Ophthalmic Immunomodulators Prior Authorization with Quantity Limit Program Summary

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1 Ophthalmic Immunomodulators Prior Authorization with Quantity Limit Program Summary FDA APPROVED INDICATIONS DOSAGE 1,4 Agent Indication Dosage and Administration Restasis (cyclosporine ophthalmic emulsion) Xiidra (lifitegrast ophthalmic solution) 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. Treatment of the signs and symptoms of dry eye disease. Choice_PS_Ophthalmic_Immunomodulators_PAQL_ProgSum_AR0716_r0117 Page 1 of 6 Instill one drop of ophthalmic emulsion twice a day in each eye approximately 12 hours apart One drop twice daily in each eye (approximately 12 hours apart). CLINICAL RATIONALE Dry eye syndrome is a group of disorders of the tear film that are due to reduced tear production or excess tear evaporation, associated with ocular discomfort and/or visual symptoms and possible disease of the ocular surface. While the symptoms of dry eye syndrome often improve with treatment, the disease usually is not curable. 2 The ocular surface and tear-secreting glands function as an integrated unit. Disease or dysfunction of this functional unit results in an unstable and poorly maintained tear film that causes ocular irritation symptoms and possible damage to the ocular surface epithelium. Dysfunction of this integrated unit may develop from aging, a decrease in supportive factors (such as androgen hormones), systemic inflammatory disease (such as Sjögren s Syndrome or rheumatoid arthritis), ocular surface diseases or surgeries that disrupt the trigeminal afferent sensory nerves, and systemic diseases or medication that disrupt the efferent cholinergic nerves that stimulate tear secretion. Decreased tear secretion and clearance initiates an inflammatory response on the ocular surface that involves both soluble and cellular mediators. Clinical and basic research suggests that this inflammation plays a role in the pathogenesis of dry eye. 2 When there is an associated systemic disease such as Sjögren s Syndrome, an inflammatory cellular infiltration of the exocrine glands (including lacrimal gland) leads to saliva and tear production deficiency. About 10% of patients with clinically significant aqueous deficient dry eye have an underlying primary Sjögren s Syndrome. 2 The Sjogren s Syndrome Foundation Guideline Management of Dry Eye Associated with Sjögren Disease (U.S., 2015) states the following. 3 In general, therapy is based upon severity of disease and patient response to each added therapy. The first line of therapy for dry eye in Sjögren disease has been volume replacement and lubrication with artificial tears, mostly available OTC. Among the wide variety of tear supplements, none is clearly superior. 3

2 A management algorithm based upon level of severity of dry eye disease shows progression of therapy is determined by response to prior treatment option. Early disease begins with tear replacement; topically applied artificial tear or lubricant solutions may be sufficient. Progressive or more severe keratoconjunctivitis sicca (KCS) requires use of dietary supplements (omega 3 essential fatty acids), antiinflammatory measures (e.g., topical corticosteroids or cyclosporine), or oral secretagogues. 3 The American Academy of Ophthalmology has 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 Mild dry eye o Symptoms of irritation, itching, soreness, ocular discomfort, burning or intermittent blurred vision. Moderate dry eye o Severe dry eye o Increased discomfort and frequency of symptoms, and negative effect on visual function may become more consistent. Increasing frequency of symptoms that may become constant as well as potentially disabling visual symptoms. The American Academy of Ophthalmology recommend treating mild dry eyes with the following: 2 Education and environmental modifications Elimination of offending topical or systemic medications Aqueous enhancement using artificial tear substitutes, gels, or ointment Eyelid therapy (warm compresses and eyelid scrubs) Treatment of contributing ocular factors such as blepharitis or meibomiantitis Correction of eyelid abnormality For treatment of moderate dry eye the following are recommended in addition to mild dry eye treatment options: 2 Topical anti-inflammatory agents (topical cyclosporine and corticosteroids), systemic omega 3 fatty acids supplements Punctal plugs Spectacle side shields and moisture chambers For treatment of severe dry eye the following are recommended in addition to mild and moderate dry eye treatment options: 2 Systemic cholinergic agonists Systemic anti-inflammatory agents Mucolytic agents Autologous serum tears Contact lenses Permanent punctal occlusion Tarsorrhaphy 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 Choice_PS_Ophthalmic_Immunomodulators_PAQL_ProgSum_AR0716_r0117 Page 2 of 6

3 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. Tear replacement is frequently unsuccessful when used as the sole treatment if additional causative factors are not concomitantly addressed. 2 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. It is also unclear whether the effects observed in cyclosporine ophthalmic emulsion clinical trials are clinically significant, and many subgroups of dry eye patients (e.g. those with meibomian gland dysfunction or keratoconjunctivitis sicca) are unlikely to experience the same benefit. 2 Efficacy The efficacy of cyclosporine ophthalmic emulsion was studied in four multicenter, randomized, adequate and well-controlled clinical studies in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca. Cyclosporine ophthalmic emulsion demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of cyclosporine ophthalmic emulsion-treated patients versus approximately 5% of vehicle-treated patients. Increased tear production was not seen in patients currently taking topical antiinflammatory drugs or using punctal plugs. 1 The efficacy of lifitegrast for the treatment of dry eye disease were assessed in a total of 1181 patients (1067 of which received lifitegrast 5%) in four 12-week, randomized, multi-center, double-masked, vehicle-controlled studies. Eye dryness Score (EDS) was rated by patients using a visual analogue scale (VAS) (0 = no discomfort, 100 = maximal discomfort) at each study visit. In three of the four studies, lifitegrast showed statistically significant improvement in EDS at day 84 vs. the vehicle [study 2 difference (95% CI): (-8.9, -0.4), study 3 difference (95% CI): (-16.4, -8.3), study 4 difference (95% CI): -7.5 (-11.6, -3.5)]. Inferior fluorescein corneal staining score (ICSS) (0 = no staining, 1 = few/rare punctate lesions, 2 = discrete and countable lesions, 3 = lesions too numerous to count but not coalescent, 4 = coalescent) was recorded at each study visit. At day 84, lifitegrast showed statistically significant improvement vs. vehicle in three of the four studies [study 1 difference (95% CI): (-0.50, -0.00), study 2 difference (95% CI): (-0.36, -0.10), study 4 difference (95% CI): (-0.30, )]. 4 Safety Cyclosporine ophthalmic emulsion is contraindicated in those with hypersensitivity to the product. 1 Lifitegrast ophthalmic emulsion has no contraindications. 4 For additional clinical information see the Prime Therapeutics Formulary Chapters 14.1B. REFERENCES 1. Restasis Prescribing Information. Allergan, Inc. June Dry eye syndrome. American Academy of Ophthalmology. September Choice_PS_Ophthalmic_Immunomodulators_PAQL_ProgSum_AR0716_r0117 Page 3 of 6

4 3. Foulks G, Forstot L, Donshik P, et al. Clinical guidelines for management of dry eye associated with Sjögren disease. The Ocular Surface. 2015;13(2): Xiidra prescribing information. Shire US, Inc. July 2016 Ophthalmic Immunomodulators Prior Authorization with Quantity Limit OBJECTIVE The intent of the Ophthalmic Immunomodulators prior authorization (PA) program is to ensure appropriate selection of patients for treatment according to product labeling and/or clinical studies and/or guidelines. The PA defines appropriate use for Restasis as treatment for patients who have tear production presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (e.g. Sjögren s Syndrome). The program will not approve for Restasis if the patient is also using a topical ophthalmic anti-inflammatory drug or punctal plug. The program defines appropriate use for Xiidra as treatment for patients with a diagnosis of dry eye disease. The program requires patients to have previously tried or are currently using aqueous enhancements. The program will also approve members who have another FDA labeled indication for the requested agent. The program will not approve those with contraindication(s) to the requested agent. Doses above the set will be approved if the requested quantity is below the FDA or when the quantity is above the FDA and the prescriber has submitted documentation in support of therapy with a higher dose for the intended diagnosis. Requests will be reviewed when patient-specific documentation has been provided. TARGET DRUG Restasis (cyclosporine ophthalmic emulsion) Xiidra (lifitegrast ophthalmic solution) Brand (generic) GPI/NDC Multisource Quantity Limit Code Restasis NA 1 bottle / 30 days (cyclosporine ophthalmic emulsion) multidose bottle Restasis M, N, O, or Y 2 vials / day (cyclosporine ophthalmic emulsion) vial Xiidra (lifitegrast ophthalmic solution) M, N, O, or Y 2 containers / day PRI AUTHIZATION CRITERIA F APPROVAL Restasis (cyclosporine ophthalmic emulsion) will be approved when ALL of the following are met: 1. ONE of the following: a. ALL of the following: i. The patient has a diagnosis of tear production presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (e.g. Sjögren s Syndrome) ii. ONE of the following: Choice_PS_Ophthalmic_Immunomodulators_PAQL_ProgSum_AR0716_r0117 Page 4 of 6

5 1. The patient is not currently using a topical ophthalmic antiinflammatory drug or punctal plug 2. The patient s current use of topical ophthalmic antiinflammatory drug or punctal plug will be discontinued before starting the requested agent iii. ONE of the following: 1. The patient has previously tried or is currently using aqueous 2. The patient has a documented intolerance, FDA labeled contraindication(s), or hypersensitivity to aqueous b. Other FDA approved indication 2. The patient does not have any FDA labeled contraindication(s) to the requested agent 3. ONE of the following: a. The requested quantity (dose) is NOT greater than the program quantity b. ALL of the following: i. The requested quantity (dose) is greater than the program quantity ii. The prescriber has submitted documentation in support of therapy with a higher dose for the intended diagnosis (must be reviewed by the Clinical Review pharmacist) Length of Approval: 12 months Xiidra (lifitegrast ophthalmic solution) will be approved when ALL of the following are met: 1. ONE of the following: a. ALL of the following: i. The patient has a diagnosis of dry eye disease ii. ONE of the following: 1. The patient has previously tried or is currently using aqueous 2. The patient has a documented intolerance, FDA labeled contraindication(s), or hypersensitivity to aqueous b. Other FDA approved indication 2. The patient does not have any FDA labeled contraindication(s) to the requested agent Choice_PS_Ophthalmic_Immunomodulators_PAQL_ProgSum_AR0716_r0117 Page 5 of 6

6 3. ONE of the following: a. The requested quantity (dose) is NOT greater than the program quantity b. ALL of the following: i. The requested quantity (dose) is greater than the program quantity ii. The prescriber has submitted documentation in support of therapy with a higher dose for the intended diagnosis (must be reviewed by the Clinical Review pharmacist) Length of Approval: 12 months Choice_PS_Ophthalmic_Immunomodulators_PAQL_ProgSum_AR0716_r0117 Page 6 of 6

Ophthalmology Times Case Study Yasmin Mali, MD. Case Study

Ophthalmology Times Case Study Yasmin Mali, MD Case Study A 57 year old female with presented with ocular irritation and discomfort in both eyes for several months. Patient was previously started on a