QUEST Integration - Sunitinib (Sutent)

I. Description

Sunitinib (Sutent) is FDA approved for the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate (Gleevec) and for the treatment of advanced renal cell carcinoma (RCC). Sunitinib is a multi-kinase inhibitor that targets several receptor tyrosine kinases to deprive the tumor cells of the blood supply and nutrients needed to grow. It is an orally administered medication.

II. Criteria/Guidelines

1. Sunitinib is covered (subject to the Limitations/Exclusions and Administrative Guidelines) for an initial three months when recommended by an oncologist for one of the following indications:
   1. Treatment of GIST after disease progression on or intolerance to imatinib (Gleevec).
   2. Treatment of advanced RCC.
   3. Treatment of thyroid carcinoma.
2. For the above diagnoses and for other diagnoses, HMSA follows NCCN level 1 or 2A and/or DrugDex level I or IIa recommendations.
3. Continuation of therapy is covered (subject to Administrative Guidelines) when the initial therapy has been approved and there is no evidence of progression of disease.

III. Limitations/Exclusions

1. These criteria will continue to apply when sunitinib becomes available in a generic form.

 IV. Administrative Guidelines

1. Precertification is required for the initial three months of therapy.
2. To precertify, please complete HMSA's Drug Review Request [PDF] and mail or fax the form as indicated. The following documentation from the medical record must be submitted:
   1. Clinical notes that include the history of previous treatments;
   2. Current oncology notes;
   3. Pathology reports;
   4. Imaging studies.
3. Precertification is required for continuation of sunitinib for each additional three month period when the initial therapy has been approved and there is no evidence of progression of disease. The following documentation from the medical record must be submitted:
   1. Current oncology notes documenting the patient's response to treatment; and
   2. Current laboratory results (if applicable) and current imaging studies that show no progression of disease when compared with previous laboratory/imaging studies.

V. Important Reminder

The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician.

Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii’s Patients’ Bill of Rights and Responsibilities Act (Hawaii Revised Statutes §432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA’s determination as to medical necessity in a given case, the physician may request that HMSA reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation.

VI. Scientific Background

Gastrointestinal Stromal Tumor

In a randomized controlled trial (n=312), for patients who failed on imatinib treatment (n=207), sunitinib showed significant improvement in: delaying the time-to-tumor progression (27.3 weeks) vs. placebo plus best supportive care (6.4 weeks, p<0.0001), increasing progression-free survival (24.1 weeks) vs. placebo (6.0 weeks, p<0.0001) and objective response rate (6.8%) vs. placebo-treated patients (0%, p<0.006). Because the study was terminated early, and because treatment crossover was allowed after the endpoint was reached, median survival could not be calculated.

Advanced Renal Cell Carcinoma

The National Comprehensive Cancer Network (NCCN) has issued guidelines for the treatment of kidney cancer that specify sunitinib as a potential first or subsequent-line therapy as a single agent for patients with relapsed or medically unresectable stage IV kidney cancer. For subsequent therapy, patients recommended should have predominant clear cell histology who have progressed on prior first-line therapy. 

In a randomized controlled trial used to qualify for FDA approval, sunitinib was compared to interferon alfa in 750 patients with previously untreated, metastatic renal cell carcinoma. The median duration of treatment for sunitinib (n=375) was six months and four months for the interferon alfa group (n=375). The median progression-free survival was 11 months in patients receiving sunitinib and five months for patients receiving interferon alfa. Median overall survival had not been reached.

Thyroid carcinoma 

Current National Comprehensive Cancer Network (NCCN) guidelines for the treatment of papillary, follicular, Hurthle cell, medullary thyroid carcinoma specify that although not FDA approved, commercially available small molecule kinase inhibitors (such as sorafenib or sunitinib) can be considered if clinical trials are not available or appropriate.  

VII. References

1. Fiedler W, et al. "A phase 1 study of SU11248 in the treatment of patients with refractory or resistant acute myeloid leukemia (AML) or not amenable to conventional therapy for the disease." Blood. 2005; 105: 986-93.
2. Motzer RJ, Dror Michaelson M, Redman BG. et al. Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006; 24(1):16-24.
3. Motzer RJ, Rini BI, Bukowski RM, et al. Sunitinib in Patients With Metastatic Renal Cell Carcinoma. JAMA. 2006; 295: 2516-2524.
4. National Comprehensive Cancer Network, Clinical Practice Guidelines in Oncology. Kidney Cancer. v.2.2010.
5. National Comprehensive Cancer Network, Clinical Practice Guidelines in Oncology. Thyroid Carcinoma. v.1.2010.
6. Sutent prescribing information, Pfizer Labs, New York, NY. 7/2010.
7. The Regence Group. Medication Policy Manual. Sutent, sunitinib. Policy No. dru128. Revised April 1, 2010. 
8. Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, et al. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomized controlled trial. Lancet. 2006 Oct 14; 368(9544):1329-38.
9. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukokowski RM, Rixe O, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11; 356(2):115-24.

Revision History