Coverage Policies

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Effective Date: 08/01/2017 Title: Afinitor (Everolimus)
Revision Date: 01/01/2020 Document: BI552:00
CPT Code(s): None
Public Statement

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Afinitor (everolimus) requires prior authorization.

2)    Afinitor is used to treat a number of different types of cancers.

3)    Afinitor is an oral specialty drug covered under the pharmacy benefit.

4)    Afinitor is now available in generic form and brand name Afinitor is not covered. Only the generic equivalent is covered.

Medical Statement

Everolimus is considered medically necessary for members who meet the following criteria for the different conditions below.

1)    Neuroendocrine Tumors

a.    Diagnosis of one of following

                                          i.    Neuroendocrine tumor of pancreatic origin

                                        ii.    Neuroendocrine tumor of gastrointestinal origin

                                       iii.    Neuroendocrine tumor of lung origin




b.    Disease is progressive




c.    One of the following

                                          i.    Disease is unresectable

                                        ii.    Disease is locally advanced

                                       iii.    Disease is metastatic


2)    Advanced Renal Cell Carcinoma

a.    Diagnosis of renal cell cancer


b.    One of the following

                                          i.    Disease has relapsed OR

                                        ii.    Stage IV disease with medically or surgically unresectable tumor


c.    One of the following

                                          i.    Patient with non-clear cell histology OR

                                        ii.    Patient with predominantly clear-cell histology with a history of failure, contraindication, or intolerance to at least one prior tyrosine kinase inhibitor therapy(e.g. Nexavar, Sutent)


3)    Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC)

a.    Diagnosis of renal angiomyolipoma and tuberoussclerosis complex (TSC, not requiring immediate surgery


4)    Subependymal Giant Cell Astrocytoma

a.    Diagnosis of Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS); AND

b.    Patient is not a candidate for curative surgical resection.


5)    Waldenstroms Macroglobulinemia or Lymphoplasmacytic Lymphoma

a.    Diagnosis of either Waldenstroms macroglobulinemia or Lymphoplasmacytic lymphoma; AND

b.    One of the following

                                          i.    Disease is non-responsive to primary treatment

                                        ii.    Disease is progressive

                                       iii.    Disease has relapsed


6)    Breast Cancer

a.    Diagnosis of breast cancer; AND

b.    Disease is recurrent or metastatic; AND

c.    Disease is hormone receptor positive (HR+); AND

d.    Disease is human epidermal growth factor receptor 2 (HER2)-negative; AND

e.    Patient is a postmenopausal woman; AND

f.     Disease has progressed while on or within 12 months of non-steroidal aromatase inhibitor (e.g. Arimidex, Femara).

g.    Will be used in combination with exemestane, fulvestrant, or tamoxifen


7)    Hodgkin Lymphoma

a.    Diagnosis of classical Hodgkin lymphoma; AND

b.    Disease is refractory or relapsed


8)    Soft Tissue Sarcoma

a.    Diagnosis of PEComa (perivascular epitheliod cell tumor); OR

b.    Diagnosis of recurrent angiomyolipoma; OR

c.    Diagnosis of lymphangioleiomyomatosis


9)    Osteosarcoma

a.    Diagnosis of osteosarcoma; AND

b.    History of failure, contraindication, or intolerance to at least one prior first-line chemotherapy regimen; AND

c.    Will be used in combination with Nexavar (sorafenib)


10)  Thymomas and Thymic Carcinomas

a.    Diagnosis of thymic carcinoma or thymoma; AND

b.    History of failure, contraindication, or intolerance to at least one prior first-line chemotherapy regimen.


As an oral specialty drug, everolimus is limited to a maximum 30-day supply per fill and must be obtained through a contracted specialty pharmacy.


1)    Clinical Pharmacology. Accessed online July 17, 2017.

2)    NCCN Drugs and Biologic Compendium. Accessed online November 15, 2019.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.