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Abstract Number: 742

Utility of HLA-B5801 Genotyping and Renal Dosing of the Starting Dose of Allopurinol in Preventing Allopurinol Hypersensitivity Syndrome: A Cost-Effectiveness Analysis

Yanyan Zhu1, Ada Man2, Tuhina Neogi3 and Hyon K. Choi4, 1Clinical Epidemiology, Boston University School of Medicine, Boston, MA, 2Rheumatology, Boston University School of Medicine, Boston, MA, 3Boston University School of Medicine, Boston, MA, 4Section of Rheumatology and the Clinical Epidemiology Unit, Boston University School of Medicine, Boston, MA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: gout

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Session Information

Title: Epidemiology and Health Services Research I: Epidemiology and Outcomes in Rheumatic Disease

Session Type: Abstract Submissions (ACR)

Background/Purpose: Allopurinol is the leading choice of urate-lowering therapy (~ 95%) for gout which affects 8.3 million US adults. However, allopurinol is associated with a rare but potentially fatal reaction: allopurinol hypersensitivity syndrome (AHS). Studies have shown that HLA-B5801 allele carriage and renal impairment are strongly associated with AHS, suggesting utility of considering these factors in treatment decisions to prevent AHS and AHS-related deaths.  We examined the cost-effectiveness of HLA-B5801 genotyping and renal dosing in preventing AHS and AHS-related deaths.

Methods: We built a decision model to compare 4 treatment strategies for 1 million hypothetical patients starting allopurinol in the US.  All key parameters and costs were derived from the literature, including the risk of AHS: 0.163%, the risk of death among AHS cases: 26%, the probabilities of HLA-B5801 allele carriage: 0.01 (Caucasians) and 0.07 (Asians), relative risk (RR) of AHS among HLA-B5801 positive patients: 96.6, sensitivity for predicting AHS by renal dosing: 90% [1], HLA-B5801 genotyping cost: $45.11 and the average AHS hospitalization cost: $50,152. Sensitivity analyses were conducted by varying the risk of AHS, RR of AHS among HLA-B5801 positive patients, sensitivity for predicting AHS by renal dosing, and AHS hospitalization cost.

Results: Initiating treatment in all patients with the standard dose resulted in 1630 AHS cases and 424 AHS related deaths. Compared with the standard dose strategy, the combined use of HLA-B5801 genotyping and renal dosing prevented 95% of AHS cases and AHS-related deaths, and saved $32,500,684. It led to incremental cost-effectiveness ratios (ICERs) of -$21,009 per AHS case avoided and -$80,647 per death avoided among Caucasians (i.e., cost-saving).  Compared with renal dosing alone, the combined use of HLA-B5801 genotyping and renal dosing avoided 80 more AHS cases and 21 more AHS-related deaths at an incremental cost of $41,072,740, resulting in ICERs of $513,409 per AHS case avoided and $1,955,845 per death avoided among Caucasians. The corresponding effectiveness and ICERs were more favorable among Asians (Table). Sensitivity analyses suggested the results were robust to variation in these model parameters.

Conclusion: The combined use of the HLA-B5801 genotyping and renal dosing of the starting dose of allopurinol was able to avert the majority of AHS cases and AHS-related deaths.  The ICERs were especially favorable among Asians due to a higher probability of HLA-B5801 allele carriage. Since renal dosing was responsible for the majority of the reduction of AHS and AHS-related deaths at no incremental costs, this strategy alone was the most cost-effective.  However, the combined use of the HLA-B5801 genotyping and renal dosing was considered cost-effective given that $7 million in the US is the median acceptable cost per life saved [2]. 

Table  Results of the Base Case Analysis*

Population

Strategy

Incremental cost

(per million patients)

AHS

Death

Cases

avoided

ICER

(per case)

Deaths

avoided

ICER

(per death)

Compared with the standard starting dose for all patients strategy

US Caucasians

1. Standard starting dose (300mg/day) for all patients

–

–

–

–

–

 

 

 

 

 

 

 

 

2. Renally-adjusted starting dose (1.5 mg allopurinol per unit eGFR (mg/ml/min)) for all patients

-$73,573,424

1467

-$50,152

382

-$192,601

 

 

 

 

 

 

 

 

3. Standard starting dose for HLA-B5801 negative patients

$4,737,399

805

$5,885

209

$22,667

 

 

 

 

 

 

 

 

4. Renally-adjusted starting dose for HLA-B5801 negative patients

-$32,500,684

1547

-$21,009

403

-$80,647

 

 

 

 

 

 

 

US Asians

1. Standard starting dose for all patients

–

–

–

–

–

 

 

 

 

 

 

 

 

2. Renally-adjusted starting dose for all patients

-$73,573,424

1467

-$50,152

382

-$192,601

 

 

 

 

 

 

 

 

3. Standard starting dose for HLA-B5801 negative patients

-$26,754,490

1433

-$18,670

373

-$71,728

 

 

 

 

 

 

 

 

4. Renally-adjusted starting dose for HLA-B5801 negative patients

-$35,649,873

1610

-$22,143

419

-$85,083

 

 

 

 

 

 

 

Compared with the renally-adjusted starting dose for all patients strategy

US Caucasians

2. Renally-adjusted starting dose for all patients

–

–

–

–

–

 

 

 

 

 

 

 

 

4. Renally-adjusted starting dose for HLA-B5801 negative patients

$41,072,740

80

$513,409

21

$1,955,845

 

 

 

 

 

 

 

US Asians

2. Renally-adjusted starting dose for all patients

–

–

–

–

–

 

 

 

 

 

 

 

 

4. Renally-adjusted starting dose for HLA-B5801 negative patients

$37,923,551

143

$265,200

37

$1,024,961

*Negative dollar amounts = cost-saving

References:

[1] Stamp LK, Taylor WJ, Jones PB, Dockerty JL, Drake J, Frampton C, Dalbeth N. Starting dose is a risk factor for allopurinol hypersensitivity   syndrome: A proposed safe starting dose of allopurinol. Arthritis Rheum. 2012 Apr 5. doi: 10.1002/art.34488

[2]  W. Kip Viscusi. The value of life. The Harvard John M. Olin Discussion Paper Series. 2005. http://www.law.harvard.edu/programs/olin_center/papers/pdf/Viscusi_517.pdf


Disclosure:

Y. Zhu,
None;

A. Man,
None;

T. Neogi,
None;

H. K. Choi,
None.

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