Treatment delivery Frequency of use: Re-treatment could be considered appropriate upon recurrence or deterioration of symptoms if a maintenance regimen has not been implemented. Duration of use: After 8 weeks should no significant reduction in symptoms be seen, treatment would be stopped. Clinical setting: Administration will be performed in the specialist consulting rooms, in private hospitals and aged care facilities – places where urethral catheterization can competently take place by trained personnel. Pre-procedure patient preparation: Minimal – light sedation for some patients. Personnel performing the procedure; Urologist, uro-gynaecologists, gynaecologists, urology nurses (under supervision), and other clinical practitioners trained in urothelial catheterisation. Additional equipment or product required for performing the procedure: 8Ch catheter, sterile swab for cleaning urethral opening, anaesthetic gel for catheter insertion, jar for excess urine collection). Additional training required before medical staff can administer the product: Nil. This service is not for investigative purposes. This service includes the use of a registered trademarked device, iAluRil®. This product contains sterile solution of sodium hyaluronate (1.6% - 800 mg/50 mL) and sodium chondroitin sulphate (2% - 1 g /50 mL). Delivery as a 50 mL pre-filled syringe for intravesical instillation. Proposed Setting The proposed setting for the delivery of this service is outpatient settings such as clinics or consulting rooms. The product can also be used in a hospital in-patient setting. Details of the delivery of this service include: The procedure is to be performed by qualified personnel under controlled and sterile conditions. The procedure can be performed in clinic/surgery rooms by a trained nurse, general practitioner or urologist, or in a hospital setting by adequately trained staff. The intended treatment duration is 12 weeks (7 instillations) or longer depending on the severity of symptoms and chance of remission. iAluRil is instilled directly into the bladder using a thin tube (in/out catheter) that is passed through the urethra into the bladder. Note: An in/out catheter is used rather than an indwelling catheter. Co-dependent information Not applicable.
UTI (likely associated with repeat catheterisation) Urinary storage symptoms (muscular hypertone induced by pain). Of note, according to post-marketing experience, urinary storage symptoms (increased frequency and urgency) have been recorded with very rare frequency. Type of economic evaluation. The economic evaluation will be a cost-effectiveness / cost-utility analysis. Fee for the proposed medical service As a service rendered in an outpatient setting, the type of funding proposed for this service is a fee, payable to the service provider. It is intended that an application seeking the inclusion of iAluRil on the Prostheses List will also be submitted. As with all new MBS Items, the proposed fee for this service will be based on the time taken, the degree of difficulty and the expertise required to perform the service and will be in line with the MBS fee for ‘similar’ services. The proposed service fee will accommodate the following: Professional Time Treating physician or urology nurse: total estimated at 20 minutes (which includes initial patient discussion (5 minutes), preparation of materials (10 minutes), and instillation (5 minutes). Due to the anxiety and pain sometimes associated with these conditions and the area of catheterisation, some patients may also require a pre-instillation admission of a light oral sedative (30 mins prior), adding to the total patient engagement time. Consumables IAluRil (at this point in time) per instillation ranges between $215 - $235 depending upon pharmacy markup. In/out catheter <$10 Latex/rubber gloves <$1 Chlorhexidine solution (prep solution) <$1 Container for residual urine collection <$1 Sterile drapes < $5 Concomittant medications Anaesthetic gel (KY gel or lignocaine syringe) <$2 Light oral sedative <$1 Relevant peri-procedure costs NA. It is anticipated that the MBS scheduled fee will be greater than: