The is usually a subject of debate and discord

The
use of rituximab
as a treatment option of choice in sjogren’s syndrome, has been extensively
studied 40-42.
The findings of all studies which were either reports, randomized trials or
open label have been variable 40-42.
The primary outcome measures, reduction of patient-reported dryness and fatigue
has been under question in two largest randomized trials of rituximab and the
goals were not met as well 43, 44. Few retrospective open label trials and
registry analyses reported that the drug might have benefit for specific
extraglandular manifestations 40-42. Similarly, Sjogren’s syndrome Foundation
clinical practice guidelines (CPGs) recommendations are feeble for the use of
rituximab in sicca symptoms and modest for other systemic symptoms of this
disease 45.

Rituximab is one of the most expensive drugs with a
calculated high cost for the treatment of patients in our study, similar to
reports of other studies 2-6. Cost is usually a subject of debate and discord
in the perspective of off-label drug use, due to limited case based evidence
and uncertainty of the cost–benefit rate. Therefore controversy exists in the
off-label prescription of many drugs. For the advantage of healthcare managers,
physicians, pharmaceutical manufacturing, and patients’ demands, reliable
decision-making is necessary. Based on the poor prognosis nature of patients’
condition and the inability of alternative treatments to provide good results,
many physicians believe that the use of these drugs may be justified
accordingly. Pharmaceutical companies are mostly concerned in increasing the
use of their products even in off-label indications 48. Healthcare managers
are not interested in restoring the treatment cost while there is little
scientific evidence supporting their use 49. When an expensive drug is
required for an off-label indication, careful evaluation of cases and
reasonable prospects regarding clinical outcome should be 

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