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Imcivree

(setmelanotide)

setmelanotide 10 MG/ML Injectable Solution [Imcivree]

NO BLACK BOX WARNING

Dosage & administration

* Select patients for treatment who have genetically determined or suspected deficiency of POMC, PCSK1, or LEPR, or who have a clinical diagnosis of BBS.
* Treat patients with variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) in the clinical context of the patient.
* Recommended starting dosage injected subcutaneously for:
* Adults and pediatric patients aged 12 years and older is 2 mg (0.2 mL) once daily for two weeks.
* Pediatric patients aged 6 to less than 12 years is 1 mg (0.1 mL) once daily for two weeks.

* Recommended target dosage for adults and pediatric patients aged 6 years and older is 3 mg (0.3 mL) injected subcutaneously once daily.
* For recommended dosage in patients with renal impairment, see Full Prescribing Information.
* For titration and administration recommendations, see Full Prescribing Information.
* Evaluate weight loss after 12-16 weeks of treatment in patients with POMC-, PCSK1-, or LEPR-deficiency or after 1 year in patients with BBS. See Full Prescribing Information for monitoring and discontinuation recommendations based on weight loss.

Imcivree prescribing information

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prior authorization

Imcivree Prior authorization resources

NOT PROVIDED BY BRANDComplete Letter of Medical Necessity

NOT PROVIDED BY BRANDCoverage Authorization Request

NOT PROVIDED BY BRANDCoverage Authorization Appeals

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Benefits investigation

Imcivree Start Form

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Reimbursement help (FRM)

NOT PROVIDED BY BRANDReimbursement help (FRM) resources

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financial assistance

Imcivree Financial assistance options

Co-pay savings program

commercial only

Imcivree Start 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+

Patient Assistance Program

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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

Imcivree Patient education

Getting started on Imcivree

Instructions For Use - Obesity ( due to genetic conditions)

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Instructions For Use - Bardet Biedl Syndrome (BBS)

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Patient toolkit

About Imcivree

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

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Imcivree FAQs

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Please note:

Access to a Field Reimbursement Manager (FRM) or Medical Science Liaison (MSL) varies by brand and may require talking with your rep first.
Samples are provided at the discretion of the brand.
We are unable to collect Protected Health Information (PHI), fill out forms, or submit them on your behalf.

Imcivree

Dosage & administration

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prior authorization

Imcivree Prior authorization resources

Benefits investigation

Reimbursement help (FRM)

financial assistance

Imcivree Financial assistance options

Co-pay savings program

Overview

Patient benefit

Patient eligibility

How to sign up

Bridge program

Overview

Patient benefit

Patient eligibility

How to sign up

Foundation programs

Overview

Patient benefit

Patient eligibility

How to sign up

patient education

Imcivree Patient education

Getting started on Imcivree

Patient toolkit

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