Medication Coverage Policy

MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY Glaucoma P&T DATE: 2/15/2017 THERAPEUTIC CLASS Ophthalmic Disorders REVIEW HISTORY 11/15, 9/12 LOB AFFECTED Medi-Cal, SJHA (MONTH/YEAR) This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the HPSJ Pharmacy and Therapeutic Advisory Committee.

 OVERVIEW Treatment of open-angle glaucoma includes 3 options, alone or in combination: medical treatment, laser therapy, or incisional glaucoma surgery. Pharmacologic options are the most common initial intervention to reduce intraocular pressure and the choice of medication is typically determined by potential cost, side effects, and dosing schedules.1 Primary angle closure glaucoma usually requires surgery and acute management.2 The purpose of this Glaucoma Coverage Policy is to review the coverage criteria of HPSJ’s formulary glaucoma agents (Table 1).

Table 1: Available Glaucoma Medications (Current as of 1/2017) Generic Name (Brand Fml Cost per Available Strengths Notes Name) Limits Rx* BETA-ADRENERGIC BLOCKERS 0.25 % eye drops, suspension - $295.79 Betaxolol Hcl (Betoptic S) 0.5 % eye drops - $43.66 Carteolol Hcl 1 % eye drops - $9.96 Levobunolol Hcl 0.5 % eye drops - $20.99 Metipranolol 0.3 % eye drops - $20.53 Timolol hemihydrate 0.5 % eye drops - $110.46 (Betimol) Timolol Maleate/Pf 0.25 % eye drops in a dropperette - $338.76 (Timoptic Ocudose (Pf)) 0.5 % eye drops in a dropperette - --- Non-Formulary: Alternatives are timolol Istalol: 0.5 % eye drops NF $142.47 maleate, betaxolol, carteolol, levobunolol, metipranol Timolol Maleate (Istalol, 0.25 % eye drops - $2.59 Timoptic) 0.5 % eye drops - $4.40 0.25 % eye gel forming solution - $93.59 0.5 % eye gel forming solution - $106.83 CARBONIC ANHYDRASE INHIBITORS 125 mg tablet - $45.40 Acetazolamide 250 mg tablet - $99.71 500 mg ER capsule - $108.50 Brinzolamide (Azopt) 1 % eye drops, suspension - $255.21 Dorzolamide Hcl 2 % eye drops - $30.45 25 mg tablet - $165.49 Methazolamide 50 mg tablet - $131.00 ALPHA-2 ADRENERGIC AGONISTS 0.1 % eye drops - $134.39 Brimonidine Tartrate 0.15% eye drops - $113.18 (Alphagan P) 0.2% eye drops - $15.66 Apraclonidine Hcl 0.5 % eye drops - $64.34 (Iopidine) 1 % eye drops in a dropperette - --- PROSTAGLANDIN ANALOGUES Bimatoprost (Lumigan) 0.01 % eye drops - $170.37 Latanoprost (Xalatan) 0.005 % eye drops - $ 8.50 Non-Formulary: Alternatives are Tafluprost (Zioptan) 0.0015 % eye drops NF $168.49 Lumigan, Latanoprost Non-Formulary: Alternatives are Travoprost (Travatan Z) 0.004 % eye drops NF $170.98 Lumigan, Latanoprost Travoprost Non-Formulary: Alternatives are 0.004 % eye drops NF $141.38 benzalkonium Lumigan, Latanoprost

Coverage Policy – Ophthalmic Disorders – Glaucoma Page 1

Generic Name (Brand Fml Cost per Available Strengths Notes Name) Limits Rx* CHOLINERGIC AGONISTS/PARASYMPATHOMIMETIC DRUGS Carbachol (Miostat) 0.01 % intraocular solution - --- Echothiophate Iodide 0.125 % eye drops - $87.57 (Phospholine Iodide) 1 % eye drops - $67.45 Pilocarpine Hcl 2 % eye drops - $65.78 4 % eye drops - $76.09 COMBINATION AGENTS Brinzolamide/Brimonidine 1 %-0.2 % eye drops, suspension - $131.35 (Simbrinza) Non-Formulary: Alternative is Dorzolamide Hcl/Timolol 2 %-0.5 % eye drops NF $147.51 dorzolamide/timolol maleate or use as Maleate Pf (Cosopt Pf) separate agents Dorzolamide Hcl/Timolol 2 %-0.5 % eye drops - $46.97 Maleate (Cosopt) Brimonidine Tartrate/Timolol 0.2 %-0.5 % eye drops - $159.61 (Combigan) NF = Non-Formulary Bolded items = Brand name drug cost/utilization *Cost/Rx based on HPSJ utilization historical data from February 2016 through January 2017

 EVALUATION CRITERIA FOR APPROVAL/EXCEPTION CONSIDERATION

Below are the coverage criteria and required information for each agent. These coverage criteria have been reviewed & approved by the HPSJ Pharmacy & Therapeutics (P&T) Advisory Committee. For conditions not covered under this Coverage Policy, HPSJ will make the determination based on Medical Necessity as described in HSPJ Medical Review Guidelines (UM06).

Beta-Adrenergic Blockers Betaxolol Hcl (Betoptic S), Carteolol Hcl, Levobunolol Hcl, Metipranolol, Timolol hemihydrate (Betimol), Timolol Maleate/Pf (Timoptic Ocudose (Pf)), Timolol Maleate (Istalol, Timoptic)

Betaxolol Hcl (Betoptic S), Carteolol Hcl, Levobunolol Hcl, Metipranolol, Timolol hemihydrate (Betimol), Timolol Maleate/Pf (Timoptic Ocudose (Pf)), Timolol Maleate (Timoptic)  Coverage Criteria: None  Limits: None  Required Information for Approval: N/A  Other Notes: None  Non-Formulary: Istalol

Carbonic Anhydrase Inhibitors Acetazolamide, Brinzolamide (Azopt), Dorzolamide Hcl, Methazolamide  Coverage Criteria: None  Limits: None  Required Information for Approval: N/A  Other Notes: None

Alpha-2 Adrenergic Agonists Brimonidine Tartrate (Alphagan P), Apraclonidine Hcl (Iopidine)  Coverage Criteria: None  Limits: None  Required Information for Approval: N/A  Other Notes: None

Coverage Policy – Ophthalmic Disorders – Glaucoma Page 2

Prostaglandin Analogues Bimatoprost (Lumigan), Latanoprost (Xalatan), Tafluprost (Zioptan), Travoprost (Travatan Z), Travoprost benzalkonium

Bimatoprost (Lumigan), Latanoprost (Xalatan)  Coverage Criteria: None  Limits: None  Required Information for Approval: N/A  Other Notes: None  Non-Formulary: Tafluprost (Zioptan), Travoprost (Travatan Z), Travoprost benzalkonium

Cholinergic Agonists/Parasympathomimetic Drugs Carbachol (Miostat), Echothiophate Iodide (Phospholine Iodide), Pilocarpine Hcl  Coverage Criteria: None  Limits: None  Required Information for Approval: N/A  Other Notes: None

Combination Agents Brinzolamide/Brimonidine (Simbrinza), Dorzolamide Hcl/Timolol Maleate (Cosopt Pf), Brimonidine Tartrate/Timolol (Combigan)

Dorzolamide Hcl/Timolol Maleate (Cosopt), Brimonidine Tartrate/Timolol (Combigan), Brinzolamide/Brimonidine (Simbrinza)  Coverage Criteria: None  Limits: None  Required Information for Approval: N/A  Other Notes: None  Non-Formulary: Cosopt Pf  CLINICAL JUSTIFICATION Primary angle-closure glaucoma is treated with iridotomy, using either a thermal or neodymium ytrium-aluminum- garnet (Nd:YAg) laser.1 Acute attacks can be treated with topical beta-blockers; topical alpha2-agonists; topical, oral, or intravenous carbonic anhydrase inhibitors; topical miotics; or oral or intravenous hyperosmotic agents, but medical therapy should be followed by iridotomy as soon as possible.1

Prostaglandin analog and beta-blocker eye drops are most commonly used as initial treatment for open-angle glaucoma. Prostaglandin analogs are the most effective at lowering IOP and are considered initial treatment while other agents may be added on. The American Academy of Ophthalmology recommends weighing effectiveness, side effects, and frequency of dosing when considering pharmacologic therapy because side effects and dosing frequency may affect adherence. If one drug fails, the ophthalmologist can replace the drug or may use combination therapy depending on whether the patient has responded to the first medication (the first medication should not be continued if there is no response in IOP lowering).2 Refractory glaucoma can be treated with laser therapy, surgery, or stents.2

Coverage Policy – Ophthalmic Disorders – Glaucoma Page 3

Table 2: Primary Open-Angle Glaucoma 20151

Coverage Policy – Ophthalmic Disorders – Glaucoma Page 4

 REFERENCES 1. American Academy of Ophthalmology Glaucoma Panel. Preferred Practice Pattern® Guidelines. Primary Angle Closure. San Francisco, CA: American Academy of Ophthalmology; 2015. Available at: https://www.aao.org/preferred-practice- pattern/primary-angle-closure-ppp-2015. 2. American Academy of Ophthalmology Glaucoma Panel. Preferred Practice Pattern® Guidelines. Primary Open-Angle Glaucoma. San Francisco, CA: American Academy of Ophthalmology; 2015 Available at: https://www.aao.org/preferred- practice-pattern/primary-open-angle-glaucoma-ppp-2015.  REVIEW & EDIT HISTORY Document Changes Reference Date P&T Chairman Creation of Policy Formulary Realignment 9-18-12.xlsx 9/12 Jonathan Szkotak, PharmD Update to Policy HPSJ Coverage Policy – Ophthalmic Disorders – 11/15 Johnathan Yeh, PharmD Glaucoma 2015-11.docx Update to Policy HPSJ Coverage Policy – Ophthalmic Disorders – 2/17 Johnathan Yeh, PharmD Glaucoma 2017-02.docx Note: All changes are approved by the HPSJ P&T Committee before incorporation into the utilization policy

Coverage Policy – Ophthalmic Disorders – Glaucoma Page 5