Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Moderate to severe pruritus (itching) associated with chronic kidney disease

Initial treatment

Patient must be on optimised haemodialysis; AND

Patient must be on haemodialysis for at least 3 months; AND

The condition must be confirmed based on both physical examination and patient history to exclude any factors that may be triggering the pruritus; AND

Patient must have experienced itch that persists for at least 6 weeks despite best supportive care; AND

Patient must have a 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) baseline score of more than 4; AND

Patient must not receive more than 12 weeks of treatment under this restriction; AND

Must be treated by a nephrologist; AND

Patient must be at least 18 years of age.

Prescriber must exclude any other causes of pruritus which include any of the following:

(i) drug/dialysis related (e.g., opioid-related pruritus);

(ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy;

(iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; liver disease; polycythaemia vera/leukemia/lymphoma; hypothyroidism; uncontrolled diabetes).

Best supportive care for patients with chronic kidney disease-associated pruritus is not limited to but includes:

(i) optimisation of dialysis;

(ii) skin hydration and nutrition (with the use of moisturiser, emollients, barrier creams or oils);

(iii) patient education on the importance of avoiding or minimising scratching.

Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the dry body weight of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 2 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4.