Subject: sunitinib-Sutent 2022-A SGM P2022

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, 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 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 unresectable, recurrent/progressive, or metastatic 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 unresectable succinate dehydrogenase (SDH)-deficient GIST as a single agent.
      4.   The requested medication will be used for palliation of symptoms if previously tolerated and effective.

D.   Pancreatic Neuroendocrine Tumor
      Authorization of 12 months may be granted for treatment of pancreatic neuroendocrine tumors as a single agent.

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, 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. 

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. The NCCN Drugs & Biologics Compendium 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed May 25, 2022.
3. 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.

October 22, 2022