CurrentConnectiCarePolicy C9697-A

Riluzole (Rilutek/Tiglutik/Exservan)

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This policy governs prior authorization and coverage criteria for oral riluzole products used to treat amyotrophic lateral sclerosis (ALS) under the pharmacy benefit.

Policy Summary

PayerConnectiCare

PolicyRiluzole (Rilutek/Tiglutik/Exservan)

Policy CodePolicy C9697-A

Change TypeNo material change

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation confirming ALS, age 18 or older, the 50 mg twice-daily dose, and qualified specialist prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ALSCovered indication

18+Minimum age

50 mg twice dailyPolicy dose

85%+Continuation adherence

12 months

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CurrentConnectiCarePolicy C9697-A

Riluzole (Rilutek/Tiglutik/Exservan)

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This policy governs prior authorization and coverage criteria for oral riluzole products used to treat amyotrophic lateral sclerosis (ALS) under the pharmacy benefit.

Policy Summary

PayerConnectiCare

PolicyRiluzole (Rilutek/Tiglutik/Exservan)

Policy CodePolicy C9697-A

Change TypeNo material change

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation confirming ALS, age 18 or older, the 50 mg twice-daily dose, and qualified specialist prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ALSCovered indication

18+Minimum age

50 mg twice dailyPolicy dose

85%+Continuation adherence

12 months

Initial authorization

>5× ULNHepatic threshold

Coverage Criteria

Initial Therapy

Covered when ALL of the following initial coverage criteria are met:

ALL of the following

Documented diagnosis of amyotrophic lateral sclerosis (ALS).
For Tiglutik and Exservan requests, documentation that the member is unable to ingest a solid dosage form (tablet or capsule) due to ONE of the following: age, oral/motor difficulties, dysphagia, or use of a feeding tube for medical administration.
Prescribed by, or in consultation with, a board-certified neurologist, neuromuscular specialist, or physician experienced in the management or treatment of ALS.
If prescribed in consultation, submit consultation notes with the initial request and reauthorization requests.
Member is 18 years of age or older.
Requested dosage is 50 mg twice daily.

Continuation Therapy

Covered when ALL of the following continuation coverage criteria are met:

ALL of the following

Adherence to therapy is at least 85% of the time, as verified by the prescriber and the member's medication fill history.>= 85% adherence
Review prescription history for compliance.
The member is not dependent on invasive ventilation or tracheostomy.
The prescriber attests to, or the clinical reviewer has found, no evidence of intolerable adverse effects or drug toxicity.

ALS Diagnostic Criteria

ALS diagnosis must meet the revised El Escorial (Airlie House) diagnostic criteria. The diagnosis is supported by the applicable clinical grade and the required diagnostic elements below.

ONE of the following clinical grades

Clinically Definite ALS: clinical evidence of both upper motor neuron (UMN) and lower motor neuron (LMN) signs in the bulbar region and at least 2 spinal regions, or UMN and LMN signs in 3 spinal regions.
Clinically Probable ALS: clinical evidence of UMN and LMN signs in at least 2 regions, with some UMN signs necessarily rostral to (above) the LMN signs.
Clinically Probable ALS, Laboratory Supported: clinical signs of UMN and LMN dysfunction in only 1 region, or UMN signs alone in 1 region, with LMN signs defined by electromyography criteria present in at least 2 regions, with proper application of neuroimaging and clinical laboratory protocols to exclude other causes.
Clinically Possible ALS: clinical signs of UMN and LMN dysfunction together in only 1 region; or UMN signs alone in 2 or more regions; or LMN signs rostral to UMN signs when Clinically Probable ALS, Laboratory Supported cannot be proven by clinical evidence together with electrodiagnostic, neurophysiologic, neuroimaging, or clinical laboratory studies. Other diagnoses must have been excluded.

For continuation therapy, the member must not be dependent on invasive ventilation or tracheostomy.

All other uses of riluzole, including uses other than ALS, are considered experimental or investigational and follow the applicable Off-Label policy.

Riluzole is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components.

Monitor patients for signs and symptoms of hepatic injury every month for the first 3 months of treatment and periodically thereafter. Riluzole is not recommended if hepatic transaminase levels exceed 5 times the upper limit of normal (ULN); discontinue riluzole if there is evidence of liver dysfunction, such as elevated bilirubin.

Discontinue riluzole immediately if interstitial lung disease develops.

Clinical Thresholds and Coding Details

Riluzole-benefit population

Forced vital capacity>60%

Reported populationPatients younger than 75 years with definite or probable ALS

Disease durationLess than 5 years

Hepatic safety threshold

Hepatic transaminase threshold>5 times the upper limit of normal

Monitoring frequencyEvery month for the first 3 months of treatment, and periodically thereafter

Action for liver dysfunctionDiscontinue riluzole if there is evidence of liver dysfunction, such as elevated bilirubin

Authorization and Documentation Requirements

Prior Authorization

Initial Authorization Requirements

Prior authorization is required for riluzole products (Rilutek, Tiglutik, or Exservan) for members meeting the applicable coverage criteria.

Documented amyotrophic lateral sclerosis (ALS) diagnosis.
Member is 18 years of age or older.
Requested product is Rilutek, Tiglutik, or Exservan.
Prescribed by, or in consultation with, a board-certified neurologist, neuromuscular specialist, or physician experienced in ALS management or treatment.
Requested dosage is 50 mg twice daily.

Prior Authorization

Continuation Authorization Requirements

Continuation authorization is available for 12 months when the member continues to meet the therapy requirements.

Adherence is at least 85%, verified by the prescriber and medication fill history.

Clinical Background

Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Rilutek tablets extend survival and/or time to tracheostomy; the efficacy of Exservan oral film and Tiglutik oral suspension is based on bioavailability studies comparing those formulations with oral riluzole tablets. Riluzole is an oral benzothiazole-class drug.

Definitions and Clinical Measures

ALS

DiagnosisAmyotrophic lateral sclerosis (ALS)

FDA-approved indicationTreatment of amyotrophic lateral sclerosis (ALS)

Covered riluzole productsRilutek, generic riluzole, Tiglutik, and Exservan

Clinically Definite ALS

Bulbar regionUpper motor neuron and lower motor neuron signs are present in the bulbar region

Spinal-region patternThe same upper and lower motor neuron signs are present in at least 2 spinal regions

Alternative pattern

Initial Therapy Criteria

Riluzole Initial Authorization

Initial authorization requires a documented ALS diagnosis and satisfaction of the applicable product, age, prescriber, and dosing requirements.

Riluzole initial authorization: The member has a documented ALS diagnosis; is at least 18 years old; riluzole is prescribed by or in consultation with a board-certified neurologist, neuromuscular specialist, or physician experienced in ALS management; and the requested dose is 50 mg twice daily.Age >= 18 years; 50 mg twice daily

For Tiglutik and Exservan, document inability to ingest a solid dosage form because of age, oral/motor difficulties, dysphagia, or use of a feeding tube for medical administration. Submit consultation notes when prescribed in consultation.

ALS Diagnosis

Initial therapy is supported when the member has ALS meeting the policy's diagnostic requirements.

ALS diagnosis: The member has evidence of lower motor neuron degeneration by clinical, electrophysiologic, or neuropathologic examination; evidence of upper motor neuron degeneration by clinical examination; progressive spread of symptoms or signs within a region or to other regions; and no electrophysiologic, pathologic, neuroimaging, or clinical laboratory evidence of another disease process explaining the findings.

Continuation Criteria and Safety Monitoring

Riluzole Continuation Authorization

Continuation authorization is granted for 12 months when all continuation requirements are met.

Riluzole continuation authorization: The member demonstrates adherence to therapy of at least 85% as verified by the prescriber and medication fill history; is not dependent on invasive ventilation or tracheostomy; and has no evidence of intolerable adverse effects or drug toxicity, as attested by the prescriber or determined by the clinical reviewer.Adherence >= 85%; authorization period: 12 months

Qualified prescriber or consultation requirements continue to apply. Submit consultation notes with reauthorization requests when applicable.

Continuation and Safety Monitoring

During continued treatment, all of the following safety requirements apply.

Ongoing safety monitoring: Monitor the member for signs and symptoms of hepatic injury every month for the first 3 months of treatment and periodically thereafter; measure serum aminotransferases before and during treatment; do not continue riluzole if hepatic transaminase levels are greater than 5 times the upper limit of normal or if there is evidence of liver dysfunction, such as elevated bilirubin; and discontinue riluzole immediately if interstitial lung disease develops.

Quantity and Dosing Limits

Riluzole quantity and dosing

MedicationRiluzole

Dose50 mg

FrequencyTwice daily

Site of Care and Benefit Administration

Billing Rule

Use pharmacy benefit and home self-administration

Oral medications covered under this policy are recommended for pharmacy benefit coverage and patient self-administration at home.

Use the pharmacy benefit for covered oral riluzole products.
Plan for patient self-administration.

Policy Summary

PayerConnectiCare

PolicyRiluzole (Rilutek/Tiglutik/Exservan)

Policy CodePolicy C9697-A

Change TypeNo material change

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

Key ActionSubmit prior authorization documentation confirming ALS, age 18 or older, the 50 mg twice-daily dose, and qualified specialist prescribing or consultation.

SourceLink

On This Page

Required diagnostic elements

Evidence of LMN degeneration by clinical, electrophysiologic, or neuropathologic examination.
Evidence of UMN degeneration by clinical examination.
Progressive spread of symptoms or signs within a region or to other regions, determined by history or examination.
Absence of electrophysiologic or pathologic evidence of other disease processes that might explain signs of LMN and/or UMN degeneration.
Absence of neuroimaging evidence of other disease processes that might explain the observed clinical and electrophysiologic signs.

Member is not dependent on invasive ventilation or a tracheostomy.

Prescriber attests, or the clinical reviewer finds, no intolerable adverse effects or drug toxicity.

Documentation Required

Medical Necessity Documentation

Submit sufficient clinical information to support medical necessity and the coverage determination. ConnectiCare may request additional information on a case-by-case basis.

Patient medical records and relevant test results.
Credentials of the provider ordering or performing the drug or service.
Member-specific dosing information, including weight, body surface area, or other measurement when required for dosing.
Documentation supporting that treatment is medically necessary, not investigational or experimental, and within the member’s benefits.

Unsupported block type: documentation

Prior Authorization

12-Month Reauthorization

Initial authorization and reauthorization are each approved for 12 months when the applicable criteria are met.

Initial authorization: 12 months.
Continuation authorization: 12 months.
Reauthorization must document adherence, ventilation or tracheostomy status, and tolerability or absence of toxicity.

Documentation Required

Consultation Notes Required

Submit consultation documentation whenever riluzole is prescribed in consultation with a qualifying specialist.

Consultation notes must accompany the initial request.
Consultation notes must also accompany reauthorization requests.

Documentation Required

ALS Diagnostic Documentation

The ALS diagnosis must be supported by clinical and, when applicable, electrophysiologic, neuropathologic, neuroimaging, and laboratory evidence consistent with the revised El Escorial criteria.

Evidence of lower motor neuron (LMN) degeneration by clinical, electrophysiologic, or neuropathologic examination.
Evidence of upper motor neuron (UMN) degeneration by clinical examination.
Progressive spread of symptoms or signs within a region or to other regions, established by history or examination.
Absence of electrophysiologic or pathologic evidence of another disease process explaining LMN or UMN degeneration.
Absence of neuroimaging evidence of another disease process explaining the observed clinical or electrophysiologic findings.

Documentation Required

Liver Function Monitoring

Monitor hepatic safety during riluzole treatment and document serum aminotransferase results before treatment begins and during therapy.

Measure serum aminotransferases before treatment.
Repeat measurements monthly for the first 3 months and periodically thereafter.
Include the monitoring results in the clinical record when requested.

Denial Risk

Insufficient Supporting Documentation

Coverage or reimbursement may be denied when submitted documentation does not support medical necessity, the policy criteria, the member’s benefits, or appropriate utilization.

ConnectiCare may request additional records, test results, provider credentials, or other supporting information.
Incomplete or unsupported documentation may result in denial or other appropriate action.

Denial Risk

Formulation Criteria Not Met

Tiglutik or Exservan may be denied when the request does not document a qualifying inability to ingest a solid dosage form.

A liquid or oral film formulation alone does not establish eligibility.
Document age, oral/motor difficulties, dysphagia, or feeding-tube use as the reason the member cannot ingest a tablet or capsule.

Denial Risk

Continuation Criteria Not Met

Continuation therapy may be denied when required clinical and utilization criteria are not met.

Adherence is below 85% or cannot be verified through prescriber attestation and medication fill history.
Member is dependent on invasive ventilation or has a tracheostomy.
Intolerable adverse effects or drug toxicity are present.

Unsupported block type: denial_risk

Upper and lower motor neuron signs are present in 3 spinal regions

Clinically Probable ALS

Evidence typeDefined on clinical evidence alone

Regional involvementUpper and lower motor neuron signs are present in at least 2 regions

Relative location of signsSome upper motor neuron signs are necessarily rostral, or above, the lower motor neuron signs

Clinically Probable ALS Laboratory Supported

Clinical findingsUpper and lower motor neuron dysfunction signs are present in only 1 region, or upper motor neuron signs alone are present in 1 region

Electromyography findingsLower motor neuron signs defined by electromyography criteria are present in at least 2 regions

Exclusion of other causesNeuroimaging and clinical laboratory protocols are properly applied to exclude other causes

Clinically Possible ALS

Combined findings patternUpper and lower motor neuron dysfunction signs are found together in only 1 region

Upper motor neuron patternUpper motor neuron signs are found alone in 2 or more regions

Diagnostic limitationOther diagnoses must be excluded, and clinically probable ALS laboratory-supported criteria cannot be established through the applicable clinical and diagnostic studies

ALSFRS-R

MeasureA 12-item composite measure of function in ALS

Assessed domainsFine motor, gross motor, bulbar, and respiratory function

ScoringEach item is scored from 0 to 4; higher scores indicate greater functional ability

The policy presents definite, probable, probable laboratory-supported, and possible ALS categories under the revised El Escorial criteria.

Hepatic transaminases >5 times the upper limit of normal

Document serum aminotransferase measurements obtained before and during treatment.