The WellPoint Outcomes-Based Formulary: Health Technology
Transcription
The WellPoint Outcomes-Based Formulary: Health Technology
The WellPoint OutcomesBased Formulary: Health Technology Assessment Guidelines Brian Sweet, RPh, MBA Chief Pharmacy Officer WellPoint NextRx Presentation Objectives • Provide an overview of WellPoint Vision and Mission • Review the WellPoint NextRx Outcomes-Based Formulary Process • Provide highlights of the 2008 WellPoint Health Technology Assessment (HTA) Guidelines • Presentation summary WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 2 NextRx Strategy Vision WellPoint NextRx will transform our industry and become the most trusted and valued Pharmacy Benefits Manager (PBM) Mission We deliver integrated pharmacy and health solutions providing exceptional value to our customers Differentiating Strategies Leader in affordable quality care Most trusted choice for consumers WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 3 The Value of Integration Collaborative Value from an Integrated Model P&T Committee P&T Decisions aligned with Medical Policy Medical Policy Pharmacy Claims Claims Data Medical Claims Customer Service Customer Service Customer Service Therapy Management Data Analytics Account Service Pharmacy Reports Clinical Programs Data Analytics Predictive Modeling Account Management Reporting Disease Management Data Analytics Account Service Medical Reports Web Services ID Card WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 4 The Value of Integration The integration of pharmacy and medical data can provide information for the improvement of health, and better management of total health care cost. Pharmacy Perspective Rx Pharmacy and Medical Perspective MEDICAL GOAL = IMPROVE HEALTH, QUALITY OF SERVICE, AND REDUCE TOTAL COSTS WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 5 Presentation Objectives • Provide an overview of WellPoint Vision and Mission • Review the WellPoint NextRx Outcomes-Based Formulary Process • Provide highlights of the 2008 WellPoint Health Technology Assessment (HTA) Guidelines • Presentation summary WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 6 Outcomes-Based Formulary Management General Approach Consider the complete burden of disease Leverage the formulary process to improve patient outcomes Clinical Burden Improve Quality of Care Epidemiology Natural History of Disease Total Cost of Care Productivity Impact Quality of Life Impact (clinical status, quality of life) Reduce Total Cost (pharmacy, medical, ancillary, home health, nursing home, etc.) Optimize Care (cost effectiveness) Improve Productivity WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 7 P & T Process and Committee Overview Clinical Review Committee (CRC) Pharmacy and Therapeutics (P&T) Committee Value Value Assessment Assessment Committee Committee (VAC) (VAC) Integrated Pharmacy and Medical Analysis Critical review of the literature, Assigns a clinical designation based on the evidence. Recommendation s sent to the VAC Clinical appropriateness FIRST OUTCOMES ADVISORY COMMITTEE Outcomes / Pharmacoeconomic Review ACTUARIAL SUBCOMMITTEE TO VAC (ASVAC) Analyzes Financial and Pharmacoeconomic Results Reviews the clinical, outcome, and financial data and makes final tier placement decisions Financial considerations SECOND WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 8 Critical Appraisal of Clinical Trial Data Each clinical trial, systematic review, and guideline is carefully critiqued before being included in the drug monograph • Only high quality evidence material is included • Many publications fall short The focus of decision-making is based on patient-oriented clinical outcomes • Outcomes that are understood and desired by patients (e.g. decreased risk of heart attack/stroke/death, effect on quality of life) versus surrogate outcomes (lowering of blood pressure or LDL) • Many publications fall short here too WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 9 Delfini Evidence and Usability Scale Considered by P&T Grade A: Useful – The evidence is strong and appears sufficient to use in making health care decisions – it is both valid and useful. Grade B: Possibly Useful - The evidence is potentially strong and might be sufficient to use in making health care decisions. Grade B-U: Possible to uncertain usefulness - The evidence might be sufficient to use in making health care decisions; however, there remains sufficient uncertainty. Not Considered by P&T Grade U: Uncertain – There is sufficient uncertainty so that caution is urged regarding the use of the information in making health care decisions. Grade UV: Uncertain Validity – perceived methodological weaknesses. Grade UU: Uncertain Usefulness – methodology appropriate but applicability of the results are uncertain. Grade UVU: Uncertain Validity and Usefulness – combination of the above. Grade UA: Uncertainty of Author – the author is uncertain about their findings. Grade X: Not Useful - studies that are so poorly done and so potentially misleading that the strongest caution is urged about their quality. © Delfini Group, LLC, 2002-2008. All rights reserved worldwide. WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 10 Proposed Data Elements (I) Clinical Study Summaries • Study reference • Study funder • Regimens studied • Placebo-controlled • Comparator controlled • Indication(s) studied • Hypothesis • Inclusion & exclusion criteria • Study design • Outcome measures (primary and secondary) • Known confounders • Randomization achieved • Comparability of baseline characteristics • Blinding achieved • Concealment of allocation • Potential bias • • • • • Selection bias Observation bias Performance bias Attrition bias Assessment bias WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 11 Proposed Data Elements (II) Clinical Study Summaries • • • • • • • Patient adherence results Duration of study Number randomized Number analyzed ITT achieved % Loss to follow-up Imputation method for ITT/loss to follow-up • Assessment of quality of results analysis • Other problems identified • Study results • Safety assessment • Study quality assessment • Rationale for assessment • External validity WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 12 Common Study Pitfalls • High-drop out rates or missing data, with no sensitivity analysis • Use of post-hoc analysis to draw cause and effect conclusions • Subgroup analysis where subgroups were not determined in advance. • Non-significant findings or power calculation is not clear • Non-ITT analysis (>5% of patients excluded from the primary outcome analysis) • Inadequate dosages, either study drug or comparator • Use of non-validated scoring methods • Disease oriented outcomes only (BP lowering vs. CV mortality) • Unclear quality assessment methods for meta-analysis studies • Study duration too short for endpoint (e.g., 6 weeks for DM meds) • Use of other medications that may influence or confound the effect of the primary drug on outcomes WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 13 Efficacy vs. Effectiveness Efficacy Effectiveness (Clinical Trial Data) (Real-World Data) Objective Does it work under ideal circumstances Does it work under usual circumstances Setting / Design Controlled clinical trial Real-world clinical practice Purpose Regulatory approval (FDA) Drug performance in real-world Intervention or treatment Fixed regimen Flexible regimen Comparator Placebo Active comparator/usual care Subjects Homogenous/highly selective (stringent inclusion/exclusion criteria) Heterogeneous / any subjects Compliance High Low to High Outcomes Clinical endpoints (e.g. BP, HbA1c, LDL) Example: Cardiovascular events, hospitalizations Internal Validity External Validity (generalize to other populations) High Low Low to medium Medium to high WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 14 Quality of Life (QoL) • Some diseases are associated with significant QoL burden • Some treatments can result in significant improvement in QoL • QoL consistent with disease in remission • QoL approaches that of the US population norm • QoL is an important endpoint from a patient perspective WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 15 Presentation Objectives • Provide an overview of WellPoint Vision and Mission • Review the WellPoint NextRx Outcomes-Based Formulary Process • Provide highlights of the 2008 WellPoint Health Technology Assessment (HTA) Guidelines • Presentation summary WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 16 Revised WellPoint HTA Guidelines for Formulary Submission: 2008 Standards and Recommendations WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 17 Roles of WellPoint (HTA) Guidelines • Summarize recommended evidence and analyses expected from manufacturers when presenting a product value case • Comparative clinical case • Comparative cost-effectiveness case • Budget/system impact case • WellPoint’s guidelines are intended to support • Applications for new products, formulations, and indications • Ongoing disease area and therapeutic class reviews • A common format allows for comparisons within and between products, therapeutic classes, and diseases areas • Supports efficient and effective resource allocation decisions to meet patient outcomes targets WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 18 Other HTA Guidelines • Global standards in health technology assessments are well established, and include both clinical and cost-effectiveness evaluations • Many major global markets have standards in place and a clearly defined set of expectations for product evaluation • National Institute for Clinical Excellence (UK – 2004; under revision) • Scottish Medicines Consortium (UK - 2005) • Canadian Agency for Drugs and Technologies in Health (2006) • College of Health Economists (France – 2004) • German Institute for Quality and Efficiency in Health (2008) • Pharmaceutical Management Agency (New Zealand – 2004) • Pharmaceutical Benefits Advisory Committee (Australia – 2006) • Academy of Managed Care Pharmacy (AMCP) (US) WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 19 WellPoint Documentation • Two documents will be posted on the WellPoint NextRx website that provide manufacturers with the recommended information to prepare a submission (update should be posted by Friday 10/10) https://www.wellpointnextrx.com/wps/portal/wpo/client/formulary/providerpharmacytheraputics • WellPoint, Health Technology Assessment Guidelines: Drug Submission Guidelines for New Products, New Indications, and New Formulations, (Updated September 2008) • WellPoint, Health Technology Assessment Guidelines: Drug Submission Guidelines for Re-Evaluation of Products, Indications, and Formulations (Updated September 2008) WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 20 WellPoint Guideline – 2008 Version Changes • The key analytical and evidentiary standards required by WellPoint have not changed materially between the previous version (2005) and the present version (2008) • New emphasis in 2008 guidelines • Usefulness & validity assessment of clinical trials • Potential medical cost offsets • Product claims that allow for monitoring and validation over short and medium time frame (3 years recommended) • Effects on patient-reported outcomes (PRO) and quality of life (QoL) • Productivity effects WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 21 WellPoint and AMCP: Differences • Clinical Evaluations: WellPoint places more emphasis on critical appraisal of the literature, including systematic reviews/metaanalyses, and linking these to comparative therapeutic claims in costeffectiveness modeling • Outcomes: WellPoint places more emphasis on real-world outcomes, productivity outcomes, and quality of life • Modeling: WellPoint encourages the use of models for new reviews, but prefers real-world claims database analyses for re-evaluations • Budget Impact: WellPoint encourages detailed total cost impacts (pharmacy, medical, and total cost) be provided • Claims: WellPoint recommends all claims should be expressed in terms that are empirically evaluable • Monitoring and Verification: WellPoint recommends that all claims are monitored, verified and reported within a 3-year timeframe WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 22 Key Elements (I) WellPoint HTA Guidelines • Reviews for new products, indications, and formulations are distinct from those for re-evaluations • Ideal ‘gold standard’ studies • High quality, comparative effectiveness/efficacy trials • Population representative of the WellPoint population • Clinical effectiveness preferred over efficacy • Naturalistic setting is preferred WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 23 Key Elements (II) WellPoint HTA Guidelines • Focus on patient health outcomes • Comparative clinical effectiveness • Pharmacovigilance / safety • Utilization patterns • Patient-reported outcomes (PRO) – Productivity • Economic outcomes • Medical cost offsets • Cost effectiveness – Cost-per-quality adjusted life year (QALY), if possible • Budget/system impact – Claims for total cost impacts, including per member per year cost projections – Treatment satisfaction – Quality of life • Generic and disease-specific • Profiles and preference-based WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 24 Key Elements (III) WellPoint HTA Guidelines • All presented claims should be amenable to monitoring and validation • Derivation of claims should be clear and transparent • Modeled claims • Models should be transparent and only as complex as necessary • All models should be provided • All product claims should be monitored, validated, and reported by manufacturers on an ongoing basis • For re-submissions, differences between expected product claims and observed data/evidence should be justified • Continuing formulary support is subject to ongoing clinical review WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 25 Anticipated Impact of WellPoint Guidelines • Provide a comprehensive and standardized assessment of the clinical and economic claims for products • Emphasize the recommendation for manufacturers to support the value case for their products, as well as comparator products, through meeting standards of evidence for clinical, economic, budget impact, and PRO claims • Establish a common set of evidentiary and analytical standards for assessments of products within disease areas and therapeutic classes • Establish the basis for continued formulary status consistent with WellPoint’s commitment to an Outcomes Based Formulary WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 26 Next Steps • Questions and feedback from manufacturers should be submitted to Donata LaPolla at: – [email protected] • Subject Line: HTAG Guideline Question and Feedback • Questions will be answered and posted https://www.wellpointnextrx.com/wps/portal/wpo/client/formulary/providerpharmacytheraputics WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 27 Presentation Objectives • Provide an overview of WellPoint Vision and Mission • Review the WellPoint NextRx Outcomes-Based Formulary Process • Provide highlights of the 2008 WellPoint Health Technology Assessment (HTA) Guidelines • Presentation summary WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 28 Presentation Summary • High quality efficacy and effectiveness data should be used to make formulary decisions • There are differences in performance of drugs within the same therapeutic category • Goal is to identify the “best” performing drugs • Health Technology Assessment Guidelines • Inform manufacturers regarding information most useful to WellPoint • Expected Outcomes • A pharmacy benefit that is high quality and cost effective • Better quality of care • Improved cost-effectiveness of care WellPoint NextRx is a registered service mark of WellPoint, Inc. Services are provided by a WellPoint PBM (either NextRx Services, Inc. or NextRx, LLC, as applicable). WellPoint NextRx is a division of WellPoint, Inc. 29