Transcript VISN FL Meeting May 18, 2006

Pharmacy Benefits
Management Services
Ophthalmology FAC
September 25, 2009
Pharmacy Benefits Management Services
www.pbm.va.gov
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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
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Key Functions of the National PBM Services
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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
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VA MedSafe
Improve the safety of prescribing practices
and medication administration for veterans
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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
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Key Objectives of the Formulary Process
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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
Pharmacy Benefits Management Services
www.pbm.va.gov
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Identify areas of opportunity
PBM-MAP Drug Use
Management Process
Monitor Performance
•Contract Participation
•Utilization Management
•Use of Criteria
Review:
•RX volume
•RX expenditures
•New Drugs
START
Implement action(s)
•One or more of:
•Issue Drug Use Criteria
•Conduct Solicitation
•Negotiate BPA
Determine action(s)
•Nothing
•One or more of :
•Guideline
•Criteria for Use
•National Contract
•Incentive Agreement
Assess feasibility
Review:
•Medical Literature
•VA Prescribing
•Clinical Need
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
How the National PBM Supports the
VANF, Providers, and Patients
Clinical Document Development
1.
New Molecular Entity Drug Monographs
(NMEs)
2.
Criteria for Use (CFU)
3.
Drug Class Reviews
4.
Guidance and White Papers
5.
Clinical Practice Guidelines
Pharmacy Benefits Management Services
www.pbm.va.gov
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New Molecular Entity Drug Monographs
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Review efficacy, safety, cost, and other data of
NMEs
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“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
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Criteria for Use
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Outline appropriate place in therapy
Use clinical trial results (drug monograph) and expert /
field opinions to determine appropriateness
Consist of
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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
9
Drug Class Reviews
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Are similar to NME monographs
Use evidence-based evaluation to determine
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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
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Peer Review Process
Pharmacy Benefits Management Services
www.pbm.va.gov
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Peer Review Process for Documents
NME Monographs, Drug Class Reviews, and CFU
sent to
 VFLs for dissemination
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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
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Peer Review Process for Documents
Conflict of Interest (COI)
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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
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National PBM Supports Implementation of
Formulary Change
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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
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Keeping up with changes
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PBM INTRAnet site vaww.pbm.va.gov
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PBM INTERnet site www.pbm.va.gov
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PBM-MAP Broadcast Programs
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PBM-MAP Ez Minutes
Pharmacy Benefits Management Services
www.pbm.va.gov
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VHAPBH Ask PBM Clinical
[email protected]
Pharmacy Benefits Management Services
www.pbm.va.gov
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Ophthalmology issues
Ophthalmic NSAID
 Bevacizumab safety
 Cyclosporine drops
 Triamcinolone drops
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Pharmacy Benefits Management Services
www.pbm.va.gov
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Ophthalmic NSAIDs
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Overall, no substantive differences in efficacy or safety
between products. (Review Posted)
Current Formulary Agents
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diclofenac, flurbiprofen, ketorolac
Most frequently used in VA: Ketorolac
Dosing differences (generally 14 days post-op)
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Diclofenac, ketorolac, flurbiprofen-QID
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Acuvail (ketorolac 0.45% PF), BID dosing, FDA approved postcataract (expected availability 9-09)
Ketorolac 0.4 and 0.5% patent expiration 11-09
Nepafenac-TID
Bromfenac-BID
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Xibrom QD-once daily product expecting FDA approval late 2009
Bromfenac’s patent expired 1-09
Pharmacy Benefits Management
www.pbm.va.gov
18
Ophthalmic NSAIDs
Recommendations (MAP and VPE)
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VPE
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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
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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
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Ophthalmology FAC
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Less frequent dosing is a significant advantage
since patients are using other drops as well.
Pricing (see attachment for new pricing)
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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
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Generic availability of ketorolac and bromfenac?
Significant price increase for bromfenac
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Nepafenac
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TID, lost VA pricing
New Products:
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Less data than ketorolac, diclofenac overall
Short-term use
Other drops may be QID as well
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
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Bevacizumab and Ranibizumab
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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
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Objective and Methods
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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
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Methods
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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
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Results (prevalence)
Drug
Patients
with VED
Endophth
almitis
Rate/1000
95% CI
Bev
3249
20
6.16
4.0-9.5
Ran
2466
16
6.49
4.0-10.6
Pharmacy Benefits Management Services
www.pbm.va.gov
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Results- incidence
Drug
Patients with Endophthalm
VED
itis
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
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Summary
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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
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Pending monographs
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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
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Recently completed
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Betaxolol 0.5% solution added to VANF
Bevacizumab in AMD CFU update
Labeling standard for ophthalmic bottles
currently on national contract
Pharmacy Benefits Management Services
www.pbm.va.gov
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