Oxlumo (lumasiran) Medication Precertification Request - Coverage Criteria
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This document is Aetna's precertification request form and instructions for Oxlumo (lumasiran) covering initiation and continuation of therapy for patients (including required clinical and insurance information) to obtain prior authorization for the medication.
No material clinical or coverage changes in this revision.
Coverage / Precertification Criteria
Precertification criteria
Covered when ALL of the following are met:
Provider should indicate confirmation method on the form.
See form sections A–F and D for administration settings.
Document response on the continuation portion of the form.
The precertification form specifically asks whether the requested medication will be used in combination with nedosiran. This response is collected to inform the prior authorization review and should be completed by the prescriber so combination therapy can be considered during the review process.
The form does not contain explicit language designating treatments as not medically necessary. However, approval depends on submission of required clinical information; lack of documented confirmation of diagnosis or absence of evidence of clinical benefit on continuation requests would prevent approval per the form instructions.
Providers should ensure all required clinical fields are completed and legible, because missing documentation (for example, confirmation of PH1 diagnosis or documentation of a positive response for continuation) may adversely affect the authorization decision.
Billing & Diagnosis Codes
| Administration code(s) (CPT): | Placeholder for CPT administration codes to be provided by the prescriber/dispensing provider |
| Primary ICD Code | Primary diagnosis ICD code to be provided |
| Secondary ICD Code | Secondary diagnosis ICD code to be provided |
| Other ICD Code | Other diagnosis ICD code to be provided |
What Providers Must Do
Precertification required — indicate start vs continuation and product details
Complete the Aetna Oxlumo precertification form for each request; indicate whether this is a start of treatment or a continuation and provide the start date or date of last treatment as requested on the form. Include the requested product, dose, and frequency in the Product Information section.
- Check the appropriate box for Start of treatment or Continuation of therapy and provide the corresponding date (Start date or Date of last treatment).
- Enter Oxlumo (lumasiran) as the product and specify the dose and frequency in Section E.
Document combination therapy — nedosiran query
Answer the form question asking specifically whether Oxlumo will be used in combination with nedosiran; the form requires a yes/no response.
- Mark Yes or No in response to: "Will the requested medication be used in combination with nedosiran?"
Required documentation — complete all fields legibly and provide clinical evidence
Complete all fields legibly on the two‑page precertification request including patient demographics, insurance/contact information, prescriber and dispensing provider details, product (dose/frequency), and diagnosis ICD codes; include required clinical information and, for continuation requests, evidence of response to therapy.
- Patient information (name, DOB, contact, weight/height, allergies) per Section A.
- Prescriber information including specialty, NPI, state license, and contact per Section C.
- Place of administration and dispensing provider details per Section D.
- Product name, dose, and frequency in Section E.
- Primary and additional ICD codes in Section F.
- Complete the required clinical information in Section G for all requests; for continuation, indicate positive response to therapy (e.g., decrease/normalization of urinary/plasma oxalate or improved kidney function).
- Signature and date required in Section H.
Fraud warning and potential penalties — provide truthful, complete information
Do not submit false or concealed information; knowingly filing a request with materially false or concealed information may constitute fraud and may subject the filer to criminal and civil penalties. The plan may request additional information or clarification to evaluate requests.
- Signature required in Section H certifies the accuracy of the information provided.
- Be prepared to supply additional documentation if the plan requests clarification.
Background
This two-page precertification form is used to request authorization for lumasiran (Oxlumo) for patients with primary hyperoxaluria type 1 (PH1). For initial authorization the form requires confirmation of PH1 by either a molecular genetic test demonstrating an AGXT gene mutation or by liver enzyme analysis showing absent or significantly reduced AGT activity. For continuation requests the form requires documentation of clinical benefit, such as a decrease or normalization in urinary and/or plasma oxalate levels or improvement in kidney function.
Definitions
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