CurrentCignaPolicy N/A

Oncology - Sunitinib Preferred Specialty Management Policy

Defines Cigna's Preferred Specialty Management program for sunitinib products, directing use of generic sunitinib capsules as the preferred product and specifying exception criteria for coverage of brand Sutent. Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Sunitinib Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJan 22, 2025

Key ActionProviders must document prior trial of generic sunitinib and submit supporting documentation to request approval of brand Sutent under the exception criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration for covered requests

Genericpreferred product

Sutentnon-preferred product

Yesdocumentation required

Coverage Criteria for Sutent (sunitinib)

Non-Preferred Product Exception Criteria (Sutent)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

Sutent exception criteria: A) Patient meets the standard Oncology - Sunitinib Prior Authorization Policy criteria;

Condition A required

Sutent exception criteria: B) Patient has tried generic sunitinib capsules [documentation required];

Condition B required — documentation may include chart notes, prescription claims records, prescription receipts, or other information

Sutent exception criteria: C) Patient cannot take sunitinib due to a formulation difference in the inactive ingredient(s) (e.g., difference in dyes, fillers, preservatives) between the brand and bioequivalent generic product which, per the prescriber, would result in a significant allergy or serious adverse reaction [documentation required].

Policy Summary

PayerCigna

PolicyOncology - Sunitinib Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJan 22, 2025

Key ActionProviders must document prior trial of generic sunitinib and submit supporting documentation to request approval of brand Sutent under the exception criteria.

SourceLink

On This Page

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Provider Requirements and Authorization

Prior Authorization

Prior authorization required

All sunitinib medications (preferred and non‑preferred) require meeting the standard Oncology - Sunitinib Prior Authorization Policy criteria; approvals are provided for 1 year.

Step Therapy

Step therapy — trial of preferred product required

The program requires a trial of the Preferred Product (generic sunitinib capsules) before approving the non‑preferred brand Sutent; if prior auth criteria are met but the preferred product has not been tried, approval will be for the preferred product.

Documentation Required

Required documentation to support exception

Documentation is required to support use of Sutent as described in the exception criteria; acceptable documentation may include chart notes, prescription claims records, prescription receipts, and/or other information demonstrating prior use of generic sunitinib and formulation‑related intolerance/allergy.

Chart notes
Prescription claims records
Prescription receipts
Other information demonstrating prior generic use or formulation‑related intolerance/allergy

Denial Risk

Denial if exception criteria not met

Requests for brand Sutent that do not meet the Non‑Preferred Product Exception Criteria, including required documentation of a prior trial of generic sunitinib and documentation of formulation‑related intolerance/allergy, are considered not medically necessary and may be denied.

Definitions

Sunitinib — drug and common indications

Drug classSunitinib is a tyrosine kinase inhibitor.

GIST indicationGastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.

Pancreatic NET indicationProgressive, well‑differentiated pancreatic neuroendocrine tumors that are unresectable locally advanced or metastatic.

Renal cell carcinoma indicationsAdvanced renal cell carcinoma and adjuvant treatment for patients at high risk of recurrent renal cell carcinoma following nephrectomy.

Preferred Product

Preferred product identificationGeneric sunitinib capsules are designated as the Preferred Product under this program.

Program purposePreferred Specialty Management program encourages use of the Preferred Product and directs trial of the preferred product prior to non‑preferred approval.

Authorization requirementAll sunitinib products (preferred and non‑preferred) must meet the standard Oncology - Sunitinib Prior Authorization Policy criteria.

Non‑Preferred Product Exception Criteria (Sutent)

Approval conditions (all required)Approve brand Sutent for 1 year only if ALL of the following are met: (A) patient meets the standard Oncology - Sunitinib Prior Authorization Policy criteria; (B) patient has tried generic sunitinib capsules (documentation required); and (C) prescriber documents that the patient cannot take the generic due to a formulation difference in inactive ingredients that would cause a significant allergy or serious adverse reaction (documentation required).

Documentation requiredDocumentation to support prior trial of the generic and the formulation‑related intolerance/allergy is required (examples include chart notes, prescription claims records, receipts).

Duration of approvalApprovals for Sutent granted under these exception criteria are provided for 1 year.

Default if criteria not metIf the patient meets the standard prior authorization criteria but does NOT meet exception elements B and/or C, the generic sunitinib capsules (preferred product) will be approved instead of brand Sutent.

Background

Sunitinib is a small-molecule kinase inhibitor with adult indications that include treatment of gastrointestinal stromal tumor (GIST) after progression on or intolerance to imatinib, progressive well-differentiated pancreatic neuroendocrine tumors (unresectable locally advanced or metastatic), advanced renal cell carcinoma, and adjuvant treatment of high-risk renal cell carcinoma following nephrectomy. In this policy the focus is on product selection—generic sunitinib capsules are designated the preferred product and brand Sutent is managed as a non-preferred product subject to the exception criteria described below. Documentation of prior trial of the preferred generic and prescriber rationale for inability to use the generic (formulation-related allergy or serious adverse reaction) are required for approval of brand Sutent.