Budget Impact Analysis of Discontinuing Tyrosin Kinase Inhibitors in Patients With Chronic Myeloid Leukemia Achieving a Complete Molecular Response by Using Probabilistic Markov Approach

Plain-language summary

This study analyzed, using a probabilistic model, the budget impact on the health system of stopping tyrosine kinase inhibitor (TKI) treatment after chronic myeloid leukemia patients achieve a complete molecular response. It was based on records of patients aged 18 and older who had received at least 3 years of regular TKI treatment and then discontinued it. It was a non-phase study that has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

University Hospital, Bordeaux

Intervention

Budget impact

Start date

12/7/2016

Estimated completion

4/1/2019

Countries

France

Related genes

Locations

• Bordeaux, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Study period between 01/01/2005 and 12/31/2015 (cf. figure) including:

* Inclusion period: 01/01/2008 to 12/31/2014;
* Date of inclusion: date of the last TKI reimbursement before discontinuation which will be defined by the absence of any TKI reimbursement without the occurrence of death during at least 61 days following the 30-day coverage period of a TKI reimbursement;
* History: 3-year period;
* Follow-up: at least 1 year after inclusion or until death whatever occurs first.

Inclusion criteria for CML population

* Patients aged 18 years or over;
* Patients with LTD registration or hospitalization for CML (primary, associated and linked ICD-10 diagnosis code, i.e. C92.1 or C921) during the study period;
* Patients who discontinued their TKI treatment for the first time during the inclusion period;
* Patients treated with TKI during the inclusion period with a minimum of 3 year-period of TKI regular treatment before TKI discontinuation. A 3 year-period of TKI regular treatment will be defined on the presence of at least 10 TKI reimbursements per year during the 3 years preceding TKI discontinuation.

Exclusion criteria for CML population

* Patients who proceeded to allogeneic or autogenic hematopoietic stem-cell transplant (hospitalization ICD-10 code diagnosis Z94.80) in the 3 year-period prior to or in the month following the last TKI reimbursement identified before TKI discontinuation;
* Patients with HIV/AIDS (hospitalization ICD-10 code diagnosis B24) or chronic Hepatitis C or B (hospitalization ICD-10 code diagnosis B18) in the 3 year-period prior to or in the month following the last TKI reimbursement identified before TKI discontinuation;
* Recent (i.e. in the previous year) or ongoing pregnancy at TKI discontinuation date identified by an algorithm based on codes of hospitalization diagnoses and medical procedures.

Causes of TKI discontinuation will be further investigated in the cohort in order to conduct analyses only patients with a TKI discontinuation due to a complete molecular response.