Pharmacy Prior Authorization Criteria

Bortezomib

Indications for Prior Authorization

Velcade (bortezomib)

• For diagnosis of Multiple Myeloma
  Indicated for the treatment of patients with multiple myeloma.

• For diagnosis of Mantle Cell Lymphoma
  Indicated for the treatment of patients with mantle cell lymphoma.

Bortezomib (bortezomib)

• For diagnosis of Multiple Myeloma
  Indicated for the treatment of patients with multiple myeloma.

• For diagnosis of Mantle Cell Lymphoma
  Indicated for the treatment of adult patients with mantle cell lymphoma.

Boruzu (bortezomib)

• For diagnosis of Multiple Myeloma
  Indicated for the treatment of adult patients with multiple myeloma.

• For diagnosis of Mantle Cell Lymphoma
  Indicated for the treatment of adult patients with mantle cell lymphoma.

Criteria

Brand Velcade, Generic bortezomib, Bortezomib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Multiple Myeloma

• Diagnosis of multiple myeloma [1, 2, 5]
AND
• Trial and failure, contraindication or intolerance to generic bortezomib (Applies to Brand Velcade Only)

Boruzu

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Multiple Myeloma

• Diagnosis of multiple myeloma
AND
• One of the following:
• Trial and failure, contraindication or intolerance to generic bortezomib
OR
• For continuation of prior therapy

Brand Velcade, Generic bortezomib, Bortezomib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Mantle Cell Lymphoma

• Diagnosis of mantle cell lymphoma [1, 3, 4, 5]
AND
• Trial and failure, contraindication or intolerance to generic bortezomib (Applies to Brand Velcade Only)

Boruzu

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Mantle Cell Lymphoma

• Diagnosis of mantle cell lymphoma
AND
• One of the following:
• Trial and failure, contraindication or intolerance to generic bortezomib
OR
• For continuation of prior therapy

Brand Velcade, Generic bortezomib, Bortezomib, Boruzu

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

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

P & T Revisions

2024-12-21, 2024-05-20, 2023-06-26, 2023-03-31, 2023-02-17, 2022-10-06, 2022-08-14, 2022-06-17, 2022-06-12, 2021-06-03

References

1. Velcade Prescribing Information. Millennium Pharmaceuticals, Inc. Cambridge, MA. November 2021.
2. Richardson PG, Sonneveld P, Schuster MW, et al. Assessment of Proteasome Inhibition for Extending Remissions (APEX) Investigators. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med. 2005 Jun 16;352(24):2487-98.
3. National Cancer Institute. Adult Non-Hodgkin Lymphoma Treatment (PDQ). Available at: http://www.cancer.gov/cancertopics/pdq/treatment/adult-non-hodgkins/healthprofessional. Accessed May 12, 2022.
4. Fisher RI, Bernstein SH, Kahl BS, et al. Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol.2006;24(30):4867-74.
5. The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org. Accessed May 12, 2022.
6. Bortezomib Prescribing Information. Fresenius Kabi USA, LLC. Lake Zurich, IL. December 2022.
7. Bortezomib Prescribing Information. Hospira, Inc.. Lake Forest, IL. December 2022.
8. Bortezomib Prescribing Information. Dr Reddy’s Laboratories, Inc. Princeton, NJ. December 2022.
9. Bortezomib Prescribing Information. Hikma Pharmaceuticals USA, Inc. Berkeley Heights, NJ. November 2021.
10. Bortezomib Prescribing Information. Fosun Pharma USA. Princeton, NJ. August 2022.
11. Boruzu Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, NJ. September 2024.
12. Boruzu Press Release. Available at:https://investors.amneal.com/news/press-releases/press-release-details/2024/Amneal-and-Shilpa-Announce-U.S.-FDA-Approval-of-BORUZU-the-First-Ready-to-Use-Version-of-Bortezomib-for-subcutaneous-administration/default.aspx. Accessed December 20, 2024.
13. FDA's 505(b)(2) Explained: A Guide to New Drug Applications. Available at: https://www.thefdagroup.com/blog/505b2. Accessed December 20, 2024.
14. Chandanais, R. 505 (b)(2) Regulatory Pathway for New Drug Approvals. Available at: https://www.pharmacytimes.com/view/505-b2-regulatory-pathway-for-new-drug-approvals-. Accessed December 20, 2024.
15. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Available at: https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm. Accessed December 20, 2024.

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Revision History

• 2024-12-21: update guideline
• 2024-05-20: 2024 Annual Review
• 2023-06-26: Removed specialist requirement.
• 2023-03-31: Updated GPIs
• 2023-02-17: update guideline
• 2022-10-06: Update UM criteria
• 2022-08-14: Update UM PA Criteria
• 2022-06-17: Update Guideline
• 2022-06-12: Update Guideline
• 2021-06-03: Annual review: Updated attached formularies and background.

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