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

Jelmyto

(mitomycin)

mitomycin 40 MG Powder for Pyelocalyceal Solution [Jelmyto]

NO BLACK BOX WARNING

Dosage & administration

* JELMYTO is for pyelocalyceal use only and not for intravenous use, topical use, or oral administration.
* Administer 1.3 g of sodium bicarbonate orally the evening prior to, the morning of, and 30 minutes prior to instillation procedure (total of 3.9 g).
* The dose of JELMYTO to be instilled is 4 mg per mL via ureteral catheter or nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin).
* Instill JELMYTO once weekly for six weeks. For patients with a complete response 3 months after JELMYTO initiation, JELMYTO instillations may be administered once a month for a maximum of 11 additional instillations.

eficacy, safety & testing

Jelmyto clinical details

Efficacy

Safety Profile

Preparing Jelmyto

Administration

drug label

Jelmyto prescribing information

Need to report a Jelmyto issue?

ONLINE FORMReport adverse event

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prior authorization

Jelmyto Prior authorization resources

Complete Letter of Medical Necessity

NOT PROVIDED BY BRANDCoverage Authorization Request

Coverage Authorization Appeals

PA & Appeals Checklist

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Benefits investigation

UroGen Support Patient Enrollment Form

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Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information

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financial assistance

Jelmyto Financial assistance options

Co-pay savings program

commercial only

UroGen Support Patient 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+

UroGen Support Patient Enrollment Form

UroGen Support 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

Jelmyto Patient education