan White, CPCExecutive Director, Access & ReimbursementinVentiv Patient Access Solutions(703) 662-1851nwhite@inventivhealth.comWebsite: www.inventivhealth.com/patientaccessJeff TrotterExecutive Vice President, Phase IV DevelopmentPharmaNet / i3(847) 943-2508jtrotter@pharmanet.comWebsite: www.pharmanet.comLujing Wang, MD, MPHPractice Area Leader, Pricing & Market AccessCampbell Alliance(973) 967-2300 ext. 2343lwang@campbellalliance.comWebsite: www.campbellalliance.com WE KNOW THE WAY IN HEALTHCARE > INVENTIV HEALTH