Subject: sunitinib-Sutent 2022-A SGM P2024
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SUTENT
(sunitinib)
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sunitinib
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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. Gastrointestinal Stromal Tumor (GIST)
Sutent is indicated for the treatment of adult patients with gastrointestinal stromal tumor
after disease progression on or intolerance to imatinib mesylate.
2. Advanced Renal Cell Carcinoma (RCC)
Sutent is indicated for the treatment of adult patients with advanced renal cell carcinoma.
3. Adjuvant Treatment of Renal Cell Carcinoma (RCC)
Sutent is indicated for the adjuvant treatment of adult patients at high risk of recurrent
RCC following nephrectomy.
4. Advanced Pancreatic Neuroendocrine Tumors (pNET)
Sutent is indicated for the treatment of progressive, well-differentiated pancreatic
neuroendocrine tumors in adult patients with unresectable locally advanced or metastatic
disease.
B. Compendial Uses
1. Relapsed or stage IV RCC
2. Soft tissue sarcoma subtypes:
a. Angiosarcoma
b. Solitary fibrous tumor
c. Alveolar soft part sarcoma
d. Extraskeletal myxoid chondrosarcoma
3. Gastrointestinal stromal tumors
4. Thymic carcinomas
5. Differentiated thyroid carcinoma (papillary, oncocytic/Hürthle cell, or follicular)
6. Medullary thyroid carcinoma
7. Meningioma
8. Recurrent chordoma
9. Lymphoid, myeloid or mixed lineage neoplasms with eosinophilia and FLT3
rearrangement in chronic or blast phase
10. Pheochromocytoma/Paraganglioma
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:
Testing or analysis confirming FLT3 rearrangement (if applicable)
III. CRITERIA FOR INITIAL APPROVAL
A. Renal Cell Carcinoma
1. Authorization of 12 months may be granted for treatment of relapsed, advanced, or stage
IV renal cell carcinoma as a single agent.
2. Authorization of up to 54 weeks total may be granted for adjuvant treatment of members
who are at high risk of recurrent renal cell carcinoma following nephrectomy.
B. Soft Tissue Sarcoma
Authorization of 12 months may be granted for treatment of the following subtypes of soft
tissue sarcoma as single-agent therapy: alveolar soft-part sarcoma (ASPS), angiosarcoma,
solitary fibrous tumor or extraskeletal myxoid chondrosarcoma.
C. Gastrointestinal Stromal Tumor (GIST)
Authorization of 12 months may be granted for treatment of gastrointestinal stromal tumor
when any of the following criteria are met:
1. The requested medication will be used for treatment of residual, unresectable, tumor
rupture or recurrent/metastatic GIST after failure of imatinib due to disease progression
or intolerable side effects as a single agent.
2. The requested medication will be used for treatment of residual, unresectable, recurrent,
or metastatic/tumor rupture GIST in combination with everolimus for disease progression
after the member has failed at least four FDA-approved therapies (e.g., imatinib,
avapritinib, regorafenib and ripretinib).
3. The requested medication will be used for treatment of residual, unresectable, tumor
rupture or recurrent/metastatic succinate dehydrogenase (SDH)-deficient GIST as a
single agent.
4. The requested medication will be used for neoadjuvant therapy as a single agent to
decrease surgical morbidity of SDH-deficient GIST.
D. Pancreatic Neuroendocrine Tumor
Authorization of 12 months may be granted for treatment of pancreatic neuroendocrine
tumors.
E. Pheochromocytoma/Paraganglioma
Authorization of 12 months may be granted for treatment of locally unresectable or
metastatic pheochromocytoma or paraganglioma as a single agent.
F. Thymic Carcinoma
Authorization of 12 months may be granted for treatment of thymic carcinoma with failure or
intolerance of one previous chemotherapy regimen as a single agent.
G. Papillary, Oncocytic/Hürthle cell, or Follicular Thyroid Carcinoma
Authorization of 12 months may be granted for treatment of progressive and/or symptomatic
papillary, oncocytic/Hürthle cell, or follicular thyroid carcinoma not amenable to radioactive
iodine (RAI) therapy.
H. Medullary Thyroid Carcinoma
Authorization of 12 months may be granted for treatment of recurrent or metastatic
medullary thyroid carcinoma when either of the following criteria are met:
1. Member has a contraindication or intolerance to FDA approved systemic therapy options
(e.g., vandetanib [Caprelsa], cabozantinib [Cometriq]); OR
2. Member has disease progression while on FDA approved systemic therapy options (e.g.,
vandetanib [Caprelsa], cabozantinib [Cometriq]).
I. Meningioma
Authorization of 12 months may be granted for treatment of surgically inaccessible recurrent
or progressive meningioma for which radiation is not possible.
J. Chordoma
Authorization of 12 months may be granted for treatment of recurrent chordoma as single-
agent therapy.
K. Myeloid/Lymphoid Neoplasms with Eosinophilia
Authorization of 12 months may be granted for treatment of myeloid and/or lymphoid
neoplasms with eosinophilia and FLT3 rearrangement in the chronic phase or blast phase.
IV. CONTINUATION OF THERAPY
A. Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization when there is no evidence of unacceptable toxicity or disease progression
while on the current regimen for the specified indications below:
1. Relapsed, advanced, or stage IV renal cell carcinoma
2. Soft tissue sarcoma
3. Pancreatic neuroendocrine tumor
4. Thymic carcinoma
5. Papillary, Oncocytic/Hürthle cell, or Follicular thyroid carcinoma
6. Medullary thyroid carcinoma
7. Meningioma
8. Chordoma
9. Myeloid and/or lymphoid neoplasms with eosinophilia
10. Pheochromocytoma/Paraganglioma
B. Authorization of up to 54 weeks total may be granted for continued treatment in members
requesting reauthorization for adjuvant treatment of renal cell carcinoma when the following
criteria are met:
1. Disease is not recurrent; AND
2. Member has not exceeded a maximum of nine 6 week cycles.
C. Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for treatment of GIST when there is no evidence of unacceptable toxicity
while on the current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Sutent [package insert]. New York, NY: Pfizer Labs.; August 2021.
- Sunitinib [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; September 2021.
- The NCCN Drugs & Biologics Compendium 2024 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 2, 2024.
- Kaley TJ, Web P, Schiff D, et al. Phase II Trial of Sunitinib for Recurrent and Progressive Atypical and Anaplastic Meningioma. Neuro Oncol. 2015:17(1):116-21.
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.
November 03, 2024
