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Ophthalmic Immunomodulators Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1134
This program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10/1/2022 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Cequa™ (cyclosporine) Ophthalmic solution |
Increase tear production in patients with keratoconjunctivitis sicca (dry eye)
|
|
1 |
Verkazia® (cyclosporine) Ophthalmic emulsion |
Treatment of vernal keratoconjunctivitis (VKC) in children and adults
|
|
10 |
Restasis® (cyclosporine)* Ophthalmic emulsion |
Indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. |
* - generic equivalent available |
2 |
Xiidra™ (lifitegrast) Ophthalmic solution |
Treatment of the signs and symptoms of dry eye disease |
|
3 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Dry Eye Disease |
Dry eye disease (also known as dry eye syndrome) is a group of tear film disorders due to reduced tear production or tear film instability, associated with ocular discomfort and/or visual symptoms and inflammatory disease of the ocular surface. The tear film secreting glands and ocular surface function as an integrated system. Disease or dysfunction of this system results in unstable and poorly maintained tear film that causes symptoms of ocular irritation and possible damage to the ocular surface. Dry eye disease may be exacerbated by systemic medications (e.g., diuretics, antihistamines, anticholinergics, systemic retinoids, antidepressants) and rosacea.(4)
Dry eye disease is often associated with Sjogren syndrome, an autoimmune multisystem disorder that most often affects the tear and salivary glands. Tear deficiency may occur in other systemic diseases, such as lymphoma, sarcoidosis, hemochromatosis, and amyloidosis. Dry eye disease may also develop due to systemic viral infections, such as retroviruses, Epstein-Barr virus, and HIV.(4)
The American Academy of Ophthalmology and the Tear Film and Ocular Surface Society (TFOS) categorized dry eye into three severity levels based on symptoms and signs. Because of the nature of the disease, the classifications are imprecise as the characteristics overlap between levels of severity.(2,6,7)
The American Academy of Ophthalmology recommend treating mild dry eye with the following:(4,8)
For treatment of moderate dry eye, the following are recommended in addition to mild dry eye treatment options:(4,8)
For treatment of severe dry eye, the following are recommended in addition to mild and moderate dry eye treatment options:(4,8)
Because of the inconsistent correlation between reported symptoms and clinical signs as well as the relatively poor specificity and/or sensitivity of clinical tests, patients with suggestive symptoms without signs should be placed on trial treatments with artificial tears when other potential causes of ocular irritation have been eliminated. As the severity of the dry eyes increases, aqueous enhancement of the eye using topical agents is appropriate. Emulsions, gels, and ointments can be used. The use of artificial tears may be increased, but the practicality of frequent tear instillation depends on the lifestyle or manual dexterity of the patient. Non-preserved tear substitutes are generally preferable; however, tears with preservatives may be sufficient for patients with mild dry eye and an otherwise healthy ocular surface. When tear substitutes are used frequently and chronically (e.g., more than 4 times a day), non-preserved tears are generally recommended. It is imperative to treat any causative factors that are amenable to treatment.(4)
Anti-inflammatory therapies may be considered in addition to aqueous enhancement therapies. However, since dry eye symptoms tend to wax and wane over long periods of time, the lack of long-term data on the effectiveness of cyclosporine and the costs of longer-term (e.g., annual, lifetime) treatment should be weighed.(4)
Pre-treatment with topical ophthalmic corticosteroids either before or during initiation with a non-glucocorticoid anti-inflammatory agent may provide more rapid improvement in symptoms of dry eye disease and decrease the incidence of severe stinging associated with non-glucocorticoid anti-inflammatory agents.(8) The AAO also notes that topical corticosteroid use for dry eye disease is controversial, but use for induction therapy prior to initiating non-glucocorticoid anti-inflammatory agents as maintenance. Steroids can also be used for acute flare-ups triggered by travel, allergies, respiratory infections, or exposures to environmental irritants with maintenance therapy.(9)
The Sjogren’s Syndrome Foundation’s Clinical Practice Guidelines on Ocular Management in Sjögren’s Patients states the following.(5)
|
Vernal Keratoconjunctivitis |
Vernal keratoconjunctivitis (VKC) is an atopic condition of the external ocular surface. VKC is typically seen in hot, dry climates. Symptoms typically present in early to mid-childhood and typically resolves after puberty. Symptoms may include eye itching, photophobia, tearing, ocular discharge, irritation, redness, and blepharospasm. VKC can be divided into three subcategories based on the presentation of disease, conjunctival, limbal, and mixed presentation. VKC is both an IgE and non-IgE mediated ocular allergic condition.
Treatment follows a step wise approach based on severity of disease.
Topical antihistamines and topical mast cell stabilizers in combination with pulse corticosteroids during an exacerbation is common practice for maintenance of VKC.(11,12)
The American Academy of Ophthalmology Preferred Practice Pattern indicate that topical mast cell stabilizers in combination with topical or oral antihistamines can be used for maintenance. The AAO also recommends topical ophthalmic corticosteroids for acute exacerbations to control severe symptoms and signs. Topical cyclosporine may allow for reduced used of topical steroids.(12) |
Safety(1-3,10) |
Restasis (cyclosporine) is contraindicated in those with hypersensitivity to any of the ingredients in the formulation. Xiidra (lifitegrast) is contraindicated in those with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation. Cequa (cyclosporine) and Verkazia (cyclosporine) do not have any FDA labeled contraindications for use. |
REFERENCES
Number |
Reference |
1 |
Cequa prescribing information. Sun Pharma Global. September 2019. |
2 |
Restasis prescribing information. Allergan, Inc. July 2017. |
3 |
Xiidra prescribing information. Shire US, Inc. June 2020. |
4 |
Dry eye syndrome Preferred Practice Pattern. American Academy of Ophthalmology. October 2018. Available at: https://www.aaojournal.org/article/S0161-6420(18)32650-2/pdf Accessed 3/12/2019. |
5 |
Ocular Management in Sjögren’s Patients. Sjögren’s Syndrome Foundation’s Clinical Practice Guidelines. Available at https://www.sjogrens.org/files/research/OcularCPG.pdf. Accessed 3/12/19 |
6 |
Craig JP et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15(3):276-283. |
7 |
Wolffsohn JS et al. TFOS DEWS II diagnostic methodology report. Ocul Surf. 2017;15(3):539-574. |
8 |
Jones L et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15(3):575-628. |
9 |
Weiner, G. (2016, May 05). Savvy steroid use. Retrieved March 10, 2021, from https://www.aao.org/eyenet/article/savvy-steroid-use |
10 |
Verkazia prescribing information. Santen Inc. June 2021. |
11 |
Kraus, C. L. (2018, January 17). Vernal Keratoconjunctivitis. American Academy of Ophthalmology. https://www.aao.org/disease-review/vernal-keratoconjunctivitis-5. |
12 |
Preferred Practice Pattern: Conjunctivitis. American Academy of Ophthalmology. 2018. Accessed June 2021 at: https://www.aao.org/preferred-practice-pattern/conjunctivitis-ppp-2018 |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Agent Names |
Strength |
Targeted MSC |
Available MSC |
Effective Date |
|
||||
CEQUA*cyclosporine (ophth) soln |
0.09 % |
M ; N ; O ; Y |
N |
|
RESTASIS (cyclosporine (ophth) emulsion ) ; RESTASIS MULTIDOSE (cyclosporine (ophth) emulsion ) |
0.05 % |
M ; N ; O ; Y |
O |
|
RESTASIS*Cyclosporine (Ophth) Emulsion 0.05% |
0.05 % |
M ; N ; O ; Y |
N ; O |
|
VERKAZIA*Cyclosporine (Ophth) Emulsion 0.1% |
0.1 % |
M ; N ; O ; Y |
N |
|
XIIDRA*lifitegrast ophth soln |
5 % |
M ; N ; O ; Y |
N |
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Agent GPI |
Agent Names |
Strength |
QL Amount |
Dose Form |
Days Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
Effective Date |
|
||||||||||
86720020002040 |
CEQUA (cyclosporine (ophth) soln ) |
0.09 % |
60.0 |
VIALS |
30 |
Days |
|
|
|
|
86720020001620 |
RESTASIS (cyclosporine (ophth) emulsion ) |
0.05 % |
60.0 |
VIALS |
30 |
Days |
|
|
00023-9163-30 ; 00023-9163-60 ; 50090-1242-00 |
|
86720020001620 |
RESTASIS (cyclosporine (ophth) emulsion ) ; RESTASIS MULTIDOSE (cyclosporine (ophth) emulsion ) |
0.05 % |
1.0 |
BOTT |
30 |
Days |
|
|
00023-5301-05 ; 50090-4476-00 |
|
86720020001630 |
VERKAZIA*Cyclosporine (Ophth) Emulsion 0.1% |
0.1 % |
120.0 |
VIALS |
30 |
Days |
|
|
|
|
86734050002020 |
XIIDRA (lifitegrast ophth soln ) |
5 % |
60.0 |
VIALS |
30 |
Days |
|
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Agent Names |
Strength |
Client Formulary |
CEQUA*cyclosporine (ophth) soln |
0.09 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
RESTASIS (cyclosporine (ophth) emulsion ) ; RESTASIS MULTIDOSE (cyclosporine (ophth) emulsion ) |
0.05 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
RESTASIS*Cyclosporine (Ophth) Emulsion 0.05% |
0.05 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
VERKAZIA*Cyclosporine (Ophth) Emulsion 0.1% |
0.1 % |
|
XIIDRA*lifitegrast ophth soln |
5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Agent Names |
Strength |
Client Formulary |
CEQUA (cyclosporine (ophth) soln ) |
0.09 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
RESTASIS (cyclosporine (ophth) emulsion ) |
0.05 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
RESTASIS (cyclosporine (ophth) emulsion ) ; RESTASIS MULTIDOSE (cyclosporine (ophth) emulsion ) |
0.05 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
VERKAZIA*Cyclosporine (Ophth) Emulsion 0.1% |
0.1 % |
|
XIIDRA (lifitegrast ophth soln ) |
5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation Restasis (cyclosporine ophthalmic emulsion) will be approved when ALL of the following are met:
Length of Approval: 6 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria
Initial Evaluation Cequa (cyclosporine), Xiidra (lifitegrast) will be approved when ALL of the following are met:
Length of Approval: 3 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria
Initial Evaluation Verkazia (cyclosporine) will be approved when ALL of the following are met:
Length of Approval: 4 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria |
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: Initial approval: Cequa and Xiidra - 3 months, Verkazia - 4 months, Restasis/cyclosporine - 6 months; Renewal approval 12 months |
This program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.
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.
BCBSAL _ PS _ Ophthalmic Immunomodulators Prior Authorization with Quantity Limit _ProgSum_ 10/1/2022 _