Budget impact analysis of conversion from cyclosporine to sirolimus as immunosuppressive medication in renal transplantation therapy

Figures & data

Table 1 Model inputs and data sources for the budget impact analysis

Components	Unit cost	Source
Immunosupressive therapy
• Cyclosporine (generic)	Price per tablet	Insurance organizations’ database
• Mycophenolate mofetil (Brand generic: Citogan®)	Price per tablet	Insurance organizations’ database
• Sirolimus (Rapamune®) Adverse events	Price per tablet	Helal-e-Ahmar pharmacy database
• CMV
○ Probability	–	Literature,^Citation3,Citation6,Citation12,Citation13, (Nafar, unpublished data, 2012)
○ Treatment
Ganciclovir	Price per vial	Insurance organizations’ database
Hospitalization	Bed per night for posttransplant patients	Accounting department database, Shahid Labbafinejad Hospital
• Acute rejection
○ Probability	–	Nafar et al^Citation7
○ Treatment
Methylprednisolon	Price per vial	Insurance organizations’ database
ATG	Price per vial	Insurance organizations’ database
Gancyclovir	Price per vial	Insurance organizations’ database
Hospitalization	Bed per night for posttransplant patients	Accounting department database, Shahid Labbafinejad Hospital
• Graft failure
○ Probability	–	Nafar et al^Citation7
○ Treatment
Dialysis	Global tariff per operation	Insurance organizations’ database
Re-transplantation	Global tariff per operation	Insurance organizations’ database
• Hyperlipidemia
○ Probability	–	Literature,^Citation3,Citation6,Citation12,Citation13, (Nafar, unpublished data, 2012)
○ Treatment
Atorvastatin	Price per tablet	Insurance organizations’ database
• Hypertension
○ Probability	–	Literature,^Citation3,Citation6,Citation12,Citation13, (Nafar, unpublished data, 2012)
○ Treatment
Amlodipine	Price per tablet	Insurance organizations’ database
• Thrombocytopenia
○ Probability	–	Literature,^Citation3,Citation6,Citation12,Citation13, (Nafar, unpublished data, 2012)
○ Treatment
Plasmapheresis	Price per operation	Insurance organizations’ database

Note: Rapamune®; Pfizer, Inc., New York, NY, USA.

Abbreviations: CMV, cytomegalovirus; ATG, anti-thymocyte globulin.

Figure 1 Schematic local randomized controlled trial protocol.

Note: Data from⁷.

Table 2 Cost of immunosuppressive agents in SRL versus CsA based therapies in Iran (2011–2012)

Immunosuppressive drugs	Dosage form	Dosage/day/patient	Unit price (IRR)	Total cost/day/patient (IRR)	Number of eligible patients	Duration (days)	Total cost (IRR)	Total cost (US$)
CsA group
Cyclosporine (generic)	Cap: 25, 100, 50 mg	150 mg qd	300, 1,200, 1,500	5,742,000a	2,200	270	1,550,340,000	126,455
Mycophenolate mofetil	Cap: 500 mg	2 g qd	11,000	44,000	2,200	270	26,136,000,000	2,131,811
Total cost							27,686,340,000	2,258,266
SRL group
SRL	Tab: 1 mg	Loading dose: 6 mg day 1, Maintenance dose: 2 mg qd	10,000	20,000	2,200	270	11,880,000,000	969,005
Mycophenolate mofetil	Cap: 500 mg	1 g qd	11,000	22,000	2,200	270	13,068,000,000	1,065,905
Total cost							24,948,000,000	2,034,910

Note:

a The value has been calculated according to the proportion of patients using each dosage of CsA (25 mg: 40%; 50 mg: 30%; 100 mg: 30%) and thus it is also including the number of patients.

Abbreviations: CsA, cyclosporine a; IRR, Iranian Rials; qd, once per day, every day; SRL, sirolimus; Cap, capsule; Tab, tablet.

Table 3 Cost of adverse events per patient in renal transplantation therapy in Iran (2011–2012)

Adverse events/drugs	Dosage form	Dosage/day/patient	Number per day	Duration (days)	Unit price (IRR)	Total cost/patient (IRR)	Total cost (US$)
CMV
Ganciclovir	For inj: 500 mg	For treatment: 5 mg/kg q 12 hours until treatment	2	7	250,000	3,500,000	285
Hospitalization	–	–	–	7	1,600,000	11,200,000	914
Acute rejection
Methylprednisolon	For inj: 500 mg	250–1000 mg	1	7	200,000	1,400,000	114
ATG	Inj: 250 mg/5 ml	10–20 mg/kg	4	7	550,000	15,400,000	1,256
Gancyclovir	For inj: 500 mg	For prophylaxis: 5 mg/kg q 24 hours until hospitalization	1	7	250,000	1,750,000	143
Hospitalization	–	–	–	7	1,600,000	11,200,000	914
Graft failure
Dialysis	–	–	–	10 times	743,200	7,432,000	606
Re-transplantation	–	–	–	–	650 ka	39,000,000	3,181
Hyperlipidemia
Atorvastatin	Tab: 10, 20, 40 mg	10–40 mg	1	270	1,100	297,000	24
Hypertension
Amlodipin	Tab: 5 mg	5–10 mg	1	270	150	40,500	3
Thrombocytopenia
Plasmapheresis	–	–	–	10 times	1,300,000	13,000,000	1,060

Note:

a k: IRR 60,000 (US$).

Abbreviations: ATG, anti-thymocyte globulin; CMV, cytomegalovirus; inj, injection; Tab, tablet; IRR, Iranian Rials; q, once per day.

Table 4 Total adverse events cost related to SRL versus CsA based therapies in renal transplantation therapy in Iran (2011–2012)

Adverse events	Probability	Number of patients (2,200)	Unit cost (IRR)	Total cost (IRR)	Total cost (US$)
CsA based therapy
CMV	0.21	462	14,700,000	6,791,400,000	553,948
Acute rejection	0.18	396	29,750,000	11,781,000,000	960,930
Hyperlipidemia	0.14	308	297,000	91,476,000	7,461
Hypertension	0.67	1,474	40,500	59,697,000	4,869
Graft failure	0.105	231	46,432,000	10,725,792,000	874,861
Thrombocytopenia	0.08	176	13,000,000	2,288,000,000	186,623
Total cost				31,737,365,000	2,588,692
SRL based therapy
CMV	0.05	110	14,700,000	1,617,000,000	131,892
Acute rejection	0.08	176	29,750,000	5,236,000,000	427,080
Hyperlipidemia	0.44	968	297,000	287,496,000	23,450
Hypertension	0.78	1,716	40,500	69,498,000	5,669
Graft failure	0.075	165	46,432,000	7,661,280,000	624,900
Thrombocytopenia	0.45	990	13,000,000	12,870,000,000	1,049,755
Total cost				27,741,274,000	2,262,747

Abbreviations: CMV, cytomegalovirus; CsA, cyclosporine a; IRR, Iranian Rials; SRL, sirolimus.

Figure 2 Budget impact of using SRL to replace the current conventional therapy with CsA in Iran (2011–2012).

Abbreviations: CsA, cyclosporine a; SRL, sirolimus.

Table 5 Budget impact results of conversion from CsA to SRL in renal transplantation therapy for insurance organizations in Iran (2011–2012)

Budget components (base-case)	SRL based therapy (IRR)	CsA based therapy (IRR)	SRL based therapy (US$)	CsA based therapy (US$)
Costs of immunosuppressive therapy	24,948,000,000	27,686,340,000	2,034,910	2,258,266
Costs of adverse events	27,741,274,000	31,737,365,000	2,262,747	2,588,692
Total costs	52,689,274,000	59,423,705,000	4,297,657	4,846,958
Total cost difference	−6,734,431,000		−549,301
PMPMa	−33,012		−2.7

Note:

a Per member per month refers to the ratio of some service or cost divided into the number of members in a particular group on a monthly basis.

Abbreviations: CsA, cyclosporine a; IRR, Iranian Rials; PMPM, per member per month; SRL, sirolimus.

Figure 3 Sensitivity analyses results for SRL market price in Iran (2011–2012). At a price between $1.22 and $1.31, the budget difference would be zero.

Abbreviations: CsA cyclosporine A; SRL, sirolimus.

Figure 4 Sensitivity analyses: total BI difference between SRL and CsA based therapies (2011–2012).

Notes: Values at the end of each bar indicate the change in BI from the base-case or the possible lowest and highest values of that input (eg, in the SRL price and treatment duration).
Abbreviations: AE, adverse events; BI, budget impact; CsA, cyclosporine a; SRL, sirolimus.

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