AETNA BETTER HEALTH Prior Authorization guideline for Growth Hormone

Transcription

1 AETNA BETTER HEALTH Prir Authrizatin guideline fr Grwth Hrmne Grwth Hrmne and related agents Frmulary:, Omnitrpe vials Nn-Frmulary - Gentrpin, Humatrpe,,Saizen, Serstim, Tev-Trpin, Valtrpin, Zrbtive (smatrpin), Nrditrpin, Nutrpin Increlex,(mecasermin), Authrizatin guidelines 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 Omnitrpe is cvered fr members that meet the fllwing indicatin specific criteria: I. Grwth Hrmne Deficiency in Children and Adlescents: Nte: Prvider must submit chart ntes that include the fllwing dcumentatin: weight, height, grwth velcity, and lab values (GH levels, IGF-1 / IGFBP-3), stim test results, bne age Grwth Hrmne will be apprved fr member wh meets all f the fllwing criteria at initiatin f treatment: Must be prescribed by r in cnsultatin with a Pediatric Endcrinlgist, Pediatric nephrlgist r Endcrinlgist Infant is less than 4 mnths f age and has grwth hrmne deficiency; OR Histry f nenatal hypglycemia assciated with pituitary disease; OR Diagnsis f pan hyppituitarism; OR Histry f irradiatin, surgery r trauma t hypthalamic-pituitary area; OR A defined CNS pathlgy cnfirmed by MRI r CT; OR Nte: MRI/CT shuld be dne t exclude a brain tumr (e.g., cranipharyngima). Patients with GHD have an abnrmality f the pituitary gland (e.g., ectpic bright spt, empty r small sella) Diagnsis f Pediatric GH deficiency cnfirmed by fllwing: Member must meet ne f the fllwing: Height: Height is > 2 SD belw mid parental height (prjected height); OR Height is > 2.25 SD belw ppulatin mean fr age and gender 1 Previus PARP Apprval: 12/2016 Current PARP Apprval: 11/2017

2 OR Grwth Velcity: GV is > 2 SD belw ppulatin mean fr age and gender OR Delayed skeletal maturatin(delayed bne age cnfirmed by X-ray): Bne age(ba) cmpared t chrnlgical age(ca) is equal t r greater than 2 SD belw mean fr age and gender (e.g., delayed mre than r equal t 2 years cmpared with chrnlgical age) Member must meet ONE f fllwing labratry results: Member has undergne TWO prvcative GH stimulatin test (e.g., Arginine, Clnidine, Glucagn, Insulin, Levdpa, GhRh) GH respnse values are less than 10 mcg/l; OR One abnrmal GH test is sufficient fr children with defined CNS pathlgy, multiple pituitary hrmne deficiency (MPHD), histry f irradiatin, r a genetic defect affecting the GH axis; OR Member is less than 1 year f age IGF-1 (insulin-like Grwth factr) r IGFBP-3 (Insulin Grwth Factr Binding Prtein-3) is belw the age and gender adjusted nrmal range as prvided by the physician s lab Epiphyses are pen (cnfirmatin f pen grwth plates in patients ver 12 years f age) Other pituitary hrmne deficiencies (e.g., hypthyridism, chrnic ischemic disease) have been ruled ut Prader-Willi Syndrme (PWS): Member must meet the fllwing fr initial apprval: Must be prescribed by r in cnsultatin with a Pediatric Endcrinlgist, Pediatric nephrlgist r Endcrinlgist; Diagnsis f Prader-Willi Syndrme (deletin in chrmsmal 15q11.2-q13 regin, maternal uniparental dismy in chrmsme 15, imprinting defects r translcatins invlving chrmsme 15) Grwth velcity: GV is > 2 SD belw ppulatin mean fr age and gender Epiphyses are pen (cnfirmatin f pen grwth plates in patients ver 12 years f age) Turner Syndrme (TS, gnadal Dysgenesis): Member must meet the fllwing fr initial apprval: Must be prescribed by r in cnsultatin with a Pediatric Endcrinlgist, Pediatric nephrlgist r Endcrinlgist Diagnsis f Turner Syndrme (karytype shwing a 45, XO gentype) Member is Female (> 2 years f age) and Bne age <14 years 2 Previus PARP Apprval: 12/2016 Current PARP Apprval: 11/2017

3 Grwth velcity: GV is > 2 SD belw ppulatin mean fr age and gender Epiphyses are pen (cnfirmatin f pen grwth plates in patients ver 12 years f age) Nnan Syndrme (NS): Member must meet the fllwing fr initial apprval: Must be prescribed by r in cnsultatin with a Pediatric Endcrinlgist, Pediatric nephrlgist r Endcrinlgist Diagnsis f Nn Syndrme Epiphyses are pen (cnfirmatin f pen grwth plates in patients ver 12 years f age) Bne age(ba) cmpared t chrnlgical age(ca) is equal t r greater than 2 SD belw mean fr age and gender (e.g., delayed mre than r equal t 2 years cmpared with chrnlgical age); OR Grwth velcity: GV > 2 SD belw ppulatin mean fr age and gender Shrt stature with SHOX (shrt stature hmebx-cntaining gene) deficiency (SHOXD): Member must meet the fllwing fr initial apprval: Must be prescribed by r in cnsultatin with a Pediatric Endcrinlgist, Pediatric nephrlgist r Endcrinlgist Diagnsis f pediatric grwth failure with shrt-stature hmebx (SHOX) gene deficiency as cnfirmed by genetic testing Epiphyses are pen (cnfirmatin f pen grwth plates in patients ver 12 years f age) Bne age(ba) cmpared t chrnlgical age(ca) is equal t r greater than 2 SD belw mean fr age and gender (e.g., delayed mre than r equal t 2 years cmpared with chrnlgical age); OR Grwth velcity: GV is > 2 SD belw ppulatin mean fr age and gender Grwth failure assciated with Chrnic Renal Insufficiency (CRI) r Chrnic Kidney disease (CKD) (up t the time f renal transplantatin): Member must meet the fllwing fr initial apprval: Must be prescribed by r in cnsultatin with a Pediatric Endcrinlgist, Pediatric nephrlgist r Endcrinlgist Diagnsis f pediatric grwth failure due t chrnic renal insufficiency (e.g., serum creatinine <30 mg/dl, up t the time f renal transplant) Bne age(ba) cmpared t chrnlgical age(ca) is equal t r greater than 2 SD belw mean fr age and gender (e.g., delayed mre than r equal t 2 years cmpared with chrnlgical age); OR Grwth velcity: GV is > 2 SD belw ppulatin mean fr age and gender 3 Previus PARP Apprval: 12/2016 Current PARP Apprval: 11/2017

4 Nte: Prir t initiatin f GH treatment, existing metablic derangements such as malnutritin, zinc deficiency, and secndary hyperparathyridism shuld be crrected. Grwth failure in Children Small fr Gestatinal Age (SGA): Nte: Prvider must submit chart ntes with that include the fllwing dcumentatin: GA, birth weight, height, and grwth chart Member must meet the fllwing fr initial apprval: Member is greater than 2 years f age Diagnsis f SGA (fetal grwth retardatin), child wh failed t catch up grwth in first 24 mnths f life (by 2 years f age) r with n catch up grwth using a 0-36 mnth grwth chart and shwing: Member is belw the 3 rd percentile fr gestatinal age (mre than 2 SD belw ppulatin mean) fr birth weight and length; Member s height remains belw the 3 rd percentile (mre than 2 SD belw ppulatin age and gender) Initial Apprval duratin: 12 mnths Renewal criteria fr GH therapy in Children: Nte: Prvider must submit dcumentatin fr renewal: previus height, current height and expected adult height gal. Member must meet the fllwing fr renewal apprval: Dcumentatin supprting psitive respnse t therapy: Height increase f at least 2.5cm/year (pst-pubertal grwth rate) r 4.5cm/year (pre-pubertal grwth rate) Expected final height is nt achieved Bne age is <16 years fr males; <14 years fr female; Grwth (epiphyseal) plates are still pen Fr children with PWS: Dcumentatin supprting psitive respnse t therapy (e.g., increase in ttal lean bdy mass, decrease in fat mass); OR abve renewal requirements. Renewal Apprval duratin: 12 mnths Discntinuatin criteria fr GH therapy in Children: Expected final adult height has been reached; OR Member had pr respnse t treatment, generally defined as an increase in GV f less than 50% frm baseline in the 1 st year f therapy; OR Increase in height velcity is less than 2 cm ttal grwth in 1 year f therapy; OR Epiphyseal fusin has ccurred; OR There are persistent and uncrrectable prblems with adherence t treatment 4 Previus PARP Apprval: 12/2016 Current PARP Apprval: 11/2017

5 Transitin Phase Adlescent patients Member must meet the fllwing fr initial apprval: Member has attained expected adult height Clsed epiphyses n bne radigraph Member is at high risk f GH deficiency due t childhd-nset GHD (COGHD) frm ne f fllwing: Hypthalamic-pituitary structural defect r tumr; OR At least 3 deficiency f anterir pituitary hrmnes (e.g., FSH/LH, TSH, ACTH, Prlactin), pan hyppituitarism; OR Genetic cause f GH IGF-1 (insulin-like Grwth factr) is belw the age and gender adjusted nrmal range as prvided by the physician s lab OR Member has stpped GH therapy fr at least ne mnth diagnsis f GHD has been recnfirmed by ONE f the fllwing: One lw IGF-1/IGFBP-3 and ne GH stim test with GH peak value f <10 mcg/ml; OR Tw GH stim tests with GH peak value f <10 mcg/ml Nte: Transitin Phase: Defined as perid f life starting in late puberty and ending with full adult maturatin ( frm mid t late teenage years until 6-7 years after achievement f final height) Adlescent: is a persn between ages f 10 and 19 as defined by WHO (wrld health rganizatin) There is n prven benefit t cntinuing GH treatment in adulthd fr childhd GH treatment f cnditins ther than GHD (e.g., Turner s syndrme) Initial Apprval duratin: 12 mnths Renewal criteria fr Transitin Phase Adlescent patients: Nte: Prvider must submit dcumentatin fr renewal: chart ntes, IGF-1 levels Member must meet the fllwing fr renewal apprval: Dcumentatin supprting psitive respnse t therapy (e.g., increased in ttal lean bdy mass, increased exercise capacity r increased IGF-1 levels) Renewal Apprval duratin: 12 mnths Adult Grwth Hrmne Deficiency: Nte: Prvider must submit dcumentatin supprting diagnsis, stim test results, IGF-1 levels. Member must meet the fllwing fr initial apprval: Diagnsis f childhd-nset GHD (COGHD); OR Diagnsis f Adult-nset GHD (AOGHD); 5 Previus PARP Apprval: 12/2016 Current PARP Apprval: 11/2017

6 Dcumentatin supprting hrmne deficiency is due t hypthalamic-pituitary disease frm rganic r knwn causes (e.g., damage frm surgery, cranial irradiatin, head trauma, r subarachnid hemrrhage); Member has undergne ONE prvcative GH stimulatin tests (e.g., ITT, Arginine+GHRH, glucagn, Arginine) cnfirming adult GH deficiency ne f fllwing peak values: Insulin tlerance test (ITT) 5 ng/ml Arginine+GHRH: 11 ng/ml if BMI < 25 kg/m2; 8 ng/ml if BMI 25 and <30 kg/m2; 4 ng/ml if BMI 30 kg/m2 Glucagn: 3 ng/ml Arginine: 0.4 ng/ml Nte: ITT is gld standard stimulatin test agent. ITT is cntraindicated with crnary artery disease, seizures, abnrmal EKG with histry f Ischemic heart disease r cardivascular disease, and nt apprpriate fr thse > age 60. Others shuld be used when ITT is cntraindicated. Glucagn has mre diagnstic accuracy. Arginine alne is rarely used. If arginine is used alne, a secnd stimulatin test may be required depending n IGF-1 levels. If the IGF-1 is subnrmal with presentatin f a hypthalamic disrder then ne stim test is required. If the IGF-1 is nrmal with hypthalamic disrder then TWO stim tests are required. OR; Member has at least 3 deficiency f anterir pituitary hrmnes (e.g., FSH/LH, TSH, ACTH, Prlactin), pan hyppituitarism; IGF-1 (insulin-like Grwth factr) is belw the age and gender adjusted nrmal range as prvided by the physician s lab Initial Apprval duratin: 12 mnths Renewal criteria fr Adult Grwth Hrmne deficiency: Nte: Prvider must submit dcumentatin fr renewal: chart ntes, IGF-1 levels Member must meet the fllwing criteria fr renewal apprval: Dcumentatin supprting psitive respnse t therapy (e.g., increased in ttal lean bdy mass, increased exercise capacity r increased IGF-1 levels) Renewal Apprval duratin: 12 mnths HIV-assciated Cachexia r Wasting: (Serstim nly) Nte: Prvider must submit dcumentatin f BMI, Weight, and IBW (prir t initiatin and after initiatin f Serstim fr renewals) Member must meet the fllwing fr initial apprval: Prescribed by r in cnsultatin with an infectius Disease r HIV Specialist; Currently n antiretrviral therapy; 6 Previus PARP Apprval: 12/2016 Current PARP Apprval: 11/2017

7 Inadequate respnse, intlerable side effects r cntraindicatin t megestrl acetate r drnabinl; Member has nt had weight lss due t ther causes (e.g., depressin, mycbacterium avium cmplex (MAC), chrnic infectius diarrhea, r malignancy with exceptin f Kapsi s sarcma limited t skin r mucus membranes); Bdy mass index (BMI) < 20 kg/m2 prir t initiating therapy with Serstim; OR Unintentinal weight lss f mre than 10% (>10%) ver last 12 mnths r mre than 5% (>5%) ver the last 6 mnths; OR Member weights less than 90% f the lwer limit f ideal bdy weight (IBW) Initial apprval duratin: 3 mnths Renewal criteria Member must meet the fllwing fr renewal apprval: Dcumentatin supprting psitive respnse t therapy (BMI has imprved r stabilized) Currently n antiretrviral therapy Renewal Apprval duratin: 9 mnths (Maximum ttal: 48 weeks) Shrt Bwel Syndrme: (Zrbtive nly) Member must meet the fllwing fr apprval: Diagnsis f Shrt Bwel syndrme; Member is 18 years r lder Patient is currently receiving specialized nutritin supprt (e.g., IV parenteral nutritin, fluid, and micrnutrient supplements) ; Member has nt previusly received 4 weeks f treatment with Zrbtive Initial Apprval: 4 weeks. Nte that treatment with Zrbtive will nt be apprved beynd 4 weeks as administratin fr mre than 4 weeks has nt been adequately studied. Additinal Infrmatin: Grwth Hrmne is NOT cvered fr members with the fllwing criteria: Amytrphic lateral sclersis Anablic therapy t enhance bdy mass r strength fr prfessinal, recreatinal r scial reasns Idipathic Shrt Stature (ISS)* Anti-aging Burn injuries Chrnic catablic states, including inflammatry bwel disease, pharmaclgic gluccrticid administratin, and respiratry failure Cnstitutinal delay f grwth and develpment Insulin-like grwth factr-i (IGF-1) deficiency (als knwn as neursecretry defect)russell-silver syndrme (that des nt result in small fr gestatinal age) Stem Cell mbilizatin Traumatic brain injury Wund healing 7 Previus PARP Apprval: 12/2016 Current PARP Apprval: 11/2017

8 *Aetna des nt cnsider Idipathic shrt stature (ISS) an illness, disease r injury therefre it is nt a cvered plan benefit. 8 Previus PARP Apprval: 12/2016 Current PARP Apprval: 11/2017

9 Medically Necessary A service r benefit is Medically Necessary if it is cmpensable under the MA Prgram and if it meets any ne f the fllwing standards: The service r benefit will, r is reasnably expected t, prevent the nset f an illness, cnditin r disability. The service r benefit will, r is reasnably expected t, reduce r amelirate the physical, mental r develpmental effects f an illness, cnditin, injury r disability. The service r benefit will assist the Member t achieve r maintain maximum functinal capacity in perfrming daily activities, taking int accunt bth the functinal capacity f the Member and thse functinal capacities that are apprpriate fr Members f the same age. Determinatin f Medical Necessity fr cvered care and services, whether made n a Prir Authrizatin, Cncurrent Review, Retrspective Review, r exceptin basis, must be dcumented in writing. The determinatin is based n medical infrmatin prvided by the Member, the Member s family/caretaker and the Primary Care Practitiner, as well as any ther Prviders, prgrams, agencies that have evaluated the Member. All such determinatins must be made by qualified and trained Health Care Prviders. A Health Care Prvider wh makes such determinatins f Medical Necessity is nt cnsidered t be prviding a health care service under this Agreement. 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 Gharib H, Ck DM, et.al. American assciatin f clinical endcrinlgists medical guidelines fr clinical practice fr grwth hrmne use in adults and children update. Endcrine Practice, 2003; 9(1): Richmnd EJ, Rgl AD. Diagnsis f grwth hrmne deficiency in children. UpTDate www. uptdate.cm. Accessed n 08/ Snyder, P. Grwth hrmne deficiency in adults. UpTDate. Accessed n 08/ Mandy, G. Small fr gestatinal age infant. UpTDate. Accessed n 08/ 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 2015 Page 9 Last Review: 10/2015 Previus PARP Apprval: 06/2015 Current PARP Apprval: 11/2018

10 11. 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 Sciety Drug and Therapeutics Cmmittee. Jurnal f Pediatrics, Accessed nline Aug Gld Standard, Inc. Zmactn. Clinical pharmaclgy [database nline] Available at Accessed Sep, Page 10 Last Review: 10/2015 Previus PARP Apprval: 06/2015 Current PARP Apprval: 11/2018