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)    Imfinzi (Durvalumab) requires prior authorization.

2)    Imfinzi is used to treat certain types of lung cancer, biliary tract cancer, and hepatocellular carcinoma.

I.     Initial Approval Criteria

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

1.    Diagnosis of NSCLC;

2.    Prescribed by or in consultation with an oncologist;

3.    Age ≥ 18 years;

4.    Request meets one of the following (a’ b or c):

a.    Disease is unresectable, stage II-III, and has not progressed following concurrent platinum-based chemotherapy and radiation therapy (RT);

b.    Disease is recurrent, advanced, or metastatic with neither sensitizing EGFR mutations, ALK genomic tumor aberrations, or negative for other actionable molecular biomarkers (e.g., KRAS, “””ROS1, BRAF, NTRK1/2/3, MET, RET, ERBB2 (HER2)) and is prescribed in combination with Imjdo (tremelimumab-actl) and platinum based chemotherapy as first-line therapy;;

c.    Continuation of maintenance therapy for recurrent, advanced, or metastatic disease that is negative for actionable molecular biomarkers, and non contraindications to PD-1 or PD-L1 inhibitors, and performance status 0-2, that achieved tumor response or stable disease following initial systemic therapy with one of the following:

a.    Imfinzi/Imjudo/pemetrexed with either carboplatin or cisplatin for nonsquamous cell histology, and Imfinzi for maintenance therapy is prescribed in combination with pemetrexed (off-label);

b.    Imfinzi/Imjudo plus chemotherapy, and Imfinzi for maintenance therapy is Prescribed as a single agent (off-label):

5.    Request meets one of the following (a, b, or c):*

a.    For unresectable, stage II-III disease (i or ii):

i.      For body weight < 30 kg: dose does not exceed 10 mg/kg every 2 weeks;

ii.    For body weight ≥ 30 kg: dose does not exceed 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks;

b.    For metastatic disease (i or ii):

i.      For body weight < 30 kg: dose does not exceed Imfinzi 20 mg/kg every 3 weeks in combination with tremelimumab-actl 1 mg/kg and platinum-based chemotherapy, and then Imfinzi 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of Imjudo 1 mg/kg in combination with Imfinzi dose 6 at Week 16;

ii.    For body weight ≥ 30 kg: dose does not exceed Imfinzi 1,500 mg every 3 weeks in combination with tremelimumab-actl 75 mg and platinum-based chemotherapy for 4 cycles, and then Imfinzi 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed maintenance therapy every 4 weeks, and a fifth dose of Imjudo 75 mg in combination with Imfinzi dose 6 at Week 16;

c.    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.   Extensive-Stage Small Cell Lung Cancer (must meet all):

1.    Diagnosis of ES-SCLC;

2.    Prescribed by or in consultation with an oncologist;

3.    Age ≥ 18 years;

4.    Prescribed as first-line treatment with etoposide and either carboplatin or cisplatin, followed by maintenance with Imfinzi as a single agent;

5.    Request meets one of the following (a, b, or c):*

a.    For body weight < 30 kg, dose does not exceed 20 mg/kg every 3 weeks in combination with chemotherapy for 4 cycles, then 10 mg/kg every 2 weeks as a single agent;

b.    For body weight ≥ 30 kg, dose does not exceed 1,500 mg every 3 weeks in combination with chemotherapy for 4 cycles, then 1,500 mg every 4 weeks as a single agent;

c.    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.   Biliary Tract Cancer (must meet all):

1.    Diagnosis of locally advanced, unresectable, recurrent (> 6 months after surgery and/or completion of adjuvant therapy), or metastatic BTC;

2.    Prescribed by or in consultation with an oncologist;

3.    Age ≥ 18 years;

4.    Prescribed in combination with gemcitabine and cisplatin;

5.    Request meets one of the following (a, b, or c):*

a.    For body weight < 30 kg, dose does not exceed 20 mg/kg every 3 weeks in combination with chemotherapy, then 20 mg/kg every 4 weeks as a single agent;

b.    For body weight ≥ 30 kg, dose does not exceed 1,500 mg every 3 weeks in combination with chemotherapy, then 1,500 mg every 4 weeks as a single agent;

c.    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

D.   Hepatocellular Carcinoma (must meet all):

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

2.    Prescribed by or in consultation with an oncologist;

3.    Age ≥ 18 years;

4.    Request meets one of the following (a, b, or c):*

a.    For body weight < 30 kg: dose does not exceed Imfinzi 20 mg/kg in combination with tremelimumab-actl 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks;

b.    For body weight ≥ 30 kg: dose does not exceed Imfinzi 1,500 mg in combination with tremelimumab-actl 300 mg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks;

c.    Dose 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

E.   Cervical Cancer (off-label) (must meet all):

1.    Diagnosis of persistent, recurrent, or metatatic small cell neuroendocrine carcinoma of the cervix (NECC);

2.    Prescribed by or in consultation with an oncologist;

3.    Age > 18 years;

4.    Prescribed in combination with etoposide and either cisplatin or carboplatin;

5.    Request meets one of the following:

a.    Dose does not exceed the PDA approved maximum recommended dose;

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

Approval Duration: 6 months

II.    Continued Therapy

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

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

2.    For NSCLC requests, member has not received more than 12 months of Imfinzi therapy;

3.    Member is responding positively to therapy;

4.    If request is for a dose increase, request meets one of the following (a, b, c, d, e, or f):*

a.    For stage II-II NSCLC (i or ii):

i.      For body weight < 30 kg: new dose does not exceed 10 mg/kg every 2 weeks;

ii.    For body weight ≥ 30 kg: new dose does not exceed 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks

b.    For metastatic NSCLC (i or ii):

i.      For body weight < 30 kg: new dose does not exceed Imfinzi 20 mg/kg every 3 weeks in combination with tremelimumab-actl and platinum-based chemotherapy for 4 cycles, then Imfinzi 20 mg/kg every 4 weeks with histology-based pemetrexed maintenance therapy;

ii.    For body weight ≥ 30 kg, new dose does not exceed Imfinzi 1,500 mg every 3 weeks in combination with tremelimumab-actl and platinum based chemotherapy for 4 cycles, then Imfinzi 1,500 mg every 4 weeks with histology-based pemetrexed maintenance therapy;

c.    For ES-SCLC (i or ii):

i.      For body weight < 30 kg, new dose does not exceed 20 mg/kg every 3 weeks in combination with chemotherapy for 4 cycles, then 10 mg/kg every 2 weeks as a single agent;

ii.    For body weight ≥ 30 kg, new dose does not exceed 1,500 mg every 3 weeks in combination with chemotherapy for 4 cycles, and then 1,500 mg every 4 weeks as a single agent;

d.    For BTC (i or ii):

i.      For body weight < 30 kg, new dose does not exceed 20 mg/kg every 3 weeks in combination with chemotherapy, then 20 mg/kg every 4 weeks as a single agent;

ii.    For body weight ≥ 30 kg, new dose does not exceed 1,500 mg every 3 weeks in combination with chemotherapy, then 1,500 mg every 4 weeks as a single agent;

e.    uHCC (i or ii):

i.      For body weight < 30 kg, new dose does not exceed 20 mg/kg in combination with tremelimumab-actl, then 20mg/kg every 4 weeks; 

ii.    For body weight ≥ 30 kg, new dose does not exceed, 1,500 mg in combination with tremelimumab-actl, then 1,500 mg every 4 weeks;

f.     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: NSCLC up to a total duration of 12 months; all other indications 12 months

Codes Used In This BI:

C9492     Imfinzi (Durvalumab (code deleted 1/1/19)

J9173      Imfinzi (Durvalumab (new code 1/1/19)

1.    Imfinzi Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2022. Available at: https://www.imfinzi.com. Accessed December 1, 2022.

2.    National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed September 9, 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 2, 2022.

4.    National Comprehensive Cancer Network. Small Cell Lung Cancer Version 2.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed February 15, 2022.

5.    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.

6.    National Comprehensive Cancer Network. Cervical Cancer Version 1.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf. Accessed January 24, 2023.

 Addendum:

1)    Effective 10/01/2017: Added new HCPCS code C9492 to policy.

2)    Effective 10/01/2018: Added criteria for non-small cell lung cancer.

3)    Effective 01/01/2019: 2019 Code Updates. Deleted HCPCS code C9492 and replaced with new HCPCS code J9173.

4)    Effective 10/01/2019: Updated criteria for NSCLC for disease has not progressed following platinum-based chemo and radiation therapy.

5)    Effective 12/01/2020: Updated to include coverage criteria for extensive stage small cell lung cancer (ES-SCLC).

6)    6) Effective 05/01/2023: Updated criteria for NSCLC, extensive-stage small cell lung cancer, biliary tract cancer, and hepatocellular carcinoma. Added continuation criteria for all coverage criteria.

7)    Effective 08/01/2023: Updated NSCLC criteria and added criteria for cervical cancer.