CurrentMass General Brigham Health PlanPolicy N/A

Hyftor (crizanlizumab-tcma) — Prior Authorization and Specialty Pharmacy Coverage Criteria

Defines prior authorization, specialty pharmacy dispensing, and coverage criteria for Hyftor for members (including pediatric ≥6 years) of Mass General Brigham Health Plan across applicable benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyHyftor (crizanlizumab-tcma) — Prior Authorization and Specialty Pharmacy Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and have medication dispensed through a contracted specialty pharmacy; for reauthorization submit clinical documentation of response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥6minimum patient age for coverage

3 moinitial approval duration

6 moreauthorization duration

specialtysite of care

Coverage Criteria for Hyftor (topical sirolimus)

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inv-01: Initial Therapy

Authorization may be granted when the member meets ALL of the following:

Initial Authorization: Member has a diagnosis of facial angiofibroma associated with tuberous sclerosis.

Document diagnosis.

Initial Authorization: Member is ≥ 6 years of age.>= 6 years

Document age.

Alternate for members new to plan: Member is new to the plan and is currently receiving treatment with Hyftor (product obtained only as samples or via manufacturer patient assistance programs is excluded).

If current treatment, supply documentation of ongoing therapy; supplies obtained only as samples or through manufacturer assistance are not acceptable.

inv-02: Continuation Therapy

Reauthorization may be granted when ALL of the following are met:

Reauthorization: Member previously met initial criteria.

Reauthorization: Physician has submitted clinical documentation of clinical response.

Initial approvals are for 3 months; reauthorizations may be granted for 6 months.

Requests will not be considered for coverage when the product was obtained only as samples or through the manufacturer's patient assistance program. Such supplies are excluded from authorization consideration and should not be used to support a prior authorization request.

Initial Therapy Requirements

inv-12: Initial Therapy

Initial authorization requirements

Initial: Member has a diagnosis of facial angiofibroma associated with tuberous sclerosis AND is ≥ 6 years of age.>= 6 years

Initial approval duration = 3 months.

Alternate: For members new to the plan: member is currently receiving treatment with Hyftor (excluding product obtained only as samples or via manufacturer patient assistance).

Document ongoing therapy; samples or manufacturer patient-assistance supplies are excluded.

Reauthorization and Continuation Criteria

inv-13: Reauthorization

Reauthorization criteria and durations

Continuation: Physician submits clinical documentation of clinical response and member previously met initial criteria.

Initial approval = 3 months; reauthorization = 6 months.

Provider Actions, Program Type, and Documentation Requirements

Prior Authorization

Prior Authorization Required; Specialty Dispensing

Prior authorization is required. This medication is designated specialty and must be obtained through a contracted specialty pharmacy.

Affected benefit: Pharmacy Benefit (specialty) and Medical Benefit (specialty limitations)
Specialty pharmacy contact (Medical and Specialty Medications): Phone 877-519-1908, Fax 855-540-3693
Non-specialty medications contact: Phone 800-711-4555, Fax 844-403-1029

Step Therapy

Program Type — Step Therapy / Quantity Limit

Program type: Step therapy and quantity limit program applies. Therapy is managed under the pharmacy benefit with specialty limitations.

Program: Quantity Limit
Benefit: Step Therapy; Pharmacy Benefit with specialty limitations

Documentation Required

Reauthorization Documentation Required

For continuation/reauthorization, the physician must submit clinical documentation demonstrating clinical response to therapy.

Reauthorization requires documentation of clinical response from the prescribing physician
Continuation of therapy is available only for members who met initial criteria

Denial Risk

Denial Triggers and Continuity of Care

Authorization may be granted for members who are currently receiving treatment prior to plan enrollment, but authorization will not be granted for use of products obtained as samples or via manufacturer's patient assistance programs.

Coverage may be granted for members new to the plan who are currently receiving Hyftor
Denial triggers: members not currently receiving treatment, products obtained as samples, or obtained through manufacturer patient assistance programs

Program	Designation	Dispensing Requirement
Step Therapy / Quantity Limit (Pharmacy Benefit)	Designated as part of a Step Therapy/Quantity Limit program with specialty limitations	Must be filled at a contracted specialty pharmacy (designated specialty medication)

Dispensing Site Requirements

Billing Rule

Must be dispensed through contracted specialty pharmacy

Dispensing must occur via a contracted specialty pharmacy as designated by the plan; Hyftor is designated specialty and must be filled at a contracted specialty pharmacy.

Specialty dispensing requirement: fill at contracted specialty pharmacy per plan.
Contact for specialty dispensing: Phone 877-519-1908; Fax 855-540-3693.

Background

Hyftor is a topical formulation of sirolimus indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients aged ≥ 6 years. The policy defines prior authorization and specialty-dispensing requirements for Hyftor under the pharmacy benefit and sets initial and continuation authorization expectations based on documented diagnosis and clinical response.

Authorization considerations include members who are already receiving Hyftor at plan initiation; however, coverage excludes products sourced solely as samples or from manufacturer patient assistance programs, and therapy must be dispensed through the plan-designated contracted specialty pharmacy.