Source: https://www.global-regulation.com/law/australia/229207/national-health-%2528listing-of-pharmaceutical-benefits%2529-amendment-instrument-2012-%2528no.-5%2529-%2528no.-pb-37-of-2012%2529.html
Timestamp: 2018-02-19 07:51:09
Document Index: 701236390

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1']

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 5) (No. PB 37 of 2012) (Australia)
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 5) (No. PB 37 of 2012)
Link to law: https://www.comlaw.gov.au/Details/F2012L01204
PB 37 of 2012
(No.5)1
Dated 7 June 2012
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 5).
(2) This Instrument may also be cited as PB 37 of 2012.
[1] Schedule 1, after entry for Amino acid formula with vitamins and minerals without methionine in the form Oral powder 500 g
[2] Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Oral powder 500 g (XPhen, Tyr Maxamum)
[3] Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Oral powder 500 g (MSUD Maxamum)
[4] Schedule 1, entry for Amino acids—synthetic, formula
Amino acids — synthetic, formula
C1687 C1688 C2734 C2735 C4033 C4034 C4035 C4036 C4037 C4038 C4039
P1687 P1688 P4033 P4034 P4035 P4036 P4037 P4038 P4039
P2734 P2735
C1687 C1688 C4033 C4034 C4035 C4036 C4037 C4038 C4039
Oral powder 400 g (Neocate Advance Tropical Flavour)
Neocate Advance Tropical Flavour
[5] Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
[6] Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and
[7] Schedule 1, entry for Apixaban
C3957 C3991 C4043 C4044 C4046
[8] Schedule 1, entry for Bortezomib
omit from the column headed “Form”: (with any determined brand of sodium chloride injection as the required solvent)
[9] Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, 10 g
(a) omit from the column headed “Responsible Person” for the brand “PAA” (twice occurring): NM substitute: IQ
(b) omit from the column headed “Responsible Person” for the brand “Viscotears” (twice occurring): NV substitute: AQ
[10] Schedule 1, entry for Carbomer in the form Eye gel 2 mg per g, single dose units 0.6 mL, 30
omit from the column headed “Responsible Person”: NV substitute: AQ
[11] Schedule 1, entry for Cefepime in the form Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)
[12] Schedule 1, entry for Ceftriaxone in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g (as sodium)
C1169 C1846 C1847
[13] Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)
Loxip 500
[14] Schedule 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)
Loxip 750
[15] Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
[16] Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
Pharmacor Clopidogrel 75
[17] Schedule 1, entry for Dabigatran etexilate
[18] Schedule 1, entry for Denosumab in the form Injection 120 mg in 1.7 mL
[19] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL [DBL Docetaxel Concentrated Injection]
[20] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [DBL Docetaxel Concentrated Injection]
[21] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL [DBL Docetaxel Concentrated Injection]
[22] Schedule 1, entry for Etonogestrel
omit from the column headed “Authorised Prescriber”: MP NP substitute: MP NP MW
[23] Schedule 1, entry for Fentanyl
Lozenges 200 micrograms (as citrate), 30
Lozenges 400 micrograms (as citrate), 30
Lozenges 600 micrograms (as citrate), 30
Lozenges 800 micrograms (as citrate), 30
Lozenges 1200 micrograms (as citrate), 30
Lozenges 1600 micrograms (as citrate), 30
[24] Schedule 1, entry for Gefitinib
C4029 C4030
[25] Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (Accu-Chek Performa)
Test strips, 100 (BGStar)
[26] Schedule 1, entry for Hypromellose in the form Eye drops 3 mg per mL, 15 mL
(a) omit from the column headed “Responsible Person” for the brand “Genteal” (twice occurring): NV substitute: AQ
(b) omit from the column headed “Responsible Person” for the brand “In a Wink Moisturising” (twice occurring): NM substitute: IQ
[27] Schedule 1, entry for Hypromellose with Carbomer 980 in the form Ocular lubricating gel 3 mg-2 mg per g, 10 g
(a) omit from the column headed “Responsible Person” for the brand “Genteal gel” (twice occurring): NV substitute: AQ
(b) omit from the column headed “Responsible Person” for the brand “HPMC PAA” (twice occurring): NM substitute: IQ
[28] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
[29] Schedule 1, entry for Levetiracetam in the form Tablet 250 mg
[30] Schedule 1, entry for Levetiracetam in the form Tablet 500 mg
[31] Schedule 1, entry for Levetiracetam in the form Tablet 1 g
[32] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
[33] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
[34] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
[35] Schedule 1, entry for Mirtazapine in each of the forms: Tablet 30 mg; and Tablet 45 mg
[36] Schedule 1, entry for Moclobemide in each of the forms: Tablet 150 mg; and Tablet 300 mg
Moclobemide-PS
[37] Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg
[38] Schedule 1, entry for Olanzapine in the form Tablet 5 mg
[40] Schedule 1, entry for Olanzapine in the form Tablet 10 mg
[41] Schedule 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium) [Max Quantity 30; Number of Repeats 1]
[42] Schedule 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium) [Max Quantity 30; Number of Repeats 5]
[43] Schedule 1, entry for Ondansetron
[44] Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Max Quantity 4; Number of Repeats 0]
[45] Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Max Quantity 10; Number of Repeats 1]
[46] Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Max Quantity 4; Number of Repeats 0]
[47] Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Max Quantity 10; Number of Repeats 1]
[48] Schedule 1, omit entry for Polygeline
[49] Schedule 1, entry for Protein hydrolysate formula with medium chain triglycerides
Oral powder 400 g (Alfaré)
C1034 C1059 C1068 C1080 C1092 C1310 C1364 C1670 C2567 C4040 C4041 C4042
Oral powder 450 g (Karicare Aptamil Pepti-Junior Gold)
Karicare Aptamil Pepti-Junior Gold
C1034 C1059 C1080 C1092 C1310 C1364 C1670 C2567 C4040 C4041 C4042
[50] Schedule 1, entry for Rivaroxaban
C3957 C3993 C4047 C4048 C4050
[51] Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 0]
(a) omit from the column headed “Responsible Person” for the brand “Terbihexal”: SZ substitute: HX
[52] Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 1]
[53] Schedule 1, entry for Teriparatide
C4031 C4032
[54] Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL
C3881 C3882
C4051 C4052
[55] Schedule 3, details relevant to Responsible person code GH
Goldshield Healthcare (Australia) Pty Limited
Mercury Pharma (Australia) Pty Limited
[56] Schedule 4, Part 1, entry for Amino acids—synthetic, formula
Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated colic or reflux) in a child up to the age of 24 months. Combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula. The name of the specialist and the date of birth of the patient must be included in the authority application
Initial treatment, in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist, for up to 6 months, for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The name of the specialist and the date of birth of the patient must be included in the authority application
Initial treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application
Treatment, in consultation with a specialist allergist or clinical immunologist, for a child with cows' milk anaphylaxis, up to the age of 24 months. Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction. The name of the specialist and the date of birth of the patient must be included in the authority application
Continuing treatment for cows' milk protein enteropathy with combined intolerance to both soy protein and protein hydrolysate formulae (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application
Continuing treatment for severe cows' milk protein enteropathy with failure to thrive (not isolated infant colic or reflux) in a child up to the age of 24 months. The child must have been assessed at least once or have an appointment to be assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. Then name of the specialist and the date of birth of the patient must be included in the authority application
Continuing treatment for combined intolerance (not isolated infant colic or reflux) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist at intervals not greater than 12 months. The name of the specialist and the date of birth of the patient must be included in the authority application
[57] Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids
[58] Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and
Initial treatment for up to 3 months, by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who requires an amino acid based formula as a component of a dietary elimination programme, and where:
(iii) eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy specimen had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;
the date of birth of the patient is included in the authority application;
treatment with oral steroids is not commenced during the period of initial treatment
Continuing treatment by a clinical immunologist, suitably qualified allergist or gastroenterologist in a patient 18 years of age or less with eosinophilic oesophagitis who has responded to an initial course of PBS-subsidised treatment, and where:
response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy specimen has 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies;
the response criteria will be deemed to have been not met if the patient commenced oral steroids during initial treatment
[59] Schedule 4, Part 1, entry for Apixaban
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy;
Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 15 days of therapy;
[60] Schedule 4, Part 1, entry for Dabigatran etexilate
[61] Schedule 4, Part 1, entry for Denosumab
[62] Schedule 4, Part 1, entry for Gefitinib
Initial PBS-subsidised treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a WHO performance status of 2 or less, where:
(1) disease progression has occurred following treatment with at least 1 chemotherapy agent; and
(2) there is evidence that the patient has an activating mutation(s) of the epidermal growth factor receptor (EGFR) gene in tumour material
Continuing PBS-subsidised treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a WHO performance status of 2 or less, where the patient has previously been issued with an authority prescription for gefitinib
[63] Schedule 4, Part 1, entry for Protein hydrolysate formula with medium chain triglycerides
Initial treatment, for up to 3 months, for intolerance (not infant colic) to both cows' milk protein and soy protein in a child up to the age of 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a soy protein as the principal formula, and where the date of birth of the patient is included in the authority application
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in a child up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in a child aged 2 years and over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides and soy protein is not tolerated or is likely not to be tolerated, and where the date of birth of the patient is included in the authority application
Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child has been assessed by a paediatric gastroenterologist or specialist allergist, and where the date of birth of the patient is included in the authority application
Initial treatment by, or in consultation with, a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child up to the age of 24 months. The child should have failed to respond to a strict soy-based cows' milk protein free diet. The date of birth of the patient must be included in the authority application
Continuing treatment by, or in consultation with, a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child up to the age of 24 months, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides. The date of birth of the patient must be included in the authority application
Treatment by a specialist allergist, clinical immunologist, paediatrician or specialist paediatric gastroenterologist for both cows' milk protein enteropathy and intolerance to soy protein (not isolated infant colic or reflux) in a child aged over 24 months. The child must have been assessed by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist. The name of the specialist and the date of birth of the patient must be included in the authority application
[64] Schedule 4, Part 1, entry for Rivaroxaban
[65] Schedule 4, Part 1, entry for Teriparatide
Initial treatment, as the sole PBS-subsidised agent, by a specialist or consultant physician, for severe, established osteoporosis in a patient with a very high risk of fracture who:
(a) has a bone mineral density (BMD) T-score of -3.0 or less; and
(b) has had 2 or more fractures due to minimal trauma; and
(c) has experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses
If treatment with anti-resorptive therapy is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, details of the contraindication must be provided at the time of application
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of 1 anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details of toxicities including severity must be provided at the time of application
Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months, disodium etidronate 200 mg with calcium carbonate 1.25 g per day, strontium ranelate 2 g per day and zoledronic acid 5 mg per annum
Details of prior anti-resorptive therapy, fracture history including the date(s) and site(s), the symptoms associated with the fracture(s) which developed during the course of anti-resorptive therapy, and the score of the qualifying BMD measurement must be provided to Medicare Australia at the time of application
Continuing treatment for severe established osteoporosis where the patient has previously been issued with an authority prescription for this drug
Teriparatide must only be used for a lifetime maximum of 18 months therapy (18 pens). Up to a maximum of 18 pens will be reimbursed through the PBS
[66] Schedule 4, Part 1, entry for Zoledronic acid
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4052