Pharmacy Prior Authorization Growth Hormone- Clinical Guidelines. Serostim Zorbtive somatropin

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1 Pharmacy Prir Authrizatin Grwth Hrmne- Clinical Guidelines Gentrpin Humatrpe Nrditrpin Nutrpin Omnitrpe Saizen Serstim Zmactn Zrbtive smatrpin General Criteria fr Apprval: Omnitrpe vial frmulatin is the preferred Grwth Hrmne prduct; cnsideratin fr an alternative prduct will be prvided upn ne f the fllwing: 1. Dcumentatin t supprt trial and failure r cntraindicatin t preferred prduct 2. An inability r disability t use vial frmatin (i.e., visual impairment) Or 3. Treatment is fr an indicatin nt supprted by the preferred GH prduct Additinal Criteria Based n Indicatin: Grwth Hrmne Deficiency: Dcumentatin t supprt diagnsis f GHD f children with grwth failure due t inadequate secretin f endgenus grwth hrmne. Prescribed by a Pediatric Endcrinlgist Failure f 2 standard grwth hrmne stimulatin tests (serum peak GH level f < 10 ng/ml, after stimulatin with insulin, levdpa, arginine, prpranll, clnidine r glucagn). Nte: ne abnrmal GH test is sufficient fr children with brain tumrs and irradiatin with dcumented multiple pituitary hrmne deficiency (MPHD). Apprpriate imaging (MRI r CT) f the brain t exclude tumr n hypthalamic-pituitary regin. AND ne f the fllwing: Child has severe grwth retardatin with height standard deviatin scre (SDS) mre than 3 SDS belw the mean fr chrnlgical age and sex; OR Child has mderate grwth retardatin with height SDS between -2 and -3 SDS belw the mean chrnlgical age and sex and decreased grwth rate (grwth velcity measured ver ne year belw 25th percentile fr age and sex); OR Child exhibits severe deceleratin in grwth rate (grwth velcity measured ver 1 year 2 SDS belw the mean fr age and sex); OR Child has decreasing grwth rate cmbined with a predispsing cnditin such as previus cranial irradiatin r tumr; OR Child exhibits evidence f ther pituitary hrmne deficiencies r signs f cngenital GHD (hypglycemia, micrphallus) Turner Syndrme, Prader Willi Syndrme, SHOX, r Nnan s Syndrme: (Nnan Syndrme: Nrditrpin) (Prader-Willi Syndrme: Gentrpin, Omnitrpe) (Turner Syndrme: Gentrpin, Humatrpe, Nrditrpin, Nutrpin, Omnitrpe) (SHOX: Humatrpe) Updated: Octber 2015 Page 1

2 Pharmacy Prir Authrizatin Grwth Hrmne- Clinical Guidelines Prescribed by an Pediatric Endcrinlgist Dcumentatin and lab results t supprt diagnsis (e.g., Turner Syndrme cnfirmed by karytype studies, Prader-Willi Syndrme cnfirmed by genetic testing). AND ne f the fllwing: Child has severe grwth retardatin with height standard deviatin scre (SDS) mre than 3 SDS belw the mean fr chrnlgical age and sex; OR Child has mderate grwth retardatin with height SDS between -2 and -3 SDS belw the mean chrnlgical age and sex and decreased grwth rate (grwth velcity measured ver ne year belw 25th percentile fr age and sex); OR Child exhibits severe deceleratin in grwth rate (grwth velcity measured ver 1 year 2 SDS belw the mean fr age and sex) Chrnic Renal Insufficiency: (Nutrpin) Prescribed by a Pediatric Endcrinlgist r Pediatric Nephrlgist Dcumentatin t supprt diagnsis f CRI Patient has nt received a renal transplant Existing metablic abnrmalities (e.g., malnutritin, acidsis, secndary hyperparathyridism and hyperphsphatemia - crrect phsphrus t < 1.5 times the upper limit fr age) have been crrected. AND ne f the fllwing: Child has severe grwth retardatin with height standard deviatin scre (SDS) mre than 3 SDS belw the mean fr chrnlgical age and sex; OR Child has mderate grwth retardatin with height SDS between -2 and -3 SDS belw the mean chrnlgical age and sex and decreased grwth rate (grwth velcity measured ver ne year belw 25th percentile fr age and sex); OR Child exhibits severe deceleratin in grwth rate (grwth velcity measured ver 1 year 2 SDS belw the mean fr age and sex) Small fr Gestatinal Age (SGA): (Gentrpin, Humatrpe, Nrditrpin, Omnitrpe) Prescribed by a Pediatric Endcrinlgist Dcumentatin t supprt diagnsis defined as birth weight r length 2 r mre standard deviatins belw the mean fr gestatinal age. Child fails t manifest catch up grwth by age 2-4 years f age, defined as height 2 r mre standard deviatins belw the mean fr age and sex. Nte: Review must include evaluatin f grwth curves frm birth Adult Grwth Hrmne Deficiency (Adult-nset r childhd- nset): (Gentrpin, Humatrpe, Nrditrpin, Nutrpin, Omnitrpe, Saizen) Updated: Octber 2015 Page 2

3 Pharmacy Prir Authrizatin Grwth Hrmne- Clinical Guidelines Prescribed by an Endcrinlgist Lab results t supprt Baseline IGF-1 Dcumentatin t supprt diagnsis f Grwth Hrmne Deficiency f childhd nset (i.e., Idipathic/Islated GHD r MPHD) OR Grwth Hrmne Deficiency f adult-nset (i.e.,hypthalamic r pituitary disease, panhyppituitarism, cranial irradiatin, pituitary adenma, r aneurysmal subarachnid hemrrhage). Member is currently receiving treatment fr the pituitary deficient hrmne(s). Member has failed t respnd t at least tw GH stimulatin tests* [GH peak < 5 ng/ml during an insulin tlerance test r a crss-validated GH threshld in an equivalent test (grwth hrmne releasing hrmne, arginine, r glucagn)]. Nte: nly ne standard GH stimulatin test is required if member has lw IGF-1 (i.e., -2 SDS belw the mean). *Childhd-Onset Transitin patients: Retesting is recmmended after 1-3 mnth f GH treatment discntinuatin. Retesting is nt required fr patients with knwn mutatins, embrypathic cngenital defects, irreversible hypthalamic-pituitary structural lesins, panhyppituitarism (at least 3 pituitary deficiencies), and IGF-1 levels belw the mean fr age and sex. Fr cnditins such as Turner s Syndrme r ISS there is n prven benefit f cntinuing treatment int adulthd. **Adult-nset: Stimulatin test is nt required fr members with irreversible hypthalamic-pituitary structural lesins, panhyppituitarism (at least 3 pituitary deficiencies), and IGF-1 levels belw the mean fr age and sex. If GH deficiency is due t traumatic brain injury r aneurysmal subarachnid hemrrhage, GH defiency may be transient; therefre, GH stimulatin testing shuld be perfrmed at least 12 mnths after the event. Adult HIV Wasting/cachexia: (Serstim) Prescribed by r in cnsultatin with an infectius Disease Specialist Dcumentatin t supprt member s height, weight, r ideal bdy weight (IBW) Invluntary weight lss f > 10% f pre-illness baseline bdy weight r bdy mass index (BMI)< 20 kg/m2, in the absence f a cncurrent illness r medical cnditin ther than HIV infectin that may cause the weight lss. Member is receiving anti-retrviral therapy Member has tried and failed r is intlerant t megestrl Adults Shrt Bwel Syndrme: (Zrbtive) Age > 18 years f age Patient is receiving specialized nutritin supprt which may include dietary adjustments, enteral feedings, parental nutritin, fluid and macrnutrients (e.g. TPN r PPN) Initial Apprval Duratin: Adults and pediatrics indicatins- 6 mnths Shrt Bwel Syndrme (Zrbtive)- 4 weeks nly Updated: Octber 2015 Page 3

4 HIV wasting- 3 mnths Pharmacy Prir Authrizatin Grwth Hrmne- Clinical Guidelines Reauthrizatin - Pediatric Indicatins 6 mnths Dcumentatin required: Final height has nt been achieved N evidence f epiphyseal clsure Grwth velcity is > 5cm/year n current dse r < 5 cm/year with intended dse increase. (Nte: Grwth velcity will typically decrease as final height is apprached (grwth velcity <2 cm/year). Fr PWS: evidence f imprvement in bdy cmpsitin Nte: fr Chrnic Renal Insufficiency (CRI) there is insufficient data regarding the benefit f treatment beynd three years Criteria fr Discntinuatin in Children r Adlescent: Adult height has been reached Epiphyseal plate clsure Uncrrectable prblem with adherence Decline f height velcity f < 2.0 cm in the past year. Nte: At cmpletin f linear grwth (i.e., grwth rate less than 2 cm/year), available guidelines indicate that GH treatment shuld be stpped fr at least 3 mnths, and GH status shuld be re-assessed t determine whether cntinued GH treatment int adulthd is necessary. Reauthrizatin - Adult Indicatins Adults with GHD: 6 mnths if IGF-1 is lw but dse is being increased OR 1 year if IGF-1 is at a stable range Requires dcumentatin t supprt imprved respnse t treatment (i.e, BMI, lipid panel, bne density, r QOL) Adults with wasting due t HIV: (Serstim) 12 weeks (maximum 48 weeks) Requires dcumentatin t supprt respnse t therapy Adults with SBS: N renewals authrized Nn Cverage Criteria: Untreated Hypthyridism Diagnsis f Idipathic Shrt Stature (ISS) Off-label treatment fr anti-aging r perfrmance enhancement Children with clsed epiphyses Acute critical illness Active prliferative r severe nn-prliferative Diabetic Retinpathy Updated: Octber 2015 Page 4

5 Pharmacy Prir Authrizatin Grwth Hrmne- Clinical Guidelines Any hypersensitivity r cntraindicatins t smattrpin Children with PWS wh are severely bese r have severe respiratry impairment Additinal Infrmatin: SI Units = Cnventinal Units X 1 (mcg/l = ng/ml X 1) Stimulatin Test: Insulin Tlerance Test (ITT)is the gld standard, hwever it is cntraindicated in patients with seizures, CVD, r cerebrvascular disease Other peak values fr adults include Glucagn 3.0 mcg/l and ARG < 0.4 mcg/l References: 1. Ck D, Yuen K, Biller B et al. American Assciatin f Clinical Endcrinlgist Medical Guidelines fr Clinical Practice fr Grwth Hrmne use in Grwth Hrmne Deficient Adults and Transitin Patients-2009 Update. Endcrine Practice, 2009; 15(Suppl 2): Accessed nline Aug Serstim [Prescribing Infrmatin]. Rckland, MA Fster City, CA: EMD Sern, Inc.; June Gld Standard, Inc. Nrditrpin. Clinical pharmaclgy [database nline] Available at Accessed Aug, Nrditrpin [Prescribing Infrmatin]. Bagsvaerd, Denmar: Nv Nrdisk Aug Nutrpin [Prescribing Infrmatin]. San Francisc, CA: Genentech; June Accessed Aug Saizen [Prescribing Infrmatin]. Rckland, MA: EMD Sern Inc.; June Accessed Aug Serstim [Prescribing Infrmatin]. Rckland, MA: EMD Sern Inc.; June Accessed July Zrbtive[Prescribing Infrmatin]. Rckland, MA: EMD Sern Inc.; Jan Accessed Aug Omnitrpe [Prescribing Infrmatin]. Princetn, NJ: Sandz, Inc.; April Accessed July Humatrpe [Prescribing Infrmatin]. Indianaplis, IN: Lilly USA, LLC; April Accessed July Gentrpin [Prescribing Infrmatin]. Belgium N.V., Puurs, Belgium: Pfizer Manufacturing; May Accessed July Mlitch M, Clemmns DR, Malzwski S et al.; The Endcrine Sciety s Guideline. Evaluatin and Treatment f Adult Grwth Hrmne Deficiency: An Endcrine Sciety Clinical Practice Guideline. Clin Endcrinl Metab. 2006;91(5): Wilsn T, Rse S, Chenp et al.; Update f Guidelines fr the use f Grwth Hrmne in Children: The Lawsn Wilkins Pediatric Endcrinlgy Scienty Drug and Therapeutics Cmmittee. Jurnal f Pediatrics, Accessed nline Aug American Assciatin f Clinical Endcrinlgist. American Assciatin f Clinical Endcrinlgist medical guidelines fr clinical practice fr grwth hrmne use in adults and children 2003 update. Endcr Pract. 2003; 9: Gld Standard, Inc. Zmactn. Clinical pharmaclgy [database nline] Available at Accessed Sep, Updated: Octber 2015 Page 5