CurrentAetnaPolicy N/A

Qalsody (tofersen) precertification for ALS treatment

Precertification request form and required clinical information for Aetna coverage of Qalsody (tofersen) for patients with amyotrophic lateral sclerosis (ALS). Applies to providers submitting initial or continuation requests to Aetna.

Policy Summary

PayerAetna

PolicyQalsody (tofersen) precertification for ALS treatment

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit Aetna precertification for start or continuation of Qalsody with required clinical documentation (ALS diagnosis, SOD1 mutation confirmation, FVC/SVC value, and specialist involvement).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

requiredspecialist involvement

≥45%FVC/SVC threshold

SOD1 requiredgenetic confirmation

Coverage Criteria for Qalsody (tofersen)

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Initial Request Criteria: Patient has a diagnosis of amyotrophic lateral sclerosis (ALS); evidence of weakness attributable to ALS (e.g., medical history and/or diagnostic testing including nerve conduction studies, imaging, and laboratory values); SOD1 mutation confirmed via genetic testing; forced vital capacity (FVC) or slow vital capacity (SVC) greater than or equal to 45% of the predicted value for gender, height, and age; medication will be prescribed by or in consultation with a neurologist, neuromuscular specialist, or physician specializing in the treatment of ALS; indicate whether administration will be at an Aetna designated gene therapy treatment center.FVC/SVC >= 45%

All listed items must be documented on the precertification form.

Continuation Therapy

Covered when ALL of the following are met

Continuation Request Criteria: For continuation requests, documentation must indicate the date of last treatment, whether the patient requires invasive ventilation or has a tracheostomy, and that the patient has demonstrated clinical benefit from therapy with the requested medication.

Continuation requires evidence of clinical benefit and updated clinical status.

The precertification form explicitly queries whether the patient has a tracheostomy and whether the patient requires invasive ventilation. These items are collected on both initial and continuation sections of the clinical information: initial requests ask “Does the patient have a tracheostomy?” and continuation requests ask “Does the patient require invasive ventilation or tracheostomy?”. Operationally, include responses to these questions on the precertification submission because they are part of the clinical status the reviewer will use to determine coverage and continuation eligibility.

Requests that do not include required clinical documentation may be incomplete or denied. The form requires confirmation that the patient has an ALS diagnosis, documentation of weakness attributable to ALS, genetic confirmation of an SOD1 mutation for initial requests, and a recorded respiratory function value showing FVC or SVC ≥ 45% of predicted. Omission of any of these items — ALS diagnosis, evidence of weakness, SOD1 mutation test results, or the FVC/SVC value — can result in the request being considered not medically necessary or insufficient for precertification review.

Administration and Diagnosis Codes

Administration / Billing codesCPT

Administration code(s) (CPT)

Administration CPT codes — provider to indicate applicable codes on form

Diagnosis codesICD-10

Primary ICD Code	Field for primary diagnosis ICD-10 code
Secondary ICD Code	Field for secondary diagnosis ICD-10 code
Other ICD Code	Field for other diagnosis ICD-10 code(s)

inv-07: Forced vital capacity (FVC) or slow vital capacity (SVC) — threshold requirement

ThresholdFVC or SVC ≥ 45% of predicted (for gender, height, and age)

Measurement types acceptedForced vital capacity (FVC) or slow vital capacity (SVC)

Applies toInitial requests for Qalsody (tofersen)

Documentation requirementValue must be documented on the precertification form

Provider Requirements and Submission Guidance

Prior Authorization

Prior Authorization Required

Aetna precertification must be submitted for start or continuation of Qalsody (tofersen). Submit the completed Qalsody Medication Precertification Request form (all fields legible) to Aetna Precertification Notification by phone or fax. Precertification contact: Phone 1-866-752-7021 (TTY: 711); Fax 1-888-267-3277. For Medicare Advantage Part B use the Medicare request form.

All fields on the two-page Qalsody precertification form must be completed
Precertification required for both start of treatment and continuation requests
Use Medicare form for Medicare Advantage Part B members

Step Therapy

Step therapy / sequencing

Initial requests must include documentation that supports the diagnosis and treatment plan; there is no member-level step therapy (no prior trial of another specific drug) specified, but the request must include the specific clinical information described under "Required clinical documentation."

No step-therapy drug sequencing is specified by Aetna
Initial requests require completion of the Initial Requests clinical checklist on the precertification form
Continuation requests require completion of the Continuation Requests clinical checklist on the form

Documentation Required

Required documentation

Complete patient demographics, prescriber information, product dosing and frequency, and diagnosis fields on the precertification form. Include the following clinical documentation with all precertification requests: confirmation of ALS diagnosis; documentation that the prescriber is a neurologist/neuromuscular specialist or consult with one; whether administration will occur at an Aetna-designated gene therapy treatment center (and name, if applicable); and responses to the Initial or Continuation clinical checklists.

Patient demographics: name, DOB, address, contact numbers, height/weight, allergies
Prescriber: name, specialty, license number, NPI, office contact, specialty (neurologist or neuromuscular specialist preferred)
Product: Qalsody (tofersen) dose and frequency
Diagnosis: primary ICD code and any secondary/other codes
Clinical checklist: ALS diagnosis confirmation; documentation of weakness attributable to ALS (supporting testing such as nerve conduction studies, imaging, labs); SOD1 mutation confirmed by genetic testing; FVC or SVC value (percent predicted); tracheostomy or invasive ventilation status; documentation of clinical benefit for continuation requests

Denial Risk

Missing required clinical documentation — denial/delay risk

Missing required clinical documentation may result in denial or delay of the precertification request. Requests lacking any of the following are at particular risk: absence of documented ALS diagnosis, missing confirmation of SOD1 mutation, or missing FVC/SVC percent predicted values (or documentation of tracheostomy/invasive ventilation status for continuation). Ensure the Initial or Continuation Requests checklist items on the precertification form are completed and supporting test reports (genetic test, pulmonary function tests, imaging, nerve studies) are uploaded or faxed with the form.

Risk factors for denial: no documented ALS diagnosis; no documented SOD1 genetic test confirming mutation; no documented FVC or SVC percent predicted value or missing tracheostomy/ventilation status
Attach supporting reports: genetic testing results, PFT reports showing FVC/SVC percent predicted, nerve conduction/EMG reports, imaging and relevant lab results
Incomplete forms or missing signatures/contact information may cause processing delays

Background

Qalsody (tofersen) is a therapy for patients with amyotrophic lateral sclerosis (ALS) who have an SOD1 mutation. The Aetna precertification form collects required clinical information to evaluate initial and continuation therapy eligibility, including confirmation of ALS diagnosis, evidence of weakness attributable to ALS, genetic test confirmation of the SOD1 mutation, and respiratory function (forced vital capacity or slow vital capacity). For continuation requests the form additionally asks whether the patient requires invasive ventilation or tracheostomy and whether the patient has demonstrated clinical benefit from therapy.

Key Definitions

inv-13: FVC / SVC — pulmonary function measures and initial-request threshold

Pulmonary function measuresAcceptable measures: Forced vital capacity (FVC) or slow vital capacity (SVC)

Initial-request respiratory thresholdFVC or SVC greater than or equal to 45% of predicted (adjusted for gender, height, and age)

When requiredRequired documentation for all initial precertification requests

Related clinical itemEvidence of weakness attributable to ALS must also be documented for initial requests

inv-14: SOD1 mutation — genetic confirmation requirement for initial requests

Genetic confirmation requiredSOD1 mutation must be confirmed via genetic testing for initial requests

Applies toInitial precertification requests for Qalsody (tofersen)

Documentation locationConfirmation must be indicated on the clinical information section of the precertification form

Consequence of missing confirmationRequests without SOD1 mutation confirmation may be considered not medically necessary or denied