GILENYA (fingolimod)

GILENYA (fingolimod)

SELF ADMINISTRATION- ORAL

Indication for Prior Authorization:

• 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:

• Patient has a documented diagnosis of relapsing forms of multiple sclerosis (MS), AND
• Prescribed by or in consultation with a neurologist

Dosing:

• 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

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:

• 11/17/20- Class review, criteria updated
• 11/14/19- Annual review
• 9/28/10- Original review

References:

• Gilenya [package insert]. East Hanover (NJ): Novartis Pharmaceuticals Corporation; 2019.
• OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.