The Lynx Group

Adverse Events Associated with Tyrosine Kinase Inhibitors Carry High Economic Burden

May 2016, Vol 7, No 4

A study using the FDA Adverse Event Reporting System (FAERS) has demonstrated the high cost burden of adverse events (AEs) associated with the use of tyrosine kinase inhibitors (TKIs) in patients with chronic myelogenous leukemia (CML). The results were presented at ASH 2015 by Nicola Wallis, MRCPath, FFPM, Bristol-Myers Squibb, Princeton, NJ.

The total medical cost per patient with CML exceeded $17,000 for those with femoral arterial stenosis (FAS) and $15,000 for patients with peripheral arterial occlusive disease (PAOD).

“The healthcare costs associated with the AEs identified in the FAERS as having the strongest association with TKI treatment may be substantial,” said Ms Wallis. “Vascular stenosis–related AEs, including FAS and PAOD, appear to have the highest cost burden.”

The introduction of BCR-ABL1 TKIs transformed the face of treatment for CML, but these treatments are not without their complications, said Ms Wallis.

“Patients nowadays have a long life expectancy, which is considered to be near normal,” she said. “However, treatment with these drugs has been associated with infrequent but clinically serious adverse events.”

According to Ms Wallis, the clinical trial data are limited by the study sample size, the entry criteria, and the follow-up duration; therefore, the real-world cost burden of AEs associated with TKIs has not been well-studied.

Study Details

The FAERS is a large, publicly accessible database that supports postmarketing safety surveillance programs for approved drugs and biologics. Statistical database techniques, said Ms Wallis, have been developed to identify the potential AEs that are associated with imatinib (Gleevec), dasatinib (Sprycel), and nilotinib (Tasigna).

The researchers selected the AEs that were identified as the most highly associated with the specific TKI, including:

  • Conjunctival hemorrhage (imatinib)
  • Pleural effusion, malignant pleural effusion, and pericardial effusion (dasatinib)
  • FAS, PAOD, intermittent claudication, and coronary artery stenosis (nilotinib).

The healthcare utilization and costs associated with all select AEs during the 12-month follow-up period were evaluated, irrespective of the TKI prescribed.“Total mean healthcare costs were highest and in the same range for patients with FAS and PAOD, while the lowest financial costs were associated with the management of conjunctival hemorrhage,” said Ms Wallis.

The greatest number of hospitalizations was observed for patients with PAOD, and only patients with PAOD or with coronary artery stenosis required more than 1 hospitalizations during the 12-month follow-up period.

“Length of stay was longest and of similar magnitude for patients with FAS and PAOD, reflective, to some extent, of their overlapping ideology,” said Ms Wallis.

“Inpatient costs primarily reflected the length of stay for the management of this disease, so the mean costs were highest in the FAS and PAOD groups,” she said. “Outpatient costs, on the other hand, were slightly different, with the greatest mean financial burden being associated with” coronary arterial stenosis ($1861).

For the outpatient-specific costs, PAOD, intermittent claudication, and pleural effusion were similar in magnitude, at approximately half the cost of coronary arterial stenosis.

“Obviously, the FAERS database is imperfect and relies on physician reporting,” said Ms Wallis. “Claims are subject to possible coding errors, including undercoding and overcoding, and verification of reported diagnoses is a challenge,” she added.

“That being said, the potential AE cost implications should be considered when treating patients with CML,” she concluded.

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