Cost-utility Analysis of the AlloMap® Test

NCT02602691 | Completed DMC

• 2 other identifiers: 69HCL14_0455IDRCB
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 13

Brief Summary

Transplant rejection is one of the most important complications of heart transplantation and requires a specific monitoring, including regular and invasive endomyocardial biopsies. The average hospital cost of a biopsy has been estimated at 3 297 dollars in United States. In France, the reimbursement rates by the Health Insurance for the corresponding stays vary from 682 to 25 865 euros, according to the finding of a rejection and its severity. AlloMap® is a non-invasive blood test that can identify patients with low probability of moderate to severe acute cell transplant rejection. The non-inferiority of the use of the AlloMap® test has been demonstrated in comparison of the usual care in terms of diagnosis of acute cellular rejection in a randomized study conducted in the United States. Following this study, the ISHLT (International Society of Heart and Lung Transplantation) made recommendations advocating its use for these patients between 6 months and 5 years after heart transplantation. This new test could be an alternative to systematic biopsies usually performed to patients whose allograft function is stable, but it is very expensive since the analysis of a blood sample cost 2 000 euros pre-tax in France. This cost has to be compared with the current patient care. By replacing biopsies performed systematically, the test should reduce the costs of full and day hospitalizations for the realization of biopsies but also the costs associated with their possible complications. In addition, it can be expected that its use provides a benefit to the patient in terms of quality of life. Indeed, the achievement of a biopsy may cause significant stress and anxiety for the patient, due to discomfort, pain and potential complications that may be severe. To this day, no medico-economic assessment has been conducted to prove the interest of the use of AlloMap® compared to systematic realization of endomyocardial biopsies. The purpose of the CUPIDON study is to assess the effectiveness of the use of the AlloMap® test for monitoring heart transplant patients in the context of usual care and in accordance with international recommendations. AlloMap® will be used and compared to the current surveillance strategy by endomyocardial biopsies from 6 months to 36 months after heart transplantation. The investigators hypothesize that the use of this test for the diagnosis of acute cellular transplant rejection would avoid the costs of a large number of biopsies, while increasing the quality of life of patients related to their health.

Conditions

Heart Transplantation

Keywords

Heart transplantation; AlloMap® gene expression profiling test; Medico-economic study

Outcome Measures

Primary Outcomes (1)

• Incremental cost per quality-adjusted life-years (QALY) between systematic biopsies and use of the gene expression profiling blood test AlloMap® in monitoring of heart transplant patients for rejection

  QALY will be measured using the EQ-5D quality of life questionnaire. The cost analysis will be conducted from the viewpoints of the French Health Insurance and the hospital, considering only hospital direct costs. All resource consumption, outside the AlloMap® test, will be commonly valued by standard costs.

  36 months after heart transplantation

Secondary Outcomes (16)

• Budget Impact analysis: estimation of the cost difference of the care of heart transplant patients before and after the introduction of the AlloMap® test

  36 months after heart transplantation

• Quality of life

  At inclusion visit (5 months after heart transplantation)

• Quality of life

  At 12 months after heart transplantation

• Quality of life

  At 18 months after heart transplantation

• Quality of life

  At 24 months after heart transplantation

Study Arms (2)

Endomyocardial biopsy

ACTIVE COMPARATOR

Systematic endomyocardial biopsies performed according to a planned monitoring schedule in usual care for patients with a heart transplantation.

Procedure: Endomyocardial biopsies

AlloMap® test

EXPERIMENTAL

Noninvasive gene expression profiling blood test (AlloMap®) performed instead of endomyocardial biopsies when planned in the monitoring schedule for patients with a heart transplantation.

Other: AlloMap®

Interventions

AlloMap® OTHER

AlloMap® test

Endomyocardial biopsies PROCEDURE

Endomyocardial biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Heart transplantation since 5 months (+/- 3 weeks)
• Stable allograft function :
• Left ventricular ejection fraction ≥ 50% measured by echocardiography
• No sign of the presence of humoral rejection or DSA (donor-specific antibodies)
• Absence of biopsy-proven or treated acute cellular rejection in the previous 3 months
• Signed consent to participate in the study
• Patient affiliated to a social security scheme or similar

You may not qualify if:

• All symptoms or clinical signs of graft failure
• Treatment of a transplant rejection with ISHLT grade 2R or higher (proven by biopsy) during the previous 3 months
• Change of immunosuppressive molecule in the previous 30 days
• Treatment with hematopoietic growth factors in progress or during the previous 30 days
• Transfusion during the previous 30 days
• End-stage renal failure requiring renal replacement therapy (hemodialysis or peritoneal dialysis)
• Major patient protected by law

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (13)

CHU, Hôpital du Haut Lévèque

Bordeaux, France

Location

CHU, Hôpital Michallon

La Tronche, France

Location

CHRU de Lille

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

CHU, Hôpital La Timone

Marseille, France

Location

CHU A. de Villeneuve

Montpellier, France

Location

CHU, Hôpital Nord Laennec

Nantes, France

Location

AP-HP, Hôpital Bichat

Paris, France

Location

AP-HP, Hôpital La Pitié Salpêtrière

Paris, France

Location

CHU de Rennes

Rennes, France

Location

CHU, Hôpital Charles Nicolle

Rouen, France

Location

CHRU de Strasbourg

Strasbourg, France

Location

CHU, Hôpital Rangueil

Toulouse, France

Location

Study Officials

• Laurent SEBBAG, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 11, 2015
• Study Start: April 1, 2016
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

FR (13)