Cost-effectiveness analysis of individualized mycophenolate mofetil dosing in kidney transplant patients in the APOMYGRE trial.
BACKGROUND
In the prospective, randomized, multicenter APOMYGRE trial conducted in France, concentration-controlled mycophenolate mofetil (MMF) dosing based on mycophenolic acid (MPA) exposure significantly reduced the treatment failure and acute rejection during the first posttransplantation year compared with fixed-dose MMF. This analysis investigated the cost effectiveness of dose individualization.


METHODS
The study included 65 patients per group (intent-to-treat population). Treatment failure (primary efficacy endpoint) was defined as death, graft loss, acute rejection, or MMF discontinuation because of adverse effects. Data on hospitalizations, drugs prescribed, physicians' fees, laboratory expenses, ambulatory visits, and transportation were retrieved. Costs were calculated from the French National Health System perspective.


RESULTS
The mean (95% confidence interval) total yearly cost per patient was Euro 47,477 (Euro 43,933; Euro 51,020) in the concentration-controlled group and Euro 46,783 ( Euro 44,152; Euro 49,414) in the fixed-dose group (P=0.7). The observed incremental cost-effectiveness ratio was Euro 3757 per treatment failure (Purchasing Power Parities United States/France: $4129). Hospitalization and drug costs accounted for approximately 50% and 25% of total costs, respectively. The cost for MPA area under the concentration-time curve and dose calculation was Euro 452 per patient, less than 1% of the total cost.


CONCLUSIONS
In the APOMYGRE trial, therapeutic MPA monitoring using a limited sampling strategy reduced the risk of treatment failure and acute rejection in renal allograft recipients during the first 12 months posttransplantation, at neutral cost.
INSERM UMR-S850, Limoges, France.
Annick
A
Rousseau
Marie-Laure
ML
Laroche
Nicolas
N
Venisse
Cecile
C
Loichot-Roselmac
Alain
A
Turcant
Guillaume
G
Hoizey
Patricia
P
Compagnon
Lionel
L
Hary
Danièle
D
Debruyne
Sylvie
S
Saivin
Evelyne
E
Jacqz-Aigrain
Mathias
M
Buchler
Claire
C
Villeneuve
Alain
A
Vergnenègre
Yannick
Y
Le Meur
Pierre
P
Marquet
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000553:Ambulatory Care / Q000191:economics; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000077552:Basiliximab; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control; D006650:Histocompatibility Testing; D006801:Humans; D007165:Immunosuppression Therapy / Q000191:economics / Q000379:methods; D007166:Immunosuppressive Agents / Q000191:economics / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D012086:Reoperation / Q000191:economics / Q000706:statistics & numerical data; D013557:Switzerland; D017211:Treatment Failure
D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D009173:Mycophenolic Acid