Subject: sunitinib-Sutent 2022-A SGM P2023

Drug

SUTENT  (sunitinib)

sunitinib

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
               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, angiosarcoma, or
               solitary fibrous tumor.

          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.   Gastrointestinal stromal tumor
               4.   Pancreatic neuroendocrine tumor
               5.   Thymic carcinoma
               6.   Papillary, Hürthle cell, or Follicular thyroid carcinoma
               7.   Medullary thyroid carcinoma
               8.   Meningioma
               9.   Chordoma
               10. Myeloid and/or lymphoid neoplasms with eosinophilia
               11. 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.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Sutent [package insert]. New York, NY: Pfizer Labs.; August 2021.
2. Sunitinib [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; September 2021.
3. The NCCN Drugs & Biologics Compendium 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 2, 2023.
4. 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.
5. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Thyroid Carcinoma. Version 1.2023. Accessed May 12, 2023.

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 20, 2023