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Pharmacy Benefits Management Services. Ophthalmology FAC September 25, 2009. 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. Key Functions of the National PBM Services.

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Pharmacy benefits management services

Pharmacy Benefits Management Services

Ophthalmology FAC

September 25, 2009

Pharmacy Benefits Management Services www.pbm.va.gov


Mission of the va pbm
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


Key functions of the national pbm services
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


Va medsafe
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


Key objectives of the formulary process
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

Pharmacy Benefits Management Services www.pbm.va.gov


Pharmacy benefits management services

PBM-MAP Drug Use Management Process

Identify areas of opportunity

  • Review:

    • RX volume

    • RX expenditures

    • New Drugs

Monitor Performance

Assess feasibility

  • Contract Participation

  • Utilization Management

    • Use of Criteria

  • Review:

    • Medical Literature

    • VA Prescribing

    • Clinical Need

START

Implement action(s)

  • One or more of:

    • Issue Drug Use Criteria

    • Conduct Solicitation

    • Negotiate BPA

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


How the national pbm supports the vanf providers and patients
How the National PBM Supports the VANF, Providers, and Patients

Clinical Document Development

  • New Molecular Entity Drug Monographs (NMEs)

  • Criteria for Use (CFU)

  • Drug Class Reviews

  • Guidance and White Papers

  • Clinical Practice Guidelines

Pharmacy Benefits Management Services www.pbm.va.gov


New molecular entity drug monographs
New Molecular Entity Drug Monographs Patients

  • 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


Criteria for use
Criteria for Use Patients

  • 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


Drug class reviews
Drug Class Reviews Patients

  • 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


Peer review process
Peer Review Process Patients

Pharmacy Benefits Management Services www.pbm.va.gov


Peer review process for documents
Peer Review Process for Documents Patients

NME 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


Peer review process for documents1
Peer Review Process for Documents Patients

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


National pbm supports implementation of formulary change
National PBM Supports Implementation of Formulary Change Patients

  • 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


Keeping up with changes
Keeping up with changes Patients

  • PBM INTRAnet site vaww.pbm.va.gov

  • PBM INTERnet site www.pbm.va.gov

  • PBM-MAP Broadcast Programs

  • PBM-MAP Ez Minutes

Pharmacy Benefits Management Services www.pbm.va.gov


Pharmacy benefits management services

VHAPBH Ask PBM Clinical Patients

AskPBMClinical@va.gov

Pharmacy Benefits Management Services www.pbm.va.gov


Ophthalmology issues
Ophthalmology issues Patients

  • Ophthalmic NSAID

  • Bevacizumab safety

  • Cyclosporine drops

  • Triamcinolone drops

Pharmacy Benefits Management Services www.pbm.va.gov


Ophthalmic nsaids
Ophthalmic NSAIDs Patients

  • 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

Pharmacy Benefits Management www.pbm.va.gov


Ophthalmic nsaids recommendations map and vpe
Ophthalmic NSAIDs PatientsRecommendations (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


Ophthalmic nsaids1
Ophthalmic NSAIDs Patients

  • 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


Ophthalmic nsaids considerations
Ophthalmic NSAIDs-Considerations Patients

  • 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


Bevacizumab and ranibizumab
Bevacizumab and Ranibizumab Patients

  • 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


Objective and methods
Objective and Methods Patients

  • 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


Methods
Methods Patients

  • 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


Results prevalence
Results (prevalence) Patients

Pharmacy Benefits Management Services www.pbm.va.gov


Results incidence
Results- incidence Patients

Pharmacy Benefits Management Services www.pbm.va.gov


Summary
Summary Patients

  • 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


Pending monographs
Pending monographs Patients

  • 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


Recently completed
Recently completed Patients

  • 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