Subject: everolimus-Afinitor Products 2021-A SGM P2022
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AFINITOR
(everolimus)
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AFINITOR DISPERZ
(everolimus)
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everolimus (generic)
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Hormone Receptor-Positive, HER2-Negative Breast Cancer
Afinitor is indicated for the treatment of postmenopausal women with advanced hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.
2. Neuroendocrine Tumors (NET)
a. Afinitor is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable,
locally advanced or metastatic disease.
b. Afinitor is indicated for the treatment of adult patients with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of
gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease.
3. Renal Cell Carcinoma (RCC)
Afinitor is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.
4. Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma
5. Afinitor is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.
Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)
Afinitor and Afinitor Disperz are indicated in adult and pediatric patients aged 1 year and older with tuberous sclerosis complex (TSC) for the treatment of
subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.
6. Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures
Afinitor Disperz is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.
B. Compendial Uses
1. Relapsed or stage IV renal cell carcinoma
2. Soft tissue sarcoma subtypes:
a. Perivascular epithelioid cell tumors (PEComa)
b. Angiomyolipoma
c. Lymphangioleiomyomatosis
3. Gastrointestinal stromal tumors (GIST)
4. Neuroendocrine tumors:
a. Neuroendocrine tumors of the gastrointestinal tract, lung and thymus (carcinoid tumors)
b. Neuroendocrine tumors of the pancreas
c. Well differentiated Grade 3 neuroendocrine tumors
5. Thymomas and thymic carcinomas
6. Classic Hodgkin lymphoma
7. Central nervous system cancers:
a. Meningiomas
b. Glioma
c. Subependymal giant cell astrocytoma (SEGA)
8. Thyroid carcinoma (papillary carcinoma, Hürthle cell carcinoma, and follicular carcinoma)
9. Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma
10. Endometrial carcinoma
11. HR+/HER2- breast cancer, recurrent unresectable or stage IV (M1)
12. Tuberous sclerosis complex
13. Histiocytic Neoplasms:
a. Erdheim-Chester Disease (ECD)
b. Langerhans Cell Histiocytosis (LCH)
c. Rosai-Dorfman Disease
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
1. Documentation of the presence of phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation (where applicable)
2. Hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status (where applicable)
III. CRITERIA FOR INITIAL APPROVAL
A. Breast Cancer
Authorization of 12 months may be granted for subsequent treatment of hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative recurrent unresectable, advanced, or metastatic breast cancer when prescribed in combination with exemestane,
fulvestrant, or tamoxifen.
B. Renal Cell Carcinoma
Authorization of 12 months may be granted for treatment of relapsed, advanced, or stage IV renal cell carcinoma when any of the following
criteria are met:
1. The requested medication is given as a single agent or in combination with lenvatinib as subsequent therapy for clear cell histology; OR
2. The requested medication is given as single-agent or in combination with lenvatinib or bevacizumab for non-clear cell histology.
C. Neuroendocrine Tumors
Authorization of 12 months may be granted for the treatment of the following neuroendocrine tumors:
1. Neuroendocrine tumors of the gastrointestinal tract, lung, and thymus (carcinoid tumors)
2. Neuroendocrine tumors of the pancreas
3. Well differentiated Grade 3 neuroendocrine tumors
D. Tuberous Sclerosis Complex (TSC)
Authorization of 12 months may be granted for treatment of TSC.
E. Soft Tissue Sarcoma
Authorization of 12 months may be granted for treatment of any of the following subtypes of soft tissue sarcoma as single agent therapy:
locally advanced unresectable or metastatic perivascular epithelioid cell tumor (PEComa), recurrent angiomyolipoma, or recurrent lymphangioleiomyomatosis.
F. Gastrointestinal Stromal Tumor (GIST)
Authorization of 12 months may be granted for treatment of unresectable, recurrent/progressive, or metastatic GIST in combination with either
imatinib, sunitinib, or regorafenib for members who have failed at least four FDA-approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib)
G. Thymoma and Thymic Carcinoma
Authorization of 12 months may be granted for treatment of thymoma or thymic carcinoma as a single agent.
H. Classic Hodgkin Lymphoma
Authorization of 12 months may be granted for treatment of relapsed or refractory classic Hodgkin lymphoma for third-line or subsequent systemic
therapy as a single agent.
I. Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma
Authorization of 12 months may be granted for treatment of Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma as a single-agent therapy
for previously treated disease.
J. Papillary, Hürthle cell, or Follicular Thyroid Carcinoma
Authorization of 12 months may be granted for treatment of progressive and/or symptomatic papillary, Hürthle cell, or follicular thyroid carcinoma not
amenable to radioactive iodine (RAI) therapy.
K. Endometrial Carcinoma
Authorization of 12 months may be granted for treatment of endometrial carcinoma in combination with letrozole.
L. Central Nervous System Cancers
Authorization of 12 months may be granted for treatment of the following central nervous system cancers:
1. Glioma (including glioblastoma) or meningioma
2. Adjuvant treatment of subependymal giant cell astrocytoma (SEGA) as a single agent
M. Histiocytic Neoplasms
Authorization of 12 months may be granted for the treatment of any of the following histiocytic neoplasm subtypes as a single agent in members
with a phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation:
1. Symptomatic or relapsed/refractory Erdheim-Chester Disease (ECD)
2. Symptomatic or relapsed/refractory Rosai-Dorfman Disease
3. Langerhans Cell Histiocytosis (LCH)
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Afinitor and Afinitor Disperz [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; February 2022.
- Everolimus [package insert]. Chestnut Ridge, NY: Par Pharmaceutical; July 2021.
- The NCCN Drugs & Biologics Compendium 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed May 5, 2022.
- Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor–positive advanced breast cancer. N Engl J Med. 2012;366(6):520-529.
- Yardley DA, Noguchi S, Pritchard KI, et al. Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther 2013;30:870-884.
- Sampson JR. Therapeutic targeting of mTOR in tuberous sclerosis. Biochem Soc Trans. 2009;37:259-264.
- Johnston PB, Inwards DJ, Colgan JP, et al. A Phase II trial of the oral mTOR inhibitor everolimus in relapsed Hodgkin lymphoma. Am J Hematol 2010;85:320-324.
- Darcy A. Krueger, Hope Northrup, et al. Tuberous Sclerosis Complex Surveillance and Management: Recommendations of the 2012 International Tuberous Sclerosis Complex Consensus Conference. Pediatric Neurology. 2013. 49: 255-265.
- Wahl Michael, Chang, Susan, et al. Probing the PI3K/mTOR Pathway in Gliomas: A Phase II Study of Everolimus for Recurrent Adult Low Grade Gliomas. Cancer. 2017; 123 (23): 4631-4639.
- Shih KC, Chowdhary S, et al. A Phase II trial of bevacizumab and everolimus as treatment for patients with refractory, progressive, intracranial meningioma. Journal of Neuro-Oncology. 2016. 129 (2): 281-8.
- Hainsworth, John D, et al. Phase II Study of concurrent radiation therapy, temozolomide, and bevacizumab followed by bevacizumab/everolimus as first-line treatment of patients with glioblastoma. Clin adv Hematol. Oncol. 2012. 10 (4): 240-6.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
October 22, 2022
