CurrentCignaPolicy N/A

Oncology - Everolimus Products Prior Authorization Policy

Defines Cigna's prior authorization criteria and coverage stance for everolimus products (Afinitor, Afinitor Disperz, Torpenz) for oncology and specified non-oncology indications affecting Cigna plan members.

Policy Summary

PayerCigna

PolicyOncology - Everolimus Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMultiple material edits (additions and revisions)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation demonstrating the patient meets indication-specific criteria (age, prior therapies, biomarker status, and combination regimen details).

SourceLink

POLICY UPDATE CHANGES

Torpenz (everolimus tablets) was added to the policy with same criteria as the other everolimus products.

Classic Hodgkin Lymphoma criteria revised to require that patient is not a candidate for high-dose therapy and autologous stem cell rescue (removed prior three-line requirement).

Histiocytic Neoplasm criterion was revised by removing specific Langerhans cell histiocytosis subtypes.

Meningioma condition of approval and criteria were added, including option for combination with bevacizumab or a somatostatin analogue.

~16Indications enumerated

1 yrTypical approval duration

PIK3CA

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Coverage Criteria for Everolimus Products

inv-01: FDA-Approved Indications - General criteria

Covered when ALL of the following are met for each indication (examples below):

Breast Cancer (approve for 1 year): A) Patient is ≥ 18 years of age; AND B) Patient has recurrent or metastatic, hormone receptor positive (HR+) (ER+ and/or PR+) disease; AND C) Patient has HER2-negative breast cancer; AND D) Patient has tried at least one prior endocrine therapy (e.g., anastrozole, letrozole, or tamoxifen); AND E) Patient meets ONE of the following: i) postmenopausal woman or man; OR ii) pre/perimenopausal woman receiving ovarian suppression/ablation with a GnRH agonist (examples: leuprolide, triptorelin, goserelin) or bilateral oophorectomy/ovarian irradiation; AND F) Medication will be used in combination with exemestane (or with fulvestrant or tamoxifen per specified criteria); AND G) Patient has not had disease progression while on everolimus.

See chunk 8 for detailed gender and combination rules.

Neuroendocrine Tumors (pancreas, GI tract, lung, thymus) (approve for 1 year): Patient is ≥ 18 years of age; AND medication indicated for progressive disease per labeling.

Chunk 10

Renal Cell Carcinoma (approve for 1 year): A) Patient is ≥ 18 years of age; AND B) Patient has relapsed or Stage IV disease; AND C) Patient meets ONE of the following: i) non-clear cell disease; OR ii) clear cell disease AND has tried at least one prior systemic therapy (examples: axitinib, lenvatinib, cabozantinib, pembrolizumab, nivolumab, pazopanib, sunitinib).

Chunk 10

Tuberous Sclerosis Complex–Associated Renal Angiomyolipoma (approve for 1 year): Patient meets diagnostic criteria for TSC-associated renal angiomyolipoma.

Chunk 10

Tuberous Sclerosis Complex–Associated SEGA (approve for 1 year): Therapeutic intervention is required but SEGA cannot be curatively resected.

Chunk 10

Tuberous Sclerosis Complex–Associated Partial Onset Seizures (approve for 1 year): Adjunctive treatment for partial onset seizures per labeling (patient meets age and other product-specific criteria).

Chunk 10

inv-02: Other Uses with Supportive Evidence

Covered when ALL specified criteria for each supportive-evidence indication are met (examples):

Endometrial Carcinoma (approve for 1 year): A) Patient is ≥ 18 years of age; AND B) Medication will be used in combination with letrozole.

Chunk 11

Gastrointestinal Stromal Tumors (GIST) (approve for 1 year): A) Patient is ≥ 18 years of age; AND B) Patient has tried each of the following: i) one of imatinib or avapritinib; AND ii) one of sunitinib or dasatinib; AND iii) regorafenib; AND iv) ripretinib; AND C) Medication will be used in combination with imatinib, sunitinib, or regorafenib.

Chunk 11

Histiocytic Neoplasm (approve for 1 year): A) Patient is ≥ 18 years of age; AND B) Patient has ONE of the following: i) Langerhans cell histiocytosis; OR ii) Erdheim–Chester disease; OR iii) Rosai–Dorfman disease; AND C) Patient has a PIK3CA mutation.

Chunk 11

This policy does not address Zortress (everolimus), which is indicated for organ‑rejection prophylaxis in adults undergoing kidney or liver transplantation. Zortress uses different tablet strengths and dosing compared with the oncology formulations (Afinitor, Afinitor Disperz, Torpenz) and therefore is outside the scope of this coverage policy.

Under CONDITIONS NOT COVERED, the policy lists the everolimus products that are governed by this document and identifies the policy's not‑covered stance for specified uses. The products enumerated are Afinitor® (everolimus tablets), Afinitor Disperz® (everolimus tablets for oral suspension), and Torpenz™ (everolimus tablets); when a requested use for one of these products is not supported by the clinical criteria in this policy, that use is considered not covered.

Regimen	Indication / Key criteria	Coverage status
Everolimus + exemestane
Breast cancer: Patient ≥ 18; recurrent/metastatic HR+ (ER+ and/or PR+) and HER2‑negative; tried at least one prior endocrine therapy; patient is postmenopausal or a man OR pre/perimenopausal woman receiving ovarian suppression/ablation; regimen per labeling (exemestane combination rules). Approve for 1 year.

Regimen	Indication / Key criteria	Coverage status
Everolimus + imatinib
Gastrointestinal stromal tumor (GIST): Patient ≥ 18; tried imatinib (or avapritinib), sunitinib (or dasatinib), regorafenib, and ripretinib; everolimus will be used in combination with imatinib, sunitinib, or regorafenib. Approve for 1 year.

Product References, Age, and Coding

Covered ProductsmixedCovered

Afinitor (everolimus tablets)	Novartis; generic available
Afinitor Disperz (everolimus tablets for oral suspension)	Novartis
Torpenz (everolimus tablets)	Upsher-Smith

Coding Notemixed

CPT/HCPCS/NDC

No specific CPT, HCPCS, or NDC codes listed in policy; submit appropriate drug NDC and J-code or billing codes per payer pharmacy/medical benefit guidance.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for prescription benefit coverage of everolimus products. All approvals are provided for the duration noted in the clinical criteria (typically 1 year for approved indications). Providers should submit prior authorization requests with supporting clinical documentation demonstrating the patient meets the specific criteria for the requested FDA‑approved indication or other uses with supportive evidence. Claims submitted for services that are not accompanied by covered diagnosis or procedure codes under this coverage policy will be denied as not covered.

Afinitor® (everolimus tablets)
Afinitor Disperz® (everolimus tablets for oral suspension)
Torpenz™ (everolimus tablets)

Step Therapy

Prior Therapy Requirements

Prior systemic therapy or specific prior agents are required for several oncology indications. Examples include: prior endocrine therapy required for HR+ metastatic breast cancer; prior systemic therapy required for clear cell renal cell carcinoma (examples: axitinib, lenvatinib, cabozantinib, pembrolizumab, nivolumab, pazopanib, sunitinib); and multiple prior kinase inhibitors required for gastrointestinal stromal tumors (imatinib or avapritinib; sunitinib or dasatinib; regorafenib; ripretinib). Step‑therapy constraints must be documented in the prior authorization request.

Background on Everolimus

Everolimus (marketed in oncology formulations as Afinitor, Afinitor Disperz, and added product Torpenz) is an mTOR kinase inhibitor with multiple oncology and tuberous sclerosis complex (TSC)‑related indications. It is used in combination with endocrine therapy for HR+ HER2‑ advanced breast cancer, for progressive neuroendocrine tumors, in certain renal cell carcinoma settings, and for multiple TSC‑associated manifestations and other rare tumor types. Note that the transplant prophylaxis formulation Zortress is distinct and excluded from this policy.

Key Definitions and Terms

HR+ (Hormone receptor positive)

DefinitionHormone receptor positive (HR+) — disease that is estrogen receptor‑positive (ER+) and/or progesterone receptor‑positive (PR+)

Context of useHR+ status is required for the breast cancer indication (recurrent or metastatic HR+ disease)

Combination therapy implicationEverolimus is used in combination with endocrine therapy for HR+ disease per specified criteria

HER2‑negative

DefinitionHER2‑negative — human epidermal growth factor receptor 2 (HER2) negative breast cancer

Requirement for breast indicationHER2‑negative status is required for approval of everolimus in recurrent/metastatic breast cancer

Line of Therapy Specifications

inv-14: second-line

Second-line — Breast cancer prior therapy: Patient must have tried at least one prior endocrine therapy before everolimus (e.g., anastrozole or letrozole); this supports use of everolimus in the second-line setting in combination with exemestane.

inv-15: second-line — Additional second-line criteria

Second-line — RCC prior therapy: For clear cell renal cell carcinoma, patient must have tried at least one prior systemic therapy; non-clear cell RCC is eligible without that prior systemic therapy requirement.

Biomarker Testing Requirements

PIK3CA (Biomarker requirement)

Biomarker requiredA PIK3CA mutation is required for approval of everolimus for Histiocytic Neoplasm (Langerhans cell histiocytosis, Erdheim‑Chester disease, or Rosai‑Dorfman disease)

Indication linkPIK3CA testing applies specifically to the Histiocytic Neoplasm supportive‑evidence indication

Approval durationWhen PIK3CA mutation is present and other criteria met, approval is provided for 1 year

Permitted Drug Regimens and Combinations

Regimen	Combination rules / Restrictions	Notes / Approval duration
Everolimus + exemestane
Used with exemestane per breast cancer criteria; patient must be ≥ 18, have recurrent/metastatic HR+ (ER+ and/or PR+) HER2‑negative disease, have tried ≥1 prior endocrine therapy, and meet menopausal/ovarian suppression rules (postmenopausal or male; or pre/perimenopausal with ovarian suppression/ablation).
Approval granted for 1 year when all criteria met.

Regimen	Combination rules / Restrictions	Notes / Approval duration
Everolimus + imatinib / sunitinib / regorafenib
Permitted only for GIST in patients ≥ 18 who have tried: (i) imatinib (or avapritinib), (ii) sunitinib (or dasatinib), (iii) regorafenib, and (iv) ripretinib; everolimus may be combined with imatinib, sunitinib, or regorafenib per policy.
Approval granted for 1 year when all criteria met.