Proposed LCD - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses (DL33394)

Luteinizing Hormone-Releasing Hormone (LHRH) Analogs - NGShas approvedLeuprolide Acetate for the following:Carcinoma, breast (treatment): palliative treatment of advanced breast carcinoma in premenopausal and perimenopausal womenSuspected endometriosis causing chronic (6 months or more) pelvic pain after an appropriate pretreatment evaluation (to exclude other causes) and failure of initial treatment with OCs and NSAIDs; not to continue beyond 3 months if there is not significant symptomatic improvementHead and Neck cancers-salivary gland tumorsGoserelin Acetate -NGS has approvedGoserelin Acetate for the following:Treatment of leiomyomata: 3.6 mg per month for short duration (3-6 months).Paclitaxel (e.g., Taxol/Abraxane ) - NGS has approved paclitaxel for the following:Hormone refractory prostate carcinomaCarcinoma of the renal pelvis and ureterRhabdomyosarcomaLeiomyosarcomaGeneral InformationAssociated InformationN/ASources of InformationN/ABibliographyThis bibliography presents those sources that were obtained during the development of this policy. National Government Services is not responsible for the continuing viability of Web site addresses listed below.Decision Memo for Anticancer Chemotherapy for Colorectal Cancer (CAG-00179N), Appendix B, The Centers for Medicare and Medicaid Services, January 28, 2005.Based on a reconsideration the following sources have been added:Jacobsen PB, Bovbjerg DH, Redd WH. Anticipatory anxiety in women receiving chemotherapy for breast cancer.Health Psychology.1993;12(6):469-475.Osoba D, Zee B, Pater J, Warr D, Latreille J, Kaizer L. Determinants of postchemotherapy nausea and vomiting in patients with cancer.J Clin Oncol.1997;15(1):116-123.Petrella T, Clemons M, Joy A, Young S, Callaghan W, Dranitsaris G. Identifying patients at high risk for nausea and vomiting after chemotherapy: the development of a practical validated prediction tool.J Support Oncol.2009;7(4):W1-W8.Shih V, Wan HS, Chan A. Clinical predictors of chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant doxorubicin and cyclophosphamide.Ann Pharmacother.2009;43:444-452.Tsavaris N, Kosmas C, Mylonakis N, et al. Parameters that influence the outcome of nausea and emesis in cisplatin based chemotherapy.Anticancer Research.2000;20:4777-4784.Park T, Cave D, Marshall C. Microscopic colitis: A review of etiology, treatment and refractory disease.World J Gastroenterol. 2015;21(29):88804-88810.Verhaegh BPM, Mnch A, Guagnozzi D, et al, Course of Disease in Patients with Microscopic Colitis: A European Prospective Incident Cohort Study.Journal of Chrons and Colitis. 2021;15(7):1174-1183. .Burke KE, DAmato M, Ng SC, Pardi DS, Ludvigsson JF, Khalili H. Microscopic colitis.Nat Rev Dix Primers.2021;7:1-10.Shor J, Churrango G, Hosseini N, Marshall C. Management of microscopic colitis: challenges and solutions.Clinical and Experimental Gastroenterology.2019;12:111-120.Daferera N, Hjortsuvang H, Ignatova S, Mnch A.Single-centre experience with anti-tumour necrosis factor treatment in budesonide-refractory microscopic colitis patients.UEG Journal.2019;7(9):1234-1260.Miehlke S, Verhaeg B, Tontini GE, Madisch A, Langner C, Milnch A. Microscopic colitis: pathophysiology and clinical management.The Lancet Gastroenterology & Hepatology.2019;4(4):305-314.Boland K, Nguyen GC. Microscopic Colitis: A Review of Collagenous and Lymphocytic Colitis.Gastroenerology & Hepatology. 201713(11):671-677.Cotter TG, Kamboj AK, Hicks SB, Tremaine WJ, Loftus EV, Pardi DS. Immune modulator therapy for microscopic colitis in a case series of 73 patients.AP&T Alimentary Pharmacology & Therapeutics. 2017:1-6.Anderson RJ, Makins R. Successful use of adalimumab in patients with treatment-refractory microscopic colitis.BMJ Case Rep. 2016. Doi:1031136/bcr-2016-215639.Pola S, Fahmy M, Evans E, Tipps A, Sandborn WJ. Successful Use of Infliximab in the Treatment of Cortico-steroid Dependent Collagenous Colitis.American College of Gastroenterology. 2013.doi:10.1038ajg.2013.43.Barahona-Garrido J, Quionez NF, Cerda-Contreras E, Sarti HM, Tleiz-Avila F. Fosfomycin-Containing Second-Line Treatment for Helicobacter Pylori Infection.American College of Gastroenterology. 2013.doi:10.1038ajg.2013.48.Mnch A, Ignatova S, Strm M. Adalimumab in budesonide and methotrexate refractory collagenous colitis.Scandinavian Journal of Gastroenterology.2012;47:56-63.Esteve M, Mahadevan U, Sainz E, Rodrigez E, Salas A, Fernndez-Baares F. Efficacy of anti-TNF therapies in refractory severe microscopic colitis.Journal of Chrons and Colitis.2011;5:612-618.