Description
Only need to do the 5.Pricing Information part.Need some data and a general framework with some simple explanations for the discussion meeting with group members in one day.The rest of this part (detailing) can be done in the remaining time( not sure yet, might extend the time)
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Drug Evaluation for Coverage Decisions
Health Technology Assessment (HTA) – Used to Inform Decision-Making
• Systematic evaluation of
properties and impact of
health care technology.
• Includes medical, social,
ethical, and economic
concerns.
?
Non-Profit Entity
US has no national HTA!
• Studies outputs for safety,
effectiveness, and costs
• Primary purpose of HTA is to
inform decision-making on
coverage and pricing.
U.S. Formulary
Submissions
AMCP Dossier
AMCP Dossier for Formulary Submission Used with PBM
Standardized Format Utilized to Evaluate Drugs for Formulary
1.0
Executive Summary
2.0
Product Information and Disease Description
Tests
3.0
4.0
2.1
Product Description
2.2
Place of the Product in Therapy
2.3
Evidence for Companion Diagnostic
Clinical Evidence
3.1
Study Summaries
3.2
Evidence Tables
5.0 Additional Supporting Evidence
5.1 Clinical Practice Guidelines
5.2 Health Technology Assessments and Systematic
Reviews
5.3 Compendia
5.4 Other Economic or Outcomes Evidence
5.5 Impact on Quality
5.6 Other Evidence or Information
6.0 Dossier Appendices
Economic Value and Modeling Report
4.1
Modeling Overview
4.2
Cost-Effectiveness Analysis
4.3
Budget Impact Model
4.4
Modeling Report and Interactive Model
Drug manufacturers develop and submit the AMCP dossier for new
drug for evaluation by customers (i.e. PBM, Health Plan)
AMCP = Academy of Managed Care Pharmacy
Formulary Decisions: https://www.formularydecisions.com/
Group Assignment: Drug Formulary Coverage Evaluation
Your group serves as the Pharmacy & Therapeutics committee for
Trojan Health Plan.
Leqembi (lecanemab) was approved for the treatment of
Alzheimer’s disease
The P&T committee is charged with evaluating Leqembi (lecanemab)
and to make recommendations for prescription coverage of the drug.
Template for Formulary Presentation
Title Page
Team Member Names
1. Disease Description
• Brief discussion of disease state
• Focus discussion on the drug’s approved indication
2. Product Information
• Product Information (PI) – Label and Product Approval Information
• Indication and usage, dosage and administration, dosage form and strength,
contraindications, warnings and precautions, adverse reactions.
• Info found at Drugs@FDA: FDA-Approved Drugs
• https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
• FDA Approval Letter and Product Information Labeling
• FDA Application Review Files
3. Clinical Assessment of Evidence
• Brief Review of Clinical trials. (Typically two Phase III Trials required)
• Efficacy
• Safety
• Population(s) studied
• Post-Approval studies requirements.
• Info found at Drugs@FDA: FDA-Approved Drugs
• https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
• FDA Approval Letter and Product Information Labeling
• FDA Application Review Files
4. Place in Therapy
• Published Clinical Guidelines for Treatment of Disease
• Does drug have place in any current treatment guidelines?
• Does drug address any unmet needs?
• Availability of Other Treatments
• Are there similar treatments already covered by health plan?
(Note: For scenario, assume there are NO similar drugs covered by the health plan)
• Are there treatments for the disease that are available but not currently covered?
• Are there treatments that may become available in near term, 1-3 years (i.e.
competitor pipelines with anticipated timeframe of approvals)
5. Pricing Information
• List Price per unit (use WAC)
• Cost per month
• Cost per year
• Micromedex, REDBOOK (Subscription. Available through USC Online Library)
• https://libproxy.usc.edu/login?url=http://www.micromedexsolutions.com/home/dispatch
6. Economic Value
• Drug manufacturers develop their own economic models to include in AMCP Dossier.
• PBM/health plan may develop their own economic analysis for new drug.
• In absence of manufacturer’s AMCP dossier, we will use the ICER report for this exercise.
1.
From ICER Report, summarize key points and findings of potential budget impact
and cost-effectiveness of drug from ICER report.
2.
Also take note of ICER’s Health Benefit Price Benchmark (HBPB) assigned (i.e.
their benchmark of how drug might be priced based on its analysis
Institute for Clinical Economic Review (ICER) report (note: not always
available at drug launch)
https://icer.org/wp-content/uploads/2023/04/ICER_Alzheimers-Disease_FinalReport_For-Publication_04172023.pdf
7. Drug Coverage, Placement, and Recommendations
Based on your analysis and synthesis of data, explain your recommendations in the presentation.
1.
2.
3.
4.
5.
6.
Under which benefit (pharmacy or medical) will this drug be covered?
How will drug be covered relative to patient stage of disease, or use of other drugs?
• E.g. specific stage of disease, specific population, 1st…3rd line use relative to other treatments
• If oral drug, which tier will drug be placed?
What patient cost sharing is recommended? How much, if at all?
Will there be utilization management restrictions placed on drug coverage? Which restrictions?
• If plan will require a prior authorization, then search for existing PA guidelines or create your
own.
Patient monitoring required while on treatment?
Post-marketing surveillance needed to demonstrate safety and effectiveness?
8. Zoom Link to Video Presentation
• Provide Zoom link of group presentation here
Deliverables
1.
Slide Deck (may use template or create own)
• Every member in group must individually submit slide deck into Bb
2.
15-20 minute Video Presentation (record via Zoom).
• Cover slide should have list of all group member names
• Every member in group must have a part in video presentation.
• Add the zoom link to last slide of deck.
3.
Grading
• Organization of Slide Deck (25%)
• Planned and Organized Video Presentation (25%)
• Cohesiveness of Slide Deck and Presentation Between Team Members (25%)
• Participation based on contribution in presentation and 360 Peer Review (25%)
4.
Due 11/3/23 via Bb Assignment Tab
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