March 2004 PBAC Outcomes - Positive Recommendations
|
Drug and form |
Drug Use / Type |
Proposed listing or request |
PBAC Recommendation |
|---|---|---|---|
| Amisulpride, oral solution, 100 mg/mL, 60 mL Solian®
Sanofi-Synthelabo Australia Pty Ltd
|
Treatment for schizophrenia | Authority required listing for schizophrenia | The PBAC had no objections to the Secretariat decision to list as for the tablet formulation of this product. Pricing should be in accordance with the usual Pricing Authority criteria. |
| Benzathine Penilillin injection 900 mg per 2 mL, Bicillin-LA®
Wyeth Australia Pty Ltd |
Antibiotic
|
Increase maximum quantity to 2 to allow appropriate dose for patients with syphilis. | The PBAC recommended a differential restricted benefit listing for syphilis with a maximum quantity of 2, for consistency with the approved dosage information for this specific indication. The current unrestricted listing with a maximum quantity of one will be retained. |
| Budesonide and Eformoterol Fumarate Dihydrate, 400 microgram - 12 microgram per inhalation, Symbicort® AstraZeneca Pty Ltd |
Treatment for asthma | Restricted benefit listing for: Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide; Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide. |
The PBAC recommended that this combination product be listed on the basis of equi-effectiveness with the individual components administered separately. The pricing of this preparation in relation to its individual components should be in accord with the Combination Product Guidelines. |
| Carvedilol, pack containing 30 tablets 3.125 mg, 30 tablets 6.25 mg and 10 tablets
12.5 mg, Dilatrend Titration Pack® Roche Products Pty Ltd |
Treatment for heart failure | Authority required listing for moderate to severe heart failure in patients stabilised on conventional therapy which must include an ACE-inhibitor if tolerated. | The PBAC recommended listing at the price requested, given that the availability of this titration pack will most likely minimise wastage and is desirable from a quality use of medicines perspective. |
| Darbepoetin Alfa, injection 80 µg in 0.4 mL, pre-filled syringe, Aranesp® Amgen Pty Ltd
|
Treatment for anaemia associated with renal disease. | Section 100 listing as for the other strengths of this product | The PBAC had no objections to the Secretariat decision to list this product at the
same price per microgram as the other strengths of darbepoetin alfa injection.
|
| Galantamine Hydrobromide tablet 12 mg, Reminyl®
Janssen-Cilag Pty Ltd |
Treatment for dementia | Authority required listing as for other strengths of this product. | The PBAC recommended listing at the same price as the 8 mg tablet, as no evidence
was presented that 12 mg twice daily provides any additional clinical benefits in terms of either effectiveness or toxicity over 8 mg twice daily. In addition, the PBAC recommended that when the listing of the 12 mg tablet eventuates, the restriction for the 4 mg and 8 mg tablet strengths be amended to remove the NOTE stating that no increased maximum quantities and/or repeats will be authorised. |
| Glucose Indicator - Blood Reagent Strips, 50, Accu-Chek Go®,
Roche Diagnostics Australia Pty Ltd |
For use by diabetics | Unrestricted listing | The PBAC had no objections to the Secretariat decision to list this product. |
| Ibandronic Acid injection for IV infusion 6 mg per 6 mL, Bondronat®
Roche Products Pty Limited |
Treatment for reducing skeletal complications of malignant disease |
Section 100 listing for bone metastases from breast cancer |
The PBAC recommended listing on a cost-minimisation basis against disodium pamidronate
with the equi-effective doses being ibandronate 6 mg IV and pamidronate 90 mg IV. |
| Imatinib Mesylate tablets 100 mg and 400 mg and capsule 100 mg, Glivec® Novartis Pharmaceuticals Australia Pty Ltd |
Treatment for chronic myeloid leukaemia and gastrointestinal stromal tumours |
Section 100 listing for certain patients with chronic myeloid leukaemia or gastrointestinal stromal tumours | The PBAC had no objection to the Secretariat decision to list the new tablet formulation of this product and ratified an amended restriction for chronic myeloid leukaemia, which allows the use of FISH or quantitative PCR, where standard karyotyping is not informative for technical reasons. |
| Infliximab powder for injection 100 mg, Remicade® Schering-Plough Pty Ltd |
Used to treat inflammatory diseases, such ankylosing spondyltis, rheumatoid arthritis and Crohn's disease | Section 100 for treatment by a rheumatologist of adults with confirmed active ankylosing spondylitis according to the New York criteria. | The PBAC recommended the listing of infliximab for ankylosing spondylitis on the basis of acceptable cost-effectiveness, noting that the reasons for deferral at the December 2003 meeting (specifically, the development of an appropriate restriction) had now been satisfactorily addressed. |
| Mesalazine, tablet, 500 mg, Salofalk®
Orphan Australia Pty Ltd |
Treatment for ulcerative colitis | Authority required listing for mild to moderate ulcerative colitis where hypersensitivity
to sulfonamides exists; Mild to moderate ulcerative colitis where intolerance to sulfasalazine exists. |
The PBAC had no objection to the Secretariat decision to list this product. Pricing should be in accordance with the usual Pricing Authority criteria compared with the 250 mg tablet. |
| Oestradiol transdermal patches, 0.39 mg, 0.585 mg, 1.17 mg and 1.56 mg, Estradot®
Novartis Pharmaceuticals Australia Pty Limited |
Hormone replacement therapy | Restricted benefit listing for use for post-menopausal symptoms where a trial of peri-
or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral
oestrogens
|
The PBAC recommended listing on a cost-minimisation basis against Menorest® formulations and other transdermal patches releasing oestradiol at the same rate. |
| Somatropin (RBE), injection 12 mg in 1 mL (36 iu), Genotropin® Pfizer Australia Pty Ltd |
Growth hormone for treatment of short stature | Section 100 listing in accordance with the Guidelines for the Availability of Human Growth Hormone (hGH) as Pharmaceutical Benefit. | The PBAC had no objection to the Secretariat decision to list this product at the same price per mg as other somatropin products. |
| Terbinafine Hydrochloride, tablet 250 mg, Lamisil®
Novartis Pharmaceuticals Australia Pty Limited |
Treatment for nail dermatophyte infection | Amend listing because of concerns of the Health Insurance Commission about the age of pathology reports. | The PBAC recommended the following additional wording for the authority required restriction: "The date of the pathology report must be provided at the time of application and must not be more than 6 months old. Pathology reports from accredited laboratories must be available for audit by the HIC." |
| Voriconazole, powder for oral suspension, 40 mg per mL, 70 mL, Vfend®,
Pfizer Pty Ltd |
Anti-fungal agent | Authority required listing as recommended for the tablet and powder for infusion formulations of this product. | The PBAC had no objections to the Secretariat decision to list this formulation, at the same price per mg as the tablet formulation. |
| Amino Acide formula without Phenylalanine, liquid 250 mL, Easiphen®
Scientific Hospital Supplies |
A food for inborn errors of metabolism | Restricted benefit listing for phenylketonuria | The PBAC recommended listing on an equivalent cost per gram of protein basis with XP Maxamum® and Phenex-2®. |
| Amino Acid formula without Phenylalanine, sachet 19 g, PK Max® Scientific Hospital Supplies |
A food for inborn errors of metabolism | Restricted benefit listing for phenylketonuria | The PBAC recommended listing on an equivalent cost per gram of protein basis with XP Maxamaid®, PKU Gel® and Minaphlex®. |
| Amino Acid formula without Phenylalanine, sachet 50 g, 30 XP Maxamum Sachets®,
Scientific Hospital Supplies |
A food for inborn errors of metabolism | Restricted benefit listing for phenylketonuria | The PBAC had no objections to the Secretariat decision to list on an equivalent cost per gram of protein basis with XP Maxamum® powder. |
| Amino Acids formula with Vitamins and Minerals without Methionine, sachet 25 g, 30,
HCU Express®
Vitaflo Australia Pty Ltd |
A food for inborn errors of metabolism | Restricted benefit listing for pyridoxine non-responsive homocystinuria | The PBAC recommended listing on an equivalent cost per gram of protein basis with XMET Maxamum®. |
| Amino Acids formula with Vitamins and Minerals without valine, leucine and isoleucine,
sachets 29 g, Mapleflex®
Scientific Hospital Supplies |
A food for inborn errors of metabolism |
Restricted benefit listing for Maple syrup urine disease | The PBAC recommended listing on an equivalent cost per gram of protein basis with Ketonex-2®. |
