National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 1) (PB 5 of 2016) (Cth)
PB 5 of 2016
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 1)
National Health Act 1953
___________________________________________________________________________
I, TONY WYND, Acting Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated 29 January 2016
Tony Wynd
Acting Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
1 Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 1).
(2)This Instrument may also be cited as PB 5 of 2016.
2 Commencement
This Instrument commences on 1 February 2016.
3 Amendment
Amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1, entry for Apomorphine
substitute:
Apomorphine Injection containing apomorphine hydrochloride 10 mg in 1 mL Injection Apomine HH EMP C4833 C4860 360 5 D Injection containing apomorphine hydrochloride 20 mg in 2 mL Injection Apomine
MovapoHH
TDEMP
EMPC4833 C4860
C4833 C4860360
3605
5D
DInjection containing apomorphine hydrochloride 50 mg in 5 mL Injection Apomine
MovapoHH
TDEMP
EMPC4833 C4860
C4833 C4860180
1805
5D
D
Schedule 1, entry for Eculizumab
substitute:
Eculizumab Solution concentrate for I.V. infusion 300 mg in 30 mL Injection Soliris XI EMP C5926 C5929 C5930 C5931 C5932 C5933 C5934 C5935 P5933 1 0 D C5926 C5929 C5930 C5931 C5932 C5933 C5934 C5935 P5931 1 4 D C5926 C5929 C5930 C5931 C5932 C5933 C5934 C5935 P5926 P5929 P5930 P5932 P5934 1 5 D C5926 C5929 C5930 C5931 C5932 C5933 C5934 C5935 P5935 1 6 D
Schedule 1, entry for Lamivudine in each of the forms: Tablet 100 mg; and Oral solution 5 mg per mL, 240 mL, and brand ‘Zeffix’
omit from the column headed “Responsible Person”: AS substitute: RW
Schedule 1, entry for Octreotide in each of the forms: Injection (modified release) 10 mg (as acetate), vial and diluent syringe: Injection (modified release) 20 mg (as acetate), vial and diluent syringe; and Injection (modified release) 30 mg (as acetate), vial and diluent syringe, and brand ‘Sandostatin LAR’:
omit from the column headed “Circumstances”: C5628 C5654 C5678 C5707 C5737 C5738
substitute: C5896 C5899 C5900 C5901 C5906 C5910Schedule 1, entry for Stavudine
omit:
Capsule 20 mg Oral Zerit BQ EMP C4454 C4512 120 5 D
Schedule 1, after entry for Tacrolimus in each of the forms: Capsule 0.5 mg; Capsule 1 mg; and Capsule 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”, after entry for Prograf:
TACROLIMUS APOTEX TX MP C5569 C5602 100 5 D
Schedule 1, entry for Thalidomide, in all forms
omit from the column headed ‘Circumstances’ : C1233 C3342
substitute: C5909 C5914
Schedule 1, entry for Valaciclovir in the form ‘Tablet 500 mg (as hydrochloride)’ and brand ‘Valtrex’:
omit from the column headed “Responsible Person” : AS substitute: RW
Schedule 1, entry for Valaciclovir in the form ‘Tablet 500 mg (as hydrochloride)’ and brand ‘Zelitrex’:
omit from the column headed “Responsible Person”: FM substitute: RF
Schedule 2, after entry for FK
omit:
FM Fawns and McAllan Proprietary Limited 16 004 296 066
Schedule 2, after entry for RO
insert:
RF Arrow Pharma Pty Ltd 35 605 909 920
Schedule 2, after entry for RF
insert:
RW Arrow Pharma Pty Ltd 35 605 909 920
Schedule 2, after entry for TB
insert:
TD Stada Pharmaceuticals Australia Pty Limited 73 154 966 944
Schedule 3, entry for Eculizumab,
substitute:
Eculizumab C5926 P5926 Atypical haemolytic uraemic syndrome (aHUS) - Continuing treatment
Patient must have received treatment under Extended Initial restriction with PBS subsidised eculizumab for this condition, AND
Patient must have demonstrated on-going treatment response of PBS-subsidised eculizumab treatment for this condition, AND
Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition, AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure .
A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and
(3) A copy of a current Certificate of vaccination; and
(4) A measurement of body weight at the time of application; and
(5) An identified genetic mutation, if applicable; and
(6) A family history of aHUS, if applicable; and
(7) A history of multiple episodes of aHUS before recommencing eculizumab treatment, if applicable; and
(8) A history of kidney transplant if applicable (especially if required due to aHUS); and
(9) An inclusion of the individual consequences of recurrent disease, if applicable; and
(10) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application; and
(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(12) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.Compliance with modified Authority Required procedures C5929 P5929 Atypical haemolytic uraemic syndrome (aHUS) - Extended Continuing treatment
Patient must have received treatment under the Continuing treatment with PBS-subsidised eculizumab for this condition,
AND
Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition, AND
Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition, AND
Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40%; OR
Patient must have severe TMA-related neurological impairment; OR
Patient must have severe TMA-related gastrointestinal impairment; OR
Patient must have severe TMA-related pulmonary impairment; OR
Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 ml/min), AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and
(3) A copy of a current Certificate of vaccination; and
(4) A measurement of body weight at the time of application; and
(5) An identified genetic mutation, if applicable; and
(6) A family history of aHUS, if applicable; and
(7) A history of multiple episodes of aHUS before commencing eculizumab treatment, if applicable; and
(8) A history of kidney transplant, if applicable (especially if required due to aHUS); and
(9) An inclusion of the individual consequences of recurrent disease; and
(10) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment; and
(11) Evidence that the patient has had a treatment response including haematological results of no more than 1 month old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 month old at the time of application; and
(12) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(13) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.Compliance with modified Authority Required procedures C5930 P5930 Atypical haemolytic uraemic syndrome (aHUS) - Recommencement of treatment
Patient must have demonstrated treatment response to previous treatment with PBS-subsidised eculizumab for this condition, AND
Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition, AND
Patient must have the following clinical conditions:(i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal;AND(ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L);OR(iii) TMA-related organ impairment including on recent biopsy, AND
*Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include:
(1) A completed authority prescription form(s); and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Recommencement of treatment; and
(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) A copy of a current Certificate of vaccination; and
(5) A measurement of body weight at the time of application, and
(6) An identified genetic mutation, if applicable; and
(7) A family history of aHUS if applicable; and
(8) A history of multiple episodes of aHUS following the treatment break, if applicable; and
(9) A history of kidney transplant if applicable (especially if required due to aHUS); and
(10) An inclusion of the individual consequences of recurrent disease; and
(11) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;
(12) Evidence that the patient has had a treatment response to their previous treatment with eculizumab; and
(13) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(14) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.Compliance with modified Authority Required procedures C5931 P5931 Atypical haemolytic uraemic syndrome (aHUS) - Initial treatment – Balance of Supply
Patient must have received PBS-subsidised initial supply of eculizumab for this condition, AND
Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample, AND
Patient must not receive more than 20 weeks supply under this restriction.
Patient must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.
ADAMTS-13 activity result must have been submitted to the Department of Human Services. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial Treatment, ADAMTS-13 activity must have been measured 1-2 weeks following the last plasma exchange or infusion, and must have been submitted to the Department of Human Services within 27 days of commencement of eculizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the two weeks prior to collection of the ADAMTS-13 assay must also have been provided to Department of Human Services.
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.Compliance with modified Authority Required procedures C5932 P5932 Atypical haemolytic uraemic syndrome (aHUS) - Grandfather eculizumab patient
Patient must have had documented history of active and progressing thrombotic microangiopathy (TMA), AND
Patient must have had documented an ADAMTS-13 activity level consistent with a diagnosis of aHUS, AND
Patient must have received treatment with eculizumab for this condition prior to 1 December 2014, AND
Patient must have received treatment with eculizumab within the last 6 months at the time of application, AND
Patient must have demonstrated on-going treatment response as specified in the Extended Initial treatment criteria for PBS-subsidised treatment with eculizumab for this condition, if the patient has received adequate therapy in order to demonstrate response, AND
Patient must not have experienced treatment failure with eculizumab for this condition as specified in the Extended Initial treatment criteria for PBS-subsidised treatment with eculizumab for this condition, AND
Patient must have clinical features of active organ damage or impairment at the time of a diagnosis of aHUS episode that required treatment with eculizumab, AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.
Evidence of active and progressing TMA is defined by the following:
(1) a platelet count of less than 150x10^9/L; and evidence of two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; OR
(2) tissue biopsy confirming TMA in patients who do not have evidence of platelet consumption and haemolysis; AND
(3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients; or
(iv) a renal biopsy
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for initial PBS-subsidised eculizumab treatment; and
(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) A copy of a current Certificate of vaccination; and
(5) A measurement of body weight at the time of application; and
(6) The result of ADAMTS-13 activity on a blood sample at the time this condition was diagnosed; and
(7) An identified genetic mutation, if applicable; and
(8) A family history of aHUS, if applicable; and
(9) A history of multiple episodes of aHUS before commencing eculizumab treatment, if applicable; and
(10) A history of kidney transplant if applicable (especially if required due to aHUS); and
(11) An inclusion of the individual consequences of recurrent disease; and
(12) Evidence that the patient has previously received treatment with eculizumab for this condition within the last 6 months at the time of application; and
(13) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application; or clinical reasons to justify the commencing of treatment with PBS-subsidised eculizumab; and
(14) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(15) A confirmed negative STEC (Shiga toxin-producing E.Coli) result if available at the time of diagnosis; or evidence that the diagnosis was not associated with an infection; and
(16) Where available in the week prior to commencing eculizumab results demonstrating:
(a) a platelet count of less than 150 x10^9/L; and evidence of two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; OR
(b) tissue biopsy confirming TMA in patients who do not have evidence of platelet consumption and haemolysis; AND
(c) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients; or
(iv) a renal biopsy
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment; and
(17) Where available within one month prior to commencement of eculizumab, evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.Compliance with modified Authority Required procedures C5933 P5933 Atypical haemolytic uraemic syndrome (aHUS) - Initial treatment
Patient must have active and progressing thrombotic microangiopathy (TMA),AND
Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L, AND
Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days, AND
Patient must have clinical features of active organ damage or impairment, AND
Patient must not receive more than 4 weeks of treatment under this restriction.
Patient must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.
Evidence of active and progressing TMA is defined by the following:
(1) a platelet count of less than 150x10^9/L; and evidence of two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; OR
(2) tissue biopsy confirming TMA in patients who do not have evidence of platelet consumption and haemolysis; AND
(3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients; or
(iv) a renal biopsy
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form - Initial PBS-subsidised eculizumab treatment; and
(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) A copy of a current Certificate of vaccination; and
(5) A measurement of body weight at the time of application; and
(6) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the two weeks prior to collection of the ADAMTS-13 assay; and
(7) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 1-2 weeks following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to the Department of Human Services within 27 days of commencement of eculizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised eculizumab treatment, under Initial treatment - balance of supply; and
(8) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days; and
(9) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within one month of application; and
(10) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.Compliance with modified Authority Required procedures C5934 P5934 Atypical haemolytic uraemic syndrome (aHUS) - Continuing recommencement of treatment
Patient must have received treatment under Recommencement of treatment restriction with PBS-subsidised eculizumab for this condition, AND
Patient must have demonstrated ongoing treatment response to the previous 24 weeks of PBS-subsidised eculizumab for this condition, AND
Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition, AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and
(3) A copy of a current Certificate of vaccination; and
(4) A measurement of body weight at the time of application; and
(5) An identified genetic mutation, if applicable; and
(6) A family history of aHUS, if applicable; and
(7) A history of multiple episodes of aHUS before recommencing eculizumab treatment, if applicable; and
(8) A history of kidney transplant if applicable (especially if required due to aHUS); and
(9) An inclusion of the individual consequences of recurrent disease, if applicable; and
(10) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application; and
(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(12) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.Compliance with modified Authority Required procedures C5935 P5935 Atypical haemolytic uraemic syndrome (aHUS) - Extended initial treatment - Assessment phase
Patient must have received treatment under the initial restriction with PBS subsidised eculizumab for this condition, AND
Patient must have demonstrated on-going treatment response of PBS-subsidised eculizumab treatment for this condition, AND
Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition, AND
Patient must not receive more than 56 weeks of treatment under this restriction.
Patient must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure .
A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
A maximum of up to 56 weeks of treatment is allowed under this restriction, however an application must be submitted at 6 months, 12 months, 18 months and 24 months following commencing PBS-subsidised eculizumab.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Extended Initial treatment; and
(3) A copy of a current Certificate of vaccination; and
(4) A measurement of body weight at the time of application; and
(5) An identified genetic mutation, if applicable; and
(6) A family history of aHUS, if applicable; and
(7) A history of multiple episodes of aHUS before commencing eculizumab treatment, if applicable; and
(8) A history of kidney transplant, if applicable, (especially if required due to aHUS); and
(9) An inclusion of the individual consequences of recurrent disease, if applicable; and
(10) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application; and
(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(12) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab.Compliance with modified Authority Required procedures
Schedule 3, entry for Octreotide
omit:
C5628 Where the patient is receiving treatment at/from a private hospital
Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures C5654 Where the patient is receiving treatment at/from a private hospital
Acromegaly
The condition must be controlled with octreotide immediate release injections,AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose), AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures C5678 Where the patient is receiving treatment at/from a public hospital
Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5678 C5707 Where the patient is receiving treatment at/from a private hospital
Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures C5737 Where the patient is receiving treatment at/from a public hospital
Acromegaly
The condition must be controlled with octreotide immediate release injections, AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose), AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5737 C5738 Where the patient is receiving treatment at/from a public hospital
Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5738 insert in numerical order after C3408:
C5896 Where the patient is receiving treatment at/from a private hospital
Acromegaly
The condition must be controlled with octreotide immediate release injections, AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose), AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures C5899 Where the patient is receiving treatment at/from a private hospital
Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures C5900 Where the patient is receiving treatment at/from a public hospital
Acromegaly
The condition must be controlled with octreotide immediate release injections, AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose), AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5900 C5901 Where the patient is receiving treatment at/from a public hospital
Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5901 C5906 Where the patient is receiving treatment at/from a public hospital
Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5906 C5910 Where the patient is receiving treatment at/from a private hospital
Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures
Schedule 3, entry for Thalidomide, in all forms
omit:
Thalidomide C1233 Where the patient is receiving treatment at/from a private hospital
Multiple myeloma.
Compliance with Written or Telephone Authority Required procedures C3342 Where the patient is receiving treatment at/from a public hospital
Multiple myeloma
Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3342 substitute:
Thalidomide P5909 Where the patient is receiving treatment at/from a private hospital
Multiple myeloma
Compliance with Written or Telephone Authority Required procedures P5914 Where the patient is receiving treatment at/from a public hospital
Multiple myeloma
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5914
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