Dosage & Administration Drug label Prior authorization Financial assistance

Ruconest

(C1 esterase inhibitor)

C1 esterase inhibitor (recombinant) 2100 UNT Injection [Ruconest]

NO BLACK BOX WARNING

Dosage & administration

For Intravenous Use Only.

•Reconstitute each vial (2100 U) by adding 14 mL sterile Water for Injection per vial to obtain a solution of 150 U per mL. ( 2.3)•Administer the reconstituted solution at room temperature as a slow intravenous injection over approximately 5 minutes. ( 2.3)•Appropriately trained patients may self-administer upon recognition of an HAE attack. ( 2.3)

Recommended dose of RUCONEST for an acute attack

Body weight	RUCONEST Dose for Intravenous Injection	Volume (mL) of Reconstituted Solution (150 U/mL) to be Administered
< 84 kg	50 U per kg	Body weight in kg divided by 3
≥ 84 kg	4200 U (2 vials)	28 mL

If the attack symptoms persist, an additional (second) dose can be administered at the recommended dose level. Do not exceed 4200 U per dose. No more than two doses should be administered within a 24 hour period.

Ruconest prescribing information

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Need to report a Ruconest issue?

ONLINE FORMReport adverse event

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prior authorization

Ruconest Prior authorization resources

NOT PROVIDED BY BRANDComplete Letter of Medical Necessity

NOT PROVIDED BY BRANDComplete Coverage Authorization request

NOT PROVIDED BY BRANDCoverage Authorization Appeals

Coverage Authorization Request - English

Coverage Authorization Request - Spanish

Billing and Coding Guide

Letter of Medical Necessity - English

Letter of Medical Necessity - Spanish

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Benefits investigation

NOT PROVIDED BY BRANDBenefits investigation resources

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Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information

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financial assistance

Ruconest Financial assistance options

Co-pay savings program

commercial only

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+

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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