Senate Community Affairs Committee ANSWERS TO ESTIMATES QUESTIONS ON NOTICE HEALTH PORTFOLIO

Transcription

1 Senate Community Affairs Committee ANSWERS TO ESTIMATES QUESTIONS ON NOTICE HEALTH PORTFOLIO Supplementary Budget Estimates , 24 October 2018 Ref No: SQ OUTCOME: 4 - Individual Health Benefits Topic: PBS listings Type of Question: Written Question on Notice Senator: Murray Watt Question: The Department has previously provided a list of medicines/vaccines that have been recommended by the PBAC but not yet listed on the PBS/NIP (SQ & SQ18-916). Please provide an updated list of medicines/vaccines that have been recommended by the PBAC but not listed on the PBS/NIP as of the date of the Department's response. Answer: An updated list of medicines/vaccines that have been recommended by the PBAC but not yet listed on the PBS/NIP is attached and is current as of 1 February Only active recommendations are provided. Where sponsors have advised that they are not proceeding with a listing, and this information has already been provided to the Senate, the recommendations are no longer included.

2 Please note the information below is accurate as at 1 February 2019 PBAC Meeting November 2018 AMINO ACIDS-SYNTHETIC, FORMULA Oral powder 400 g (Neocate Junior Vanilla) Neocate Junior Vanilla Nutricia Australia Pty Limited Cow s milk allergy, multiple protein food intolerance and other medical conditions where an elemental diet is required BRENTUXIMAB VEDOTIN Powder for I.V. infusion 50 Adcetris Takeda Pharmaceuticals Australia ENCORAFENIB and BINIMETINIB Encorafenib: capsule 50 capsule 75 Binimetinib: tablet 15 BRAFTOVI and MEKTOVI Pierre Fabre Australia FERRIC CARBOXYMALTOSE Injection 1,000 (iron) in 20 ml Ferinject Vifor Pharma Pty Limited FOLLITROPIN ALFA with LUTROPIN ALFA Injection 900 I.U I.U. in 1.44 ml multi-dose cartridge Pergoveris Merck Serono Australia GLYCOMACROPEPTIDE AND ESSENTIAL AMINO ACIDS WITH VITAMINS AND MINERALS Oral liquid 250 ml, 30 (PKU Glytactin RTD 15 Lite) PKU Glytactin RTD 15 LITE Cortex Health GLYCOMACROPEPTIDE FORMULA WITH DOCOSAHEXAENOIC ACID WITH LOW PHENYLALANINE Sachets containing oral powder 33.3 g, 16 (PKU GMPro) PKU GMPro Nutricia Australia Pty Limited HYPROMELLOSE Eye drops 3 per ml, 10 ml In a Wink Moisturising, Genteal Alcon Laboratories (Australia) Pty Ltd INACTIVATED QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION) Injection 0.5mL in pre-filled syringe Afluria Quad Seqirus Australia INOTUZUMAB OZOGAMICIN Powder for I.V. infusion 1 Besponsa Pfizer Australia INSULIN ASPART Injections (human analogue), pre filled pen, 100 units per ml, 3mL Injections (human analogue), vial, 100 units per ml, 10 ml Injections (human analogue), cartridges, 100 units per ml, 3 ml Fiasp Novo Nordisk Pharmaceuticals ISOTRETINOIN Capsule 5 Oratane Oraderm Pharmaceuticals Cutaneous T-cell lymphomas (CTCL) Melanoma Iron deficiency anaemia Stimulation of follicular development Phenylketonuria (PKU) Phenylketonuria (PKU) Severe dry eye syndrome, including Sjogren's syndrome Prevention of seasonal influenza Acute lymphoblastic leukaemia (ALL) Diabetes Mellitus Severe cystic acne The vaccine will be made available on the NIP for the 2019 influenza season.

3 PBAC Meeting November 2018 LACOSAMIDE Tablet 50 Tablet 100 Tablet 150 Tablet 200 Oral liquid 10 per ml, 200 ml Vimpat UCB Pharmaceuticals Partial epileptic seizures LENVATINIB Capsule 4 (as mesilate) Lenvima Eisai Australia NIVOLUMAB and IPILIMUMAB nivolumab: infusion 40 in 4 ml infusion 100 in 10 ml ipilimumab: infusion 50 in 10 ml infusion 200 in 40 ml Opdivo and Yervoy Bristol-Myers Squibb Australia PEGFILGRASTIM Injection 6 in 0.6 ml single use pre-filled syringe Fulphila Alphapharm PEMBROLIZUMAB Solution concentrate for I.V. infusion 100 in 4 ml Keytruda Merck Sharp & Dohme (Australia) PONATINIB Tablet 15 (as hydrochloride) Tablet 45 (as hydrochloride) Iclusig Specialised Therapeutics Australia RILUZOLE Oral liquid 50 per 10 ml, 300 ml Teglutik Seqirus (Australia) Hepatocellular carcinoma Renal cell carcinoma (RCC) Chemotherapy-induced neutropenia Melanoma Chronic myeloid leukaemia (CML) Amyotrophic lateral sclerosis (ALS) RIVAROXABAN Tablet 10 Xarelto Bayer Australia Ltd SAFINAMIDE Tablet 50 Tablet 100 Xadago Seqirus Australia SAPROPTERIN Tablet (soluble) containing sapropterin dihydrochloride 100 Kuvan BioMarin Pharmaceutical Australia SARILUMAB Injection 200 in 1.14 ml pre-filled syringe Injection 150 in 1.14 ml pre-filled syringe Kevzara Sanofi-Aventis Australia SEASONAL INFLUENZA VACCINES Injection 0.5 ml in pre-filled syringe Afluria Quad FluQuadri Fluarix Tetra Seqirus (Australia) Sanofi-Aventis Australia GlaxoSmithKline Australia Venous thromboembolism Parkinson disease Hyperphenylalaninemia (HPA) Rheumatoid arthritis Prevention of seasonal influenza These vaccines will be made available on the NIP for the 2019 influenza season.

4 PBAC Meeting November 2018 TESTOSTERONE Transdermal gel (pump pack) 23 per 1.15 g dose, 56 doses Testavan Ferring Pharmaceuticals Androgen deficiency; Micropenis; Pubertal induction; Constitutional delay of growth or puberty TIOTROPIUM Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 actuations) Spiriva Respimat Boehringer Ingelheim TOFACITINIB Tablet 5 Xeljanz Pfizer Australia VENETOCLAX Tablet 10 Tablet 50 Tablet 100 Venclexta AbbVie Asthma Psoriatic arthritis Relapsed or refractory chronic lymphocytic leukaemia PBAC Meeting July 2018 ADALIMUMAB Severe active rheumatoid arthritis; Injection 20 in 0.2 ml pre-filled syringe Sever psoriatic arthritis; Injection 80 in 0.8 ml pre-filled pen Humira AbbVie Ankylosing spondylitis; Severe chronic plaque psoriasis; Sever active juvenile idiopathic arthritis; Sever Crohn disease; Refractory fistulating Crohn disease; Moderate to severe ulcerative colitis; AMINO ACID FORMULA WITH VITAMINS, MINERALS AND LONG CHAIN POLYUNSATURATED FATTY ACIDS, WITHOUT PHENYLALANINE AMINO ACID FORMULA WITH FAT, CARBOHYDRATE, VITAMINS, MINERALS AND LONG CHAIN POLYUNSATURATED FATTY ACIDS WITHOUT PHENYLALANINE AND SUPPLEMENTED WITH DOCOSAHEXAENOIC ACID Oral powder 400 g Oral liquid 500 ml, 20 PKU Start PKU Baby Vitaflo Australia Orpharma ARIPIPRAZOLE Powder for injection 400 (as monohydrate) with diluent, pre-filled syringe Abilify Maintena Lundbeck Australia AVELUMAB Solution concentrate for I.V. infusion 200 in 10 ml Bavencio Merck Serono Australia (with Pfizer Australia ) BUDESONIDE Capsule (modified release) 3 Entocort Emerge Health CARMELLOSE HYPROMELLOSE Eye drops containing carmellose sodium 5 per ml, 10 ml Eye drops containing hypromellose 3 per ml, 10 ml Evolve carmellose Evolve hypromellose Contact Lens Centre Australia Moderate to severe hidradenitis suppurativa Phenylketonuria Schizophrenia Metastatic merkel cell carcinoma (MCC) Mild to moderate Crohn disease Severe dry eye syndrome

5 PBAC Meeting July 2018 GUANFACINE Tablet containing guanfacine hydrochloride 1 Tablet containing guanfacine hydrochloride 2 Tablet containing guanfacine hydrochloride 3 Tablet containing guanfacine hydrochloride 4 Intuniv Shire Australia Pty Limited Attention deficit hyperactivity disorder (ADHD) INSULIN GLARGINE Injections (human analogue), cartridges, 100 units per ml, 3 ml, 5 Selee Alphapharm IXEKIZUMAB Injection 80 in 1 ml single dose pre-filled pen Injection 80 in 1 ml single dose pre-filled syringe Taltz Eli Lilly Australia PEMBROLIZUMAB Solution concentrate for I.V. infusion 100 in 4 ml Keytruda Merck Sharp & Dohme (Australia) SOFOSBUVIR WITH VELPATASVIR AND VOXILAPREVIR Tablet containing sofosbuvir 400 with velpatasvir 100 and voxilaprevir 100 Vosevi Gilead Sciences TENOFOVIR ALAFENAMIDE WITH EMTRICITABINE AND BICTEGRAVIR Tablet containing tenofovir alafenamide 25 with emtricitabine 200 and bictegravir 50 Biktarvy Gilead Sciences TRIGLYCERIDES MEDIUM CHAIN FORMULA Sachets containing oral powder 16 g, 30 (MCT Pro-Cal) MCT Pro-Cal Vitaflo Australia Pty Limited Unrestricted (indicated for diabetes mellitus) Severe active psoriatic arthritis Locally advanced or metastatic urothelial cancer (LA or muc) Chronic hepatitis C virus (HCV) infection Human immunodeficiency virus (HIV) infection Chylous ascites; Chylothorax; Fat malabsorption; Hyperlipoproteinanaemia type 1; Long chain fatty acid oxidation disorders PBAC meeting March 2018 ADRENALINE (AdrenaJect) I.M. injection 150 micrograms in 0.3 ml single dose syringe auto-injector I.M. injection 300 micrograms in 0.3 ml single dose syringe auto-injector Anaphylaxis Sun Pharma ANZ BENRALIZUMAB (Fasenra ) 30 in 1 ml solution for injection prefilled syringe AstraZeneca RAMUCIRUMAB (Cyramza ) infusion 100 in 10 ml infusion 500 in 50 ml Eli Lilly Australia RANOLAZINE (Ranexa ) Tablet (modified release) 375 Tablet (modified release) 500 Tablet (modified release) 750 A. Menarini Australia Eosinophilic asthma Advanced gastric or gastro-oesophageal junction adenocarcinomas Visual impairment due to choroidal neovascularisation (CNV)

6 PBAC meeting December 2017 ADALIMUMAB Injection 40 in 0.4 ml pre-filled syringe Injection 40 in 0.4 ml pre-filled pen Humira AbbVie All existing indications PBAC meeting November 2017 DEFERIPRONE Tablet 1000 Ferriprox Iron overload Apotex INSULIN LISPRO Injections (human analogue), cartridges, 200 units per ml, 3 ml, 5 Humalog U200 Kwikpen Eli Lilly Australia RADIUM (223Ra) Injection containing radium (223Ra) dichloride 6.6 MBq in 6 ml vial Xofigo Bayer Australia Ltd SEVELAMER Powder for oral liquid 2.4 g (as carbonate) Renvela Sanofi-Aventis Australia Diabetes mellitus Metastatic castrate resistant prostate cancer (mcrpc) Hyperphosphataemia in patients with chronic kidney disease PBAC meeting March 2017 TENOFOVIR ALAFENAMIDE Tablet 25 Vemlidy Gilead Sciences Chronic hepatitis B PBAC meeting July 2016 PNEUMOCOCCAL CONJUGATE VACCINE 13-Valent Adsorbed Pre-Filled Syringe, 0.5 ml, Prevenar 13 Pfizer Australia Prevention of pneumococcal disease Aboriginal and Torres Strait Islander adults 50+ and non- Indigenous adults 65+ Awaiting the outcomes of the PBAC s review of the 23 valent pneumococcal vaccine (Pneumovax 23, Seqirus) at the March 2019 PBAC meeting.