CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Serostim (somatropin) for HIV-associated wasting/cachexia — Coverage Criteria

Covers medical benefit criteria for use of Serostim (recombinant human growth hormone) to treat HIV-associated wasting/cachexia for Neighborhood Health Plan of Rhode Island members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySerostim (somatropin) for HIV-associated wasting/cachexia — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date06/01/2021

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing HIV-associated wasting/cachexia, current antiretroviral therapy, trials of at least three alternatives (or contraindication), and BMI calculations to request a 12-week authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 wksinitial auth duration

0.1 mg/kgstudied dose

J2941HCPCS

<18.5initiation BMI

<27continuation BMI

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Coverage Criteria for Serostim (somatropin)

Initial Therapy

Authorization of 12 weeks may be granted when ALL of the following are met:

Initial Authorization - ALL criteria: A. Member is diagnosed with HIV-associated wasting/cachexia; B. Member is currently on antiretroviral therapy; C. Trial with suboptimal response or contraindication or intolerance to at least three alternative therapies (e.g., cyproheptadine, dronabinol, megestrol acetate, or testosterone if hypogonadal); D. BMI was less than 18.5 kg/m2 prior to initiating therapy with Serostim (see Appendix A).12 weeks

FDA-approved indication only; concomitant antiretroviral therapy is necessary; other indications are considered investigational.

Continuation Therapy

Authorization of 12 weeks may be granted when ALL of the following are met for members already receiving Serostim:

Continuation Authorization - ALL criteria: A. Member is diagnosed with HIV-associated wasting/cachexia; B. Member is currently on antiretroviral therapy; C. Member is currently receiving treatment with Serostim (excluding medication obtained only as samples or via manufacturer's patient assistance programs); D. Current BMI is less than 27 kg/m2 (see Appendix A).12 weeks

Coverage considered when member is already on therapy; excludes medication obtained only as samples or via manufacturer assistance.

All uses of Serostim outside of the FDA-approved indication for HIV-associated wasting/cachexia are considered limitations to coverage. Specifically, any request for treatment of conditions other than HIV-associated wasting/cachexia, or use at doses or for clinical conditions not recognized as medically accepted in standard compendia, will be evaluated as investigational and are not covered. Neighborhood does not provide coverage for drugs when used for investigational purposes.

Requests that do not meet the policy's specific approval criteria — including documented diagnosis of HIV-associated wasting/cachexia, concurrent antiretroviral therapy, prior trials of alternative therapies (or documented contraindication/intolerance), and the BMI threshold for initiation — are subject to denial as not meeting medical necessity criteria.

Use of Serostim for indications other than the FDA-approved treatment of HIV-associated wasting/cachexia is considered experimental/investigational and not medically necessary. Coverage is restricted to the approved indication when the member meets the plan’s clinical criteria.

Coding and Measurement Thresholds

Applicable HCPCS/CPT CodesHCPCS

J2941

Injection, somatropin, 1 mg

BMI classification thresholds

Underweight< 18.5 kg/m2

Normal weight18.5 - 24.9 kg/m2

Overweight25 - 29.9 kg/m2

Obesity (class 1)30 - 34.9 kg/m2

Obesity (class 2)35 - 39.9 kg/m2

Extreme obesity≥ 40 kg/m2

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorizations may be granted for up to 12 weeks when criteria are met for treatment of HIV-associated wasting/cachexia to increase lean body mass and body weight and improve physical endurance.

Authorization duration: 12 weeks when ALL required criteria are met
Applicable HCPCS: J2941 (Injection, somatropin, 1 mg) — submission of this code does not guarantee approval; medical necessity criteria still required

Step Therapy

Step Therapy and Exemptions

MMP members with prior receipt of this medication within the past 365 days are exempt from Step Therapy requirements. Otherwise, members must have trialed and had suboptimal response or contraindication/intolerance to at least three alternative therapies (examples include cyproheptadine, dronabinol, megestrol acetate, or testosterone therapy if hypogonadal) before Serostim will be authorized.

365-day exemption applies only to MMP members with documented prior receipt within past 365 days

Definitions

HIV-associated wasting/cachexia

DefinitionClinically significant weight loss and loss of lean body mass in persons with HIV infection; treated with antiretroviral therapy.

Clinical contextAssociated with reduced body weight, decreased lean body mass, and impaired physical endurance; Serostim (somatropin) studied to increase lean body mass and body weight.

Evidence basisApproval supported by a 12-week randomized, double‑blind, placebo‑controlled trial showing increased lean body mass (mean difference 3.1 kg) and improved treadmill work output.

Background

Serostim (recombinant human growth hormone, somatropin) is FDA-approved for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight and to improve physical endurance. The FDA-labeled indication requires concomitant antiretroviral therapy. Clinical evidence supporting approval includes randomized trial data demonstrating increases in lean body mass and improvements in physical performance over a 12-week treatment period.

Dosing guidance in the source document notes weight-based regimens (for example, 6 mg SC daily for patients >55 kg and weight-based pediatric dosing down to 0.1 mg/kg daily for the smallest weight band) and reiterates that use at doses or for conditions not recognized in standard reference compendia is investigational and not covered by the plan.