CurrentCignaPolicy N/A

Libtayo Prior Authorization Request Form

This document is a payer-specific prior authorization (PA) request form to collect patient, prescriber, diagnosis, and clinical information for coverage review of Libtayo (cemiplimab-rwlc). It guides submission methods, urgency designation, administration/dispensing location, and detailed diagnosis-specific clinical questions to support PA decisions.

Policy Summary

PayerCigna

PolicyLibtayo Prior Authorization Request Form

Policy CodePolicy N/A

Change TypeInformational PA form

Effective Date

Next Review Date

Key ActionFax the completed form to (855) 840-1678 or submit online via covermymeds.com or SureScripts in EHR; call (800) 882-4462 for urgent requests to expedite.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes — brief indicates this is an informational PA form without material change.

11Enumerated Diagnosis Options on Form

5 business daysStandard response time

Policy snapshot & scope

This is a payer-specific prior authorization (PA) request form for Libtayo (cemiplimab-rwlc) that collects patient, prescriber, diagnosis, and clinical information to support coverage review. The form can be submitted by fax to (855) 840-1678 or online via covermymeds.com or SureScripts in the EHR, and urgent requests require a phone call to (800) 882-4462 to expedite. Requesters must indicate Urgency: Standard or Urgent, specify where the medication will be obtained or administered (Onco360, prescriber office stock billed on medical claim, home health/home infusion vendor, or other) and provide facility/dispensing details (including Tax ID). The form gathers asterisk-marked required identifiers and detailed, diagnosis-specific clinical questions to support the payer's medical necessity determination.

Key facts

Policy TitleLibtayo (cemiplimab-rwlc) prior authorization request form

PayerCigna

Policy NumberN/A

StatusCURRENT

Effective Date / Next Review Date

Enumerated Diagnosis Options on Form11

Standard response time5 business days

Scope summary linkThis document is a payer-specific prior authorization (PA) request form to collect patient, prescriber, diagnosis, and clinical information for coverage review of Libtayo (cemiplimab-rwlc).

Form purpose and structure

Background: This PA form collects structured clinical and administrative information and enumerates multiple cancer indications with conditional, indication-specific questions (e.g., CSCC, BCC, NSCLC, colorectal, appendiceal, small bowel, anal, cervical/vaginal/vulvar). The clinical section requires disease-stage and treatment-pathway details (such as prior therapies, candidacy for surgery/radiation, single-agent versus combination use, and biomarker status). The form includes a prescriber attestation with signature and date and notes the payer may perform routine audits and request medical records. There is also a free-text field for additional pertinent clinical information.

Conditional clinical questions (form logic)

Form Sections and Conditional Clinical Questions

The form collects required patient and prescriber data and then asks disease-specific conditional questions. Answers will be used by the payer to assess medical necessity.

Form Sections and Conditional Clinical Questions (root)

Patient and prescriber identification fields marked with * must be completed for the payer to respond via fax (physician name, DEA/NPI/TIN, patient name, Cigna ID, date of birth, patient street address).
Urgency: Requester must indicate Urgency: Standard or Urgent (attestation that standard review may jeopardize life/health/ability to regain function).
Medication requested and prescription details: Medication requested: Libtayo or other (specify); include ICD-10, directions/dose/quantity/duration.
Acquisition/dispensing location: Indicate where medication will be obtained: Onco360, prescriber's office stock (bill on medical claim), home health/home infusion vendor, or other.
Facility/doctor dispensing information: Provide facility/doctor dispensing/administering information including Tax ID and address; indicate if medication is for chronic/long-term condition necessary for life of patient (Yes/No).
Diagnosis selection (ONE or more applicable)
- Anal carcinoma
- Appendiceal adenocarcinoma
- Basal cell carcinoma (BCC)
- Cervical cancer
- Colorectal cancer
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
CSCC specific questions
- Metastatic or locally advanced disease: Does the patient have metastatic or locally advanced disease? (Yes/No)
- If metastatic or locally advanced = Yes
  - Candidate for curative surgery or radiation: Is the patient a candidate for curative surgery or radiation? (Yes/No)
- If not metastatic/locally advanced OR is a candidate for surgery/radiation
  - Adjuvant treatment for high risk of recurrence: Will the requested medication be used as adjuvant treatment for a patient at high risk of recurrence after surgery and radiation? (Yes/No)
BCC specific questions
- Locally advanced disease (laBCC): Does the patient have locally advanced disease (laBCC)? (Yes/No)
- Metastatic disease (mBCC): Does the patient have metastatic disease (mBCC)? (Yes/No)
- Prior HHI therapy: Has the patient previously been treated with a hedgehog pathway inhibitor (HHI)? (Yes/No)
- If HHI not used: HHI not appropriate: If HHI not previously used: Is HHI not considered appropriate for this patient? (Yes/No)
NSCLC specific questions
- Single-agent therapy: Will the requested medication be used as single agent therapy? (Yes/No)
- If single-agent = Yes
  - First therapy for diagnosis: Is the requested medication the first therapy given for this diagnosis? (Yes/No)
  - Advanced disease: Does the patient have advanced disease? (Yes/No)
  - PD-L1 >=50%: Does the patient's tumor have PD-L1 expression of 50% or more? (Yes/No)
Cervical, vaginal, vulvar cancer questions
- Single-agent therapy (cervical/vaginal/vulvar): Will the requested medication be used as single agent therapy? (Yes/No)
- Second-line or subsequent therapy (cervical/vaginal/vulvar): Will the requested medication be used as second line or subsequent therapy? (Yes/No)
Anal carcinoma questions
- Single-agent therapy (anal): Will the requested medication be used as single agent therapy? (Yes/No)
- Pre-abdominoperineal resection use: Is the requested medication being requested for treatment before proceeding to abdominoperineal resection? (Yes/No)
- Locally recurrent/progressive disease: Does the patient have locally recurrent, progressive disease? (Yes/No)
Appendiceal adenocarcinoma questions
- Systemic therapy for advanced/metastatic disease: Is the requested medication to be used as systemic therapy for advanced or metastatic disease? (Yes/No)
- dMMR/MSI-H or POLE/POLD1 ultra-hypermutated (example TMB >50): Is the patient's disease dMMR/MSI-H OR does the patient have POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb)? (Yes/No)
- Candidate for immunotherapy: Is the patient a candidate for immunotherapy? (Yes/No)
- Prior immunotherapy: If candidate: Has the patient previously received any immunotherapy? (Yes/No)
Colorectal cancer questions
- dMMR/MSI-H or POLE/POLD1 ultra-hypermutated (colorectal): Is the patient's disease dMMR/MSI-H OR does the patient have POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb)? (Yes/No)
- Neoadjuvant for clinical T4b or bulky nodal disease: Is the requested medication being used as neoadjuvant therapy for clinical T4b or bulky nodal disease? (Yes/No)
- Neoadjuvant for resectable synchronous liver and/or lung metastases: If no to T4b/bulky nodal: Is the requested medication being used as neoadjuvant therapy for resectable synchronous liver and/or lung metastases? (Yes/No)
- Prior checkpoint inhibitor if neoadjuvant: If yes to neoadjuvant: Has the patient previously received treatment with a checkpoint inhibitor? (Yes/No)
Small bowel adenocarcinoma questions
- dMMR/MSI-H or POLE/POLD1 ultra-hypermutated (small bowel): Is the patient's disease dMMR/MSI-H OR does the patient have POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb)? (Yes/No)
- Locally unresectable or medically inoperable disease: Does the patient have locally unresectable or medically inoperable disease? (Yes/No)
- If locally unresectable/inoperable: primary treatment: If yes (locally unresectable/inoperable): Is the requested medication being used for primary treatment of this disease? (Yes/No)
- Advanced or metastatic disease: If not locally unresectable/inoperable OR not for primary treatment: Does the patient have advanced or metastatic disease? (Yes/No)
Single-agent use for appendiceal/small bowel/colorectal: For appendiceal, small bowel adenocarcinoma, or colorectal cancer: Will the requested medication be used as single agent therapy? (Yes/No)
Additional clinical information: Additional pertinent clinical information free-text field required as applicable.
Prescriber attestation and signature/date required; payer may perform routine audit and request medical information to verify accuracy.

Code systems referenced on form

ICD-10ICD-10

No codes listed

Submission, documentation & billing actions

Prior Authorization

Submit completed PA form

Fax the completed prior authorization form to (855) 840-1678. You may also submit online via covermymeds.com or via SureScripts through your EHR. For URGENT requests, call (800) 882-4462 to expedite the review.

Documentation Required

Complete required fields

Complete all fields marked with an asterisk. The payer will not respond via fax unless all asterisked items are filled in — including physician identifiers (DEA, NPI, or TIN), patient identifiers (patient name, Cigna ID), date of birth, and patient and office addresses.

Documentation Required

Clinical detail per diagnosis

Provide diagnosis-specific clinical details to support medical necessity: disease stage (e.g., metastatic, locally advanced), prior therapies including hedgehog pathway inhibitors (HHIs) and prior checkpoint inhibitors, and relevant biomarker status — PD-L1, dMMR/MSI-H or POLE/POLD1 mutation (ultra-hypermutated phenotype, e.g., TMB > 50 mut/Mb). Include any additional indication-specific items requested on the form.

Disease stage (metastatic, locally advanced, etc.)
Prior therapies (including HHI and checkpoint inhibitors)
Biomarker status: PD-L1; dMMR/MSI-H; POLE/POLD1; TMB (example threshold referenced: >50 mut/Mb)
Any indication-specific questions listed on the form (neoadjuvant/adjuvant status, surgical candidacy, combination therapy, etc.)

Billing Rule

Indicate acquisition/dispensing method

Indicate where the medication will be obtained and provide billing details. Select Onco360, prescriber's office stock (to be billed on a medical claim), Home Health/Home Infusion vendor, or Other, and supply the facility/doctor dispensing information including the facility Tax ID for billing.

Definitions

Definitions: HHI — Hedgehog pathway inhibitor (abbreviated on the form).; dMMR/MSI-H — Deficient mismatch repair / microsatellite instability-high status used to determine eligibility for immunotherapy in some tumor types.; TMB — Tumor mutational burden (example threshold referenced on the form: > 50 mut/Mb).

Document changes & timeline

Policy Summary

PayerCigna

PolicyLibtayo Prior Authorization Request Form

Policy CodePolicy N/A

Change TypeInformational PA form

Effective Date

Next Review Date

Key ActionFax the completed form to (855) 840-1678 or submit online via covermymeds.com or SureScripts in EHR; call (800) 882-4462 for urgent requests to expedite.

SourceLink

On This Page

Small bowel adenocarcinoma

Candidate for resection/chemoradiation:

Is the patient a candidate for surgical resection or definitive chemoradiation? (Yes/No)

EGFR/ALK/ROS1 aberrations: Do the patient's tumors have any EGFR, ALK, or ROS1 aberrations? (Yes/No)

If not single-agent

Combination with platinum-based chemotherapy: Will the requested medication be used in combination with platinum-based chemotherapy? (Yes/No)
First therapy for diagnosis (combo): Is the requested medication the first therapy given for this diagnosis? (Yes/No)
EGFR/ALK/ROS1 aberrations (combo): Do the patient's tumors have any EGFR, ALK, or ROS1 aberrations? (Yes/No)
Metastatic disease (combo): Does the patient have metastatic disease? (Yes/No)
If not metastatic: locally advanced?: If not metastatic: Does the patient have locally advanced disease? (Yes/No)
If not metastatic: candidate for resection/chemoradiation?: If not metastatic: Is the patient a candidate for surgical resection or definitive chemoradiation? (Yes/No)

Initial treatment for resectable metachronous metastases: If not neoadjuvant OR has previously received checkpoint inhibitor: Is the requested medication being used as initial treatment for resectable metachronous metastases? (Yes/No)

Prior immunotherapy if metachronous: If yes to metachronous: Has the patient previously received any immunotherapy? (Yes/No)

Prior checkpoint inhibitor (small bowel): If yes (advanced/metastatic): Has the patient previously received treatment with a checkpoint inhibitor? (Yes/No)