National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No. 6) (No. PB 48 of 2014)

Link to law: https://www.comlaw.gov.au/Details/F2014L00766

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PB 48 of 2014
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No. 6)
 
National Health Act 1953
___________________________________________________________________________
 
 
I, KIM BESSELL, 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 16 June 2014
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KIM BESSELL
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 for hospitals) Special Arrangement Amendment Instrument 2014 (No.6).
 
(2)                This Instrument may also be cited as PB 48 of 2014.
 
2              Commencement
This Instrument commences on 1 July 2014.
3              Amendments to PB 116 of 2010
Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).
 
 
Schedule 1       Amendments
[1]           Schedule 1, entry for Lanreotide in the form Powder for suspension for injection 30 mg (as acetate) with diluent
omit from the column headed “Circumstances”:            C2619  C3387                                     substitute:     C4559 C4567
[2]           Schedule 1, entry for Lanreotide in the form Injection 60 mg (as acetate) in single dose pre-filled syringe
(a)      omit from the column headed “Circumstances”: C2620  C2621  C3388  C3389                   substitute:      C4569  C4570  C4574  C4575
(b)      omit from the column headed “Number of Repeats”:      11        substitute:      5
[3]           Schedule 1, entry for Lanreotide in the form Injection 90 mg (as acetate) in single dose pre-filled syringe
(a)      omit from the column headed “Circumstances”: C2620  C2621  C3388  C3389                   substitute:      C4569  C4570  C4574  C4575
(b)      omit from the column headed “Number of Repeats”:      11        substitute:      5
[4]           Schedule 1, entry for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre-filled syringe
(a)      omit from the column headed “Circumstances”: C2620  C2621  C3388  C3389                   substitute:      C4569  C4570  C4574  C4575
(b)      omit from the column headed “Number of Repeats”:      11        substitute:      5
[5]           Schedule 1, entry for Octreotide in the form Injection (modified release) 10 mg (as acetate), vial and diluent syringe
(a)      omit from the column headed “Circumstances”:         C2624  C2625  C3409  C3410           substitute:        C4560 C4561 C4563 C4564 C4568 C4571
(b)      omit from the column headed “Maximum Quantity”:      1          substitute:      2
(c)      omit from the column headed “Number of Repeats”:      11        substitute:      5
[6]           Schedule 1, entry for Octreotide in the form Injection (modified release) 20 mg (as acetate), vial and diluent syringe
(a)      omit from the column headed “Circumstances”:        C2624  C2625  C3409  C3410            substitute:        C4560 C4561 C4563 C4564 C4568 C4571
(b)      omit from the column headed “Maximum Quantity”:      1          substitute:      2
(c)      omit from the column headed “Number of Repeats”:      11        substitute:      5
[7]           Schedule 1, entry for Octreotide in the form Injection (modified release) 30 mg (as acetate), vial and diluent syringe
(a)      omit from the column headed “Circumstances”:        C2624  C2625  C3409  C3410            substitute:        C4560 C4561 C4563 C4564 C4568 C4571
(b)      omit from the column headed “Maximum Quantity”:      1          substitute:      2
(c)      omit from the column headed “Number of Repeats”:      11        substitute:      5
[8]           Schedule 3, entry for Lanreotide
substitute:

Lanreotide
C4559
 
Where the patient is receiving treatment at/from a private hospital
Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 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, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Compliance with Written or Telephone Authority Required procedures


 
C4567
 
Where the patient is receiving treatment at/from a public hospital
Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 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, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4567


 
C4569
 
Where the patient is receiving treatment at/from a private hospital
Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; 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 120 mg every 28 days
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


 
C4570
 
Where the patient is receiving treatment at/from a public hospital
Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide 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, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4570


 
C4574
 
Where the patient is receiving treatment at/from a private hospital
Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide 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, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Compliance with Written or Telephone Authority Required procedures

 
C4575
 
Where the patient is receiving treatment at/from a public hospital
Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; 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 120 mg every 28 days
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 4575

[9]           Schedule 3, entry for Octreotide
(a)        omit:

 
C2624
 
Where the patient is receiving treatment at/from a private hospital
Acromegaly 
Acromegaly in a patient controlled on Sandostatin subcutaneous injections. 
In a patient treated with radiotherapy, treatment must cease 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). Octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. 
Treatment must cease if IGF1 is not lower after 3 months of treatment
Compliance with Written or Telephone Authority Required procedures

 
C2625
 
Where the patient is receiving treatment at/from a private hospital
Functional carcinoid tumour or VIPoma 
Functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) with symptom control on Sandostatin subcutaneous injections. 
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 Sandostatin subcutaneous 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

(b)        omit:

 
C3409              
 
Where the patient is receiving treatment at/from a public hospital
Acromegaly 
Acromegaly in a patient controlled on Sandostatin subcutaneous injections. 
In a patient treated with radiotherapy, treatment must cease 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). Octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. 
Treatment must cease if IGF1 is not lower after 3 months of treatment
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3409

 
C3410
 
Where the patient is receiving treatment at/from a public hospital
Functional carcinoid tumour or VIPoma 
Functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) with symptom control on Sandostatin subcutaneous injections. 
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 Sandostatin subcutaneous 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 3410

(c)        insert in numerical order following existing text:

 
C4560
 
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 and Telephone Authority Required procedures

 
C4561
 
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 and Telephone Authority Required procedures - Streamlined Authority Code 4561

 
C4563
 
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 remission
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4563

 
C4564
 
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 and Telephone Authority Required procedures - Streamlined Authority Code 4564

 
C4568
 
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 and Telephone Authority Required procedures

 
C4571
 
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 remission
Compliance with Written and Telephone Authority Required procedures