CurrentUnitedHealthcarePolicy N/A

Serostim (growth hormone) for HIV-associated wasting or cachexia — coverage criteria

Defines prior authorization criteria, dosing, documentation, and approval durations for Serostim (recombinant human growth hormone) to treat HIV-associated wasting or cachexia in adult UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicySerostim (growth hormone) for HIV-associated wasting or cachexia — coverage criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete, sign, and date the Serostim prior authorization form and submit required medical records including a six‑month weight history and documentation of ART and nutritional assessment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 daysinitial approval period

30 daysretreatment approval period

≥18age requirement

>=7.5% / >=10% / BMI<20weight/BMI thresholds

weight bandsdosing method

Policy Summary

PayerUnitedHealthcare

PolicySerostim (growth hormone) for HIV-associated wasting or cachexia — coverage criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Initial Therapy

Covered when ALL of the following are met for initial approval

Age: Recipient must be 18 years of age or older.>=18 years

Diagnosis of HIV-associated wasting or cachexia.

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

Weight/BMI/BCM criteria: Recipient must have at least 7.5% unintentional weight loss within the last 6 months OR 10% involuntary weight loss in the last 12 months OR BMI < 20 for initial approval; alternatively, BCM < 35% (male) or < 23% (female) of total body weight OR >=5% BCM loss over 6 months (attach series of BIA results if applicable).see text

Attach a series of bioelectric impedance analysis (BIA) results if using BCM.

Nutritional assessment: Treatment must include nutritional assessment and counseling; consider total parenteral nutrition for GI disease and document trials of appetite stimulants as appropriate.

Document adequacy of caloric intake and rule out malabsorption and psychosocial factors.

Contraindications: No active neoplasia must be confirmed (Serostim is contraindicated in patients with active neoplasia).

Required documentation: Physician must complete, sign, and date the Serostim PA form and submit official medical records including a six-month weight chronicle with recent weights and answers to PA form questions.

Failure to provide required records may result in non-approval.

Continuation / Retreatment

Continuation / retreatment covered when criteria met

Response assessment: Positive response defined as a >=2% increase in body weight and/or BCM; if positive response occurs but wasting persists, treatment may be continued with monthly reevaluation.>=2% increase

Retreatment will be approved for a maximum of 30 days at a time.

New prior authorization: Physician must submit a new PA form for additional therapy and document prior treatment results including start/end dates, weights and BMI.

Dosing by weight

Dosing must follow weight-based guidelines

>55 kg: Dose = 6 mg subcutaneous (SC) daily for recipients >55 kg (121 lb).>55 kg

45-55 kg: Dose = 5 mg SC daily for recipients 45-55 kg (99-121 lb).45-55 kg

35-45 kg: Dose = 4 mg SC daily for recipients 35-45 kg (75-99 lb).35-45 kg

<35 kg: Dose = 0.1 mg/kg SC daily for recipients <35 kg (<75 lb).

Serostim is contraindicated in patients with active neoplasia. The prescribing physician must confirm the absence of active neoplastic disease on the PA form prior to approval; requests for members with active neoplasia will not be approved.

Requests will be considered not medically necessary or ineligible for approval when required criteria or documentation are not met. Examples include failure to meet the specified weight/BMI/BCM thresholds for initial approval (such as at least 7.5% unintentional weight loss in 6 months, 10% in 12 months, or BMI < 20), absence of required supporting medical records (including the completed, signed PA form and a six‑month weight chronicle), or documentation showing active neoplasia.

An incomplete PA form or failure to submit the official medical records requested on the form (for example, weight history, confirmation of antiretroviral therapy, nutritional assessment, appetite‑stimulant or anabolic steroid trial documentation, and recent chart notes/labs) may result in return of the form or denial of the request.

Clinical Thresholds and Coding-related Criteria

inv-06: Weight loss / BMI thresholds — initial approval numeric thresholds

Initial approval weight/BMI thresholdsAt least 7.5% unintentional weight loss within the last 6 months OR 10% involuntary weight loss in the last 12 months OR BMI < 20

Minimum ageRecipient must be 18 years of age or older

Diagnosis requirementDiagnosis of HIV-associated wasting or cachexia

Antiretroviral therapyRecipient must be on anti-retroviral therapy

inv-07: Body Cell Mass thresholds — BCM cutoffs and loss percentage

BCM percentage cutoffsBCM < 35% for males OR BCM < 23% for females of total body weight

Alternate BCM qualifierBody Mass Index less than 27 when BCM cutoff used

BCM loss over time>= 5% BCM loss over 6 months qualifies

Documentation instructionAttach a series of bioelectric impedance analysis (BIA) results if applicable

Prior Authorization Requirements and Provider Responsibilities

Prior Authorization

Prior Authorization and Supporting Records

Prior authorization is required. The prescribing physician must complete, sign, and date the Serostim PA form and submit it for review. For initial therapy or requests for additional therapy/retreatment, submit the completed PA form plus official medical records that support every question on the form.

Fax PA form to 1-866-940-7328
Pharmacy PA Call Center: 1-800-310-6826

Denial Risk

Incomplete Documentation or Missing Records

If required documentation is incomplete, missing, or the PA form is not fully completed, the request may be returned or denied. An incomplete form may be returned for completion; absent supporting medical records for initial or additional therapy will place the request in the denial pathway.

Incomplete PA form may be returned to the provider
Missing six-month weight chronology or supporting medical records may result in denial

Documentation Required

Required Documentation and Record Retention

Providers must submit and retain required documentation: the fully completed PA form, a six-month weight chronology with dates and weights (including current weight and weights at 3 and 6 months prior), documentation of HAART regimen, nutritional assessment/counseling, appetite stimulant trials (if applicable), anabolic steroid trial documentation or rationale, confirmation of absence of active neoplasia, and related labs and chart notes.

Retain copies of all documentation for five years
Attach a series of BIA results if BCM criteria are used
Include dates, dosages, and outcomes for appetite stimulants and anabolic steroids

Documentation Required

Required Conservative Therapy Trials / Assessments

Before Serostim will be approved, medical records must document required conservative therapy trials and assessments: a documented nutritional assessment and counseling to assure adequate caloric intake and rule out malabsorption/psychosocial causes; trial of appetite stimulant if inadequate intake/anorexia (document drug, dose, and dates); and a minimum 4-week trial of an anabolic steroid (e.g., oxandrolone) or documented rationale if not tried.

Document nutritional assessment results and counseling provided
If appetite stimulant used, provide drug/directions and start/end dates
Document anabolic steroid drug/directions and dates or provide rationale for omission

Background

HIV‑associated wasting (cachexia) is defined by involuntary weight loss and reduced lean body mass in the setting of HIV infection. Serostim (recombinant human growth hormone) is an adjunctive treatment option for adults with documented HIV‑associated wasting who meet defined weight or body composition thresholds and who are on antiretroviral therapy. Appropriate use requires a nutritional assessment and trials of conservative measures (for example appetite stimulants and anabolic steroids where indicated) before initiating therapy.

Body composition criteria that may qualify a member include either percent weight‑loss thresholds (e.g., ≥7.5% unintentional weight loss in the prior 6 months or ≥10% in the prior 12 months, or BMI < 20) or Body Cell Mass (BCM) criteria (for example BCM < 35% for males or < 23% for females, or ≥5% BCM loss over 6 months), with BIA result series attached if BCM is used to support the diagnosis.

Definitions and Measurement Criteria

inv-14: HIV-associated wasting or cachexia — diagnostic definition and qualifying weight/BCM criteria

DefinitionHIV-associated wasting or cachexia = diagnosis of involuntary weight loss or reduced lean body mass in the setting of HIV infection

Qualifying weight criteriaAt least 7.5% unintentional weight loss within last 6 months OR 10% involuntary weight loss in last 12 months OR BMI < 20

Qualifying BCM criteriaAlternatively, BCM <35% (male) or <23% (female) of total body weight OR >=5% BCM loss over 6 months (attach BIA series if used)

inv-15: Body Cell Mass (BCM) criteria — numeric BCM cutoffs and BIA attachment instruction

Numeric BCM cutoffsBCM < 35% for males; BCM < 23% for females

BCM loss threshold>= 5% BCM loss over 6 months qualifies

BMI consideration with BCMWhen using BCM criteria, BMI should be less than 27 as an additional qualifier

BIA attachment instructionAttach a series of bioelectric impedance analysis (BIA) results if applicable

OpenPayer

Serostim (growth hormone) for HIV-associated wasting or cachexia — coverage criteria

Coverage Criteria for Serostim (HIV-associated wasting)

Clinical Thresholds and Coding-related Criteria

Prior Authorization Requirements and Provider Responsibilities

Background

Definitions and Measurement Criteria