September 2003 PBAC Outcomes - Positive Recommendations

September 2003 PBAC Outcomes - Positive Recommendations

table containing positive recommendations made by the PBAC in September 2003
Drug and Form	Drug Use / Type	Proposed Listing or Request	PBAC Recommendation
AMOXYCILLIN TRIHYDRATE powder for oral suspension 500 mg in 5 mL, Maxamox® Biochemie Australia Pty Ltd	Antibiotic	Unrestricted listing	The PBAC recommended unrestricted listing on the basis of clinical need for this strength and formulation of the drug. Pricing should be in accordance with the usual Pricing Authority criteria.
CITALOPRAM HYDROBROMIDE, tablets 10 mg and 40 mg, Celapram® Alphapharm Pty Ltd	Treatment for depression	Restricted benefit listing for major depressive disorders	The PBAC recommended listing of these new strengths of citalopram hydrobromide, noting the clinical need of both strengths for some patients. The wording of the restriction should be the same as that which currently applies to the 20 mg strength and pricing should be in accordance with the usual Pricing Authority criteria.
DEFERIPRONE tablet 500 mg, Ferriprox® Orphan Australia Pty Ltd	Treatment of a life-threatening blood disorder	Section 100 listing for treatment of iron overload in patients with thalassaemia major who are unable to take desferrioxamine therapy or in whom desferrioxamine therapy has proven ineffective.	The PBAC recommended listing as requested by the sponsor on the basis of acceptable cost-effectiveness. Although acknowledging that prescribing would be limited to specialists with expertise in treating patients with thalassaemia, the PBAC was concerned over the toxicity associated with this product. Consequently, it requested that the Highly Specialised Drugs Working Party inform prescribers of the toxicity risk. The PBAC was advised that the National Prescribing Service would consider conducting an education campaign for consumers. In addition, the PBAC noted that there would be instances where patients would use deferiprone and desferrioxamine concomitantly and advised the HIC that this is clinically acceptable.
DONEPEZIL HYDROCHLORIDE tablets 5 mg and 10 mg, Aricept® Pfizer Pty Ltd	Treatment for Alzheimer's disease	Request from the Australian Medical Association to amend listing to allow the request for a two months' initial supply by telephone.	The PBAC recommended the change as requested in response to concerns over delays in initiating therapy as a result of the requirement that initial applications must be written.

table containing positive recommendations made by the PBAC in September 2003
Drug and Form	Drug Use / Type	Proposed Listing or Request	PBAC Recommendation
ESCITALOPRAM OXALATE tablets 10 mg and 20 mg, Lexapro® Lundbeck Australia Pty Ltd	Treatment for depression	Restricted benefit listing for major depressive disorders	The PBAC recommended listing on a cost-minimisation basis with citalopram, with escitalopram 10 mg being equivalent to citalopram 20 mg and escitalopram 20 mg being equivalent to citalopram 40 mg.
FENOFIBRATE tablet 160 mg and capsule 67 mg, Lipidil® Laboratoires Fournier	A lipid lowering drug	Restricted benefit listing, as for all other lipid lowering drugs, in accordance with the "General Statement for Lipid-lowering Drugs Prescribed as Pharmaceutical Benefits"	The PBAC recommended listing on a cost minimisation with gemfibrozil, with the equi-effective doses being fenofibrate 160 mg per day (of the tablet formulation) and gemfibrozil 1200 mg per day. In making the above recommendation, the PBAC noted the sponsor only intended to market the 67 mg capsule and 160 mg tablet and therefore limited its listing recommendation to these two formulations. The PBAC was concerned over the increased risk of myopathy when used in combination with the statins or other fibrates and therefore recommended that the relevant part of the product information, which warns of this risk be incorporated into the listing as part of a NOTE.
GALANTAMINE HYDROBROMIDE tablets 4 mg and 8 mg, Reminyl® Janssen-Cilag Pty Ltd	Treatment for Alzheimer's disease	Request from the Australian Medical Association to amend listing to allow the request for a two months' initial supply by telephone.	The PBAC recommended the change as requested in response to concerns over delays in initiating therapy as a result of the requirement that initial applications must be written.
GRANISETRON HYDROCHLORIDE tablet 2mg (base) and injection 3mg (base) in 3mL Kytril® Mayne Pharma Pty Ltd	Treatment for nausea and vomiting associated with chemotherapy and radiotherapy	Restricted benefit Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy. Maximum quantity: 2 (tablet) 1 (injection) Repeats: Nil	The PBAC recommended listing on a cost-minimisation basis accepting the claimed equi-effective doses used in the submission, i.e granisetron 2 mg is no worse than ondansetron 16 mg for the tablet formulation, and granisetron 3 mg is no worse than ondansetron 8 mg for the parenteral formulation. The PBAC noted that the tablet formulation is not TGA-approved for the radiotherapy indication, and consequently this part of the application was not accepted at this time. The PBAC encouraged the sponsor to lodge an application with the TGA with data to support a request to extend the approval for the tablet formulation for this indication to allow patients on radiotherapy an appropriate treatment continuum.
GRANISETRON HYDROCHLORIDE Injection 3mg (base) in 3mL, Kytril® Mayne Pharma Pty Ltd		Authority required Management of nausea and vomiting associated with radiotherapy being used to treat malignancy. Maximum quantity: 1 Repeats: Nil

table containing positive recommendations made by the PBAC in September 2003
Drug and Form	Drug Use / Type	Proposed Listing or Request	PBAC Recommendation
IMATINIB MESYLATE capsule 100 mg, Glivec® Novartis Pharmaceuticals Australia Pty Ltd	Treatment for chronic myeloid leukaemia (CML) and gastrointestinal stromal tumours (GIST)	Amend recommended listing for use in chronic phase of CML to allow patients under 18 years and above 70 years to be initiated with treatment.	The PBAC recommended changes as follows: eligibility for PBS subsidy has been extended to cover paediatric patients (following an extension to that effect to the TGA-approved indication); the reference to age has been removed in the restriction to allow patients aged over 70 years to receive treatment. Although there were a lack of data in use of imatinib in patients greater than 70 years not previously treated with interferon, this was stated to be because of the known poor tolerability of interferon and cytarabine, the other treatment arm in the pivotal clinical trial. The PBAC agreed that age alone had not been shown to be a treatment effect modifier; the wording has been amended to clarify that the imatinib in the chronic phase of CML will only be subsidised for patients who are not receiving concomitant PBS-subsidised interferon alfa therapy; and the wording has been amended to clarify that imatinib is not subsidised for leukaemias other than chronic myeloid leukaemia.
IMATINIB MESYLATE capsule100 mg, Glivec® Novartis Pharmaceuticals Australia Pty Ltd	Treatment for chronic myeloid leukaemia (CML) and gastrointestinal stromal tumours (GIST)	Section 100 (Special Authority Program) Initial treatment (up to three months) with imatinib mesylate at a dose of up to 400 mg/day of adult patients with an histologically-confirmed malignant gastrointestinal stromal tumour which is: 1. Metastatic or unresectable; and 2. Confirmed by the detection of CD117 on immunohistochemical staining. Continuing treatment with imatinib mesylate of adult patients with a gastrointestinal stromal tumour who: 1. have achieved, or are sustaining, a response during treatment with imatinib mesylate as a pharmaceutical benefit; or 2.have failed to achieve, or to sustain, a response during treatment with imatinib mesylate at 400 mg/day as a pharmaceutical benefit; or 3. have achieved, or are sustaining, a response during treatment with non-PBS subsidised imatinib mesylate for a period of three months or more up to the date at which this listing took effect. Patients for whom a response has been demonstrated will be eligible for PBS-subsidised treatment with imatinib mesylate for up to three months at the dose (up to 600 mg/day) at which that response was achieved. Response is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater.	The PBAC recommended listing on the basis of an acceptable, but high, cost-effectiveness ratio. As previously, the PBAC considered that the rule of rescue was applicable in this case, given that no other effective treatments exist for this condition. The introduction of a continuation rule that allows PBS-subsidised treatment with imatinib to continue only in patients who have achieved a partial response also meant that the previously unacceptable cost-effectiveness ratio was more favourable. Further, although the revised cost-effectiveness ratio was not quality-adjusted, the PBAC considered that patients who achieve a partial response would also achieve a benefit in quality of life terms during the period that the partial response is maintained. In addition, the amended wording of the restriction adequately addressed the issues of concern that were raised previously with respect to the exclusion of adjuvant and neo-adjuvant use, and the issues surrounding the dose. Overall, these changes were sufficient to allow a positive PBAC recommendation.

table containing positive recommendations made by the PBAC in September 2003
Drug and Form	Drug Use / Type	Proposed Listing or Request	PBAC Recommendation
LANREOTIDE ACETATE solution for injection prolonged release, 60 mg in 0.3 mL, 90 mg in 0.3 mL, and 120 mg in 0.5 mL Somatuline Autogel® Ipsen Pty Ltd	Treatment for acromegaly	Section 100 listing for the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory.	The PBAC recommended section 100 listing for active acromegaly in patients with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre AND after failure of other therapy including dopamine agonists; or as interim treatment in patients awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or 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 (8 weeks after the 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 IFG1 after 3 months treatment. The PBAC recommended listing on a cost-minimisation basis against the comparators, with the equi-effective doses as follows: lanreotide autogel 93.3 mg every 28 days: octreotide acetate long acting formulation (Sandostatin LAR) 20 mg every 28 days : lanreotide acetate long acting formulation (Somatuline LA) 30 mg every 11.7 days.
LEFLUNOMIDE, tablets 10 mg and 20 mg, Arava®, Aventis Pharma Pty Limited	Treatment for rheumatoid arthritis	Amend listing to allow initiation by consultant physicians with lower strengths of leflunomide.	The PBAC recommended that initiation with the lower strengths of leflunomide be permitted by consultant physicians, to minimise the risk of toxicity, consistent with recent changes to the approved product information.
LEUPRORELIN ACETATE, injection, 7.5 mg, 22.5 mg and 30 mg (base), EligardÒ 1, 3 and 4 month, Mayne Pharma Pty Ltd	For prostate cancer	Authority required listing for advanced carcinoma of the prostate.	The PBAC recommended listing an authority required restriction for locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate. Listing was recommended on a cost-minimisation basis compared with leuprorelin acetate IM injection modified release (Lucrin Depot®), on a mg per mg basis.
NARATRIPTAN HYDROCHLORIDE tablet 2.5 mg (base), Naramig® GlaxoSmithKline Australia Pty Ltd	Treatment for migraine	Increase maximum quantity to 4 and remove NOTE which disallows authority applications for increased maximum quantities or repeats.	The PBAC recommended an increase in the listed maximum quantity from 2 to 4 tablets as requested. The DUSC was asked to review the impact on total usage (including under co-payment usage) of increasing the maximum quantity to 4 tablets for 12 months at which point the PBAC will consider whether the restriction should be further amended.

table containing positive recommendations made by the PBAC in September 2003
Drug and Form	Drug Use / Type	Proposed Listing or Request	PBAC Recommendation
OXYCODONE HYDROCHLORIDE, controlled release tablets, 5 mg, O xyContin® Mundipharma Pty Ltd	Opioid analgesic	Restricted benefit listing for chronic severe disabling pain not responding to non-narcotic analgesics, with CAUTION and NOTE as for other strengths of OxyContin	The PBAC had no objection to a Secretariat proposal to list a new (lower) strength of oxycodone controlled release with a maximum quantity of 20 tablets. Pricing should be in accordance with the usual Pricing Authority criteria.
RIVASTIGMINE HYDROGEN TARTRATE capsules 1.5 mg, 3 mg, 4.5 mg, 6 mg and oral solution 2 mg per mL, Exelon® Novartis Pharmaceuticals Australia Pty Ltd	Treatment for Alzheimer's disease	Request from the Australian Medical Association to amend listing to allow the request for a two months' initial supply by telephone.	The PBAC recommended the change as requested in response to concerns over delays in initiating therapy as a result of the requirement that initial applications must be written.
SUMATRIPTAN SUCCINATE tablet 50 mg (base), Imigran® GlaxoSmithKline Australia Pty Ltd	Treatment for migraine	Increase maximum quantity to 2 to 4 and remove NOTE which disallows authority applications for increased maximum quantities or repeats.	The PBAC recommended an increase in the listed maximum quantity from 2 to 4 tablets as requested. The DUSC was asked to review the impact on total usage (including under co-payment usage) of increasing the maximum quantity to 4 tablets for 12 months at which point the PBAC will consider whether the restriction should be further amended.
ZOLMITRIPTAN, tablet 2.5 mg, Zomig® Astra Zeneca Pty Ltd	Treatment for migraine	Refer to recommendations for sumatriptan succinate and naratriptan hydrochloride	The PBAC recommended an increase in the listed maximum quantity from 2 to 4 tablets for consistency with a recommendation to amend the listing of similarly listed products. The DUSC was asked to review the impact on total usage (including under co-payment usage) of increasing the maximum quantity to 4 tablets for 12 months at which point the PBAC will consider whether the restriction should be further amended.
AMINO ACID FORMULA without PHENYLALANINE, bar 42 g, Phlexy-10® bars, Scientific Hospital Supplies	A food for inborn errors of metabolism	Restricted benefit listing for phenylketonuria	The PBAC recommended listing on an equivalent gram per protein basis with the capsule formulation.
AMINO ACID FORMULA without PHENYLALANINE, tablet 1 g, Phlexy-10® Scientific Hospital Supplies	A food for inborn errors of metabolism	Amend recommended maximum quantity from 22 jars to 24 jars	The PBAC recommended an increase in maximum quantity as requested.