June 2003 PBAC Outcomes - "1st time" decisions not to recommend

1st time decisions not to recommend from the Pharmaceutical Benefits Advisory Committee (PBAC) Outcomes in June 2003

Table containing 1st time decision not to recommend from June 2003 PBAC Outcomes
Drug and Form Drug Use / Type Listing requested by Sponsor PBAC Outcome and Comments
Anastrozole tablet 1 mg, Arimidex®

AstraZeneca Pty Ltd assistance

 

 Treatment for breast cancer Amend restricted benefit listing. The PBAC rejected the submission because of issues with the clinical claim and the resulting cost-effectiveness claim.

Sponsor's comments:
The sponsor will be considering its position regarding any future course of action. Please refer to the AstraZeneca website for further information.
Weblink:

www.astrazeneca.com.au
Aripiprazole, tablets 10 mg, 15 mg, 20 mg and 30 mg, Abilify®

Bristol-Myers Squibb Pharmaceuticals

 

 Treatment for schizophrenia Authority required listing for:
Schizophrenia 		The PBAC rejected the submission because of concerns with the clinical claim and the resulting cost-effectiveness claim.

Sponsor's comments:
The sponsor disagrees with the decision.

Darbepoetin alfa injections
10 µg in 0.4 mL, 20 µg in 0.5 mL, 30 µg in 0.3 mL, 40 µg in 0.4 mL, 50 µg in 0.5 mL, 60 µg in 0.3 mL, 100 µg in 0.5 mL, 150 µg in 0.3 mL and 300 µg in 0.6 mL, Aranesp®

Amgen Australia Pty Ltd

 Treatment for severe anaemia Section 100 listing. The PBAC rejected the submission because of issues with the clinical claim and the resulting cost-effectiveness claim.

Sponsor's comments:
The sponsor intends to clarify the issues with the PBAC and then consider its course of action.

Fentanyl Citrate, lozenges 200 µg, 400 µg, 600 µg, 800 µg, 1.2 mg and 1.6 mg, Actiq®

Orphan Australia Pty Ltd

 

 

 Narcotic analgesic Section 100 listing for:

Management of breakthrough cancer pain in patients with malignancies who are:
Receiving transdermal fentanyl patch for their underlying persistent cancer pain and fall into one of the following categories:

  1. cannot tolerate other opioids (eg morphine, oxycodone, hydromorphone) for breakthrough cancer pain, as manifested by a documented morphine, oxycodone or hydromorphone related toxicity, as defined in the NCI/NIH Common Toxicity Criteria (1999) as follows:
  2. nausea (Grade 2) ­ persisting after 1 ­ 2 doses despite adequate trials of anti-nauseants; or
  3. vomiting (Grade 2) ­ persisting after 1 ­ 2 doses despite adequate trials of anti-nauseants; or
  4. depressed level of consciousness
    (Grade 2) ­ persisting after 1 ­ 2 doses; or
  5. constipation (Grade 2) ­ persisting
    for up to a week despite adequate trials of laxatives; or
  6. Confusion (Grade 3) persisting for more than 24 hours.
    OR
  7. cannot tolerate other opioids (eg morphine, oxycodone, hydromorphone) due to
    Hypersensitivity reactions
    OR
  8. other opioids (eg. morphine, oxycodone, hydromorphone) are contra-indicated due to renal impairment
    OR
  9. are unable to consistently obtain satisfactory breakthrough pain (BTP) relief from maximal doses of other opioids (eg. morphine, oxycodone, hydromorphone) for that BTP.
The PBAC rejected the submission because of concerns with the clinical claim and the resulting cost-effectiveness claim.

Sponsor's comments:
The sponsor needs to clarify the decision with the PBAC


 

Table containing 1st time decision not to recommend from June 2003 PBAC Outcomes
Drug and Form Drug Use / Type Listing requested by Sponsor PBAC Outcome and Comments
Gefitinib, tablet 250 mg, Iressa®

AstraZeneca Pty Ltd

 Treatment for lung cancer Authority required listing. The PBAC rejected the submission because of issues with the clinical claim and the resulting cost-effectiveness claim.

Sponsor's comments:
The sponsor needs to clarify the decision with the PBAC. Please refer to the AstraZeneca website for further information.

Weblink: www.astrazeneca.com.au
Memantine Hydrochloride, tablet 10 mg and oral solution 10 mg per g, Ebixa®

Lundbeck Australia Pty Ltd

 Treatment for Alzheimer's disease Authority required listing for:

For the initial treatment of moderately severe to severe Alzheimer's Disease.
The diagnosis must be by a specialist/ consultant physician (including a psychiatrist). The authority application must be in writing and must include the result of the baseline Mini Mental State Examination (MMSE). This baseline MMSE must be a score of 15 or less. The result of the baseline Severe Impairment Battery (SIB) must also be specified. Up to a maximum of 1 month's therapy plus 5 repeats will be issued.

Continuing therapy, following initial therapy of moderately in cognitive severe to severe Alzheimer's Disease with demonstrated lack of deterioration as measured by a Severe Impairment Battery (SIB) result no worse tan the baseline result (the initial authority application for continuing treatment must include the relevant result from the SIB and must be in writing)

The PBAC rejected the submission because of concerns with the extent of the clinical effect size and the resulting cost-effectiveness claim.


Sponsor's comments:
The sponsor disagrees with the decision.

Risedronate Sodium, tablets 5 mg and 35 mg, Actonel®

Aventis Pharma Pty Ltd

 Treatment for osteoporosis Amend authority required listing to:

Treatment of postmenopausal osteoporosis in patients between the ages of 57 and 71 years, who have a T-score of less than -3.

The PBAC rejected the submission because of concerns with the cost-effectiveness claim.

Sponsor's comments:
The sponsor disagrees with the decision and intends to lodge a re-submission.

Teriparatide, injection 250 µg per mL, Forteo®

Eli Lilly Australia Pty Limited

 Treatment for osteoporosis Section 100 listing. The PBAC rejected the submission because of concerns with the clinical claim and the resulting cost-effectiveness claim.


Sponsor's comments:
The sponsor disagrees with the decision and needs to clarify the decision with the PBAC. Please refer to the Eli Lilly Australia website for further information.

Weblink: www.lilly.com.au