PRIOR AUTHORIZATION CRITERIA

Transcription

1 DRUG CLASS BRAND NAME (generic) PRI AUTHIZATION CRITERIA TESTOSTERONE PRODUCTS (BRAND AND GENERIC) ANDRODERM (teststerne transdermal patch) ANDROGEL AXIRON (teststerne tpical slutin) DELATESTRYL (teststerne enanthate injectin) DEPO-TESTOSTERONE (teststerne cypinate injectin) FTESTA NATESTO (teststerne nasal gel) STRIANT (teststerne mucadhesive buccal system) TESTIM TESTOPEL (teststerne prpinate implant pellets) (teststerne cream) (teststerne intment) Teststerne Prducts TGC Plicy 1210-A CVS Caremark is an independent cmpany that prvides pharmacy benefit management services t CareFirst BlueCrss BlueShield and CareFirst BlueChice, Inc. members. CareFirst BlueCrss BlueShield is the shared business name f CareFirst f Maryland, Inc. and Grup Hspitalizatin and Medical Services, Inc. CareFirst f Maryland, Inc., Grup Hspitalizatin and Medical Services, Inc., CareFirst BlueChice, Inc., The Dental Netwrk and First Care, Inc. are independent licensees f the Blue Crss and Blue Shield Assciatin. In the District f Clumbia and Maryland, CareFirst MedPlus is the business name f First Care, Inc. In Virginia, CareFirst MedPlus is the business name f First Care, Inc. f Maryland (used in VA by: First Care, Inc.). Registered trademark f the Blue Crss and Blue Shield Assciatin Page 1 f 5

2 Status: CVS Caremark Criteria Type: Initial Prir Authrizatin VOGELXO POLICY FDA-APPROVED INDICATIONS Tpical, buccal, nasal, implant, and injectable teststerne prducts are indicated fr replacement therapy in adult males fr cnditins assciated with a deficiency r absence f endgenus teststerne. Primary hypgnadism (cngenital r acquired) - testicular failure due t cnditins such as cryptrchidism, bilateral trsin, rchitis, vanishing testis syndrme, rchiectmy, Klinefelter Syndrme, chemtherapy, r txic damage frm alchl r heavy metals. These men usually have lw serum teststerne cncentratins and gnadtrpins (FSH, LH) abve the nrmal range. Hypgnadtrpic hypgnadism (cngenital r acquired) - gnadtrpin r luteinizing hrmnereleasing hrmne (LHRH) deficiency r pituitary-hypthalamic injury frm tumrs, trauma, r radiatin. These men have lw teststerne serum cncentratins but have gnadtrpins in the nrmal r lw range. Limitatins f Use Safety and efficacy f tpical, buccal, nasal, implant, and injectable teststerne prducts in men with age-related hypgnadism (als referred t as late-nset hypgnadism ) have nt been established. Safety and efficacy f tpical, buccal, nasal, implant, and injectable teststerne prducts in males less than 18 years ld have nt been established. Tpical teststerne prducts may have different dses, strengths r applicatin instructins that may result in different systemic expsure. Delatestryl Males Delatestryl (Teststerne Enanthate Injectin) is indicated fr replacement therapy in cnditins assciated with a deficiency r absence f endgenus teststerne. Primary hypgnadism (cngenital r acquired) - testicular failure due t cryptrchidism, bilateral trsin, rchitis, vanishing testis syndrme, r rchiectmy. Hypgnadtrpic hypgnadism (cngenital r acquired) - gnadtrpin r luteinizing hrmnereleasing hrmne (LHRH) deficiency, r pituitary-hypthalamic injury frm tumrs, trauma, r radiatin. (Apprpriate adrenal crtical and thyrid hrmne replacement therapy are still necessary, hwever, and are actually f primary imprtance). If the abve cnditins ccur prir t puberty, andrgen replacement therapy will be needed during the adlescent years fr develpment f secndary sexual characteristics. Prlnged andrgen treatment will be required t maintain sexual characteristics in these and ther males wh develp teststerne deficiency after puberty. Safety and efficacy f Delatestryl in men with age-related hypgnadism (als referred t as late-nset hypgnadism ) have nt been established. Delayed puberty - Delatestryl (Teststerne Enanthate Injectin) may be used t stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern f delayed puberty that is nt secndary t a pathlgical disrder; puberty is expected t ccur Page 2 f 5

3 spntaneusly at a relatively late date. Brief treatment with cnservative dses may ccasinally be justified in these patients if they d nt respnd t psychlgical supprt. The ptential adverse effect n bne maturatin shuld be discussed with the patient and parents prir t andrgen administratin. An X- ray f the hand and wrist t determine bne age shuld be btained every six mnths t assess the effect f treatment n the epiphyseal centers. Females Metastatic Mammary Cancer - Delatestryl (Teststerne Enanthate Injectin) may be used secndarily in wmen with advancing inperable metastatic (skeletal) mammary cancer wh are ne t five years pstmenpausal. Primary gals f therapy in these wmen include ablatin f the varies. Other methds f cunteracting estrgen activity are adrenalectmy, hypphysectmy, and/r anti-estrgen therapy. This treatment has als been used in pre-menpausal wmen with breast cancer wh have benefited frm phrectmy and are cnsidered t a have a hrmne-respnsive tumr. Judgment cncerning andrgen therapy shuld be made by an nclgist with expertise in this field. Dep-Teststerne Dep-Teststerne Injectin is indicated fr replacement therapy in the male in cnditins assciated with symptms f deficiency r absence f endgenus teststerne. Primary hypgnadism (cngenital r acquired) - testicular failure due t cryptrchidism, bilateral trsin, rchitis, vanishing testes syndrme; r rchiectmy. Hypgnadtrpic hypgnadism (cngenital r acquired) - gnadtrpic r LHRH deficiency, r pituitary- hypthalamic injury frm tumrs, trauma r radiatin. Safety and efficacy f Dep-Teststerne (teststerne cypinate) in men with age-related hypgnadism (als referred t as late-nset hypgnadism ) have nt been established. Cmpendial Uses Gender Dysphria in Female-t-Male transgender patients13-14, Testpel Males Andrgens are indicated fr replacement therapy in cnditins assciated with a deficiency r absence f endgenus teststerne. Primary hypgnadism (cngenital r acquired) - testicular failure due t cryptrchidism, bilateral trsin, rchitis, vanishing testes syndrme; r rchiectmy. Hypgnadtrpic hypgnadism (cngenital r acquired) - gnadtrpic LHRH deficiency, r pituitary - hypthalamic injury frm tumrs, trauma r radiatin. If the abve cnditins ccur prir t puberty, andrgen replacement therapy will be needed during the adlescent years fr develpment f secndary sex characteristics. Prlnged andrgen treatment will be required t maintain sexual characteristics in these and ther males wh develp teststerne deficiency after puberty. Safety and efficacy f Testpel (teststerne pellets) in men with age-related hypgnadism (als referred t as late-nset hypgnadism ) have nt been established. Andrgens may be used t stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern f delayed puberty that is nt secndary t a pathlgical disrder; puberty is expected t ccur spntaneusly at a relatively late date. Brief treatment with cnservative dses may ccasinally be justified in these patients if they d nt respnd t psychlgical supprt. The ptential adverse effect n bne maturatin shuld be discussed with the patient and parents prir t andrgen administratin. An x-ray f the hand and wrist t determine bne age shuld be taken every 6 mnths t assess the effect f treatment n epiphyseal centers. COVERAGE CRITERIA Teststerne prducts will be cvered with prir authrizatin when the fllwing criteria are met: The requested drug is being prescribed fr primary r hypgnadtrpic hypgnadism [Nte: Safety and efficacy f teststerne prducts in patients with age-related hypgnadism (als referred t as late-nset hypgnadism ) have nt been established.] AND Page 3 f 5

4 Befre the start f teststerne therapy, the patient has at least tw cnfirmed lw teststerne levels accrding t current practice guidelines r yur standard male lab reference values Fr cntinuatin f teststerne therapy: befre the patient started teststerne therapy, the patient had a cnfirmed lw teststerne level accrding t current practice guidelines r yur standard male lab reference values Delatestryl (teststerne enanthate injectin) is being prescribed fr inperable metastatic breast cancer in a patient wh is 1 t 5 years pstmenpausal AND the patient had an incmplete respnse t ther therapy fr metastatic breast cancer Delatestryl (teststerne enanthate injectin) is being prescribed fr a pre-menpausal patient with breast cancer wh has benefited frm phrectmy and is cnsidered t a have a hrmne-respnsive tumr Delatestryl (teststerne enanthate injectin) r Testpel (teststerne prpinate implant pellets) is being prescribed fr delayed puberty The requested drug is being prescribed fr female-t-male gender reassignment in a patient wh is 14 years f age r lder and able t make an infrmed, mature decisin t engage in therapy REFERENCES 1. Andrderm [package insert]. Parsippany, NJ: Actavis Pharma, Inc.; July Andrgel 1% [package insert]. Nrth Chicag, IL: Abbvie Inc; Nvember Andrgel 1.62% [package insert]. Nrth Chicag, IL: Abbvie Inc; Octber Axirn [package insert]. Indianaplis, IN: Lilly USA, LLC; Octber Delatestryl [package insert]. Malvern, PA: End Pharmaceuticals Slutins Inc.; May Dep-Teststerne [package insert]. New Yrk, NY: Pharmacia and Upjhn Cmpany; Nvember Frtesta [package insert]. Malvern, PA: End Pharmaceuticals Inc.; Octber Natest [package insert]. Malvern, PA: End Pharmaceuticals; July Striant [package insert]. Malvern, PA: End Pharmaceuticals.; Nvember Testim [package insert]. Chesterbrk, PA: Auxilium Pharmaceuticals, Inc.; Octber Testpel Pellets [package insert]. Malvern, PA: Auxilium Pharmaceuticals, Inc; Octber Vgelx [package insert]. Maple Grve, MN: Upsher-Smith Labratries, Inc.; Nvember AHFS DI (Adult and Pediatric) [database nline]. Hudsn, OH: Lexi-Cmp, Inc.; [available with subscriptin]. Accessed February Micrmedex Slutins [database nline]. Greenwd Village, CO: Truven Health Analytics Inc. Updated peridically. [available with subscriptin]. Accessed February Petak S, Nankin H, Spark R, et al. American Assciatin f Clinical Endcrinlgists Medical Guidelines fr Clinical Practice fr the Evaluatin and Treatment f Hypgnadism in Adult Male Patients 2002 update. Endcrine Practice 2002;8(6): Bhasin S, Cunningham G, Hayes F, et al. Teststerne Therapy in Adult Men with Andrgen Deficiency Syndrmes: An Endcrine Sciety Clinical Practice Guideline. Jurnal f Clinical Endcrinlgy & Metablism (6): Hembree WC, Chen-Kettenis P, Delemarre-van de Waal HA, et al; Endcrine Sciety. Endcrine treatment f transsexual persns: an Endcrine Sciety clinical practice guideline. J Clin Endcrinl Metab Sep;94(9): Knezevich EL, Viereck LK, Drincic AT. Medical Management f Adult Transsexual Persns. Pharmactherapy. 2012;32(1): Cleman E, Bckting W, Btzer M, et al. Standards f Care fr the Health f Transsexual, Transgender, and Gender Nncnfrming Peple. Wrld Prfessinal Assciatin fr Transgender Page 4 f 5

5 Health. Last Updated Available at: %20-%202011%20WPATH%20(2)(1).pdf. Accessed February American Psychiatric Assciatin. The Diagnstic and Statistical Manual f Mental Disrders, Fifth Editin (DSM-V) Available at Page 5 f 5