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| Medical Policy: | I-83-006 |
| Topic: | bortezomib (Velcade) |
| Section: | Injections |
| Effective Date: | July 9, 2018 |
| Issue Date: | July 9, 2018 |
| Last Reviewed: | February 2018 |
Bortezomib (Velcade®) is a proteasome inhibitor, used for targeted antineoplastic therapy. Proteasome is involved in degrading proteins that control the cell cycle and in cellular processes that maintain cell homeostasis. Bortezomib (Velcade) has demonstrated the ability to delay tumor growth in vivo in several tumor models, including multiple myeloma. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Bortezomib (Velcade) may be considered medically necessary for the treatment of ANY of the following indications:
- Adult T-cell leukemia/lymphoma
- Second-line therapy as a single agent for nonresponders to first-line therapy for acute disease or lymphoma or as subsequent therapy after high dose therapy/autologous stem cell rescue (HDT/ASCR).
- Mantle cell lymphoma
- Less aggressive induction therapy with VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) regimen; or
- Second line therapy with or without rituximab to achieve complete response after partial response to induction therapy or for relapsed, refractory or progressive disease; or
- Second line therapy with bendamustine and rituximab to achieve complete response after partial response to induction therapy or for relapsed, refractory or progressive disease.
- Used for stage I-II disease, aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV disease as:
- Castleman's disease (CD)
- Used as subsequent therapy with or without rituximab for multi-centric CD that has progressed following treatment of relapsed/refractory or progressive disease.
- Multiple myeloma (including plasma cell leukemia, plasmacytoma)
- Primary therapy for active (symptomatic) myeloma or for disease relapse after Six (6) months following primary therapy with the same regimen:
- In combination with dexamethasone and lenalidomide (preferred regimen); or
- In combination with dexamethasone and cyclophosphamide (preferred initial treatment in patients with acute renal insufficiency); or
- In combination with dexamethasone and doxorubicin for transplant candidates; or
- In combination with dexamethasone (useful under some circumstances); or
- In combination with dexamethasone and thalidomide for transplant candidates (useful under some circumstances); or
- In VTD-PACE (bortezomib, thalidomide, dexamethasone, cisplatin, doxorubicin, cyclophosphamide and etoposide) regimen for transplant candidates (useful under some circumstances); or
- Maintenance therapy as a single agent:
- For active (symptomatic) myeloma responding to primary myeloma therapy; or
- For stable or responsive disease following stem cell transplant; or
- Therapy for previously treated myeloma for disease relapse or progressive disease in:
- Combination with dexamethasone and lenalidomide (preferred regimen); or
- Combination with dexamethasone and daratumumab (preferred regimen); or
- Combination with dexamethasone and bendamustine; or
- Combination with dexamethasone and liposomal doxorubicin; or
- Combination with dexamethasone and cyclophosphamide; or
- Combination with dexamethasone; or
- Combination with elotuzumab and dexamethasone; or
- Combination with panobinostat and dexamethasone for patients who have received at least two (2) prior regimens, including bortezomib and an immunomodulatory agent; or
- Combination with pomalidomide and dexamethasone for patients who have received at least two (2) prior therapies, including an immunomodulatory agent and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy; or
- VTD-PACE (bortezomib, thalidomide, dexamethasone, cisplatin, doxorubicin, cyclophosphamide, and etoposide) regimen (useful under some circumstances, generally reserved for the treatment of aggressive myeloma).
- Primary therapy for active (symptomatic) myeloma or for disease relapse after Six (6) months following primary therapy with the same regimen:
- Peripheral T-Cell Lymphoma
- Second-line or subsequent therapy for relapsed or refractory anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, nodal peripheral T-cell lymphoma with T follicular helper (TFH) phenotype, or follicular T-cell lymphoma, in patients with no intention to transplant as a single agent.
- Mycosis Fungoides/Sezary Syndrome
- Systemic therapy as primary treatment for:
- Stage IB-IIA mycosis fungoides (MF) with histologic evidence of folliculotropic or large-cell transformed MF, with or without skin-directed therapy for generalized tumor lesions; or
- Stage IIB MF with generalized tumor lesions, with or without skin-directed therapy; or
- Stage IV non Sezary or visceral disease (solid organ), with or without radiation therapy for local control; or
- Systemic therapy as treatment for
- Stage IB-IIA mycosis fungoides (MF) that is refractory to multiple previous therapies or progression; or
- Stage IIB MF with limited tumor lesions refractory to multiple previous therapies or progression, with or without skin-directed therapies; or
- Stage IIB MF with generalized tumor lesions that is relapsed with T3 disease or has persistent T3 disease, with or without skin-directed therapies; or
- Stage III MF that is refractory to multiple previous therapies or progression; or
- Stage IV Sezary syndrome that is refractory to multiple previous therapies or progression; or
- Stage IV non Sezary or visceral disease (solid organ) that is relapsed or persistent, with or without radiation therapy for local control.
- Systemic therapy as primary treatment for:
- Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders
- Therapy for primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions, or cutaneous ALCL with regional nodes (excludes systemic ALCL), as a single agent for relapsed/refractory disease.
- Systemic light-chain amyloidosis
- Primary treatment as a single agent or in combination with dexamethasone with or without melphalan or with or without cyclophosphamide; or
- Treatment for relapsed/refractory disease as a single agent or in combination with dexamethasone with or without melphalan.
- Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma
- Used as a single agent, in combination with dexamethasone, or in combination with rituximab with or without dexamethasone as primary therapy for previously treated disease that does not respond to primary therapy or for progressive or relapsed disease.
Bortezomib (Velcade) is considered not medically necessary for all other indications.
NOTE: Dosage recommendations per the FDA label. |
| Place of Service: Outpatient |
The administration of bortezomib (Velcade) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
04/2017, Clinical criteria updated for Velcade® (bortezomib)
04/2018, Clinical Guidelines Revised for bortezomib (Velcade)
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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Room 509F, HHH Building
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