CurrentMass General Brigham Health PlanPolicy N/A

Imjudo (tremelimumab-actl) — Coverage Criteria

Defines prior authorization, coverage criteria, and limits for Imjudo (tremelimumab-actl) when used under the Mass General Brigham Health Plan pharmacy and specialty benefits for commercial/exchange and MassHealth UPPL members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyImjudo (tremelimumab-actl) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization for Imjudo under the pharmacy/specialty benefit and document that the member meets the applicable coverage criteria or is currently receiving Imjudo through the plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA indications

2Disease criteria sets

1mo / 6moInitial approval

Prior authAuthorization type

Coverage Criteria for Imjudo (tremelimumab-actl)

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Hepatocellular Carcinoma (Initial)

Authorization may be granted when ALL of the following are met for unresectable hepatocellular carcinoma:

HCC Initial Therapy: 1. Diagnosis of unresectable hepatocellular carcinoma; 2. Member will be using Imjudo in combination with Imfinzi (durvalumab).

Reauthorization may be granted if initial criteria continue to be met or member is currently receiving Imjudo through the plan.

Non-small Cell Lung Cancer (Initial)

Authorization may be granted when ALL of the following are met for NSCLC:

NSCLC Initial Therapy: 1. Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC); 2. Tumor negative for EGFR exon 19 deletion and L858R mutations and ALK gene mutations; 3. Member will be using Imjudo in combination with Imfinzi (durvalumab) and platinum-based chemotherapy; Note: regimens consistent with NCCN may be reviewed for medical necessity.

Reauthorization may be granted if initial criteria continue to be met or member is currently receiving Imjudo through the plan.

Authorization exclusions: products obtained as samples or via the manufacturer's patient assistance programs are excluded from authorization consideration for members new to the plan. Authorization may be granted for members new to the plan only if they are already receiving treatment with Imjudo and the product was not obtained as a sample or through a patient assistance program, or when the member meets all other coverage criteria for the requested indication.

Initial Therapy Specifics

HCC Initial Therapy

HCC initial therapy requirements

HCC Initial: Diagnosis of unresectable hepatocellular carcinoma and use in combination with Imfinzi (durvalumab).

Initial approval duration: 1 month.

NSCLC Initial Therapy

NSCLC initial therapy requirements

NSCLC Initial: Diagnosis of recurrent, advanced, or metastatic NSCLC; tumor negative for EGFR exon 19 deletion and L858R mutations and ALK gene mutations; use in combination with Imfinzi (durvalumab) and platinum-based chemotherapy.

Initial approval duration: 6 months.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Imjudo under the pharmacy/specialty benefit; authorization is granted only if the member meets the coverage criteria or is already receiving treatment with Imjudo (excludes samples and medication obtained via manufacturer patient assistance programs). Lack of these conditions may result in denial.

Authorization required under pharmacy/specialty benefit
Authorization may be granted for members already receiving Imjudo (not including samples or manufacturer patient assistance program supply)
Authorization may be granted when all coverage criteria are met — otherwise request may be denied

Note

Contact Information for Prior Authorization and Exceptions

Providers may submit prior authorization requests and exception requests using the contact information below.

Medical and Specialty Medications (All Plans) Phone: 877-519-1908 Fax: 855-540-3693
Non-Specialty Medications Phone: 800-711-4555 Fax: 844-403-1029

Denial Risk

Denial Triggers

Authorization may be denied if the member does not meet the plan's specified coverage criteria and is not already receiving treatment with Imjudo. Note exclusions for product obtained as samples or through manufacturer patient assistance programs when assessing ongoing use.

Denial likely if coverage criteria are not met
Denial likely if member is not already receiving treatment and criteria are not satisfied
Products obtained as samples or via manufacturer patient assistance programs are excluded from consideration for continuing authorization

Key Definitions

EGFR/ALK negative NSCLC — definition

DefinitionNon-small cell lung cancer (NSCLC) tumors that are negative for sensitizing EGFR mutations (specifically EGFR exon 19 deletion and L858R) and negative for ALK genomic tumor aberrations.

Clinical implicationRequired tumor molecular status for Imjudo NSCLC indication: member’s tumor must lack sensitizing EGFR mutations and ALK gene mutations.

Associated therapyImjudo is indicated for this NSCLC population only when used in combination with durvalumab and platinum-based chemotherapy.

Diagnosis contextApplies to recurrent, advanced, or metastatic NSCLC when the tumor meets the EGFR/ALK-negative definition.

Reference to guidanceRegimens consistent with NCCN guidelines may be reviewed for medical necessity in this population.

Background on Imjudo (tremelimumab-actl)

Imjudo (tremelimumab-actl) is an immune checkpoint inhibitor used in combination regimens for certain advanced cancers. The policy permits authorization for members already receiving Imjudo or when the member meets the disease-specific coverage criteria for a listed indication and combination therapy.

Program Type	Step Requirements / Prior Agents
Step Therapy	Program type indicated but no specific prior agents or step requirements are detailed in this policy.