National Health Act 1953 Determinations under sections 85, 85A and 88 (No. PB 9 of 2005) (Cth)
COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DETERMINATIONS UNDER SECTIONS 85, 85A AND 88
No. PB 9 of 2005
I, SUSAN LEIGH CAMPION, Acting Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, pursuant to sections 85, 85A and 88 of the National Health Act 1953, hereby make the following Determinations:
1. These Determinations commence on 1 May 2005.
The Determinations under sections 85, 85A and 88 of the National Health Act 1953 made on 22 March 2005 with effect from 1 April 2005 are, in these Determinations, referred to as the Principal Determinations.
The First Schedule — Part 2 to the Principal Determinations is amended:
(a) in respect of the pharmaceutical benefits Hydromorphone Hydrochloride tablet 2 mg, tablet 4 mg, tablet 8 mg and oral liquid 1 mg per mL, 473 mL, by omitting the details in the column headed “Purposes” and substituting the following details:
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where treatment was initiated in a hospital (in-patient or out-patient) prior to 1 April 2005
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient’s pain management has been reviewed through consultation with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
(b) in respect of the pharmaceutical benefits Methadone Hydrochloride tablet 10 mg and injection 10 mg in 1 mL ampoule, by omitting the details in the column headed “Purposes” and substituting the following details:
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where treatment was initiated in a hospital (in-patient or out-patient) prior to 1 April 2005
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient’s pain management has been reviewed through consultation with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
(c) in respect of the pharmaceutical benefits Morphine Hydrochloride oral solution 2 mg per mL, 200 mL, oral solution 5 mg per mL, 200 mL and oral solution 10 mg per mL, 200 mL, by omitting the details in the column headed “Purposes” and substituting the following details:
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where treatment was initiated in a hospital (in-patient or out-patient) prior to 1 April 2005
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient’s pain management has been reviewed through consultation with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
(d) in respect of the pharmaceutical benefit Morphine Sulfate tablet 30 mg, by omitting the details in the column headed “Purposes” and substituting the following details:
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where treatment was initiated in a hospital (in-patient or out-patient) prior to 1 April 2005
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient’s pain management has been reviewed through consultation with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
(e) in respect of the pharmaceutical benefits Morphine Sulfate tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 15 mg (controlled release), tablet 30 mg (controlled release), tablet 60 mg (controlled release), tablet 100 mg (controlled release), capsule 10 mg (containing sustained release pellets), capsule 20 mg (containing sustained release pellets), capsule 30 mg (controlled release), capsule 50 mg (containing sustained release pellets), capsule 60 mg (controlled release), capsule 90 mg (controlled release), capsule 100 mg (containing sustained release pellets), capsule 120 mg (controlled release), sachet containing controlled release granules for oral suspension, 20 mg per sachet, sachet containing controlled release granules for oral suspension, 30 mg per sachet, sachet containing controlled release granules for oral suspension, 60 mg per sachet and sachet containing controlled release granules for oral suspension, 100 mg per sachet, by omitting the details in the column headed “Purposes” and substituting the following details:
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where treatment was initiated in a hospital (in-patient or out-patient) prior to 1 April 2005
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient’s pain management has been reviewed through consultation with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
(f) in respect of the pharmaceutical benefits Oxycodone Hydrochloride tablet 5 mg, capsule 5 mg, capsule 10 mg, capsule 20 mg and oral solution 5 mg per 5 mL, 250 mL, by omitting the details in the column headed “Purposes” and substituting the following details:
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where treatment was initiated in a hospital (in-patient or out-patient) prior to 1 April 2005
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient’s pain management has been reviewed through consultation with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
(g) in respect of the pharmaceutical benefits Oxycodone Hydrochloride tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 20 mg (controlled release), tablet 40 mg (controlled release) and tablet 80 mg (controlled release), by omitting the details in the column headed “Purposes” and substituting the following details:
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Chronic severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where treatment was initiated in a hospital (in-patient or out-patient) prior to 1 April 2005
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient’s pain management has been reviewed through consultation with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
(h) in respect of the pharmaceutical benefit Oxycodone Pectinate suppository equivalent to 30 mg oxycodone, by omitting the details in the column headed “Purposes” and substituting the following details:
Purposes: In compliance with authority procedures set out in subparagraph 11 (d):
Severe disabling pain associated with proven malignant neoplasia
Chronic severe disabling pain not responding to non-narcotic analgesics where treatment was initiated in a hospital (in-patient or out-patient) prior to 1 April 2005
Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient’s pain management has been reviewed through consultation with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Dated this 21st day of April 2005.
SUSAN LEIGH CAMPION
Acting Assistant Secretary
Pharmaceutical Benefits Branch
Department of Health and Ageing
Delegate of the Minister for Health and Ageing
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