Medical Policy
Effective Date:01/01/2024 Title:Imjudo
Revision Date: Document:BI731:00
CPT Code(s):J9347
Public Statement

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)    Imjudo (tremelimumab-actl) requires prior authorization.

2)    Imjudo is indicated for the treatment of unresectable hepatocellular carcinoma (uHCC) in combination with durvalumab and metastatic non-small cell lung cancer (NSCLC).

3)    Imjudo is covered under the medical benefit.
Medical Statement

Imjudo is considered medically necessary when the following criteria are met:

 

I.             Initial Approval Criteria

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

                                          i.    Diagnosis of NSCLC;

                                        ii.    Prescribed by or in consultation with an oncologist;

                                       iii.    Age > 18 years;

                                       iv.    Prescribed in combination with durvalumab and platinum-based therapy;

                                        v.    Dosing is consistent with FDA-labeling

 

b.    Hepatocellular Carcinoma (must meet all):

                                          i.    Diagnosis of unresectable, liver-confined, or metastatic hepatocellular carcinoma;

                                        ii.    Prescribed by  or in consultation with an oncologist;

                                       iii.    Age 18 years;

                                       iv.    Prescribed in combination with durvalumab;

                                        v.    Dosing is consistent with FDA-labeling;

Initial Approval Duration: 6 months

 

II.            Continued Therapy

a.    Member is responding to therapy;

b.    Dosing is consistent with FDA-labeling

Continued Therapy Approval Duration: 12 months

 

Codes Used In This BI:

 

1)    J9347 – Injection, tremelimumab-actl, 1mg
Limits
Intentially left empty
Reference

1)    Imjudo Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf. Accessed December 1, 2022.

2)    2. 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 2, 2022.

3)    3. National Comprehensive Cancer Network. Hepatobiliary Cancers Version 3.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed December 2, 2022.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.