National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 20 of 2009) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 20 of 2009
Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953
Amendment determination under subsection 85(2A) of the National Health Act 1953
I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.
Dated 3rd March 2009
DIANA MACDONELL
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment declaration and determination — drugs and medicinal preparations
1 Commencement
This instrument commences on 1 April 2009.
2 Amendment of PB 113 of 2008
Schedule 1 amends PB 113 of 2008.
Schedule 1 Amendments
Schedule 1, item dealing with Adalimumab
(a) omit from “Column 3” under the heading “Psoriatic arthritis” (first occurring):
| (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and |
(b) re-number next paragraph (5) in “Column 3” as (4)
Omit item dealing with Amino acid formula without phenylalanine, and vitamins with minerals
Schedule 1, after item dealing with Carbohydrate, fat, vitamins, minerals and trace elements
insert in the columns in the order indicated:
| Carbomer | In respect of the eye gel 2 mg per g, 10 g: Severe dry eye syndrome, including Sjogren's syndrome For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements In respect of the eye gel 2 mg per g, single dose units 0.6 mL, 30: In compliance with authority procedures set out in subparagraph 14 (d): Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops |
| 1359 |
Schedule 1, omit item dealing with Carbomer 980
Schedule 1, item dealing with Desmopressin
insert after existing text in the columns in the order indicated:
| In respect of the wafer 120 micrograms (as acetate): In compliance with authority procedures set out in subparagraph 14 (d): | |
| 2641 | Primary nocturnal enuresis in patients aged 6 years or older who are refractory to an enuresis alarm |
| 2642 | Primary nocturnal enuresis in patients aged 6 years or older for whom an enuresis alarm is contraindicated, and where the reason for the contraindication is documented in the patient's medical records when treatment is initiated |
Schedule 1, item dealing with Escitalopram
omit all text from “Column 3” after “Major depressive disorders” in respect of the oral solution 10 mg (as oxalate) per mL, 28 mL and substitute:
| Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared |
| Moderate to severe generalised anxiety disorder (GAD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist |
| Continuing PBS-subsidised treatment, for moderate to severe generalised anxiety disorder (GAD), of a patient commenced on escitalopram prior to 1 November 2008 |
| Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and for whom a GP Mental Health Care Plan, as described under item 2710 of the Medicare Benefits Schedule, has been prepared |
| Moderate to severe social anxiety disorder (social phobia, SAD), as described by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, in a patient who has not responded to non-pharmacological therapy and who has been assessed by a psychiatrist |
| Continuing PBS-subsidised treatment, for moderate to severe social anxiety disorder (social phobia, SAD), of a patient commenced on escitalopram prior to 1 November 2008 |
Schedule 1, item dealing with Etanercept
(a) omit from “Column 3” under the heading “Psoriatic arthritis” (first occurring):
| (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and |
(b) re-number next paragraph (5) in “Column 3” as (4)
Schedule 1, item dealing with Glucose Indicator―Blood
omit from “Column 3”:
electrode strips, 50 (Freestyle)
and substitute:
electrode strips, 50 (FreeStyle)
Schedule 1, item dealing with Oxycodone
omit from “Column 3”:
| In respect of the tablet containing oxycodone hydrochloride 5 mg (controlled release), tablet containing oxycodone hydrochloride 10 mg (controlled release), tablet containing oxycodone hydrochloride 20 mg (controlled release), tablet containing oxycodone hydrochloride 40 mg (controlled release) and tablet containing oxycodone hydrochloride 80 mg (controlled release): Chronic severe disabling pain not responding to non-narcotic analgesics |
and substitute:
| In respect of the tablet containing oxycodone hydrochloride 5 mg (controlled release), tablet containing oxycodone hydrochloride 10 mg (controlled release), tablet containing oxycodone hydrochloride 15 mg (controlled release), tablet containing oxycodone hydrochloride 20 mg (controlled release), tablet containing oxycodone hydrochloride 30 mg (controlled release), tablet containing oxycodone hydrochloride 40 mg (controlled release) and tablet containing oxycodone hydrochloride 80 mg (controlled release): Chronic severe disabling pain not responding to non-narcotic analgesics |
Schedule 1, item dealing with Pramipexole
omit all text from “Column 3” and substitute:
| In respect of the tablet containing pramipexole hydrochloride 125 micrograms: Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations |
| Treatment of severe primary restless legs syndrome in a patient who manifests all 4 diagnostic criteria listed below and whose baseline International Restless Legs Syndrome Rating Scale (IRLSRS) score is greater than or equal to 21 points prior to initiation of pramipexole, where the date and IRLSRS score are documented in the patient's medical records at the time pramipexole treatment is initiated, and where the diagnostic criteria for restless legs syndrome are: |
| (a) an urge to move the legs usually accompanied or caused by unpleasant sensations in the legs; and |
| (b) the urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting; and |
| (c) the urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues; and |
| (d) the urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur during the evening or night |
| In respect of the tablet containing pramipexole hydrochloride 250 micrograms: |
| Treatment of severe primary restless legs syndrome in a patient who manifests all 4 diagnostic criteria listed below and whose baseline International Restless Legs Syndrome Rating Scale (IRLSRS) score is greater than or equal to 21 points prior to initiation of pramipexole, where the date and IRLSRS score are documented in the patient's medical records at the time pramipexole treatment is initiated, and where the diagnostic criteria for restless legs syndrome are: |
| (a) an urge to move the legs usually accompanied or caused by unpleasant sensations in the legs; and |
| (b) the urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting; and |
| (c) the urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues; and |
| (d) the urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur during the evening or night |
| Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations |
| In respect of the tablet containing pramipexole hydrochloride 1 mg: Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations |
Schedule 1, item dealing with Risedronic acid and calcium with colecalciferol
insert in the columns in the order indicated after “In compliance with authority procedures set out in subparagraph 14 (d):”:
| 3070 | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated |
Schedule 1, item dealing with Sitagliptin
omit all text from “Column 3” and substitute in the columns in the order indicated:
| In compliance with authority procedures set out in subparagraph 14 (d): | |
| 3097 | Treatment of type 2 diabetes, in combination with metformin or a sulfonylurea, in a patient in whom a combination of metformin and a sulfonylurea is contraindicated or not tolerated, and: |
| (a) whose glycosylated haemoglobin (HbA1c) prior to initiation of sitagliptin is greater than 7%, despite treatment with either metformin or a sulfonylurea; or | |
| (b) in the case of patients who have clinical conditions with reduced red blood cell survival (including haemolytic anaemias and haemoglobinopathies) and/or who have had red cell transfusion within the previous 3 months — where blood glucose monitoring over a 2 week period prior to initiation of sitagliptin shows blood glucose levels greater than 10 mmol per L in more than 20% of tests, despite treatment with either metformin or a sulfonylurea; and | |
| where the qualifying HbA1c level and date of measurement, or the results of the blood glucose monitoring, whichever are applicable in the circumstance, are documented in the patient's medical records, and are no more than 4 months old, at the time sitagliptin treatment is initiated |
Schedule 1, item dealing with Ziprasidone
insert in the columns in the order indicated after existing text:
| 3084 | Monotherapy, for up to 6 months, of an episode of acute mania or mixed episodes associated with bipolar I disorder |
Schedule 1, item dealing with Zoledronic acid
omit all text from “Column 3” and substitute:
| In compliance with authority procedures set out in subparagraph 14 (d): |
| Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in women aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated, and where PBS-subsidised treatment is limited to 3 doses per patient in their lifetime, administered as 1 dose each year for 3 years |
| Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in women with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body, and where PBS-subsidised treatment is limited to 3 doses per patient in their lifetime, administered as 1 dose each year for 3 years |
| Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in men with hip fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, and where PBS-subsidised treatment is limited to 3 doses per patient in their lifetime, administered as 1 dose each year for 3 years |
Schedule 1, after item dealing with Zolmitriptan
insert in the columns in the order indicated:
| Zonisamide | In compliance with authority procedures set out in subparagraph 14 (d): |
| 2664 | Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs |
Schedule 2, item dealing with Oxycodone
omit from “Column 2”:
| In respect of the tablet containing oxycodone hydrochloride 5 mg (controlled release), tablet containing oxycodone hydrochloride 10 mg (controlled release), tablet containing oxycodone hydrochloride 20 mg (controlled release), tablet containing oxycodone hydrochloride 40 mg (controlled release) and tablet containing oxycodone hydrochloride 80 mg (controlled release): Chronic severe disabling pain not responding to non-narcotic analgesics |
and substitute:
| In respect of the tablet containing oxycodone hydrochloride 5 mg (controlled release), tablet containing oxycodone hydrochloride 10 mg (controlled release), tablet containing oxycodone hydrochloride 15 mg (controlled release), tablet containing oxycodone hydrochloride 20 mg (controlled release), tablet containing oxycodone hydrochloride 30 mg (controlled release), tablet containing oxycodone hydrochloride 40 mg (controlled release) and tablet containing oxycodone hydrochloride 80 mg (controlled release): Chronic severe disabling pain not responding to non-narcotic analgesics |
Schedule 2A, after item dealing with Aciclovir
insert in the columns in the order indicated:
| Carbomer | In respect of the eye gel 2 mg per g, 10 g: Severe dry eye syndrome, including Sjogren's syndrome |
| For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements | |
| In respect of the eye gel 2 mg per g, single dose units 0.6 mL, 30: In compliance with authority procedures set out in subparagraph 14 (d): | |
| Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops |
Schedule 2A, omit item dealing with Carbomer 980
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