CurrentUnitedHealthcarePolicy N/A

Growth hormone (Serostim) for HIV‑associated wasting in adults

Policy governing prior authorization, clinical criteria, dosing, and approval durations for Serostim (growth hormone) to treat HIV-associated wasting or cachexia in adult recipients covered by the payer.

Policy Summary

PayerUnitedHealthcare

PolicyGrowth hormone (Serostim) for HIV‑associated wasting in adults

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit completed and signed Serostim prior authorization form with required medical records and a six‑month weight chronicle.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 daysInitial approval period

30 daysMax retreatment period

≥7.5% / 10% / BMI <20Weight/BMI thresholds

≥18Minimum age

Weight‑basedDosing

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Coverage Criteria for Serostim (HIV-associated wasting)

Initial Therapy — Covered when ALL of the following are met for initial therapy

Covered when ALL of the following are met for initial therapy:

Age: Recipient is 18 years of age or older.

Diagnosis: Recipient has a diagnosis of HIV-associated wasting or cachexia.

Antiretroviral therapy: Recipient is on anti-retroviral therapy (HAART).

Weight/BMI/BCM criteria: Recipient has at least one of: ≥7.5% unintentional weight loss within the last 6 months; 10% involuntary weight loss within the last 12 months; BMI <20 for initial approval; OR Body Cell Mass (BCM) <35% (male) or <23% (female) with BMI <27; OR ≥5% BCM loss over 6 months.

Attach a series of bioelectric impedance analysis (BIA) results if BCM criteria are used.

Nutritional assessment: Documented nutritional assessment and counseling; total parenteral nutrition (TPN) if clinically indicated; trials of appetite stimulants (e.g., megestrol) as appropriate.

No active neoplasia: Confirmed absence of active neoplasia (Serostim is contraindicated in patients with active malignancy).

Supportive therapy trials: Documentation of a minimum 4-week trial of an anabolic steroid (e.g., oxandrolone) or documented rationale for not using anabolic steroids; consider testosterone replacement for hypogonadal men for at least 4 weeks.

Document dosage and dates of anabolic steroid use or provide rationale if not used.

PA form and records: Physician must complete, sign, and date the Serostim PA form and submit official medical records answering all form questions, including a six-month weight chronicle and recent related labs.

Provider must retain copies of documentation for five years.

Continuation / Retreatment — Conditions for continuation or retreatment

Conditions for continuation or retreatment:

Approval period: Retreatment requires submission of a new PA form and will be approved for a maximum of 30 days at a time.Maximum 30 days per retreatment

Initial approval period is a total of 90 days.

Response requirement: Positive response defined as a ≥2% increase in body weight and/or BCM; if positive response occurs but wasting persists, therapy may be continued and reevaluated monthly.≥2% increase in body weight and/or BCM

Retreatment may be continued month-by-month if positive response is documented.

Dosing within guidelines: Serostim dosing must be adjusted according to recipient weight and conform to recommended weight-based dosing bands.

Serostim is contraindicated in recipients with active neoplasia. The policy requires confirmation that there are no active malignancies prior to approval; documentation on the PA form indicating absence of active neoplasia is required.

Requests that do not include the required documentation or that fail to meet the clinical criteria are not approvable. Required submission elements include a completed, signed, and dated Serostim PA form and official medical records that answer all questions on the form, plus a six-month weight chronicle showing recent weights and relevant laboratory results.

An incomplete PA form or missing supporting medical documentation (including the six-month weight chronicle, documentation of nutritional assessment, trial of appetite stimulants or anabolic steroids when indicated, and confirmation of HAART therapy) may result in return of the form and denial of the request.

Clinical criteria that must be met for approval include age ≥18, diagnosis of HIV-associated wasting/cachexia, current antiretroviral therapy, and meeting the specified weight/BMI/BCM thresholds. Requests that do not meet these criteria should not be approved.

Clinical Thresholds, Dosing, and Coding-related Criteria

Unintentional weight loss or BMI — initial approval

6-month weight loss≥7.5% unintentional weight loss within the last 6 months

12-month weight loss≥10% involuntary weight loss within the last 12 months

Body Mass IndexBMI <20 qualifies for initial approval

Alternative Body Cell Mass (BCM) criteria

Male BCM cutoffBCM <35% of total body weight (male)

Female BCM cutoffBCM <23% of total body weight (female)

BCM loss qualifier≥5% BCM loss over 6 months (attach BIA results if applicable)

BCM plus BMIBCM threshold must be accompanied by BMI <27 when used as alternate criterion

Dosing thresholds by weight (subcutaneous)

>55 kg6 mg SC daily

45–55 kg5 mg SC daily

35–45 kg4 mg SC daily

<35 kg0.1 mg/kg SC daily

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Serostim (growth hormone) for HIV-associated wasting. Initial approval is for a total of 90 days; retreatment approvals are for a maximum of 30 days at a time. The physician must complete, sign, and date the Serostim prior authorization (PA) form and submit it for review.

Initial approval: 90 days
Retreatment maximum: 30 days per approval
Physician must complete, sign, and date Serostim PA form

Prior Authorization

Supportive Therapies Required / Considered

Supportive therapies and assessments must be performed and documented before or during consideration for Serostim therapy. Treatment must include nutritional assessment and counseling; if inadequate caloric intake or anorexia is present, a trial of an appetite stimulant should be documented. A minimum 4-week trial of an anabolic steroid (e.g., oxandrolone) should be attempted and documented unless a medical rationale is provided. Hypogonadal men should have consideration of testosterone replacement therapy (minimum 4 weeks) as appropriate. Active neoplasia must be excluded prior to therapy.

Document nutritional assessment and counseling
If inadequate caloric intake/anorexia: document trial of appetite stimulant (drug, dose, dates) or reason none given
Document minimum 4-week trial of anabolic steroid (drug, directions, dates) or provide rationale for omission
Confirm and document absence of active neoplasia
If hypogonadal, document whether testosterone replacement therapy has been given (minimum 4 weeks)

Documentation Required

Required Documentation

All required documentation must accompany the PA request. Incomplete or missing documentation (including an incomplete PA form) may result in return, delay, or denial of the request. Providers must retain copies of all documentation for five years.

Completed, signed, and dated Serostim PA form
Official medical records answering all PA form questions
Six-month weight chronicle showing the most recent weights (weights at 6 months and 3 months prior and current weight/BMI)
Related recent labs and diagnostic evaluations (attach BIA results if BCM used)
Documentation of HAART regimen and meeting age/diagnosis/weight-loss or BMI/BCM criteria

Denial Risk

Incomplete Documentation — Risk of Return or Denial

An incomplete PA form or missing required medical records (e.g., weight chronicle, labs, documentation of supportive therapy trials, confirmation of no active neoplasia) may be returned unprocessed or denied. Ensure all fields on the PA form are completed and that supporting chart notes and lab results are attached before faxing.

Incomplete or missing PA form may be returned
Missing weight chronicle, labs, or documentation of appetite stimulant/anabolic steroid trials may delay or result in denial
Fax completed PA form and records to 1-866-940-7328; pharmacy PA inquiries: 1-800-310-6826

Background

HIV-associated wasting or cachexia is characterized by significant unintentional weight loss and loss of body cell mass despite antiretroviral therapy. Per policy, the diagnosis is a prerequisite for Serostim consideration and must be supported by documented evidence of weight loss or body composition change.

Treatment considerations include ensuring the recipient is on HAART, completing a nutritional assessment and counseling, and documenting trials of appetite stimulants and anabolic agents (for example, a minimum 4-week trial of oxandrolone) or providing rationale if these are not used. Serostim is intended to increase body weight and body cell mass in eligible adults when these criteria are met.

Definitions and Thresholds

HIV-associated wasting or cachexia — diagnostic findings required

Clinical definitionDiagnosis of HIV-associated wasting or cachexia (unintentional weight loss and loss of body cell mass despite antiretroviral therapy)

Required ageRecipient must be 18 years of age or older

Supporting findingsMust be on antiretroviral therapy and meet weight/BMI/BCM criteria as specified for initial approval

Contraindication checkNo active neoplasia (Serostim contraindicated with active malignancy)

Body Cell Mass (BCM) thresholds