Pharmacy Prior Authorization Criteria

Nexavar (sorafenib)

Indications for Prior Authorization

Nexavar (sorafenib)

• For diagnosis of Renal Cell Carcinoma
  Indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

• For diagnosis of Hepatocellular Carcinoma
  Indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

• For diagnosis of Differentiated Thyroid Carcinoma
  Indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.

Criteria

Brand Nexavar, generic sorafenib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Months [A]
For diagnosis of Renal cell carcinoma

• Diagnosis of advanced renal cell carcinoma
AND
• Trial and failure or intolerance to generic sorafenib (Applies to Brand Nexavar only)

Brand Nexavar, generic sorafenib

Prior Authorization (Reauthorization)

Length of Approval: 12 Months
For diagnosis of Renal cell carcinoma

• Patient does not show evidence of progressive disease while on therapy

Brand Nexavar, generic sorafenib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Hepatocellular carcinoma

• Diagnosis of hepatocellular carcinoma
AND
• Trial and failure or intolerance to generic sorafenib (Applies to Brand Nexavar only)

Brand Nexavar, generic sorafenib

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Hepatocellular carcinoma

• Patient does not show evidence of progressive disease while on therapy

Brand Nexavar, generic sorafenib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Differentiated Thyroid Carcinoma

• Diagnosis of differentiated thyroid carcinoma
AND
• One of the following:
• Locally recurrent disease
• Metastatic disease
AND
• Patient has progressive disease
AND
• Disease is refractory to radioactive iodine (RAI) treatment
AND
• Trial and failure or intolerance to generic sorafenib (Applies to Brand Nexavar only)

Brand Nexavar, generic sorafenib

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Differentiated Thyroid Carcinoma

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-05-02, 2023-06-29, 2023-06-07, 2022-07-22, 2022-07-22, 2022-07-05, 2022-04-11, 2021-09-27, 2021-05-11, 2020-04-29

References

1. Nexavar Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. August 2023.
2. Brose MS, Nutting CM, Sherman SI, et al. Rationale and design of DECISION: a doubleblind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer. BMC Cancer. 2011;349.
3. National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium [internet database]. https://www.nccn.org. Accessed April 3, 2021.
4. National Comprehensive Cancer network (NCCN) Clinical Practice Guidelines in Oncology. Kidney Cancer. V.2.2020. NCCN Website. https://www.nccn.org/professionals/physician_gls/default.aspx. Accessed April 3, 2020.
5. National Comprehensive Cancer network (NCCN) Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers. V.2.2021. NCCN Website. https://www.nccn.org/professionals/physician_gls/default.aspx. Accessed April 3, 2021
6. National Comprehensive Cancer network (NCCN) Clinical Practice Guidelines in Oncology. Thyroid Carcinoma. V.1.2021. NCCN Website. https://www.nccn.org/professionals/physician_gls/default.aspx. Accessed April 3, 2021
7. Sorafenib Prescribing Information. Dr. Reddys Laboratories Inc. Princeton, NJ. November 2022.

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End Notes

1. Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs. Mean progression-free survival in Study 1 as described in the Nexavar prescribing information indicates a median progression-free survival of 167 days in Nexavar-treated patients with renal cell carcinoma. [1]

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Revision History

• 2024-05-02: Annual review: No criteria changes. Updated references.
• 2023-06-29: Removed specialist requirement
• 2023-06-07: Annual review: Updated RCC criteria to include "advanced" RCC to align with labeling. Removed NCCN-associated criteria from HCC and DTC indications. Removed coverage for off-label indication of MTC.
• 2022-07-22: Updated indications section. No changes to criteria.
• 2022-07-22: Minor formatting update, no changes to criteria
• 2022-07-05: Addition of new generic, sorafenib
• 2022-04-11: Annual review: no criteria changes, updated references
• 2021-09-27: Annual Review
• 2021-05-11: Annual Review
• 2020-04-29: Annual Review

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