Recommended Authorization Criteria — Egrifta (tesamorelin)
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Recommended prior authorization criteria for coverage of Egrifta (tesamorelin) for reduction of excess abdominal fat in adults with HIV-associated lipodystrophy; applies to pharmacy benefit coverage determinations by Medical Mutual - Ohio.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial therapy criteria
Covered when ALL of the following are met:
ALL of the following
ALL of the following
- Patient is at least 18 years of age (>= 18).
ALL of the following
- No disruption of the hypothalamic-pituitary axis (e.g., hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma).
- No active malignancy.
- Patient is not pregnant.
ALL of the following
- Prescribed by or in consultation with an endocrinologist or HIV specialist.
- Indication: prescribed for reduction of excess abdominal (visceral) fat in HIV-associated lipodystrophy.
ONE of the following anthropometric criteria
- Male: waist circumference >= 95 cm (37.4 in) AND waist-to-hip ratio >= 0.94.
- Female: waist circumference >= 94 cm (37 in) AND waist-to-hip ratio >= 0.88.
ALL of the following
- Patient has been stable on an antiretroviral regimen for at least 8 weeks.
Continuation therapy criteria
Covered when ALL of the following are met:
ALL of the following
ALL of the following
- Patient is at least 18 years of age (>= 18).
ALL of the following
- Patient is not pregnant.
ALL of the following
- Prescribed by or in consultation with an endocrinologist or HIV specialist.
ALL of the following
- Evidence of improvement based on waist circumference measurement or CT scan.
Initial Therapy
Initial therapy
Initial authorization is recommended when ALL of the following are satisfied:
ALL of the following
ALL of the following
- Patient is at least 18 years of age.
ALL of the following
- No disruption of the hypothalamic-pituitary axis (hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma).
- No active malignancy.
- Patient is not pregnant.
ALL of the following
- Prescribed by or in consultation with an endocrinologist or HIV specialist.
ALL of the following
- Prescribed for reduction of excess abdominal (visceral) fat in HIV-associated lipodystrophy.
Anthropometric threshold (one must apply)
- Male: waist circumference >= 95 cm (37.4 in) AND waist-to-hip ratio >= 0.94.
- Female: waist circumference >= 94 cm (37 in) AND waist-to-hip ratio >= 0.88.
ALL of the following
- Stable on an antiretroviral regimen for at least 8 weeks prior to initiation.
Continuation Criteria
Continuation therapy
Continuation/renewal is recommended when ALL of the following are met:
ALL of the following
ALL of the following
- Patient is at least 18 years of age.
ALL of the following
- Patient is not pregnant.
ALL of the following
- Prescribed by or in consultation with an endocrinologist or HIV specialist.
ALL of the following
- Evidence of improvement documented by reduction in waist circumference or by CT scan.
ALL of the following
- Initial approval: 6 months.
- Extended approval: 6 months (requires documented response as above).
Anthropometric Thresholds & Stability
Provider Actions & Administrative Requirements
Prior authorization and specialist prescriber requirement
Prior authorization is recommended for pharmacy benefit coverage of Egrifta. Initial approvals must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., an endocrinologist or HIV specialist).
- Initial approvals require specialist prescription or documented consultation.
- All initial approvals are for the initial approval duration; continuation requires demonstrated response to therapy unless otherwise noted.
Provide documentation on request — denial risk if not supplied or not medically necessary
The Company may request additional documentation (patient records, test results, provider credentials) to support coverage decisions. Reimbursement may be denied if the drug or services are determined to be not medically necessary, investigational/experimental, outside member benefits, or if billing/practice patterns are inappropriate or excessive.
- Provide patient records, relevant test results, and provider credentials upon request.
- Failure to supply requested documentation or evidence of non‑medical necessity may result in denial of reimbursement.
Approval durations and requirement for demonstrated response
Initial authorization is granted for 6 months; extended (reauthorization) approval is also 6 months. Continuation of therapy requires evidence of response to treatment (response to therapy is required for continuation unless otherwise noted).
- Initial Approval: 6 months.
- Extended Approval: 6 months.
- Reauthorization requires documented response to therapy for continuation.
Definitions
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