CurrentCignaPolicy N/A

Rystiggo (rozanolixizumab-noli) Prior Authorization Form

A Cigna prior authorization form to collect patient, prescriber, and clinical information to support coverage review for Rystiggo (rozanolixizumab-noli) infusions across multiple dose presentations and administration settings. It requests indication, antibody status, concomitant therapy, dosing frequency, and functional scores to determine benefit availability and medical necessity.

Policy Summary

PayerCigna

PolicyRystiggo (rozanolixizumab-noli) Prior Authorization Form

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAttach antibody confirmation and clinical documentation and submit the completed prior authorization form via CoverMyMeds, SureScripts, or fax.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

4Medication presentations listed

63 daysMinimum interval between cycles

>=3MG-ADL score threshold

Policy snapshot and scope

A Cigna prior authorization form to collect patient, prescriber, and clinical information to support coverage review for Rystiggo (rozanolixizumab-noli) infusions across multiple dose presentations. It requests the indication (generalized myasthenia gravis or other), antibody status (anti‑AChR or MuSK), whether the prescriber is a neurologist, concomitant therapies, dosing frequency and interval, and functional scores (MG‑ADL and MGFA) to determine benefit and medical necessity.

Information required for authorization review

Complete all asterisked items and answer the following clinical questions to support prior authorization:

ALL of the following

Patient identifiers and contact: Patient Name, Cigna ID, Date of Birth, Patient Street Address, Patient Phone
Asterisked items must be completed for response via fax
Physician identifiers: Physician Name, Specialty, DEA, NPI or TIN, Office Contact Person, Office Phone, Office Fax, Office Street Address
Medication requested: select one of Rystiggo 280mg/2mL, 420mg/3mL, 560mg/4mL, or 840mg/6mL
Dose, frequency, duration of therapy, J-Code, ICD-10 (to be provided)
Weight of patient (lb/kg)
Therapy status
- Initial therapy (checkbox)
- Currently receiving Rystiggo (checkbox) with follow-up: prescriber attests if patient continues to derive benefit (Yes/No) and examples of benefit
Where medication will be obtained (select one): CVS Specialty Pharmacy, KabaFusion, PantherRx, Hospital Outpatient, Ambulatory Infusion Center, Other, Home Health/Home Infusion vendor, Physician's office stock
Facility/doctor dispensing information: Facility Name, State, Tax ID, Address
Administration location (select one): Patient's Home, Physician's Office, Hospital Outpatient, Other
Plan-specific note: infusion must occur in least intensive medically appropriate setting for some Cigna plans; candidate for re-direction to alternate setting? (Yes/No) with rationale if No
Is the medication for a chronic/long-term condition? (Yes/No)
Indication
- Generalized myasthenia gravis (gMG) (checkbox)
- All other indications or diagnoses (checkbox)
If indication is generalized myasthenia gravis (gMG)
- Will medication be used concomitantly with another Neonatal Fc Receptor Blocker, a Complement Inhibitor, or a Rituximab product? (Yes/No)
- Is the requested medication being prescribed by (or in consultation with) a neurologist? (Yes/No)
- Antibody confirmation (initial therapy)
  - Documentation that patient has confirmed anti-acetylcholine receptor antibody-positive gMG (Yes required for initial therapy); medical documentation must be attached
  - If not anti-AChR positive, documentation of confirmed anti-muscle-specific tyrosine kinase (MuSK) antibody-positive gMG (Yes/No); documentation must be attached
- Will treatment cycles be no more frequent than every 63 days from the start of the previous treatment cycle? (Yes/No)
Additional pertinent information field and prescriber attestation signature and date

The form is used to collect patient, prescriber, and clinical details (including medication presentation, dose, frequency, duration, weight, and diagnosis) and requires attachments of supporting documentation; for initial gMG therapy, documentation confirming anti‑acetylcholine receptor antibody positivity or confirmed MuSK antibody positivity must be attached. Items marked with an asterisk are required for fax responses and must be completed to receive a faxed outcome.

Codes and medication presentations on form

Billing Rule

Provide dispensing and billing site details

Providers must specify where the medication will be obtained, the exact dispensing facility/doctor information, and facility Tax ID to support correct billing and claim submission. Provide one of the listed dispensing sources and complete facility details when the drug will be dispensed or administered by a facility.

Specify dispensing source: CVS Specialty Pharmacy, KabaFusion, PantherRx, Hospital Outpatient, Ambulatory Infusion Center, Home Health/Home Infusion vendor, Physician's office stock, Other (specify)
When facility or doctor will dispense/ administer medication, include: Facility Name; Full address (city, state, zip); State; Facility Tax ID# (required for billing on medical claim forms)
If billing on a medical claim form, indicate whether physician office stock will be used and ensure Tax ID and NPI are provided

Actions, documentation, and submission instructions

Prior Authorization

Submit completed prior authorization form

Complete all required fields and submit the prior authorization form via CoverMyMeds, SureScripts (in your EHR), or fax. Cigna's standard response time for prescription drug coverage requests is 5 business days. For urgent requests, call Cigna to expedite the request.

Documentation Required

Attach antibody confirmation and clinical documentation

For initial therapy in generalized myasthenia gravis, attach documentation confirming anti-acetylcholine receptor antibody–positive status or confirmed MuSK antibody–positive status. Acceptable attachments include chart notes, prescription claims records, prescription receipts, or other medical documentation.

Documentation Required

Provide evidence of prior therapies and intolerance

Document prior receipt of pyridostigmine when applicable. If pyridostigmine was not received, provide documentation of inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine.

Documentation Required

Attestation and signature

The prescriber must sign the attestation that the information provided is true and accurate. The plan or insurer may perform routine audits and request medical information to verify the accuracy of the form.

Administration location and medication supply

The form captures where the drug will be obtained (CVS Specialty Pharmacy, KabaFusion, PantherRx, Hospital Outpatient, Ambulatory Infusion Center, Home Health/Home Infusion vendor, Physician's office stock, or Other) and collects facility/doctor dispensing details including Tax ID for billing. Administration location options include Patient's Home, Physician's Office, Hospital Outpatient, or Other. The form notes that for some Cigna plans, infusion MUST occur in the least intensive medically appropriate setting and asks whether the patient is a candidate for re‑direction to an alternate setting (Yes/No) with a rationale if not, to guide potential re‑direction to alternate infusion sites or home with Specialty Care Options Case Manager assistance.

Billing Rule

Indicate dispensing and administration site for billing

Indicate where the drug will be obtained and where it will be administered, and provide facility/doctor dispensing Tax ID and address to support medical claim billing.

OpenPayer

Rystiggo (rozanolixizumab-noli) Prior Authorization Form

Policy snapshot and scope

Information required for authorization review

Codes and medication presentations on form

Actions, documentation, and submission instructions

Administration location and medication supply

Definitions

Document changes