23 April 2018 - 71 submissions were considered by the PBAC; 66 relate to the listing of a medicine, medicinal preparation or gene therapy on the Pharmaceutical Benefits Scheme; the remaining five relate to the listing of a vaccine on the National Immunisation Program.

Submissions

• All 71 submissions were lodged by a sponsor/pharmaceutical company (i.e. there were no third-party submissions)
  
• 28 (42%) were major submissions
  
• 47 (66%) were initial submissions and 24 (34%) were resubmissions
  
• 13 (18%) submissions were for a ‘new medicine’
  
• 16 (22%) submissions included a CEA/CUA. The economic evaluation in some submissions is as yet unknown.
  
• 29 (41%) submissions were for medicines in WHO ATC Group L (anti-neoplastic and immunomodulating agents), 8 (11%) were for medicines in WHO ATC Group A (alimentary tract and metabolism) and 8 (11%) were for medicines/medicinal preparations in WHO ATC Group J (anti-infectives)
  
• Two submissions appear to have been withdrawn; one was for a new medicine
  
• The PBAC considered a few minor submissions that were not included in the published agenda
  

Outcomes

• The 71 submissions yielded 115 outcomes; 64 (56%) recommendations, 28 (24%) rejections, 22 (19%) deferrals and 1 (1%) no outcome. Insofar as some submissions included multiple requests; the number of outcomes exceeds the number of submissions.
  
• 8 of the 13 submissions for a new medicine considered by the PBAC were recommended
  
• The 16 submissions that are known to have included a CEA/CUA yielded 20 outcomes; 12 (60%) recommendations and 8 (40%) rejections
  
• 12 of the 28 rejections were for medicines in WHO ATC Group L (some of these rejections are for a medicine that is not used by patients with cancer)
  
• The 24 resubmissions yielded 34 outcomes of which 15 (43%) were recommendations
  

New medicines

• Apremilast (Otezla) - rejection
  
• Asfotase alfa (Strensiq) - Rejection
  
• Baricitinib (Olumiant) - Recommendation
  
• Benralizumab (Fasenra) - Recommendation
  
• Ertogliflozin pidolate (Steglatro) - Recommendation
  
• Guselkumab (Tremfya) - Rejection
  
• Palbociclib (Ibrance) - Recommendation
  
• Perfluorohexyloctane (NovaTears) - Recommendation
  
• Ramucirumab (Cyramza) - Recommendation
  
• Ranolazine (Raneza) - Rejection
  
• Ribociclib succinate (Kisqali) - Recommendation
  
• Sodium phenylbutyrate (Pheburane) - Rejection
  
• Tolvaptan (Jinarc) - Deferral
  

New indications

• Abatacept (Orencia) - Rejection
  
• Cetuximab (Erbitux) - Recommendation
  
• Cladribine (Mavenclad) - Rejection
  
• Dexamethasone (Ozurdex) - Recommendation (second-line), Rejection (first-line)
  
• Evolocumab (Repatha) - Recommendation
  
• Filgrastim (multiple brands) - Recommendation
  
• Ibrutinib (Imbruvica) - Recommendation (Mantle cell)
  
• Ibrutinib (Imbruvica) - Rejection
  
• Ibrutinib (Imbruvica) - Rejection
  
• Irinotecan hydrochloride trihydrate (Onivyde) - Rejection
  
• Lenvatinib mesylate (Lenvima) - Rejection
  
• Lipegfilgrastim (Lonquex) - Recommendation
  
• Meningococcal Groups A, C, W135 & Y conjugate vaccine (Nimenrix) - Recommendation
  
• Meningococcal Groups A, C, W135 & Y conjugate vaccine (Nimenrix) - Recommendation
  
• Nivolumab (Opdivo) - Recommendation
  
• Obinutuzumab (Gazyva) - Deferral
  
• Pegfilgrastim (Neulasta) - Recommendation
  
• Pembrolizumab (Keytruda) - Deferral
  
• Ranibizumab (Lucentis) - Recommendation
  
• Ranibizumab (Lucentis) - Recommendation
  
• Regorafenib monohydrate (Stivarga) - Rejection
  
• Sapropterin dihydrochloride (Kuvan) - Deferral
  
• Tiotropium bromide monohydrate (Spiriva) - Rejection
  

New combination products

• Bictegravir sodium with emtricitabine and tenofovir alafenamide fumarate - No outcome
  
• Ertugliflozin pidolate with metformin hydrochloride (Segluromet) - Recommendation
  
• Insulin degludec with insulin aspart (Ryzodeg) - Recommendation
  
• Insulin glargine with lixisenatide (Soliqua) - Rejection
  
• Sofosbuvir with velpatasvir and voxilaprevir (Vosevi) - Deferral
  
• Tramadol hydrochloride with paracetamol (Zaldiar) - Rejection
  
• Trifluridine with tipiracil hydrochloride (Lonsurf) - Rejection
  

More analysis and insights will be published in Thursday's issue of MAESTrO Daily (public holiday tomorrow).