GILENYA, Fingolimod HCl Form

Fingolimod (Gilenya®, Tascenso ODT™) is a sphingosine 1-phosphate receptor modulator. FDA Approved Indication(s) Gilenya and Tascenso ODT are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Gilenya and Tascenso ODT are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Multiple Sclerosis (must meet all):

1. Diagnosis of one of the following (a, b, or c): a. Clinically isolated syndrome; b. Relapsing-remitting MS, and if age ≥ 18 years, failure of generic dimethyl fumarate at up to maximally indicated doses, unless contraindicated, clinically significant adverse effects are experienced, or member has highly active MS; c. Secondary progressive MS;
2. Prescribed by or in consultation with a neurologist;
   3. Age ≥ 10 years;
   4. If request is for Tascenso ODT, member must use Gilenya 0.25 mg or generic fingolimod 0.5 mg, unless contraindicated, clinically significant adverse effects are experienced, or documentation supports inability to swallow capsules;
3. For brand Gilenya 0.5 mg requests, member must use generic fingolimod, unless contraindicated or clinically significant adverse effects are experienced;
4. The requested agent is not prescribed concurrently with other disease modifying therapies for MS (see Appendix D);
5. Documentation of both baseline number of relapses per year and expanded disability status scale (EDSS) score;

6. At the time of request, member does not have baseline QTc interval ≥ 500 msec;
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   CLINICAL POLICY Fingolimod

7. Dose does not exceed both of the following (a and b): a. One of the following (i or ii): i. Body weight > 40 kg: 0.5 mg per day; ii. Body weight ≤ 40 kg: 0.25 mg per day; b. 1 capsule or orally disintegrating tablet per day. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):
8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid; or
9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Multiple Sclerosis (must meet all):
10. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
    2. Member meets one of the following (a or b): a. If member has received < 1 year of total treatment: Member is responding positively to therapy;
       b. If member has received ≥ 1 year of total treatment: Member meets one of the following (i, ii, iii, or iv): i. Member has not had an increase in the number of relapses per year compared to baseline; ii. Member has not had ≥ 2 new MRI-detected lesions; iii. Member has not had an increase in EDSS score from baseline; iv. Medical justification supports that member is responding positively to therapy;
11. The requested agent is not prescribed concurrently with other disease modifying therapies for MS (see Appendix D);

12. If request is for Tascenso ODT, documentation supports continued inability to swallow capsules; Page 2 of 7

    CLINICAL POLICY Fingolimod

13. For brand Gilenya 0.5 mg requests, member must use generic fingolimod, unless contraindicated or clinically significant adverse effects are experienced;
14. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. One of the following (i or ii): i. Body weight > 40 kg: 0.5 mg per day; ii. Body weight ≤ 40 kg: 0.25 mg per day; b. 1 capsule or orally disintegrating tablet per day.
    Approval duration:
    If member has received < 1 year of total treatment – up to a total of 12 months of treatment If member has received ≥ 1 year of total treatment – 12 months B. Other diagnoses/indications (must meet 1 or 2):
15. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.PMN.16 for Medicaid; or

16. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.PMN.53 for Medicaid or evidence of coverage documents; B. Primary progressive MS. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key EDSS: expanded disability status scale
    FDA: Food and Drug Administration MS: multiple sclerosis Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Page 3 of 7

    CLINICAL POLICY Fingolimod Drug Name Dosing Regimen Dose Limit/ Maximum Dose 480 mg/day dimethyl fumarate (Tecfidera®) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Initial: 120 mg PO BID for 7 days Maintenance: 240 mg PO BID Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure o History of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker o Baseline QTc interval ≥ 500 msec o Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs o Hypersensitivity to fingolimod or its excipients o Concomitant use with other products containing fingolimod (Tascenso ODT only) • Boxed warning(s): none reported Appendix D: General Information • Disease-modifying therapies for MS are: glatiramer acetate (Copaxone®, Glatopa®), interferon beta-1a (Avonex®, Rebif®), interferon beta-1b (Betaseron®, Extavia®), peginterferon beta-1a (Plegridy®), dimethyl fumarate (Tecfidera®), diroximel fumarate (Vumerity®), monomethyl fumarate (Bafiertam™), fingolimod (Gilenya®, Tascenso ODT™), teriflunomide (Aubagio®), alemtuzumab (Lemtrada®), mitoxantrone (Novantrone®), natalizumab (Tysabri®), ocrelizumab (Ocrevus®), cladribine (Mavenclad®), siponimod (Mayzent®), ozanimod (Zeposia®), ponesimod (Ponvory™), ublituximab-xiiy (Briumvi™), and ofatumumab (Kesimpta®). • Per the American Academy of Neurology 2018 MS practice guidelines, definitions of highly active MS vary and can include measures of relapsing activity and MRI markers of disease activity, such as numbers of gadolinium-enhanced lesions. V. Dosage and Administration
    Indication Relapsing MS Dosing Regimen Adults and pediatric patients 10 years of age and older weighing > 40 kg: 0.5 mg PO QD Maximum Dose 0.5 mg/day Pediatric patients 10 years of age and older weighing ≤ 40 kg: 0.25 mg PO QD VI. Product Availability
    • Hard capsules (Gilenya): 0.25 mg, 0.5 mg • Orally disintegrating tablets (Tascenso ODT): 0.25 mg, 0.5 mg ____ Available generically Page 4 of 7

    CLINICAL POLICY Fingolimod VII.