CurrentMass General Brigham Health PlanPolicy N/A

Serostim (recombinant human growth hormone) for HIV-associated wasting/cachexia — Prior Authorization Criteria

Covers prior authorization requirements for Serostim under the pharmacy benefit for Commercial/Exchange members; defines clinical criteria for initial and continuation authorization and specialty pharmacy dispensing.

Policy Summary

PayerMass General Brigham Health Plan

PolicySerostim for HIV‑associated wasting/cachexia — Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization under the pharmacy benefit and document member is on antiretroviral therapy with required BMI and trial/intolerance of listed alternatives.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksstandard approval duration

<18.5initial BMI threshold

<27continuation BMI threshold

Commercialapplicable plan

Coverage Criteria for Serostim

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Initial Therapy

Covered when ALL of the following are met

Initial Authorization for Serostim: 1. Member is currently on antiretroviral therapy; 2. Trial with suboptimal response to alternative therapies (See Appendix A) or documented contraindication or intolerance to alternative therapies; 3. Body mass index (BMI) was less than 18.5 kg/m2 prior to initiating therapy with Serostim (See Appendix B)

Authorization may be granted for members new to the plan who are currently receiving treatment with the requested medication (excluding samples or manufacturer assistance).

Continuation Therapy

Covered when ALL of the following are met

Continuation Authorization for Serostim: 1. Member is currently on antiretroviral therapy; 2. Member is currently receiving treatment with Serostim (excluding obtainment as samples or via manufacturer's patient assistance programs); 3. Current BMI is less than 27 kg/m2 (See Appendix B)

Approvals will be granted for 12 weeks.

All indications for Serostim other than treatment of HIV-associated wasting/cachexia are considered experimental/investigational and not medically necessary.

Use of Serostim for any indication other than HIV-associated wasting/cachexia is not medically necessary and will not be approved.

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required under the pharmacy benefit for Commercial/Exchange members. This medication is designated as specialty and must be dispensed through a contracted specialty pharmacy.

Applies to Commercial/Exchange members under the Pharmacy Benefit
Designated specialty — must be filled at a contracted specialty pharmacy
Contact Pharmacy Benefit: Phone 800-711-4555, Fax 844-403-1029

Step Therapy

Alternative Therapy Requirement

For initial authorization, the prescriber must document a trial and suboptimal response to at least one alternative therapy for HIV-associated wasting or document a contraindication/intolerance to alternatives.

Trial with suboptimal response to alternative therapies (see Appendix A) OR documented contraindication/intolerance to alternatives
Alternative therapies include: cyproheptadine; Marinol (dronabinol); Megace (megestrol acetate); testosterone therapy if hypogonadal

Documentation Required

Required Clinical Documentation

Required clinical documentation includes evidence of current antiretroviral therapy, BMI measurements as specified for initial and continuation requests, and documentation of prior trials or contraindications to alternative therapies.

Documentation that member is currently on antiretroviral therapy
For initial authorization: BMI < 18.5 kg/m2 prior to initiating therapy (See Appendix B)
For continuation/reauthorization: current BMI < 27 kg/m2 (See Appendix B)
Documentation of trial with suboptimal response to listed alternative therapies OR documentation of contraindication/intolerance to alternatives
If member is new to plan, documentation that member was receiving the requested medication prior to plan enrollment (excluding samples or manufacturer patient assistance programs)

Denial Risk

Denial Triggers

Requests will be denied if required criteria or documentation are not met.

Member is not currently on antiretroviral therapy
For initial requests: BMI not documented as < 18.5 kg/m2 prior to initiating therapy
For continuation requests: current BMI not documented as < 27 kg/m2
No documentation of trial and suboptimal response to alternative therapies and no documented contraindication/intolerance to alternatives
Requested medication was obtained only as samples or via manufacturer's patient assistance program (for members new to plan)