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Mycophenolate Mofetil

A Pharmacoeconomic Review of its Use in Solid Organ Transplantation

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Summary

Abstract

Most pharmacoeconomic studies of mycophenolate mofetil have focused on its use as part of maintenance immunosuppression for renal transplantation, involving short-term (3 to 12 months) time frames. In general, mycophenolate mofetil reduced the treatment costs for rejection episodes and graft failure which offset its higher drug acquisition cost compared with azathioprine.

Several cost analyses have been modelled on the large multicentre trials of adult renal transplant recipients. The use of mycophenolate mofetil was associated with either cost savings or no additional costs after 6 or 12 months in French, US and Canadian analyses of triple or quadruple immunosuppressant therapy. A further cost analysis utilising a registry database of renal transplant recipients in the US found mycophenolate mofetil to be cost saving compared with azathioprine after 6.4 years when evaluating costs due to graft loss only.

Of the limited cost-effectiveness analyses with the drug, one US study modelled the 1- and 10-year cost effectiveness of mycophenolate mofetil and various other immunosuppressants used in combined regimens. Long-term use of mycophenolate mofetil was less cost effective than other regimens, but the use of long-term mycophenolate mofetil in high-risk patients was shown to be a relatively cost-effective strategy. In another US analysis comparing mycophenolate mofetil with azathioprine as part of quadruple therapy, mycophenolate mofetil was associated with slightly lower costs during the first year after renal transplantation as well as improved clinical outcomes.

Conclusion: Pharmacoeconomic studies support the use of mycophenolate mofetil as part of immunosuppressant therapy in renal transplantation, at least in the short term. Although the cost effectiveness of mycophenolate mofetil in the long term is less clear, limited pharmacoeconomic data available appear promising. Among issues to be examined in future economic analyses in renal transplantation are the calcineurin-sparing potential of mycophenolate mofetil and the feasibility of using more efficient mycophenolate mofetil dosage regimens when using the drug on a long-term basis. Additional pharmacoeconomic analyses of mycophenolate mofetil are also needed in other types of solid organ transplantation.

Economic Costs of Solid Organ Transplantation

Transplantation of a solid organ is a complex and expensive procedure. In the early to mid-1990s, the cost of renal transplantation for the first year in several European countries was about $US20 000 to $US30 000 per patient, and corresponding costs in the US were about 4-fold higher (≈$US100 000). Annual treatment costs beyond the first year were much lower (≈$US10 000 to $US15 000) and were broadly similar between these geographical regions, although still higher in the US. There are fewer cost data for other forms of organ transplant, but these procedures appear to be slightly more costly than renal transplants. Following transplantation, considerable costs continue to accrue due to maintenance immunosuppressive drug treatment, follow-up consultations and treatment of any complications. In the US, immunosuppressant agents account for approximately 83 to 84% of outpatient drug costs during the first 3 years after renal transplantation; outpatient drugs account for 35 to 43% of total healthcare expenditures during this period. Despite the high utilisation of healthcare resources, the costs of solid organ transplantation compare well with treatment of end-stage disease. In particular, renal transplants are the most cost-effective solid organ transplants, showing marked cost savings compared with dialysis treatment in various studies; however, this is an issue that requires ongoing scrutiny as costs for organ procurement, immunosuppression and other items continue to change.

Any complications which may occur post-transplantation, such as rejection episodes, infections, and graft failure, will result in increased costs. To optimise clinical and economic outcomes in transplant recipients appropriate measures must be taken to minimise complications with good transplant procedures and optimal immunosuppressant therapy.

Clinical Profile of Mycophenolate Mofetil

The clinical benefits of mycophenolate mofetil as part of a maintenance immunosuppression regimen for renal transplant recipients have been clearly demonstrated in three large multicentre, randomised, controlled trials involving nearly 1500 adult renal transplant recipients. When used in combination with cyclosporin and corticosteroids, mycophenolate mofetil reduced the incidence of acute rejection by approximately 50% compared with azathioprine and by 70% compared with placebo. In addition, rejection episodes experienced by patients receiving mycophenolate mofetil tended to be less severe than those of patients receiving azathioprine or placebo. When the studies were extended to 3 years there appeared to be a general trend towards better graft and patient survival in patients receiving mycophenolate mofetil.

These results are supported by those from large databases or registries of many thousands of renal transplant recipients. In the 1990s during a period of markedly increased use of mycophenolate mofetil, the risk of graft loss was reduced by 60% and the risk of death was halved compared with azathioprine. Mycophenolate mofetil was also found to decrease the relative risk for the development of chronic renal graft failure by 27%.

The clinical efficacy of mycophenolate mofetil as maintenance immunosuppressive therapy has also been demonstrated in cardiac transplant recipients in a large multicentre, randomised, double-blind study comparing mycophenolate mofetil with azathioprine (both in combination with cyclosporin and corticoste-roids). At 3 years after transplantation, mycophenolate mofetil was associated with better graft survival than azathioprine (88.1 vs 81.6%) and a 36% relative reduction in patient mortality.

A large multicentre, double-blind, randomised study in liver transplant recipients also observed a lower incidence of acute rejection or graft loss in the mycophenolate mofetil group compared with the azathioprine group at 6 months (38.5 vs 47.7%). Patients in this trial also received cyclosporin and corticosteroids. Mycophenolate mofetil has also been evaluated as part of maintenance immunosuppression in other solid organ transplants but to date there are no large, controlled, double-blind trials.

Tacrolimus combined with mycophenolate mofetil and corticosteroids has also been used successfully in renal and cardiac transplantation, although data are quite limited for the latter. In two large studies of liver transplant recipients the addition of mycophenolate mofetil to a tacrolimus-based regimen was not shown to be superior to a tacrolimus-based regimen without mycophenolate mofetil.

Mycophenolate mofetil has also been effective as rescue treatment in acute rejection episodes in solid organ transplantation. In the treatment of acute rejection in renal transplantation, mycophenolate mofetil was shown to be more effective than azathioprine in reversing early acute rejection episodes. Furthermore, mycophenolate mofetil was associated with a significant reduction in the use of antilymphocyte agents for persistent rejection. Mycophenolate mofetil has also found to be superior to high-dose corticosteroids in reversing persistent and/or refractory rejection.

The use of mycophenolate mofetil in solid organ transplantation has enabled dose reduction or complete withdrawal of other immunosuppressant agents, thus lowering the long-term adverse effects of these drugs (cyclosporin, tacrolimus and corticosteroids). The addition of mycophenolate mofetil and the reduction of cyclosporin dose in maintenance immunosuppressant therapy has been shown to improve renal function in solid organ transplant recipients. However, to date, the majority of studies have been performed only in transplant patients with a stable condition. Corticosteroid withdrawal in patients receiving mycophenolate mofetil has been performed with a small increase in the risk of subsequent rejection episodes.

The main adverse effects of mycophenolate mofetil are gastrointestinal disturbances, haematological toxicity and increased incidence of some types of infections. Most gastrointestinal disturbances respond readily to temporary dosage reduction or drug discontinuation, or an increased interval between administration of mycophenolate mofetil and other immunosuppressive agents. Gastrointestinal adverse effects may also be reduced if mycophenolate mofetil is administered with food, or if the total daily dosage is split into three or four divided doses. Leucopenia and anaemia are the most commonly reported haematological adverse effects. Viral infections, particularly cytomegalovirus, tend to occur more frequently with mycophenolate mofetil than azathioprine, but this is likely to be an effect of immunosuppressive load, rather than a characteristic of the drug itself.

Pharmacoeconomic Analyses

Pharmacoeconomic evaluation of mycophenolate mofetil, to date, has largely been focused on renal transplantation using cost analyses. Most studies have compared mycophenolate mofetil with azathioprine as part of triple therapy regimens with cyclosporin and corticosteroids. In these analyses, the use of mycophenolate mofetil was associated with lower treatment costs and associated hospital admissions due to a reduced incidence and severity of rejection episodes, as well as lower costs of dialysis (in renal transplant recipients) due to a lower incidence of graft failure. These factors have offset the higher drug acquisition costs of mycophenolate mofetil, so that its use in the short term is cost equivalent or cost saving compared with azathioprine.

Six single-centre cost analyses have been published to date, five evaluating renal transplantation and one study of liver transplant recipients. The range of study duration varied from 3 months to 1 year. Five of these studies, including the study in liver transplant recipients, reported no significant difference in total healthcare costs between patients receiving mycophenolate mofetil, and those receiving either azathioprine or no mycophenolate mofetil, as part of combined regimens. One US study observed significantly lower costs with mycophenolate mofetil therapy at 6 months, but at 1 year the difference was not statistically significant between patients receiving mycophenolate mofetil or azathioprine.

Four cost analyses have been modelled on the large multicentre trials of adult renal transplant recipients. The use of mycophenolate mofetil was associated with cost savings in all three trial protocols ranging from 7074 French francs (FF) to FF16 849 (1994 costs) in a French cost analysis, although acquisition costs of mycophenolate mofetil and azathioprine were excluded. A US cost analysis of a US multicentre trial found no difference in the 1-year total costs of the two study groups receiving quadruple therapy which included either mycophenolate mofetil or azathioprine. Similarly, a Canadian analysis of another multicentre trial also found no difference in 1-year costs in patients receiving either mycophenolate mofetil or azathioprine as part of a triple therapy regimen. Both the US and Canadian analyses included acquisition costs of the study drugs. A cost analysis of renal transplantation in paediatric patients, observed lower costs with mycophenolate mofetil than azathioprine in cadaveric renal transplants (but not living donor) and/or when antilymphocyte therapy had been used to treat rejection episodes.

A cost analysis utilising a US registry database of renal transplant recipients enabled long-term graft survival to be modelled in patients receiving mycophenolate mofetil or azathioprine as part of combined immunosuppressive therapy. Mycophenolate mofetil was found to be cost saving to Medicare compared with azathioprine after 6.4 years when evaluating the costs of graft loss alone.

There are few cost-effectiveness studies of mycophenolate mofetil. The 1-year and 10-year cost effectiveness of mycophenolate mofetil and various other immunosuppressants used in combined regimens were calculated in a US study. This study indicated that long-term use of mycophenolate mofetil is less cost effective than other regimens due to its high acquisition cost. However, the use of long-term mycophenolate mofetil in high-risk patients was shown to be a relatively cost-effective strategy, although ‘high risk’ was not clearly defined in this analysis.

A US cost-effectiveness analysis incorporating data from a large multicentre trial of quadruple therapy, which included either mycophenolate mofetil or azathioprine, found a small 1-year cost advantage as well as improved clinical outcomes with mycophenolate mofetil, thus making it the dominant strategy.

A Canadian cost-effectiveness (and cost-utility) study compared mycophenolate mofetil and azathioprine as part of triple therapy regimens. The study was based on data from a large multicentre trial, and generally favourable cost-effectiveness ratios were obtained ($Can14 268 per graft-year gained and $Can50 717 per quality-adjusted life-year gained; year of costing not reported).

The cost effectiveness of mycophenolate mofetil for rescue treatment of rejection episodes was compared with muromonab CD3, using a decision-analysis model in Japan. The study showed a lower cost per graft surviving at 90 days with mycophenolate mofetil ($US13 730) than muromonab CD3 ($US29 060; year of costing not reported).

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Young, M., Plosker, G.L. Mycophenolate Mofetil. Pharmacoeconomics 20, 675–713 (2002). https://doi.org/10.2165/00019053-200220100-00004

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