Positive Recommendations made by the PBAC in December 2001

Positive Recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in December 2001

Table containing PBAC Positive Recommendations for December 2001
Drug and Form Drug use and type Listing requested by Sponsor PBAC Recommendation and Comments
Amoxycillin trihydrate, tablets 1g, Maxamox® - Biochemie Australia Pty Ltd

New listing

 An antibiotic Unrestricted listing Recommended for restricted benefit listing for acute exacerbations of chronic bronchitis, on the basis that this restriction is in accord with the TGA-approved indication.
Carbomer 980 ocular lubricating gel, 2mg per g (0.2%) 30 x 0.6 g single dose units, Viscotears® - Novartis Pharmaceuticals Pty Ltd

New listing

 Ocular lubricant Authority required listing for severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops. Recommended for listing as requested.
Ciprofloxacin tablets 250 mg, 500 mg and 750 mg, Ciproxin®, Bayer Australia Limited

Change to listing

 A fluoroquinolone antibiotic Retain the listing for immunocompromised patients. Amend the listing for as follows:

Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients;

Bacterial gastroenteritis proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients.

Recommended to clarify that this is the patient group to whom ciprofloxacin should be targeted to limit further the possibility of development of resistance.

Clonazepam tablets 500 g and 2 mg Rivotril®- Roche Product Pty Ltd and Paxam - Alphapharm Pty Ltd

Change restriction

 A benzodiazepine used to treat epilepsy. Amend authority required restriction to "Neurologically proven epilepsy" and add a caution "Abuse of clonazepam has been reported. Refer to the current product information." Recommended following advice from the Health Insurance Commission that clonazepam continues to be a drug of abuse.
Clostridium botulinum type A haemagglutinin complex, Dysport® - Ipsen Pty Ltd

Additional indication

 A drug to treat spasticity. Treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients 2 years of age or older. Recommended as requested. A minor change was also recommended to the Botox brand for consistency by insertion of the word "ambulant"

 

Table containing PBAC Positive Recommendations for December 2001
Drug and Form Drug use and type Listing requested by Sponsor PBAC Recommendation and Comments
Dalteparin sodium, pre-filled syringes 5 000 units, 7 500 units, and 10 000 units Fragmin® - Pharmacia Australia Pty Ltd

Change listing

 An antithrombotic. Transfer to unrestricted listing Recommended as requested for consistency with September 2001 recommendation for enoxaparin (Clexane®).
Donepezil hydrochloride, tablets 5 mg and 10 mg, Aricept®, Pfizer Pty Ltd

Amend restriction

 A drug to treat mild to moderate Alzheimer's disease To allow certain patients who cannot achieve a score on the MMSE scale of 10 or more, for reasons other than their Alzheimer's disease (AD), who would normally be diagnosed as suffering from severe AD, subsidised access to the drug. The PBAC recommended that the restriction be revised for equity reasons, as follows:

Initial treatment of mild to moderately severe Alzheimer's disease. Confirmation of this diagnosis must be made by a specialist/consultant physician (including a psychiatrist). The authority application must be in writing and include the result of the baseline Mini-Mental State Examination (MMSE). This baseline MMSE must be a score of 10 or more and, if this score is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) must also be specified. Up to a maximum of 1 month's therapy plus 5 repeats will be issued.

Continuing treatment, following initial therapy, of mild to moderately severe Alzheimer's Disease in patients with demonstrated improvement in cognitive function as measured by an increase of at least 2 points from baseline on the Mini-Mental State Examination (MMSE); OR a decrease of at least 4 points from baseline on the Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) for patients with an MMSE baseline score of at least 25 points (the initial authority application for continuing treatment must include the relevant result from the MMSE or the ADAS-Cog and must be in writing);

Initial treatment of mild to moderately severe Alzheimer's disease of patients with a baseline Mini-Mental State Examination (MMSE) score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, as specified below. Confirmation of this diagnosis must be made by a specialist/consultant physician (including a psychiatrist). Such patients will need to be assessed subsequently using the Clinicians Interview Based Impression of Change (CIBIC) scale. The authority application must be in writing, include the result of the baseline MMSE and specify to which group(s) (see below) the patient belongs. Patients who qualify under this criterion are from one or more of the following groups:

  1. Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
  2. Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
  3. Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE test;
  4. Intellectual (developmental or acquired) disability, eg Down's syndrome;
  5. Significant sensory impairment despite best correction, which precludes completion of an MMSE test;
  6. Prominent dysphasia, out of proportion to other cognitive and functional impairment.

Up to a maximum of 1 month's therapy plus 5 repeats will be issued.


Continuing treatment, following initial therapy, of mild to moderately severe Alzheimer's Disease in patients with demonstrated improvement in function, based on a rating of "very much improved" or "much improved" on the CIBIC scale, which must be assessed by the same clinician who initiated treatment (the initial authority application for continuing treatment must state the improvement achieved on the CIBIC scale and must be in writing).
Eptifibatide bolus injection 20 mg per 10 mL and infusion 75 mg per 100 mL, Integrelin® - Schering-Plough Pty limited

New listing

 Platelet aggregation inhibitor. Authority required listing for (1) patients with high risk unstable angina; (2) patients with non-Q-wave myocardial infarction; (3) and the prevention of death, myocardial infarction, urgent revascularisation and the need for acute antithrombotic rescue therapy in patients undergoing non-urgent percutaneous coronary intervention with intracoronary stenting. Recommended for listing as an authority required benefit for patients with high risk unstable angina who have ongoing chest pain lasting longer than 10 minutes, AND either:

(i) ST elevation or depression greater than 0.5mm; or

(ii) deep T wave inversion in three or more leads; or

(iii) elevated markers of myocardial injury (especially cardiac troponin I or T).

Patients with non-Q-wave myocardial infarction.

(2) The prevention of death, myocardial infarction, urgent revascularisation and the need for acute antithrombotic rescue therapy in patients undergoing non-urgent percutaneous coronary intervention with intracoronary stenting.

Recommended on a cost-minimisation basis vs tirofiban.

 

Table containing PBAC Positive Recommendations for December 2001
Drug and Form Drug use and type Listing requested by Sponsor PBAC Recommendation and Comments
Galantamine hydrobromide, 4 mg (base) and 8 mg (base), Reminyl® - Janssen-Cilag Pty Ltd

Amend restriction

 A drug to treat mild to moderate Alzheimer's disease To allow certain patients who cannot achieve a score on the MMSE of 10 or more for reasons other than their Alzheimer's disease (AD), who would normally be diagnosed as suffering from severe AD, subsidised access to the drug. The PBAC recommended that the restriction be revised for equity reasons, as follows:

Initial treatment of mild to moderately severe Alzheimer's disease. Confirmation of this diagnosis must be made by a specialist/consultant physician (including a psychiatrist). The authority application must be in writing and include the result of the baseline Mini-Mental State Examination (MMSE). This baseline MMSE must be a score of 10 or more and, if this score is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) must also be specified. Up to a maximum of 1 month's therapy plus 5 repeats will be issued.

Continuing treatment, following initial therapy, of mild to moderately severe Alzheimer's Disease in patients with demonstrated improvement in cognitive function as measured by an increase of at least 2 points from baseline on the Mini-Mental State Examination (MMSE); OR a decrease of at least 4 points from baseline on the Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) for patients with an MMSE baseline score of at least 25 points (the initial authority application for continuing treatment must include the relevant result from the MMSE or the ADAS-Cog and must be in writing);

Initial treatment of mild to moderately severe Alzheimer's disease of patients with a baseline Mini-Mental State Examination (MMSE) score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, as specified below. Confirmation of this diagnosis must be made by a specialist/consultant physician (including a psychiatrist). Such patients will need to be assessed subsequently using the Clinicians Interview Based Impression of Change (CIBIC) scale. The authority application must be in writing, include the result of the baseline MMSE and specify to which group(s) (see below) the patient belongs. Patients who qualify under this criterion are from one or more of the following groups:

(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;

(2) Limited education , as defined by less than 6 years of education, or who are illiterate or innumerate;

(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE test;

(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;

(5) Significant sensory impairment despite best correction, which precludes completion of an MMSE test;

(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.

Up to a maximum of 1 month's therapy plus 5 repeats will be issued.

Continuing treatment, following initial therapy, of mild to moderately severe Alzheimer's Disease in patients with demonstrated improvement in function, based on a rating of "very much improved" or "much improved" on the CIBIC scale, which must be assessed by the same clinician who initiated treatment (the initial authority application for continuing treatment must state the improvement achieved on the CIBIC scale and must be in writing).

 

Table containing PBAC Positive Recommendations for December 2001
Drug and Form Drug use and type Listing requested by Sponsor PBAC Recommendation and Comments
Gliclazide tablet 80 mg, Glyade® - Alphapharm Pty Limited

Pricing matter

 Oral hypoglycaemic To justify higher price compared with glibenclamide. The PBAC accepted the small price premium that immediate release gliclazide has over glibenclamide is warranted.
Gliclazide tablet 80 mg, Diamicron® - Servier Laboratories (Australia) Pty Ltd

Pricing matter

 Oral hypoglycaemic To justify higher price compared with glibenclamide. The PBAC accepted the small price premium that immediate release gliclazide has over glibenclamide is warranted.
Lopinavir with ritonavir capsule 133.3 mg-33.3 mg and oral solution 400 mg-100 mg per 5 mL, Kaletra® - Abbott Australasia Pty Ltd

Re-submission

 A combination treatment for HIV/AIDS. Section 100 for treatment of HIV infection in patients with CD4 counts less than 500 per mm3, or viral load greater than 10,000 copies per mL. Recommended for listing on a cost-effectiveness basis, as requested, for use in combination with 2 or more other anti-retroviral drugs.
Montelukast sodium tablets 4 mg and 5 mg, Singulair® - Merck Sharp & Dohme

New listing

 Asthma treatment Authority required listing for first line preventer medication for children, 2-5 years (4 mg) and 6-14 years (5 mg) when used other than in conjunction with cromolyns or inhaled corticosteroids. Recommended on a cost-minimisation basis vs sodium cromoglycate, with advice to the Pricing Authority that a price-volume arrangement be negotiated, with volumes to be based on the sponsor's submission to the PBAC.
Oxcarbazepine, tablets 150 mg, 300 mg and 600 mg, Trileptal® - Novartis Pharmaceuticals Australia Pty Ltd

Re-submission

 An anti-epileptic Authority required listing for treatment of partial epileptic seizures and primary generalised tonic-clonic seizures, which are not satisfactorily controlled by other anti-epileptic drugs. Recommended for listing on a cost-minimisation basis, as requested, in the second-line setting compared with lamotrigine, with advice to the Pricing Authority that a price-volume arrangement be negotiated.
Quetiapine fumarate tablet 300 mg (base) Seroquel® - Astra Zeneca Pty Ltd

New listing

 For schizophrenia Authority required listing for schizophrenia Recommended for listing on the basis of the price being acceptable relative to the existing strengths of quetiapine fumarate.
Reboxetine mesilate tablet 4 mg (base), Vestra® - Pharmacia Australia

New listing

 An antidepressant Restricted benefit listing for major depressive disorders Recommended for listing as requested on a cost-minimisation basis compared with fluoxetine, on the basis that 8.73 mg reboxetine is equivalent to 25.67 mg fluoxetine.

 

Table containing PBAC Positive Recommendations for December 2001
Drug and Form Drug use and type Listing requested by Sponsor PBAC Recommendation and Comments
Risedronate sodium tablet 5 mg, Actonel® - Aventis Pharma Pty Limited

Re-submission

 Re-submission requests listing in patients who have already sustained a fracture. Original submission proposed listing as prevention before fracture had occurred. Authority required listing for the preservation of bone mineral density in patients who are osteopenic (T-score<-1), who are undergoing long term treatment with high dose corticosteroids (> 7.5 mg prednisolone or equivalent) and who have fracture due to minimal trauma; for the treatment of corticosteroid induced osteoporosis in patients undergoing long term treatment with high dose corticosteroids (> 7.5 mg prednisolone or equivalent) and who have fracture due to minimal trauma. A change was recommended to allow use in patients with established cortico-steroid induced osteoporosis in patients with fracture due to minimal trauma.
Rivastigmine hydrogen tartrate, capsules 1.5 mg, 3 mg, 4.5 mg and 6 mg and oral solution, 2 mg (base) per mL, 120 mL, Exelon® - Novartis Pharmaceuticals Australia

Amend restriction

 A drug to treat mild to moderate Alzheimer's disease To allow certain patients who cannot achieve a score on the MMSE of 10 or more for reasons other than their Alzheimer's disease (AD), who would normally be diagnosed as suffering from severe AD, subsidised access to the drug. The PBAC recommended that the restriction be revised for equity reasons, as follows:

Initial treatment of mild to moderately severe Alzheimer's disease. Confirmation of this diagnosis must be made by a specialist/consultant physician (including a psychiatrist). The authority application must be in writing and include the result of the baseline Mini-Mental State Examination (MMSE). This baseline MMSE must be a score of 10 or more and, if this score is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) must also be specified. Up to a maximum of 1 month's therapy plus 5 repeats will be issued.

Continuing treatment, following initial therapy, of mild to moderately severe Alzheimer's Disease in patients with demonstrated improvement in cognitive function as measured by an increase of at least 2 points from baseline on the Mini-Mental State Examination (MMSE); OR a decrease of at least 4 points from baseline on the Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) for patients with an MMSE baseline score of at least 25 points (the initial authority application for continuing treatment must include the relevant result from the MMSE or the ADAS-Cog and must be in writing);

Initial treatment of mild to moderately severe Alzheimer's disease of patients with a baseline Mini-Mental State Examination (MMSE) score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, as specified below. Confirmation of this diagnosis must be made by a specialist/consultant physician (including a psychiatrist). Such patients will need to be assessed subsequently using the Clinicians Interview Based Impression of Change (CIBIC) scale. The authority application must be in writing, include the result of the baseline MMSE and specify to which group(s) (see below) the patient belongs. Patients who qualify under this criterion are from one or more of the following groups:

(1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;

(2) Limited education , as defined by less than 6 years of education, or who are illiterate or innumerate;

(3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE test;

(4) Intellectual (developmental or acquired) disability, eg Down's syndrome;

(5) Significant sensory impairment despite best correction, which precludes completion of an MMSE test;

(6) Prominent dysphasia, out of proportion to other cognitive and functional impairment.

Up to a maximum of 1 month's therapy plus 5 repeats will be issued.

Continuing treatment, following initial therapy, of mild to moderately severe Alzheimer's Disease in patients with demonstrated improvement in function, based on a rating of "very much improved" or "much improved" on the CIBIC scale, which must be assessed by the same clinician who initiated treatment (the initial authority application for continuing treatment must state the improvement achieved on the CIBIC scale and must be in writing).

Sildenafil citrate tablets 25 mg, 50 mg and 100 mg, Viagra® - Pfizer Pty Limited

Re-submission

 For erectile dysfunction. Authority required listing for use in males with erectile dysfunction of organic origin secondary to: Diabetes (type I and II), treatment of prostate pathology, multiple sclerosis, Parkinson's disease, radical pelvic surgery, renal failure (transplant and dialysis treatment), severe pelvic injury, spinal cord injury, spina bifida.

Only one application per six months with no increased maximum quantities or repeats will be authorised.

Recommended for listing with minor changes to the proposed restriction:

For use in males with erectile dysfunction of organic origin secondary to:

(1) pharmacological treatment for diabetes (Type I and II); or

(2) surgical treatment for prostate hypertrophy; or

(3) surgical or chemical or radiation treatment for prostate cancer; or

(4) multiple sclerosis; or

(5) Parkinson's disease; or

(6) radical pelvic surgery; or

(7) dialysis treatment for renal failure or renal transplant; or

(8) severe pelvic injury; or

(9) spinal cord injury; or

(10) spina bifida.

Recommended on the basis that the Government has previously decided that subsidised treatment for erectile dysfunction is appropriate and with the advice that the PBAC has grave concerns that the projections for usage may be substantially underestimated.

Temazepam capsule 10 mg Normison® - Wyeth

Temaze® - Alphapharm

Euhypnos® - Sigma

 Hypnotic Amend unrestricted listing to authority required listing "As an adjunct in the management of insomnia in individuals who have failed to respond to treatment with a tablet presentation of temazepam, either because of insufficient effectiveness or an inability to use that dosage form appropriately" Recommended as requested because of concerns of misuse by IV-injecting drug abusers. A "Caution" is also recommended to apply, stating that "Significant adverse health outcomes are associated with the injection of temazepam in gel-filled capsule form. Tablets should be prescribed in preference to capsules whenever possible."

 

Table containing PBAC Positive Recommendations for December 2001
Drug and Form Drug use and type Listing requested by Sponsor PBAC Recommendation and Comments
Tramadol hydrochloride injection 100 mg per 2 mL, Tramal® - CSL Limited

New listing

 Injectable analgesic. Restricted benefit listing for acute pain. Listing in Emergency Drug (Doctor's Bag) Supplies. Recommended for listing as requested on a cost-minimisation basis compared with pethidine injection, on a 1-to-1 pricing ratio.
Whey protein formula supplemented with amino acids, vitamins & minerals; low in protein, phosphate, potassium and lactose, powder 400g can, Kindergen® - Scientific Hospital Supplies

New listing

 A food product for seriously ill children Authority required listing for infants and young children with chronic renal failure requiring treatment with a low protein and a low phosphorus diet, or a low protein, a low phosphorus and a low potassium diet Recommended for listing on the basis of acceptable cost-effectiveness.
Zoledronic acid, injection set containing1 vial powder for IV infusion 4mg and 1 ampoule solvent 5mL, Zometa ® - Novartis Pharmaceuticals Australia Pty Ltd

Re-submission

 Bisphosphonate used to treat hypercalcaemia. Section 100 availability for treatment of hypercalcaemia of malignancy (HCM) refractory to anti-neoplastic therapy. Recommended for listing as requested on the basis of acceptable cost-effectiveness.
Amino acids-synthetic formula, compound powder, 400 g, EleCare® - Abbott Australasia Pty Limited

New listing

 A food for inborn error of metabolism Authority required listing for initial and continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formula in children, 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;

Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formula in children, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months;

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formula has failed or the patient has been receiving parenteral nutrition;

Galactosaemia;

Glycogen storage disease due to glucose-6-phophatase deficiency in children.

 Authority required listing for initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formula in children up to the age of 2 years, 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 age of the patient must be included in the authority application;

Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formula in children up to the age of 2 years, where the child is assessed by a suitably qualified allergist or paediatrician. The age of the patient must be included in the authority application;

Treatment for combined intolerance (not infant colic) to cows milk protein, soy protein and protein hydrolysate formula in children over the age of 2 years, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months. The age of the patient must be included in the authority application;

Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formula have failed or the patient has been receiving parenteral nutrition.

 

Table containing PBAC Positive Recommendations for December 2001
Drug and Form Drug use and type Listing requested by Sponsor PBAC Recommendation and Comments
Carbohydrate, fat, vitamins, mineral and trace elements, powder 400 g, Pro-Phree® - Abbott Australasia Pty Limited

New listing

 A food product for inborn errors of metabolism Restricted benefit listing for patients with inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae Restricted benefit listing as requested.
Mineral mixture, powder 250 g jar, Metabolic Mineral Mixture® Scientific Hospital Supplies

New listing

 Mineral supplement to accompany certain foods for inborn errors of metabolism Restricted benefit listing for metabolic disorders Recommended for listing as requested.
Protein formula with essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements, powder 400 g, Kindergen® - Scientific Hospital Supplies

New listing

 A food product for special medical purposes Restricted benefit listing for infants and young children with renal disease who have the following symptoms:
  • Inadequate nutrient intake and anorexia
  • Disturbances in electrolyte balance
  • Imbalances in serum phosphate and calcium levels (renal osteodystrophy)
  • Anaemia
  • Growth retardation
  • Fluid overload requiring fluid restriction.
 Recommended for listing as requested
Soy protein and fat formula with vitamins and minerals - carbohydrate free, liquid 384 mL, RCF® - Abbott Australasia Pty Limited

New listing

 A food product for inborn errors of metabolism Restricted listing for patients with inborn errors of metabolism who are unable to meet their energy requirements with permitted food and formulae Recommended for listing as requested