Tascenso ODT - OpenPayer

Coverage Summary

FDA-Approved Indication - Approve for 1 year

Approve for 1 year if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient has a relapsing form of multiple sclerosis (examples: clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease)
- Patient is ≥ 10 years of age
- Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis
- Preferred product criteria is met for the product(s) as listed in the Employer Plans or Individual and Family Plans tables (plan-specific criteria)
B) Currently Receiving Tascenso ODT for ≥ 1 Year
- Patient has a relapsing form of multiple sclerosis (examples: clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease)
- Patient is ≥ 10 years of age
- Patient response
  - Patient experienced a beneficial clinical response when assessed by at least one objective measure (examples: MRI stabilization/decrease in gadolinium enhancing lesions or new/enlarging T2 lesions; stabilization/reduced worsening on EDSS; achievement of NEDA-3 or NEDA-4; improvement on FSIQ-RMS; reduction/absence of relapses; improvement/maintenance on 6-minute walk test or 12-Item MS Walking Scale; improvement on MSFC; attenuation of brain volume loss)
  - Patient experienced stabilization, slow progression, or improvement in at least one symptom (examples: motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, pain/numbness/tingling) per prescriber assessment

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Employer Plans - Tascenso ODT 0.5 mg (coverage conditions)

Approve when BOTH of the following (i and ii) are met:

ALL of the following

i. ONE of
- Patient cannot swallow or has difficulty swallowing tablets or capsules
- Patient has been established on Tascenso ODT ≥ 120 days
- Patient is ≥ 10 to < 18 years of age
- d) Both of
  - Patient has tried generic dimethyl fumarate delayed-release capsules
    Note: Prior use of Tecfidera, Bafiertam, or Vumerity also counts.

Individual and Family Plans - Tascenso ODT 0.5 mg (coverage conditions)

Approve when BOTH of the following (i and ii) are met:

ALL of the following

i. ONE of
- Patient cannot swallow or has difficulty swallowing tablets or capsules
- Patient has been established on Tascenso ODT ≥ 120 days
- Patient is ≥ 10 to < 18 years of age
- d) Both of
  - Patient has tried generic dimethyl fumarate delayed-release capsules (requires prior authorization)

Conditions Not Covered (Not Medically Necessary)

Tascenso ODT for any other use is considered not medically necessary including:

Conditions Not Covered

Concurrent use with other disease-modifying agents used for multiple sclerosis (agents are not indicated for combination use)
Non-relapsing forms of multiple sclerosis (e.g., primary progressive multiple sclerosis)

Safety, Prescribing & Monitoring Requirements

Safety / Prescribing and Monitoring Requirements

Prior to and during therapy the following safety measures apply:

ALL of the following

Prior Authorization is required for benefit coverage of Tascenso ODT
Tascenso ODT must be prescribed by or in consultation with a physician who specializes in the condition being treated (neurologist or MS specialist)
First-dose monitoring: First dose should be given in a setting with resources to manage symptomatic bradycardia; monitor all patients for 6 hours after first dose with hourly pulse and blood pressure measurement
ECG/QTc guidance:

Applicable Codes & Appendix

NDC / ProductNDCCovered

Tascenso ODT 0.25 mg	fingolimod orally disintegrating tablet, pediatric dose option (FDA-approved)
Tascenso ODT 0.5 mg	fingolimod orally disintegrating tablet, adult dose option (FDA-approved)

Related MS disease-modifying therapies (Appendix - informational list)mixed

Gilenya	fingolimod capsules (generic) - alternative formulation
Tecfidera	dimethyl fumarate delayed-release capsules (generic)
Bafiertam	monomethyl fumarate delayed-release capsules
Vumerity	diroximel fumarate delayed-release capsules
Zeposia	ozanimod capsules
Mayzent	siponimod tablets
Ponvory	ponesimod tablets
Ocrevus	ocrelizumab intravenous infusion
Ocrevus Zunovo	ocrelizumab and hyaluronidase subcutaneous injection

Background & Clinical Evidence

Tascenso ODT (fingolimod orally disintegrating tablets) is an oral sphingosine 1‑phosphate receptor modulator indicated for treatment of relapsing forms of multiple sclerosis (examples: clinically isolated syndrome, relapsing‑remitting disease, active secondary progressive disease) in patients aged ≥ 10 years. (FDA prescribing information.)

Dosing is weight‑based for pediatric patients: 0.25 mg once daily for patients ≥ 10 years who weigh ≤ 40 kg, and 0.5 mg once daily for adults and pediatric patients ≥ 10 years who weigh > 40 kg. Tascenso ODT is administered as an orally disintegrating tablet placed on the tongue and allowed to dissolve; it is available in 0.25 mg and 0.5 mg strengths. (FDA prescribing information.)

Key safety concerns requiring monitoring include first‑dose decreases in heart rate and possible atrioventricular conduction effects — the first dose should be given in a setting able to manage symptomatic bradycardia with 6‑hour observation with hourly pulse and blood pressure checks, and overnight continuous ECG monitoring if prolonged QTc or QT‑prolonging medications are present. Other serious toxicities include increased risk of infections, macular edema, pulmonary toxicity, elevated liver enzymes, and rare reports of progressive multifocal leukoencephalopathy (PML). (Prescribing information; safety section.)

Key clinical evidence and guidance sources cited in the policy include the FDA Prescribing Information for Tascenso ODT (Cycle/Handa, July 2024), a Multiple Sclerosis Coalition consensus guidance on use of disease‑modifying therapies (Sept 2019), and the randomized phase‑3 INFORMS trial (Lancet 2016).

Relevance to coverage: the INFORMS trial showed that fingolimod did not slow disease progression in primary progressive MS, informing the policy exclusion for non‑relapsing forms of MS and supporting coverage limited to relapsing forms. The FDA prescribing information provides dosing, first‑dose monitoring, contraindications, and the enumerated safety risks that underpin the policy’s monitoring and specialist‑prescribing requirements. The MS Coalition guidance is cited as a clinical guidance source for use of disease‑modifying therapies in MS.

Definitions

Relapsing forms of multiple sclerosis: Includes clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease; these are the MS phenotypes for which Tascenso ODT coverage is approved in the policy.

Established on Tascenso ODT: Defined in the policy as a patient who has been taking Tascenso ODT for ≥ 120 days (used in Employer and Individual/Family plan criteria).

Preferred product criteria: Plan‑specific criteria (Employer vs Individual and Family Plans) that require trials of specified generics or documentation of inability to use them (for example prior trial of generic dimethyl fumarate or generic fingolimod capsules, with prior authorization and documentation requirements per plan).

Surface thresholds and key policy stats

Established-use threshold≥ 120 days

Minimum patient age≥ 10 years (pediatric dosing by weight)

Pediatric dosing≤ 40 kg = 0.25 mg once daily; > 40 kg = 0.5 mg once daily

Approval duration

Revision History

12/01/2024added (non-material)

Added a definition for documentation.

12/01/2024added (material)

Added a specialist prescribing requirement (Tascenso ODT must be prescribed by or in consultation with a neurologist or MS specialist).

12/01/2024added (material)

Added criteria for patients Currently Receiving Tascenso ODT for ≥ 1 Year (continuation criteria require evidence of benefit or stabilization).