Applications received for new investments since 1 November 2008

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1 Applications received for new investments since 1 November 2008 Details of Funding Applications received are published on PHARMAC s website, in accordance with the Terms of Reference for the Pharmacology and Therapeutics Advisory Committee (PTAC) and PTAC Subcommittees Applications Received Since November 2008 Chemical (Trade) names Indication Applicant Date Received Varenicline (Champix) Smoking cessation Pfizer 5/12/2008 Erlotinib (Tarceva) Non small-cell lung cancer Astra Zeneca 5/12/2008 Losartan Review of Special Authority criteria for congestive heart failure or hypertension AstraZeneca 8/12/2008 Gefitinib (Iressa) Non small-cell lung cancer AstraZeneca 8/12/2008 Rosuvastatin (Crestor) Hyperlipdaemia AstraZeneca 9/12/2008 Etanercept (Enbrel) Severe chronic plaque psoriasis Wyeth 9/12/2008 Palivizumab (Syngagis) Respiratory syncytial virus Waikato DHB 9/12/2008 Cyclosporin Amendment of SA for steroid resistant nephrotic syndrome Individual 9/12/2008 Travoprost/timolol (Duotrav) Glaucoma Alcon 5/12/2008 Deferiprone (Ferriprox) Iron overload in thalassaemia major patients Orphan 9/12/2008 Gluten free foods Amendment to SA biopsy requirement Individual 9/12/2008 Folic Acid Prevention of neural tube defects Ministry of Health 9/12/2008

2 Gemcitabine (Gemzar) Pancreatic cancer New Zealand Association of Cancer Specialists 11/12/2008 Paliperidone (Invega) Schizophrenia Janssen-Cilag 11/03/2009 Olanzapine (Zyprexa Adhera) Schizophrenia Eli Lilly 6/03/2009 Buprenorphine (Norspan) Moderate to severe pain Mundipharma 9/03/2009 Sitagliptin (Januvia) Type 2 diabetes mellitus Merck Sharp & Dohme 20/04/2009 Sitagliptin and metformin (Janumet) Type 2 diabetes mellitus Merck Sharp & Dohme 20/04/2009 Riluzole (Rilutek) Amyotrophic lateral sclerosis Sanofi-Aventis 28/05/2009 Sorafenib (Nexavar) Hepatocellular carcinoma Bayer 8/06/2009 Thalidomide (Thalidomide Pharmion) Multiple Myeloma Celgene 11/06/2009 Budesonide (Entocort) Chron s disease New Zealand Society of Gastroenterology 11/06/2009 Lenalidomide (Revlimid) Multiple Myeloma Celgene 12/06/2009 Vildagliptin (Galvus) Type 2 diabetes mellitus Novartis 12/06/2009 Aliskirin (Rasilez) Hypertension Novartis 16/06/2009 Cox-2 inhibitors Pain New Zealand Haemophilia Treaters Group 16/06/2009 Ambrisentan (Volibris) Pulmonary arterial hypertension Glaxo 17/06/2009

3 Insulin glulisine (Apidra) Type 1 and 2 diabetes Sanofi Aventis 15/06/2009 Gluten free multi-seed bread mix Gluten intolerance Bakels 1/07/2009 Etravirine (Intelence) Antiretroviral for HIV Janssen-Cilag 03/09/2009 Rivaroxaban (Xarelto) Venous thromboembolism prophylaxis. Bayer 09/09/2009 Budesonide/eformoterol (Symbicort Turbuhaler) Asthma AstraZeneca 15/09/2009 Sunitinib (Sutent) Advanced renal cell carcinoma Pfizer 15/09/2009 Gemcitabine (Gemzar) Pancreatic cancer Gastrointestinal Cancer Special Interest Group of the New Zealand Association of Cancer Specialists 15/09/2009 Dornase alpha Cystic fibrosis Individual 15/09/2009 Milk substitute formula (S-26 Gold premgro) Premature infants Wyeth 19/10/2009 Gemcitabine Cholangiocarcinoma Gastro-Intestinal Special Interest Group 21/10/2009 Naltrexone Alcohol addiction Individuals 30/10/2009 Docetaxel Early breast cancer New Zealand Breast Cancer Special Interest Group 11/11/2009 Oral supplementary food (Enprocal) Malnutrition and physical frailty Warrnambool 03/12/2009 Bevacizumab (Avastin) Metastatic colorectal cancer Roche 07/12/2009

4 Imiquimod (Aldara) Actinic keratosis. Douglas 07/12/2009 Multiple sclerosis treatments Multiple sclerosis Individual 07/12/2009 Bortezomib (Velcade) Multiple myeloma. Janssen-Cilag 07/12/2009 Prasugrel (Effient) Acute coronary syndromes Eli Lilly 08/12/2009 Isopropyl alcohol and anhydrous glycerine (Ear clear) Prevention of swimmers ear Key Pharmaceuticals 08/12/2009 Losartan (Cozaar, Hyzaar) Gout Ngā Kaitiaki o Te Puna Rongoā o Aotearoa 30/12/2009 Levofloxacin Helicobacter pylori Clinician 16/02/2010 Tenofovir/emtricitabine (Truvada) HIV Gilead 26/02/2010 Tenofovir/emtricitabine/efavirenz (Atripla) HIV Gilead 26/02/2010 Teriparatide (Forteo) Osteoporosis Eli Lilly 01/03/2010 Sildenafil (Viagra) Persistent pulmonary hypertension of the newborn with associated lung disease; congenital diaphragmatic hernia; chronic neonatal lung disease Clinician 04/03/2010 Rituximab (Mabthera) Chronic lymphocytic leukaemia Roche 8/03/2010 Metronidazole (Zidoval Gel) Bacterial vaginosis Douglas Pharmaceuticals Limited 8/03/2010 Vitamin D (OsteoVit-D) Vitamin D deficiency Wilson Consumer Products 9/03/2010

5 Vitamin D and calcium (OsteoVit-D & Calcium) Golimumab (Simponi) Vitamin D deficiency and osteoporosis Wilson Consumer Products 9/03/2010 Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis Merck Sharpe and Dohme 09/03/2010 Darunavir (Prezista) HIV Janssen-Cilag 9/03/2010 Levonorgestrel micronizado (Jadelle) Long-acting contraception Bayer 09/03/2010 Sildenafil Pulmonary arterial hypertension Individual 12/04/2010 Hydrolysed rice protein formula (Risolac) Food allergies Heinz Watties 21/04/2010 Oral nutritional feed (Fortisip compact) Malnutrition Nutricia 23/04/2010 Paediatric oral feed (Infatrini) Paediatric oral feed (Nutrini Energy Multi Fibre) Paediatric oral feed (Nutrini Low Energy Multi Fibre) Infants with increased nutritional requirements Nutricia 23/04/2010 Disease related malnutrition Nutricia 23/04/2010 Enteral nutritional support Nutricia 23/04/2010 Oral nutritional supplement (Fortijuce) Malnutrition Nutricia 23/04/2010 Paediatric oral feed (Neocate Nutra) Food allergies Nutricia 23/04/2010 Ketogenic supplement (KetoCal) Chronic intractable epilepsy Nutricia 23/04/2010 Oral nutritional supplement (PKU Anamix Junior LQ) Phenylketonuria Nutricia 23/04/2010 Elemental formula (Alfara) Gastrointestinal and other malabsorptive problems Nestle Nutrition 04/05/2010

6 Bortezomib Multiple myeloma Individual 5/05/2010 Naltrexone Henoch-schonlein purpura Individual 26/03/2010 Pipobroman Polycythemia rubra vera and essential thrombocythaemia Individual 31/03/2010 Multiple Sclerosis Treatments Multiple Sclerosis Individual 12/04/2010 Prasugrel (Effient) Acute coronary syndromes Eli Lilly 3/05/2010 Paliperidone (Invega) Schizophrenia Janssen-Cilag 17/05/2010 Azacitidine (Vidaza) Myelodysplastic syndrome Celgene 18/05/2010 Lacosamide (Vimpat) Epilepsy UCB 21/05/2010 Deferasirox (Exjade) Iron overload Novartis 25/05/2010 Quetiapine extended release (Seroquel XR) Schizophrenia AstraZeneca 25/05/2010 Riluzole (Rilutek) Amyotrophic lateral sclerosis Sanofi Aventis 25/05/2010 Sitagliptin/metformin (Januvia/Janumet) Diabetes Merck Sharp & Dohme 25/05/2010 Dabigatran (Pradaxa) Stroke, systemic embolism, atrial fibrillation Boehringer Ingelheim 25/05/2010 Varenicline (Champix) Smoking cessation Pfizer 25/05/2010 Deferiprone (Ferriprox) Iron overload Orphan 21/06/2010

7 Imiglucerase Gaucher s disease Individual 6/07/2010 Bortezomib AL amyloidosis Individual 16/07/2010 Lapatinib HER 2 positive metastatic breast cancer New Zealand Breast Cancer Special Interest Group 21/07/2010 Rifabutin H. Pylori Individual 27/07/2010 Paracetamol and ibuprofen (Maxigesic) Analgesia and fever reduction AFT Pharmaceuticals 4/08/2010 Miglustat (Zavesca) Type 1 Gaucher s disease Actelion 17/08/2010 Fluticasone propionate / salmeterol xinafoate (Seretide) Asthma Glaxo Smith Kline 17/08/2010 Adalimumab (Humira) Juvenile idiopathic arthritis Abbott 17/08/2010 Posaconazole (Noxafil) Aspergillus Merck Sharp & Dohme 17/08/2010 Nab-paclitaxel (Abraxane) Advanced breast cancer Specialised Therapeutics 17/08/2010 Ivermectin Crusted scabies Individual 19/09/2010 Clodronate (Ostac) Osteoradionecrosis Individual 19/10/2010 Mycophenolate Severe atopic eczema Individual 17/11/2010 Pazopanib (Votrient) Advanced and/or metastatic renal cell carcinoma GlaxoSmithKline 23/11/2010 Trastuzumab (Herceptin) Metastatic HER2 positive gastric cancer Roche 26/11/2010

8 Lapatinib (Tykerb) HER2 positive metastatic breast cancer GlaxoSmithKline 29/11/2010 Docetaxel Metastatic castration resistant prostate cancer Individual 19/11/2010 Mycophenolate Lupus nephritis Individual 29/11/2010 Tiotropium bromide (Spiriva) Chronic obstructive pulmonary disease Boehringer Ingelheim 30/11/2010 Nilotinib (Tasigna) Chronic myeloid leukaemia Novartis 22/12/2010 Olanzapine (Olanzaccord) Psychoses Airflow Products 22/01/2011 Bortezomib Dabigatran (Pradaxa) Levonorgestrel (Mirena) Testosterone undecanoate (Reandron 1000) First line multiple myeloma with cast nephropathy Stroke, systemic embolism, atrial fibrillation Contraception Clinician 26/01/2011 Boehringer Ingelheim 03/02/2011 Royal Australian and New Zealand College of Obstetricians and Gynaecologists 17/02/2011 Testosterone replacement Bayer 22/02/2011 Ustekinumab (Stelara) Psoriasis Janssen-Cilag 22/02/2011 Rituximab (Mabthera) Cevimeline Relapsed/refractory follicular non- Hodgkin s lymphoma Dry mouth (including Sjogren s syndrome) Roche 22/02/2011 Sjogren s Syndrome Society of NZ Inc. 1/03/2011 Valganciclovir Cytomegalovirus Haematology Society 30/05/2011

9 Fluticasone/salmeterol Asthma Individual 30/05/2011 Pregabalin (Lyrica) Neuropathic pain Pfizer 31/05/2011 Sorafenib (Nexavar) Hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC) Bayer New Zealand Ltd 30/08/2011 Everolimus (Afinitor) Advanced renal cell carcinoma (RCC) Novartis New Zealand Ltd 30/08/2011 Sunitinib (Sutent) Gastrointestinal stromal tumour (GIST) Pfizer 30/08/2011 Gefitinib (Iressa) Locally advanced or metastatic non small cell lung cancer (NSCLC) AstraZeneca 30/08/2011 Ticagrelor (Brilinta) Acute coronary syndromes AstraZeneca 30/08/2011 Tiotropium Bromide (Spiriva) Ammendment to SA for chronic obstructive pulmonary disease Boehringer Ingleheim 30/08/2011 Adalimumab (Humira) Crohn s disease Abbott Laboratories NZ 30/08/2011 Saxagliptin (Onglyza) Type II diabetes AstraZeneca 30/08/2011 Tocilizumab (Actemra) Rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis (sjia) Roche Products (New Zealand) Ltd 30/08/2011 Indacaterol (ONBREZ inhaler) Chronic obstructive pulmonary disease Novartis 22/11/2011 Cetolizumab (Cimzia) Rheumatoid arthritis UCB 22/11/2011 Dutasteride (Avodart) Benign prostatic hyperplasia GlaxoSmithKline 22/11/2011 Eculizumab (Solaris) Paroxysmal nocturnal haemaglobinuria Alexion Pharmaceuaticals 22/11/2011

10 Vemurafenib (Zelboraf) Eltrombopag (Revolade) Erlotinib (Tarceva) Stage IIIC/IV melanoma BRAF V600 mutation Idiopathic Thrombocytoponic Purpura (ITP) Non-small cell lung cancer with EGFR activating mutation Roche 22/11/2011 GlaxoSmithKline 22/11/2011 Roche 22/11/2011 Fingolimod (Gilenya) Multiple Sclerosis Novartis 22/11/2011 Telaprevir (Incivo) Hepatitis C Janssen-Cliag Pty Ltd 22/11/2011 Azithromycin Pertussis and Neonatal Ophthalmia Paediatric Society of NZ 24/02/2012 Boceprevir (Victrelis) Hepatitis C MSD 28/02/2012 Capsaicin Tropical Cream (Zostrix) Osteoarthritis AFT Pharmaceuticals 25/01/2012 Denosumab (Prolia) Postmenopausal Osteoporosis Amgen 28/02/2012 Gemcitabine Metastatic Breast Cancer New Zealand Breast Cancer Special Interest Group 01/02/2012 Natalizumab (Tysabri) Multiple Sclerosis Biogen 28/02/2012 Liraglutide (Victoza) Type II Diabetes Novo Nordisk 28/02/2012 Temozolomide (Temodal) Testosterone Undecanoate (Reandron) Widen access for oligondendroglial tumours Clinician s Application 21/02/2012 Testosterone Deficiency Bayer Health Care 28/02/2012 Progesterone (Utrogestan) Unwanted symptoms of menopause Pharmaco 02/04/2012

11 TNF Inhibitors Rituximab Oxaliplatin and Irinotecan (Folfoxiri) Behcet s Disease ANCA associated vasculitis and polyarteritis nodosa Metastatic Pancreas Adenocarcinoma New Zealand Rheumatology Association New Zealand Rheumatology Association Gastrointestinal Cancer Special Interest Group of NZACS 26/04/ /05/ /05/2012 Asenapine (SAPHRIS) Schizophrenia and Bipolar 1 disorder Lundbeck 15/05/2012 Rivaroxaban (Xarelto) Rivaroxaban (Xarelto) Ipilimumab (Yervoy) Bovine Lipid Extract Surfactant (BLES) Sodium Hyaluronate Eye Drops (Hylo- Fresh and Hylo-Forte) Tenofovir Disoproxil Fumarate (Viread) Rituximab Stroke prevention in atrial fibrillation (SPAF) Treatment of DVT and prevention of recurrent DVT and PE Previously treated unresectable stage IIIc or IV melanoma Bayer Health Care 21/05/2012 Bayer Health Care 21/05/2012 Bristol-Myers Squibb 21/05/2012 Neonatal Respiratory Distress Syndrome Rex Medical 01/08/2012 Dry eyes AFT Pharmaceuticals 27/08/2012 Hepatitis B with advanced fibrosis/cirrhosis Refractory Systemic Lupus Erythematosus (SLE) Gilead Sciences 27/08/2012 New Zealand Rheumatology Association 06/06/2012 Rituximab 17p Chronic Lymphocytic Leukaemia Clinician s Application 24/08/2012 Pegylated-Asparaginase Acute Lymphoblastic Leukaemia Clinician s Application 12/06/2012 Nilotinib Chronic Myeloid Leukaemia Haematology Society 02/08/2012 Infliximab Juvenile Idiopathic Arthritis with chronic anterior uveitis New Zealand Paediatric Rheumatology Service 02/08/2012

12 Ferric Carboxymaltose (Ferinject) Iron Deficiency Anaemia Vifor Pharma 27/08/2012 Saxagliptin (Onglyza) Type 2 Diabetes with renal impairment Astra Zeneca 28/08/2012 Melatonin (Circadin) Insomnia Aspen Pharma 28/08/2012 Carbetocin (Duratocin) Sevelamer (Renagel) Uterine Atony and excessive bleeding following elective caesarean under epidural or spinal anaesthesia Hyperphosphataemia in adult patients with chronic kidney disease on dialysis Pharmaco 01/10/2012 Sanofi 26/11/2012 Rilpivirine (Edurant) HIV/AIDS Janssen-Cilag 27/11/2012 Bortezomib (Velcade) Multiple Myeloma Janssen-Clag 27/11/2012 Everolimus Sub-ependymal giant cell astrocytoma not amenable to neurosurgical resection Clinician 29/11/2012 Long-Acting Ocreotide Metastatic or Unresectable SI-NET s Clinician 19/09/2012 Renal Multivtamins Renal Disease Douglas Pharmaceuticals 27/11/2012

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