OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES TO MEDICAL PUBLICATIONS

Transcription

1 OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES TO MEDICAL PUBLICATIONS April 27 29, 2015 Hyatt Regency Crystal City Arlington, VA, USA 11TH ANNUAL MEETING OF ISMPP 1

2 ORGANIZED HEALTHCARE SYSTEMS: USE AND IMPACT OF MEDICAL PUBLICATIONS ON DECISION-MAKING Michael J. Sax, Pharm.D. President The Pharmacy Group 11TH ANNUAL MEETING OF ISMPP 2

3 Market Access Stakeholder Segments Associations Healthcare Information Technology Healthcare Services Payers (Employers/Health Plans/PBMs) Pharmaceutical Companies 11TH ANNUAL MEETING OF ISMPP 3

4 TPG Family of Companies The Pharmacy Group ( offers consulting services to healthcare services, information technology and pharmaceutical companies to grow the revenue of their productsand services. TPG Data Services ( manages the financial performance of healthcare transactions to help healthcare services, payors and pharmaceutical companies. TPG Healthcare Consulting ( offers consulting services to Blue Cross Blue Shield organizations,regional health plans and other payors on all aspects of managing the pharmacy benefit. TPG International Health Academy ( develops and conducts educational programs in countries outside the United States for senior healthcare executives. TPG National Payor Roundtable ( delivers access to medical directors from payors for healthcare services, information technology and pharmaceutical companies 11TH ANNUAL MEETING OF ISMPP 4

5 A Pharmaceutical Centric Healthcare World Physicians G Government Drug Companies Hospitals Old World Employers Pharmacies Health Plans PBMS New World Consumers 11TH ANNUAL MEETING OF ISMPP 5

6 What Do We Know About Providers and Consumers Providers Trust peer reviewed journals Listen to patients Reluctant to change Respond to financial incentives Consumers Respond to their physician Listen in teachable moments via personalized tools Reluctant to change Respond to financial incentives 11TH ANNUAL MEETING OF ISMPP 6

7 The Payer View of the World Disease management efforts are a start in the right direction.. A broader, more systematic strategy is needed to address costs and quality Changing the way care is delivered is the key to reducing costs Consumers will play a larger role, but they need help 11TH ANNUAL MEETING OF ISMPP 7

8 THE CHANGING ROLE OF PHARMACY AND THERAPEUTICS (P&T) COMMITTEES 11TH ANNUAL MEETING OF ISMPP 8

9 P&T Committee Purpose: Ensure access to clinically sound & cost effective medications, biologics, and devices Roles & Responsibilities: Develops and manages: Formulary(ies) Practices and policies for formulary management activities, such as prior/pre authorization, step therapies, quantity limitations, Generic substitutions and other drug utilization activities that affect access 11TH ANNUAL MEETING OF ISMPP 9

10 P&T Committee Structure Primarily physicians and pharmacists Includes practitioners from a variety of specialties May also include: Nurses Other health care providers Legal Contracting Quality assurance Administration 11TH ANNUAL MEETING OF ISMPP 10

11 Drivers of Change Over the Past Decade Cost (Reimbursement) Quality Access Accreditation 11TH ANNUAL MEETING OF ISMPP 11

12 Drivers of Future Change Responsible for optimal medication prescribing management Development of novel economic models of pharmacy practice Avoid potential conflicts in drug procurement, sales, or distribution Decision making economics in hospitals and other health care settings 11TH ANNUAL MEETING OF ISMPP 12

13 Drivers of Future Change Separation and/or systematic oversight of medication selection processes and sales no matter who the prescriber is or what organized health care setting the prescriber represents Ability to interpret economic and regulatory requirements and foresee their implications for their own organizations 11TH ANNUAL MEETING OF ISMPP 13

14 Answering Basic Questions CAN IT WORK? DOES IT WORK? IS IT WORTH IT? RCTs CER HTA EBM Clinical Guidelines Patient Level Decision Making Coverage Decision Making 11TH ANNUAL MEETING OF ISMPP 14

15 Sources of Information Clinical experience Data from observational studies Data from randomized clinical trials (RCTs) Expert opinion Formal training Lab tests Local practice standards N of 1 trials Narratives produced by patient or clinician Trials performed by commercial entities (drug manufacturers) 11TH ANNUAL MEETING OF ISMPP 15

16 P&T Committee Decision Making Process Formulary management decisions are based on the strength of scientific evidence and standards of practice, including assessing: Peer reviewed medical and clinical literature including clinical trials and well established treatment guidelines, comparative effectiveness reports, pharmacoeconomic studies and outcomes data FDA approved prescribing information and related FDA information including safety data Relevant information on use of medications by patients and experience with specific medications 11TH ANNUAL MEETING OF ISMPP 16

17 P&T Committee Decision Making Process Current therapeutic use and access guidelines and the need for revised or new guidelines Economic data, such as total health care costs, including drug costs Drug and other health care cost data (not all P&T committees review drug specific economic data) Health care provider recommendations Other such information as deemed appropriate in order to achieve appropriate, safe, and cost effective drug therapy 11TH ANNUAL MEETING OF ISMPP 17

18 Evidence Based Medicine (EBM) Quantify and mange medical uncertainty Confrontation of clinical uncertainty and provides systematic procedures Questions reliance on noncontrolled observations, experience, and experts opinions Rejects practice standards based on beliefs or unquestioned intuition Awareness of susceptibility of sources of information random and systematic error 11TH ANNUAL MEETING OF ISMPP 18

19 Evidence Based Medicine (EBM) Link clinical practice and policy decisions to support evidence Increased attention in practice guidelines and public policy Way into insurer s decisions about coverage, government decisions about health financing Medico legal judgement guided by results of clinical trials, systematic reviews, and evidence based practice guidelines 11TH ANNUAL MEETING OF ISMPP 19

20 Perform EBM Frame a clinical question Search peer-reviewed literature Critically appraise the results Translate evidence into a workable clinical action plan Evaluate outcomes and performance 11TH ANNUAL MEETING OF ISMPP 20

21 Evidence Based Medicine (EBM) Incorporate EBM in 5 areas overseen by Medical management Coverage decisions Disease management Provider profiling Pay for performance Consumer directed care programs 11TH ANNUAL MEETING OF ISMPP 21

22 Key Considerations and Tools Managed Care vs. Self Insured (Employees) Economy and Resources Mini Monographs Timing of Dossiers and Placement on AMCP edossier System for Easy Access Realistic Economic Modeling Financial Considerations Rebates Cost per ETG or Episode Treatment Group Pay for Performance Copay Impact Benefit Caps Reasonable Member / Employee / Patient Impact 11TH ANNUAL MEETING OF ISMPP 22

23 Mini Monographs Description (to include Indication, FDA approval, Mechanism of Action) Considerations Dosing (Dosing, Special considerations, Available formulations) Safety Adverse Effects Drug Interactions Contraindications Caution Efficacy (Description of trials) Effectiveness 11TH ANNUAL MEETING OF ISMPP 23

24 Mini-Monographs Cont d Comparison of Alternative agents (May include nationally accepted treatment guidelines) Utilization Data Cost Comparison Compare estimated ingredient cost of new product if not included in the utilization data. May also provide cost projection/comparison to existing therapies. Potential for Duplication Recommendation Rationale References 11TH ANNUAL MEETING OF ISMPP 24

25 Format for AMCP Formulary Submissions A process to obtain a standardized set of data and information about a drug from its manufacturer Primarily used by commercial insurance plans to evaluate drug therapy options for reimbursement Often supplemented by independent analysis and review by individual health plans Provides an opportunity for dialogue between the health plan and the manufacturer regarding definition and willingness to pay for value 11TH ANNUAL MEETING OF ISMPP 25

26 Challenges Importance to balance between clinical and financial concerns Rapid evolution of our health care system compel clinical professionals to forge a closer relationship with those who evaluate effectiveness as a means of improving system performance Changes in health system organization and access to providers Proliferation of biologic therapies Aging population 11TH ANNUAL MEETING OF ISMPP 26

27 Takeaways for Publication Planners Peer-reviewed publications are critical in establishing the evidence base Decision-makers review all evidence Not just RCTs Ultimately want pharmacoeconomic outcomes and real world evidence Communication of value is important Timing of guidelines may lag Local/regional practice standards or standard of care may be considered as more current Expert opinion may contribute to decisions 11TH ANNUAL MEETING OF ISMPP 27

28 Key Considerations and Tools Managed Care vs. Self Insured (Employers) Economy and Resources Mini Monographs Timing of Dossiers and Placement on AMCP edossier System for Easy Access Realistic Economic Modeling Financial Considerations Rebates Cost per ETG or Episode Treatment Group Pay for Performance Copay Impact Benefit Caps Reasonable Member / Employee / Patient Impact 11TH ANNUAL MEETING OF ISMPP 28

29 QUESTIONS? 11TH ANNUAL MEETING OF ISMPP 29

30 THANK YOU 11TH ANNUAL MEETING OF ISMPP 30

31 OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES TO MEDICAL PUBLICATIONS April 27 29, 2015 Hyatt Regency Crystal City Arlington, VA, USA 11TH ANNUAL MEETING OF ISMPP 31