Dosage & Administration Efficacy safety testing Drug label Prior authorization Financial assistance

Lutathera

(dotatate)

25 ML lutetium Lu 177 dotatate 10 MCI/ML Injection [Lutathera]

NO BLACK BOX WARNING

Dosage & administration

* Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA.
* Administer 7.4 GBq (200 mCi) every 8 weeks (± 1 week) for a total of 4 doses.
* Administer long-acting octreotide 30 mg intramuscularly 4 to 24 hours after each LUTATHERA dose and short-acting octreotide for symptomatic management.
* Continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing LUTATHERA until disease progression or for 18 months following treatment initiation.
* Administer antiemetics before recommended amino acid solution.
* Initiate recommended intravenous amino acid solution 30 minutes before LUTATHERA infusion; continue during and for at least 3 hours after LUTATHERA infusion. Do not decrease dose of amino acid solution if LUTATHERA dose is reduced.

eficacy, safety & testing

Lutathera clinical details

Mechanism of Action (MOA)

Efficacy

Safety Profile

Dosing & Administration

drug label

Lutathera prescribing information

Have more Lutathera questions?

Submit MSL Request

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Need to report a Lutathera issue?

ONLINE FORMReport adverse event

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prior authorization

Lutathera Prior authorization resources

NOT PROVIDED BY BRANDComplete Letter of Medical Necessity

NOT PROVIDED BY BRANDCoverage Authorization Request

Coverage Authorization Appeals

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Benefits investigation

AAA PatientCONNECT Lutathera Enrollment Form

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Reimbursement help (FRM)

NOT PROVIDED BY BRANDReimbursement help (FRM) resources

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financial assistance

Lutathera Financial assistance options

Co-pay savings program

commercial only

AAA PatientCONNECT Lutathera Enrollment Form

Enroll in Patient Savings Program

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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

Bridge program

commercial only

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Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

under insured

no insurance

goverment insurance

65+

AAA PatientCONNECT Lutathera Enrollment Form

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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

Lutathera Patient education