CurrentCignaPolicy N/A

Oncology - Everolimus Products Preferred Specialty Management Policy

Defines Cigna's Preferred Specialty Management program for everolimus products (brand and generics) and the exception criteria for non-preferred products; applies to Cigna-administered health benefit plans and providers requesting authorization.

Policy Summary

PayerCigna

PolicyOncology - Everolimus Products Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for all everolimus medications; approvals are issued for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearauthorization duration for approvals

3everolimus products named

preferred trial requiredexception requires prior trial

2026-03-18policy last reviewed

Coverage Criteria

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General requirement: Patient must meet the standard Oncology - Everolimus Products Prior Authorization Policy criteria

Standard prior auth policy applies to all everolimus medications

Step requirement for non-preferred product approval: Patient must have tried one Preferred Product (generic everolimus tablets or Torpenz) prior to approval of a Non-Preferred Product

Program directs trial of one preferred product

Formulation intolerance exception: Patient cannot continue to use the Preferred medication due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) which, per the prescriber, would result in a significant allergy or serious adverse reaction

This clinical rationale must be documented by the prescriber

Requests for non-preferred everolimus products that do not meet the exception criteria (including required trial of a Preferred Product and documented inability to tolerate the preferred formulation due to inactive-ingredient–related significant allergy or serious adverse reaction) will be considered not medically necessary.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

All everolimus medications (Preferred and Non-Preferred) require prior authorization per the referenced Oncology - Everolimus Products Prior Authorization Policy. Approvals are provided for 1 year.

All requests must meet the criteria in the standard Oncology - Everolimus Products Prior Authorization Policy.
Approvals are valid for 1 year.

Step Therapy

Preferred‑first Requirement

Patient must try one Preferred Product (generic everolimus tablets or specified Preferred formulation) before a Non-Preferred Product will be approved. Requests for Non-Preferred Products will be reviewed using the Non‑Preferred Product Exception Criteria; if exception criteria are not met, coverage will be for the Preferred Product only.

Preferred Product: generic everolimus tablets for oral suspension.
Non-Preferred Product example: Afinitor Disperz tablets for oral suspension (brand).
If exception criteria are met, Non-Preferred products may be approved for 1 year.

Documentation Required

Plan‑document and Coding Requirements

Providers must follow the terms of the applicable benefit plan document and submit the appropriate diagnosis and procedure codes when requesting coverage. Claims submitted without covered diagnosis or procedure codes referenced in the applicable coverage policy will be denied as not covered. When billing, use the most appropriate codes effective on the date of service.

Reimbursement depends on the member's specific benefit plan document (Evidence of Coverage/Certificate of Coverage/SPD).
Claims without covered diagnosis/procedure codes under this policy will be denied.
Use the most appropriate codes as of the submission date.

Definitions

Afinitor Disperz — formulation-specific definition and indication notes

DefinitionAfinitor Disperz: everolimus tablets for oral suspension (formulation for oral suspension).

FDA-approved formulation-specific indicationsApproved for TSC-associated subependymal giant cell astrocytoma (SEGA) requiring therapeutic intervention in patients ≥ 1 year of age and for TSC-associated partial-onset seizures as adjunctive treatment in patients ≥ 2 years of age (Afinitor Disperz only).

Preferred-specialty program statusListed as a non-preferred product under the Preferred Specialty Management program; exception criteria apply for approval of Afinitor/Afinitor Disperz.

Exception rationale allowedMedical exception may be granted if patient cannot continue preferred product due to formulation (inactive ingredient) difference causing a documented significant allergy or serious adverse reaction as determined by the prescriber.

Approval duration if exception metApprovals for non-preferred products meeting exception criteria are issued for 1 year in duration.

Background

Everolimus is an mTOR inhibitor indicated for multiple FDA‑approved oncology and tuberous sclerosis complex (TSC)‑related conditions, including treatment of advanced hormone receptor‑positive, HER2‑negative breast cancer (with exemestane), select neuroendocrine tumors, advanced renal cell carcinoma after prior VEGF‑targeted therapy, and several TSC‑associated manifestations such as renal angiomyolipoma, subependymal giant cell astrocytoma (SEGA), and TSC‑associated partial‑onset seizures (formulation‑specific indications apply).

Initial Therapy Criteria

Initial Therapy Preference

Preferred-first policy for initiating therapy under this program.

Preferred product trial: For initiation, the patient is required to try one Preferred Product prior to approval of a Non-Preferred Product

Preferred Products are generic everolimus tablets (including Torpenz)

Continuation / Renewal Criteria

Continuation / Renewal

Duration of approval for continued therapy when approved under this program.

Approval duration: All approvals are provided for 1 year in duration

Renewal subject to prior authorization and policy criteria

Step Therapy Requirements

Step	Requirement / Exception	Coverage Status
1	Trial requirement: Patient must have tried ONE Preferred Product (generic everolimus tablets or Torpenz) prior to approval of a Non-Preferred Product.
2	Exception: Approve for 1 year if all are met — A) patient meets the standard Oncology - Everolimus Products Prior Authorization Policy criteria; AND B) patient has tried a Preferred Product (generic everolimus tablets or Torpenz); AND C) patient cannot continue the Preferred medication due to a formulation difference in inactive ingredients that, per the prescriber, would cause a significant allergy or serious adverse reaction.
3	If the patient meets standard prior authorization criteria but has not tried a Preferred Product and does not meet the formulation-intolerance exception, approval will be for a Preferred Product only; requests for Non-Preferred products that do not meet exception criteria are considered not medically necessary.