CurrentCignaPolicy N/A

Oxlumo Prior Authorization Form

This is a Cigna prior authorization request form to obtain approval for Oxlumo (lumasiran) including patient, prescriber, dosing, administration site, pharmacy source, and required clinical documentation to support initial or continuation therapy. It documents the specific clinical questions and evidentiary items that must be submitted with the request.

Policy Summary

PayerCigna

PolicyOxlumo Prior Authorization Form

Policy CodePolicy N/A

Change TypeForm / informational (no material coverage change)

Effective Date

Next Review Date

Key ActionFax the completed PA form with attached supporting documentation (chart notes, genetic test results, labs) or submit via CoverMyMeds/SureScripts; call for urgent requests to expedite.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes — form collects documentation required for PA and references existing Oxlumo Utilization Management Medical Policy.

3Primary Hyperoxaluria types listed

2Objective laboratory thresholds specified

1Specialty pharmacy options listed

Oxlumo (lumasiran) prior authorization form — at-a-glance

This is a Cigna prior authorization request form to collect clinical and administrative information required to review requests for Oxlumo (lumasiran). The form references the Oxlumo Utilization Management Medical Policy and requires attached genetic and laboratory documentation to support initial therapy or reauthorization. Key items collected include patient and prescriber details, medication selection and dosing (e.g., Oxlumo 94.5 mg/0.5ml vial), and site-of-care/pharmacy information (specialty pharmacy, retail, hospital outpatient, home infusion, physician office stock). Responses and attached documentation inform the authorization decision (coverage stance: informational).

Form-driven clinical criteria for initial and continuation therapy

Initial Therapy criteria questions (documentation required)

Documentation must be attached; answers collected on form inform authorization per Oxlumo Utilization Management Medical Policy

ALL of the following

Is this initial therapy?
If Initial Therapy, ALL of the following should be documented
- Genetic confirmation: Genetic test confirming diagnosis of PH1 via identification of biallelic pathogenic variants in AGXT
  Medical documentation must be attached; absence may lead to denial
- Urinary oxalate excretion >= 0.5 mmol/24 hours/1.73 m2 with absence of secondary sources of oxalate>= 0.5 mmol/24 hours/1.73 m2
  Documentation must be attached
- If urinary oxalate excretion data not provided, ONE of the following may be provided
  - Urinary oxalate:creatinine ratio above the age-specific upper limit of normal
    Documentation must be attached
  - Plasma oxalate level >= 20 micromoles/L>= 20 micromoles/L
    Documentation must be attached
- Transplant status: Patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1
  Yes/No captured on form
- Prescriber specialty: Prescribed by or in consultation with a nephrologist or urologist
  Yes/No captured on form
Site of care selection: Where will medication be obtained and where administered (site of care) documented
Options include specialty pharmacies, retail, hospital outpatient, home infusion, physician office stock

Continuation / Reauthorization criteria

For patients currently receiving Oxlumo, documentation of continued benefit must be attached

ALL of the following

Current use: Is patient currently receiving Oxlumo?
Examples of continued benefit (one or more)
- Reduced urinary oxalate excretion from baseline
- Decreased urinary oxalate:creatinine ratio from baseline
- Reduced plasma oxalate levels from baseline

Concurrent therapy question

Form collects whether concurrent use with Rivfloza (nedosiran) will occur

ANY of the following

Concurrent therapy: Will patient use Oxlumo concurrently with Rivfloza? (Yes/No)

Actions required from submitting provider

Prior Authorization

Submit completed PA form with supporting documentation

Fax the completed prior authorization form with supporting documentation (chart notes, genetic test results, laboratory data) to the number on the form. If the request is urgent, call the phone number listed to expedite review. Alternatively, submit the request electronically via CoverMyMeds or SureScripts through your EHR.

Documentation Required

Genetic and laboratory evidence required for initial therapy

For initial therapy, attach genetic testing confirming biallelic pathogenic AGXT variants for PH1 and provide urinary oxalate evidence (>= 0.5 mmol/24 hours/1.73 m2) or, if not available, an elevated urinary oxalate:creatinine ratio or plasma oxalate (>= 20 micromoles/L). The form notes that failure to attach required medical documentation may lead to denial.

Documentation Required

Documentation of continued benefit required for reauthorization

For patients currently receiving Oxlumo, submit objective evidence of continued benefit, such as reduced urinary oxalate excretion, decreased urinary oxalate:creatinine ratio, reduced plasma oxalate from baseline, or improved/stabilized clinical signs or symptoms. Medical documentation must be attached to support reauthorization.

Billing Rule

Site-of-care documentation

Document on the form where the medication will be obtained and where it will be administered (options include specialty pharmacies, retail, hospital outpatient, home infusion, physician office stock). Indicate if physician office stock will be billed on a medical claim form and provide facility/dispensing information as requested.

Denial Risk

Incomplete asterisked fields prevent fax outcome response

The form specifies that Cigna will not return the outcome via fax unless all asterisked (*) items are completed; leaving required asterisked fields incomplete may delay or prevent a faxed response.