Viva Health leuprolide depot Coverage Update | OpenPayer

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Viva Health leuprolide depot Coverage Update | OpenPayer

Coverage Criteria

Initial Therapy - CPP

Prior authorization validity is provided in the following conditions: Patient is at least 18 years of age (unless otherwise specified); AND

ALL of the following

Central Precocious Puberty (CPP): Patient must have a contraindication, intolerance, or failure to Leupron Depot-Ped®, Supprelin® LA, AND Triptodur® prior to consideration of Fensolvi®; AND
Patient is less than 13 years of age; AND
Onset of secondary sexual characteristics earlier than age 8 for females and 9 for males associated with pubertal pituitary gonadotropin activation; AND
Diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to stimulation by native growth hormone-releasing hormone (GnRH); AND
Bone age advanced greater than 2 standard deviations (SD) beyond chronological age; AND
Tumor has been ruled out by appropriate testing (e.g., brain imaging to exclude intracranial tumor; pelvic/testicular/adrenal ultrasound to exclude steroid-secreting tumors; and human chorionic gonadotropin levels to exclude hCG-secreting tumor); AND
Will not be used in combination with growth hormone

Initial Therapy - Endometriosis

Covered when ALL of the following are met:

ALL of the following

Endometriosis: Patient's diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment); AND
Patient is premenopausal unless otherwise specified; AND
Prior to treatment, clinicians document that the patient has failed or is intolerant to first-line conservative therapies when applicable (e.g., hormonal contraceptives, NSAIDs) — and will receive add-back therapy if extended GnRH-agonist use is planned; AND
Treatment duration and dosing will follow recommended dosing (e.g., 3.75 mg IM monthly or 11.25 mg IM every 3 months); AND
For retreatment/continuation: patient has not received a total of 12 months of GnRH-agonist therapy, continues to have symptoms or symptoms recur after the initial 6-month course, will have bone density assessment prior to retreatment, and extended treatment will be used with norethindrone add-back therapy

Initial Therapy - Uterine Leiomyomata

Covered when ALL of the following are met:

ALL of the following

Uterine Leiomyomata (fibroids): Patient's diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment); AND
Patient is receiving iron therapy; AND
Therapy is intended for short-term use as a preoperative or symptom-bridging measure consistent with dosing guidance (e.g., 3.75 mg IM monthly or 11.25 mg IM single dose) and recommended duration (recommended duration is 3 months or less; retreatment dependent on return of symptoms); AND
Do not concurrently use fractional or mixed depot formulations due to differing release characteristics

Initial Therapy - Breast Cancer

Covered when ALL of the following are met:

ALL of the following

Breast Cancer: Patient is a premenopausal woman AND disease is hormone receptor-positive AND therapy will be used in combination with adjuvant endocrine therapy or in combination with endocrine therapy for recurrent unresectable (local or regional) or stage IV (M1) disease; OR
Patient is a male (sex assigned at birth) AND therapy is used in combination with an aromatase inhibitor; AND
Dosing and administration follow guideline-based regimens (e.g., intramuscular or subcutaneous formulations as indicated)

Initial Therapy - Prostate Cancer

Covered when ALL of the following are met:

ALL of the following

Prostate Cancer: Patient must have a contraindication, intolerance, or failure to Camcevi®, Eligard®, AND Firmagon® prior to consideration of Lupron®; AND
Indication and planned use are consistent with guideline-based management (e.g., androgen deprivation therapy) and appropriate dosing/formulation is selected (e.g., J9217, J1952, J1954 product-specific codes); AND
Treatment will be monitored for efficacy and toxicity per standard practice

Initial Therapy - Uterine Sarcoma

Covered when ALL of the following are met:

ALL of the following

Uterine Sarcoma: Patient has a diagnosis of low-grade endometrial stromal sarcoma (ESS) or adenosarcoma without sarcomatous overgrowth; AND
Patient is premenopausal and not suitable for surgery (e.g., bilateral salpingo-oophorectomy); AND
Used for patients with small tumor volume or an indolent growth pace; AND
Therapy is used in combination with anastrozole, letrozole, or exemestane

Initial Therapy - Head and Neck Cancer

Covered when ALL of the following are met:

ALL of the following

Head and Neck Cancer: Patient has salivary gland tumors; AND
Therapy is used as a single agent OR in combination with abiraterone and prednisone; AND
Patient has androgen-receptor positive recurrent disease with one of the following: distant metastases; OR unresecatable locoregional recurrence with prior radiation therapy; OR unresectable second primary with prior radiation therapy

Initial Therapy - Fertility Preservation

Covered when ALL of the following are met:

ALL of the following

Fertility Preservation While Receiving Chemotherapy: Patient is premenopausal; AND
Patient is receiving cytotoxic chemotherapy with potential to cause ovarian damage/toxicity (e.g., cyclophosphamide, melphalan, procarbazine, vinblastine, imatinib, etc.); AND
Patient has failed or is not a candidate for other fertility preservation methods (e.g., cryopreservation); AND
Therapy will be provided only while the patient is still receiving cytotoxic chemotherapy; AND
Treatment will be monitored for absence of unacceptable toxicity (e.g., significant loss of bone mineral density, hypersensitivity reactions, convulsions, new or worsening clinical depression)

Initial Therapy - Gender Dysphoria

Covered when ALL of the following are met:

ALL of the following

Gender Dysphoria: Patient has experienced pubertal development to at least Tanner stage 2 (applies to patients <18 years); AND
Patient has a diagnosis of gender dysphoria confirmed by a qualified mental health professional (MHP) or meets DSM-5-TR criteria; AND
A qualified MHP has confirmed that the patient has a long-lasting, intense pattern of gender nonconformity or gender dysphoria, that dysphoria worsened with onset of puberty, that coexisting problems likely to interfere with treatment have been addressed and stability for treatment established, and that the patient has sufficient capacity to give informed consent to this reversible treatment; AND
Patient and guardians (when applicable) have been informed of effects and side effects including potential loss of fertility and options to preserve fertility, and consent has been obtained/parents are involved as appropriate; AND

Coding and Mappings

Primary HCPCS codeHCPCSCovered

J1950

Leuprolide acetate (for depot suspension), various strengths

Additional HCPCS codes (covered)HCPCSCovered

J1951	Injection, leuprolide acetate for depot suspension (fensolvi), 0.25 mg
J1952	Leuprolide injectable, camcevi, 1 mg
J1954	Injection, leuprolide acetate for depot suspension (lutrate depot), 7.5 mg
J9217	Leuprolide acetate (for depot suspension), 7.5 mg

Initial Therapy Criteria

Initial therapy general — Initial coverage requires meeting indication-specific clinical criteria

Initial coverage requires meeting indication-specific clinical criteria

General age requirement: Patient is at least 18 years of age unless otherwise specified by the indication

Initial dosing guidance — Dosing and administration guidance by indication and product

Dosing and administration guidance by indication and product

Endometriosis dosing: Administer 3.75 mg IM monthly or 11.25 mg IM every 3 months

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CPP dosing: Fensolvi subcutaneous kit: 45 mg SC once every 6 months; Lupron Depot-Ped IM weight-based monthly dosing (≤25 kg: 7.5 mg; >25–37.5 kg: 11.25 mg; >37.5 kg: 15 mg) with 3-month options (11.25 mg or 30 mg)

Continuation / Renewal Criteria

Renewal — Renewal rules vary by indication

Renewal rules vary by indication

Standard renewal: Prior authorization validity may be renewed every 12 months unless otherwise specified

Endometriosis renewal: May be renewed up to one time only for 6 months

HCT and Fibroids renewal: HCT-related bleeding: may NOT be renewed; Uterine leiomyomata: may NOT be renewed

Fertility preservation renewal: May be renewed every 12 months while patient is receiving concomitant cytotoxic chemotherapy

Provider Actions and Documentation

Prior Authorization

Prior authorization validity and initial duration

Prior authorization is required for leuprolide products. Initial authorizations are generally issued for 12 months unless the policy lists a shorter initial validity for the specific indication (e.g., endometriosis and HCT-related bleeding: 6 months; uterine leiomyomata: 3 months).

Prior Authorization

Prior authorization renewal conditions

Prior authorization is required and may be renewed only when the patient continues to meet the indication-specific criteria and the original authorization duration has not been exceeded; renewals are generally every 12 months unless the policy specifies otherwise.

Prior Authorization

Prior authorization applies to J1950

Prior authorization is applied to leuprolide mesylate billed as J1950; the NQTL checklist documents that indication and drug cost were factors considered when designing PA requirements.

Quantity Limits

Leuprolide (J1950) — per-indication units and intervals

Endometriosis / Fibroids / Gender dysphoria (J1950)3 billable units every 84 days (J1950); typical dosing examples include 3.75 mg IM monthly or 11.25 mg IM every 3 months

Certain cancers (J1950)6 billable units every 84 days for specified oncologic indications

CPP (Lupron Depot-Ped mapping)Lupron Depot-Ped product mappings referenced for pediatric dosing; see dosing guidance for weight-based pediatric regimens

Leuprolide (J1951/J1952) — per-indication units and intervals

CPP / Gender dysphoria (J1951)180 billable units every 168 days (J1951)

Prostate / Head and Neck (J1952)42 billable units every 168 days (J1952)

Step Therapy / Product Selection

Requirement	Details
Prior agent trial required	For Central Precocious Puberty (CPP): patient must have a contraindication, intolerance, or failure to Leupron Depot-Ped, Supprelin LA, AND Triptodur prior to consideration of Fensolvi (J1950/J1951).
Prior agent trial required	For Prostate Cancer: patient must have a contraindication, intolerance, or failure to Camcevi, Eligard, AND Firmagon prior to consideration of Lupron (J9217, J1952, J1954).

Topic	Policy detail
Step therapy sequencing	No explicit stepwise (fail-first) sequencing is specified in the document for leuprolide products; required prior-agent trials are indicated for selected indications but a multi-step algorithm is not provided.
Product-specific administration	Some products are formulation- and setting-specific: Lupron Depot, Lupron Depot-Ped, Lutrate Depot, and Leuprolide Acetate Depot are IM; Eligard, Vabrinty, Fensolvi, and Camcevi are SC. Camcevi, Eligard, Vabrinty, Fensolvi and Lupron Depot-Ped must be administered by a healthcare provider.
Caution on combining depots	Policy warns not to use concurrently a fractional dose or a combination of doses of this or any depot formulation due to different release characteristics.

NQTL factor	Consideration / conclusion
Indication considered for PA	Indication: Yes — considered when designing prior authorization for this drug group.
Safety and efficacy	Safety and efficacy: No — not a primary reason to apply PA per the checklist.
Potential for misuse/abuse	Potential for misuse/abuse: No — not a primary reason to apply PA per the checklist.
Cost of drug	Cost: Yes — cost was considered and is a factor in applying utilization management such as prior authorization.

Site of Care and Administration

Note

Formulation and site of care (no restriction listed)

Leuprolide products are intramuscular or subcutaneous formulations; the policy does not further restrict site of care in this section.

Step Therapy

Provider-administered depot products and administration routes

Certain depot products (Camcevi, Eligard, Vabrinty, Fensolvi, Lupron Depot-Ped) must be administered by a healthcare provider; administration routes are specified as IM or SC by product.

Note: do not combine fractional doses or combine different depot formulations due to differing release characteristics.

Background

Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist used in depot formulations to suppress gonadal steroid production. It is indicated across pediatric and adult settings including central precocious puberty (CPP), hormone-sensitive cancers (breast, ovarian, prostate, head and neck), endometriosis, uterine leiomyomata (fibroids), management of menstrual bleeding for HCT, fertility preservation during cytotoxic chemotherapy, and pubertal suppression for gender dysphoria. Clinical use requires diagnostic confirmation and, for select indications, prior trial or intolerance to specified alternative agents; dosing and administration vary by product and indication and many depot formulations must be administered by a healthcare provider.

Definitions

Qualified mental health professional (MHP) — short label

Short labelQualified mental health professional (MHP)

RoleLicensed clinician with training/experience in gender dysphoria assessment

Minimum qualificationHolds at minimum a master’s degree or equivalent in a relevant clinical field

Qualified mental health professional (MHP) — detailed definition

Licensure and educationLicensed by statutory body and holds at minimum a master's degree or equivalent training in a relevant clinical field

Clinical competenciesAble to identify coexisting mental health or psychosocial concerns and distinguish these from gender dysphoria; competent in ICD diagnosis where required

Revision History

2011-11-28policy_origin

Policy originated (Date of Origin recorded).

2011-12initial_review

Initial review period entries begin (document review history includes 12/2011).

2012-03review

Document listed a review in 03/2012 as part of ongoing review history.