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

Rozlytrek

(entrectinib)

entrectinib 100 MG Oral Capsule [Rozlytrek]entrectinib 200 MG Oral Capsule [Rozlytrek]

NO BLACK BOX WARNING

Dosage & administration

* Select patients for treatment based on the presence of ROS1 rearrangement(s) or NTRK gene fusion.
* Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer: 600 mg orally once daily.
* Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors:
* Adults: 600 mg orally once daily
* Pediatric Patients 12 Years and Older: Recommended dosage is based on body surface area (BSA) as shown below
* BSA greater than 1.50 m2: 600 mg once daily
* BSA 1.11 to 1.50 m2: 500 mg once daily
* BSA 0.91 to 1.10 m2: 400 mg once daily

eficacy, safety & testing

Rozlytrek clinical details

Mechanism of Action (MOA)

Dosing & Administration

NTRK Testing

ROS1 Testing

Efficacy: NTRK Fusion-positive Solid Tumors

Safety Profile: NTRK Fusion-positive Solid Tumors

Efficacy: ROS1-positive Non-small Cell Lung Cancer (NSCLC)

Safety Profile: ROS1-positive Non-small Cell Lung Cancer (NSCLC)

drug label

Rozlytrek prescribing information

Have more Rozlytrek questions?

Submit MSL Request

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Need to report a Rozlytrek issue?

ONLINE FORMReport adverse event

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prior authorization

Rozlytrek Prior authorization resources

Complete Letter of Medical Necessity

NOT PROVIDED BY BRANDCoverage Authorization Request

Coverage Authorization Appeals

Patient Consent Form

Patient Consent Form - Spanish

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Benefits investigation

Rozlytrek Prescriber Service & Patient Consent Form

Rozlytrek Prescriber Service Form - Online Portal

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Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information

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financial assistance

Rozlytrek Financial assistance options

Co-pay savings program

commercial only

Rozlytrek Prescriber Service & Patient Consent Form

Rozlytrek Prescriber Service Form - Online Portal

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+

Rozlytrek Prescriber Service & Patient Consent Form

Rozlytrek Prescriber Service Form - Online Portal

Genentech Patient Foundation Application Form (1/2)

Genentech Patient Foundation Application Form (2/2) - Patient Consent 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

Rozlytrek Patient education

Getting started on Rozlytrek

NOT PROVIDED BY BRANDInstructions For Use: NTRK Fusion-positive Solid Tumors

NOT PROVIDED BY BRANDInstructions For Use: ROS1-positive Non-small Cell Lung Cancer (NSCLC)