TobramycinDBL Tobramycin Injection
Treatment of Pseudomonas aeruginosa infection in patients aged 6 years or older with cystic fibrosis.
Decisions on record
- Meeting Nov 2013 Recommended 28 mg, powder for inhalation, capsule
- Meeting Mar 2011 Recommended Inhaled antibiotic for the treatment of lung infections in patients with cystic fibrosis
- Meeting Mar 2010 Not recommended Anti-infective no PSD
- Meeting Nov 2008 Recommended Antibiotic no PSD
Access path
- TGA registered · DBL Tobramycin Injection
TGA label narrower than the PBS population
- Mar 2013Not recommended
uncertainty in comparative benefit of TIP over TSI, potentially less favourable comparative tolerability, higher…
- ↻ resubmittedNov 2013Recommended · restricted
- PBS listing · Authority Required
Cost-effectiveness
No numeric ICER calculated. The submission used a discrete choice experiment to estimate consumer surplus rather than a traditional cost-utility analysis with ICER.
The PBAC considered that the evidence presented in the submission did not provide a reasonable basis for a cost-utility approach to the economic analysis as patient treatment satisfaction was not considered to be an appropriate basis for a cost-effectiveness claim. PBAC · 2013
Decision context
PopulationPatients aged 6 years or older with cystic fibrosis who have proven Pseudomonas aeruginosa infection, have been assessed for bronchial hyperresponsiveness with a negative test result, and tolerate the dry powder formulation following a 4 week trial.
Risk sharingRisk Sharing Arrangement: the sponsor bears the cost of providing TIP to the patient for the 4 week trial period before the patient can access continuing PBS-subsidised TIP.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2013 | Recommended · restricted | tobramycin solution for inhalation (TSI) | — | RCT · FEV1 % predicted |
| Mar 2013 | Not recommended | tobramycin solution for inhalation (TSI) | $15k–45k | RCT · Safety |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| Trial 2302 (EAGER) | Ph 3 | 517 | Number of Participants With Treatment-emergent Adverse Events | completed |
| Trial 2301 (EVOLVE) | Ph 3 | 98 | Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5. | terminated |
| Trial 2303 (EDIT) | Ph 3 | 62 | Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Pre… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to age ≥6 years, proven infection, negative bronchial hyperresponsiveness, and tolerance to dry powder formulation.