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Pharmacy Benefits Management Services www.pbm.va.gov 1
Pharmacy Benefits Management Services
Ophthalmology FAC
September 25, 2009
Pharmacy Benefits Management Services www.pbm.va.gov 2
Mission of the VA PBM
To improve the health status of veterans by encouraging the appropriate use of medications in a comprehensive medical care setting.
Pharmacy Benefits Management Services www.pbm.va.gov 3
Key Functions of the National PBM Services Drug benefit design Evidence-based formulary management Utilization management Staff education (CE / CME) Patient safety (VAMedSafe, adverse drug event
(ADE) reporting, post marketing surveillance)
Pharmacy Benefits Management Services www.pbm.va.gov 4
VA MedSafe
Improve the safety of prescribing practices and medication administration for veterans Identify and track ADEs Address preventable ADEs Evaluate interventions Educate and communicate Promote medication safety research in VA
Pharmacy Benefits Management Services www.pbm.va.gov 5
Key Objectives of the Formulary Process Promote formulary decisions that are evidenced-based,
not preference-based Promote appropriate drug therapy and discourage
inappropriate drug therapy Reduce the geographic variability in utilization of
pharmaceuticals across the VA Promote portability and uniformity of the drug benefit Initiate patient safety of the drug benefit Design and implement relevant outcomes assessment
projects
Review:•RX volume•RX expenditures•New Drugs
Identify areas of opportunity
Review:•Medical Literature•VA Prescribing•Clinical Need
Assess feasibility
Present issue to stakeholders
•Medical Advisory Panel (MAP)•VISN Formulary Leaders (VFLs)
•Get input from front line clinical staff
•Chief Clinical Consultants•DoD
•Pharmacoeconomic Center•P & T Committee
Determine action(s)
•Nothing•One or more of :
•Guideline•Criteria for Use•National Contract•Incentive Agreement
Implement action(s)
•One or more of:•Issue Drug Use Criteria•Conduct Solicitation•Negotiate BPA
Monitor Performance
•Contract Participation•Utilization Management
•Use of Criteria
PBM-MAP Drug Use Management Process
START
Pharmacy Benefits Management Services www.pbm.va.gov 7
How the National PBM Supports the VANF, Providers, and Patients
Clinical Document Development1. New Molecular Entity Drug Monographs
(NMEs)2. Criteria for Use (CFU)3. Drug Class Reviews4. Guidance and White Papers5. Clinical Practice Guidelines
Pharmacy Benefits Management Services www.pbm.va.gov 8
New Molecular Entity Drug Monographs Review efficacy, safety, cost, and other data of
NMEs “A medication containing an active substance that has never
before been approved for marketing in any form in the United States”
Includes drug and biologic products
Involve an extensive literature review and evidence-based medicine approach
Assess the evidence and clinical significance Recommend place in therapy Support criteria for use decisions
Pharmacy Benefits Management Services www.pbm.va.gov 9
Criteria for Use Outline appropriate place in therapy Use clinical trial results (drug monograph) and expert /
field opinions to determine appropriateness Consist of
Inclusion and exclusion criteria checklists Renewal or discontinuation criteria checklist Dosing, monitoring, and special considerations
Discourage inappropriate use Encourage safe and cost-effective use Aim to provide uniform pharmacy benefit
Pharmacy Benefits Management Services www.pbm.va.gov 10
Drug Class Reviews
Are similar to NME monographs Use evidence-based evaluation to determine
Therapeutic interchangeability Eligibility for competitive solicitation
Compare data for efficacy, safety, tolerability, monitoring, drug interactions, drug administration, cost, and other pharmaceutical issues
Pharmacy Benefits Management Services www.pbm.va.gov 12
Peer Review Process for DocumentsNME Monographs, Drug Class Reviews, and CFU
sent to VFLs for dissemination
VISN and local P&T Committees Pharmacy Chiefs Chief Medical Officers Local subject matter experts
Field Advisory Committees (FACs) or Technical Advisory Groups (TAGs)
VHA Chief Consultants
Pharmacy Benefits Management Services www.pbm.va.gov 13
Peer Review Process for Documents
Conflict of Interest (COI) Required with comments on Drug Class Reviews for
national contracting Requested of field reviewers on CFU documents
Pharmacy Benefits Management Services www.pbm.va.gov 14
National PBM Supports Implementation of Formulary
Change Announcement of National Formulary changes in
PBM-MAP Ez Minutes Letters to prescribers and patients Addition of drug-drug interactions to the NDF ADE reporting and monitoring
Pharmacy Benefits Management Services www.pbm.va.gov 15
Keeping up with changes
PBM INTRAnet site vaww.pbm.va.gov
PBM INTERnet site www.pbm.va.gov
PBM-MAP Broadcast Programs
PBM-MAP Ez Minutes
Ophthalmology issues
Ophthalmic NSAID Bevacizumab safety Cyclosporine drops Triamcinolone drops
Pharmacy Benefits Management Services www.pbm.va.gov 17
Pharmacy Benefits Management www.pbm.va.gov 18
Ophthalmic NSAIDs Overall, no substantive differences in efficacy or safety between
products. (Review Posted) Current Formulary Agents
diclofenac, flurbiprofen, ketorolac
Most frequently used in VA: Ketorolac Dosing differences (generally 14 days post-op)
Diclofenac, ketorolac, flurbiprofen-QID Acuvail (ketorolac 0.45% PF), BID dosing, FDA approved post-cataract (expected
availability 9-09) Ketorolac 0.4 and 0.5% patent expiration 11-09
Nepafenac-TID Bromfenac-BID
Xibrom QD-once daily product expecting FDA approval late 2009 Bromfenac’s patent expired 1-09
Ophthalmic NSAIDsRecommendations (MAP and
VPE) VPE No changes to the VANF at this time Ask Ophthalmology FAC if they have a preference between ketorolac,
bromfenac or nepafenac PBM to seek TPR or BPA from manufacturers Once the pricing and preferences between the 3 agents are known, the
VPE/MAP can determine which “third ophthalmic NSAID” would be preferred NF or added to the VANF.
MAP Keep the current formulary ophthalmic NSAIDs and add bromfenac to
the VANF due to the less frequent dosing and cost advantage (cost was ~$23)
The MAP also agreed with the VPEs for the PBM to solicit reduced pricing for all branded products (ketorolac, bromfenac and nepafenac).
Pharmacy Benefits Management www.pbm.va.gov 19
Ophthalmic NSAIDs Ophthalmology FAC
Less frequent dosing is a significant advantage since patients are using other drops as well.
Pricing (see attachment for new pricing) Inadequate time for PBM to seek TPR or BPA
from all branded manufacturers Price of bromfenac increased >100% Lost VA price for nepafenac
Pharmacy Benefits Management www.pbm.va.gov 20
Ophthalmic NSAIDs-Considerations Generic availability of ketorolac and bromfenac?
Significant price increase for bromfenac Less data than ketorolac, diclofenac overall Short-term use Other drops may be QID as well
Nepafenac TID, lost VA pricing
New Products: Acuvail (ketorolac 0.45% PF): BID dosing, expected availability
9-09 Xibrom QD: QD dosing, expected approval late 2009
Refer to attachment for updated pricing, use and purchases from FY2Q09 and FY3Q09
Pharmacy Benefits Management www.pbm.va.gov 21
Bevacizumab and Ranibizumab Rapid cycle analysis using integrated
databases to assess potential endophthalmitis for patients administered an intravitreal injections of bevacizumab and ranibizumab was conducted
Pharmacy Benefits Management Services www.pbm.va.gov 22
Objective and Methods
Objective: To determine the prevalence and crude incidence rate of endophthalmitis following bevacizumab or ranibizumab intravitreal injections
Datasets: Rx data: from April 2006 to 1Qtr 09 was used. All
patients with Rx for bevacizumab and ranibizumab were extracted
Dx Data: patients with an ICD-9 code for endophthalmitis (4/06-9/08) were identified from the AAC
Pharmacy Benefits Management Services www.pbm.va.gov 23
Methods
Prevalence rate was determined for endohpthalmitis for bevacizumab and ranibizumab. A retrospective new-user, follow-up design was used to determine the crude incidence rate for endopthalmitis for both agents with calculated 95% CI. Events were validated and the verified numbers were used to calculate the crude incidence rate
Pharmacy Benefits Management Services www.pbm.va.gov 24
Results (prevalence)
Pharmacy Benefits Management Services www.pbm.va.gov 25
Drug Patients with VED
Endophthalmitis
Rate/1000 95% CI
Bev 3249 20 6.16 4.0-9.5
Ran 2466 16 6.49 4.0-10.6
Results- incidence
Drug Patients with VED
Endophthalmitis
Rate/1000 95% CI
Bev 2126 7 2.24 1.1-4.7
ran 2362 4 1.69 0.6-4.5
Pharmacy Benefits Management Services www.pbm.va.gov 26
Summary
Early bevacizumab and ranibizumab signal showed slight increased rates of endophthalmitis. Further validation and detailed confirmation decreased rate to less than 1 per 1000 patients ( Bev =0.96, Ran=0.43
Spike in site cases secondary to other issues potentially associated with drug administration.
Pharmacy Benefits Management Services www.pbm.va.gov 27
Pending monographs
Cyclosporine ophthalmic Preservative free triamcinolone ophthalmic Artificial tears- nomenclature CFU for DRVO (retinal vein occlusion) DME (macular
edema) Difluprednate Lidocaine ointment Update pegaptanib monograph Update ranibizumab monograph
Pharmacy Benefits Management Services www.pbm.va.gov 28