Quarterly Report on Completed Drug Submission Reviews

Transcription

1 Quarterly Report on Completed Drug Submission Reviews Overview Last updated October 18, 2017 The Quarterly Report on Completed Drug Submission Reviews report is divided into three reports for each year 1 : 1. The Type, Timelines and Number of Completed Drug Submission Reviews, by Quarter reports provide detailed information on the type of drug review, the target and actual timelines for each review, the total number of reviews, and the percentage of reviews that are completed and result in a PharmaCare coverage decision within the specific timeline for the given year. 2. The Drug Review Decisions Summary reports provide detailed information on the Ministry s coverage decision for each drug that PharmaCare has reviewed in the given year. 3. The Patient and Caregiver Input Summary provides information on the number of responses to the Ministry s call for patient, caregiver and patient group input for each drug that PharmaCare has reviewed in the given year. Responses are collected via the PharmaCare Your Voice website. Completed Drug Submission Reviews Reports... 3 Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter... 3 Drug Review Decisions Summary... 4 Patient and Caregiver Input Summary Reports... 9 Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter... 9 Drug Review Decisions Summary Patient and Caregiver Input Summary Reports Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter Drug Review Decisions Summary Patient and Caregiver Input Summary Reports Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter Drug Review Decisions Summary Patient and Caregiver Input Summary Note that there is no Patient and Caregiver Input Summary report for Reporting procedures changed in the fourth quarter of As a result, drug decision data and timelines from have been revised. Pharmaceutical Services Division October 2017

2 Quarterly Report on Completed Drug Submission Reviews 2 of Reports Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter Drug Review Decisions Summary Patient and Caregiver Input Summary Reports Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter Drug Review Decisions Summary... 35

3 Quarterly Report on Completed Drug Submission Reviews 3 of Reports Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter Reporting Period Q1 (Mar/17) Q2 (Jun/17) Q3 (Sep/17) Q4 (Dec/17) 2017 YTD Total Review Type 3 Target Timeline (months) Reviews Completed 4 Actual Review Times (months) Avg. Min. Max. Reviews Meeting Target Timeline (%) Priority 6 0 N/A N/A N/A N/A Standard Complex Other 5 N/A 7 N/A N/A N/A N/A Priority Standard Complex Other N/A 1 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 1 N/A N/A N/A N/A Priority 6 Standard 9 Priority Complex 9 Complex 12 Other N/A Priority Standard Complex Other N/A 8 N/A N/A N/A N/A Submissions with Timelines Review types are defined in The Drug Review Process in B.C. Detailed on the PharmaCare website. 4 A submission review is complete on the date of the formulary decision or the coverage effective date. 5 The Other category covers submissions not subject to target timelines. 6 Does not include drugs counted in the Other category.

4 Quarterly Report on Completed Drug Submission Reviews 4 of 40 Drug Review Decisions Summary Generic Name Trade Name Indication canakinumab Ilaris active systemic Juvenile Idiopathic Arthritis (sjia) in patients 2 years and older denosumab Xgeva Prevention of skeletalrelated events due to bone metastases from solid tumours denosumab Xgeva Prevention of skeletalrelated events due to bone metastases from breast cancer filgrastim Grastofil Sterile Solution for Injection filgrastim Grastofil Biosimilar Prevention or treatment of neutropenia in various indications filgrastim Neupogen Cancer patients receiving Myelosuppressive Chemotherapy filgrastim Neupogen Neutropenia tofacitinib Xeljanz Rheumatoid Arthritis denosumab Prolia Postmenopausal osteoporosis denosumab Prolia Osteoporosis (men) lipase amylase protease CREON Pancreatic enzymes tinzaparin sodium Innohep VTE in patients associated with cancer Submission Type 7 NI MI MI LE LE MC MI NI LE MC Decision Date 10-Jan Jan Jan Jan Jan Jan Jan Jan Feb Feb Feb Feb-17 Decision 8 Status Quo - Palliative Care Status Quo - Palliative Care Status Quo - Regular asunaprevir Sunvepra Chronic Hepatitis C 21-Mar-17 7 Submission type key: Blood Glucose Test Strips (BGTS), Clinician Submissions (CS), Line Extensions (LE), Modification of /criteria (MC), Ministry Initiated (MI), New Indications (NI), New Submissions (), Resubmissions (R), and Therapeutic Review of Drug Class (TR). 8 Before PharmaCare will cover a drug, the patient s prescriber has to obtain approval from the PharmaCare Special Authority Unit. For limited coverage criteria, visit For more details on each submission, visit

5 Quarterly Report on Completed Drug Submission Reviews 5 of 40 daclatasvir Daklinza Hepatitis C elbasvir-grazoprevir Zepatier Chronic Hepatitis C lumacaftor-ivacaftor Orkambi Cystic Fibrosis, F508del CFTR mutation Technivie Chronic Hepatitis C (genotype 4) sofosbuvir-velpatasvir Epclusa Chronic Hepatitis C MI 21-Mar Mar Mar Mar Mar-17 ombitasvir-paritaprevirritonavir adalimumab Humira Hidradenitis Suppurativa NI 18-Apr-17 amphetamine salts mixture dextroamphetamine lisdexamfetamine methylphenidate atomoxetine guanfacine methotrexate sodium METOJECT Single pre-use pre-filled syringes Attention Deficit Hyperactivity Disorder (ADHD) Disease Modifying Antirheumatic (DMARD) TR 18-Apr-17 LE 2-May-17 vedolizumab Entyvio Ulcerative Colitis 2-May-17 riociguat Adempas Pulmonary Arterial Hypertension (WHO group 1) NI 2-May-17 vedolizumab Entyvio Crohn's Disease NI 2-May-17 fentanyl Fentora Breakthrough cancer pain budesonide adalimumab levonorgestrel mifepristone and misoprostol etanercept Cortiment Humira Kyleena Mifegymiso Brenzys Biosimilar Ulcerative Colitis Ulcerative Colitis Conception control Medical termination of pregnancy (abortion) Rheumatoid arthritis, ankylosing spondylitis 16-May- 17 NI 13-Jun-17 NI 20-Jun-17 LE 27-Jun-17 Regular Viacoram Hypertension 11-Jul Jul Jul-17 Regular perindopril arginineamlodipine

6 Quarterly Report on Completed Drug Submission Reviews 6 of 40 calcipotriol betamethasone dipropionate Enstilar Psoriasis LE deferasirox Jadenu Iron Overload MI teduglutide Revestive Short Bowel Syndrome (SBS) ticagrelor Brilinta Prevention of atherothrombotic events with history of myocardial infarction NI 08-Aug Aug Aug Sep-17

7 Quarterly Report on Completed Drug Submission Reviews 7 of 40 Patient and Caregiver Input Summary Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver Patient Group adalimumab Humira Hidradenitis Suppurativa adalimumab Humira Ulcerative Colitis asunaprevir Sunvepra Chronic Hepatitis C budesonide Cortiment Ulcerative Colitis canakinumab Ilaris active systemic Juvenile Idiopathic Arthritis (sjia) in patients 2 years and older denosumab Prolia Osteoporosis (men) denosumab Xgeva Prevention of skeletal-related events due to bone metastases from solid tumours denosumab Xgeva Prevention of skeletal-related events due to bone metastases from breast cancer elbasvirgrazoprevir Zepatier Chronic Hepatitis C fentanyl Fentora Breakthrough cancer pain filgrastim Grastofil SEB Prevention or treatment of neutropenia in various indications Liraglutide 9 Victoza Type 2 Diabetes Mellitus lumacaftorivacaftor mifepristone and misoprostol ombitasvir paritaprevir ritonavir Orkambi Mifegymiso Cystic Fibrosis, F508del CFTR mutation Medical termination of pregnancy (abortion) Technivie Chronic Hepatitis C (genotype 4) riociguat Adempas Pulmonary Arterial Hypertension (WHO group 1) sofosbuvir velpatasvir Epclusa Chronic Hepatitis C Patient input was gathered for Liraglutide (Victoza) for type 2 diabetes mellitus, however, no coverage decision was made because the drug was withdrawn from the review process at the request of the manufacturer.

8 Quarterly Report on Completed Drug Submission Reviews 8 of 40 teduglutide Revestive Short Bowel Syndrome (SBS) ticagrelor Brilinta Prevention of atherothrombotic events with history of myocardial infarction tofacitinib Xeljanz Rheumatoid Arthritis vedolizumab Entyvio Crohn's Disease vedolizumab Entyvio Ulcerative Colitis 0 0 1

9 Quarterly Report on Completed Drug Submission Reviews 9 of Reports Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter Reporting Period Q1 (Mar/16) Q2 (Jun/16) Q3 (Sep/16) Q4 (Dec/16) 2016 Total Review Type 10 Target Timeline (months) Reviews Completed 11 Actual Review Times (months) Avg. Min. Max. Reviews Meeting Target Timeline (%) Priority 6 0 N/A N/A N/A N/A Standard Complex Other 12 N/A 1 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 11 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 3 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 4 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 19 N/A N/A N/A N/A Submissions with Timelines Review types are defined in The Drug Review Process in B.C. Detailed on the PharmaCare website. 11 A submission review is complete on the date of the formulary decision or the coverage effective date. 12 The Other category covers submissions not subject to target timelines. 13 Does not include drugs counted in the Other category.

10 Quarterly Report on Completed Drug Submission Reviews 10 of 40 Drug Review Decisions Summary Generic Name Trade Name Indication macitentan insulin glargine Opsumit Toujeo Pulmonary arterial hypertension Diabetes type 1 or 2 for adult patients ( 18 years) Submission Type 14 LE Decision Date 26-Jan-16 9-Feb-16 certolizumab pegol Cimzia Psoriatic arthritis NI 19-Feb-16 certolizumab pegol Cimzia Ankylosing spondylitis NI 19-Feb-16 infliximab Biosimilar Inflectra Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis 19-Feb-16 tocilizumab Actemra SC Rheumatoid arthritis 19-Feb-16 colesevelam hydrochloride umeclidinium donepezil galantamine rivastigmine aclidinium bromideformoterol fumarate dihydrate Lodalis 3.75 g Powder for Oral Suspension Incruse Ellipta Aricept Reminyl Exelon Duaklir Genuair Hypercholesterolemia LE 1-Mar-16 Chronic Obstructive Pulmonary Disease (COPD) Alzheimers Drug Therapy Initiative (ADTI) Chronic Obstructive Pulmonary Disease (COPD) apixaban Eliquis Treatment and prevention of recurrence of venous thromboembolic events (VTE) TR NI 15-Mar-16 1-Apr-16 5-Apr-16 5-Apr-16 Decision 15 Regular 14 Submission type key: Blood Glucose Test Strips (BGTS), Clinician Submissions (CS), Line Extensions (LE), Modification of /criteria (MC), Ministry Initiated (MI), New Indications (NI), New Submissions (), Resubmissions (R), and Therapeutic Review of Drug Class (TR). 15 Before PharmaCare will cover a drug, the patient s prescriber has to obtain approval from the PharmaCare Special Authority Unit. For limited coverage criteria, visit For more details on each submission, visit

11 Quarterly Report on Completed Drug Submission Reviews 11 of 40 mometasone furoate drug powder inhaler 100 mcg/metered inhalation Asmanex Twisthaler Pediatric asthma LE 5-Apr-16 ribavirin Ibavyr (200 mg tablets) Chronic Hepatitis C LE 5-Apr-16 tiotropium bromide Spiriva Respimat COPD 5-Apr-16 tiotropium-olodaterol Inspiolto Respimat COPD 5-Apr-16 lidocaine infusion for subcutaneous infusion Lidocaine Chronic pain management MI 13-Apr-16 daclatasvir Daklinza Chronic Hepatitis C 19-Apr-16 insulin lispro Humalog 200 u/ml KwikPen Diabetes LE 17-May- 16 Blood Glucose Test Strips Dario Diabetes BGTS 24-May- 16 Regular Blood Glucose Test Strips Spirit Blood Glucose Test Strips Diabetes BGTS 24-May- 16 Regular CareSens N Blood Glucose Test Strip CareSens N Blood Glucose Test Strip Diabetes BGTS 24-May- 16 Regular eculizumab Soliris Atypical Hemolytic Uremic Syndrome MI 31-May- 16 golimumab Simponi I.V. Rheumatoid arthritis 31-May- 16 golimumab Simponi Ulcerative colitis NI 31-May- 16 Nutramigen A+ Nutramigen A+ Cystic Fibrosis 31-May- 16 Pregestimil A+ 500 kcal/100 g powder (454 g Can) Pregestimil A+ 500 kcal/100 g powder (454 g Can) Cystic Fibrosis 31-May- 16 vitamin D analogues Vitamin D analogues Kidney (renal) dialysis 31-May- 16 adalimumab Humira Systemic juvenile idiopathic arthritis (sjia) MC 07-Jun-16 secukinumab Cosentyx Plaque psoriasis 28-July-16 somatropin Norditropin Nordiflex Growth Hormone Deficiency in children L 2-Aug-16 fesoterodine fumarate Toviaz Overactive Bladder 4-Aug-16

12 Quarterly Report on Completed Drug Submission Reviews 12 of 40 mirabegron Myrbetriq Overactive Bladder R 4-Aug-16 Overactive Bladder Various Drugs Overactive Bladder Various Drugs Overactive Bladder TR 4-Aug-16 (solifenacin generics) peginterferon beta-1a Plegridy Relapsing Remitting Multiple Sclerosis 4-Aug-16 deferasirox Jadenu Iron Overload L 16-Aug-16 fluticasone furoatevilanterol (as trifenatate) Breo Ellipta Asthma NI 13-Sep-16 fluticasone furoate Arnuity Ellipta Asthma 13-Sep-16 Regular ivermectin Rosiver Rosacea 27-Sep-16 deferiprone Ferriprox Transfusional iron overload 25-Oct-16 - Special Authority required infliximab Inflectra Biosimilar Crohn's disease and Ulcerative Colitis NI 01-Nov-16 - Special Authority required levonorgestrel 1.5mg Tablet Plan B Emergency Contraception LE 03-Nov-16 Regular omalizumab Xolair Chronic idiopathic urticarial (CIU) NI 29-Nov-16 On Call Vivid Self Monitoring Blood Glucose Test Strips On Call Vivid Self Monitoring Blood Glucose Test Strips Diabetes BGTS 29-Nov-16 Regular Allevia Plus Blood Glucose Test Strips Allevia Plus Blood Glucose Test Strips Diabetes BGTS 06-Dec-16 Regular Strefa Insulin Pen Needle & Lancet Strefa Insulin Pen Needle & Lancet Diabetes BGTS 13-Dec-16 Regular tesamorelin Egrifta Lipodystrophy, HIVinfected patients 13-Dec-16

13 Quarterly Report on Completed Drug Submission Reviews 13 of 40 Patient and Caregiver Input Summary Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver Patient Group aclidinium bromideformoterol fumarate dihydrate Duaklir Genuair Chronic Obstructive Pulmonary Disease (COPD) apixaban Eliquis Treatment and prevention of recurrence of venous thromboembolic events (VTE) certolizumab Cimzia Psoriatic arthritis certolizumab Cimzia Ankylosing spondylitis daclatasvir Daklinza Chronic Hepatitis C deferiprone Ferriprox Transfusional iron overload donepezil galantamine rivastigmine fesoterodine fumarate fluticasone furoate fluticasone furoate + vilanterol (as trifenatate) Aricept Reminyl Exelon Alzheimers Drug Therapy Initiative (ADTI) therapeutic review Toviaz Overactive Bladder Arnuity Ellipta Asthma Breo Ellipta Asthma golimumab Simponi Ulcerative colitis infliximab infliximab SEB Inflectra Biosimilar Inflectra Crohn's disease and Ulcerative Colitis Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis ivermectin Rosiver Rosacea macitentan Opsumit Pulmonary arterial hypertension mirabegron Myrbetriq Overactive Bladder omalizumab Xolair Chronic idiopathic urticarial (CIU) 3 0 0

14 Quarterly Report on Completed Drug Submission Reviews 14 of 40 Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver Patient Group aclidinium bromideformoterol fumarate dihydrate Duaklir Genuair Chronic Obstructive Pulmonary Disease (COPD) apixaban Eliquis Treatment and prevention of recurrence of venous thromboembolic events (VTE) certolizumab Cimzia Psoriatic arthritis certolizumab Cimzia Ankylosing spondylitis daclatasvir Daklinza Chronic Hepatitis C deferiprone Ferriprox Transfusional iron overload donepezil galantamine rivastigmine fesoterodine fumarate fluticasone furoate fluticasone furoate + vilanterol (as trifenatate) Aricept Reminyl Exelon Alzheimers Drug Therapy Initiative (ADTI) therapeutic review Toviaz Overactive Bladder Arnuity Ellipta Asthma Breo Ellipta Asthma golimumab Simponi Ulcerative colitis infliximab infliximab SEB Inflectra Biosimilar Inflectra Crohn's disease and Ulcerative Colitis Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis ivermectin Rosiver Rosacea Overactive Bladder various drugs peginterferon beta-1a Overactive Bladder various drugs Plegridy Overactive Bladder Therapeutic Review Relapsing-remitting Multiple Sclerosis (MS) secukinumab Cosentyx Plaque psoriasis tesamorelin tiotropiumolodaterol Egrifta Inspiolto Respimat Lipodystrophy, HIV-infected patients COPD 0 0 1

15 Quarterly Report on Completed Drug Submission Reviews 15 of 40 Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver Patient Group aclidinium bromideformoterol fumarate dihydrate Duaklir Genuair Chronic Obstructive Pulmonary Disease (COPD) apixaban Eliquis Treatment and prevention of recurrence of venous thromboembolic events (VTE) certolizumab Cimzia Psoriatic arthritis certolizumab Cimzia Ankylosing spondylitis daclatasvir Daklinza Chronic Hepatitis C deferiprone Ferriprox Transfusional iron overload donepezil galantamine rivastigmine fesoterodine fumarate fluticasone furoate fluticasone furoate + vilanterol (as trifenatate) Aricept Reminyl Exelon Alzheimers Drug Therapy Initiative (ADTI) therapeutic review Toviaz Overactive Bladder Arnuity Ellipta Asthma Breo Ellipta Asthma golimumab Simponi Ulcerative colitis infliximab infliximab SEB Inflectra Biosimilar Inflectra Crohn's disease and Ulcerative Colitis Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis ivermectin Rosiver Rosacea tocilizumab Actemra SC Rheumatoid arthritis umeclidinium Incruse Ellipta COPD 1 0 1

16 Quarterly Report on Completed Drug Submission Reviews 16 of Reports Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter Reporting Period Q1 (Mar/15) Q2 (Jun/15) Q3 (Sep/15) Q4 (Dec/15) 2015 Total Review Type 16 Target Timeline (months) Reviews Completed 17 Actual Review Times (months) Avg. Min. Max. Reviews Meeting Target Timeline (%) Priority Standard Complex Other 18 N/A 2 N/A N/A N/A N/A Priority Standard Complex Other N/A 1 N/A N/A N/A N/A Priority Standard Complex Other N/A 2 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 1 N/A N/A N/A N/A Priority Standard Complex Other N/A 6 N/A N/A N/A N/A Submissions with Timelines Review types are defined in The Drug Review Process in B.C. Detailed on the PharmaCare website. 17 A submission review is complete on the date of the formulary decision or the coverage effective date. 18 The Other category covers submissions not subject to target timelines. 19 Does not include drugs counted in the Other category.

17 Quarterly Report on Completed Drug Submission Reviews 17 of 40 Drug Review Decisions Summary Generic Name Trade Name Indication guanfacine hydrochloride Intuniv XR Attention deficit hyperactivity disorder (ADHD) Submission Type 20 Decision Date Decision Jan-15 phleum pratense Grastek Grass allergy 20-Jan-15 ocriplasmin Jetrea Vitreomacular adhesion 27-Jan-15 ipratropium bromide and salbutamol sulfate inhalation solution Combivent Respimat Bronchospasm associated with chronic obstructive pulmonary disease (COPD) tinzaparin sodium Innohep Deep vein thrombosis (DVT) and/or pulmonary embolism betamethasone valerate LE 17-Feb-15 Regular LE 6-Mar-15 Luxiq Psoriasis LE 10-Mar-15 riociguat Adempas Chronic thromboembolic pulmonary hypertension ivacaftor Kalydeco Cystic Fibrosis (G551D mutation) fosfomycin tromethamine Monurol Uncomplicated Urinary Tract Infections 10-Mar Mar ; exceptional coverage 24-Mar-15 Regular ledipasvir + sofosbuvir Harvoni Chronic Hepatitis C 24-Mar-15 norethindrone acetate and ethinyl estradiol LOLO Lower Dose Oral Contraceptive pill LE 24-Mar-15 ribavirin Ibavyr Chronic Hepatitis C 24-Mar-15 sofosbuvir Sovaldi Chronic Hepatitis C 24-Mar-15 aripiprazole Abilify Major Depressive NI 14-Apr Submission type key: Blood Glucose Test Strips (BGTS), Clinician Submissions (CS), Line Extensions (LE), Modification of /criteria (MC), Ministry Initiated (MI), New Indications (NI), New Submissions (), Resubmissions (R), and Therapeutic Review of Drug Class (TR). 21 Before PharmaCare will cover a drug, the patient s prescriber has to obtain approval from the PharmaCare Special Authority Unit. For limited coverage criteria, visit For more details on each submission, visit 22 Ivacaftor (Kalydeco) is a, but is also covered on an exceptional case by case basis.

18 Quarterly Report on Completed Drug Submission Reviews 18 of 40 Disorder (MDD) ticagrelor Brilinta Prevention of thrombotic events in Acute Coronary Syndromes (ACS) MI 14-Apr-15 vitamin D3 ViDextra Vitamin D insufficiency LE 14-Apr-15 methadone hydrochloride alogliptin plus metformin Metadol-D Detoxification treatment of opioid addiction (heroin or other morphine-like drugs) NI 21-Apr-15 Kazano Type 2 diabetes mellitus 5-May-15 alogliptin Nesina Type 2 diabetes mellitus 5-May-15 dalteparin Fragmin Thromboprophylaxis in conjunction with surgery; Treatment of acute deep venous thrombosis; Unstable coronary artery disease (UCAD) fluticasone furoatevilanterol LE 5-May-15 Breo Ellipta COPD 15-May- 15 levonorgestrel Jaydess Conception control LE 19-May- 15 ustekinumab Stelara Psoriatic arthritis NI 26-May- 15 indacaterolglycopyrronium Ultibro Breezhaler lomitapide Juxtapid Homozygous Familial Hypercholesterolemia COPD NI 2-Jun Jun-15 stiripentol Diacomit Dravet Syndrome 7-Jul-15 eltrombopag Revolade Thrombocytopenia associated with Chronic Hepatitis C infection Blood Glucose Test Strips FORA Test N' Go Blood Glucose Test Strips (BGTS) everolimus Afinitor Subependymal giant cell astrocytoma associated with tuberous sclerosis complex NI 14-Jul-15 BGTS 28-Jul-15 Regular NI 28-Jul-15 lurasidone Latuda Schizophrenia LE 28-Jul-15 ombitasvir/paritaprevir/ ritonavir/dasabuvir Holkira Pak Chronic Hepatitis C 28-Jul-15

19 Quarterly Report on Completed Drug Submission Reviews 19 of 40 aripiprazole Abilify Maintena Schizophrenia 11-Aug-15 umeclidinium/vilanterol Anoro Ellipta COPD 11-Aug-15 pasireotide Signifor Cushing's disease 1-Sep-15 elosulfase alfa Vimizim Mucopolysaccharidosis IVA (Morquio A syndrome) azelastine and fluticasone buprenorphinenaloxone methadone hydrochloride 1 mg/ml oral solution brinzolamidebrimonidine Dymista Seasonal allergic rhinitis and rhino-conjunctivitis 22-Sep Sep-15 Suboxone Opioid dependence MI 13-Oct-15 Regular Metadol-D Simbrinza Detoxification treatment of opioid addiction Glaucoma and ocular hypertension LE 27-Oct Oct-15 Regular eslicarbazepine acetate Aptiom Partial-onset seizure 10-Nov-15 vitamin B12- cyanocobalamin 1500 mcg Tablet, Multilayer, Extended Release Beduzil 1500 Cobalamin deficiency LE 22-Dec-15 apremilast Otezla Plaque psoriasis 22-Dec-15 linaclotide Constella Irritable bowel syndrome with constipation 22-Dec-15

20 Quarterly Report on Completed Drug Submission Reviews 20 of 40 Patient and Caregiver Input Summary Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver adalimumab 23 Humira Ulcerative colitis alogliptin Nesina Type 2 diabetes mellitus Kazano Type 2 diabetes mellitus apremilast Otezla Plaque psoriasis aripiprazole Abilify Major Depressive Disorder (MDD) aripiprazole azelastine HCl and fluticasone propionate alogliptinmetformin brinzolamidebrimonidine elosulfase alfa eltrombopag Abilify Maintena Dymista Simbrinza Vimizim Revolade Schizophrenia Seasonal allergic rhinitis and rhino-conjunctivitis Glaucoma and ocular hypertension Mucopolysaccharidosis IVA (Morquio A syndrome) Thrombocytopenia associated with Chronic Hepatitis C Infection eslicarbazepine Aptiom Partial-onset seizure everolimus fluticasone furoate - vilanterol fosfomycin tromethamine guanfacine hydrochloride indacaterol - glycopyrronium Afinitor Breo Ellipta Monurol Intuniv XR Ultibro Breezhaler Subependymal giant cell astrocytoma associated with tuberous sclerosis complex Chronic Obstructive Pulmonary Disease (COPD) Uncomplicated Urinary Tract Infections Attention deficit hyperactivity disorder (ADHD) COPD ivacaftor Kalydeco Cystic Fibrosis (G551D mutation) linaclotide Constella Irritable bowel syndrome with constipation lomitapide Juxtapid Homozygous Familial Hypercholesterolemia Patient Group 23 This drug submission was withdrawn by the manufacturer and is not counted as a completed review in this report.

21 Quarterly Report on Completed Drug Submission Reviews 21 of 40 Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver Patient Group ombitasvir/parit aprevir/ritonavir /dasabuvir Holkira Pak Chronic Hepatitis C pasireotide Signifor Cushing's disease phleum pratense Grastek Grass allergy riociguat Adempas Pulmonary hypertension, chronic thromboembolic sofosbuvir Sovaldi Chronic Hepatitis C stiripentol Diacomit Dravet syndrome Umeclidinium/ vilanterol Anoro Ellipta COPD ustekinumab Stelara Psoriatic arthritis 0 0 0

22 Quarterly Report on Completed Drug Submission Reviews 22 of Reports Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter Reporting Period Q1 (Mar/14) Q2 (Jun/14) Q3 (Sep/14) Q4 (Dec/14) 2014 Total Review Type 24 Target Timeline (months) Reviews Completed 25 Actual Review Times (months) Avg. Min. Max. Reviews Meeting Target Timeline (%) Priority 6 0 N/A N/A N/A N/A Standard Priority Complex Complex Other 26 N/A 0 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 1 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 0 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 3 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Priority Complex Complex Other N/A 4 N/A N/A N/A N/A Submissions with Timelines Review types are defined in The Drug Review Process in B.C. Detailed on the PharmaCare website. 25 A submission review is complete on the date of the formulary decision or the coverage effective date. 26 The Other category covers submissions not subject to target timelines. 27 Does not include drugs counted in the Other category.

23 Quarterly Report on Completed Drug Submission Reviews 23 of 40 Drug Review Decisions Summary Generic Name Trade Name Indication pirfenidone Esbriet Idiopathic Pulmonary fibrosis pegvisomant for injection Somavert Last line of treatment for acromegaly eculizumab Soliris Atypical Hemolytic Uremic Syndrome doxycycline monohydrate Submission Type 28 Decision Date Decision Jan-14 R 14-Jan-14 NI 14-Jan-14 Apprilon Rosacea 28-Jan-14 methadone MethaDose Substitution therapy for opioid dependence abatacept subcutaneous (sc) 1-Feb-14 Regular Orencia Rheumatoid arthritis R 25-Feb-14 fidaxomicin Dificid Clostridium difficile infection adalimumab Humira Pediatric juvenile idiopathic arthritis (pjia) collagenase clostridium histolyticum Xiaflex Dupuytrens contracture with a palpable cord interferon beta-1a Rebif Clinically Isolated Syndrome 25-Feb-14 NI 25-Feb Mar-14 NI 25-Mar-14 nebivolol Bystolic Hypertension 25-Mar-14 ingenol mebutate Picato Actinic keratosis 5-Jun-14 Contour Next (50 strips box) Contour Next Blood Glucose Test Strips (BGTS) dimethyl fumarate Tecfidera Relapsing-remitting Multiple Sclerosis (MS) dimethyl fumarate 240 mg delayedrelease capsule BGTS 17-Jun Jun-14 Tecfidera Relapsing-remitting MS LE 24-Jun-14 zolpidem tartrate Sublinox Insomnia 24-Jun Submission type key: Blood Glucose Test Strips (BGTS), Clinician Submissions (CS), Line Extensions (LE), Modification of /criteria (MC), Ministry Initiated (MI), New Indications (NI), New Submissions (), Resubmissions (R), and Therapeutic Review of Drug Class (TR). 29 Before PharmaCare will cover a drug, the patient s prescriber has to obtain approval from the PharmaCare Special Authority Unit. For limited coverage criteria, visit For more details on each drug submission, visit

24 Quarterly Report on Completed Drug Submission Reviews 24 of 40 colesevelam Lodalis Hypercholesterolemia MI 24-Jun-14 Regular azilsartan medoxomilchlorthalidone azilsartan medoxomil Saxagliptinmetformin saxagliptin hydrochloride 2.5 mg tablet Edarbyclor Hypertension 29-Jul-14 Edarbi Hypertension 29-Jul-14 Jentadueto Type 2 diabetes mellitus 5-Aug-14 Komboglyze Type 2 diabetes mellitus 5-Aug-14 Onglyza Type 2 diabetes with renal impairment LE 5-Aug-14 saxagliptin Onglyza Type 2 diabetes mellitus R 5-Aug-14 sitagliptin phosphate monohydrate 25 and 50 mg tablets linagliptinmetformin sitagliptinmetformin hydrochloride Januvia Type 2 diabetes mellitus with renal insufficiency LE 5-Aug-14 Janumet XR Type 2 diabetes mellitus LE 5-Aug-14 somatropin Genotropin Growth hormone deficiency in adults somatropin Genotropin Growth hormone deficiency in children 5-Aug-14 5-Aug-14 somatropin Genotropin Turner syndrome NI 5-Aug-14 everolimus Afinitor Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) 12-Aug-14 perampanel Fycompa Partial-onset seizure 15-Aug-14 insulin detemir Levemir FlexTouch lurasidone Latuda Management of the manifestations of Schizophrenia somatropin 5 and 20 mg aclidinium bromide Nutropin AQ Nuspin Tudorza Genuair Diabetes type 1 or 2 LE 28-Aug-14 Growth Hormone Deficiency; growth failure associated with chronic renal insufficiency and Turner syndrome Chronic Obstructive Pulmonary Disease R 16-Sep-14 LE 23-Sep Sep-14

25 Quarterly Report on Completed Drug Submission Reviews 25 of 40 (COPD) rivaroxaban Xarelto Venous thromboembolic events (VTE), pulmonary embolism epoprostenol sodium peginterferon alfa- 2a Caripul Pegasys RBV ProClick Autoinjector Primary pulmonary hypertension and secondary pulmonary hypertension simeprevir Galexos Chronic Hepatitis C (genotype 1) NI 30-Sep Oct-14 Chronic Hepatitis B and C LE 28-Oct Oct-14 rotigotine Neupro Parkinsons disease 18-Nov-14 OnabotiliniumtoxinA Botox Chronic migraine NI 18-Nov-14 eplerenone Inspra Heart failure, NYHA class II Blood Glucose Test Strips SURETEST Blood Glucose Test Strips Bravo Blood Glucose Test Strips ketorolac tromethamine GE200 Glucose Test Strips SURETEST Blood Glucose Test Strips Bravo Blood Glucose Test Strips Acuvail NI 18-Nov-14 BGTS BGTS 18-Nov-14 Regular BGTS BGTS 18-Nov-14 Regular BGTS BGTS 18-Nov-14 Regular Treatment of pain and inflammation following cataract surgery LE 9-Dec-14 Regular teriflunomide Aubagio Relapsing-remitting MS 9-Dec-14 tocilizumab Actemra Pediatric juvenile idiopathic arthritis (pjia) NI 9-Dec-14

26 Quarterly Report on Completed Drug Submission Reviews 26 of 40 Patient and Caregiver Input Summary Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver abatacept subcutaneous (sc) aclidinium bromide Orencia Rheumatoid arthritis Tudorza Genuair Chronic Obstructive Pulmonary Disease (COPD) adalimumab Humira Juvenile idiopathic arthritis alemtuzumab 30 azilsartan medoxomil azilsartan medoxomil + chlorthalidone collagenase clostridium histolyticum dimethyl fumarate doxycycline monohydrate eculizumab Lemtrada Relapsing-remitting Multiple Sclerosis (MS) Edarbi Hypertension Edarbyclor Hypertension Xiaflex Dupuytrens contracture with a palpable cord Tecfidera Relapsing-remitting MS Apprilon Rosacea Soliris Atypical Hemolytic Uremic syndrome eplerenone Inspra NYHA class II heart failure everolimus Afinitor Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) fidaxomicin Dificid Clostridium difficile infection ingenol mebutate interferon beta- 1a linagliptinmetformin lurasidone Picato Actinic keratosis Rebif Clinically Isolated Syndrome Jentadueto Type 2 diabetes mellitus Latuda Management of the manifestations of Schizophrenia Patient Group 30 This drug submission was withdrawn by the manufacturer and is not counted in the completed drug review table in this report.

27 Quarterly Report on Completed Drug Submission Reviews 27 of 40 Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver nebivolol Bystolic Hypertension pegvisomant for injection Botox Chronic migraine Somavert Last line of treatment for acromegaly perampanel Fycompa Partial onset seizures pirfenidone Esbriet Idiopathic Pulmonary fibrosis ( rivaroxaban Xarelto Venous thromboembolic events (VTE), pulmonary embolism rotigotine Neupro Parkinsons Disease saxagliptin Onglyza Type 2 diabetes mellitus OnabotiliniumtoxinA saxagliptinmetformin Komboglyze Type 2 diabetes mellitus simeprevir Galexos Chronic Hepatitis C (genotype 1) somatropin somatropin Genotropin Genotropin Growth Hormone Deficiency in adults Growth Hormone Deficiency in children somatropin Genotropin Turner syndrome teriflunomide Aubagio Relapsing-remitting MS tocilizumab Actemra pjia zolpidem tartrate Sublinox Insomnia Patient Group

28 Quarterly Report on Completed Drug Submission Reviews 28 of Reports Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter Reporting Period Q1 (Mar/13) Q2 (Jun/13) Q3 (Sep/13) Q4 (Dec/13) 2013 Total Review Type 31 Target Timeline (months) Reviews Completed 32 Actual Review Times (months) Avg. Min. Max. Reviews Meeting Target Timeline (%) Priority 6 0 N/A N/A N/A N/A Standard Complex Other 33 N/A 0 N/A N/A N/A NA Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 1 N/A N/A N/A N/A Priority Standard Complex Other N/A 0 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 0 N/A N/A N/A N/A Priority Standard Complex Other N/A 1 N/A N/A N/A N/A Submissions with Timelines Review types are defined in The Drug Review Process in B.C. Detailed on the PharmaCare website. 32 A submission review is complete on the date of the formulary decision or the coverage effective date. 33 The Other category covers submissions not subject to target timelines.

29 Quarterly Report on Completed Drug Submission Reviews 29 of 40 Drug Review Decisions Summary Generic Name Trade Name Indication oseltamivir phosphate dexamethasone intravitreal implant Submission Type 35 Decision Date Decision 36 Tamiflu Influenza LE 8-Jan-13 Regular for Plan B Patients Ozurdex Macular Edema following CRVO belimumab Benlysta Systemic Lupus Erythematosus epinephrine Allerject Emergency treatment of anaphylactic reactions in patients who are identified to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions 7-Jan Jan-13 LE 19-Feb-13 Regular asenapine Saphris Bipolar 1 14-Mar-13 asenapine Saphris Schizophrenia 14-Mar-13 prucalopride Resotran Constipation 14-Mar-13 onabotulinumtoxina Botox Neurogenic Detrusor Overactivity NI 28-Mar-13 escitalopram Cipralex Meltz Antidepressant LE 11-Apr-13 tocilizumab Actemra Juvenile idiopathic arthritis alfacalcidol One-Alpha Hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in patients with chronic renal failure Blood Glucose Test Strips MyGlucoHealth Test Strips NI 11-Apr-13 LE 16-May- 13 Diabetes BGTS 16-May- 13 Regular Regular 34 Does not include drugs counted in the Other category. 35 Submission type key: Blood Glucose Test Strips (BGTS), Clinician Submissions (CS), Line Extensions (LE), Modification of /criteria (MC), Ministry Initiated (MI), New Indications (NI), New Submissions (), Resubmissions (R), and Therapeutic Review of Drug Class (TR). 36 Before PharmaCare will cover a drug, the patient s prescriber has to obtain approval from the PharmaCare Special Authority Unit. For limited coverage criteria, visit For more details on each drug submission, visit

30 Quarterly Report on Completed Drug Submission Reviews 30 of 40 Generic Name Trade Name Indication Submission Type 35 Decision Date fingolimod Gilenya Multiple Sclerosis (MS) 16-May- 13 rituximab Rituxan Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA) rivaroxaban Xarelto Deep vein thrombosis (DVT) indacaterol Onbrez Chronic Obstructive Pulmonary Disease (COPD) 5-aminosalicylic acid Pentasa Ulcerative Colitis and Crohn s Disease colesevelam hydrochloride NI NI 16-May May May- 13 Decision 36 LE 13-Jun-13 Regular Lodalis Hypercholesterolemia 13-Jun-13 fampridine Fampyra MS, improve walking disability 20-Jun-13 exenatide Byetta Type 2 diabetes mellitus 20-Jun-13 ustekinumab Stelara Psoriasis LE 20-Jun-13 natalizumab Tysabri MS MC 25-Jul-13 No Change to tolvaptan Samsca hypovolemic hyponatremia transdermal estradiol gel Divigel 0.1% Moderate to severe vasemotor symptoms (MSVMS) associated with menopause apixaban Eliquis Prevention of stroke and systemic embolism in patients with atrial fibrillation glycopyrronium bromide Seebri COPD, maintenance bronchodilator treatment 15-Aug Aug-13 NI 19-Sep Sep-13 lurasidone Latuda Schizophrenia 19-Sep-13 boceprevir Victrelis HIV/Hepatitis C MC 10-Oct-13 isotretinoin Epuris Treatment of severe acne LE 10-Oct-13 telaprevir Incivek HIV/Hepatitis C MC 10-Oct-13

31 Quarterly Report on Completed Drug Submission Reviews 31 of 40 Generic Name Trade Name Indication clostridium botulinum toxin, type A grass pollen allergen extract Xeomin Oralair Symptomatic management of blepharospasm cervical dystonia, and poststroke spasticity of the upper limb Allergic rhinitis (grass pollen) palonosetron Aloxi (capsule) Prevention of chemotherapy-induced nausea and vomiting palonosetron oxycodone hydrochloride (Controlled Release) Aloxi (injection) Prevention of chemotherapy-induced nausea and vomiting Submission Type 35 Decision Date Decision 36 LE 31-Oct Oct Oct Oct-13 OxyNEO Chronic pain R 29-Nov-13 No Change to apixaban Eliquis Prevention of venous thromboembolic events (VTE) 10-Dec-13

32 Quarterly Report on Completed Drug Submission Reviews 32 of 40 Patient and Caregiver Input Summary Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver apixaban Eliquis Prevention of venous thromboembolic events (VTE) asenapine Saphris Bipolar asenapine Saphris Schizophrenia belimumab Benlysta Systemic Lupus Erythematosus colesevelam hydrochloride dexamethasone intravitreal implant Lodalis Hypercholesterolemia Ozurdex Macular Edema following CRVO exenatide Byetta Tyoe 2 Diabetes mellitus fampridine Fampyra Multiple Sclerosis (MS), improve walking disability fingolimod Gilenya MS glycopyrronium bromide grass pollen allergen extract Seebri Chronic Obstructive Pulmonary Disease (COPD), maintenance bronchodilator treatment Oralair Allergic rhinitis (grass pollen) indacaterol Onbrez COPD lurasidone Latuda Schizophrenia mirabegron 37 Myrbetriq Overactive Bladder onabotulinumto xina palonosetron palonosetron Botox Neurogenic detrusor overactivity Aloxi (capsule) Aloxi (injection) Prevention of chemotherapyinduced nausea and vomiting Prevention of chemotherapyinduced nausea and vomiting prucalopride Resotran Constipation rituximab Rituxan Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA) rivaroxaban Xarelto Deep vein thrombosis (DVT) tocilizumab Actemra Juvenile idiopathic arthritis Patient Group 37 This drug submission was withdrawn by the manufacturer and is not counted as a completed review in this report.

33 Quarterly Report on Completed Drug Submission Reviews 33 of 40 Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver ustekinumab Stelara Psoriasis Patient Group

34 Quarterly Report on Completed Drug Submission Reviews 34 of Reports Type, Timelines, and Number of Completed Drug Submission Reviews, by Quarter Reporting Period Q1 (Mar/12) Q2 (Jun/12) Q3 (Sep/12) Q4 (Dec/12) 2012 Total Review Type 38 Target Timeline (months) Reviews Completed 39 Actual Review Times (months) Avg. Min. Max. Reviews Meeting Target Timeline (%) Priority Standard Complex Other 40 N/A 9 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 1 N/A N/A N/A N/A Priority Standard Priority Complex Complex N/A Other N/A 7 N/A N/A N/A N/A Priority 6 0 N/A N/A N/A N/A Standard Complex Other N/A 2 N/A N/A N/A N/A Priority Standard Priority Complex Complex Other N/A 19 N/A N/A N/A N/A Submissions with Timelines Review types are defined in The Drug Review Process in B.C. Detailed on the PharmaCare website. 39 A submission review is complete on the date of the formulary decision or the coverage effective date. 40 The Other category covers submissions not subject to target timelines.

35 Quarterly Report on Completed Drug Submission Reviews 35 of 40 Drug Review Decisions Summary Generic Name Trade Name Indication Submission Type 42 Decision Date Decision 43 febuxostat Uloric Gout 5-Jan-12 tenofovir Viread Hepatitis B MC 9-Jan-12 tenofovir Viread Treatment of lamivudineresistant chronic hepatitis B MI 19-Jan-12 acarbose Glucobay Type 2 diabetes MC 20-Jan-12 lacosamide Vimpat Epilepsy 25-Jan-12 paliperidone palmitate oxycodone hydrochloride Blood Glucose Test Strips Blood Glucose Test Strips Blood Glucose Test Strips Invega Sustenna Schizophrenia 25-Jan-12 OxyNEO Pain LE 25-Feb-12 OneTouch Verio Diabetes BGTS 6-Mar-12 Regular Rightest GS100 Diabetes BGTS 6-Mar-12 Regular BGStar Diabetes BGTS 6-Mar-12 Regular cyclosporine Restasis Moderate to severe dry eye 13-Mar-12 boceprevir Victrelis Hepatitis C 15-Mar-12 Blood Glucose Test Strips Rapid Response Diabetes BGTS 30-Mar-12 Regular 41 Does not include drugs counted in the Other category. 42 Submission type key: Blood Glucose Test Strips (BGTS), Clinician Submissions (CS), Line Extensions (LE), Modification of /criteria (MC), Ministry Initiated (MI), New Indications (NI), New Submissions (), Resubmissions (R), and Therapeutic Review of Drug Class (TR). 43 Before PharmaCare will cover a drug, the patient s prescriber has to obtain approval from the PharmaCare Special Authority Unit. For limited coverage criteria, visit For more details on each drug submission, visit

36 Quarterly Report on Completed Drug Submission Reviews 36 of 40 Generic Name Trade Name Indication Creon 6 Creon 6 Pancreatic enzyme replacement therapy where digestion is not adequate due to pancreatic exocrine insufficiency (PEI) hydromorphone hydrochloride Submission Type 42 Decision Date Decision 43 LE 30-Mar-12 Regular Jurnista Chronic pain R 30-Mar-12 liraglutide Victoza Type 2 diabetes mellitus 30-Mar-12 roflumilast Daxas Chronic Obstructive Pulmonary Disease (COPD) 30-Mar-12 buprenorphine BuTrans Persistent pain R 15-May-12 tapentadol Nucynta Moderate to moderately severe pain dabigatran Pradax Prevention of stroke and systemic embolism in patients with atrial fibrillation eltrombopag Revolade Adult immune idiopathic thrombocytopenic mometasone furoate / formoterol fumarate mometasone furoate 15-May-12 NI 23-May May-12 Zenhale Asthma 28-Jun-12 Asmanex Prophylactic management of steroidresponse bronchial asthma 28-Jun-12 Regular risedronate soduim Actonel DR Osteoporosis LE 28-Jun-12 zoledronic acid Zometa Prevention of skeletalrelated events in patients with castrate-resistant prostate cancer MI 28-Jun-12 Status Quo telaprevir Incivek Hepatitis C 5-Jul-12 alitretinoin Toctino Eczema 17-Jul-12 Low Molecular Weight Heparin Prophylaxis in patients undergoing abdominal surgery due to cancer CS 17-Jul-12 zoledronic acid Aclasta Osteoporosis MC 17-Jul-12

37 Quarterly Report on Completed Drug Submission Reviews 37 of 40 Generic Name Trade Name Indication Submission Type 42 Decision Date Decision 43 fentanyl citrate Abstral Pain from Cancer 31-Jul-12 fentanyl citrate Onsolis Pain from Cancer 31-Jul-12 sapropterin Kuvan Phenylketonuria (PKU) 31-Jul-12 rivaroxaban Xarelto Stroke prevention in patients with atrial fibrillation rufinamide Banzel Lennox-Gastaut Syndrome Blood Glucose Test Strips Blood Glucose Test Strips Blood Glucose Test Strips FreeStyle Precision Bayer Contour NEXT Medisure Diabetic Test Strips NI 2-Aug Aug-12 Diabetes BGTS 15-Aug-12 Regular Diabetes BGTS 15-Aug-12 Regular Diabetes BGTS 15-Aug-12 Regular linagliptin Trajenta Type 2 diabetes mellitus 30-Aug-12 telmisartanamlodipine Twynsta Hypertension 30-Aug-12 aztreonam Cayston Cystic Fibrosis with chronic pulmonary pseudomonas aeruginosa infections ticagrelor Brilinta Thrombosis in Acute Coronary Syndromes (ACS) 13-Sep-12 R 13-Sep-12 tobramycin TOBI Cystic Fibrosis MI 13-Sep-12 dienogest Visanne Pelvic pain associated with endometriosis silodosin Rapaflo Treatment of benign prostatic hyperplasia (BPH) oxycodone HCI / naloxone HCI Targin Pain and relief of opiodinduced constipation 2-Oct-12 2-Oct-12 R 16-Oct-12 prasugrel Effient ACS R 30-Oct-12 7% hypertonic sodium chloride solution HyperSal 7% Cystic Fibrosis 1-Dec-12 Regular

38 Quarterly Report on Completed Drug Submission Reviews 38 of 40 Generic Name Trade Name Indication hypertonic sodium chloride solution for Inhalation methylprednisolone sodium succinate for injection USP Submission Type 42 Decision Date Decision 43 Nebusal 7% Cystic Fibrosis 1-Dec-12 Regular SOLUMEDROL ACT-O-VIALS Corticosteroidresponsive conditions celecoxib Celebrex Osteoarthritis, adult rheumatoid arthritis, ankylosing spondilitis, short term management of moderate to severe acute pain in adults denosumab Xgeva Prevention of skeletalrelated events due to bone metastases from solid tumours dexlansoprazole Dexilant Healing of erosive esophagitis; Maintaining healing of erosive esophagitis; GERD oxybutynin chloride gel somatropin LE 1-Dec-12 Regular MC 18-Dec Dec Dec-12 Gelnique Overactive Bladder 18-Dec-12 Nutropin AQ NuSpin Growth Hormone Deficiency, Growth failure associated with chronic renal insufficiency and Turner Syndrome LE 18-Dec-12

39 Quarterly Report on Completed Drug Submission Reviews 39 of 40 Patient and Caregiver Input Summary Drug Details Patient Responses to calls for input Generic Name Trade Name Indication Patient Caregiver alitretinoin Toctino Eczema aztreonam Cayston Cystic Fibrosis with chronic pulmonary pseudomonas aeruginosa infections boceprevir Victrelis Hepatitis C buprenorphine BuTrans Persistent pain celecoxib Celebrex Osteoarthritis, adult rheumatoid arthritis, ankylosing spondilitis, short term management of moderate to severe acute pain in adults cyclosporine Restasis Dry eye dabigatran denosumab 44 dexlansoprazole dienogest eltrombopag Pradax Xgeva Dexilant Visanne Revolade Prevention of stroke and systemic embolism in patients with atrial fibrillation Prevention of skeletal-related events due to bone metastases from solid tumours Healing of erosive esophagitis; Maintaining healing of erosive esophagitis; GERD Pelvic pain associated with endometriosis Adult immune idiopathic thrombocytopenic febuxostat Uloric Gout fentanyl citrate Abstral Pain from Cancer fentanyl citrate Onsolis Pain from Cancer hydromorphone hydrochloride Jurnista Chronic pain lacosamide Vimpat Epilepsy linagliptin Trajenta Type 2 diabetes mellitus liraglutide Victoza Type 2 diabetes mellitus Patient Group 44 A combined call for input was issued for denosumab (Xgeva) and zoledronic acid (Xgeva). Responses should only be counted once as respondents were commenting on both drugs.