CurrentClover HealthPolicy 7252-A

Blenrep Coverage and Prior Authorization

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This policy governs Medicare Part B coverage and prior authorization for Blenrep (belantamab mafodotin-blmf), including FDA-approved and specified compendial uses, for initial and continuation authorization requests.

Policy Summary

PayerClover Health

PolicyBlenrep Coverage and Prior Authorization

Policy CodePolicy 7252-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation identifying a covered indication and applicable prior lines of therapy, including chart notes demonstrating failure of previous therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsStandard authorization period

2+Minimum prior lines for combination therapy

8 cyclesMaintenance treatment duration

3+Minimum prior lines for single-agent treatment

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CurrentClover HealthPolicy 7252-A

Blenrep Coverage and Prior Authorization

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Policy Summary

PayerClover Health

PolicyBlenrep Coverage and Prior Authorization

Policy CodePolicy 7252-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation identifying a covered indication and applicable prior lines of therapy, including chart notes demonstrating failure of previous therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsStandard authorization period

2+Minimum prior lines for combination therapy

8 cyclesMaintenance treatment duration

3+Minimum prior lines for single-agent treatment

Covered indication categories

Not coveredOther indications

Covered and Non-Covered Indications

Multiple Myeloma

Authorization of 12 months may be granted for the treatment of relapsed or refractory multiple myeloma when ALL of the following are met:

ALL of the following

The member has relapsed or refractory multiple myeloma.
ONE of the following treatment settings:
- In combination with bortezomib and dexamethasone, when the member has received at least two lines of prior therapy, including a proteasome inhibitor and an immunomodulatory agent.
- As a single agent for maintenance therapy after completing 8 cycles of combination treatment with bortezomib and dexamethasone, when the member has received at least two lines of prior therapy, including a proteasome inhibitor and an immunomodulatory agent.
- As a single agent, when the member has received at least three lines of prior therapy.

POEMS, MIDD, and MGRS

Authorization of 12 months may be granted, as a single agent or in combination with bortezomib and dexamethasone, for the treatment of the following plasma-cell disorders:

ONE of the following:

Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome.
Plasma-cell related monoclonal immunoglobulin deposition disease (MIDD).
Plasma cell-related monoclonal gammopathy of renal significance (MGRS).

Continuation Therapy

All members requesting authorization for continuation of therapy, including new members, must meet ALL of the following criteria. Authorization for 12 months may be granted:

ALL of the following

The member is currently receiving therapy with the requested drug.
The requested drug is being used to treat an indication in the coverage criteria section.
The member is receiving benefit from therapy, defined as ALL of the following:
- No unacceptable toxicity while on the current regimen.
- No evidence of disease progression while on the current regimen.

Covered compendial uses include: relapsed or refractory multiple myeloma; polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome; plasma-cell related monoclonal immunoglobulin deposition disease (MIDD); and plasma cell-related monoclonal gammopathy of renal significance (MGRS).

All other indications are considered experimental/investigational and not medically necessary.

Prior-Therapy and Maintenance Requirements

Prior therapy requirements

Minimum prior therapyAt least 2 lines of prior therapy

Required therapy classesPrior therapy must include a proteasome inhibitor and an immunomodulatory agent

Applicable treatment settingsCombination treatment or single-agent maintenance for relapsed or refractory multiple myeloma

Single-agent treatment requirement

Minimum prior therapyAt least 3 lines of prior therapy

Treatment settingSingle-agent treatment for relapsed or refractory multiple myeloma

Authorization period

Authorization and Documentation Requirements

Prior Authorization

Blenrep Prior Authorization Required

Prior authorization is required for Blenrep. Authorization may be granted for covered indications when the applicable treatment regimen and prior-therapy criteria are met.

Relapsed or refractory multiple myeloma: in combination with bortezomib and dexamethasone after at least 2 prior therapy lines, including a proteasome inhibitor and an immunomodulatory agent.
Relapsed or refractory multiple myeloma: single-agent maintenance after 8 cycles of bortezomib and dexamethasone, with at least 2 prior therapy lines including a proteasome inhibitor and an immunomodulatory agent.
Relapsed or refractory multiple myeloma: single-agent therapy after at least 3 prior therapy lines.
POEMS syndrome, plasma cell-related MIDD, or plasma cell-related MGRS: single-agent therapy or therapy combined with bortezomib and dexamethasone.
Initial authorization is for 12 months when coverage criteria are met.

Documentation Required

Policy and Therapy Context

Blenrep (belantamab mafodotin-blmf) is a targeted therapy used for specified plasma-cell disorders, including relapsed or refractory multiple myeloma. The policy addresses FDA-approved combination treatment with bortezomib and dexamethasone after specified prior therapy, selected single-agent multiple myeloma treatment and maintenance, and covered compendial use in POEMS syndrome, plasma cell-related MIDD, and plasma cell-related MGRS. Initial authorizations may be granted for 12 months when the applicable coverage criteria are met.

Initial Authorization Criteria

Multiple Myeloma Initial Authorization

Authorization for 12 months may be granted for relapsed or refractory multiple myeloma when any one of the following treatment settings applies.

Multiple myeloma initial treatment setting

Combination treatment: Blenrep is used in combination with bortezomib and dexamethasone after at least two lines of prior therapy, including a proteasome inhibitor and an immunomodulatory agent.At least 2 prior lines including a proteasome inhibitor and an immunomodulatory agent
Maintenance treatment: Blenrep is used as a single agent for maintenance therapy after completing 8 cycles of combination treatment with bortezomib and dexamethasone and after at least two lines of prior therapy, including a proteasome inhibitor and an immunomodulatory agent.8 cycles completed; at least 2 prior lines including a proteasome inhibitor and an immunomodulatory agent

Continuation Authorization Criteria

Blenrep Continuation Therapy

Authorization for 12 months, including for new members, may be granted when all of the following criteria are met.

Continuation requirements

Benefit from therapy: The member has no unacceptable toxicity while on the current regimen and no evidence of disease progression while on the current regimen.No unacceptable toxicity and no evidence of disease progression

Policy Summary

PayerClover Health

PolicyBlenrep Coverage and Prior Authorization

Policy CodePolicy 7252-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation identifying a covered indication and applicable prior lines of therapy, including chart notes demonstrating failure of previous therapy.

SourceLink

On This Page

12 months may be granted when the criteria are met

Maintenance therapy eligibility

Required combination treatmentBortezomib and dexamethasone

Minimum treatment durationComplete 8 cycles of combination treatment before starting single-agent maintenance

Prior therapy requirementAt least 2 lines of prior therapy, including a proteasome inhibitor and an immunomodulatory agent

Document Previous Therapy Failure

Submit documentation with the prior authorization request to support the member’s treatment history and medical necessity.

Provide chart notes or medical records demonstrating failure of previous lines of therapy.

Denial Risk

Unapproved or Unsupported Indication

Blenrep is not medically necessary for indications outside the covered policy scope. All other indications are considered experimental or investigational and are not covered.

Covered compendial indications include relapsed or refractory multiple myeloma, POEMS syndrome, plasma cell-related MIDD, and plasma cell-related MGRS.
Confirm that the requested use matches one of the indications listed in the coverage criteria.

Denial Risk

Insufficient Prior Therapy

Requests may be denied when the member does not meet the required prior-therapy history for the requested multiple myeloma regimen.

Combination with bortezomib and dexamethasone requires at least 2 prior therapy lines, including a proteasome inhibitor and an immunomodulatory agent.
Single-agent maintenance requires completion of 8 cycles of combination treatment with bortezomib and dexamethasone, plus at least 2 prior therapy lines including a proteasome inhibitor and an immunomodulatory agent.
Single-agent treatment requires at least 3 prior therapy lines.

Denial Risk

Continuation Criteria Must Be Met

Continuation authorization may be denied unless the member is currently receiving Blenrep for a covered indication and is receiving clinical benefit without unacceptable toxicity or disease progression.

The member must currently be receiving therapy with the requested drug.
The requested drug must be used for an indication listed in the coverage criteria.
The member must have no unacceptable toxicity on the current regimen.
The member must have no evidence of disease progression on the current regimen.
Continuation authorization, including for new members, may be granted for 12 months when all criteria are met.

Single-agent treatment: Blenrep is used as a single agent after at least three lines of prior therapy.At least 3 prior lines

POEMS, MIDD, or MGRS Initial Authorization

Authorization for 12 months may be granted for POEMS syndrome, plasma cell-related MIDD, or plasma cell-related MGRS.

Covered plasma-cell disorder treatment: The member has POEMS syndrome, plasma cell-related monoclonal immunoglobulin deposition disease (MIDD), or plasma cell-related monoclonal gammopathy of renal significance (MGRS), and Blenrep is used as a single agent or in combination with bortezomib and dexamethasone.