Medication Prior Authorization Form

Lupron

Policy Number: 1047

Eligard (leuprolide acetate) 7.5mg Lupron Depot Ped (leuprolide acetate) 7.5mg Eligard (leuprolide acetate) 22.5mg Lupron Depot Ped (leuprolide acetate) 11.25mg Eligard (leuprolide acetate) 30mg Lupron Depot Ped (leuprolide acetate) 15mg Eligard (leuprolide acetate)45mg Lupron Depot Ped (three month) (leuprolide acetate) 11.25mg and 30mg Firmagon (degarelix) Supprelin LA (histrelin acetate) Lupaneta Pack (leuprolide acetate and Synarel Nasal Spray (nafarelin acetate) norethindrone) Leuprolide acetate (immediate release) Trelstar (triptorelin pamoate) 22.5mg Lupron Depot (one month) (leuprolide acetate) Trelstar Depot (triptorelin pamoate) 3.75mg 3.75mg Lupron Depot (one month) (leuprolide acetate) 7.5mg Trelstar LA (triptorelin pamoate) 11.25mg Lupron Depot (three month) (leuprolide acetate) Vantas Implant (histrelin acetate) 11.25mg and 22.5mg Lupron Depot (four month) (leuprolide acetate) 30mg Zoladex (one month) (goserelin acetate) Lupron Depot (six month) (leuprolide acetate) 45mg Zoladex (three month) (goserelin acetate)

Policy History Approve Date: 06/01/2018 Effective Date: 06/01/2018

Preauthorization All Plans Benefit plans vary in coverage and some plans may not provide coverage for certain service(s) listed in this policy. Decisions for authorization are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations as well as applicable state and/or federal laws. Please review the benefit plan descriptions for details.

We utilize a combination of MCG and internally developed evidence-based clinical guidelines to support our prior authorization work. All internally developed prior authorization guidelines follow a rigorous process including, but not limited to, review by clinical pharmacist, clinical nurse manager, Chief Medical Officer, independent 3rd party physician review agency and Health Tradition’s Medical Advisory Committee. Prior authorization guidelines are reviewed at least annually, or when there are significant labeling changes made by FDA or peer-reviewed clinical outcomes (via Cochrane or Hayes).

HT MHS 7024 0918

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INSTRUCTIONS: Please review section I and complete sections II, III, and IV (type or print clearly).

Prescribers are asked to submit this form along with supporting clinical documentation to Health Tradition for review.

Submission of form does not guarantee approval.

Submit preauthorization (PA) by fax to the Health Tradition at (608) 781-9654 or by mail to Health Tradition, Pharmacy Services Prior Authorization, P.O. Box 21538, Eagan MN 55121-5038.

Section I—Approval Criteria

I. Breast Cancer – Goserelin acetate or leuprolide acetate A. Goserelin acetate or leuprolide acetate is medically necessary for the treatment of men and pre- or peri- menopausal women with hormone receptor positive breast cancer B. Goserelin acetate or leuprolide acetate is not medically necessary for the treatment of breast cancer when the criteria above are not met

II. Ovarian Cancer (including fallopian tube cancer and primary peritoneal cancer) – Leuprolide acetate Leuprolide acetate is medically necessary for ovarian cancer when ANY of the following criteria are met: A. Hormonal therapy for clinical relapse in individuals with stage II-IV granulosa cell tumors OR B. Hormonal therapy for treatment of epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer as a single agent for: i. Progressive, stable or persistent disease on primary chemotherapy OR ii. Relapse after complete remission following primary chemotherapy OR iii. Stage II-IV disease showing partial response to primary treatment OR iv. Low grade or focal recurrences after a disease free interval of greater than six months C. Leuprolide acetate is not medically necessary for ovarian cancer when the criteria above are not met

III. Prostate Cancer- Degarelix, goserelin acetate, histrelin acetate (Vantas), leuprolide acetate or triptorelin pamoate A. Degarelix, goserelin acetate, histrelin acetate (Vantas), leuprolide acetate, or triptorelin pamoate is medically necessary for the treatment of prostate cancer when ANY of the following indications are met: i. Clinically localized disease with intermediate (T2b to T2c cancer, Gleason score of 7 or prostate specific antigen (PSA) value of 10-20 ng/ml) or higher risk of recurrence as neoadjuvant therapy with radiation therapy or cryosurgery OR ii. Following radical prostatectomy as adjuvant therapy when lymph node metastases are present OR iii. Locally advanced disease OR iv. Other advanced, recurrent, or metastatic disease B. Definitions i. Clinically localized prostate cancer: cancer presumed to be confined within the prostate based on pre-treatment findings such as physical exam, imaging, and biopsy findings ii. Locally advanced disease (prostate cancer): cancer that has spread from where it started to nearby tissue or lymph nodes iii. Metastatic: the spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original (primary) tumor and have spread iv. Advanced prostate cancer: disease that has spread beyond the prostate to surrounding tissues or distant organs C. Degarelix, goserelin acetate, histrelin acetate (Vantas), leuprolide acetate, or triptorelin pamoate are not medically necessary for treatment of prostate cancer when the criteria above are not met

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IV. Central Precocious Puberty- Leuprolide acetate (Lupron Depot-Ped), nafarelin acetate or histrelin acetate subcutaneous implant (Supprelin LA) A. Leuprolide acetate (Lupron Depot-Ped), nafarelin acetate or histrelin acetate subcutaneous implant (Supprelin LA) may be approved for the treatment of children known to have central precocious puberty (defined as the beginning of secondary sexual characteristics before age eight in girls and nine in boys) B. Leuprolide acetate (Lupron Depot-Ped), nafarelin acetate or histrelin acetate subcutaneous implant (Supprelin LA) may NOT be approved for the treatment of central precocious puberty when the criteria above are not met

V. Gynecology Uses- Goserelin acetate, leuprolide acetate, leuprolide acetate for depot suspension and norethindrone (Lupaneta Pack), or nafarelin acetate A. Goserelin acetate, leuprolide acetate, or nafarelin acetate are medically necessary when the following is met: i. To induce amenorrhea in women in certain populations, including menstruating women diagnosed with severe thrombocytopenia or aplastic anemia B. Goserelin acetate is medically necessary for ANY of the following additional indications: i. Endometriosis (duration of treatment limited to six months) OR ii. Dysfunctional uterine bleeding OR iii. Endometrial thinning prior to endometrial ablation for dysfunctional uterine bleeding (3.6 mg implant only) C. Leuprolide acetate is medically necessary for ANY of the following additional indications: i. Initial treatment of endometriosis (duration of treatment limited to six months) OR ii. Retreatment of endometriosis (duration of treatment limited to six months) OR iii. Preoperative treatment as adjunct to surgical treatment of uterine fibroids (leiomyoma uteri). May be used to reduce size of fibroids to allow for a vaginal procedure OR iv. Prior to surgical treatment (myomectomy or hysterectomy) in individuals with documented anemia D. Leuprolide acetate for depot suspension and norethindrone acetate tablets (Lupaneta Pack) are medically necessary for any of the following indications: i. Initial treatment of endometriosis (duration of treatment limited to six months) OR ii. Retreatment of endometriosis (duration of treatment limited to six months) E. Nafarelin acetate is medically necessary for the following additional indication: i. Endometriosis (duration of treatment limited to six months) F. Goserelin acetate, leuprolide acetate, leuprolide acetate for depot suspension or norethindrone acetate tablets, or nafarelin acetate are not medically necessary for gynecological uses when the criteria above are not met.

Renewal Criteria

I. All renewals will be for six months based upon continued effectiveness and absence of significant adverse effects where treatment benefits outweigh risk for serious harm

References

1. Lexicomp 2015 2. FDA approved product labeling 3. Lupron Depot 1-month 7.5 mg, 3-month 22.5 mg, 4-month 30 mg, 6-month 45 mg (leuprolide) [prescribing information]. North Chicago, IL: AbbVie Inc; June 2014

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Section II—Member Information Name (Last, First, Middle Initial) Date of Birth

Health Tradition Subscriber Number

Diagnosis

1. MEDICATION 2. STRENGTH

□ Eligard (leuprolide acetate) □ 7.5mg □ 22.5mg □ 30mg □ 45mg □ Firmagon (degarelix acetate) □ 80mg □ 120mg □ Lupaneta Pack (leuprolide acetate and norethindrone) □ 3.75mg □ 11.25mg □ Lupron (leuprolide) □ 5mg/mL □ Lupron Depot (one month) (leuprolide acetate) □ 3.75mg □ 7.5mg □ Lupron Depot (three month) (leuprolide acetate) □ 11.25mg □ 22.5mg □ Lupron Depot (four month) (leuprolide acetate) □ 30mg □ Lupron Depot (six month) (leuprolide acetate) □ 45mg □ Lupron Depot Ped (leuprolide acetate) □ 7.5mg □ 11.25mg □ 15mg □ Lupron Depot Ped (three month) (leuprolide acetate) □ 11.25mg □ 30mg Supprelin LA (histrelin) □ □ 50mg Synarel Nasal Spray (nafarelin) □ □ 2mg/mL Trelstar (triptorelin pamoate) □ □ 22.5mg □ Trelstar Depot (triptorelin pamoate) □ 3.75mg □ Trelstar LA (triptorelin pamoate) □ 11.25mg □ Vantas Implant (histrelin acetate) □ 50mg □ Zoladex (one month) (goserelin acetate) □ 3.6mg □ Zoladex (three months) (goserelin acetate) □ 10.8mg

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3. APPROVAL CRITERIA: CHECK ALL BOXES THAT APPLY NOTE: Any areas not filled out are considered not applicable to your patient and MAY AFFECT THE OUTCOME of this request.

Oncology Uses □ Yes □ No Does the patient have hormone receptor positive breast cancer? If yes: □ Yes □ No Is the patient premenopausal? □ Yes □ No Is the patient perimenopausal? □ Yes □ No Is the patient male? □Yes □ No Does the patient have ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)? If yes: □ Yes □ No Is the medication being used as hormonal therapy for clinical relapse in individuals with stage II‐IV granulosa cell tumors? □ Yes □ No Is the medication being used as hormonal therapy for treatment of epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer as a single agent for any of the following? Please indicate: □ Progressive, stable or persistent disease on primary chemotherapy □ Relapse after complete remission following primary chemotherapy □ Stage II‐IV disease showing partial response to primary treatment □ Low grade or focal recurrences after a disease free interval of greater than six months □ Yes □ No Does the patient have prostate cancer? If yes: □ Yes □ No Is the disease clinically localized (clinically localized prostate cancer: cancer presumed to be confined within the prostate based on pre‐treatment findings such as physical exam, imaging, and biopsy findings) with intermediate (T2b to T2c cancer, Gleason score of 7, or prostate specific antigen [PSA] value of 10‐20 ng/ml) or higher risk of recurrence as neoadjuvant therapy with radiation therapy or cryosurgery? □ Yes □ No Is the request drug being used following radical prostatectomy as adjuvant therapy when lymph node metastases are present? □ Yes □ No Is the disease locally advanced (locally advanced disease [prostate cancer]: cancer that has spread from where it started to nearby tissue or lymph nodes)? □ Yes □ No Is the disease other advanced (advanced prostate cancer: disease that has spread beyond the prostate to surrounding tissues or distant organs), recurrent, or metastatic (metastatic: the spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original [primary] tumor and have spread)? Endocrine Uses □ Yes □ No Is the patient a child known to have central precocious puberty (defined as the beginning of secondary sexual characteristics before age eight in girls and nine in boys)?

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Gynecology Uses □ Yes □ No Is the medication being used to induce amenorrhea in women in certain populations, including menstruating women diagnosed with severe thrombocytopenia or aplastic anemia? □ Yes □ No Does the patient have endometriosis? If yes: □ Yes □ No Is the medication being used as initial treatment? □Yes □ No Is the medication being used as retreatment? □ Yes □ No Does the patient have dysfunctional uterine bleeding? □ Yes □ No Does the patient have endometrial thinning prior to endometrial ablation for dysfunctional uterine bleeding? □ Yes □ No Is the medication being used as preoperative treatment as adjunct to surgical treatment of uterine fibroids ([leiomyoma uteri] may be used to reduce size of fibroids to allow for a vaginal procedure)? □ Yes □ No Is the medication being used prior to surgical treatment (myomectomy or hysterectomy) in individuals with documented anemia?

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Section III—Physician Information Physician Name National Provider Identification (NPI) Number

Clinic Name

Address (Street, City, State, Zip Code)

Physician Telephone Number Physician Fax Number

Physician Signature Date

Section IV—For Health Tradition Use Only

Plan: Copay Tiers: Date of Receipt:

Remarks:

 Approve  Deny  More information is needed  Incomplete form

Submission and review of this form does not guarantee approval of this request. Unless approved, payment of the brand-name medication will be limited to the amount Health Tradition would have paid for the generic equivalent. Insureds and providers will be informed of the decision in writing within approximately 30 days.

Fax to: Pharmacy Services (608) 781-9654

Mail to: Health Tradition Pharmacy Services Prior Authorization PO Box 21538 Eagan MN 55121-5038