Positive Recommendations made by the PBAC in September 2002
Positive Recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in September 2002
| Drug and form | Drug use and type | Purpose of application | PBAC Recommendation |
|---|---|---|---|
| Baclofen intrathecal injection 10 mg in 5 mL and 10 mg in 20 mL, Lioresal® Novartis Pharmaceuticals Australia Pty Limited Additional indication |
For spasticity of cerebral origin (eg stroke, injury) | Section 100 for patients with severe chronic spasticity of cerebral origin where oral antispastic agents have failed or have caused unacceptable side effects. | Recommended for listing in patients with severe chronic spasticity of cerebral origin on the basis of acceptable cost-effectiveness. The additional clinical data provided reassurance of the clinical importance of the results reported in the studies presented in the submission. The PBAC accepted the consistency of findings across several clinical and utility studies as some reassurance that the cost-utility estimates would be unlikely to become unfavourable if the evidentiary basis were improved. Given the method of administration, the risk of usage beyond expectations or beyond the restriction is likely to be small. |
| Bimatoprost eye drops 0.3 mg in 1 mL, Lumigan®
New listing |
An eye drop for glaucoma | Unrestricted listing | Recommended for listing on a cost-minimisation basis compared with latanoprost eye drops, with one bottle of bimatoprost eye drops 0.03% being considered equivalent to one bottle of latanoprost eye drops 0.005% (both providing one month's supply). The disadvantage of a higher incidence of conjunctival hyperaemia with bimatoprost was not considered to be of sufficient clinical importance to affect this conclusion. |
| Darbepoetin alfa pre-filled syringes, Aranesp® Amgen Pty Ltd Amend listing |
To stimulate production of red blood cells | Request by the Highly Specialised Drugs Working Party to tighten listing to minimise use outside the intended population. | Section 100 listing to be changed to Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g/L, associated with chronic renal failure, defined as a glomerular filtration rate of less than 60 mL/min, where treatment is initiated by, or follows consultation by the prescriber with, a nephrologist. Recommended to define the term "chronic renal failure" following consultation with expert groups, the consumer's group and sponsors. |
| Epoetin alfa pre-filled syringes, Eprex® Janssen-Cilag Pty Ltd Amend listing |
To stimulate production of red blood cells | Request by the Highly Specialised Drugs Working Party to tighten listing to minimise use outside the intended population. | Section 100 listing to be changed to Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g/L, associated with chronic renal failure, defined as a glomerular filtration rate of less than 60 mL/min, where treatment is initiated by, or follows consultation by the prescriber with, a nephrologist. Recommended to define the term "chronic renal failure" following consultation with expert groups, the consumer's group and sponsors. |
| Eptifibatide 20 mg in 10 mL injection and 75 mg in 100 mL infusion, Integrilin® Schering-Plough Pty Limited Change to recommended listing |
Blood-thinning drug. | Authority required listing for patients undergoing non-urgent percutaneous intervention with intracoronary stenting. | Recommended for listing on a cost-minimisation basis compared with abciximab as follows.
Eptifibatide: two IV boluses of 180 mgram/kg followed by a continuous infusion at 2.0m /kg/minute for up to 18.3 hours is no worse than abciximab: one IV bolus of 0.25 mg/kg followed by a continuous infusion at 0.125 m /kg/minute for 12 hours. |
| Drug and form | Drug use and type | Purpose of application | PBAC Recommendation |
|---|---|---|---|
| Gatifloxacin 400 mg tablets, 400 mg/40 mL vial, 400 mg/200mL infusion Tequin® Bristol-Myers Squibb Pharmaceuticals New listing |
Antibiotic | Authority required listing for radiologically proven community-acquired pneumonia in penicillin allergic patients greater than 12 years old' | IV formulation: Initial treatment of radiologically-confirmed, severe community-acquired
pneumonia, requiring admission to an intensive care or high dependency unit, in patients
greater than 12 years old with a history of hypersensitivity to penicillin. Oral tablets:
Oral treatment, following initial intravenous treatment with gatifloxacin of radiologically-confirmed,
severe community-acquired pneumonia, requiring admission to an intensive care or high
dependency unit, in patients greater than 12 years old with a history of hypersensitivity
to penicillin. Radiologically-confirmed, severe community-acquired pneumonia requiring hospitalisation, in patients greater than 12 years old with a history of hypersensitivity to penicillin. Recommended for listing on a cost-minimisation basis, dividing usage for severe community acquired pneumonia between admission to ICU (20%) and to a hospital ward (80%), as follows. ICU admission: IV ceftriaxone 1 g per day plus IV erythromycin (50% using 500 mg QID and 50% using 1 g QID), both IV antibiotics for three days, followed by oral roxithromycin 300 mg per day for 10 days. Ward admission: IV ceftriaxone 1 g per day for three days followed by oral cephalosporin for seven days (50 % using cefaclor 375 mg BD and 50% using cefuroxime 500 mg BD), plus IV erythromycin (50% using 500 mg QID and 50% using 1 g QID) for one day, plus oral roxithromycin 300 mg per day for the full ten days of cephalosporin IV and oral administration. |
| Hydrochlorothiazide tablet 25 mg Pharmalab New listing |
Treatment of hypertension | Unrestricted listing | Recommended for listing as requested to replace Dichlotride®, which was recently deleted. |
| Imatinib mesylate capsule 100 mg (base), Glivec® Novartis Pharmaceuticals Australia Pty Limited Additional indication |
Treatment for certain forms of cancer | Section 100 listing for treatment of 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. | Recommended for listing as requested with additional requirement that patients must achieve a major cytogenetic response within 18 months and demonstrate that the response is maintained by testing every 12 months. The PBAC will review new survival data after 1 year, 2 and 5 years. |
| Levonorgestrel intrauterine contraceptive system 52 mg releasing
20 ?g levonorgestrel in 24 hours, Mirena® Schering Pty Ltd New listing |
Contraceptive | Unrestricted listing or listing as a restricted benefit for use as a contraceptive. | Recommended for listing on a cost-minimisation basis compared with etonogestrel implant 68 mg with Mirena® providing contraception for five years compared with etonogestrel implant for three years while being at the same price. Other costs of insertion and removal do not increase the comparative costs for Mirena® |
| Linezolid infusion 2mg per mL, 300 mL tablet 600 mg and granules for oral suspension 20 mg per mL, 150mL
Zyvox® Pharmacia Australia Pty Limited New listing |
Antibiotic | Authority required listing for treatment initiated in a hospital for infections due to microbiologically proven multi-resistant methicillin-resistant Staphylococcus species where no other antimicrobial agent can be used because of demonstrated treatment failure, laboratory-confirmed resistance, intolerance or potential drug interaction. | Recommended for listing on the basis of an acceptable, but high, cost-effectiveness ratio. The PBAC noted that the implication of not achieving an extra cure in this patient group would be a high mortality rate and therefore that this was particularly clinically important. |
| Moxifloxacin 400 mg tablet, 400 mg IV infusion Avelox®
Bayer Australia Limited New listing |
Antibiotic | Authority required listing for 9radiologically confirmed severe community-acquired pneumonia, requiring admission to hospital in penicillin allergic patients greater than 12 years old' | IV formulation: Initial treatment of radiologically-confirmed, severe community-acquired
pneumonia, requiring admission to an intensive care or high dependency unit, in patients
greater than 12 years old with a history of hypersensitivity to penicillin. Oral tablets:
Oral treatment, following initial intravenous treatment with moxifloxacin of radiologically-confirmed,
severe community-acquired pneumonia, requiring admission to an intensive care or high
dependency unit, in patients greater than 12 years old with a history of hypersensitivity
to penicillin.
Radiologically-confirmed, severe community-acquired pneumonia requiring hospitalisation, in patients greater than 12 years old with a history of hypersensitivity to penicillin. Recommended for listing on a cost-minimisation basis, dividing usage for severe community acquired pneumonia between admission to ICU (20%) and to a hospital ward (80%), as follows. ICU admission: IV ceftriaxone 1 g per day plus IV erythromycin (50% using 500 mg QID and 50% using 1 g QID), both IV antibiotics for three days, followed by oral roxithromycin 300 mg per day for 10 days. Ward admission: IV ceftriaxone 1 g per day for three days followed by oral cephalosporin for seven days (50 % using cefaclor 375 mg BD and 50% using cefuroxime 500 mg BD), plus IV erythromycin (50% using 500 mg QID and 50% using 1 g QID) for one day, plus oral roxithromycin 300 mg per day for the full ten days of cephalosporin IV and oral administration. |
| Drug and form | Drug use and type | Purpose of application | PBAC Recommendation |
|---|---|---|---|
| Oestradiol nasal spray 150 ?g per actuation, 60 doses, Aerodiol® Servier Laboratories (Australia Pty Ltd)
New listing |
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. | Recommended for listing on a cost-minimisation basis compared with oestradiol transdermal patch 4 mg (releasing approximately 50 m g per 24 hours), Estraderm® 50. The PBAC accepted that there were fewer incidences of mastalgia with Aerodiol® than with Estraderm® 50, although there was no difference in withdrawal rates between the spray and the patch. The Committee also noted a higher rate of nasal intolerance to the spray. |
| Pegfilgrastim injection 6 mg in 0.6 mL pre-filled syringe, Neulasta®Amgen Australia Pty Ltd
New listing |
Stimulates production of white blood cells. | Section 100 listing: For use in patients undergoing induction and consolidation therapy for acute myeloid leukaemia;Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in: Acute lymphoblastic leukaemia Ewing's sarcomaGerm cell tumoursInfants and children with CNS tumoursNeuroblastomaNon-Hodgkin's lymphoma (intermediate or high grade)OsteosarcomaRelapsed Hodgkin's diseaseRhabdomyosarcoma;Patients with breast cancer receiving standard dose adjuvant chemotherapy who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned;Patients receiving first-line chemotherapy for Hodgkin's disease who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned;Patients receiving chemotherapy for myeloma who have had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned. | Recommended for listing on a cost-minimisation basis compared with filgrastim. Single dose pegfilgrastim 6mg is considered to be of similar efficacy and safety to filgrastim 5m g/kg per day (as used on the PBS) for an average of 11.25 days. |
| Risedronate sodium, tablet 35 mg, Actonel® Aventis Pharma Pty Limited
New listing |
Treatment for osteoporosis (once weekly presentation) | Authority required listing for treatment for established osteoporosis in patients with fracture due to minimal trauma. | Recommended for listing as requested. |
| Rituximab 500 mg/50mL and 100 mg/10mL solutions for infusion Mabthera®Roche Products Pty Ltd
Change to listing |
Anti-cancer drug | Extend authority required listing to include the treatment of 9CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma'. | Recommended for listing on the basis of a high, but acceptable cost-effectiveness ratio in the revised restriction, noting that a quality of life gain is expected in addition to a survival gain. The PBAC accepted that currently RCHOP-21 versus CHOP-21 is the appropriate comparison for this submission based on the responses received, which emphasised that clinical practice is unlikely to change in response to the German trial comparing CHOP-21 with CHOP-14 until it is fully published. |
| Telmisartan with hydrochlorothiazide tablets 40 mg-12.5 mg and 80 mg-12.5 mg, Micardis® Plus - Boehringer Ingelheim Pty
LimitedPritor® - GlaxoSmithKline Australia
New listing |
For treatment of hypertension | Restricted benefit listing for treatment of hypertension in patients who are not adequately controlled with either hydrochlorothiazide or telmisartan monotherapy | Recommended for listing on a cost-minimisation basis at a price to pharmacist no greater than the sum of the individual components. |
| Drug and form | Drug use and type | Purpose of application | PBAC Recommendation |
|---|---|---|---|
| Zoledronic acid powder for IV infusion 4 mg per vial with diluent, Zometa®Novartis Pharmaceuticals Australia Pty Limited
Additional indication |
Normalises bone re-modelling | Section 100 for multiple myeloma and bone metastases from breast cancer. | Recommended for listing on a cost-minimisation basis. Zoledronic acid 4 mg is considered to be equivalent to disodium pamidronate 90 mg in terms of efficacy and safety. The cost-minimisation analysis should include an accepted difference in the costs of administration (2 hours for disodium pamidronate and 15 minutes for zoledronic acid), but there is insufficient basis to accept a difference in the number of infusions required. |
| Zoledronic acid powder for IV infusion 4 mg per vial with diluent, Zometa®Novartis Pharmaceuticals Australia Pty Limited
Additional indication |
Normalises bone re-modelling | Section 100 for bone metastases from hormone resistant prostate cancer. | Recommended on a cost-minimisation basis compared with disodium pamidronate or zoledronic acid, when used to treat multiple myeloma and bone metastases from breast cancer. Adopting on this "frame of reference" comparison to help guide the consistency of its decision making, the PBAC reached the conclusion that the therapeutic impact in patient-relevant terms of zoledronic acid in prostate cancer would be similar to the therapeutic impact of disodium pamidronate or zoledronic acid in multiple myeloma and breast cancer. |
| Amino acid formula with vitamins and minerals without valine, leucine and isoleucine, powder 25 g x 30, cartonMSUD Express®Vitaflo Ltd
New listing |
A food for inborn errors of metabolism | Restricted benefit listing for maple syrup urine disease. | Recommended for listing on a cost-minimisation basis compared with MSUD Maxamaid on a gram for gram of protein basis. |
| Amino acid formula with vitamins and minerals without phenylalanine and tyrosine, 20 g x 25, cartonTYR Gel®Vitaflo Ltd
New listing |
A food for inborn errors of metabolism | Restricted benefit listing for tyrosinaemia | Recommended for listing on a cost-minimisation basis compared with Xphen, Tyr Maxamaid on a gram for gram of protein basis. |
| Milk protein and fat formula with vitamins and minerals-carbohydrate free, Carbohydrate Free Mixture®, 225 g canSHS Australia Products
New listing |
A food for inborn errors of metabolism | Restricted benefit listing for patients with intractable seizures requiring treatment with a ketogenic diet; glucose transport protein defects; pyruvate dehydrogenase deficiency; and infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance. | Recommended for listing on a cost-minimisation basis compared with RCF®. 14.97 g Carbohydrate Free Mixture® is considered equivalent to 125 mL RCF® on a Kjoule for Kjoule of energy basis. |
| Triglycerides-medium chain, formula, powder, 420 g, Caprilon® Scientific Hospital Supplies Australia
New listing |
A food for inborn errors of metabolism | Restricted benefit listing for chronic liver disease with fat malabsorption;Intractable malabsorption with steatorrhoea;Short bowel syndrome;Biliary atresia;Chyloascites;Chylothorax;Alpha-1-antitrypsin deficiency;Cystic fibrosis | Recommended for listing on the basis of acceptable cost-effectiveness. |
