CurrentAvMedPolicy N/A

Prior authorization for Duvyzat (givinostat)

Rules and documentation requirements for pharmacy prior authorization and step-edit requests for Duvyzat (givinostat) for AvMed members, including initial and reauthorization criteria for treating Duchenne muscular dystrophy.

Policy Summary

PayerAvMed

PolicyPrior authorization for Duvyzat (givinostat)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete the prior authorization form and submit required clinical documentation (weight, genetic confirmation, motor function assessments, and safety labs).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial authorization duration

12 mL/dayQuantity limit

6 yearsMinimum age

Specialty PharmacyDispensing

Coverage Criteria for Duvyzat (givinostat)

Initial Authorization

Policy Summary

PayerAvMed

PolicyPrior authorization for Duvyzat (givinostat)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete the prior authorization form and submit required clinical documentation (weight, genetic confirmation, motor function assessments, and safety labs).

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Authorization: Member is 6 years of age or older; medication is prescribed by or in consultation with a physician who specializes in the treatment of Duchenne muscular dystrophy and/or neuromuscular disorders; diagnosis of Duchenne Muscular Dystrophy confirmed by genetic testing with a confirmed pathogenic variant in the dystrophin gene (documentation required); member is ambulatory; member has been on a stable systemic corticosteroid therapy regimen for at least 6 months (verified by chart notes and/or pharmacy paid claims); baseline evaluation including a standardized assessment of motor function (one of: 4 Standard Stairs (4SC) climb, Rise From Floor, Total North Star Ambulatory Assessment (NSAA), Six-Minute Walk Test) documented; member does NOT have any of the following clinically significant abnormal lab values: QTc interval > 500 ms or change from baseline > 60 ms; platelets ≤ 150 x 10^9/L; white blood cells ≤ 2.0 x 10^9/L; hemoglobin ≤ 8.0 g/dL; fasting triglycerides > 300 mg/dL; and dosing aligns with weight-based recommended dosing and quantity limit of 12 mL per day.

All documentation (labs, diagnostics, chart notes, weight with date obtained) must be submitted or request may be denied.

Reauthorization

Covered when ALL of the following are met:

Reauthorization: Member continues to meet ALL initial authorization criteria; member is continuing to receive stable systemic corticosteroid therapy (verified by chart notes and/or pharmacy paid claims); provider submits documentation confirming continued benefit from therapy demonstrated by stabilization or slowed decline on timed function tests (e.g., 4-stair climb, 6-minute walk test, time-to-rise) or improved/maintained NSAA score.

Reauthorization interval: 12 months. Documentation (labs, tests, chart notes) must be provided or request may be denied.

Initial Therapy Dosing and Requirements

Initial Therapy Dosing

Dosing and Duration: Weight-based dosing per product labeling: 10 to <20 kg: 22.2 mg twice daily (2.5 mL twice daily); 20 to <40 kg: 31 mg twice daily (3.5 mL twice daily); 40 to <60 kg: 44.3 mg twice daily (5 mL twice daily); ≥60 kg: 53.2 mg twice daily (6 mL twice daily). Initial authorization duration: 12 months. Quantity limit: 12 mL per day.

Prescriber must document member weight and date weight obtained.

Reauthorization / Continuation Criteria

Reauthorization

Continuation Therapy: Member continues to meet initial authorization criteria; continues stable systemic corticosteroid therapy; provider documents continued benefit with stabilization or slowed decline on timed function tests (e.g., 4-stair climb, 6-minute walk test, time-to-rise) or NSAA score.

12-month reauthorization interval; provider must submit documentation to confirm continued benefit or request may be denied.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Complete and submit the AvMed prior authorization form and include all required clinical documentation. Use the PA form to provide member and prescriber details, drug name/form/strength, dosing schedule, length of therapy, diagnosis/ICD code, weight (if applicable), and supporting attachments (lab results, diagnostics, chart notes).

Fax completed form to 1-305-671-0200
Include phone and fax numbers on the form to avoid extra contact

Step Therapy

Samples Do Not Meet Step-Edit/PA Requirements

Use of drug samples to start therapy does not satisfy AvMed step-edit or prior authorization requirements. Do not rely on samples to meet initiation criteria.

Documentation Required

Provider Submission Details — Signature and Required Fields

Prescriber must sign and clearly print their name on the authorization request (preprinted stamps are not valid). Provide complete member and prescriber information: member name, AvMed ID, date of birth, prescriber name, signature, date, office contact name, phone, fax, and NPI. Include full drug details and dosing (drug name/form/strength, dosing schedule, length of therapy), diagnosis and ICD code, weight and date obtained if applicable, and attach all supporting documentation.

Prescriber signature and printed name required; preprinted stamps are not acceptable
List office contact phone and fax to prevent delays
Attach lab results, diagnostics, and chart notes to support each checked clinical criterion

Denial Risk

Incomplete Documentation May Delay or Deny Authorization

Authorization can be delayed or the request may be denied if the PA form or supporting documentation is incomplete, incorrect, or illegible. Ensure all requested clinical documentation (e.g., genetic testing confirming a pathogenic dystrophin variant, baseline motor function assessments, lab values, and evidence of corticosteroid regimen) is provided to avoid delay or denial.

Incomplete or illegible forms risk delay or denial
Provide documentation for all clinical criteria checked on the form (labs, diagnostics, chart notes)

Verification method	Notes
Pharmacy paid claims	Previous therapies will be verified through pharmacy paid claims.
Submitted chart notes	Previous therapies may be documented via submitted chart notes to verify prior treatment history.
Samples	Use of samples to initiate therapy does not meet step edit/preauthorization criteria and are not acceptable to satisfy prior-therapy requirements.

Site-of-Care / Dispensing

Billing Rule

Dispense through designated specialty pharmacy

This medication is dispensed through the designated specialty pharmacy (Specialty Pharmacy - Proprium Rx).

Medication being provided by Specialty Pharmacy - Proprium Rx.

Ambulatory definition

DefinitionMember is able to ambulate (documented as ambulatory).

Use in criteriaAmbulatory status is required for initial authorization of Duvyzat; documentation must be submitted.

VerificationAmbulatory status should be documented in chart notes or baseline motor function assessment submission.

Genetically confirmed DMD definition

RequirementDiagnosis of Duchenne Muscular Dystrophy confirmed by genetic testing with a documented pathogenic variant in the dystrophin gene (documentation required).

DocumentationGenetic testing report with the confirmed pathogenic dystrophin variant must be submitted with the PA request.

Role in approvalGenetic confirmation is a required criterion for initial and continued authorization of therapy.

Background

Duvyzat (givinostat) is indicated in this policy for patients with Duchenne muscular dystrophy (DMD) confirmed by genetic testing with a pathogenic dystrophin variant. The policy expects treatment in ambulatory patients aged 6 years or older, prescribed by or in consultation with a physician who specializes in DMD or neuromuscular disorders, and requires documented baseline standardized motor function assessment and ongoing monitoring of safety laboratory values.

OpenPayer