Positive Recommendations made by the PBAC in September 2001
Positive Recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in September 2001
| Drug and Form | Drug use and type | Purpose of application | PBAC Recommendation |
|---|---|---|---|
| Amino acid formula with vitamins and minerals without phenylalanine powder 500 gm, PKU-gel
New listing |
A food supplement for inborn errors of metabolism | Restricted benefit listing for phenylketonuria | Recommended for listing as requested at an equivalent cost per day to XP Maxamaid® |
| Amino acid formula without phenylalanine capsule 500 mg, PKU
New listing |
A food supplement for inborn errors of metabolism | Restricted benefit listing for phenylketonuria | Recommended for listing as requested on the basis that the slightly higher cost per day compared with XP Maxamum® is justified because of improved compliance with a capsule formulation. |
| Amprenavir capsule 150 mg and oral solution 15 mg per mL, Agenerase®
New listing |
An anti-retroviral for HIV/AIDS | Section 100 listing for treatment of HIV infection in patients who have failed or experienced treatment-limiting toxicity with other protease inhibitors | Recommended for listing on the basis of acceptable cost-effectiveness, with 30 days' supply at the standard recommended dose for adults (1.2 g per day) priced the same as other protease inhibitors. With respect to the oral solution, the PBAC recommended that pricing be based on equivalent doses of 1.2 g for the capsule versus 1.4 g for the oral solution. |
| Benzydamine hydrochloride with chlorhexidine gluconate mouth and throat rinse, 22.5 mg-18 mg per 15 mL, 500 mL, Difflam-C® Alcohol Free Solution
New listing |
Antibacterial mouth wash | Restricted benefit listing for treatment of radiation induced mucositis | Recommended for listing as requested on a cost-minimisation basis compared with benzydamine hydrochloride mouth and throat rinse, which contains alcohol, but not chlorhexidine. |
| Dorzolamide hydrochloride with timolol maleate eye drops 20 mg (base) - 5 mg (base) per mL (2%-0.5%), 5 mL, Cosopt®
New listing |
A combination product for glaucoma | Restricted benefit listing for treatment of elevated intra-ocular pressure in patients with ocular hypertension or open-angle glaucoma when concomitant medications are indicated. | Recommended with a restricted benefit listing for reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are not adequately controlled with timolol maleate 0.5 mg (base) per mL (0.5%) eye drops on a cost-minimisation basis compared with the individual components. |
| Doxorubicin hydrochloride, pegylated liposomal, suspension for IV infusion 20 mg in 10 mL and 50 mg in 25 mL,
Caelyx®
Add indication |
Anti-cancer drug | Authority required listing for the treatment of advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen | Recommended for listing as requested on a cost-minimisation basis compared with topotecan, accepting differences in the cost of administration. |
| Enoxaparin sodium injections 40 mg, 40 mg, 80 mg and 100 mg, Clexane®
Change to listing |
A treatment for blood clots | Transfer to unrestricted listing | Recommended as requested. |
| Filgrastim 300g in 1 mL vial, 300g in 0.5 mL pre-filled syringe, 480g in 1 mL vial and 480g in 0.5 mL pre-filled
syringe, Neupogen®
Additional indication |
Drug that stimulates production of neutrophils (white blood cells) | Extend section 100 listing in peripheral blood progenitor cell transplantation to include use in healthy donors. | Amend the second and third patient groups in the current section 100 availability
to form four patient groups as follows:
Mobilisation of peripheral blood progenitor cells to facilitate harvest of such cells for autologous transplantation into patients with non-myeloid malignancies who have had myeloablative or myelosuppressive therapy; Mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic transplantation; Patients receiving marrow-ablative chemotherapy and subsequent bone marrow transplantation; Patients with non-myeloid malignancies receiving marrow-ablative chemotherapy and subsequent autologous peripheral blood progenitor cell transplantation. Recommended on the basis of acceptable cost-effectiveness in these patient groups. |
| Gabapentin tablet 600 mg
Neurontin® New listing |
An anti-epileptic drug | List as for the other strengths of gabapentin as an authority required benefit for treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs. | Recommended for listing on the basis of the price being acceptable relative to the existing strengths of gabapentin. |
| Galantamine hydrobromide 4 mg (base) per mL, 100 mL, Reminyl®
New listing |
A drug to treat Alzheimer's disease | List as for the tablet formulations of this drug with an authority required restriction for certain patients with mild to moderate Alzheimer's disease | Recommended for listing at the same flat price as the tablet formulations. |
| General statement for lipid-lowering drugs
Change to listing |
To ensure that patients already established on a particular drug are not forced to switch to another drug in the group to retain PBS eligibility | Add the following :
Patients already established on a particular lipid-lowering drug, where use satisfies the PBS qualifying criteria, but is outside the registered indications for that drug, are not required to switch to another drug in the class to retain PBS eligibility. |
|
| Imatinib mesylate capsule 100 mg, Glivec®
New listing |
An anti-cancer drug | Section 100 listing for treatment patients with chronic myeloid leukaemia expressing
the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase. Patients must be in:
The chronic phase where the use of interferon alfa-has failed or is inappropriate; the accelerated phase; or blast crisis. |
Recommended for listing with an authority required restriction for treatment of adult patients in the accelerated phase or in the blast phase of chronic myeloid leukemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase. Recommended for listing on the basis of acceptable, but high cost-effectiveness ratios in these patient groups. |
| Indinavir sulfate capsule 100 mg (base), 180, Crixivan 100 mg®
New listing |
An anti-retroviral for HIV/AIDS | Section 100 listing for treatment of HIV infection in patients with CD4 cell counts of less than 500 per mm3, or viral load greater than 10,000 copies per mL | Recommended for listing on the basis of the price being acceptable relative to the existing strengths of indinavir sulfate. |
| Interferon alfa-2a, injections 4.5 million IU, 6 million IU and 9 million IU, Roferon A®
Change to listing |
An immuno- modulating drug to treat a range of conditions | Extend authority required listing for myeloproliferative disease with excessive thrombocytosis to allow use of these strengths in addition to the 3 million IU strength. | Recommended as requested. |
| Lanreotide acetate 30 mg powder for suspension for injection in 2 mL, prolonged release, Somatuline
LA®
New listing |
A drug to treat acromegaly (over-production of growth hormone) | S 100 listing for the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain normal after surgery and/or radiotherapy or in patients who are dopamine agonist refractory. | Recommended for listing under section 100 for Active acromegaly in patients with persistent
elevation of mean growth hormone levels of greater than 2.5 micrograms per litre AND
(a) after failure of other therapy including dopamine agonists; or (b) as interim treatment in patients awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or (c) where surgery and radiotherapy are contraindicated. Treatment is to cease in patients previously treated with radiotherapy where there is biochemical evidence of remission (normal IGF1) after lanreotide acetate withdrawal for at least 4 weeks (6 weeks after last dose). Lanreotide acetate should be withdrawn for assessment of remission every 2 years in the 10 years after radiotherapy. Treatment is to cease if there has been failure to lower IGF1 after 3 months treatment. Recommended on a cost-minimisation basis compared with octreotide acetate (modified release) injection, with lanreotide acetate prolonged release 30 mg every 11.7 days being considered equivalent to octreotide acetate modified release 20.07 mg every 28 days. The Pricing Authority should note for its pricing negotiations that there is an extra cost of administering at least one injection per month with lanreotide over octreotide acetate modified release. |
| Lenograstim powder for injection 13,400,00 i.u. and 33.600,000 i.u. Granocyte 13®, Granocyte 34®
Additional indication |
Drug that stimulates production of neutrophils (white blood cells) | Extend section 100 listing in peripheral blood progenitor cell transplantation to include use in healthy donors. | Recommended for listing under section 100 for mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic transplantation to facilitate harvest of such cells in healthy donors, on the basis of acceptable cost-effectiveness in this patient group. |
| Meloxicam tablets 7.5 mg and 15 mg, Mobic®
New listing |
A COX-2 selective non-steroidal antiinflammatory drug | Restricted benefit listing for chronic arthritis with an inflammatory component | Recommended for restricted benefit listing for symptomatic treatment of osteoarthritis. Listing was recommended on a cost-minimisation basis compared with the COX-II inhibitors. Meloxicam was accepted as being of similar safety and efficacy compared with celecoxib and rofecoxib. The Pricing Authority should be advised that a price volume agreement, should be negotiated. |
| Nortriptyline hydrochloride tablets 10 mg and 25 mg, Allegron®
Change to listing |
Anti-depressant | Transfer to restricted benefit listing for major depression or dysthymic disorder where other antidepressant therapy is inappropriate, and increase the price. | Recommended with the advice to the Pricing Authority that a price premium over amitriptyline, and thus also over other tricyclic anti-depressants, is acceptable in this patient group. The restriction was recommended to be consistent with TGA-approved indications. |
| Pioglitazone hydrochloride tablets 15 mg, 30 mg and 45 mg, Actos®
New listing |
Oral anti-diabetic drug | Authority required listing for use in combination with either metformin or a sulfonylurea
in type-2 diabetic patients whose blood glucose concentrations are inadequately controlled
despite diet, exercise and maximal tolerated doses of metformin or sulfonylureas and
in whom combination therapy with metformin plus sulfonylureas is contra-indicated
or not tolerated;
Insulin-treated type 2 diabetic patients whose blood glucose concentrations are not adequately controlled despite concomitant use or oral-anti-diabetic agents or where metformin is contra-indicated |
Recommended for listing as requested on a cost-minimisation basis compared with rosiglitazone. |
| Protein hydrolysate formula with medium chain triglycerides compound powder 400 g, Alfare®; and compound powder 450 g , Pepti Junior®
Change to listing |
A food supplement for inborn errors of metabolism | Add the authority required restrictions for chronic liver failure with fat malabsorption and proven fat malabsorption. | Recommended on the advice of the PBAC Working Party on Nutritional Products. |
| Somatropin, injection 72 iu (24 mg) with 3.15 mL diluent (with preservative), Humatrope®
New listing |
Human growth hormone. | List under section 100 for short stature in accordance with the "Guidelines for Availability of Human Growth Hormone (hGH) as a Pharmaceutical Benefit" | Recommended for listing as requested at the same price per iu as the currently listed strengths of Humatrope®. |
| Triglycerides medium chain formula, compound powder
400 g, Monogen® Change to listing |
A food supplement for inborn errors of metabolism | Add the restricted benefit restrictions for chronic liver failure with fat malabsorption, chyloascites, chylothorax and proven fat malabsorption. | Recommended on the advice of the PBAC Working Party on Nutritional Products. |
