CurrentMass General Brigham Health PlanPolicy N/A

Besremi (ropeginterferon alfa-2b) — coverage criteria for polycythemia vera

Policy governing prior authorization, quantity/step therapy, and specialty pharmacy requirements for Besremi for adults with polycythemia vera under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBesremi (ropeginterferon alfa-2b) — coverage criteria for polycythemia vera

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date07/01/2022

Next Review DateN/A

Key ActionObtain prior authorization; initial approval requires member ≥18, diagnosis of polycythemia vera, and intolerance/contraindication to hydroxyurea.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum age for coverage

12 moapproval duration

Polycythemia veraindication

Prior authauthorization requirement

Contracted onlyspecialty pharmacy

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Initial Therapy

Authorization may be granted when ALL of the following criteria is met:

Initial Authorization Criteria: Member is at least 18 years of age; Member has a diagnosis of polycythemia vera; Member has intolerance, adverse event, or contraindication to hydroxyurea.>= 18 years

Items listed as all must be met.

New-to-Plan Continuation

Alternative coverage pathway for members new to the plan:

New-to-plan continuation: Member is currently receiving Besremi and is stable on therapy.

Excludes when product obtained as samples or via manufacturer's patient assistance programs.

Continuation of Therapy

Reauthorization criteria:

Reauthorization: Member demonstrates benefit from therapy evidenced by improvement in signs and symptoms and/or disease markers (e.g., morphological response, reduction/stabilization in spleen size, improvement of thrombocytosis/leukocytosis).

Reauthorizations granted for 12 months.

For members who are new to the plan and seeking continuation of therapy, products obtained as samples or through a manufacturer's patient assistance program are excluded from the authorization pathway. Authorization for new-to-plan members is limited to those who are already receiving Besremi and are documented to be stable on therapy; documentation that the drug was supplied only as a sample or via assistance programs does not meet the requirement for coverage continuation.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required; initial authorization conditions.

Authorization may be granted for members new to the plan who are currently receiving treatment and are stable on Besremi (excludes samples or manufacturer patient assistance program supply).
Initial requests: member is ≥ 18 years of age; diagnosis of polycythemia vera; and history of intolerance, adverse event, or contraindication to hydroxyurea.

Step Therapy

Benefit and Specialty Pharmacy Designation

Step therapy/quantity limits and specialty pharmacy designation apply.

This medication is designated specialty and must be filled at a contracted specialty pharmacy (Medical and Specialty Medications).
Benefit: Pharmacy benefit with quantity limits and step therapy as applicable; Medical benefit specialty limitations may apply.
Contact: All Plans Phone: 877-519-1908; Fax: 855-540-3693. Non-Specialty Medications Phone: 800-711-4555; Fax: 844-403-1029.

Documentation Required

Reauthorization Clinical Response Documentation

Documentation must demonstrate clinical benefit for reauthorization.

Reauthorization granted only for members demonstrating benefit from therapy, evidenced by improvement in signs/symptoms and/or disease markers (for example: morphological response, reduction or stabilization in spleen size, improvement of thrombocytosis/leukocytosis).

Note

Stability Requirement for New-to-Plan Members

Stability requirement for new-to-plan members.

New-to-plan authorizations limited to members who are currently receiving and clinically stable on Besremi; excludes supply obtained solely as samples or through manufacturer patient assistance programs.

Denial Risk

Age, Diagnosis, and Prior Therapy Requirement

Age, diagnosis, and prior therapy requirement for initial approval.

Requests for members under 18 years of age may be declined unless criteria for pediatric use are documented.
Member must have a diagnosis of polycythemia vera.
Member must have intolerance, adverse event, or contraindication to hydroxyurea prior to approval.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBesremi (ropeginterferon alfa-2b) — coverage criteria for polycythemia vera

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date07/01/2022

Next Review DateN/A

Key ActionObtain prior authorization; initial approval requires member ≥18, diagnosis of polycythemia vera, and intolerance/contraindication to hydroxyurea.

SourceLink

On This Page

OpenPayer

Besremi (ropeginterferon alfa-2b) — coverage criteria for polycythemia vera

Coverage Criteria for Besremi (ropeginterferon alfa-2b)

Coding, Age, and Benefit Details

Provider Actions and Documentation Requirements

Background

Definitions