Propylene Glycol

6.1 The PBAC recommended the listing of propylene glycol (Systane Balance) for the treatment of severe dry eye syndrome on a cost-minimisation basis to the lowest cost PBS-listed ocular lubricant. The PBAC noted that propylene glycol was a PC eye drop and the nominated comparator was PF hyaluronate containing eye drop.PSD · Jul 2024

6.2 The PBAC noted that under Section 101(3B) of the National Health Act 1953 (“the Act”), when the proposed medicine is substantially more costly than an alternative therapy, the Committee cannot make a positive recommendation unless it is satisfied that, for some patients, the proposed medicine provides a significant improvement in efficacy and/or reduction of toxicity over the alternative therapy.PSD · Jul 2024

5.16 The submission presented two cost-minimisation approaches (CMAs) of propylene glycol. The first was a comparison against 0.1%/0.2% hyaluronate sodium MDPF eye drops and the second, against 0.5% carmellose sodium + glycerol MDPC as presented in Table 2. The equi-effective dose for propylene glycol used was 1:1 for both 0.1%/0.2% hyaluronate sodium MDPF and 0.5% carmellose sodium + glycerol MDPC. 4PSD · Jul 2024

5.17 The submission claimed a PBS listing for propylene glycol is not expected to result in changes in resource use resulting from differences in prescribing or administration profiles, management of adverse events or monitoring requirements. The CMA only includes the cost of medicines with the analysis undertaken on a per treatment basis, defined as 1 drop in each eye.PSD · Jul 2024

5.14 The submission claimed the non-inferior comparative effectiveness and non-inferior comparative safety of propylene glycol compared with 0.1%/0.2% hyaluronate sodium MDPF eye drops and 0.5% carmellose + glycerol MDPC eye drops.PSD · Jul 2024

5.15 The PBAC considered that the claims of non-inferior comparative effectiveness and non-inferior comparative safety were reasonable and supported by the data.PSD · Jul 2024