Abstract
Purpose
Gout is a chronic disease characterized by the deposition of urate crystals in the
joints and throughout the body, caused by an excess burden of serum uric acid (sUA).
The study estimates pharmacy and medical cost budgetary impacts of wider adoption
by US payers of febuxostat, a urate-lowering therapy (ULT) for the treatment of gout.
Methods
A US payer-perspective budget impact model followed ULT patients from a 1,000,000-member
plan over 3 years. The current market share scenario, febuxostat (6%) and ULT allopurinol
(94%), was compared with an 18% febuxostat market share. Data were implemented from
randomized controlled trials, census and epidemiologic studies, and real-world database
analyses. An innovation was the inclusion of gout-related chronic kidney disease costs.
Cost results were estimated as annual and cumulative incremental costs, expressed
as total costs, cost per member per month, and cost per treated member per month.
Clinical results were also estimated.
Findings
Increasing the febuxostat market share resulted in a 6.3% increase in patients achieving
the sUA target level of <6.0 mg/dL and a 1.4% reduction in gout flares during the
3-year period. Total cost increased 1.4%, with a 49.9% increase in ULT costs, a 1.4%
reduction in flare costs, a 1.2% reduction in chronic kidney disease costs, and a
2.8% reduction in gout care costs. The cumulative incremental costs were $1,307,425
in the first year, $1,939,016 through the second year, and $2,092,744 through the
third year. By the third year, savings in medical costs offset most of the increase
in treatment costs. Impacts on cumulative cost per member per month and cumulative
cost per treated member per month followed the same pattern, with the highest impact
in the first year and cumulative impacts declining during the 3-year period. The cumulative
cost per member per month impact was estimated as $0.109, $0.081, and $0.058 and the
cumulative cost per treated member per month impact was estimated as $12.416, $9.207,
and $6.625 in the first year, through the second year, and through the third year,
respectively.
Implications
Expanding the febuxostat market share would result in improved clinical outcomes,
but with an overall increase in costs over 3 years due to higher costs of treatment.
By the third year, savings in medical costs, primarily in chronic kidney disease costs,
would offset most of the increase in treatment costs. Expanded use of febuxostat in
the treatment of all gout patients, independent of renal impairment status, should
be considered based on improved clinical outcomes and longer-term medical cost savings
associated with these improved outcomes.
Key words
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Clinical TherapeuticsAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Rising burden of gout in the UK but continuing suboptimal management: a nationwide population study.Ann Rheum Dis. 2015; 74: 661-667
- New insights into the epidemiology of gout.Rheumatology (Oxford). 2009; 48: ii2-ii8
- Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: Part II.Arthritis Rheum. 2008; 58: 26-35
- Prevalence of gout and hyperuricemia in the US general population: the National Health and Nutrition Examination Survey 2007-2008.Arthritis Rheum. 2011; 63: 3136-3141
- A revised estimate of the burden of illness of gout.Curr Ther Res Clin Exp. 2013; 75: 1-4
- The role of hyperuricemia and gout in kidney and cardiovascular disease.Cleve Clin J Med. 2008; 75: S13-S16
- Pathogenesis of gout.Ann Intern Med. 2005; 143: 499-516
- 2012 American College of Rheumatology guidelines for management of gout. Part 1: Systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia.Arthritis Care Res. 2012; 64: 1431-1446
- Update on gout and hyperuricemia.Int J Clin Pract. 2010; 64: 371-377
- Is there a pathogenetic role for uric acid in hypertension and cardiovascular and renal disease?.Hypertension. 2003; 41: 1183-1190
- Uric acid: a novel mediator and marker of risk in chronic kidney disease?.Curr Opin Nephrol Hypertens. 2009; 18: 526-530
- New insights into uric acid effects on the progression and prognosis of chronic kidney disease.Ren Fail. 2012; 34: 510-520
- Is hyperuricemia an independent risk factor for new-onset chronic kidney disease? A systematic review and meta-analysis based on observational cohort studies.BMC Nephrol. 2014; 15: 122
- Effect of uric-acid-lowering therapy on progression of chronic kidney disease: a meta-analysis.J Huazhong Univ Sci Technol Med Sci. 2014; 34: 476-481
- Allopurinol and progression of CKD and cardiovascular events: long-term follow-up of a randomized clinical trial.Am J Kidney Dis. 2015; 65: 543-549
- We can make gout management more successful now.Curr Opin Rheumatol. 2008; 20: 167-172
- Allopurinol in the treatment of gout.Ann Intern Med. 1966; 64: 229-258
- The effect of allopurinol in primary and secondary gout.Arthritis Rheum. 1965; 8: 905-906
- Treatment adherence in patients with gout.Joint Bone Spine. 2011; 78: 456-459
- Rates of adherence and persistence with allopurinol therapy among gout patients in Israel.Rheumatology (Oxford). 2013; 52: 1126-1131
Watson Laboratories Inc. Allopurinol [Package Insert]. Corona, CA; 2006. http://pi.watson.com/data_stream.asp?product_group=1197&p=pi&language=E. Accessed May 10, 2013.
- Gout medication treatment patterns and adherence to standards of care from a managed care perspective.Mayo Clin Proc. 2006; 81: 925-934
- Febuxostat compared with allopurinol in patients with hyperuricemia and gout.N Engl J Med. 2005; 353: 2450-2461
- The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial.Arthritis Res Ther. 2010; 12: R63
- Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial.Arthritis Rheum. 2008; 59: 1540-1548
U.S. Census Bureau. Current population survey, annual social and economic supplement. 2010. http://www.census.gov/population/age/data/2010comp.html. Accessed October 30, 2013.
- Gout epidemiology: results from the UK General Practice Research Database, 1990-1999.Ann Rheum Dis. 2005; 64: 267-272
- Eligibility for and prescription of urate-lowering treatment in patients with incident gout in England.JAMA. 2014; 312: 2684-2686
US Food and Drug Administration. Press Announcements - FDA Approves Drug for Gout Management. US Food and Drug Administration News & Events. 2009. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149534.htm. Accessed March 30, 2014.
Takeda Pharmaceuticals America, Inc. Uloric (febuxostat) [Package Insert]. Deerfield, IL; 2009.
- Severe allopurinol toxicity. Description and guidelines for prevention in patients with renal insufficiency.Am J Med. 1984; 76: 47-56
- Allopurinol dosing in renal impairment: walking the tightrope between adequate urate lowering and adverse events.Semin Dial. 2007; 20: 391-395
- Understanding the dose-response relationship of allopurinol: predicting the optimal dosage.Br J Clin Pharmacol. 2013; 76: 932-938
Centers for Disease Control and Prevention. National Health and Nutrition Examination Survey 2007-2008. 2009. http://wwwn.cdc.gov/nchs/nhanes/search/nhanes07_08.aspx. Accessed February 17, 2014.
Centers for Disease Control and Prevention. National Health and Nutrition Examination Survey 2009-2010. 2011. Available at: http://wwwn.cdc.gov/nchs/nhanes/search/nhanes09_10.aspx. Accessed February 17, 2014.
Centers for Disease Control and Prevention. Incidence of diagnosed diabetes per 1,000 population aged 18-79 years, 1980-2011. Diabetes Public Health Resource. 2012. http://www.cdc.gov/diabetes/statistics/incidence/fig3.htm. Accessed February 16, 2014.
- Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study.Rheumatology (Oxford). 2009; 48: 188-194
- Hyperuricaemia and accelerated reduction in renal function.Scand J Rheumatol. 2011; 40: 116-121
- Frequency, risk, and cost of gout-related episodes among the elderly: does serum uric acid level matter?.J Rheumatol. 2009; 36: 1032-1040
- Association between serum uric acid and development of type 2 diabetes.Diabetes Care. 2009; 32: 1737-1742
- Serum urate and incidence of kidney disease among veterans with gout.J Rheumatol. 2013; 40: 1166-1172
- 2012 American College of Rheumatology guidelines for management of gout. Part 2: Therapy and antiinflammatory prophylaxis of acute gouty arthritis.Arthritis Care Res. 2012; 64: 1447-1461
- Pearson IV. Cost-effectiveness of febuxostat in chronic gout.Eur J Health Econ. 2014; 15: 453-463
- Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy.Nucleosides Nucleotides Nucleic Acids. 2008; 27: 585-591
- The incidence of allopurinol hypersensitivity syndrome: a population perspective (abstract 1362).Arthritis Rheum. 2008; 58: S672-S673
- PMS22 Economic impact of allopurinol hypersensitivity syndrome.Value Health. 2008; 11: A261
- Abstract 143 - Proposed gout treatment guidelines and meeting serum urate and flare goals.Arthritis Rheum. 2012; 64: S62
- 16-year excess all-cause mortality of newly diagnosed type 2 diabetic patients: a cohort study.BMC Public Health. 2009; 9: 400
- Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization.N Engl J Med. 2004; 351: 1296-1305
- A new perspective on the pharmacoeconomics of colchicine.Curr Med Res Opin. 2011; 27: 931-937
American Medical Association. AMA CodeManager: CPT Code/Relative Value Search. https://ocm.ama-assn.org/OCM/CPTRelativeValueSearch.do. Accessed October 21, 2013.
Avalere Health LLC. Trendwatch 2013 chartbook: trends affecting hospitals and health systems. 2013. http://www.aha.org/research/reports/index.shtml.
Walk-In Lab. Uric acid serum test. Kidney Tests. http://www.walkinlab.com/kidney-tests/uricacidserumtest.html. Accessed February 21, 2014.
- The effect of serum urate on gout flares and their associated costs: an administrative claims analysis.J Clin Rheumatol. 2009; 15: 3-7
- A health policy model of CKD 2: The cost-effectiveness of microalbuminuria screening.Am J Kidney Dis. 2010; 55: 463-473
US Renal Data System. USRDS 2011 annual data report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Chapter 11. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2011. http://www.usrds.org/atlas11.aspx. Accessed March 30, 2014.
Bureau of Labor Statistics. Consumer Price Index–all urban consumers. Medical Care. http://data.bls.gov/cgi-bin/surveymost?cu. Accessed December 22, 2014.
- Patients with gout adhere to curative treatment if informed appropriately: proof-of-concept observational study.Ann Rheum Dis. 2013; 72: 826-830
- Effectiveness of a pharmacist-based gout care management programme in a large integrated health plan: results from a pilot study.BMJ Open. 2014; 4: e003627
Article info
Publication history
Published online: June 03, 2016
Accepted:
May 11,
2016
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.
