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Effective Date
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Date of Origin
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1/1/2024
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FDA APPROVED INDICATIONS AND DOSAGE
|
Agent(s)
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FDA Indication(s)
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Notes
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Ref#
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IYUZEH™
(latanoprost)
Ophthalmic Solution
|
Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
|
|
14
|
|
Lumigan®
(bimatoprost)*
Ophthalmic solution
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The reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
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*generic available
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1
|
|
Travatan Z®
(travoprost)*
Ophthalmic solution
|
The reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
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*generic available
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2
|
|
Vyzulta®
(latanoprostene bunod)
Ophthalmic solution
|
The reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
|
|
5
|
|
Xalatan®, Latanoprost*
Ophthalmic solution
|
The reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
|
*generic available
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3
|
|
Xelpros®
(latanoprost)
Ophthalmic emulsion
|
The reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
|
|
4
|
|
Zioptan®
(tafluprost)*
Ophthalmic solution
|
The reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
|
*generic available
|
6
|
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
|
Open Angle Glaucoma
|
Glaucoma describes a group of conditions in which there is characteristic cupping of the optic disc with corresponding visual field defects, due to retinal ganglion cell loss. It is a progressive condition and is the most common cause of irreversible blindness worldwide. Primary open angle glaucoma (POAG) is a subset of the glaucomas defined by an open, normal appearing anterior chamber angle and raised intraocular pressure (IOP), with no other underlying disease. IOP is considered the most important risk factor for the progression to POAG from ocular hypertension (OHT) and remains the only known modifiable risk factor.(13) Visual loss from glaucoma is irreversible, and therefore early diagnosis and treatment is a key strategy to preventing morbidity from this condition.(7,13)
The American Academy of Ophthalmology (AAO) guidelines for open angle glaucoma indicate that medical therapy is presently the most common initial intervention to lower intraocular pressure (IOP). There are many drugs available for initial therapy and medication choice may be influenced by potential cost, side effects, dosing schedules, and degree of pressure lowering needed. If target IOP is not achieved by one medication, then either switching or adding medications should be considered depending on whether the individual patient has responded to the first medication. The first medication should not be continued in the regimen if there is no response to lowering IOP.(7)
Prostaglandin analogs are the most frequently prescribed eye drops for lowering IOP in patients with glaucoma because they are most efficacious, well tolerated, and instilled only once daily. Other glaucoma agents include topical beta-blockers, topical alpha-2 adrenergic agonists, topical parasympathomimetics, topical rho-kinase inhibitors, and topical and oral carbonic anhydrase inhibitors. Guidelines recommend prostaglandin analogs as first-line therapy, but do not recommend one medication over another.(7)
The AAO guidelines note that adequate treatment of glaucoma requires a high level of adherence to therapy to achieve goal IOP. The guidelines also note that patients have relatively poor adherence (nearly 45% of patients in one study administered less than 75% of prescribed doses). Dosing frequency, difficulty in administration, comorbidities, cost, and patients running out of medication prior to being able to refill their prescription are the leading causes of poor adherence.(7)
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Drops/Bottle and Days of Supply
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The drop size dispensed is dependent on a number of factors for these ophthalmic solutions which include the viscosity, surface tension, design of the dropper tip, the angle the bottle is held when the drop is dispensed, and the manufacturer. A number of studies have been completed evaluating the number of drops per bottle for the prostaglandin analogs. These studies have determined that overfilling the bottles is a common occurrence for the prostaglandin analogs with an average of roughly 30 drops/mL for each 2.5 mL bottle.(8-12) With the average of 30 drops/mL, a 2.5 mL bottle should last 37.5 days if patients are treating both eyes.
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Safety
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The combined use of two or more prostaglandins or prostaglandin analogs is not recommended. It has been shown that administration of these prostaglandin agents more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP.(3,4)
Iyuzeh and Xelpros are contraindicated in patients with a known hypersensitivity to latanoprost or any other ingredients in the product.(4,14)
Lumigan is contraindicated in patients with a hypersensitivity to bimatoprost or to any of the ingredients.(1)
Xalatan is contraindicated in patients with a known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in the product.(3)
Travatan Z, Vyzulta, and Zioptan have no FDA labeled contraindications for use.(2,5,6)
|
REFERENCES
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Number
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Reference
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|
1
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Lumigan prescribing information. Allergan, Inc. March 2022.
|
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2
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Travatan Z prescribing information. Alcon Laboratories, Inc. May 2020.
|
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3
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Xalatan prescribing information. Pfizer Inc/Pharmacia & Upjohn Company. December 2022.
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4
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Xelpros prescribing information. Sun Pharmaceutical Industries, Inc. February 2021.
|
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5
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Vyzulta prescribing information. Bausch & Lomb Incorporated. May 2019.
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6
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Zioptan prescribing information. Akorn Inc. November 2018.
|
|
7
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Primary open-angle glaucoma Preferred Practice Pattern 2020. American Academy of Ophthalmology. https://www.aao.org/education/preferred-practice-pattern/primary-open-angle-glaucoma-ppp
|
|
8
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Fiscella, R., Wilensky, J. T., Chiang, T. H., & Walt, J. G. (2006). Efficiency of instillation methods for prostaglandin medications. Journal of Ocular Pharmacology and Therapeutics, 22(6), 477–482. https://doi.org/http://doi.org/10.1089/jop.2006.22.477
|
|
9
|
Frenkel, R. E. P., Frenkel, M., & Toler, A. (2007). Pharmacoeconomic analysis of prostaglandin and prostamide therapy for patients with glaucoma or ocular hypertension. BMC Ophthalmology, 7(1). https://doi.org/https://doi.org/10.1186/1471-2415-7-16
|
|
10
|
Rylander, N. R., & Vold, S. D. (2008). Cost analysis of glaucoma medications. American Journal of Ophthalmology, 145(1), 106–113. https://doi.org/10.1016/j.ajo.2007.08.041
|
|
11
|
Queen, J. H., Feldman, R. M., & Lee, D. A. (2016). Variation in number of doses, bottle volume, and calculated yearly cost of generic and branded latanoprost for glaucoma. American Journal of Ophthalmology, 163, 70–74. https://doi.org/10.1016/j.ajo.2015.11.021
|
|
12
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Moore, D. B., Beck, J., & Kryscio, R. J. (2017). An objective assessment of the variability in number of drops per bottle of glaucoma medication. BMC Ophthalmology, 17(1). https://doi.org/10.1186/s12886-017-0473-8
|
|
13
|
Jindal, A. P., Salim, S., Kozak, A., Aref, A. A., Akkara, J. D., Khawaja MA(Cantab), A., & Sheybani, A. (2021, December 20). Primary open-angle glaucoma. EyeWiki. https://eyewiki.aao.org/Primary_Open-Angle_Glaucoma
|
|
14
|
Iyuzeh prescribing information. Thea Pharma Inc. December 2022.
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POLICY AGENT SUMMARY QUANTITY LIMIT
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Target Brand Agent Name(s)
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Target Generic Agent Name(s)
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Strength
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QL Amount
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Dose Form
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Day Supply
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Duration
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Addtl QL Info
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Allowed Exceptions
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Targeted NDCs When Exclusions Exist
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|
|
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Iyuzeh
|
latanoprost (pf) ophth soln
|
0.005 %
|
30
|
Containers
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30
|
DAYS
|
|
"No dose optimization 1. Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage]"
|
|
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Iyuzeh ; Xalatan
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latanoprost (pf) ophth soln ; latanoprost ophth soln
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0.005 %
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2.5
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mLs
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30
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DAYS
|
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"No dose optimization
1. Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage]"
|
|
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Lumigan
|
bimatoprost ophth soln
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0.01 % ; 0.03 %
|
2.5
|
mLs
|
30
|
DAYS
|
|
"No dose optimization
1. Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage]"
|
|
|
Travatan z
|
travoprost ophth soln
|
0.004 %
|
2.5
|
mLs
|
30
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DAYS
|
|
"No dose optimization
1. Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage]"
|
|
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Vyzulta
|
latanoprostene bunod ophth soln
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0.024 %
|
2.5
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mLs
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30
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DAYS
|
|
"No dose optimization
1. Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage]"
|
|
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Xelpros
|
latanoprost ophth emulsion
|
0.005 %
|
2.5
|
mLs
|
30
|
DAYS
|
|
"No dose optimization
1. Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage]"
|
|
|
Zioptan
|
Tafluprost Preservative Free (PF) Ophth Soln 0.0015%
|
0.015 MG/ML
|
30
|
Containers
|
30
|
DAYS
|
|
"No dose optimization
1. Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage]"
|
|
CLIENT SUMMARY – QUANTITY LIMITS
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Target Brand Agent Name(s)
|
Target Generic Agent Name(s)
|
Strength
|
Client Formulary
|
|
Iyuzeh
|
latanoprost (pf) ophth soln
|
0.005 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Iyuzeh ; Xalatan
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latanoprost (pf) ophth soln ; latanoprost ophth soln
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0.005 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Lumigan
|
bimatoprost ophth soln
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0.01 % ; 0.03 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Travatan z
|
travoprost ophth soln
|
0.004 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Vyzulta
|
latanoprostene bunod ophth soln
|
0.024 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Xelpros
|
latanoprost ophth emulsion
|
0.005 %
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
|
|
Zioptan
|
Tafluprost Preservative Free (PF) Ophth Soln 0.0015%
|
0.015 MG/ML
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Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
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QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
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Module
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Clinical Criteria for Approval
|
|
|
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
- The requested quantity (dose) does NOT exceed the program quantity limit OR
- Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage] OR
- The requested quantity (dose) is greater than the program quantity limit AND BOTH of the following:
- The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
- Information has been provided to support therapy with a higher dose for the requested indication
Length of Approval: up to 12 months
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This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Ophthalmic Prostaglandins _QL _ProgSum_ 1/1/2024
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