CurrentCignaPolicy N/A

Oncology - Everolimus Products Preferred Specialty Management Policy

Defines Cigna's Preferred Specialty Management program for everolimus products (Afinitor, Afinitor Disperz, Torpenz, and generics), including preferred vs non-preferred products, exception criteria for non-preferred products, requirement to meet the standard Oncology - Everolimus Products Prior Authorization Policy, and approval duration.

Policy Summary

PayerCigna

PolicyOncology - Everolimus Products Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeSelected revision (added preferred product); routine annual reviews

Effective Date

Next Review Date

Key ActionAll everolimus medication requests require meeting the standard Oncology - Everolimus Products Prior Authorization Policy criteria and will be reviewed against that policy.

POLICY UPDATE CHANGES

Torpenz was added as one of the Preferred Products and included in the Afinitor exception criteria.

Annual revisions on 10/18/2023 and 06/26/2024 and 03/19/2025 noted 'No criteria changes.'

3Preferred product options named

2Brand products with exception pathway

12Months approval duration

Coverage Summary

This policy defines Cigna's Preferred Specialty Management program for everolimus products (Afinitor, Afinitor Disperz, Torpenz, and generic everolimus formulations). The program is intended to encourage use of Preferred Products and directs that, for all everolimus medications (Preferred and Non-Preferred), the patient must meet the standard Oncology - Everolimus Products Prior Authorization Policy criteria. The program requires trial of a Preferred Product prior to approval of a Non-Preferred Product and specifies that all approvals are authorized for a duration of 1 year.

Medical-Necessity Criteria

General Requirement

All everolimus medication requests must meet the standard Oncology - Everolimus Products Prior Authorization Policy criteria:

Patient meets the standard Oncology - Everolimus Products Prior Authorization Policy criteria

Preferred Product Handling and Prior Authorization

Program directs trial of Preferred Product prior to Non-Preferred; approvals provided for 1 year:

If patient meets standard prior authorization criteria but has not tried a Preferred Product, approval will be authorized for a Preferred Product

All approvals are provided for a duration of 1 year

Afinitor (Brand) - Non-Preferred Product Exception Criteria

Approve non-preferred brand Afinitor for 1 year if ALL of the following are met:

Patient meets the standard Oncology - Everolimus Products Prior Authorization Policy criteria

Patient has tried ONE of: generic everolimus tablets or Torpenz

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

Alternative if exception criteria not met: If patient has met the standard prior authorization criteria but has NOT met exception criterion (tried preferred or formulation allergy), approve generic everolimus tablets or Torpenz (preferred products) instead of brand Afinitor

Afinitor Disperz (Brand) - Non-Preferred Product Exception Criteria

Approve non-preferred brand Afinitor Disperz for 1 year if ALL of the following are met:

Patient meets the standard Oncology - Everolimus Products Prior Authorization Policy criteria

Patient has tried generic everolimus tablets for oral suspension

Alternative if exception criteria not met: If patient has met the standard prior authorization criteria but has NOT met exception criterion (tried preferred or formulation allergy), approve generic everolimus tablets for oral suspension (preferred) instead of brand Afinitor Disperz

Products Named in Policy (Codes/Identifiers)

Products named in policymixed

Afinitor	everolimus tablets (Novartis) - brand
Afinitor Disperz	everolimus tablets for oral suspension (Novartis) - brand
Torpenz	everolimus tablets (Upsher-Smith) - brand
generic everolimus tablets	generic formulations of everolimus tablets
generic everolimus tablets for oral suspension	generic formulations of everolimus tablets for oral suspension

Products named in policymixed

Afinitor	everolimus tablets (Novartis) - brand
Afinitor Disperz	everolimus tablets for oral suspension (Novartis) - brand
Torpenz	everolimus tablets (Upsher-Smith) - brand
generic everolimus tablets	generic formulations of everolimus tablets
generic everolimus tablets for oral suspension	generic formulations of everolimus tablets for oral suspension

Provider Actions & Requirements

Prior Authorization

Prior authorization required

All everolimus medications (Preferred and Non-Preferred) require meeting the standard Oncology - Everolimus Products Prior Authorization Policy criteria; requests will be reviewed against that policy.

Documentation Required

Exception documentation for non-preferred product

For approval of a Non-Preferred product (brand Afinitor or Afinitor Disperz), the provider must document both: a trial of the specified Preferred product and a prescriber statement that the patient cannot continue the Preferred medication due to a formulation difference in inactive ingredients that, per the prescriber, would result in a significant allergy or serious adverse reaction.

Documentation that the patient tried the specified Preferred product (e.g., generic everolimus tablets or Torpenz; or generic everolimus tablets for oral suspension for Disperz requests).
Prescriber statement that the patient cannot continue the Preferred medication because of a formulation difference in inactive ingredients (e.g., dyes, fillers, preservatives) that would cause a significant allergy or serious adverse reaction.

Billing Rule

Approval duration

Approvals for preferred specialty management are authorized for a duration of 1 year (12 months).

Background & Evidence

Everolimus is a kinase inhibitor with multiple FDA indications including various oncology uses (e.g., HR+ breast cancer in combination with exemestane, neuroendocrine tumors, renal cell carcinoma) and tuberous sclerosis complex (TSC)-related indications (renal angiomyolipoma, SEGA, and TSC-associated partial-onset seizures for Afinitor Disperz). This policy is a Preferred Specialty Management program designed to encourage use of Preferred everolimus products and requires that all requests meet the standard Oncology - Everolimus Products Prior Authorization Policy; the program also directs trial of a Preferred Product prior to approval of Non-Preferred Products.

Prescribing information sources cited for evidence and reference are: Afinitor/Afinitor Disperz prescribing information (January 2025) and Torpenz prescribing information (March 2024).

Definitions

Preferred ProductProduct designated by the program as preferred (generic everolimus tablets, Torpenz, Afinitor tablets; or generic/brand oral suspension for Disperz grouping).

Non-Preferred Product Exception CriteriaClinical and trial requirements that must be met for approval of a non-preferred (brand) product, including prior authorization criteria, trial of a preferred product, and documented inability to use preferred product due to inactive ingredient-related allergy or serious adverse reaction.

Revision History

09/25/2024material_revision

Selected revision on 09/25/2024 added Torpenz as one of the Preferred Products and included Torpenz in the Afinitor exception criteria.

10/18/2023annual_review

Annual revision on 10/18/2023 noted: No criteria changes.

06/26/2024annual_review

Annual revision on 06/26/2024 noted: No criteria changes.

03/19/2025annual_reviewLatest

Early annual revision on 03/19/2025 noted: No criteria changes.

Policy Summary

PayerCigna

PolicyOncology - Everolimus Products Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeSelected revision (added preferred product); routine annual reviews

Effective Date

Next Review Date

Key ActionAll everolimus medication requests require meeting the standard Oncology - Everolimus Products Prior Authorization Policy criteria and will be reviewed against that policy.

On This Page