1.  The whole of this instrument

1 May 2024

1 May 2024

Difelikefalin

Solution for I.V. injection 50 micrograms (as acetate) in 1 mL

Injection

Korsuva

C15171 C15211 C15227

See Schedule 2

See Schedule 2

Selinexor

Tablet 20 mg

Oral

Xpovio

C14021 C14022 C14023 C14024 C14031 C14037 C14039 C14045

See Schedule 2

See Schedule 2

Tacrolimus XR Sandoz

C5569 C9697

60

5

Tacrolimus XR Sandoz

C5569 C9697

120

5

Tacrolimus XR Sandoz

C5569 C9697

100

3

Tacrolimus XR Sandoz

C5569 C9697

60

5

Tenofovir Disoproxil Emtricitabine Mylan 300/200

C6985 C6986

60

5

Difelikefalin

C15171

Sufficient for treatment for 4 weeks

2

C15211 C15227

Sufficient for treatment for 4 weeks

5

Eltrombopag

C13327 C14126 C14127 C14129

1 pack

5

C15192

3 packs

3

C15173 C15174 C15191

3 packs

5

Selinexor

C14021 C14022 C14045

16

2

C14023 C14024 C14037

20

2

C14031 C14039

32

2

Difelikefalin

C15171

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.

Must be treated by a nephrologist.

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.

Compliance with Authority Required procedures

C15211

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

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated an adequate response to treatment with this drug including at least a 3-point improvement from baseline in 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score.

Must be treated by a nephrologist; OR

Must be treated by a medical practitioner in consultation with a nephrologist.

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 5 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.

Compliance with Authority Required procedures

C15227

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

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2024; AND

Patient must have met all other PBS eligibility criteria that a non-'Grandfather' patient would ordinarily be required to meet, meaning that at the time non-PBS-subsidised supply was commenced, the patient: (i) was on optimised haemodialysis; (ii) was on haemodialysis for at least 3 months; (iii) had a condition confirmed based on both physical examination and patient history to exclude any factors that may be triggering the pruritus; (iv) had experienced itch that persists for at least 6 weeks despite best supportive care; (v) had a 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) of more than 4 at baseline; AND

Patient must have demonstrated an adequate response to the most recent non-PBS-subsidised treatment with this drug for this condition, including at least a 3-point improvement from baseline in 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score.

Must be treated by a nephrologist.

Patient must be at least 18 years of age.

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 5 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.

Compliance with Authority Required procedures

C15173

Severe aplastic anaemia

Continuing treatment - Second line treatment

The condition must be severe aplastic anaemia; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; AND

Patient must have demonstrated a response to PBS-subsidised treatment with this drug.

Platelet, haemoglobin and neutrophil counts must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.

Once platelet count is greater than 50 x 109/L, haemoglobin is greater than 100 g/L in the absence of red blood cell (RBC) transfusion, and absolute neutrophil (ANC) is greater than 1 x 109/L for more than 8 weeks, the dose of eltrombopag should be reduced as per the Product Information.

For the purposes of this restriction, a response is defined as no longer meeting the criteria for severe aplastic anaemia.

Compliance with Authority Required procedures

C15174

Severe aplastic anaemia

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements - First line treatment

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2024; AND

The condition must be severe aplastic anaemia; AND

Patient must not have received treatment with immunosuppressive therapy for this condition prior to initiating non-PBS-subsidised treatment; AND

The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND

Patient must be considered ineligible for haemopoietic stem cell transplant; AND

Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime.

If the application is submitted through HPOS form upload or mail, it must include:

(i) A completed authority prescription form; and

(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

A patient may qualify for PBS-subsidised treatment under this restriction once only.

Compliance with Authority Required procedures

C15191

Severe aplastic anaemia

First line treatment

The condition must be severe aplastic anaemia; AND

Patient must not have received treatment with immunosuppressive therapy for this condition; AND

The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND

Patient must be considered ineligible for haemopoietic stem cell transplant; AND

Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime.

If the application is submitted through HPOS form upload or mail, it must include:

(i) A completed authority prescription form; and

(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Authority Required procedures

C15192

Severe aplastic anaemia

Initial treatment - Second line treatment

The condition must be severe aplastic anaemia; AND

Patient must not have achieved an adequate response to prior immunosuppressive therapy including anti-thymocyte antibody and ciclosporin; OR

Patient must have relapsed following prior immunosuppressive therapy including anti-thymocyte antibody and ciclosporin; AND

Patient must not receive more than 16 weeks of treatment under this restriction.

The authority application must be made via the online PBS Authorities (real time assessment), or in writing via HPOS form upload or mail and must include:

(a) prior immunosuppressive therapy, including dates of treatment.

If the application is submitted through HPOS form upload or mail, it must include:

(i) A completed authority prescription form; and

(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures