Budget impact analysis of discontinuing Tyrosin Kinase Inhibitors in patients with chronic myeloid leukemia achieving a complete molecular response by using probabilistic Markov approach (ECOSTIM)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Medico-economic study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01XE) Protein kinase inhibitors

  Protein kinase inhibitors
• Medical condition to be studied:
  Chronic myeloid leukaemia

Population studied

• Short description of the study population:
  Chronic myeloid leukemia (CML) patients aged 18 years or older treated with tyrosin kinase inhibitors (TKI) identified from the French nationwide claims and hospital database (SNIIRAM) for the study period of 1 January 2005 to 31 December 2015.; Inclusion criteria: ; • 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: ; • 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.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic myeloid leukemia patients
• Estimated number of subjects:
  800

Study design details

• Main study objective:
  The main objective of the study is to assess the budget impact, of discontinuing TKI treatment in patients with CML, treated since at least 3 years and achieving deep molecular response compared with current practice (treatment during entire life), between 2008 and 2015 from the healthcare system point of view, by using a probabilistic Markov model.
• Data analysis plan:
  The following analyses will be performed for the cohort: • A flow chart depicting the number of patients and sequences of treatment available in the database satisfying the cohort criteria and follow-up duration, • Description of baseline characteristics, comorbidities and CML diagnosis, • Description of the duration and causes of TKI discontinuation and the resumed TKI in case of treatment resumption in the year following the discontinuation, • Description of the healthcare resources use and costs

Documents

Study results

astrugue value in health 2021

Study publications

Astrugue C, Bénard A, Bosco-Levy P, Dulucq S, Rouyer M, Lassalle R, Hayes N, Ma…