OPHTHALMOLOGY FIELD ADVISORY COMMITTEE MEETING Virtual Teleconference October 20, :00 PM 3:00 PM EST

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1 OPHTHALMOLOGY FIELD ADVISORY COMMITTEE MEETING Virtual Teleconference October 20, :00 PM 3:00 PM EST Reference/Issue 1:00 Pharmacy EST Dr. Linda Margulies Discussion Guests: Deb Khachikian, PharmD, Kelly Echevarria, PharmD, Pharmacy Benefits Management (PBM) representatives Restasis 1) Patents transferred to the Saint Regis Mohawk tribe to circumvent a patent challenge from generic drug makers. 2) 78,446 prescriptions written for VA patients over last 12 months 3) Court recently invalidated Restasis patents Mohawk-Tribe-Deal-As-Court-Invalidates-Restasis-Patents Intracameral antibiotics at the time of surgery 1) Conference call 8/18/17 with Kelly Echevarria PharmD PBM Program Manager 2) Discussion at Ophthalmology Field Advisory Committiee meeting 10/20/17 a. Discussed the use of intracameral antibiotics and the indications a. Vigamox brand (moxifloxacin) undiluted is directly injected inside the eye at the conclusion of eye surgery b. Vigamox intracameral is commonly used at the VA and in the private sector (Kaiser Permanente has an SOP (J Cataract Refract Surg. 2013; 39: ). Northern California NCHCS and Houston VA and developed SOPs c. Generic moxifloxacin now available for use instead of brand Vigamox d. Local VA pharmacy sites are requesting or mandating ophthalmologists to use the generic drug e. Concerns raised by ophthalmology if the generic moxifloxacin is safe to use intracamerally and requested information and guidance from PBM. f. Ophthalmology discussed generic drugs do not always have the same efficacy and safety profile as brand drugs and mentioned examples. g. One site (Boston) is purchasing Cefuroxxime from local compounding pharmacy for intracameral injections at a low cost. h. Pharmacy discussed safety concerns with compounded medications. Ie. outbreak of meningitis with compounded products was harmful. Hundreds affected with several deaths. i. VA issued guidance in 2014: Veterans Health Administration (VHA) Pharmacy Benefits Management Services (PBM) Guidance for Compounded Sterile Products (CSPs) j. Some data from Europe suggests resistance to vigamox is on the rise 1

2 a. PBM representatives Deb Khachikian, PharmD and Kelly Echevarria, PharmD will investigate further generic versus brand moxifloxacin for safety and efficacy. b. FAC members requested specific written guidelines to the field from PBM c. Interim conference call occurred on October 27, with ophthalmology FAC members and PBM representatives to further discuss safety of using generic moxifloxacin. d. The Interim conference call discussed the following: PBM representatives have contacted Sandoz and determined that moxifloxacin is an Authorized Generic meaning it is produced by Alcon and is the exact same product as the Alcon brand vigamox but marketed under a different label. PBM representatives have requested this information in writing from Sandoz. Ophthalmology requested a delay on mandating the use of generic moxifloxacin at local sites until the ophthalmology concerns are resolved and requested PBM communicate this to the field. PBM will have their VISNs Pharmacy Call on Nov 13 and will discuss the above. A recent TASS outbreak occurred at a VA and Amy Chomsky and the Surgical Advisory Board will investigate further to see if any relationship to intracameral generic vigamox. Links to information on Authorized Generics included newdrugapplicationandagenerics/ucm htm Anti VEGF use in the VA: 1) Some providers wish to use different lot numbers of Anti-VEGF medications when bilateral injections are done 2) Ophthalmologists are unable to obtain different lot numbers from local VA Pharmacy and from vendors. 3) VA Evidence-based Synthesis Program: Comparative Clinical and Economic Effectiveness of Anti-VEGF Agents completed: Results were a. No clear, consistent, clinically meaningful differences between anti-vegf drugs were found for most effectiveness and harms outcomes. b. Aflibercept may provide a greater visual acuity benefit than the other agents among patients with low baseline visual acuity over the short-term, but the longer-term findings are unclear and more trials assessing the effects of aflibercept are needed. c. Compounded bevacizumab treatment is likely to be the most cost-effective of the 3 drugs. d. In choosing amongst these drugs, clinicians may also need to consider factors such as patient preference, 2

3 individual treatment response, convenience, and distance to facility. 4) No new update regarding guidance from FDA for aliquoted Avastin (FDA USP 797, Compounding Pharmacies). FDA document is still in draft form, but latest 2017 draft changed duration of time for aliquoted Avastin to 8 hours post puncture. 5) Currently, due to FDA draft guidelines, the VA policy remains at one vial of avastin is used per patient. a. PBM representatives Debbie Khachikian, PharmD will research the issue of obtaining different lot numbers of Anti-VEGF medications for bilateral injections b. PBM will continue to monitor FDA draft guidelines for avastin use. Omidria 1) Alternative is intracameral PF epinephrine a. Recent Shortage of epinephrine -- b. Potential for mix up with epinephrine (re: Par Pharmaceutical adding tartaric acid to formulation) c. VA now has epinephrine (NDC # ) product that can be used in intraocular surgeries. 2) Alternative is pupil expansion ring 3) Increasing use of toric IOLs --- need for continued dilation late into surgical procedure 4) Alpha agonist use in Veteran population may be higher than community 5) Recent articles (2016 & 2017) since PBM review show need for malyugan rings decreased 8% to 3% with Omidria. Though new data showed low level evidence retrospective chart reviews and omidria administered by unapproved method of intracameral injection instead of irrigation a. J Cataract Refract Surg 2017; 43: b. Patient Preference and Adherence 2016: c. Clinical Ophthalmology 2017: a. PBM awaiting several other retrospective studies with manuscripts in preparation b. PBM planning to re-review Omidria in 2018 for possible formulary addition once manuscripts available Lifitegrast 5.0% Ophthalmic Solution (XIIDRA) 1) New medication for dry eye disease 2) PBM completed monograph review. 3) High cost $320/month 3

4 a. Lifitegrast was not added to VA formulary and is available as NFDR Avenova 1) Is a non detergent base spray product for eyelid and lash hygiene that removes microorganisms and debris for dry eyes and blepharitis 2) Patients are requesting this item at the VA via their private or VCP ophthalmologist a. PBM representative Debbie Khachikian, PharmD will research this item further to see what information is available and if a drug monograph should be done Ozurdex Implant 1) Has been added to national VA formulary in 2017 with prior authorization criteria that was agreed upon by the ophthalmology Field Advisory Group. a. Ophthalmologists may need to check with their local pharmacy sites, if Ozurdex does not appear on their local formulary menu. Quick orders may be established at local sites to make ordering easier and to meet the criteria for use. Olopatadine 0.7% (Pazeo) 1) Added to the national VA formulary in day expiration of multi-use dilating eyedrops 1) Request from Wiley Chambers to PBM: This is a request to amend VHA Directive by deleting section 15.b.9. The request is being made to remove a potential safety hazard to patients. Section 15.b.9. currently reads Use of multi-dose products stored in ward stock centralized areas and outpatient surgical and procedure clinics must be labeled with an expiration date upon opening or entering the multi-dose product (e.g., to include but not limited to parenterals, insulin, ophthalmic drops) that does not exceed 28 days; or a shorter expiration date when recommended by the manufacturer. 2) Response from Puri Subramaniam: The that the current VHA Directive is based on concurrence by Ophthalmology on the 28 day limitation any request for a change would need to come from [FAC] since [FAC] agreed to the current policy. 3) Wiley maintains that USP <797> does not apply to the use of approved ophthalmic drug products used as labeled 4

5 Puri Subramaniam Pharmd D is the USP expert and any changes would need to be initiated through the clinical group. a. Additional discussion occurred at the follow up interim meeting on October 27, 2017 with PBM representatives and Ophthalmology. Joint Commission Standards, reference material, and VA policy were reviewed. b. Members agreed that the 28 day expiration of multii-use dilating drops made sense for patient safety and would not request a change to the policy at this time. JAMA Ophthalmol. 2014;132(12): doi: /jamaophthalmol Handling post-op meds 1) No consistent practice. Some solutions in the field: a. Patient picks up post-op meds on POD 1 at the Pharmacy b. Order sets created for cataract surgery. Antibiotics and steroids sent to OR from Pharmacy for each patient. Dispensed immediately at surgery and placed in Eye Kit for patients to take home. c. Pre/post op drops mailed to patients prior to surgery. Patient brings drops on the day of surgery. The RN uses the antibiotic, but uses dilation drops from their pixis med unit. The RN then returns the antibiotics back to the Vet to use post op. a. PBM is not involved in how facilities handle posts op medications and this would need to be addressed at the local sites. Compounding Pharmacies 1) Leiter s will have both a 503A and a 503B pharmacy as part of their organization. 2) VA given the green light to use Burderer for EDTA per a representative from the National compounding group as long as we verify that they are not doing batch compounding and that we have their recipe for making this product. Lidocaine Gel 1) Dermatology products such as Akorn s lidocaine 2% jelly, while required to have a low bioburden, are not required to be sterile. This product is not approved for ophthalmic use 2) Akten (lidocaine hydrochloride ophthalmic gel) 3.5% is sterile and approved for ocular surface anesthesia during ophthalmic procedures. 5

6 Miscellaneous Items 1) Discussion occurred as to the PBM process and mechanisms for Ophthalmology FAC members to be involved with reviewing monographs and PBM decisions. 2) Sandoz Prednisolone --- reports from field that less effective than brand prednisolone inadvertent inflammation 3) Zirgan use restriction dropped. Had been restricted as second line therapy to Ophthalmology. 4) Difluprednate (Durezol) criteria for use changed. No longer restricted to Ophthalmology for recalcitrant inflammation. PBM Web Site Links 1) To view the ophthalmic formulary according to drug class, use this link and search for Ophthalmology with OP. Spreadsheets)/VA%20National%20Formulary-by%20class-July%202016(2).xls 2) For monographs or criteria for nonformulary drugs through the formulary drug listing., go to clinical guidance tab on the SharePoint site then select the Drug Monographs or Criteria for Use tabs. Drugs are listed alphabetically. 6