Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Libtayo (cemiplimab-rwlc) requires prior authorization.

2)    Libtayo is used to treat cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma, and non-small cell lung cancer (NSCLC).

3)    Libtayo is a specialty medication covered under the medical benefit.

I.     Initial Approval Criteria

A.   Cutaneous Squamous Cell Carcinoma (must meet all):

1.    Diagnosis of CSCC;

2.    Disease is metastatic or locally advanced;

3.    Prescribed by or in consultation with an oncologist;

4.    Age ≥ 18 years;

5.    Member is not a candidate for curative surgery or curative radiation;

6.    Request meets one of the following (a or b):*

a.    Dose does not exceed both of the following (i and ii):

i.      350 mg every 3 weeks;

ii.    1 vial every 3 weeks;

a.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 6 months

B.   Basal Cell Carcinoma (must meet all):

1.    Diagnosis of BCC;

2.    Disease is metastatic or locally advanced;

3.    Prescribed by or in consultation with an oncologist;

4.    Age ≥ 18 years;

5.    Previous treatment with a hedgehog pathway inhibitor (e.g., Erivedge®, Odomzo®), unless clinically significant adverse effects are experienced, all are contraindicated, or medical justification indicates that hedgehog pathway inhibitor therapy is not appropriate;

6.    Request meets one of the following (a or b):*

a.    Dose does not exceed both of the following (i and ii):

i.      350 mg every 3 weeks;

ii.    1 vial every 3 weeks;

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 6 months

C.   Non-Small Cell Lung Cancer (must meet all):

1.    Diagnosis of NSCLC;

2.    Disease is metastatic or locally advanced where members are not candidates for surgical resection or definitive chemoradiation;

3.    Prescribed by or in consultation with an oncologist;

4.    Age ≥ 18 years;

5.    Disease is EGFR wild-type, ALK negative, and ROS1 negative;

6.    Prescribed in one of the following ways (a, b, or c):

a.    As a single agent, and one of the following (i or ii):

i.      Tumor has high PD-L1 expression (TPS ≥ 50%);

ii.    Tumor has PD-L1 expression < 50%, and therapy is prescribed following first-line therapy with Libtayo combination therapy (e.g., cemiplimab-rwlc, [pemetrexed or paclitaxel], and [carboplatin or cisplatin]);

b.    In combination with platinum-based chemotherapy (e.g., cisplatin carboplatin);

c.    In combination with pemetrexed as continuation maintenance therapy following first-line therapy with Libtayo combination therapy for non-squamous cell tumors;

7.    Request meets one of the following (a or b):*

a.    Dose does not exceed both of the following (i or ii):

i.      350 mg every 3 weeks;

ii.    1 vial every 3 weeks;

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 6 months

II.    Continued Therapy

A.   All Indications in Section I (must meet all):

1.    Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving Libtayo for a covered indication and has received this medication for at least 30 days;

2.    Member is responding positively to therapy;

3.    If request is for a dose increase, request meets one of the following (a or b):*

a.    New dose does not exceed both of the following (i or ii):

i.      350 mg every 3 weeks;

ii.    1 vial every 3 weeks;

b.    New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 12 months

Codes Used In This BI:

C9044            Injection, cemiplimab-rwlc, 1mg

J9119             Injection, cemiplimab-rwlc, 1mg

1.    Libtayo Prescribing Information. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; November 2022. Available at: https://www.libtayohcp.com. Accessed November 30, 2022.

2.    Cemiplimab. In: National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed December 12, 2022.

3.    National Comprehensive Cancer Network. Non-Small Cell Lung Cancer, Version 6.2022. Available at https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed December 12, 2022.

 Addendum:

1)    Effective 05/01/2023: Updated CSCC criteria and added criteria for basal cell carcinoma and non-small cell lung cancer (NSCLC).