CurrentCignaPolicy N/A

Ryplazim

This document is Cigna's prior-authorization request form and instructions for Ryplazim (plasminogen). It defines required documentation, clinical questions for initial and continuation therapy, pharmacy dispensing options, and contact/fax information for submission.

Policy Summary

PayerCigna

PolicyRyplazim

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionFax the completed form and supporting documentation (genetic test results, plasminogen activity labs, clinical notes) to (855) 840-1678 or submit online via CoverMyMeds; urgent requests must be phoned to (800) 882-4462.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

3Primary documentation requirements

2Quantitative lab thresholds

1Preferred specialty pharmacy listed

Policy summary

This is Cigna's prior-authorization request form and instructions for Ryplazim (plasminogen). It supports Cigna's adjudication by collecting confirmation of diagnosis (genetic testing), baseline and trough plasminogen activity levels, and clinical response information needed for initial and continuation therapy decisions.

Documentation required for coverage decisions

Initial therapy documentation requirements

Coverage request will require ALL of the following documentation for initial therapy:

ALL of the following

Diagnosis of plasminogen deficiency type 1 (hypoplasminogenemia) confirmed by biallelic pathogenic variants in the PLG gene.
Medical documentation specific to the response must be attached (chart notes, laboratory results, genetic test results, etc.).
Baseline plasminogen activity level (prior to initiating Ryplazim) less than or equal to 45% of normal based on the reporting laboratory's reference range.<= 45% of normal
Documentation must be attached.
History of lesions and symptoms consistent with congenital plasminogen deficiency.
Documentation must be attached.
Prescriber specialty indicated; ideally prescribed by or in consultation with a hematologist.
Form asks whether the medication is being prescribed by or in consultation with a hematologist (Yes/No).

Continuation therapy documentation requirements

For patients currently receiving Ryplazim, coverage request should include ONE of the following to demonstrate clinical benefit:

ANY of the following

Documentation that the patient has had a clinical response to Ryplazim as determined by the prescriber.
Examples include resolution of active lesions, stabilization of current lesions, and prevention of new or recurrent lesions.
Alternate biochemical response: Trough plasminogen activity level increased by >= 10% absolute above baseline trough level (prior to initiating Ryplazim).>= 10% absolute change
Used when clinical response is not documented; form asks Yes/No.

What clinicians and billing staff must do

Prior Authorization

Submit prior authorization with documentation

Fax the completed prior authorization form and all supporting documentation to (855) 840-1678 or submit online via CoverMyMeds (CoverMyMeds/SureScripts). For URGENT requests, phone Cigna at (800) 882-4462 to attest to urgency.

Fax: 855-840-1678
Submit online: CoverMyMeds (www.covermymeds.com) / SureScripts
Urgent phone attestation: 800-882-4462

Documentation Required

Attach confirming genetic and laboratory evidence for initial therapy

For initial therapy, attach confirmatory genetic and laboratory evidence: documentation of biallelic pathogenic PLG variants and a baseline plasminogen activity level ≤45% of normal, plus clinical history of lesions/symptoms consistent with congenital plasminogen deficiency. Include patient-identifying information with all records.

Genetic test results confirming biallelic PLG pathogenic variants
Baseline plasminogen activity lab report showing ≤45% of normal
Clinical chart notes describing lesions/symptoms

Documentation Required

Provide evidence of clinical response for continuation

For continuation, provide prescriber-documented clinical response such as resolution of active lesions, stabilization of existing lesions, or prevention of new/recurrent lesions. If clinical response is not documented, submit trough plasminogen activity demonstrating an absolute increase ≥10% above baseline trough.

Clinical response examples: resolution, stabilization, or prevention of lesions
Alternate biochemical evidence: ≥10% absolute trough plasminogen activity improvement over baseline

Billing Rule

Site of care / dispensing selection required

Specify where the medication will be obtained; Cigna designates Accredo as its nationally preferred specialty pharmacy. Options include Accredo Specialty Pharmacy, hospital outpatient, retail, home health/home infusion, physician office stock, or other—provide dispensing facility details as requested on the form.

Accredo Specialty Pharmacy (Cigna's nationally preferred specialty pharmacy)
Hospital outpatient
Retail pharmacy
Home Health / Home Infusion vendor
Physician's office stock

Administrative and submission requirements

Administrative / submission requirements

Completion and submission requirements:

ALL of the following

All asterisked patient and physician identifying items on the form must be completed for Cigna to respond via fax.
Includes physician name, DEA/NPI/TIN, Cigna ID, patient DOB, patient address, etc.
Attach medical documentation to support responses; may include chart notes, lab results, genetic testing, claims records, prescription receipts.
All documentation must include patient-specific identifying information.
Our standard response time for prescription drug coverage requests is 5 business days.
Standard response time is 5 business days.
If Urgent, caller must check Urgent box and call phone number to attest that applying standard review timeframe may seriously jeopardize the customer's life, health, or ability to regain maximum function.
Urgent request process; caller must phone the provided number.
Specify site where medication will be obtained (Accredo specialty pharmacy, hospital outpatient, retail, home health/home infusion, physician office stock, other).
Accredo is Cigna's nationally preferred specialty pharmacy.

Submission/contact: Fax completed form and supporting documentation to (855) 840-1678. Submit online via CoverMyMeds (www.covermymeds.com) or via SureScripts in your EHR. Accredo is Cigna's nationally preferred specialty pharmacy (orders can be placed via E-prescribe, Fax 888.302.1028, or Verbal 866.759.1557). For URGENT requests call (800) 882-4462.

Common questions

Q: What documentation demonstrates response for continuation requests? A: Clinical documentation showing resolution, stabilization, or prevention of lesions as determined by the prescriber, or a trough plasminogen activity level showing a >= 10% absolute increase above baseline trough level. Q: What must be provided for initial therapy? A: Documentation of biallelic pathogenic PLG variants and a baseline plasminogen activity ≤ 45% of normal, plus history of lesions consistent with congenital plasminogen deficiency. Q: Where and how should prior authorization be submitted? A: Fax the completed form and supporting records to (855) 840-1678, submit online via CoverMyMeds/SureScripts, and call (800) 882-4462 for urgent requests. Q: Which specialty pharmacy is preferred? A: Accredo is Cigna's nationally preferred specialty pharmacy (ordering options include e-prescribe, Fax 888.302.1028, or Verbal 866.759.1557).