Budget impact of switching from an immediate-release to a prolonged-release formulation of tacrolimus in renal transplant recipients in the UK based on differences in adherence

Patient Preference and Adherence

Volumn 8, Issue , 2014, Pages 391-399

  Muduma, Gorden ^a   Odeyemi, Isaac ^a   Smith Palmer, Jayne ^b   Pollock, Richard F ^b  

^a Astellas Pharma Europe Ltd   (United Kingdom)

^b Ossian Health Economics and Communications   (Switzerland)

Author keywords

Costs and cost analysis; Great Britain; Patient adherence; Tacrolimus

Indexed keywords

TACROLIMUS;

ACUTE GRAFT REJECTION; ARTICLE; BUDGET; CLINICAL ASSESSMENT; COST CONTROL; DRUG COST; DRUG FORMULATION; GRAFT FAILURE; GRAFT RECIPIENT; GRAFT SURVIVAL; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MORTALITY; PATIENT COMPLIANCE; PERITONEAL DIALYSIS; PRESCRIPTION; UNITED KINGDOM;

EID: 84897479528     PISSN: None     EISSN: 1177889X     Source Type: Journal    
DOI: 10.2147/PPA.S60213     Document Type: Article

References (43)

1. European Medicines Agency. Advagraf European public assessment report annex I: summary of product characteristics. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000712/WC500022234.pdf. Accessed June 4, 2013.
2. US Food and Drug Administration. Drug approval package: Prograf (tacrolimus) injection. 2003. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050708_prograf_toc.cfm. Accessed June 4, 2013.
3. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet. 2004;43(10):623-653.
4. Dew MA, DiMartini AF, De Vito Dabbs A, et al. Rates and risk factors for nonadherence to the medical regimen after adult solid organ t{stroke}ransplantation. Transplantation. 2007;83(7):858-873.
5. Dharancy S, Giral M, Tetaz R, Fatras M, Dubel L, Pageaux GP. Adherence with immunosuppressive treatment after transplantation: results from the French trial PREDICT. Clin Transplant. 2012;26(3): E293-E299.
6. Weng FL, Israni AK, Joffe MM, et al. Race and electronically measured adherence to immunosuppressive medications after deceased donor renal transplantation. J Am Soc Nephrol. 2005;16(6): 1839-1848.
7. National Health Service Business Services Authority. Prescription cost analysis (PCA) data. 2013. Available from: http://www.nhsbsa.nhs.uk/PrescriptionServices/3494.aspx. Accessed July 31, 2013.
8. European Medicines Agency. European public assessment report: Advagraf - summary for the public. 2008. Available from: http://www.emea.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000712/WC500022235.pdf. Accessed June 4, 2013.
9. Saini SD, Schoenfeld P, Kaulback K, Dubinsky MC. Effect of medication dosing frequency on adherence in chronic diseases. Am J Manag Care. 2009;15(6):e22-e33.
10. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23(8):1296-1310.
11. Kuypers DR, Peeters PC, Sennesael JJ, etal. Improved adherence to tacrolimus once-daily formulation in renal recipients: a randomized controlled trial using electronic monitoring. Transplantation. 2013;95(2): 333-340.
12. Dobbels F, Ruppar T, De Geest S, Decorte A, Van Damme-Lombaerts R, Fine RN. Adherence to the immunosuppressive regimen in pediatric kidney transplant recipients: a systematic review. Pediatr Transplant. 2010;14(5):603-613.
13. Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant. 2009;9(11):2597-2606.
14. Spivey CA, Chisholm-Burns MA, Damadzadeh B, Billheimer D. Determining the effect of immunosuppressant adherence on graft failure risk among renal transplant recipients. Clin Transplant. 2014;28(1): 96-104.
15. Butler JA, Roderick P, Mullee M, Mason JC, Peveler RC. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review. Transplantation. 2004;77(5):769-776.
16. NHS Blood and Transplant. Transplant activity in the UK. Activity report 2011-12. Available from: http://www.organdonation.nhs.uk/statistics/transplant_activity_report/archive_activity_reports/pdf/ukt/activity_report_2011_12.pdf. Accessed March 3, 2014.
17. McEwan P, Dixon S, Baboolal K, Conway P, Currie CJ. Evaluation of the cost effectiveness of sirolimus versus tacrolimus for immune suppression following renal transplantation in the UK. Pharmacoeconomics. 2006;24(1):67-79.
18. Krämer BK, Charpentier B, Bäckman L, et al. Tacrolimus once daily (Advagraf) versus twice daily (Prograf) in de novo renal t{stroke}ransplantation: a randomized phase III study. Am J Transplant. 2010;10(12): 2632-2643.
19. Zhang J, Yu KF. What's the relative risk? A method of correcting the odds ratio in cohort studies of common outcomes. JAMA. 1998;280(19):1690-1691.
20. National Institute for Health and Care Excellence. CG125: peritoneal dialysis - NICE guideline. 2012. Available from: http://guidance.nice.org.uk/CG125/NICEGuidance/pdf/English. Accessed June 4, 2013.
21. Renal Association. Haemodialysis. Available from: http://www.renal.org/clinical/guidelinessection/haemodialysis.aspx. Accessed June 4, 2013.
22. Joint Formulary Committee. British National Formulary online. London: BMJ Group and Pharmaceutical Press. §8.2.2 Corticosteroids and other immunosuppressants: Tacrolimus (Advagraf). March 2013. Available from: http://www.medicinescomplete.com/mc/bnf/current/PHP5647-advagraf.htm. (Registration required) Accessed August 20, 2013.
23. Joint Formulary Committee. British National Formulary online. London: BMJ Group and Pharmaceutical Press. §8.2.2 Corticosteroids and other immunosuppressants: Tacrolimus (Prograf). March 2013. Available from: http://www.medicinescomplete.com/mc/bnf/current/PHP5643-prograf.htm. (Registration required) Accessed August 20, 2013.
24. Joint Formulary Committee. British National Formulary online. London: BMJ Group and Pharmaceutical Press. §8.2.2 Corticosteroids and other immunosuppressants: Tacrolimus (Adoport). March 2013. Available from: http://www.medicinescomplete.com/mc/bnf/current/PHP5643-prograf.htm. (Registration required) Accessed August 20, 2013.
25. Joint Formulary Committee. British National Formulary online. London: BMJ Group and Pharmaceutical Press. §8.2.1 Antiproliferative immune-suppressants: Mycophenolate mofetil. March 2013. Available from: http://www.medicinescomplete.com/mc/bnf/current/PHP5609-mycophenolate-mofetil-non-proprietary.htm. (Registration required) Accessed August 20, 2013.
26. Joint Formulary Committee. British National Formulary online. London: BMJ Group and Pharmaceutical Press. §6.3.2 Glucocorticoid therapy: Betamethasone. March 2013. Available from: http://www.medicinescom-plete.com/mc/bnf/current/PHP18872-betamethasone-non-proprietary.htm. (Registration required) Accessed August 20, 2013.
27. Joint Formulary Committee. British National Formulary online. London: BMJ Group and Pharmaceutical Press. §6.3.2 Glucocorticoid therapy: Methylprednisolone. March 2013. Available from: http://www.medicinescomplete.com/mc/bnf/current/PHP4373-solu-medrone.htm. (Registration required) Accessed August 20, 2013.
28. Joint Formulary Committee. British National Formulary online. London: BMJ Group and Pharmaceutical Press. §8.2.2 Corticosteroids and other immunosuppressants: Antithymocyte immunoglobulin (rabbit). March 2013. Available from: http://www.medicinescomplete.com/mc/bnf/current/PHP5620-antithymocyte-immunoglobulin-rabbit.htm. (Registration required) Accessed August 20, 2013.
29. National Health Service. National Tariff 2012-13. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216214/dh_133578.xls. Accessed August 20, 2013.
30. 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(5):336-347.
31. National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal. 2008. Available from: http://www.nice.org.uk/media/B52/A7/TAMethodsGuideUpdatedJune2008.pdf. Accessed June 4, 2013.
32. Beaudet A, Palmer JL, Timlin L, etal. Cost-utility of exenatide once weekly compared with insulin glargine in patients with type 2 diabetes in the UK. J Med Econ. 2011;14(3):357-366.
33. Sellarés J, de Freitas DG, Mengel M, et al. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012;12(2): 388-399.
34. Wiebe C, Gibson IW, Blydt-Hansen TD, etal. Evolution and clinical pathologic correlations of de novo donor-specific HLA antibody post kidney transplant. Am J Transplant. 2012;12(5):1157-1167.
35. Sabbatini M, Garofalo G, Borrelli S, etal. Efficacy of a reduced pill burden on therapeutic adherence to calcineurin inhibitors in renal transplant recipients: an observational study. Patient Prefer Adherence. 2014;8:73-81.
36. Griva K, Davenport A, Harrison M, Newman SP. Non-adherence to immunosuppressive medications in kidney transplantation: intent vs forgetfulness and clinical markers of medication intake. Ann Behav Med. 2012;44(1):85-93.
37. Vo AA, Peng A, Toyoda M, etal. Use of intravenous immune globulin and rituximab for desensitization of highly HLA-sensitized patients awaiting kidney transplantation. Transplantation. 2010;89(9):1095-1102.
38. National Health Service. Third National Immunoglobulin Database Report. London NHS; 2012.
39. Joint Formulary Committee. British National Formulary online. London: BMJ Group and Pharmaceutical Press. MabThera. Available from: http://www.medicinescomplete.com/mc/bnf/current/PHP5664-mabthera.htm. (Registration required) Accessed September 20, 2013.
40. Galliford J, Lawrence C, Chan K, etal. Eculizumab reverses resistant acute Antibody Mediated Rejection and prevents allograft loss. Poster presented at: 14th Annual Congress of the British Transplantation Society; March 9-11, 2011; Bournemouth, UK.
41. Joint Formulary Committee. British National Formulary online. London: BMJ Group and Pharmaceutical Press. Soliris. Available from: http://www.medicinescomplete.com/mc/bnf/current/PHP5923-soliris.htm. (Regsitration required) Accessed September 18, 2013.
42. Puttarajappa C, Shapiro R, Tan HP. Antibody-mediated rejection in kidney transplantation: a review. J Transplant. 2012;2012:193724.
43. Guirado L, Cantarell C, Franco A, etal. Efficacy and safety of conversion from twice-daily to once-daily tacrolimus in a large cohort of stable kidney transplant recipients. Am J Transplant. 2011;11(9):1965-1971.