Libtayo
(cemiplimab)7 ML cemiplimab-rwlc 50 MG/ML Injection [Libtayo]
NO BLACK BOX WARNING
Dosage & administration
The recommended dosage of LIBTAYO is 350 mg as an intravenous infusion over 30 minutes every 3 weeks.
eficacy, safety & testing
Libtayo clinical details
Mechanism of Action
Dosing
Dose Modifications
Clinical Trial [Combination Therapy]: NSCLC
Clinical Trial [Monotherapy]: NSCLC
Efficacy - OS [Combination Therapy]: NSCLC
Efficacy - PFS [Combination Therapy]: NSCLC
Safety Profile [Combination Therapy]: NSCLC
Safety Profile - Immune-Mediated Adverse Reactions [Combination Therapy]: NSCLC
Safety Profile [Monotherapy]: NSCLC
Safety Profile - Immune-Mediated Adverse Reactions [Monotherapy]: NSCLC
Efficacy Overview [Monotherapy]: NSCLC
Efficacy - OS [Monotherapy]: NSCLC
Efficacy - PFS [Monotherapy]: NSCLC
Efficacy - Subgroup Analysis: Baseline Characteristics [Monotherapy]: NSCLC
Efficacy - Exploratory Analysis: PD-L1 Expression Levels ≥50% [Monotherapy]: NSCLC
Clinical Trial [Studies 1423 and 1540]: Advanced CSCC
Clinical Trial [Baseline Characteristics]: Advanced CSCC
Efficacy Overview: Advanced CSCC
Efficacy [ORR & DOR]: Advanced CSCC
Efficacy [Long-term Follow Up Data]: Advanced CSCC
Efficacy [Tumor Response]: Advanced CSCC
Safety Profile: Advanced CSCC
Long-Term Follow Up Safety Data: Advanced CSCC
Safety Profile [Immune-mediated Adverse Reactions]: Advanced CSCC
Clinical Trial [Baseline Characteristics]: Locally Advanced BCC
Clinical Trial: Locally Advanced BCC
Efficacy [ORR DOR & TTR]: Locally Advanced BCC
Efficacy [Long-Term Follow Up Data]: Locally Advanced BCC
Safety Profile: Locally Advanced BCC
Safety Profile [Immune-Mediated Adverse Reactions]: Locally Advanced BCC
drug label
Libtayo prescribing information
Have more Libtayo questions?
Submit MSL Request
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Your request will be referred to the appropriate Regeneron Pharmaceuticals, Inc. medical professional, such as a Libtayo pharmaceutical rep; Medical Science Liaison (MSL) or medical affairs.
Need to report a Libtayo issue?
ONLINE FORMReport adverse event
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You can report a Libtayo adverse event on MedWatch, the FDA's medical product safety reporting program for health professionals, patients and consumers.
prior authorization
Libtayo Prior authorization resources
Complete Letter of Medical Necessity
NOT PROVIDED BY BRANDCoverage Authorization Request
Coverage Authorization Appeals
Sample Letter of Medical Exception
PA Checklist
Learn More
If available, these templates are provided by the brand to help you navigate insurance, especially with newer drugs.
Benefits investigation
Libtayo Surround Enrollment Form
Libtayo Surround Enrollment Form - Spanish
Learn More
Benefits investigations are conducted to determine whether a therapy is covered under a patient's insurance, if a prior authorization is required, and which specialty pharmacies are preferred.
Reimbursement help (FRM)
Receive Assistance from an FRM Regarding Reimbursement Information
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Some brands offer a field reimbursement manager who will work with your clinical staff and preferred pharmacy to help make sure patients don't fall through the cracks.
financial assistance
Libtayo Financial assistance options
Co-pay savings program
commercial only
Libtayo Surround Enrollment Form
Libtayo Surround Enrollment Form - Spanish
Enroll in Patient Savings Program
Enroll in Patient Savings Program (HCP Office)
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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
Learn More
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+
Libtayo Surround Enrollment Form
Libtayo Surround Enrollment Form - Spanish
Libtayo Surround Patient Assistance Program
Learn More
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
Libtayo Patient education
Getting started on Libtayo
NOT PROVIDED BY BRANDInstructions For Use: Non-Small Cell Lung Cancer
NOT PROVIDED BY BRANDInstructions For Use: Basal Cell Carcinoma
Patient toolkit
About Libtayo: Non-Small Cell Lung Cancer
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
How Libtayo Works: Non-Small Cell Lung Cancer
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Receiving Libtayo: Non-Small Cell Lung Cancer
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Side Effects: Non-Small Cell Lung Cancer
ASK PATIENT TO:
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Scan QR Code & Tap Link
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Patient Resources: Non-Small Cell Lung Cancer
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
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Caregiver Resources: Non-Small Cell Lung Cancer
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
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Patient Stories: Non-Small Cell Lung Cancer
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
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Scan QR Code & Tap Link
Patient Navigators Flashcard
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Patient Brochure: Non-Small Cell Lung Cancer
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
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Biomarker Testing: Non-Small Cell Lung Cancer
ASK PATIENT TO:
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Patient Brochure: Non-Small Cell Lung Cancer - English
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Patient Brochure: Non-Small Cell Lung Cancer - Korean
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Patient Brochure: Non-Small Cell Lung Cancer - Vietnamese
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Patient Brochure: Non-Small Cell Lung Cancer - Spanish
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Patient Brochure: Non-Small Cell Lung Cancer - Chinese
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Patient Wallet Card - English
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Libtayo Surround Copay Program Brochure
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
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Scan QR Code & Tap Link
Libtayo Surround Overview Brochure
ASK PATIENT TO:
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Scan QR Code & Tap Link
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About Libtayo: Basal Cell Carcinoma
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
How Libtayo Works: Basal Cell Carcinoma
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Receiving Libtayo: Basal Cell Carcinoma
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Side Effects: Basal Cell Carcinoma
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link