Positive Recommendations made by the PBAC in June 2001
Pharmaceutical Benefits Advisory Committee (PBAC) positive recommendations from June 2001
| Drug and Form | Drug use and type | Purpose of application | PBAC Recommendation |
|---|---|---|---|
| Abacavir sulfate with lamivudine and zidovudine tablet 300 mg (base) - 150 mg - 300 mg, Trizivir® |
HIV/AIDS treatment | 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 as requested on a cost-minimisation basis compared with the individual components. |
| Brimonidine tartrate eye drops 0.2%, Alphagan® |
Glaucoma treatment | Change therapeutic relativity sheet to remove link between brimonidine and timolol; and to be priced equivalent to carbonic anhydrase inhibitors (CAIs). | Accepted as requested. |
| Carvedilol tablet 6.25 mg, 12.5 mg, and 25 mg, Dilatrend® |
For heart failure | Amend the current listing from "moderate symptomatic heart failure in patients stabilised on conventional therapy where treatment is initiated in a hospital (in-patient or out-patient)" by removing the requirement for initiation of carvedilol in a hospital setting. | Recommended that listing be changed to "Moderate symptomatic heart failure in patients stabilised on conventional therapy" as requested. |
| Conjugated oestrogens with and without medroxyprogesterone acetate tablet 0.625 mg - 10 mg Premia® 10 |
Hormone replacement therapy for peri-menopausal and post-menopausal women | Unrestricted listing | Recommended for listing as requested on a cost-minimisation basis compared with other hormone replacement therapy products. |
| Darbepoetin alfa 10g per 0.4 mL, 20g per 0.5 mL, 30g per 0.3 mL, 40g per 0.4 mL, 50g per 0.5 mL, 60g
per 0.3 mL, 100g per 0.5 mL, Aranesp® |
Stimulates red blood cell production | Section 100 for the treatment of anaemia requiring transfusion, associated with chronic renal failure | Recommended for listing as requested on a cost-minimisation basis compared with epoetin, with 37.5 ?g darbepoetin weekly being of similar safety and efficacy to 7275.9 IU epoetin weekly. |
| Enoxaparin sodium 40 mg (4,000 i.u.) in 0.4 mL pre-filled syringe for injection, Clexane® |
An anti-coagulant (blood thinning) agent | Amend the maximum quantity from 5 plus 1 repeat to a MQ of 10 with nil repeats for the Authority indication "non-surgical patients at high risk of venous thromboembolism who are confined to bed in hospital" | Increased maximum quantity to 6 or 7 with one repeat. |
| Galantamine tablets 4 mg and 8 mg Reminyl® |
Alzheimer's disease | Authority required listing for initial treatment of mild to moderately severe Alzheimer's
disease. Confirmation of diagnosis must be by a specialist/consultant physician (including
a psychiatrist). The authority application must state the result of the baseline Mini-Mental
State Examination (MMSE) and, if this result is at least 25 points, the result of
the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale (ADAS-Cog).
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 a 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). |
Recommended for listing on a cost-minimisation basis compared with donepezil, with 16 mg per day of galantamine being accepted to be of similar safety and efficacy to 10 mg per day of donepezil. |
| Gliclazide, modified release tablet, 30 mg, Diamicron MR® |
Oral anti-diabetic | Unrestricted listing | Recommended for listing as requested, on the basis that 30 mg modified release gliclazide is of similar safety and efficacy as 80 mg immediate release gliclazide. |
| Hypromellose with carbomer 980 3 mg-2 mg per g, 10 g, Genteal® |
Lubricant eye drop | Restricted benefit listing for severe dry eye syndrome, including Sjogren's syndrome | Recommended for listing on the basis of similar safety and efficacy to other ocular multi-dose lubricant preparations. |
| Interferon alfa-2b 10,000,000 i.u. powder for injection with water for injection (diluent) - single
use product, Intron A® |
Skin cancer | Authority required listing for basal cell carcinoma when more efficacious treatments are considered inappropriate. | Recommended for listing as requested, as being the only currently available interferon-alfa preparation that is suitable for such use. |
| Levetiracetam tablets 250 mg, 500 mg and 1 g, Keppra® |
Antiepileptic | Authority required listing for treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | Recommended for listing on a cost-minimisation basis compared with other "add-on" anti-epileptics, with 2 gm levetiracetam being accepted as being of similar safety and efficacy to 300 mg lamotrigine. |
| Oxaliplatin powder for infusion 50 mg and 100 mg, Eloxatin® |
Cancer treatment | Authority required listing for the second line treatment of advanced colorectal cancer, in combination with 5-fluorouracil and folinic acid | Recommended for listing on a cost-minimisation basis compared with irinotecan hydrochloride for metastatic colorectal cancer after failure of fluorouracil-based therapy in patients with WHO performance status of 2 or less, to be used in combination with 5-fluorouracil and folinic acid. |
| Rivastigmine hydrogen tartrate oral solution 2 mg/mL, 120 mL Exelon® |
Alzheimer's disease drug | Listing as for rivastigmine capsules for mild-moderate Alzheimer's disease. | Recommended for listing as proposed at the same price as the other formulations of rivastigmine. |
| Tacrolimus capsule 500g, Prograf® |
For prevention of rejection | Section 100 for the prevention and treatment of rejection in liver transplant and renal transplant recipients. | Recommended for listing on a cost-minimisation basis on a mg to mg basis. |
