The PBAC will consider 48 (26 major, 22 minor) industry submissions at its next meeting in early March (Table 1).
Table 1. Submissions by medicine type
| Medicine category | Number | Percentage |
| PBS medicine or vaccine | 36 | 75 |
| PBS medicinal preparation* | 10 | 21 |
| NIP vaccine | 0 | 0 |
| LSDP medicine** | 2 | 4 |
PBS = Pharmaceutical Benefits Scheme; NIP = National Immunisation Program; LSDP = Life Saving Drugs Program. * Blood glucose indicator test strips and nutritional supplements; ** Section 100 or LSDP
21 of the 48 submissions are for new listings (Table 2).
Table 2. Submissions by listing type
| Listing type | Number | Percentage |
| New listing | 21 | 44 |
| New indication | 10 | 21 |
| New combination product | 3 | 6 |
| Restriction change | 5 | 10 |
| New strength | 0 | 0 |
| New formulation | 9 | 19 |
15 (31%) of the 48 submissions are resubmissions; most are for new listings (Table 3).
Table 3. Resubmissions by listing type
| Listing type | Number | Percentage |
| New listing* | 13 | 87 |
| New indication | 1 | 7 |
| New combination product | 1 | 7 |
| Restriction change | 0 | 0 |
| New strength | 0 | 0 |
| New formulation | 0 | 0 |
*The minor submission to rescind the September 2002 recommendation for linezolid has been classified as a resubmission.
This will be the third time the PBAC has considered a resubmission for icatibant and the second time for mannitol and agomelatine. For the remaining 12 medicines, it is their first resubmission.
19 of the 48 medicines are from two therapeutic areas (Table 4).
Table 4. Medicines by WHO ATC main group
| WHO ATC main group* | Number | Percentage |
| Alimentary | 4 | 8 |
| Blood | 3 | 6 |
| Cardiovascular | 3 | 6 |
| Dermatological | 0 | 0 |
| Genitourinary | 3 | 6 |
| Systemic hormonal | 0 | 0 |
| Anti-infective | 3 | 6 |
| Anti-neoplastic and immunomodulatory | 9 | 19 |
| Musculoskeletal | 4 | 8 |
| Nervous | 5 | 10 |
| Anti-parasitic | 0 | 1 |
| Respiratory | 1 | 2 |
| Sensory | 3 | 6 |
| Various** | 10 | 20 |
*WHO ATC = World Health Organization Anatomical Therapeutic Chemical; ** All 10 are medicinal preparations
Three companies lodged five submissions (Table 5).
Table 5. Submissions by sponsors
| Sponsor | Number of submissions | Number of major submissions |
| Pfizer* | 5 | 4 |
| Nutricia** | 5 | 0 |
| Vitaflo** | 5 | 0 |
| BMS* | 4 | 3 |
| MSD | 4 | 3 |
| Bayer | 3 | 3 |
| Janssen-Cilag | 3 | 3 |
*Minor submission for apixaban that is co-marketed by BMS and Pfizer has been coded to BMS; ** Minor submissions for medicinal preparations
No comments:
Post a Comment