Notification

Bortezomib (Velcade®)


Notification Issue Date: 07/07/2010

This is only a notification of the policy that will be in effect on 08/06/2010. For the current version of this policy, click the following link: 08.00.73a, Bortezomib (Velcade®).



Medical Policy Bulletin


Title:Bortezomib (Velcade®)

Policy #:08.00.73c

The below medical or claim payment policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products for dates of service on or after 1/01/2015 are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Intent

The intent of this policy is to communicate the medical necessity criteria for bortezomib (Velcade®).

For information on policies related to this topic, refer to the Cross References section in this policy.
Description

Bortezomib (Velcade®) is a proteasome inhibitor, which is a new class of drug that is used for targeted antineoplastic therapy. The proteasome is an enzyme complex that is found in all biological cells. It is involved in degrading proteins that control the cell cycle and in cellular processes that maintain cell homeostasis. By blocking the proteasome, bortezomib (Velcade®) disrupts numerous biologic pathways, including those related to the growth and survival of cancer cells. Bortezomib (Velcade®) has demonstrated the ability to delay tumor growth in vivo in several tumor models, including multiple myeloma.

In May 2003, bortezomib (Velcade®) was approved by the US Food and Drug Administration (FDA) as an orphan drug (a drug used to treat, prevent, or diagnose a rare disease) under the accelerated approval program for use in the treatment of individuals with multiple myeloma. In December 2006, the FDA approved the use of bortezomib (Velcade®) in the treatment of individuals with mantle cell lymphoma (a form of non-Hodgkin's lymphoma affecting the B-lymphocytes) who have received at least one prior therapy. In June 2008, the FDA granted supplemental approval for bortezomib (Velcade®) that removed the prior therapy requirement for individuals with multiple myeloma.

In addition, the FDA issued a supplemental approval for doxorubicin HCl liposome injection (Doxil®). As of May 2007, the updated product labeling for doxorubicin HCl liposome injection (Doxil®) allows for its use in combination with bortezomib (Velcade®) for the treatment of individuals with multiple myeloma who had previously not taken bortezomib (Velcade®) and who have received at least one prior therapy.

Bortezomib (Velcade®) is also recognized as an appropriate medical treatment in published clinical research and/or company recognized drug compendia (eg, National Comprehensive Cancer Network [NCCN] compendium, Micromedex DrugDex compendium), when used for the following indications:
  • Individuals with relapsed or refractory peripheral T-cell lymphoma (a T-cell non-Hodgkin’s lymphoma), as second-line therapy for those who are not candidates for high-dose therapy with autologous stem cell rescue
  • As a single agent in the treatment of individuals with systemic light-chain amyloidosis
    • The NCCN compendium notes that individuals should be treated within the context of a clinical trial when possible, as there is insufficient data to indicate the optimal treatment of amyloidosis.
  • As a single agent with plasmapheresis in the treatment of individuals with Waldenström's macroglobulinemia with symptomatic hyperviscosity
    Policy

Bortezomib (Velcade®) is considered medically necessary and, therefore, covered for the following indications:

MULTIPLE MYELOMA
  • The treatment of individuals with multiple myeloma, including progressive solitary plasmacytoma
NON-HODGKIN’S LYMPHOMA
  • The treatment of individuals with relapsed or refractory B-cell non-Hodgkin’s lymphoma, specifically mantle cell lymphoma or follicular lymphoma, who have received at least one prior therapy
PERIPHERAL T-CELL LYMPHOMA
  • The treatment of individuals with relapsed or refractory peripheral T-cell lymphoma (a T-cell non-Hodgkin’s lymphoma), as second-line therapy for those who are not candidates for high-dose therapy with autologous stem cell rescue
SYSTEMIC LIGHT-CHAIN AMYLOIDOSIS
  • As a single agent in the treatment of individuals with systemic light-chain amyloidosis
WALDENSTROM'S MACROGLOBULINEMIA
  • As a single agent with plasmapheresis in the treatment of individuals with Waldenström's macroglobulinemia with symptomatic hyperviscosity
EXPERIMENTAL/INVESTIGATIONAL

All other uses of bortezomib (Velcade®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics. Uses of bortezomib (Velcade®) that are not supported in either this medical policy or the off-label coverage policy are considered experimental/investigational and, therefore, not covered.

ABSOLUTE CONTRAINDICATIONS

Bortezomib (Velcade®) is considered not medically necessary and, therefore, not covered for individuals with the following absolute contraindication:

  • Hypersensitivity to bortezomib, boron, or mannitol

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.


Guidelines

Bortezomib (Velcade®) is given as an intravenous bolus injection and should be administered under the supervision of a physician who is experienced in the use of chemotherapy.

PRIOR THERAPIES

For mantle cell lymphoma, prior therapy with at least one treatment can include, but is not limited to, a regimen of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP regimen), fludarabine-based regimens, CHOP plus rituximab, or hyperCVAD (fractionated cyclophosphamide, doxorubicin, vincristine, dexamethasone) with or without stem cell transplantation.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, bortezomib (Velcade®) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, when bortezomib (Velcade®) is given to an individual who has any of the absolute contraindications listed in the policy, it is considered not medically necessary and, therefore, not covered.

MEDICARE

There is no Medicare coverage determination addressing this service; therefore, the Company policy is applicable.

For Medicare Advantage members, certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when bortezomib (Velcade®) is covered under a member's medical benefit (Part B benefit). It does not address instances when bortezomib (Velcade®) is covered under a member’s pharmacy benefit (Part D benefit).

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

BORTEZOMIB (VELCADE®)
The FDA granted initial approval for the use of bortezomib (Velcade®) to Millennium Pharmaceuticals, Inc. (Cambridge, MA) on May 13, 2003; supplemental approvals have since been issued.

DOXORUBICIN HCL LIPOSOME INJECTION (DOXIL®)
The FDA granted a supplemental approval on May 17, 2007, to ALZA Corporation (Raritan, NJ) for doxorubicin HCl liposome injection (Doxil®) for use in combination with bortezomib (Velcade®) in the treatment of individuals with multiple myeloma who previously have not taken bortezomib (Velcade®) and who have received at least one prior therapy.
References

Bortezomib (Velcade®). American Hospital Formulary Service (AHFS). AHFS Drug Information 2010. [STAT!Ref Web site]. January 2010. Available at: http://online.statref.com [via subscription only]. Accessed April 27, 2010.


Bortezomib (Velcade®). Elsevier Gold Standard’s Clinical Pharmacology Compendium. [MD Consult Web site]. 01/08/2010. Available at: http://www.mdconsult.com [via subscription only]. Accessed April 27, 2010.

Bortezomib (Velcade®). Micromedex® Healthcare Series. DrugDex®. [Micromedex® Web site]. March 2010. Available at: http://www.thomsonhc.com [via subscription only]. Accessed April 27, 2010.

Doxil® (doxorubicin HCl liposome injection) [prescribing information]. Raritan, NJ: Ortho Biotech Products, LP. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050718s033lbl.pdf. Accessed April 27, 2010.

National Cancer Institute. Clinical trial results. Bortezomib (Velcade®) delays progression of advanced multiple myeloma longer than standard therapy: Results of the APEX Trial. [National Cancer Institute Web site]. Original: 06/05/04. (Reviewed: 08/21/07). Available at: http://www.cancer.gov/clinicaltrials/results/bortezomib0604. Accessed April 27, 2010.

National Cancer Institute. Drug information: Bortezomib. [National Cancer Institute Web site]. Original: 10/05/06. (Revised: 02/25/09). Available at: http://www.cancer.gov/cancertopics/druginfo/bortezomib. Accessed April 27, 2010.

National Cancer Institute. NCI FactSheet. Waldenström macroglobulinemia: Questions and answers. [National Cancer Institute Web site]. 09/25/07. Available at: http://www.cancer.gov/cancertopics/factsheet/Sites-Types/WM. Accessed April 27, 2010.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Multiple Myeloma. V.3. 2010 [NCCN Web site]. 04/20/10. Available at: http://www.nccn.org/professionals/physician_gls/PDF/myeloma.pdf [via subscription only]. Accessed April 27, 2010.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Non-Hodgkin's Lymphomas. V.1.2010. [NCCN Web site]. 04/08/10. Available at: http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf [via subscription only]. Accessed April 27, 2010.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium™. Bortezomib. [NCCN Web site]. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed April 27, 2010.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Doxil® (doxorubicin HCl liposome injection). Supplemental approval letter. [FDA Web site]. 05/17/07. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050718s028,s029ltr.pdf. Accessed April 27, 2010.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Drug details: Velcade® (bortezomib). [FDA Web site]. 12/30/09. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021602s019s020lbl.pdf. Accessed April 27, 2010.

Velcade® (bortezomib) [prescribing information]. Cambridge, MA: Millennium Pharmaceuticals, Inc.; June 2008. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021602s015lbl.pdf. Accessed April 27, 2010.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A

ICD - 9 Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

ICD-10-PCS codes will be in effect on the determined ICD-10 compliance date. However, they are being added to policy for informational purposes only.




ICD - 9 Diagnosis Code Number(s)

TO REPORT MANTLE CELL LYMPHOMA, USE THE FOLLOWING CODES


200.40: Mantle cell lymphoma, unspecified site, extranodal and solid organ sites

200.41: Mantle cell lymphoma, lymph nodes of head, face, and neck

200.42: Mantle cell lymphoma, intrathoracic lymph nodes

200.43: Mantle cell lymphoma, intra-abdominal lymph nodes

200.44: Mantle cell lymphoma, lymph nodes of axilla and upper limb

200.45: Mantle cell lymphoma, lymph nodes of inguinal region and lower limb

200.46: Mantle cell lymphoma, intrapelvic lymph nodes

200.47: Mantle cell lymphoma, spleen

200.48: Mantle cell lymphoma, lymph nodes of multiple sites

TO REPORT FOLLICULAR LYMPHOMA, USE THE FOLLOWING CODES

202.00: Nodular lymphoma, unspecified site, extranodal and solid organ sites

202.01: Nodular lymphoma of lymph nodes of head, face, and neck

202.02: Nodular lymphoma of intrathoracic lymph nodes

202.03: Nodular lymphoma of intra-abdominal lymph nodes

202.04: Nodular lymphoma of lymph nodes of axilla and upper limb

202.05: Nodular lymphoma of lymph nodes of inguinal region and lower limb

202.06: Nodular lymphoma of intrapelvic lymph nodes

202.07: Nodular lymphoma of spleen

202.08: Nodular lymphoma of lymph nodes of multiple sites

202.80: Other malignant lymphomas, unspecified site, extranodal and solid organ sites

202.81: Other malignant lymphomas of lymph nodes of head, face, and neck

202.82: Other malignant lymphomas of intrathoracic lymph nodes

202.83: Other malignant lymphomas of intra-abdominal lymph nodes

202.84: Other malignant lymphomas of lymph nodes of axilla and upper limb

202.85: Other malignant lymphomas of lymph nodes of inguinal region and lower limb

202.86: Other malignant lymphomas of intrapelvic lymph nodes

202.87: Other malignant lymphomas of spleen

202.88: Other malignant lymphomas of lymph nodes of multiple sites

TO REPORT PERIPHERAL T-CELL LYMPHOMA, USE THE FOLLOWING CODES

202.70: Peripheral T-cell lymphoma, unspecified site, extranodal and solid organ sites

202.71: Peripheral T-cell lymphoma, lymph nodes of head, face, and neck

202.72: Peripheral T-cell lymphoma, intrathoracic lymph nodes

202.73: Peripheral T-cell lymphoma, intra-abdominal lymph nodes

202.74: Peripheral T-cell lymphoma, lymph nodes of axilla and upper limb

202.75: Peripheral T-cell lymphoma, lymph nodes of inguinal region and lower limb

202.76: Peripheral T-cell lymphoma, intrapelvic lymph nodes

202.77: Peripheral T-cell lymphoma, spleen

202.78: Peripheral T-cell lymphoma, lymph nodes of multiple sites

TO REPORT MULTIPLE MYELOMA (INCLUDING SOLITARY PLASMACYTOMA, USE THE FOLLOWING CODES

203.00: Multiple myeloma, without mention of having achieved remission

203.01: Multiple myeloma, in remission

203.02: Multiple myeloma, in relapse

238.6: Neoplasm of uncertain behavior of plasma cells

TO REPORT SYSTEMIC LIGHT-CHAIN AMYLOIDOSIS, USE THE FOLLOWING CODE

277.30: Amyloidosis, unspecified

TO REPORT WALDENSTROM'S MACROGLOBULINEMIA, USE THE FOLLOWING CODE

273.3: Macroglobulinemia


ICD -10 Diagnosis Code Number(s)

ICD-10-CM codes will be in effect on the determined ICD-10 compliance date. However, they are being added to policy for informational purposes only.



HCPCS Level II Code Number(s)

J9041: Injection, bortezomib, 0.1 mg

Revenue Code Number(s)

N/A


Cross References



Version Effective Date: 08/06/2010

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