CurrentMass General Brigham Health PlanPolicy N/A

Cosela (trilaciclib) prior authorization and coverage

Defines prior authorization, coverage criteria, and limitations for Cosela (trilaciclib) for members of Mass General Brigham Health Plan (AllWays Health Partners) when used to decrease chemotherapy-induced myelosuppression in extensive-stage small cell lung cancer.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCosela (trilaciclib) prior authorization and coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of extensive-stage small cell lung cancer, the planned platinum/etoposide- or topotecan-containing regimen, and confirmation Cosela will not be used with G-CSF/ESA as primary prophylaxis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsapproval period

prior authauthorization type

ES-SCLCindication

No G-CSF/ESAconcomitant restriction

Coverage Criteria

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inv-01: Initial Authorization

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

Initial authorization criteria: Documentation the member has extensive-stage small cell lung cancer; The member is using Cosela to decrease the incidence of chemotherapy-induced myelosuppression; Cosela will be administered prior to either a platinum/etoposide-containing regimen OR a topotecan-containing regimen; The requested medication will not be used with granulocyte colony-stimulating factor (G-CSF) and/or erythropoiesis-stimulating agents (ESAs) as primary prophylaxis during the cycle.

Documentation should include the planned chemotherapy regimen (platinum/etoposide or topotecan).

inv-02: Continuation of Therapy

Reauthorization criteria:

Reauthorization will be granted if the member continues to meet all initial authorization criteria.

Initial authorization duration applies.

Use of Cosela (trilaciclib) concurrently with granulocyte colony-stimulating factor (G-CSF) and/or erythropoiesis-stimulating agents (ESAs) as primary prophylaxis during the chemotherapy cycle is not allowed. Authorization requires that Cosela not be planned for use together with G-CSF and/or ESAs for primary prophylaxis in the same cycle.

Initial Therapy

inv-11: Initial Therapy

Initial authorization

Initial therapy: 1) Documentation the member has extensive-stage small cell lung cancer; 2) The member is using Cosela to decrease the incidence of chemotherapy-induced myelosuppression; 3) Cosela will be given prior to a platinum/etoposide-containing regimen OR a topotecan-containing regimen; 4) Cosela will not be used concurrently with G-CSF and/or ESAs as primary prophylaxis during the chemotherapy cycle.

Provide documentation of the planned chemotherapy regimen; exclude concurrent primary prophylactic G-CSF/ESA.

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cosela (trilaciclib) under the pharmacy benefit for applicable plans; authorization requests may be reviewed for members new to the plan who are currently receiving treatment with Cosela. Exceptions include when the product is obtained as samples or via manufacturer patient assistance programs.

All plans: Phone: 877-519-1908; Fax: 855-540-3693
Non-Specialty Medications: Phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

None specified in the policy for Cosela.

Documentation Required

Required Documentation

Documentation must show that the member has extensive-stage small cell lung cancer (ES-SCLC) and that Cosela will be used to decrease the incidence of chemotherapy-induced myelosuppression. Also document the intended chemotherapy regimen (either a platinum/etoposide–containing regimen or a topotecan-containing regimen) and that Cosela will be administered prior to the chemotherapy regimen. Note: Cosela should not be used with granulocyte colony-stimulating factor (G-CSF) and/or erythropoiesis-stimulating agents (ESAs) as primary prophylaxis during the same cycle.

Documentation of diagnosis: extensive-stage small cell lung cancer (ES-SCLC)
Documentation of intended use: to decrease chemotherapy-induced myelosuppression
Planned chemotherapy regimen: platinum/etoposide–containing regimen OR topotecan-containing regimen
Confirmation Cosela will be given prior to the chemotherapy regimen
Confirmation Cosela will not be used with G-CSF and/or ESAs as primary prophylaxis during the same cycle

Denial Risk

Denial Triggers

Authorization may be denied if documentation does not demonstrate ES-SCLC, appropriate intent to use Cosela to reduce chemotherapy-induced myelosuppression, or if the required regimen or concurrent-agent constraints are not met.

Missing documentation of ES-SCLC
No documentation that Cosela is intended to decrease chemotherapy-induced myelosuppression
Requested use not prior to an eligible chemotherapy regimen (platinum/etoposide or topotecan)
Request indicates concurrent primary prophylactic use of G-CSF and/or ESAs during the same cycle

Definitions

Extensive-stage small cell lung cancer (ES-SCLC) — indication for Cosela

DefinitionExtensive-stage small cell lung cancer (ES-SCLC): the disease indication for which Cosela is authorized to decrease chemotherapy-induced myelosuppression when given prior to a platinum/etoposide- or topotecan-containing regimen.

Patient populationAdults with extensive-stage small cell lung cancer (ES-SCLC).

Intended effectDecrease the incidence of chemotherapy-induced myelosuppression.

Primary prophylaxis with G-CSF/ESA — definition and restriction

DefinitionPrimary prophylaxis with G-CSF/ESA: use of granulocyte colony-stimulating factor (G-CSF) and/or erythropoiesis-stimulating agents (ESAs) as primary prophylaxis during a chemotherapy cycle.

Policy restrictionCosela will not be used with G-CSF and/or ESAs as primary prophylaxis during the chemotherapy cycle.

Implication for authorizationRequests documenting concurrent primary prophylactic G-CSF/ESA use will not meet coverage criteria.

Background

Trilaciclib (Cosela) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-stage small cell lung cancer (ES-SCLC) when administered prior to specified chemotherapy regimens. Authorization requires documentation that Cosela will be given prior to either a platinum/etoposide-containing regimen or a topotecan-containing regimen, with the intent of providing myelopreservation by administering Cosela before chemotherapy.

Step	Requirement
1	No specific step therapy requirements stated in the policy for Cosela (trilaciclib).

Quantity Limits

Cosela (trilaciclib) — quantity limit details (placeholder)

Quantity limitNo specific numeric quantity limit listed in the policy (quantity limit field left blank).

Benefit typePharmacy benefit; Quantity limit program applies per plan details.

Specialty/step therapySpecialty limitations: N/A; Step therapy: none specified.

Cosela (trilaciclib) — approval duration (6 months)

Approval durationInitial approvals and reauthorizations will be granted for 6 months.

Applies toBoth initial authorization and reauthorization periods.

ReviewAuthorization duration subject to policy review at reauthorization time.