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ph-1205

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™ (latanoprost) Ophthalmic Solution	Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension		14
Lumigan® (bimatoprost)* Ophthalmic solution	The reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension	*generic available	1
Travatan Z® (travoprost)* Ophthalmic solution	The reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension	*generic available	2
Vyzulta® (latanoprostene bunod) Ophthalmic solution	The reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension		5
Xalatan®, Latanoprost (latanoprost) Ophthalmic solution	The reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension	*generic available	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)
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) Iyuzeh, Lumigan, and Xelpros are contraindicated in patients with a known hypersensitivity to any ingredients in the product.(1,4,14) 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

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: The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication Length of Approval: up to 12 months

Module

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
The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication OR
2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR
3. BOTH of the following:
  1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication

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