Erythropoiesis Stimulating Agents (ESAs): Aranesp (darbepoetin alfa) Related Medical Guideline Off-Label Use of FDA-Approved Drugs and Biologicals

Transcription

1 (Subcutaneus/Intravenus) Last Review Date: January 1, 2019 Number: MG.MM.PH.80 *NON-DIALYSIS* Medical Guideline Disclaimer C All rights reserved. The treating physician r primary care prvider must submit t EmblemHealth the clinical evidence that the patient meets the criteria fr the treatment r surgical prcedure. Withut this dcumentatin and infrmatin, EmblemHealth will nt be able t prperly review the request fr prir authrizatin. The clinical review criteria expressed belw reflects hw EmblemHealth determines whether certain services r supplies are medically necessary. EmblemHealth established the clinical review criteria based upn a review f currently available clinical infrmatin (including clinical utcme studies in the peer-reviewed published medical literature, regulatry status f the technlgy, evidence-based guidelines f public health and health research agencies, evidence-based guidelines and psitins f leading natinal health prfessinal rganizatins, views f physicians practicing in relevant clinical areas, and ther relevant factrs). EmblemHea lth expressly reserves the right t revise these cnclusins as clinical infrmatin changes, and welcmes further relevant infrmatin. Each benefit prgram defines which services are cvered. The cnclusin that a particular service r supply is medically necessary d es nt cnstitute a representatin r warranty that this service r supply is cvered and/r paid fr by EmblemHealth, as sme prgrams exclude cverage fr services r supplies that EmblemHealth cnsiders medically necessary. If there is a discrepancy between this guideline and a member's benefits prgram, the benefits prgram will gvern. In additin, cverage may be mandated by applicable legal requirements f a state, the Federal Gvernment r the Centers fr Medicare & Medicaid Services (CMS) fr Medicare and Medicaid members. All cding and web site links are accurate at time f publicatin. EmblemHealth Services Cmpany LLC, ( EmblemHealth ) has adpted the herein plicy in prviding management, administrative and ther services t HIP Health Plan f New Yrk, HIP Insurance Cmpany f New Yrk, Grup Health Incrprated and GHI HMO Select, related t health benefit plans ffered by these entities. All f the afrementined entities are affiliated cmpanies under cmmn cntrl f EmblemHealth Inc. Related Medical Guideline Off-Label Use f FDA-Apprved Drugs and Bilgicals LENGTH OF AUTHORIZATION Cverage will be prvided fr 60 daysand may be renewed. DOSING LIMITS Max Units (per dse and ver time) [Medical Benefit]: MDS r MPN (J0881 nly): 900 billable units every 21 days All ther indicatins: 600 billable units every 21 days Guideline I. INITIAL APPROVAL CRITERIA Lab values are btained within 30 days f the date f administratin (unless therwise indicated); AND Prir t initiatin f therapy, patient shuld have adequate irn stres as demnstrated by serum ferritin 100 ng/ml (mcg/l) and transferrin saturatin (TSAT) 20%*; AND Initiatin f therapy Hemglbin (Hb) < 10 g/dl and/r Hematcrit (Hct) < 30%; AND Other causes f anemia (e.g. hemlysis, bleeding, vitamin deficiency, etc.) have been ruled ut; AND Aranesp is cvered fr the fllwing indicatin(s): Anemia secndary t myeldysplastic syndrme (MDS)

2 Page 2 f 6 Treatment f lwer risk disease assciated with symptmatic anemia; AND Endgenus serum erythrpietin level f 500 munits/ml Anemia secndary t Myelprliferative Neplasms (MPN) - Myelfibrsis Endgenus serum erythrpietin level f < 500 munits/ml Anemia secndary t Hepatitis C treatment Patient must be receiving interfern AND ribavirin Anemia secndary t chemtherapy treatment Patient is receiving cncurrent myelsuppressive chemtherapy; AND Patient s chemtherapy is nt intended t cure their disease (i.e., palliative treatment); AND There are a minimum f tw additinal mnths f planned chemtherapy Anemia secndary t chrnic kidney disease (nn-dialysis patients) FDA apprved indicatins; Cmpendium apprved indicatins II. RENEWAL CRITERIA Cverage can be renewed based upn the fllwing criteria: Last dse less than 60 days ag; AND Disease respnse; AND Absence f unacceptable txicity frm the drug. Examples include pure red cell aplasia, severe allergic reactins (anaphylaxis, angiedema, brnchspasm, etc), severe cardivascular events (strke, mycardial infarctin, cngestive heart failure, thrmbemblism, uncntrlled hypertensin), seizures, increased risk f tumr prgressin/recurrence in patients with cancer, etc.; AND Lab values are btained within 30 days f the date f administratin (unless therwise indicated); AND Adequate irn stres as demnstrated by serum ferritin 100 ng/ml (mcg/l) and transferrin saturatin (TSAT) 20% measured within the previus 3 mnths*; AND Other causes f anemia (e.g., hemlysis, bleeding, vitamin deficiency, etc.) have been ruled ut; AND Anemia secndary t myeldysplastic syndrme (MDS): Hemglbin (Hb) < 12 g/dl and/r Hematcrit (Hct) < 36% Anemia secndary t myelprliferative neplasms (MF, pst-pv myelfibrsis, pst-et myelfibrsis) Hemglbin (Hb) < 10 g/dl and/r Hematcrit (Hct) < 30%

3 Page 3 f 6 Anemia secndary t chemtherapy treatment Hemglbin (Hb) < 10 g/dl and/r Hematcrit (Hct) < 30%; AND Patient is receiving cncurrent myelsuppressive chemtherapy; AND There are a minimum f tw additinal mnths f planned chemtherapy Anemia secndary t chrnic kidney disease: Pediatric patients: Hemglbin (Hb) < 12 g/dl and/r Hematcrit (Hct) < 36% Adults: Hemglbin (Hb) < 11 g/dl and/r Hematcrit (Hct) < 33% Anemia secndary t Hepatitis C treatment: Hemglbin (Hb) < 11 g/dl and/r Hematcrit (Hct) < 33%; AND Patient must be receiving interfern AND ribavirin * Intravenus irn supplementatin may be taken int accunt when evaluating irn status Limitatins/Exclusins Aranesp is nt cnsidered medically necessary fr indicatins ther than thse listed abve due t insufficient evidence f therapeutic value. Applicable Prcedure Cdes J0881 Injectin, darbepetin alfa, 1 micrgram (nn-esrd use) = 1 billable unit Applicable NDCs Single-dse Vial Single-dse Prefilled Syringe 1 Vial/Pack, 4 Packs/Case 1 Syringe/Pack, 4 Packs/Case 200 mcg/1 ml mcg/0.4 ml mcg/1 ml mcg/0.6 ml mcg/1 ml Vials/Pack, 10 Packs/Case 4 Syringes/Pack, 10 Packs/Case 25 mcg/1 ml mcg/0.4 ml mcg/1 ml mcg/0.42 ml mcg/1 ml mcg/0.4 ml mcg/1 ml mcg/0.3 ml mcg/0.75 ml mcg/0.5 ml mcg/0.3 ml Applicable Diagnsis Cdes B18.2 Chrnic viral hepatitis C B19.20 Unspecified viral hepatitis C withut hepatic cma C92.10 Chrnic myelid leukemia, BCR/ABL-psitive, nt having achieved remissin C93.10 Chrnic myelmncytic leukemia, nt having achieved remissin C94.40 Acute panmyelsis with myelfibrsis nt having achieved remissin C94.41 Acute panmyelsis with myelfibrsis in remissin

4 Page 4 f 6 C94.42 Acute panmyelsis with myelfibrsis in relapse C94.6 Myeldysplastic disease, nt classified D46.0 Refractry anemia withut ring siderblasts, s stated D46.1 Refractry anemia with ring siderblasts D46.20 Refractry anemia with excess f blasts, unspecified D46.21 Refractry anemia with excess f blasts 1 D46.4 Refractry anemia, unspecified D46.9 Myeldysplastic syndrme, unspecified D46.A Refractry cytpenia with multilineage dysplasia D46.B Refractry cytpenia with multilineage dysplasia and ring siderblasts D46.C Myeldysplastic syndrme with islated del(5q) chrmsmal abnrmality D46.Z Other myeldysplastic syndrmes D47.1 Malignant neplasm f peripheral nerves f upper limb, including shulder D47.4 Malignant neplasm f peripheral nerves f abdmen D61.1 Drug-induced aplastic anemia D61.2 Aplastic anemia due t ther external agent D63.0 Anemia in neplastic disease D63.1 Anemia in chrnic kidney disease D63.8 Anemia in ther chrnic diseases classified elsewhere D64.81 Anemia due t antineplastic chemtherapy D64.9 Anemia unspecified D75.81 Secndary plycythemia I12.0 Hypertensive chrnic kidney disease with stage 5 chrnic kidney disease r end stage renal disease Hypertensive chrnic kidney disease with stage 1 thrugh stage 4 chrnic kidney disease, r I12.9 unspecified chrnic kidney disease Hypertensive heart and chrnic kidney disease with heart failure and stage 1 thrugh stage 4 I13.0 chrnic kidney disease, r unspecified chrnic kidney disease Hypertensive heart and chrnic kidney disease withut heart failure, with stage 1 thrugh stage 4 I13.10 chrnic kidney disease, r unspecified chrnic kidney disease Hypertensive heart and chrnic kidney disease withut heart failure, with stage 5 chrnic kidney I13.11 disease, r end stage renal disease Hypertensive heart and chrnic kidney disease with heart failure and with stage 5 chrnic kidney I13.2 disease, r end stage renal disease N18.1 Chrnic kidney disease, stage 1 N18.2 Chrnic kidney disease, stage 2 (mild) N18.3 Chrnic kidney disease, stage 3 (mderate) N18.4 Chrnic kidney disease, stage 4 (severe) N18.5 Chrnic kidney disease, stage 5 N18.6 End stage renal disease N18.9 Chrnic kidney disease, unspecified Z51.11 Encunter fr antineplastic chemtherapy Z51.89 Encunter fr ther specified aftercare DUAL CODING REQUIREMENTS: J0881 must be billed in cnjunctin with BOTH D63.1 AND ne f the I r N series f cdes fr CKD nt n dialysis J0881 must be billed in cnjunctin with BOTH D63.8 OR D64.9 AND ne f the B series f cdes fr anemia due t HCV Revisin Histry N/A References

5 Page 5 f 6 1. Aranesp [package insert] Thusand Oaks, CA; Amgen Inc; January Accessed March Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) darbepetin alfa. Natinal Cmprehensive Cancer Netwrk, The NCCN Cmpendium is a derivative wrk f the NCCN Guidelines. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, and NCCN GUIDELINES are trademarks wned by the Natinal Cmprehensive Cancer Netwrk, Inc. T view the mst recent and cmplete versin f the Cmpendium, g nline t NCCN.rg. Accessed March Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) Cancer-and Chemtherapy-Induced Anemia Versin Natinal Cmprehensive Cancer Netwrk, The NCCN Cmpendium is a derivative wrk f the NCCN Guidelines. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, and NCCN GUIDELINES are trademarks wned by the Natinal Cmprehensive Cancer Netwrk, Inc. T view the mst recent and cmplete versin f the Cmpendium, g nline t NCCN.rg. Accessed March Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) Myeldysplastic Syndrme Versin Natinal Cmprehensive Cancer Netwrk, The NCCN Cmpendium is a derivative wrk f the NCCN Guidelines. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, and NCCN GUIDELINES are trademarks wned by the Natinal Cmprehensive Cancer Netwrk, Inc. T view the mst recent and cmplete versin f the Cmpendium, g nline t NCCN.rg. Accessed March Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) Myelprliferative Neplasms Versin Natinal Cmprehensive Cancer Netwrk, The NCCN Cmpendium is a derivative wrk f the NCCN Guidelines. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, and NCCN GUIDELINES are trademarks wned by the Natinal Cmprehensive Cancer Netwrk, Inc. T view the mst recent and cmplete versin f the Cmpendium, g nline t NCCN.rg. Accessed March Yunssi ZM, Nader FH, Bai C, et al. A phase II dse finding study f darbepetin alpha and filgrastim fr the management f anaemia and neutrpenia in chrnic hepatitis C treatment. Jurnal f Viral Hepatitis 2008; 15(5): Cervantes F, Alvarez-Laran A, Hernandez-Bluda JC, et al. Darbepetin-alpha fr the anaemia f myelfibrsis with myelid metaplasia. British Jurnal f Haematlgy, 134: di: /j x 8. Wiscnsin Physicians Service Insurance Crpratin. Lcal Cverage Determinatin (LCD): Erythrpiesis Stimulating Agents (ESAs) (L34633). Centers fr Medicare & Medicaid Services, Inc. Updated n 09/20/2017 with effective dates 10/1/2017. Accessed March CGS Administratrs, Inc. Lcal Cverage Determinatin (LCD): Erythrpiesis Stimulating Agents (ESAs) (L34356). Centers fr Medicare & Medicare Services. Updated n 02/26/2018 with effective dates 10/01/2017. Accessed March 2018.

6 Page 6 f First Cast Service Optins, Inc. Lcal Cverage Determinatin (LCD): Erythrpiesis Stimulating Agents (ESAs) (L36276). Centers fr Medicare & Medicare Services. Updated n 02/22/2018 with effective dates 02/08/2018. Accessed March Natinal Cverage Determinatin (NCD); Erythrpiesis Stimulating Agents (ESAs) in Cancer and Related Neplastic Cnditins (110.21). Centers fr Medicare & Medicaid Services, Inc. Updated n 12/3/2015 with effective dates 10/01/2015. Accessed March 2018.