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Ophthalmic Prostaglandins Quantity Limit Program Summary
Policy Number: PH-1205
This program applies to Commercial, Blue Partner, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Iyuzeh™ |
Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension |
|
14 |
Lumigan® |
The reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension |
*generic available |
1 |
Travatan Z® |
The reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension |
*generic available |
2 |
Vyzulta® |
The reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension |
|
5 |
Xalatan*®, Latanoprost |
The reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension |
*generic available |
3 |
Xelpros® |
The reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension |
|
4 |
Zioptan® |
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) |
Drops/Bottle and Days of Supply |
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. |
Safety |
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) |
REFERENCES
Number |
Reference |
1 |
Lumigan prescribing information. Allergan, Inc. March 2022. |
2 |
Travatan Z prescribing information. Alcon Laboratories, Inc. May 2020. |
3 |
Xalatan prescribing information. Pfizer Inc/Pharmacia & Upjohn Company. December 2022. |
4 |
Xelpros prescribing information. Sun Pharmaceutical Industries, Inc. June 2022. |
5 |
Vyzulta prescribing information. Bausch & Lomb Incorporated. January 2024. |
6 |
Zioptan prescribing information. Akorn Inc. November 2018. |
7 |
Primary Open-Angle Glaucoma PPP 2020. American Academy of Ophthalmology. Published October 5, 2022. https://www.aao.org/education/preferred-practice-pattern/primary-open-angle-glaucoma-ppp |
8 |
Fiscella RG, Wilensky JT, Chiang TH, Walt JG. Efficiency of instillation methods for prostaglandin medications. Journal of Ocular Pharmacology and Therapeutics. 2006;22(6):477-482. doi:10.1089/jop.2006.22.477 |
9 |
Frenkel REP, Frenkel M, Toler AR. Pharmacoeconomic analysis of prostaglandin and prostamide therapy for patients with glaucoma or ocular hypertension. BMC Ophthalmology. 2007;7(1). doi:10.1186/1471-2415-7-16 |
10 |
Rylander NR, Vold SD. Cost analysis of glaucoma medications. American Journal of Ophthalmology. 2008;145(1):106-113. doi:10.1016/j.ajo.2007.08.041 |
11 |
Queen JH, Feldman RM, Lee DA. Variation in number of doses, bottle volume, and calculated yearly cost of generic and branded Latanoprost for glaucoma. American Journal of Ophthalmology. 2016;163:70-74.e1. doi:10.1016/j.ajo.2015.11.021 |
12 |
Moore DB, Beck J, Kryscio RJ. An objective assessment of the variability in number of drops per bottle of glaucoma medication. BMC Ophthalmology. 2017;17(1). doi:10.1186/s12886-017-0473-8 |
13 |
Primary Open-Angle glaucoma - EyeWiki. Published March 20, 2023. https://eyewiki.aao.org/Primary_Open-Angle_Glaucoma |
14 |
Iyuzeh prescribing information. Thea Pharma Inc. December 2022. |
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Iyuzeh |
latanoprost (pf) ophth soln |
0.005 % |
30 |
Containers |
30 |
DAYS |
|
Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage] |
|
Lumigan |
bimatoprost ophth soln |
0.01 % ; 0.03 % |
2.5 |
mLs |
30 |
DAYS |
|
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 |
DAYS |
|
Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage] |
|
Vyzulta |
latanoprostene bunod ophth soln |
0.024 % |
2.5 |
mLs |
30 |
DAYS |
|
Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage] |
|
Xalatan |
Latanoprost Ophth Soln 0.005% |
0.005 % |
2.5 |
mLs |
30 |
DAYS |
|
Wastage is significant but cannot be avoided [The patient or care provider is not able to properly instill eye drops without excess wastage] |
|
Xelpros |
latanoprost ophth emulsion |
0.005 % |
2.5 |
mLs |
30 |
DAYS |
|
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 |
|
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
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 |
Lumigan |
bimatoprost ophth soln |
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 |
Xalatan |
Latanoprost Ophth Soln 0.005% |
0.005 % |
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 |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months |
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_ 10-01-2024