Danyelza

(naxitamab)

DANYELZA 40 MG in 10 ML Injection

Dosage & administration

The recommended dosage of DANYELZA is 3 mg/kg/day (up to 150 mg/day), administered as an intravenous infusion after dilution on Days 1, 3, and 5 of each treatment cycle. Treatment cycles are repeated every 4 weeks until complete response or partial response, followed by 5 additional cycles every 4 weeks. Subsequent cycles may be repeated every 8 weeks.

Discontinue DANYELZA and GM-CSF for disease progression or unacceptable toxicity. Administer GM-CSF subcutaneously prior to and during each treatment cycle as recommended.

biomarker testing

Danyelza clinical details

Genetic testing requirements were obtained from the NCCN guidelines for each cancer type.

drug label

Danyelza prescribing information

Contact Medical Science Liaison Report Adverse Event

prior authorization

Danyelza prior authorization resources

Most recent Danyelza prior authorization forms

View By Payer

Updated: May 30, 2023Cigna - Danyelza Prior Authorization Form

Updated: May 24, 2023Aetna - Danyelza Prior Authorization Form

Updated: May 23, 2023Aetna - Medicare Part B Danyelza Prior Authorization Form

PDFComplete Letter of Medical Necessity

PDFCoverage Authorization Appeals

Learn More

Benefits investigation

PDFY-mAbs Connect Enrollment Form

Learn More

Reimbursement help (FRM)

OTHERReceive Assistance from an FRM Regarding Reimbursement Information

Learn More

financial assistance

Danyelza financial assistance options

Co-pay savings program

commercial only

PDFY-mAbs Connect Enrollment Form

OTHEREnroll in Patient Savings Program

Learn More

Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Foundation programs

under insured

no insurance

goverment insurance

65+

OTHERY-mAbs Connect Patient Assistance Program

Learn More

Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and co-pays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.

How to sign up

Patients submit proof of out-of-pocket drug costs to charities for reimbursement

patient education

Danyelza patient education

Getting started on Danyelza

To share resource; ask patient to:

1.Pull out phone

2.Open camera

3.Scan QR code with camera

4.Tap link