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Ophthalmic Immunomodulators Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-91134
This program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
04/01/2024 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Cequa® |
Increase tear production in patients with keratoconjunctivitis sicca (dry eye)
|
|
1 |
Restasis® |
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 available |
2 |
Verkazia® |
Treatment of vernal keratoconjunctivitis (VKC) in children and adults
|
|
10 |
Vevye™ |
Treatment of the signs and symptoms of dry eye disease |
|
13 |
Xiidra® |
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 multifactorial disease of the ocular surface with loss of homeostasis of the tear film. It is accompanied by ocular symptoms where tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.(6) 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 |
Dry eye disease (also known as dry eye syndrome) is a multifactorial disease of the ocular surface with loss of homeostasis of the tear film. It is accompanied by ocular symptoms where tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.(6) 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)
|
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.(11,12)
|
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.(11,12)
|
Safety |
Restasis (cyclosporine) is contraindicated in patients with hypersensitivity to any of the ingredients in the formulation.(2) |
Safety |
Restasis (cyclosporine) is contraindicated in patients with hypersensitivity to any of the ingredients in the formulation.(2) |
REFERENCES
Number |
Reference |
1 |
Cequa prescribing information. Sun Pharma Global. December 2022. |
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. https://doi.org/10.1016/j.ophtha.2018.10.023 |
5 |
Ocular Management in Sjögren’s Patients. Sjögren’s Syndrome Foundation’s Clinical Practice Guidelines. https://sjogrens.org/sites/default/files/inline-files/SF_CPG-Ocular_2022_0.pdf |
6 |
Craig, J. P., Nichols, K. K., Akpek, E. K., Caffery, B., Dua, H. S., Joo, C.-K., Liu, Z., Nelson, J. D., Nichols, J. J., Tsubota, K., & Stapleton, F. (2017). TFOS DEWS II definition and classification report. The Ocular Surface, 15(3), 276–283. https://doi.org/10.1016/j.jtos.2017.05.008 |
7 |
Wolffsohn, J. S., Arita, R., Chalmers, R., Djalilian, A., Dogru, M., Dumbleton, K., Gupta, P. K., Karpecki, P., Lazreg, S., Pult, H., Sullivan, B. D., Tomlinson, A., Tong, L., Villani, E., Yoon, K. C., Jones, L., & Craig, J. P. (2017). TFOS DEWS II Diagnostic Methodology Report. The Ocular Surface, 15(3), 539–574. https://doi.org/10.1016/j.jtos.2017.05.001 |
8 |
Jones, L., Downie, L. E., Korb, D., Benitez-del-Castillo, J. M., Dana, R., Deng, S. X., Dong, P. N., Geerling, G., Hida, R. Y., Liu, Y., Seo, K. Y., Tauber, J., Wakamatsu, T. H., Xu, J., Wolffsohn, J. S., & Craig, J. P. (2017). TFOS DEWS II management and therapy report. The Ocular Surface, 15(3), 575–628. https://doi.org/10.1016/j.jtos.2017.05.006 |
9 |
Weiner, G. Savvy steroid use. American Academy of Ophthalmology. (2016, May 5). https://www.aao.org/eyenet/article/savvy-steroid-use |
10 |
Verkazia prescribing information. Santen Inc. June 2022. |
11 |
Kraus, C. L. (2018, January 17). Vernal keratoconjunctivitis. American Academy of Ophthalmology. https://www.aao.org/education/disease-review/vernal-keratoconjunctivitis-5 |
12 |
Varu, D. M., Rhee, M. K., Akpek, E. K., Amescua, G., Farid, M., Garcia-Ferrer, F. J., Lin, A., Musch, D. C., Mah, F. S., & Dunn, S. P. (2018). Conjunctivitis preferred practice pattern®. Ophthalmology, 126(1), 94–169. https://doi.org/https://doi.org/10.1016/j.ophtha.2018.10.020 |
13 |
Vevye prescribing information. Novaliq GmbH. May 2023. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Restasis ; Restasis multidose |
Cyclosporine (Ophth) Emulsion 0.05% |
0.05 % |
M ; N ; O ; Y |
O ; Y |
|
|
Cyclosporine in klarity ; Verkazia |
Cyclosporine (Ophth) Emulsion 0.1% |
0.1 % |
M ; N ; O ; Y |
N |
|
|
Cequa ; Vevye |
cyclosporine (ophth) soln |
0.09 % ; 0.1 % |
M ; N ; O ; Y |
N |
|
|
Xiidra |
lifitegrast ophth soln |
5 % |
M ; N ; O ; Y |
N |
|
|
Restasis ; Restasis multidose |
cyclosporine (ophth) emulsion |
0.05 % |
M ; N ; O ; Y |
O ; Y |
|
|
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 |
|
|||||||||
Cequa |
Cyclosporine (Ophth) Soln 0.09% (PF) |
0.09 % |
60 |
Vials |
30 |
DAYS |
|
|
|
Cyclosporine in klarity ; Verkazia |
Cyclosporine (Ophth) Emulsion 0.1% |
0.1 % |
120 |
Vials |
30 |
DAYS |
|
|
|
Restasis |
cyclosporine (ophth) emulsion |
0.05 % |
60 |
Vials |
30 |
DAYS |
|
|
00023916330 ; 00023916360 ; 00378876058 ; 00378876091 ; 10702080803 ; 10702080806 ; 50090124200 ; 50090447600 ; 60505620201 ; 60505620202 ; 68180021430 ; 68180021460 |
Restasis ; Restasis multidose |
cyclosporine (ophth) emulsion |
0.05 % |
1 |
Bottle |
30 |
DAYS |
|
|
00023530105 ; 50090447600 |
Vevye |
cyclosporine (ophth) soln |
0.1 % |
2 |
mLs |
30 |
DAYS |
|
|
|
Xiidra |
Lifitegrast Ophth Soln 5% |
5 % |
60 |
Vials |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Cequa ; Vevye |
cyclosporine (ophth) soln |
0.09 % ; 0.1 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Cyclosporine in klarity ; Verkazia |
Cyclosporine (Ophth) Emulsion 0.1% |
0.1 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Restasis ; Restasis multidose |
cyclosporine (ophth) emulsion |
0.05 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Restasis ; Restasis multidose |
Cyclosporine (Ophth) Emulsion 0.05% |
0.05 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Xiidra |
lifitegrast ophth soln |
5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Cequa |
Cyclosporine (Ophth) Soln 0.09% (PF) |
0.09 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Cyclosporine in klarity ; Verkazia |
Cyclosporine (Ophth) Emulsion 0.1% |
0.1 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Restasis |
cyclosporine (ophth) emulsion |
0.05 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Restasis ; Restasis multidose |
cyclosporine (ophth) emulsion |
0.05 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Vevye |
cyclosporine (ophth) soln |
0.1 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Xiidra |
Lifitegrast Ophth Soln 5% |
5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
PA |
Initial Evaluation Cequa (cyclosporine), Xiidra (lifitegrast), Vevye (cyclosporine) 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 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 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 |
QL with PA |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: Initial: Cequa, Xiidra, Vevye - 3 months, Restasis/cyclosporine - 6 months, Verkazia - 4 months; Renewal - 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.
ALBP _ Commercial _ PS _ Ophthalmic_Immunomodulators_PAQL _ProgSum_ 04-01-2024 _