CurrentCignaPolicy IP0408

Oncology - Everolimus Products

Defines Cigna prior authorization and medical necessity criteria for coverage of everolimus products (Afinitor, Afinitor Disperz, Torpenz) for FDA‑approved oncology indications and specified other uses with supportive evidence; includes product-specific and plan-specific preferred product/step criteria and employer/individual plan substitution rules.

Policy Summary

PayerCigna

PolicyOncology - Everolimus Products

Policy CodePolicy IP0408

Change TypeAnnual revision — title update, added Torpenz, criteria simplifications, added supportive‑evidence uses

Effective Date

Next Review Date

Key ActionObtain prior authorization and document age, diagnosis, prior therapies, combination intent, and lack of progression on prior everolimus; approvals are typically for 1 year and must meet listed clinical and preferred product criteria.

POLICY UPDATE CHANGES

Updated coverage policy title to 'Oncology - Everolimus Products' and added Torpenz to FDA-Approved Indications.

Tuberous Sclerosis Complex-Associated Renal Angiomyolipoma criteria: removed age screening and removed requirement for angiomyolipoma ≥ 3 cm on imaging.

Tuberous Sclerosis Complex-Associated Partial Onset Seizures criteria: removed age screening, removal of failure/intolerance to two antiepileptic drugs, removed requirement for adjunctive therapy and specialist consultation.

Added multiple 'Other Uses with Supportive Evidence' indications (e.g., endometrial carcinoma, GIST, histiocytic neoplasm, classic Hodgkin lymphoma, meningioma, soft tissue sarcoma, thymic tumors, differentiated thyroid carcinoma, uterine sarcoma, Waldenström macroglobulinemia).

Specified that approvals are provided for 1 year for listed indications and that preferred product criteria apply.

5FDA-Approved Indications listed

11Other Uses with Supportive Evidence listed

IP0408Policy Number

Coverage Summary

This Cigna Coverage Policy, titled Oncology - Everolimus Products, defines prior authorization and medical necessity criteria for everolimus products (listed in the policy: Afinitor, Afinitor Disperz, Torpenz) for FDA‑approved oncology indications and selected other uses with supportive evidence. The policy stance is covered_with_criteria, with approvals generally provided for 1 year where specified. Zortress (everolimus) used for transplant prophylaxis is not targeted by this policy and is excluded. The policy references the NCCN Compendium as supporting many of the listed uses and includes plan- and product-specific preferred product and substitution requirements that must be met for approval.

Policy metadata

Policy NumberIP0408

StatusCURRENT

Last review2025-06-15

Next review

Has material changestrue (see Revision Details: title change, addition of Torpenz, criteria simplifications, new supportive-evidence uses)

Medical Necessity Criteria and Authorization Rules

Prior Authorization Requirement

Prior Authorization is required for prescription benefit coverage of everolimus products. All approvals are provided for the duration noted in each indication.

ALL of the following

Prior Authorization obtained

FDA-Approved Indications - Breast Cancer

Approve for 1 year if ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age
Patient has recurrent or metastatic, hormone receptor positive (HR+) [ER+ and/or PR+] disease

Provider Actions and Billing Rules

Prior Authorization

Prior authorization required

Prior Authorization is required for prescription benefit coverage of everolimus products. Approvals are typically provided for 1 year (duration noted per indication). Coverage determinations require that the listed clinical criteria and any applicable preferred product requirements are met.

Documentation Required

Documentation of prior therapies and clinical details

Document the patient's age, specific diagnosis, prior therapies/trials (examples provided in the relevant indication criteria), intended combination therapy when applicable, and lack of disease progression while on prior everolimus when relevant. Note: receipt of sample product does not satisfy criteria requirements for coverage.

Coding and Policy Identifier

Coverage policy identifiermixed

IP0408

Coverage Policy Number (Cigna)

Medication NDCs, HCPCS, or other billing codes and formulary-preferred product listings may vary by plan or line of business; refer to the plan formulary tables and the Coverage Policy instructions for the appropriate, plan-specific preferred product lists and billing guidance when submitting claims.

Background and Evidence Sources

Background: Everolimus is a kinase inhibitor with multiple FDA‑approved oncology indications (including breast cancer, neuroendocrine tumors, renal cell carcinoma, and tuberous sclerosis complex-associated indications such as renal angiomyolipoma and SEGA). Zortress (everolimus) for organ transplant prophylaxis is noted as a separate formulation and is not covered under this policy. The policy also states that the NCCN Compendium recommends use of everolimus for the indications listed in the FDA‑Approved Indications and Other Uses with Supportive Evidence sections.

Source	Reference
Prescribing information	Afinitor — Jan 2025; Torpenz — Mar 2024; Zortress — Feb 2024
NCCN Compendium access	Accessed March 13, 2025

Definitions

Preferred product criteriaPlan/formulary-specific requirements for product selection (tables referenced in policy) that must be met for approval.

Postmenopausal woman / man (asterisk)Specified gender terms refer to biological traits: a woman is an individual with the biological traits of a woman and a man is an individual with the biological traits of a man, regardless of gender identity or expression.

Revision History

6/15/2024revised

Annual Revision dated 6/15/2024: Updated coverage policy title to 'Oncology - Everolimus Products' and removed age screening and requirement for angiomyolipoma ≥ 3 cm for TSC-associated renal angiomyolipoma; removed age screening, requirement to fail/intolerant to two antiepileptic drugs, requirement for adjunctive therapy, and requirement for specialist consultation for TSC-associated partial onset seizures.

3/2024revised

Added Torpenz (everolimus tablets - Upsher-Smith) to FDA-approved indications for breast cancer, neuroendocrine tumors, renal angiomyolipoma/TSC, and TSC-associated SEGA.

6/15/2025revised

Policy Summary

PayerCigna

PolicyOncology - Everolimus Products

Policy CodePolicy IP0408

Change TypeAnnual revision — title update, added Torpenz, criteria simplifications, added supportive‑evidence uses

Effective Date

Next Review Date

On This Page

Patient has HER2-negative breast cancer

Patient has tried at least one prior endocrine therapy (e.g., anastrozole, letrozole, or tamoxifen)

menopausal status

Patient is a postmenopausal woman * or a man *
pre/perimenopausal woman*
- Patient is receiving ovarian suppression/ablation with a GnRH agonist (examples: leuprolide acetate, triptorelin, goserelin)
- Patient has had surgical bilateral oophorectomy or ovarian irradiation

combination therapy

use with exemestane
- Medication will be used in combination with exemestane
- Patient is a man * and is receiving a GnRH analog (examples: leuprolide, triptorelin, goserelin, degarelix, relugolix)
- Patient is a woman *
OR the medication will be used in combination with fulvestrant or tamoxifen

Patient has not had disease progression while on everolimus

Preferred product criteria is met for the product(s) as listed in the below table(s)

FDA-Approved Indications - Neuroendocrine Tumors (NET) of pancreas, GI tract, lung, thymus (carcinoid)

Approve for 1 year if BOTH of the following are met:

ALL of the following

Patient is ≥ 18 years of age
Preferred product criteria is met for the product(s) as listed in the below table(s)

FDA-Approved Indications - Renal Cell Carcinoma

Approve for 1 year if ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age
Patient has relapsed or Stage IV disease
ANY of the following
- Patient has non-clear cell disease
- Patient has clear cell disease and has tried at least one prior systemic therapy (examples: axitinib, lenvatinib, cabozantinib, pembrolizumab, nivolumab, pazopanib, sunitinib)
Preferred product criteria are met for the product(s) as listed in the below table(s)

FDA-Approved Indications - TSC-associated Renal Angiomyolipoma

Approve for 1 year if the following is met:

ALL of the following

Preferred product criteria are met for the product(s) as listed in the below table(s)

FDA-Approved Indications - TSC-associated SEGA

Approve for 1 year if BOTH are met:

ALL of the following

Therapeutic intervention is required but SEGA cannot be curatively resected
Preferred product criteria are met for the product(s) as listed in the below table(s)

FDA-Approved Indications - TSC-associated Partial Onset Seizures

Approve for 1 year if the following is met:

ALL of the following

Preferred product criteria are met for the product(s) as listed in the below table(s)

Other Uses with Supportive Evidence (selected examples)

Approve for 1 year when specified criteria (age, prior therapies, combinations, and preferred product criteria) are met for each listed use:

List of supported other uses (each has its own subcriteria)

Endometrial Carcinoma
- Patient is ≥ 18 years of age
- Medication will be used in combination with letrozole
- Preferred product criteria are met for the product(s) as listed in the below table(s)
Gastrointestinal Stromal Tumors (GIST)
- Patient is ≥ 18 years of age
- Patient has tried one of imatinib or avapritinib
- Patient has tried one of sunitinib or dasatinib
- Patient has tried regorafenib (Stivarga)
- Patient has tried ripretinib (Qinlock)
- Medication will be used in combination with imatinib, sunitinib, or regorafenib
- Preferred product criteria are met for the product(s) as listed in the below table(s)
Histiocytic Neoplasm
- Patient is ≥ 18 years of age
- Patient has Langerhans cell histiocytosis or Erdheim-Chester disease or Rosai-Dorfman disease
- Patient has a PIK3CA mutation
- Preferred product criteria are met for the product(s) as listed in the below table(s)
Classic Hodgkin Lymphoma
- Patient is ≥ 18 years of age
- Patient has relapsed or refractory disease
- Patient is not a candidate for high-dose therapy and autologous stem cell rescue
- Preferred product criteria are met for the product(s) as listed in the below table(s)
Meningioma
- Patient is ≥ 18 years of age
- Patient has recurrent or progressive disease
- Patient has surgically inaccessible disease and radiation therapy is not possible
- Medication will be used in combination with a somatostatin analogue (example: octreotide) or with bevacizumab
- Preferred product criteria are met for the product(s) as listed in the below table(s)
Soft Tissue Sarcoma
- Patient is ≥ 18 years of age
- Perivascular epithelioid cell tumor (PEComa) or recurrent angiomyolipoma/lymphangioleiomyomatosis
- Preferred product criteria are met for the product(s) as listed in the below table(s)
Thymomas and Thymic Carcinomas
- Patient is ≥ 18 years of age
- Patient has tried at least one chemotherapy regimen (examples listed) or cannot tolerate chemotherapy
- Preferred product criteria are met for the product(s) as listed in the below table(s)
Thyroid Carcinoma, Differentiated
- Patient is ≥ 18 years of age
- Patient has differentiated thyroid carcinoma (examples: papillary, follicular, oncocytic)
- Disease is refractory to radioactive iodine therapy
- Preferred product criteria are met for the product(s) as listed in the below table(s)
Uterine Sarcoma
- Patient is ≥ 18 years of age
- Patient has advanced, recurrent, metastatic, or inoperable disease
- Patient has a perivascular epithelioid cell tumor (PEComa)
- Patient has tried at least one systemic regimen (examples: doxorubicin, docetaxel, ifosfamide, dacarbazine, gemcitabine)
- Preferred product criteria are met for the product(s) as listed in the below table(s)
Waldenström Macroglobulinemia / Lymphoplasmacytic Lymphoma
- Patient is ≥ 18 years of age
- Patient has tried at least one systemic regimen (examples listed)
- Preferred product criteria are met for the product(s) as listed in the below table(s)

Employer and Individual/Family Plans formulary substitution criteria

Plan-specific requirement when product substitution is considered

ALL of the following

Employer Plans - Afinitor/Afinitor Disperz substitution rules
- Trial of everolimus tablets (bioequivalent generic) is required
- Member cannot take the requested product due to a formulation difference in inactive ingredients that would result in a significant allergy or serious adverse reaction
Individual and Family Plans - Afinitor/Afinitor Disperz substitution rules
- Trial of everolimus tablets (bioequivalent generic) is required
- Member cannot take the requested product due to a formulation difference in inactive ingredients that would result in a significant allergy or serious adverse reaction

Not Medically Necessary

Everolimus products for any other use not listed above

ALL of the following

Any use not specified in the FDA-Approved Indications or Other Uses with Supportive Evidence sections is considered not medically necessary

Billing Rule

Use appropriate codes

When billing, use the most appropriate diagnosis and billing codes as of the date of service. Claims submitted without covered diagnosis/procedure codes under this policy will be denied as not covered.

Step Therapy

Preferred product / trial of generic required for plan-level substitution

For Employer and Individual/Family Plans, a trial of bioequivalent everolimus tablets (generic) is required prior to approving Afinitor or Afinitor Disperz. Exception: the member is unable to take the requested product due to a formulation difference in inactive ingredients that would cause a significant allergy or serious adverse reaction.

Annual Revision dated 6/15/2025: Title change and addition of Torpenz noted; added multiple 'Other Uses with Supportive Evidence' indications (endometrial carcinoma, GIST, histiocytic neoplasm, classic Hodgkin lymphoma, meningioma, soft tissue sarcoma, thymic tumors, differentiated thyroid carcinoma, uterine sarcoma, Waldenström macroglobulinemia/lymphoplasmacytic lymphoma).

clarified

Clarified that approvals are provided for 1 year for listed indications and that preferred product criteria apply throughout policy.