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Your resource for understanding reimbursement for ZOLGENSMA

The materials below are provided to offer reimbursement support to your office throughout the ZOLGENSMA treatment journey:

Health Plan Policy Materials

Prior Authorization Criteria Guide
A simple guide to anticipated prior authorization criteria for ZOLGENSMA

Prior Authorization Criteria GuidePrior Authorization Criteria Guide

Letter of Medical Necessity Guide
Suggestions for key elements to include when writing a letter of medical necessity in support of ZOLGENSMA
Letter of Medical Necessity GuideLetter of Medical Necessity Guide

Sample Letter of Medical Necessity
A sample letter of medical necessity for ZOLGENSMA that may be used for reference
Sample Letter of Medical NecessitySample Letter of Medical Necessity

Letter of Appeals Guide
Suggestions on how to navigate the appeals process for ZOLGENSMA

Letter of Appeals GuideLetter of Appeals Guide
Coding and Billing

Coding and Billing Guide

Coding and Billing Guide
This detailed guide provides information related to codes and forms required for billing and reimbursement for ZOLGENSMA
Coding and Billing GuideCoding and Billing Guide
ZOLGENSMA CopayAssist™ Program

ZOLGENSMA CopayAssist™ Flashcard

ZOLGENSMA CopayAssist™ Flashcard
This flashcard provides detailed instructions for Buy and Bill providers on how to submit a claim through the zolgensmacopayassist.com portal ZOLGENSMA CopayAssist™ FlashcardZOLGENSMA CopayAssist™ Flashcard
Clinical Literature

Clinical Reprint List

Clinical Reprint List
Summary of clinical publications that may be referenced to help support access
for ZOLGENSMA
Clinical Reprint ListClinical Reprint List
ZOLGENSMA Prescription Form

ZOLGENSMA Prescription Form
This official prescription form is required for all patients who are prescribed ZOLGENSMA. The 4-page document also includes instructions for filling out the prescription form and a separate Patient Consent Form, which is required for enrollment into the OneGene Program®
ZOLGENSMA Prescription FormZOLGENSMA Prescription Form
ZOLGENSMA Prescribing Information

Full Prescribing Information
Download the Full Prescribing Information to review the efficacy, safety, and dosing of ZOLGENSMA
Full Prescribing InformationFull Prescribing Information

Indication and Important Safety InformationISI Tray Icon

Indication

ZOLGENSMA is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.

Indication and Important Safety Information

Indication

ZOLGENSMA is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.

Limitations of Use

The safety and effectiveness of repeat administration or the use in patients with advanced SMA (e.g., complete paralysis of limbs, permanent ventilator dependence) has not been evaluated with ZOLGENSMA.

Important Safety Information

BOXED WARNING: Acute Serious Liver Injury and Acute Liver Failure

Acute serious liver injury, acute liver failure, and elevated aminotransferases can occur with ZOLGENSMA. Patients with preexisting liver impairment may be at higher risk. Prior to infusion, assess liver function of all patients by clinical examination and laboratory testing (e.g., hepatic aminotransferases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], total bilirubin, and prothrombin time). Administer a systemic corticosteroid to all patients before and after ZOLGENSMA infusion. Continue to monitor liver function for at least 3 months after infusion.

WARNINGS AND PRECAUTIONS

Thrombocytopenia
Transient decreases in platelet counts, some of which met the criteria for thrombocytopenia, were typically observed within the first two weeks after ZOLGENSMA infusion. Monitor platelet counts before ZOLGENSMA infusion and on a regular basis for at least 3 months afterwards.

Thrombotic Microangiopathy
Cases of thrombotic microangiopathy (TMA) were reported approximately 1 week after ZOLGENSMA infusion. Obtain baseline creatinine and complete blood count before ZOLGENSMA infusion.  Following infusion, monitor for thrombocytopenia as well as other signs and symptoms of TMA.  Consult a pediatric hematologist and/or pediatric nephrologist immediately to manage if clinically indicated.

Elevated Troponin-I
Increases in cardiac troponin-I levels were observed following ZOLGENSMA infusion. Monitor troponin-I before ZOLGENSMA infusion and on a regular basis for at least 3 months afterwards.

ADVERSE REACTIONS

The most commonly observed adverse reactions (incidence ≥5%) in clinical studies were elevated aminotransferases and vomiting.

Please see accompanying Full Prescribing Information.