GILENYA (fingolimod)

GILENYA (fingolimod)

SELF ADMINISTRATION- ORAL

Indication for Prior Authorization:

• Relapsing Multiple Sclerosis (MS): Indicated 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

Coverage Criteria:

For diagnosis of relapsing MS:

• Patient has a documented diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions)  AND
• Patient is 10 years of age or older AND
• Not used in combination with another disease-modifying therapy for MS AND
• Prescribed by or in consultation with a neurologist
• For Gilenya 0.5mg only:
  • Failure after a trial of at least 4 weeks or intolerance to generic fingolimod

Dosing:

For diagnosis of relapsing MS:

• Adults and pediatric patients 10 years of age and older weighing more than 40 kg: 0.5 mg once-daily
• Pediatric patients 10 years of age and older weighing less than or equal to 40 kg: 0.25 mg once daily
• Fingolimod doses higher than 0.5 mg are associated with a greater incidence of adverse reactions without additional benefit

Reauthorization Criteria:

For diagnosis of relapsing MS:

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression AND

• Paid claims or submission of medical records (e.g., chart notes) confirming failure after a trial of at least 4 weeks, or intolerance to generic fingolimod AND

• Not used in combination with another disease-modifying therapy for MS AND
• Prescribed by or in consultation with a neurologist

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Contraindications:
  • Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs
  • In the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or Class III/IV heart failure
  • A history or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker
  • A baseline QTc interval ≥ 500 msec
• Additional warnings for: bradyarrhythmia and atrioventricular blocks, infections, Progressive Multifocal Leukoencephalopathy, macular edema, liver injury, posterior reversible encephalopathy syndrome, respiratory effects, fetal risk, Tumefactive Multiple Sclerosis, increased blood pressure, and malignancies
• Pregnancy: Gilenya may cause fetal harm when administered to a pregnant woman. In females planning to become pregnant, Gilenya should be stopped 2 months before planned conception
• Lactation: There are no data on the presence of fingolimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Fingolimod is excreted in the milk of treated rats
• Drug Interactions:
  • QT prolonging drugs: The initiation of Gilenya treatment results in decreased heart rate and may prolong the QT interval, patients on QT prolonging drugs with a known risk of torsades de pointes (e.g., citalopram, chlorpromazine, haloperidol, methadone, erythromycin) should be monitored overnight with continuous ECG in a medical facility
  • Ketoconazole: The blood levels of fingolimod and fingolimod-phosphate are increased by 1.7-fold when used concomitantly with ketoconazole. Monitor closely if Gilenya and systemic ketoconazole are used concomitantly
  • Vaccines: Gilenya reduces the immune response to vaccination. Vaccination may be less effective during and for up to 2 months after discontinuation of treatment with Gilenya 
  • Antineoplastic, Immunosuppressive, or Immune-Modulating Therapies: Antineoplastic, immune-modulating, or immunosuppressive therapies, (including corticosteroids) are expected to increase the risk of immunosuppression, and the risk of additive immune system effects must be considered if these therapies are coadministered with Gilenya. When switching from drugs with prolonged immune effects, such as natalizumab, teriflunomide or mitoxantrone, the duration and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects when initiating Gilenya 
  • Drugs That Slow Heart Rate or Atrioventricular Conduction (e.g., beta blockers or diltiazem): initiation of Gilenya treatment may result in an additional decrease in heart rate, concomitant use of these drugs during Gilenya initiation may be associated with severe bradycardia or heart block

Review History:

• 9/28/10- Original review
• 11/14/19- Annual review
• 11/17/20- Class review, criteria updated
• 6/1/2024 (policy effective date)- RRT MS update, added SSE (P&T 5/20/2024) (P&T Meeting May)  

References:

• Gilenya [package insert]. East Hanover (NJ): Novartis Pharmaceuticals Corporation; 2019.
• Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis. Neurology 2018;90:777-788. 
• National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed March 29, 2019. 
• Per clinical consultation with MS specialist, December 29, 2010. 
• Wingerchuk, D., & Carter, J. (2014). Multiple Sclerosis: Current and Emerging Disease-Modifying Therapies and Treatment Strategies. Mayo Clinic Proceedings, 89(2), 225-240. 
• Sorensen, P., Lycke, J., Erälinna, J., Edland, A., Wu, X., & Frederiksen, J. et al. (2011). Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial. The Lancet Neurology, 10(8), 691-701. 
• Gilenya. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed April 15, 2024. http://www.micromedexsolutions.com.