CurrentCignaPolicy IP0514

Tascenso ODT

Defines prior authorization and coverage criteria for Tascenso ODT for treatment of relapsing forms of multiple sclerosis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTascenso ODT

Policy CodePolicy IP0514

Change TypeMaterial updates to criteria and prescribing requirements

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and ensure the medication is prescribed by or in consultation with a neurologist or MS specialist.

SourceLink

POLICY UPDATE CHANGES

Added a specialist prescribing requirement.

Added criteria for patients currently receiving Tascenso ODT for ≥ 1 year.

Updated Employer and Individual/Family Plans preferred product criteria.

Updated the conditions not covered statement.

Added preferred product criteria for Individual and Family Plans.

Added a definition for documentation.

≥10minimum patient age for approved use

0.25/0.5available tablet strengths

1 yrduration of initial approvals

6 hrs

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Coverage Criteria for Tascenso ODT

Patient Currently Receiving Tascenso ODT 6gt;= 1 Year

Patient is Currently Receiving Tascenso ODT for 6gt;= 1 Year — Approve for 1 year if the patient meets ALL of the following:

ALL of the following

Patient has a relapsing form of multiple sclerosis; AND Note : Examples of relapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
Patient is ≥ 10 years of age; AND
Patient response
- Patient experienced a beneficial clinical response when assessed by at least one objective measure (for example: stabilization or reduced worsening in disease activity on MRI [absence or a decrease in gadolinium enhancing lesions, decrease in the number of new or enlarging T2 lesions]; stabilization or reduced worsening on the Expanded Disability Status Scale [EDSS]; achievement of No Evidence of Disease Activity [NEDA]-3 or NEDA-4; improvement on the fatigue symptom and impact questionnaire - relapsing multiple sclerosis [FSIQ-RMS]; reduction or absence of relapses; improvement or maintenance on the six-minute walk test or 12-Item MS Walking Scale; improvement on the Multiple Sclerosis Functional Composite [MSFC]; and/or attenuation of brain volume loss].)
- Patient experienced stabilization, slow progression, or improvement in at least one symptom such as motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling sensation;
Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Coding and Dose Information

Covered/Necessary coding notemixed

No codes listed

Pediatric weight-based dosing threshold

Pediatric weight-based dosing≤ 40 kg: 0.25 mg once daily; > 40 kg: 0.5 mg once daily (Tascenso ODT available in 0.25 mg and 0.5 mg tablets)

Minimum approved age≥ 10 years for treatment of relapsing forms of MS

AdministrationPlace tablet on tongue to dissolve; may be taken with or without water

Excess dosing riskDoses higher than twice the recommended dosage are associated with greater adverse events without added benefit

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Tascenso ODT. All approvals are provided for one year. Because of the specialized skills required for evaluation and diagnosis of patients treated with Tascenso ODT and monitoring for adverse events and efficacy, approval requires Tascenso ODT to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Approvals provided for 1 year
Prescriber must be a specialist in the condition being treated

Denial Risk

Prior authorization and correct coding required

Requests that do not include appropriate diagnosis/procedure codes or that do not meet the coverage criteria will be denied. Prior authorization must be obtained before billing. When submitting a request, include the documentation defined in this policy to support medical necessity.

Background on Tascenso ODT

Tascenso ODT (fingolimod orally disintegrating tablets) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis in patients aged ≥ 10 years. For pediatric patients dosing is weight-based: ≤ 40 kg → 0.25 mg once daily; > 40 kg → 0.5 mg once daily. Initiation of therapy requires first-dose monitoring because the medication can cause decreases in heart rate; observe patients for 6 hours after the first dose with hourly pulse and blood pressure checks, with extended monitoring (continuous ECG) when indicated.

Definitions and Monitoring

Relapsing forms of multiple sclerosis

Relapsing forms of MS (definition)Includes clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease

Indication contextTascenso ODT is indicated for treatment of relapsing forms of multiple sclerosis

Age specificationIndicated in patients ≥ 10 years of age

First‑dose monitoring

Standard first‑dose observationObserve all patients for 6 hours after the first dose with hourly pulse and blood pressure checks

Overnight monitoring criteriaPatients with prolonged QTc at baseline or during the 6‑hour observation, or taking drugs that increase torsades risk, should be observed overnight with continuous ECG monitoring

Documentation Required

Documentation definition

For the purposes of prior authorization and coverage review, "documentation" refers to relevant clinical records that substantiate the requested use, such as: clinical notes describing diagnosis and disease status, prior medication history including dates and reasons for discontinuation or intolerance, objective measures of treatment response (when applicable), and documentation from the prescribing specialist when consultation is required. (Specific checklist elements previously listed in the policy were removed; reviewers will accept the clinical records above as adequate documentation.)

Clinical notes describing diagnosis and disease status
Prior medication history with dates and reasons for discontinuation/intolerance
Objective measures of treatment response, when applicable
Documentation from the prescribing specialist when consultation is required

Step Therapy

Preferred product / step therapy exceptions

Preferred product (step therapy) exceptions are allowed as specified for Employer Plans and Individual and Family Plans. Exceptions include: inability to swallow tablets/capsules; established use of Tascenso ODT for ≥ 120 days; age 10 to <18 years; or documented trial and inadequate efficacy or significant intolerance to preferred agents per prescriber. For the brand-versus-generic exception, approval may be granted if the prescriber documents that the patient cannot continue a bioequivalent generic due to a formulation difference in inactive ingredients that would, per the prescriber, result in a significant allergy or serious adverse reaction.

Inability to swallow tablets or capsules qualifies as an exception
Established use of Tascenso ODT ≥ 120 days qualifies as an exception
Age 10 to <18 years qualifies as an exception
Trial and inadequate efficacy or significant intolerance to preferred products qualifies as an exception
Documented significant allergy or serious adverse reaction to a generic due to inactive ingredient differences may qualify