Targets Agents and indications:

Supprelin^® (histrelin acetate) is FDA approved: For the treatment of children with central precocious puberty (CPP).

Firmagon^® (degarelix) is FDA approved: For the treatment of patients with advanced prostate cancer

Trelstar^® (triptorelin pamoate) is FDA approved: For the treatment of patients with advanced prostate cancer

Triptodur^® (triptorelin) is FDA approved: For the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).

Zoladex^® (goserelin) is FDA approved:

·        For use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate.

·        For the palliative treatment of advanced carcinoma of the prostate

Camcevi^® (leuprolide) is FDA approved: For the treatment of adult patients with advanced prostate cancer.

Lupron Depot^® (leuprolide) is FDA approved:

·        For the treatment of adult patients with advanced prostate cancer.

·        For the management of endometriosis, including pain relief and reduction of endometriotic lesions

·        In combination with iron therapy for the preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary.

·        For the treatment of pediatric patients with central precocious puberty (CPP).

Eligard^® (leuprolide acetate) is FDA approved: For the treatment of advanced prostate cancer

Vabrinty^® (leuprolide acetate susp, extended release) is FDA approved: For the treatment of advanced prostate cancer

Initial Evaluation

I.                 Target Agent(s) may be considered medically necessary when ALL of the following are met:

A.     The patient has no contraindications to requested agent and ONE of the following:

                                                                                  i.     The diagnosis is central precocious puberty AND ONE of the following:

1.     The request is for Triptodur OR

2.     The request is for Supprelin and patient has failed Triptodur OR

                                                                                 ii.     The diagnosis is for gender dysphoria and ONE of the following:

1.     The patient is at least 19 years of age and ONE of the following:

i.       Patient has completed psychosocial evaluation for gender dysphoria AND

ii.      Prescriber is specialist in gender dysphoria or has consulted specialist AND

iii.     The requested medication will not be used for puberty blocking purposes OR

2.     The patient is under the age of 19 years old AND ALL of the following:

i.       The prescriber has attested to completion of Category 1 Continuing Competency Education as required in LB574 AND

ii.      Prescriber indicates that gender nonconformity or gender dysphoria is driving the patient’s distress and not other mental or physical condition or reasonable expectation of natural resolution of gender nonconformity AND

iii.     Documentation of long-lasting and intense pattern of gender nonconformity or gender dysphoria as evidenced that patient has lived at least 6 months primarily as preferred gender AND

iv.     Patient has completed a minimum 40 gender-identity-focused contact hours of therapeutic treatment prior to receiving prescribed medications AND will continue to receive at least one therapeutic contact hour every 90 days AND

v.      The appropriate supports are in place for the patient including social and familial support AND

vi.     Injectable medications will be administered in the prescribing practitioner’s office by trained staff OR

                                                                                iii.     The diagnosis is prostate cancer OR

                                                                               iv.     The diagnosis is supported in NCCN Guidelines at category 2A rating or higher.

Length of Approval:

Renewal Evaluation

I.                 Renewal of Target Agent(s) may be considered medically necessary when

A.     The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND

B.     Patient has been adherent to requested medications as evidenced by pharmacy claims, medical claims, or clinical notes AND

C.    The patient has no contraindications to therapy

Length of Approval: 12 months