Budget impact of pasireotide LAR for the treatment of acromegaly, a rare endocrine disorder

References

• Del Porto LA, Liubinas SV, Kaye AH. Treatment of persistent and recurrent acromegaly. J Clin Neurosci 2011;18:181-90
   PubMed Web of Science ®Google Scholar
• Holdaway IM, Rajasoorya C. Epidemiology of acromegaly. Pituitary 1999;2:29-41
   PubMedGoogle Scholar
• Burton T, Le Nestour E, Neary M, et al. Prevalence of acromegaly in a large US managed care population. ENDO. 2015;FRI-489.
   Google Scholar
• Ribeiro-Oliveira An, Jr, Barkan A. The changing face of acromegaly–advances in diagnosis and treatment. Nat Rev Endocrinol 2012;8:605-11
   PubMed Web of Science ®Google Scholar
• Holdaway IM. Excess mortality in acromegaly. Horm Res 2007;68(5 Suppl):166-72
   PubMedGoogle Scholar
• Dekkers OM, Biermasz NR, Pereira AM, et al. Mortality in acromegaly: a metaanalysis. J Clin Endocrinol Metab 2008;93:61-7
   PubMed Web of Science ®Google Scholar
• Ben-Shlomo A, Melmed S. Acromegaly. Endocrinol Metab Clin N Am 2008;37:101-22, viii
   PubMed Web of Science ®Google Scholar
• Didoni G, Grottol S, Gasco V, et al. Cost-of-illness study in acromegalic patients in Italy. J Endocrinol Invest 2004;27:1034-9
   PubMed Web of Science ®Google Scholar
• Orme SM, McNally RJQ, Cartwright RA, et al. Mortality and cancer incidence in acromegaly: a retrospective cohort study. J Clin Endocrinol Metab 1998;83:2730-4
   PubMed Web of Science ®Google Scholar
• Holdaway IM, Bolland MJ, Gamble GD. A meta-analysis of the effect of lowering serum levels of GH and IGF-I on mortality in acromegaly. Eur J Endocrinol 2008;159:89-95
   PubMed Web of Science ®Google Scholar
• Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2014;99:3933-51
   PubMed Web of Science ®Google Scholar
• Melmed S, Colao A, Barkan A, et al. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab 2009;94:1509-17
   PubMed Web of Science ®Google Scholar
• Katznelson L, Laws ER, Melmed S, et al. Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2014;99:3933-51
   PubMed Web of Science ®Google Scholar
• Giustina A, Bronstein MD, Casanueva FF, et al. Current management practices for acromegaly: an international survey. Pituitary 2011;14:125-33
   PubMed Web of Science ®Google Scholar
• Signifor LAR (pasireotide) for injectable suspension, for intramuscular use [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp, 2014
   Google Scholar
• Bureau of Labor Statistics. US Department of Labor. Consumer Price Index (CPI) for Medical Care Services (CUSR0000SAM2). 2014. http://www.bls.gov/cpi/. Accessed December 11, 2015
   Google Scholar
• Mauskopf JA, Sullivan SD, Annemans L, et al. Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices–budget impact analysis. Value Health 2007;10:336-47
   PubMed Web of Science ®Google Scholar
• Rosario PW. Frequency of acromegaly in adults with diabetes or glucose intolerance and estimated prevalence in the general population. Pituitary 2011;14:217-21
   PubMed Web of Science ®Google Scholar
• Daly AF, Rixhon M, Adam C, et al. High prevalence of pituitary adenomas: a cross-sectional study in the province of Liege, Belgium. J Clin Endocrinol Metab 2006;91:4769-75
   PubMed Web of Science ®Google Scholar
• Cannavo S, Ferrau F, Ragonese M, et al. Increased prevalence of acromegaly in a highly poluuted area. Eur J Endocrinol 2010;163:509-13
   PubMed Web of Science ®Google Scholar
• Schneider HJ, Sievers C, Saller B, et al. High prevalence of biochemical acromegaly in primary care patients with elevated IGF-1 levels. Clin Endocrinol 2008;69:432-5
   PubMed Web of Science ®Google Scholar
• Giustina A, Barkan A, Casanueva FF, et al. Criteria for cure of acromegaly: a consensus statement. J Clin Endocrinol Metab 2000;85:526-9
   PubMed Web of Science ®Google Scholar
• RedBook ReadyPrice Online. New York, NY: Thomson Reuters, 2010. http:// Q24 www.thomsonhc.com/micromedex2/librarian. Accessed 11 December, 2015
   Google Scholar
• Data on file. Internal Communication. Novartis Pharmaceuticals Corp, 2014
   Google Scholar
• Novartis Data on File. A Medical Chart Review to Study the Association between Biochemical Control and Comorbidity in Treated Acromegaly Patients. 2014
   Google Scholar
• Novartis. Budget impact analysis of Signifor in Cushing's disease. 2011:Data on File
   Google Scholar
• Somavert (pegvisomant for injection) [prescribing information]. New York, NY: Pfizer Inc, 2010
   Google Scholar
• Ben-Shlomo A, Sheppard MC, Stephens JM, et al. Clinical, quality of life, and economic value of acromegaly disease control. Pituitary 2011;14:284-94
   PubMed Web of Science ®Google Scholar
• Vilar L, Naves LA, Costa SS, et al. Increase of classic and nonclassic cardiovascular risk factors in patients with acromegaly. Endocr Pract 2007;13:363-72
   PubMedGoogle Scholar
• Colao A, Marzullo P, Ferone D, et al. Cardiovascular effects of depot long-acting somatostatin analog Sandostatin LAR in acromegaly. J Clin Endocrinol Metab 2000;85:3132-40
   PubMed Web of Science ®Google Scholar
• Colao A, Cannava S, Marzullo P, et al. Twelve months of treatment with octreotide-LAR reduces joint thickness in acromegaly. Eur J Endocrinol 2003;148:31-8
   PubMed Web of Science ®Google Scholar
• Bonadonna S, Mazziotti G, Nuzzo M, et al. Increased prevalence of radiological spinal deformities in active acromegaly: a cross-sectional study in postmenopausal women. J Bone Miner Res 2005;20:1837-44
   PubMed Web of Science ®Google Scholar
• Ciresi A, Amato MC, Pivonello R, et al. The metabolic profile in active acromegaly is gender-specific. J Clin Endocrinol Metab 2013;98:E51-9
   PubMed Web of Science ®Google Scholar
• Tzanela M, Vassiliadi DA, Gavalas N, et al. Glucose homeostasis in patients with acromegaly treated with surgery or somatostatin analogues. Clin Endocrinol (Oxf) 2011;75:96-102
   PubMed Web of Science ®Google Scholar
• Fleck J, Pedroncelli A, Kodama L, et al. A phase III, multicenter, randomized, parallel-group study to assess the efficacy and safety of double-blind pasireotide LAR 40 mg and pasireotide LAR 60 mg versus open-label octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly (CSR Study No. CSOM230C2402). Novartis, 2013
   Google Scholar
• Gadelha MR, Bronstein MD, Brue T, et al. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial. Lancet Diabetes Endocrinol 2014;2(1);875-884.
   PubMed Web of Science ®Google Scholar
• Broder MS, Neary MP, Chang E, et al. Treatments, complications, and healthcare utilization associated with acromegaly: a study in two large United States databases. Pituitary 2014;17:333-41
   PubMed Web of Science ®Google Scholar
• Truong HL, Nellesen D, Ludlam WH, et al. Budget impact of pasireotide for the treatment of Cushing's disease, a rare endocrine disorder associated with considerable comorbidities. J Med Econ 2014;17:288-95
   PubMedGoogle Scholar
• Greenstone LLC. Cabergoline (tablet) [prescribing information]. Peapack, NJ: Greenstone LLC, December, 2017.
   Google Scholar
• Centers for Medicare and Medicaid Services (CMS). Medicare Physician Fee Schedule. 2011.
   Google Scholar
• Acromegaly. National Endocrine and Metabolic Diseases Information Service. NIH, 2008. Publication No. 08-3924. http://www.endocrine.niddk.nih.gov/pubs/acro/acro.aspx. Accessed December 11, 2015
   Google Scholar
• Novartis Data on File. Acromegaly Treatment Flow Analysis. 2014
   Google Scholar
• Davi MV, Dalle Carbonare L, Giustina A, et al. Sleep apnoea syndrome is highly prevalent in acromegaly and only partially reversible after biochemical control of the disease. Eur J Endocrinol 2008;159:533-40
   PubMed Web of Science ®Google Scholar
• RedBook ReadyPrice Online. New York, NY: Thomson Reuters, 2010. http://www.thomsonhc.com/micromedex2/librarian. Accessed December 11, 2015
   Google Scholar
• Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics 2011. Circulation 2011;123:e18â-e18â
   Google Scholar
• Ray GT, Collin F, Lieu T, et al. The cost of health conditions in a health maintenance organization. Med Care Res Rev 2000;57:92-109
   PubMed Web of Science ®Google Scholar
• Tosteson AN, Burge RT, Marshall DA, et al. Therapies for treatment of osteoporosis in US women: cost-effectiveness and budget impact considerations. Am J Manag Care 2008;14:605-605
   PubMed Web of Science ®Google Scholar