Drug Therapy Guidelines

Transcription

1 Applicable Medical Benefit x Effective: 5/1/18 Pharmacy- Frmulary 1 x Next Review: 3/18 Pharmacy- Frmulary 2 x Date f Origin: 4/99 Gnadtrpin-Releasing Hrmne Agnists- Eligard, Luprn, Luprn-Dept, Luprn Dept-Ped, Lupaneta (leuprlide, nrethindrne pack), Triptdur (triptrelin), Trelstar (triptrelin, including Dept and LA), Synarel (nafarelin acetate) Pharmacy- Frmulary 3/Exclusive x Review Dates: 4/1/99, 11/28/00, 11/27/01, 11/19/02, 12/16/03, Pharmacy- Frmulary 4/AON x 11/16/04, 12/7/05, 1/15/06, 10/15/06, 11/5/07, 12/15/08, 12/09, 9/11, 9/12, 9/13, 9/14, 3/15, 3/16, 3/17, 12/17, 3/18 I. Medicatin Descriptin Gnadtrpin Releasing Hrmne (GnRH) agnists act as ptent inhibitr f gnadtrpin secretin, initially increasing FSH and LH secretin resulting in transient increases in estrgen in females and teststerne levels in males. Lng-term therapy suppresses gnadtrpin release frm the pituitary gland and reduces steridgenesis in the varies and testicles. II. Psitin Statement Cverage is determined thrugh a prir authrizatin prcess with supprting clinical dcumentatin fr every request. III. Plicy Cverage fr Eligard, Luprn Dept, leuprlide injectin, and Trelstar fr nclgy indicatins is available when the fllwing criteria have been met: The medicatin is prescribed by a hematlgist/nclgist (r a urlgist, when requested fr the treatment f prstate cancer) AND Either f the fllwing: The medicatin is requested fr the treatment f prstate cancer OR The requested use is therwise supprted by the Natinal Cmprehensive Cancer Netwrk (NCCN) Clinical Practice Guidelines (NCCN Guidelines ) and/r NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) with a recmmendatin f categry level 1 r 2A. Cverage fr Luprn Dept/Luprn Dept Ped is als prvided fr treatment f the fllwing cnditins: Central Preccius Puberty (idipathic r neurgenic): Cverage is requested by an endcrinlgist AND Patient is less than 11 years ld fr females r 12 years ld fr males OR If age is greater than the abve, clear medical necessity f further treatment must be utlined with physician statement an supprted by patient chart/prgress ntes Endmetrisis Fr the preperative treatment f anemia due t uterine leimymata (fibrids). Gender dysphria Page 1 f 6

2 Gnadtrpin-Releasing Hrmne Agnists The diagnsis f gender dysphria and the referral fr hrmne therapy have been made by a mental health prfessinal in accrdance with the WPATH criteria AND The patient must be fllwed by an endcrinlgist OR If used fr suppressin f puberty, therapy shuld nt be started earlier than Tanner stage 2 Cverage fr Lupaneta is prvided fr the treatment f endmetrisis. Cverage fr leuprlide injectin is als prvided fr the treatment f the fllwing cnditins: Central preccius puberty (idipathic r neurgenic): Treatment is requested by an endcrinlgist AND Patient is less than 11 years ld fr females r 12 years ld fr males OR If age is greater than the abve, clear medical necessity f further treatment must be utlined with physician statement and supprted by patient chart/prgress ntes Cverage fr Synarel is prvided fr the treatment f the fllwing cnditins: Central preccius puberty (idipathic r neurgenic): Treatment is requested by an endcrinlgist AND Patient is less than 11 years ld fr females r 12 years ld fr males OR If age is greater than the abve, clear medical necessity f further treatment must be utlined with physician statement and supprted by patient chart/prgress ntes Endmetrisis Cverage fr Triptdur is prvided fr treatment f: Central Preccius Puberty: Cverage is requested by an endcrinlgist AND Patient is less than 11 years ld fr females r 12 years ld fr males OR If age is greater than the abve, clear medical necessity f further treatment must be utlined with physician statement an supprted by patient chart/prgress ntes IV. Quantity Limitatins Eligard: 45mg every 6 mnths Luprn Dept/Luprn Dept Ped: Prstate cancer: up t ttal f 90mg per 12 mnths Central preccius puberty: 15mg every mnth (180mg every 12 mnths) All ther indicatins: 11.25mg every 3 mnths (22.5mg every 6 mnths) Luprn: t allw fr desired respnse within FDA-dsing guidelines Lupaneta: leuprlide: 11.25mg every 3 mnths nrethindrne 5mg tablets: 90 every 3 mnths Triptdur: 22.5mg every 6 mnths Trelstar: 22.5mg every 6 mnths Page 2 f 6

3 Gnadtrpin-Releasing Hrmne Agnists Synarel: 800mcg/day V. Cverage Duratin Cverage will be prvided as fllws: Prstate cancer: 12 mnths and may be renewed Central Preccius Puberty: Until female patient reaches 11 years f age Until male patient reaches 12 years f age Endmetrisis, Breast Cancer, Ovarian Cancer: 6 mnths and may be renewed Uterine Fibrids: 3 mnths and may be renewed Gender dysphria: 12 mnths and may be renewed VI. Cverage Renewal Criteria Cverage can be renewed based upn the fllwing criteria: Prstate Cancer: n/a Breast Cancer, Ovarian Cancer: Tumr respnse with stabilizatin f disease r decrease in size f tumr r tumr spread AND Absence f unacceptable txicity frm the drug Central Preccius Puberty: Absence f unacceptable txicity frm the drug AND One f the fllwing is true: Patient s age is less than 11 years fr females and 12 years fr males OR If age is greater than the abve, clear medical necessity f further treatment is utlined with physician statement and supprted by patient chart/prgress ntes Uterine fibrids/endmetrisis: Renewal is dependent n recurrence f symptms AND There is an absence f unacceptable txicity frm the drug AND Dcumentatin f why member cannt underg surgical interventin is prvided AND If used lnger than 12 mnths, apprpriate peridic bne mineral density assessment is ensured Gender dysphria: Absence f unacceptable txicity frm the drug AND Chart ntes assessing pubertal develpment, height, weight, BMI, bne age, bne mineral density AND Physician statement utlining medical necessity and treatment plan VII. Billing/Cding Infrmatin Eligard Available as 7.5mg, 22.5mg, 30mg, and 45mg suspensin J billable unit equals 7.5mg Available as a medical benefit Page 3 f 6

4 Gnadtrpin-Releasing Hrmne Agnists Luprn Dept/Luprn Dept Ped Available as 3.75mg, 7.5mg, 11.25mg, 15mg, 22.5mg, 30mg, 45mg pwder fr suspensin J billable unit equals 3.75 mg J billable unit equals 7.5 mg Available as a medical benefit Leuprlide injectin Available as 1mg/0.2ml slutin J billable unit equals 1 mg Available as a medical benefit and a pharmacy benefit Lupaneta Available as a 1-mnth kit cntaining 3.75mg leuprlide acetate fr suspensin with 30 cunt bttle f 5mg nrethindrne ral tablets and 3-mnth kit cntaining 11.25mg leuprlide acetate fr suspensin with 90 cunt bttle f 5mg nrethindne ral tablets J3490 Available as a medical benefit Synarel Available as 8ml bttle cntaining a 2mg/ml nasal slutin Triptdur Trelstar Available as 22.5mg triptrelin as a pwder cake fr recnstitutin with the c-packaged 2ml f diluent SWFI C9016: 1 billable unit equals 3.75 mg Available as medical benefit Available as 3.75mg, mg, and 22.5mg as a single dse vial cntaining sterile lyphilized micrgranules with the c-packaged 2ml f diluent SWFI J3315: 1 billable unit equals 3.75 mg Available as a medical benefit Pertinent diagnses: Breast cancer: C50.019, C50.029, C50.119, C50.219, C50.319, C50.419, C50.519, C50.619, C50.819, C50.919, C50.929, Z85.3 Central Preccius Puberty: E30.1, E30.8 Endmetrisis: N80.0, N80.1, N80.2, N80.3, N80.4, N80.5, N80.6, N80.8, N80.9 Ovarian Cancer: C48.1, C48.2, C48.8, C56.1, C56.2 C56.9, C57.00-C57.02, C57.10-C57.12, C C57.22, C57.3, C57.4, C57.7-C57.9, Z85.43 Prstate Cancer: C61, Z85.46 Uterine Fibrids: D25.0, D25.1, D25.2, D25.9 Gender identity disrder: F64.1, F64.2 VIII. Summary f Plicy Changes 1/1/12 Requirement f irn usage timeframes added fr anemia secndary t uterine leimymata Page 4 f 6

5 Gnadtrpin-Releasing Hrmne Agnists Quantity allwances and cverage duratin revised Remval f diagnsis frm autpay, will be reviewed Central preccius puberty (259.1) n lnger autpay diagnsis, will be reviewed Cverage criteria utlined Renewal criteria utlined Clarificatin f pharmacy benefit vs. medical benefit made Cverage criteria fr breast and varian cancers included 12/15/12 Remval f trial f irn supplementatin required fr fibrid treatment Additin f mnitring fr bne density t warnings Additin f renewal criteria fr uterine fibrids/endmetrisis t address surgical interventin 6/2013: added Lupaneta t plicy 12/15/13: Change in criteria fr varian cancer and uterine fibrids Clarified Luprn Dept is nt cvered under the pharmacy benefit 1/1/15: Updated breast cancer cverage criteria t mirrr current NCCN treatment guidelines Added quantity limits t Lupaneta Added requirement fr peridic bne mineral density screening when treating endmetrisis r fibrids fr ver 12 mnths 3/15/15: Additin f cverage criteria in the setting f gender dysphria 7/1/15: frmulary distinctins made 10/1/15: ICD9 references mitted 6/15/16: n plicy changes 4/5/17: remved requirement fr btaining dcumentatin f infrmed cnsent and labratry testing when requested fr the treatment f gender dysphria 1/1/18: cverage criteria updated t allw use as supprted by current NCCN guidelines; requests fr all diagnstic cdes will require prir authrizatin; addendum with diagnstic cdes exceptins remved; additin f Triptdur and billing/cding infrmatin updated 1/10/18: clarified cverage criteria fr the treatment f prstate cancer 5/1/18: added Synarel t plicy; mved Trelstar frm Abbreviated Criteria; updated ICD-10 cdes; updated quantity limits and cverage duratin IX. References 1. Up-t-date Online, accessed 1/ Clinical Pharmaclgy Online, accessed 1/ Facts and Cmparisns Online, accessed 1/ NCCN Drugs and Bilgics Cmpendium - Leuprlide. Accessed 1/ Prduct Infrmatin: Luprn Dept (leuprlide), revised 6/ Prduct Infrmatin: leuprlide, revised 10/ Prduct Infrmatin: Eligard (leuprlide), revised 11/2017. Page 5 f 6

6 Gnadtrpin-Releasing Hrmne Agnists 8. Schmid P, Untch M, Wallwiener D, et al. Cyclphsphamide, methtrexate and flururacil (CMF) versus hrmnal ablatin with leuprrelin acetate as adjuvant treatment f nde-psitive, premenpausal breast cancer patients: preliminary results f the TABLE-study (Takeda Adjuvant Breast cancer study with Leuprrelin Acetate). Anticancer Res 2002;22: Bccard F, Rubagtti A, Amrs D, et al. Endcrinlgical and clinical evaluatin f tw dept frmulatins f leuprlide acetate in pre- and perimenpausal breast cancer patients. Cancer Chemther Pharmacl 1999;43: Prduct Infrmatin: Luprn Dept Ped (leuprlide). Revised 5/ Prduct Infrmatin: Lupaneta Pack (leuprlide fr dept suspensin; nrethindrne tablets). AbbVie Inc. Nrth Chicag, IL Revised 6/ Micrmedex - Leuprlide. Accessed 1/ The Endcrine Sciety s Clinical Guidelines. Endcrine Treatment f Transsexual Persns: An Endcrine Sciety Clinical Practice Guideline. J Clin Endcrinl Metab 2009;94: Standards f Care fr the Health f Transsexual, Transgender, and Gender-Nncnfrming Peple. The Wrld Prfessinal Assciatin fr Transgender Health. Assciatin Management Online. 7 th ed Accessed 3/ Prescribing Infrmatin: Triptdur. Arbr Pharmaceuticals, LLC, Atlanta, GA. Revised 9/ Prescribing Infrmatin: Trelstar. Allergan USA, Inc. Irvine, CA Revised 11/ Prescribing Infrmatin: Synarel. Pfizer Inc. New Yrk, NY Revised 12/2017 The Plan fully expects that nly apprpriate and medically necessary services will be rendered. The Plan reserves the right t cnduct pre-payment and pst-payment The preceding plicy applies nly t members fr whm the abve named pharmacy benefit medicatins are included n their cvered frmulary. Members with clsed frmulary benefits are subject t trying all apprpriate frmulary alternatives befre a cverage exceptin fr a nn-frmulary medicatin will be cnsidered. The preceding plicy is a guideline t allw fr cverage f the pertinent medicatin/prduct, and is nt meant t serve as a clinical practice guideline. Page 6 f 6