Posted by Michael Wonder on 26 Aug 2015
Summary of the agenda for the PBAC November 2015 meeting
27 August 2015 - The PBAC will consider 69 submissions (34 major & 35 minor) at its next scheduled meeting in November (Table 1).
Table 1. Submissions by medicine type
|
Medicine category |
Number |
Percentage |
|
PBS medicine or vaccine |
57 |
83 |
|
PBS medicinal preparation* |
11 |
16 |
|
NIP vaccine |
1 |
1 |
|
LSDP medicine** |
0 |
0 |
PBS = Pharmaceutical Benefits Scheme; NIP = National Immunisation Program; LSDP = Life Saving Drugs Program. * Blood reagent strips and nutritional supplements; ** Section 100 or LSDP
The Committee will also consider five reports from the Drug Utilisation Subcommittee (DUSC) for medicines for
- Neuropathic pain (1 medicines)
- Malignant melanoma (2 medicines)
- Multiple sclerosis (6 medicines)
- Nutritional products (>150 products)
- Psoriatic arthritis (5 medicines)
- Panic disorder (1 medicine)
16 of the 69 submissions are for new medicines/vaccines (Table 2).
Table 2. Submissions by listing type
|
Listing type |
Number |
Percentage |
|
New medicine |
16 |
23 |
|
New vaccine |
0 |
0 |
|
New indication |
19 |
28 |
|
New combination product |
5 |
7 |
|
Restriction change |
8 |
12 |
|
New strength |
3 |
4 |
|
New formulation |
18 |
26 |
|
Review |
0 |
0 |
16 (23%) of the 69 submissions are resubmissions; most are for new listings or new indications (Table 3).
Table 3. Resubmissions by listing type
|
Listing type |
Number |
Percentage |
|
New listing |
6 |
38 |
|
New indication |
5 |
31 |
|
New combination product |
1 |
6 |
|
New strength |
2 |
13 |
|
New formulation |
2 |
13 |
This is the fourth submission for adalimumab (Humira) for patients with ulcerative colitis. This is the third submission for netupitant with palonosetron hydrochloride (Akynzeo) for patients with nausea and vomiting and sorafenib tosylate (Nexavar) for patients with thyroid cancer. The PBAC will consider a second submission for the remaining 13 medicines.
Just under a third of all submissions are for medicines in WHO ATC main group L (Table 4).
Table 4. Medicines by WHO ATC main group
|
WHO ATC main group* |
Number |
Percentage |
|
Alimentary |
11 |
16 |
|
Blood |
0 |
0 |
|
Cardiovascular |
1 |
1 |
|
Dermatological |
1 |
1 |
|
Genitourinary |
0 |
0 |
|
Systemic hormonal |
2 |
3 |
|
Anti-infective |
7 |
10 |
|
Anti-neoplastic and immunomodulatory |
22 |
32 |
|
Musculoskeletal |
0 |
0 |
|
Nervous |
5 |
7 |
|
Anti-parasitic |
0 |
0 |
|
Respiratory |
4 |
6 |
|
Sensory |
1 |
2 |
|
Various** |
15 |
22 |
*WHO ATC = World Health Organization Anatomical Therapeutic Chemical; **11 of the 15 are medicinal preparations.
Nutricia, Orpharma, BMS and Novartis are the leading applicants (Table 5).
Table 5. Submissions by applicant
|
Sponsor |
Number of submissions |
Number of major submissions |
|
Nutricia |
6 |
0 |
|
Orpharma |
6 |
0 |
|
BMS |
5 |
4 |
|
Novartis |
5 |
2 |
Appendix
Table 6. Submissions for new medicines
|
Medicine |
Sponsor |
Disease/condition |
Submission attempt |
|
Apremilast (Otezla) |
Celgene |
Psoriatic arthritis |
Resubmission |
|
Armodafanil (Nuvigil) |
Teva Pharmaceuticals |
Narcolepsy |
Initial |
|
Blinatomumab (Blincyto) |
Amgen |
Acute lymphoblastic leukaemia |
Initial |
|
Citrulline (Citrulline Easy Tablets) |
Orpharma |
Urea cycle disorder |
Initial |
|
Daclatasvir dihydrochloride (Daklinza) |
BMS |
Hepatitis C |
Resubmission |
|
Ibrutinib (Imbruvica) |
Janssen-Cilag |
Chronic lymphocytic leukaemia |
Initial |
|
Ibrutinib (Imbruvica) |
Janssen-Cilag |
Non-Hodgkin's lymphoma |
Initial |
|
Idelalisib (Zydelig) |
Gilead |
Chronic lymphocytic leukaemia |
Resubmission |
|
Idelalisib (Zydelig) |
Gilead |
Non-Hodgkin's lymphoma |
Resubmission |
|
Lenvatinib mesylate (Lenvima) |
Eisai |
Thyroid cancer |
Initial |
|
Nalmefene hydrochloride dihydrate (Selincro) |
Lundbeck |
Alcohol dependence |
Initial |
|
Nintedanib esylate (Ofev) |
Boehringer Ingelheim |
Idiopathic pulmonary fibrosis |
Resubmission |
|
Nivolumab (Opdivo) |
BMS |
Malignant melanoma |
Initial |
|
Pasireotide acetate (Signifor) |
Novartis |
Acromegaly |
Initial |
|
Pirfenidone (Esbriet) |
Roche |
Idiopathic pulmonary fibrosis |
Initial |
|
Pralatrexate (Fotolyn) |
Mundipharma |
Non-Hodgkin's lymphoma |
Initial |
|
Vinflunine ditartrate (Javlor) |
Pierre Fabre |
Urinary tract cancer |
Resubmission |
Table 7. Submissions for new indications
|
Medicine |
Sponsor |
Disease/condition |
Submission attempt |
|
Adalimumab (Humira) |
AbbVie |
Ulcerative colitis |
Resubmission |
|
Aflibercept (Eylea) |
Bayer |
Macular oedema |
Initial |
|
Aprepitant (Emend) |
MSD |
Nausea and vomiting |
Initial |
|
Arsenic trioxide (Phenasen) |
Phebra |
Acute promyelocytic leukaemia |
Initial |
|
Bevacizumab (Avastin) |
Roche |
Cervical cancer |
Initial |
|
Empagliflozin (Jardiance) |
Boehringer Ingelheim |
Type 2 diabetes mellitus |
Initial |
|
Enzalutamide (Xtandi) |
Astellas |
Prostate cancer |
Initial |
|
Human papilloma virus vaccine (bivalent) (Cervarix)* |
GSK |
Vaccination |
Initial |
|
Ipilimumab (Yervoy) |
BMS |
Malignant melanoma |
Initial |
|
Lanreotide acetate (Somatuline Autogel) |
Ipsen |
Pancreatic neuroendocrine tumour |
Initial |
|
Lenalidomide (Revlimid) |
Celgene |
Multiple myeloma |
Initial |
|
Nivolumab (Opdivo) |
BMS |
Malignant melanoma |
Initial |
|
Omalizumab (Xolair) |
Novartis |
Urticaria |
Initial |
|
Paclitaxel (nanoparticle albumin bound) (Abraxane) |
Specialised Therapeutics |
Breast cancer |
Initial |
|
Propranolol hydrochloride (Hemangiol) |
Pierre Fabre |
Hemangioma |
Resubmission |
|
Protein formula with carbohydrate, fat, fibre, vitamins and minerals (Nutrini Low Energy Multi Fibre) |
Nutricia |
Nutricia |
Initial |
|
Saxagliptin hydrochloride (Onglyza) |
AstraZeneca |
Type 2 diabetes mellitus |
Resubmission |
|
Saxagliptin hydrochloride with metformin hydrochloride XR (Kombiglyze XR) |
AstraZeneca |
Type 2 diabetes mellitus |
Resubmission |
|
Sitagliptin phosphate monohydrate (Januvia) |
MSD |
Type 2 diabetes mellitus |
Resubmission |
|
Sitagliptin phosphate monohydrate with metformin hydrochloride (Janumet, Janumet XR) |
MSD |
Type 2 diabetes mellitus |
Resubmission |
|
Sorafenib tosylate (Nexavar) |
Bayer |
Thyroid cancer |
Resubmission |
* Vaccine
Table 8. New combination products
|
Medicine |
Sponsor |
Disease/condition |
Submission attempt |
|
Atazanavir sulphate with cobictat (Evotaz) |
BMS |
HIV infection |
Initial |
|
Darunavir ethanolate with cobicistat |
Janssen-Cilag |
HIV infection |
Initial |
|
Emtricitabine with elvitegravir and cobicistat and tenofovir alafenamide |
Gilead |
HIV infection |
Initial |
|
Empagliflozin with metformin hydrochloride |
Boehringer Ingelheim |
Type 2 diabetes mellitus |
Initial |
|
Netupitant with palonosetron hydrochloride (Akynzeo) |
Specialised Therapeutics |
Nausea and vomiting |
Resubmission |
Table 9. Selected new formulations
|
Medicine |
Sponsor |
Disease/condition |
Submission attempt |
|
Insulin glargine (Basaglar, Basaglar KwikPen) |
Eli Lilly |
Diabetes mellitus |
Resubmission |
