Subject: Sutent 2022-A SGM P2021
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 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 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 patients with unresectable locally advanced or metastatic disease.
B. Compendial Uses
1. Relapsed or stage IV RCC
2. Soft tissue sarcoma subtypes:
a. Angiosarcoma; as single-agent therapy
b. Solitary fibrous tumor; as single-agent therapy
c. Alveolar soft part sarcoma; as single-agent therapy
3. Gastrointestinal stromal tumors
a. Subsequent therapy of unresectable, recurrent or metastatic disease as a single agent.
b. Subsequent therapy in combination with everolimus for unresectable, recurrent or metastatic disease after failure on approved therapies.
4. Thymic carcinomas, second-line therapy as a single agent
5. Differentiated thyroid carcinoma (papillary, Hürthle cell, or follicular), progressive and/or symptomatic not amenable to radioactive iodine (RAI) therapy
6. Medullary thyroid carcinoma
7. Meningioma; surgically inaccessible recurrent or progressive disease for which radiation is not
possible
8. Recurrent chordoma; as single-agent therapy
9. Myeloid/lymphoid neoplasms with eosinophilia and FLT3 rearrangement in chronic phase
10. Lymphoid, myeloid or mixed lineage neoplasms with eosinophilia and FLT3 rearrangement in blast phase
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, angiosarcoma, or solitary fibrous tumor.
C. Gastrointestinal Stromal Tumor (GIST)
1. Authorization of 12 months may be granted for treatment of gastrointestinal stromal tumor after failure
of imatinib due to progression or intolerable side effects as a single agent.
2. Authorization of 12 months may be granted for treatment of unresectable, recurrent, or metastatic GIST in combination with everolimus for disease progression after the member has failed at least four
FDA-approved therapies (e.g., imatinib, sunitinib, regorafenib and ripretinib).
D. Pancreatic Neuroendocrine Tumor
Authorization of 12 months may be granted for treatment of pancreatic neuroendocrine tumors
as a single agent.
E. 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.
F. 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.
G. Medullary Thyroid Carcinoma
Authorization of 12 months may be granted for treatment of 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]).
H. Meningioma
Authorization of 12 months may be granted for treatment of surgically inaccessible recurrent or progressive meningioma for which radiation is not possible.
I. Chordoma
Authorization of 12 months may be granted for treatment of recurrent chordoma as single-agent therapy.
J. 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. Gastrointestinal stromal tumor
4. Pancreatic neuroendocrine tumor
5. Thymic carcinoma
6. Papillary, Hürthle cell, or Follicular thyroid carcinoma
7. Medullary thyroid carcinoma
8. Meningioma
8. Chordoma
10. Myeloid and/or lymphoid neoplasms with eosinophilia
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.
Place of Service:
Outpatient
The above policy is based on the following references:
- Sutent [package insert]. New York, NY: Pfizer Labs.; August 2020.
- The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 6, 2021.
- 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.
September 20, 2021
