| Multiple Sclerosis, Relapsing-Remitting
Gilenya vs Mavenclad
Side-by-side clinical, coverage, and cost comparison for multiple sclerosis, relapsing-remitting.Deep comparison between: Fingolimod vs Mavenclad with Prescriber.AI
AI compares prescribing info and payer-specific access barriers across 1,200+ formularies. Here's a preview of what prescribers are already asking.Safety signalsMavenclad has a higher rate of injection site reactions vs Fingolimod based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Mavenclad but not Fingolimod, including UnitedHealthcare
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Category
Fingolimod
Mavenclad
At A Glance
Oral
Daily
Sphingosine 1-phosphate receptor modulator
Oral
2 yearly treatment courses
Nucleoside metabolic inhibitor
Indications
- Multiple Sclerosis, Relapsing-Remitting
- Clinically isolated syndrome
- Multiple Sclerosis, Secondary Progressive
- Multiple Sclerosis, Relapsing-Remitting
- Multiple Sclerosis, Secondary Progressive
Dosing
Multiple Sclerosis, Relapsing-Remitting, Clinically isolated syndrome, Multiple Sclerosis, Secondary Progressive 0.5 mg orally once daily for adults and pediatric patients >40 kg; 0.25 mg orally once daily for pediatric patients 10 years of age and older weighing <=40 kg; may be taken with or without food; first-dose monitoring for bradycardia required.
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive Cumulative dose of 3.5 mg/kg administered orally, divided into 2 yearly treatment courses (1.75 mg/kg per course); each course consists of 2 cycles of 4 to 5 consecutive days of dosing; no more than 2 tablets (20 mg) per day; do not administer additional treatment during the 2 years following completion of 2 courses.
Contraindications
- Myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure within the last 6 months
- History or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome without a functioning pacemaker
- Baseline QTc interval >= 500 msec
- Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs
- Hypersensitivity to fingolimod or any excipient in fingolimod capsules
- Current malignancy
- Pregnancy, or women or men of reproductive potential not using effective contraception during dosing and for 6 months after the last dose in each treatment course
- HIV infection
- Active chronic infections (e.g., hepatitis or tuberculosis)
- History of hypersensitivity to cladribine
- Breastfeeding on a treatment day and for 10 days after the last dose
Adverse Reactions
Most common (>=10%) Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, pain in extremity
Serious Bradyarrhythmia, AV block, infections, progressive multifocal leukoencephalopathy, macular edema, liver injury, posterior reversible encephalopathy syndrome, fetal risk, malignancies, hypersensitivity reactions
Postmarketing Hemolytic anemia, thrombocytopenia, cryptococcal infections, HPV infection, seizures including status epilepticus, melanoma, Merkel cell carcinoma, cutaneous T-cell lymphoma, Kaposi's sarcoma, squamous cell carcinoma
Most common (>20%) Upper respiratory tract infection, headache, lymphopenia
Serious Malignancies, teratogenicity, lymphopenia, infections, hematologic toxicity, graft-versus-host disease with blood transfusion, liver injury, hypersensitivity, cardiac failure, seizures, myelodysplastic syndrome
Postmarketing Nocardiosis, varicella zoster, histoplasmosis, cryptococcosis, toxoplasmosis, liver injury
Pharmacology
Sphingosine 1-phosphate (S1P) receptor modulator; fingolimod is metabolized to fingolimod-phosphate, which binds S1P receptors 1, 3, 4, and 5 with high affinity, blocking lymphocyte egress from lymph nodes and reducing peripheral blood lymphocyte counts, potentially reducing lymphocyte migration into the central nervous system.
Cladribine is a nucleoside metabolic inhibitor that exerts cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes; this lymphocyte-depleting mechanism is thought to underlie its therapeutic effects in relapsing forms of multiple sclerosis.
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Most Common Insurance
Anthem BCBS
Fingolimod
- Covered on 5 commercial plans
- PA (11/12) · Step Therapy (2/12) · Qty limit (11/12)
Mavenclad
- Covered on 5 commercial plans
- PA (10/12) · Step Therapy (10/12) · Qty limit (9/12)
UnitedHealthcare
Fingolimod
- Covered on 4 commercial plans
- PA (6/8) · Step Therapy (0/8) · Qty limit (8/8)
Mavenclad
- Covered on 4 commercial plans
- PA (4/8) · Step Therapy (4/8) · Qty limit (4/8)
Humana
Fingolimod
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (2/3) · Qty limit (3/3)
Mavenclad
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (3/3) · Qty limit (1/3)
Coverage data sourced from MMIT. Updated monthly.
Savings
Cost estimate not availableAssistance Fund: Multiple Sclerosis: Waitlist
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
Cost estimate not availableAccessia Health: Multiple Sclerosis - Private Insurance: Waitlist
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
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FingolimodView full Fingolimod profile
MavencladView full Mavenclad profile
Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.