The WellPoint Outcomes-Based Formulary: Health Technology

Transcription

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
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
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
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Process
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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
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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
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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
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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.
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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
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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
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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
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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
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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
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Process
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Revised WellPoint
HTA Guidelines for
Formulary
Submission: 2008
Standards and
Recommendations
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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
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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)
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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)
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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
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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
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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
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Key Elements (II)
• 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
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Key Elements (III)
• 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
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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
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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
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Process
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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
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The WellPoint Outcomes-Based Formulary: Health Technology

Transcription

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