Sandstatin LAR (ctretide suspensin) Dcument Number: IC-0111 Last Review Date: 02/06/2018 Date f Origin: 06/21/2011 Dates Reviewed: 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 01/2015, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018 I. Length f Authrizatin Cverage is prvided fr six mnths and may be renewed. II. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: 10 mg kit: 1 per 28 days 20 mg kit: 2 per 28 days 30 mg kit: 1 per 28 days B. Max Units (per dse and ver time) [Medical Benefit]: 40 units every 28 days III. Initial Apprval Criteria Cverage is prvided in the fllwing cnditins: Patient is at least 18 years ld; AND Carcinid tumrs/neurendcrine tumrs (e.g. GI tract, Lung, Thymus, Pancreas, Adrenal) Patient has severe diarrhea/flushing episdes (carcinid syndrme) ; OR Used fr tumr cntrl f unresectable and/r metastatic tumr; OR Symptm cntrl f smatstatin-receptr psitive adrenal gland tumr; OR Used t treat symptms related t hrmne hypersecretin in pancreatic tumrs; OR Primary treatment f unresected primary gastrinma Diarrhea assciated with Vasactive intestinal peptide tumrs (VIPmas) [pancreatic neurendcrine (islet cell) tumr, insulinma, glucagnma, smatstatinma, and gastrinma] Patient has prfuse watery diarrhea Acrmegaly Baseline grwth hrmne (GH) and IGF-I bld levels (renewal will require reprting f current levels); AND Patient has dcumented inadequate respnse t surgery and/r raditherapy; OR Mda Health Plan, Inc. Medical Necessity Criteria Page 1/5
Surgery and/r raditherapy is nt an ptin fr this patient Meningimas (CNS Cancers) Patient s disease is unresectable; AND Patient s disease is recurrent r prgressive meningima; AND Radiatin treatment is nt pssible fr the patient s disease Thymic Carcinmas/Thymmas Must be used as secnd-line therapy with r withut prednisne FDA Apprved Indicatin(s); Cmpendia recmmended indicatin(s) IV. Renewal Criteria Patient cntinues t meet criteria identified in sectin III; AND Absence f unacceptable txicity frm the drug. Examples f unacceptable txicity include the fllwing: biliary tract abnrmalities, hypthyridism, giter, sinus bradycardia, cardiac arrhythmias, cardiac cnductin abnrmalities, pancreatitis, etc.; AND Disease respnse with imprvement in patient s symptms including reductin in symptmatic episdes (such as diarrhea, rapid gastric dumping, flushing, bleeding, etc) and/r stabilizatin f glucse levels and/r decrease in size f tumr r tumr spread; OR Acrmegaly ONLY: Disease respnse indicated by reductin f grwth hrmne (GH) and/r IGF-I bld levels frm baseline V. Dsage/Administratin Indicatin Acrmegaly Carcinid Tumrs and VIPmas Dse 20 mg intramuscularly every 4 weeks (after 3 mnths f therapy, dses may be titrated up if required with a maximum dse f 40 mg every 4 weeks) 20 mg intramuscularly every 4 weeks (after 2 mnths f therapy, dses may be titrated up if required with a maximum dse f 40 mg every 4 weeks) All Other Indicatins Up t 40 mg intramuscularly every 28 days VI. Billing Cde/Availability Infrmatin Jcde: J2353- Injectin, ctretide, dept frm fr intramuscular injectin, 1 mg: 1 mg = 1 billable unit NDC: 10 mg single-use kit: 00078-0811-XX 20 mg single-use kit: 00078-0818-XX 30 mg single-use kit: 00078-0825-XX Mda Health Plan, Inc. Medical Necessity Criteria Page 2/5
VII. References 1. Sandstatin LAR [package insert]. East Hanver, NJ; Nvartis Pharmaceuticals Crpratin; July 2016. Accessed January 2018. 2. Giustina A, Chansn P, Kleinberg D, et al. Expert cnsensus dcument: A cnsensus n the medical treatment f acrmegaly. Nat Rev Endcrinl. 2014 Apr; 10(4):243-8. di: 10.1038/nrend.2014.21. Epub 2014 Feb 25. 3. Katznelsn L, Laws ER Jr, Melmed S, et al. Acrmegaly: an endcrine sciety clinical practice guideline. J Clin Endcrinl Metab. 2014 Nv; 99(11):3933-51. di: 10.1210/jc.2014-2700. Epub 2014 Oct 30. 4. Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) fr Octretide. Natinal Cmprehensive Cancer Netwrk, 2018. 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 January 2018. 5. Palmett GBA. Lcal Cverage Determinatin (LCD): Octretide Acetate fr Injectable Suspensin (Sandstatin LAR dept) (L33438). Centers fr Medicare & Medicaid Services, Inc. Updated n 12/7//2017 with effective date 2/26/2018. Accessed January 2018. Appendix 1 Cvered Diagnsis Cdes ICD-10 C25.4 Malignant neplasm f endcrine pancreas C37 Malignant neplasm f thymus C70.0 Malignant neplasm f cerebral meninges C70.1 Malignant neplasm f spinal meninges C70.9 Malignant neplasm f meninges, unspecified C7A.00 C7A.010 C7A.011 C7A.012 C7A.019 C7A.020 C7A.021 C7A.022 C7A.023 C7A.024 C7A.025 C7A.026 C7A.029 C7A.090 C7A.091 C7A.092 Malignant carcinid tumr f unspecified site Malignant carcinid tumr f the dudenum Malignant carcinid tumr f the jejunum Malignant carcinid tumr f the ileum ICD-10 Descriptin Malignant carcinid tumr f the small intestine, unspecified prtin Malignant carcinid tumr f the appendix Malignant carcinid tumr f the cecum Malignant carcinid tumr f the ascending cln Malignant carcinid tumr f the transverse cln Malignant carcinid tumr f the descending cln Malignant carcinid tumr f the sigmid cln Malignant carcinid tumr f the rectum Malignant carcinid tumr f the large intestine, unspecified prtin Malignant carcinid tumr f the brnchus and lung Malignant carcinid tumr f the thymus Malignant carcinid tumr f the stmach Mda Health Plan, Inc. Medical Necessity Criteria Page 3/5
ICD-10 ICD-10 Descriptin C7A.093 Malignant carcinid tumr f the kidney C7A.094 Malignant carcinid tumr f the fregut, unspecified C7A.095 Malignant carcinid tumr f the midgut, unspecified C7A.096 Malignant carcinid tumr f the hindgut, unspecified C7A.098 Malignant carcinid tumrs f ther sites C7A.1 Malignant prly differentiated neurendcrine tumrs C7A.8 Other malignant neurendcrine tumrs C7B.00 Secndary carcinid tumrs, unspecified site C7B.01 Secndary carcinid tumrs f distant lymph ndes C7B.02 Secndary carcinid tumrs f liver C7B.03 Secndary carcinid tumrs f bne C7B.04 Secndary carcinid tumrs f peritneum C7B.09 Secndary carcinid tumrs f ther sites D15.0 Benign neplasm f thymus D32.0 Benign neplasm f cerebral meninges D32.1 Benign neplasm f spinal meninges D32.9 Benign neplasm f meninges, unspecified D3A.00 Benign carcinid tumr f unspecified site D3A.010 Benign carcinid tumr f the dudenum D3A.011 Benign carcinid tumr f the jejunum D3A.012 Benign carcinid tumr f the ileum D3A.019 Benign carcinid tumr f the small intestine, unspecified prtin D3A.020 Benign carcinid tumr f the appendix D3A.021 Benign carcinid tumr f the cecum D3A.022 Benign carcinid tumr f the ascending cln D3A.023 Benign carcinid tumr f the transverse cln D3A.024 Benign carcinid tumr f the descending cln D3A.025 Benign carcinid tumr f the sigmid tumr D3A.026 Benign carcinid tumr f the rectum D3A.029 Benign carcinid tumr f the large intestine, unspecified prtin D3A.090 Benign carcinid tumr f the brnchus and lung D3A.091 Benign carcinid tumr f the thymus D3A.092 Benign carcinid tumr f the stmach D42.0 Neplasm f uncertain behavir f cerebral meninges D42.1 Neplasm f uncertain behavir f spinal meninges D42.9 Neplasm f uncertain behavir f meninges, unspecified E16.1 Other hypglycemia E16.3 Increased secretin f glucagn E16.4 Increased secretin f gastrin E16.8 Other specified disrders f pancreatic internal secretin E22.0 Acrmegaly and pituitary gigantism Mda Health Plan, Inc. Medical Necessity Criteria Page 4/5
ICD-10 E24.8 Other Cushing s syndrme E34.0 Carcinid syndrme ICD-10 Descriptin Z85.020 Persnal histry f malignant carcinid tumr f stmach Z85.030 Persnal histry f malignant carcinid tumr f large intestine Z85.040 Persnal histry f malignant carcinid tumr f rectum Z85.060 Persnal histry f malignant carcinid tumr f small intestine Z85.07 Persnal histry f malignant neplasm f pancreas Z85.110 Persnal histry f malignant carcinid tumr f brnchus and lung Z85.841 Persnal histry f malignant neplasm f brain Z85.848 Persnal histry f malignant neplasm f ther parts f nervus system Z85.858 Persnal histry f malignant neplasm f ther endcrine glands Appendix 2 Centers fr Medicare and Medicaid Services (CMS) Medicare cverage fr utpatient (Part B) drugs is utlined in the Medicare Benefit Plicy Manual (Pub. 100-2), Chapter 15, 50 Drugs and Bilgicals. In additin, Natinal Cverage Determinatin (NCD) and Lcal Cverage Determinatins (LCDs) may exist and cmpliance with these plicies is required where applicable. They can be fund at: http://www.cms.gv/medicare-cveragedatabase/search/advanced-search.aspx. Additinal indicatins may be cvered at the discretin f the health plan. Medicare Part B Cvered Diagnsis Cdes (applicable t existing NCD/LCD): Jurisdictin(s): M NCD/LCD Dcument (s): L33438 https://www.cms.gv/medicare-cverage-database/search/lcd-datesearch.aspx?dcid=l33438&bc=gaaaaaaaaaaaaa== Medicare Part B Administrative Cntractr (MAC) Jurisdictins Jurisdictin Applicable State/US Territry Cntractr E (1) CA, HI, NV, AS, GU, CNMI Nridian Healthcare Slutins, LLC F (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Nridian Healthcare Slutins, LLC 5 KS, NE, IA, MO Wiscnsin Physicians Service Insurance Crp (WPS) 6 MN, WI, IL Natinal Gvernment Services, Inc. (NGS) H (4 & 7) LA, AR, MS, TX, OK, CO, NM Nvitas Slutins, Inc. 8 MI, IN Wiscnsin Physicians Service Insurance Crp (WPS) N (9) FL, PR, VI First Cast Service Optins, Inc. J (10) TN, GA, AL Palmett GBA, LLC M (11) NC, SC, WV, VA (excluding belw) Palmett GBA, LLC L (12) DE, MD, PA, NJ, DC (includes Arlingtn & Fairfax cunties and the city f Alexandria in VA) Nvitas Slutins, Inc. K (13 & 14) NY, CT, MA, RI, VT, ME, NH Natinal Gvernment Services, Inc. (NGS) 15 KY, OH CGS Administratrs, LLC Mda Health Plan, Inc. Medical Necessity Criteria Page 5/5