Study type

Study topic

Disease /health condition
Medical procedure

Study type

Non-interventional study

Scope of the study

Healthcare resource utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Case-control
Study drug and medical condition

Medical condition to be studied

Chronic kidney disease-associated pruritus
Population studied

Short description of the study population

Patients with vs without CKD-aP, based on the presence/absence of supplies of CKD-aP-related treatment (according to common clinical practice and guidelines), and undergoing in-hospital/outpatient hemodialysis

Age groups

  • In utero
  • Paediatric Population (< 18 years)
    • Neonate
      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
Study design details

Study design

During the 2015-2017 accrual period, patients with at least one in-hospital/outpatient hemodialysis procedure (ICD-9-CM code 39.95) were identified.
Patients with vs without CKD-aP were described at 1 year before/after index date for CKD-aP treatments and at 1-year follow-up for healthcare costs

Main study objective

This study identified hemodialysis patients presumably affected or not affected by CKD-aP and integrated healthcare costs, from the perspective of the Italian administrative healthcare data.

Setting

Italian inhabitants or potential beneficiaries of the SSN which is a universal coverage health system. Accrual period 2015-2017.
Overall observation period 2013-2018.
Selection criteria: in-hospital/outpatient hemodialysis procedure (ICD-9-CM code 39.95); reimbursed supplies of gabapentin, pregabalin, thalidomide and antihistamines, recommended by the current guidelines, and the performance of UV phototherapy were used as proxies of CKD-aP. Patients with CKD-aP were treated patients, while patients without CKD-aP were untreated patients, according to the treatments listed above.
Treatments had to be supplied 180 days before and/or 180 days after the hemodialysis, to be considered as associated to hemodialysis.

Comparators

an individual matched pair case-control analysis was performed to assess the average annual cost by healthcare administrative database and overall, through an even more realistic perspective. Matched variables were sex, age and local HA of residency.
Cases were people on hemodialysis potentially affected by CKD-aP, while controls were those without CKD-aP, according to the categorization by the presence or absence of CKD-aP-related treatments

Summary results

Of 1239 people on hemodialysis for ≥2 years, CKD-aP affected 218 patients.
Patients with CKD-aP were older and with more comorbidities. During the follow-up year, on average, the INHS spent €37,065 per case, €31,286 per control and € 35,988 per non-CKD-aP subject.
High-efficiency dialytic therapies performed to people on hemodialysis with CKD-aP largely weighed on the overall mean annual cost.