Pharmacy Benefits Management Services Pharmacy Benefits Management Services Ophthalmology FAC September 25, 2009

Pharmacy Benefits Management Services www.pbm.va.gov 1

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 Drug benefit design Evidence-based formulary management Utilization management Staff education (CE / CME) Patient safety (VAMedSafe, adverse drug event

(ADE) reporting, post marketing surveillance)


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


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


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


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


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


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


Peer Review Process


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


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


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


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


VHAPBH Ask PBM Clinical

[email protected]

Ophthalmology issues

Ophthalmic NSAID Bevacizumab safety Cyclosporine drops Triamcinolone drops


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).


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


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


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


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


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


Results (prevalence)


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


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.


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


Recently completed

Betaxolol 0.5% solution added to VANF Bevacizumab in AMD CFU update Labeling standard for ophthalmic bottles

currently on national contract
