Association of teriparatide adherence and persistence with clinical and economic outcomes in Medicare Part D recipients: a retrospective cohort study

BMC Musculoskeletal Disorders

Russel T Burge²  Claudia L Uribe¹  Shonda A Foster²  Anthony M Louder¹  Leslie Hazel-Fernandez¹ 

[1] Competitive Health Analytics Inc., Humana Inc, 3501 SW 160 Ave, Miramar, FL, 33029, USA;Eli Lilly and Company, Indianapolis, IN, USA

关键词: Outcomes;    Fractures;    Medicare part D;    Discontinuation;    Persistence;    Adherence;    Teriparatide;    Osteoporosis;   

Others  :  1134285
DOI  :  10.1186/1471-2474-14-4

 received in 2012-05-18, accepted in 2012-12-27,  发布年份 2013

【 摘 要 】

Background

Improper medication adherence is associated with increased morbidity, healthcare costs, and fracture risk among patients with osteoporosis. The objective of this study was to evaluate the healthcare utilization patterns of Medicare Part D beneficiaries newly initiating teriparatide, and to assess the association of medication adherence and persistence with bone fracture.

Methods

This retrospective cohort study assessed medical and pharmacy claims of 761 Medicare members initiating teriparatide in 2008 and 2009. Baseline characteristics, healthcare use, and healthcare costs 12 and 24 months after teriparatide initiation, were summarized. Adherence, measured by Proportion of Days Covered (PDC), was categorized as high (PDC ≥ 80%), moderate (50% ≥ PDC < 80%), and low (PDC < 50%). Non-persistence was measured as refill gaps in subsequent claims longer than 60 days plus the days of supply from the previous claim. Multivariate logistic regression evaluated the association of adherence and persistence with fracture rates at 12 months.

Results

Within 12 months of teriparatide initiation, 21% of the cohort was highly-adherent. Low-adherent or non-persistent patients visited the ER more frequently than did their highly-adherent or persistent counterparts (χ2 = 5.01, p < 0.05 and χ2 = 5.84, p < 0.05), and had significantly lower mean pharmacy costs ($4,361 versus $13,472 and $4,757 versus $13,187, p < 0.0001). Furthermore, non-persistent patients had significantly lower total healthcare costs. The healthcare costs of highly-adherent patients were largely pharmacy-related. Similar patterns were observed in the 222 patients who had fractures at 12 months, among whom 89% of fracture-related costs were pharmacy-related. The regression models demonstrated no significant association of adherence or persistence with 12-month fractures. Six months before initiating teriparatide, 50.7% of the cohort had experienced at least 1 fracture episode. At 12 months, these patients were nearly 3 times more likely to have a fracture (OR = 2.9, 95% C.I. 2.1-4.1 p < 0.0001).

Conclusions

Adherence to teriparatide therapy was suboptimal. Increased pharmacy costs seemed to drive greater costs among highly-adherent patients, whereas lower adherence correlated to greater ER utilization but not to greater costs. Having a fracture in the 6 months before teriparatide initiation increased fracture risk at follow-up.

【 授权许可】

   
2013 Hazel-Fernandez et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]U.S. Department of Health and Human Services: Bone health and osteoporosis: a report of the surgeon general. Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General; 2004.
• [2]Dontas IA, Yiannakopoulos CK: Risk factors and prevention of osteoporosis-related fractures. J Musculoskelet Neuronal Interact 2007, 7:268-272.
• [3]Sandhu S, Hampson G: The pathogenesis, diagnosis, investigation and management of osteoporosis. J Clin Pathol 2011, 11:1042e-1050e.
• [4]Chesnut CH: Treating osteoporosis with bisphosphonates and addressing adherence: a review of oral ibandronate. Drugs 2006, 66:1351-1359.
• [5]Bock O, Felsenberg D: Bisphosphonates in the management of postmenopausal osteoporosis – optimizing efficacy on clinical practice. Clin Interv Aging 2008, 3:279-297.
• [6]Yu S, Burge RT, Foster SA, Gelwicks S, Meadows ES: The impact of teriparatide adherence and persistence on fracture outcomes. Osteoporos Int 2012, 23:1103-1113.
• [7]Downey TW, Foltz S, Boccuzzi SJ, Omar MA, Kahler KH: Adherence and persistence associated with the pharmacologic treatment of osteoporosis in a managed care setting. South Med J 2006, 99:570-575.
• [8]Kennel KA, Drake MT: Adverse effects of bisphosphonates: implications for osteoporosis management. Mayo Clin Proc 2009, 84:632-638.
• [9]Lee S, Glendenning P, Inderjeeth CA: Efficacy, side effects and route of administration are more important than frequency of dosing of anti-osteoporosis treatments in determining patient adherence: a critical review of published articles from 1970 to 2009. Osteoporos Int 2011, 22:741-753.
• [10]Hodsman AB, Bauer DC, Dempster DW, Dian L, Hanley DA, Harris ST, Kendler DL, McClung MR, Miller PD, Olszynski WP, Orwoll E, Yuen CK: Parathyroid hormone and teriparatide for the treatment of osteoporosis: a review of the evidence and suggested guidelines for its use. Endoc Rev 2005, 26:688-703.
• [11]Gold DT, Weinstein DL, Pohl G, Krohn KD, Chen Y, Meadows ES: Factors associated with persistence with teriparatide therapy: results from the DANCE observational study. J Osteoporos 2011, 314970.
• [12]Tamariz L, Uribe CL, Luo J, Hanna JW, Ball DE, Krohn K, Meadows ES: Persistence with biologic therapies in the medicare coverage gap. Am J Manag Care 2011, 17:753-759.
• [13]Raebel M, Delate T, Ellis JL, Bayliss EA: Effects of reaching the drug benefit threshold on medicare members’ healthcare utilization during the first year of Medicare Part D. Med Care 2008, 46:1116-1122.
• [14]Hsu J, Fung V, Price M, Huang J, Brand R, Hui R, Fireman B, Newhouse JP: Medicare Beneficiaries’ knowledge of Part D prescription drug program benefits and responses to drug costs. JAMA 2008, 226:1929-1936.
• [15]Patel UD, Davis MM: Falling into the doughnut hole: drug spending among beneficiaries with end-stage renal disease under Medicare pPart D plans. J Am Soc Nephrol 2006, 17:2546-2553.
• [16]Madden JM, Graves AJ, Zhang F, Adams AS, Briesacher BA, Ross-Degnan D, Gurwitz JH, Pierre-Jacques M, Gelb Safran D, Adler GS, Soumerai SB: Cost-related medication nonadherence and spending on basic needs following implementation of Medicare Part D. JAMA 299:1922-1928.
• [17]Zhang JX, Yin W, Sun SX, Alexander GC: The impact of Medicare Part D prescription benefit on generic drug Use. J Gen Intern Med 2008, 23:1673-1678.
• [18]Tseng CW, Brook RH, Keeler E, Steers WN, Mangione CM: Cost-lowering strategies used by Medicare beneficiaries who exceed drug benefit caps and have a gap in drug coverage. JAMA 2004, 292:952-960.
• [19]Cronk A, Humphries TL, Delat T, Clark D, Morris B: Medication strategies used by Medicare beneficiaries who reach the Part D standard drug-benefit threshold. Am J Health Syst Pharm 2008, 65:1062-1070.
• [20]Conwell LJ, Esposito D, Garavaglia S, Meadows ES, Colby M, Herrera V, Goldfarb S, Ball D, Marciniak M: Out-of-pocket drug costs and drug utilization patterns of postmenopausal Medicare beneficiaries with osteoporosis. Am J Geriatr Pharmacother 2011, 9:241-249.
• [21]Gandek B, Sinclair SJ, Kosinski M, Ware JE: Psychometric evaluation of the SF-36® health survey in medicare managed care. Health Care Financ Rev 2004, 25:5-25.
• [22]Polinski JM, Bhandari A, Saya UY, Schneeweiss S, Shrank WH: Medicare beneficiaries’ knowledge of and choices regarding Part D, 2005 to the present. J Am Geriatr Soc 2010, 58:950-966.
• [23]Brod M, Rousculp M, Cameron A: Understanding compliance issues for daily self-injectable treatment in ambulatory care settings. Patient Prefer Adherence 2008, 2:129-136.
• [24]Brookhart MA, Avorn J, Katz JN, Finkelstein JS, Arnold M, Polinski JM, Patrick AR, Mogun H, Solmon DH: Gaps in treatment among users of osteoporosis medications: the dynamics of noncompliance. Am J Med 2007, 120:251-256.
• [25]Foster SA, Foley KA, Meadows ES, Johnston JA, Wang SS, Pohl GM, Long SR: Adherence and persistence with teriparatide among patients with commercial, Medicare, and Medicaid insurance. Osteoporos Int 2011, 22:551-557.
• [26]Gold DT: Medication adherence: a challenge for patients with postmenopausal osteoporosis and other chronic illnesses. J Manag Care Pharm 2006, 12(Suppl S-a):S20-S25.
• [27]Halpern R, Becker L, Iqbal SU, Kazis LE, Macarios D, Badamgarav E: The association of adherence to osteoporosis therapies with fracture, all-cause medical costs, and all-cause hospitalizations: a retrospective claims analysis of female health plan enrollees with osteoporosis. J Manag Care Pharm 2011, 17:25-39.
• [28]Fogelman I, Fordham JN, Fraser WD, Spector TD, Christiansen C, Morris SA, Fox J: Parathyroid hormone(1-84) treatment of postmenopausal women with Low Bone Mass Receiving Hormone Replacement Therapy. Calcif Tissue Int 2008, 83:85-92.
• [29]Arden NK, Earl S, Fisher DJ, Cooper C, Carruthers S, Goater M: Persistence with teriparatide in patients with osteoporosis: the UK experience. Osteoporos Int 2006, 7:1626-16299.
• [30]Adachi JD, Hanley DA, Lorraine JK, Yu M: Assessing compliance, acceptance, and tolerability of teriparatide in patients with osteoporosis who fractured while on antiresorptive treatment or were intolerant to previous antiresorptive treatment: an 18-month, multicenter, open-label, prospective study. Clin Ther 2007, 29:2055-2067.
• [31]Sikon A, Batur P: Profile of teriparatide in the management of postmenopausal osteoporosis. Int J Womens Health 2010, 2:37-44.
• [32]Klotzbuecher CM, Ross PD, Landsman PB, Abbott TA 3rd, Berger M: Patients with prior fractures have an increased risk of future fractures: A summary of the literature and statistical synthesis. J Bone Miner Res 2000, 5:721-739.
• [33]Haentjens P, Autier P, Collins J, Velkeniers B, Vanderschueren D, Boonen S: Colles fracture, spine fracture, and subsequent risk of hip fracture in men and women. A meta-analysis. J Bone Joint Surg Am 2003, 85-A:1936-1943.
• [34]Lindsay R, Silverman SL, Cooper C, Hanley DA, Barton I, Broy SB, Licata A, Benhamou L, Geusens P, Flowers K, Stracke H, Seeman E: Risk of new vertebral fracture in the year following a fracture. JAMA 2001, 285:320-323.
• [35]Lindsay R, Burge RT, Strauss DM: One year outcomes and costs following a vertebral fracture. Osteoporos Int 2005, 16:78-85.
• [36]Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A: Incidence and economic burden of osteoporosis related fractures in the United States, 2005–2025. J Bone Miner Res 2007, 22:465-475.
• [37]Cummings SR, Black DM, Thompson DE, Applegate WB, Barrett-Connor E, Musliner TA, Palermo L, Prineas R, Rubin SM, Scott JC, Vogt T, Wallace R, Yates AJ, LaCroix AZ: Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 1998, 280:2077-2082.
• [38]Curtis JR, Westfall AO, Cheng H, Lyles K, Saag KG, Delzell E: Benefit of adherence with bisphosphonates depends on age and fracture type: Results from an analysis of 101,038 new bisphosphonate users. J Bone Miner Res 2008, 23:1435-1441.
• [39]Siris ES, Harris ST, Rosen CJ, Barr CE, Arvesen JN, Abbott TA, Silverman S: Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clinic Proc 2006, 81:1013-1022.
• [40]Deyo RA, Cherkin DC, Ciol MA: Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. Clin Epidemiol 1992, 45:613-619.
• [41]Leslie RS: Using Arrays to Calculate Medication Utilization. Orlando, FL: Proceedings of the 2007 SAS Global Forum; Paper 043-2007. http://www.lexjansen.com/pharmasug/2008/pr/pr07.pdf webcite