How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study

Transcription

1 RESEARCH PAPER How Safe and Are First-in-Class Drugs Approved by Health Canada: A Cohort Study L innocuité et l aspect innovant des nouvelles classes de médicaments approuvés par Santé Canada : une étude de cohorte JOEL LEXCHIN Appendix 1. List of drugs with first-in-class and innovation status and Anatomical Therapeutic Chemical group Abiraterone Yes Yes antineoplastic and immunomodulating agents Abatacept Yes No antineoplastic and immunomodulating agents Abacavir No No anti-infective for systemic use Acamprosate Yes No nervous system Adalimumab No No antineoplastic and immunomodulating agents Adefovir No No anti-infective for systemic use Agalsidase beta Yes No alimentary tract and metabolism Alatrofloxacin No No anti-infective for systemic use Alefacept Yes No antineoplastic and immunomodulating agents Alemtuzumab Yes Yes antineoplastic and immunomodulating agents Alfuzosin No No genito-urinary system and sex hormones Alglucosidase alfa Yes Yes alimentary tract and metabolism Aliskiren No No cardiovascular system Alitretinoin No No antineoplastic and immunomodulating agents Almotriptan No No nervous system Ambrisentan No No cardiovascular system Amprenavir No No anti-infective for systemic use Anakinra Yes No antineoplastic and immunomodulating agents Anidulafungin No No anti-infective for systemic use [1] HEALTHCARE POLICY Vol.12 No.2, 2016

2 Joel Lexchin Aprepitant Yes No alimentary tract and metabolism Aripiprazole Yes No nervous system Atazanavir No No anti-infective for systemic use Atomoxetine Yes No nervous system Atorvastatin No No cardiovascular system Azacitidine Yes Yes antineoplastic and immunomodulating agents Basiliximab No No antineoplastic and immunomodulating agents Becaplermin Gel Yes No dermatologicals Belimumab Yes No antineoplastic and immunomodulating agents Besifloxacin No No sensory organs Bevacizumab Yes No antineoplastic and immunomodulating agents Bimatoprost No No sensory organs Bivalirudin No No blood and blood-forming agents Bortezomib Yes No antineoplastic and immunomodulating agents Bosentan Yes Yes cardiovascular system Botulinum toxin type B No No musculoskeletal system Brimonidine No No sensory organs Brinzolamide No No sensory organs Cabazitaxel No No antineoplastic and immunomodulating agents Cabergoline No No nervous system Canakinumab No Yes antineoplastic and immunomodulating agents Candesartan No No cardiovascular system Capecitabine No No antineoplastic and immunomodulating agents Caspofungin Yes Yes anti-infective for systemic use Celecoxib Yes No musculoskeletal system Cerivastatin No No cardiovascular system Certolizumab pegol No No antineoplastic and immunomodulating agents Cetrorelix No No systemic hormonal preparations, excluding sex hormones and insulins Cetuximab Yes No antineoplastic and immunomodulating agents Ciclesonide No No respiratory system Cidofovir No No anti-infective for systemic use Cinacalcet Yes Yes systemic hormonal preparations, excluding sex hormones and insulins [2] HEALTHCARE POLICY Vol.12 No.2, 2016

3 How Safe and Are First-in-Class Drugs Approved by Health Canada: A Cohort Study Citalopram No No nervous system Clofarabine No Yes antineoplastic and immunomodulating agents Clopidogrel No No blood and blood-forming agents Collagenase clostridium histolyticum Yes Yes musculoskeletal system Crizotinib Yes No antineoplastic and immunomodulating agents Dabigatran No No blood and blood-forming agents Daclizumab Yes No antineoplastic and immunomodulating agents Dalfopristin Yes No anti-infective for systemic use Daptomycin Yes No anti-infective for systemic use Darbepoetin alfa No No blood and blood-forming agents Darifenacin No No genitourinary system and sex hormones Darunavir No Yes anti-infective for systemic use Dasatinib No Yes antineoplastic and immunomodulating agents Deferasirox No No various Degarelix No No antineoplastic and immunomodulating agents Delavirdine No No anti-infective for systemic use Denosumab Yes No musculoskeletal system Desloratadine No No respiratory system Desvenlafaxine No No nervous system Dexmedetomidine No No nervous system Dienogest No No genitourinary system and sex hormones Docosanol Yes No dermatologicals Dolasetron No No alimentary tract and metabolism Donepezil No Yes nervous system Doripenem No No anti-infective for systemic use Doxercalciferol No No systemic hormonal preparations, excluding sex hormones and insulins Dronedarone No No cardiovascular system Drospirenone No No genitourinary system and sex hormones Drospirenone/ethinyl estradiol No No genitourinary system and sex hormones Drotrecogin alfa Yes Yes blood and blood-forming agents Duloxetine No No nervous system Dutasteride No No genitourinary system and sex hormones [3] HEALTHCARE POLICY Vol.12 No.2, 2016

4 Joel Lexchin Eculizumab Yes No antineoplastic and immunomodulating agents Efalizumab Yes No antineoplastic and immunomodulating agents Efavirenz No Yes anti-infective for systemic use Eflornithine Yes No dermatologicals Eletriptan No No nervous system Eltrombopag No No blood and blood-forming agents Emedastine No No sensory organs Emtricitabine No No anti-infective for systemic use Enfuvirtide Yes Yes anti-infective for systemic use Entacapone No No nervous system Entecavir No No anti-infective for systemic use Eplerenone No No cardiovascular system Epoprostenol Yes No blood and blood-forming agents Eprosartan No No cardiovascular system Eptifibatide No No blood and blood-forming agents Eribulin Yes No antineoplastic and immunomodulating agents Erlotinib No No antineoplastic and immunomodulating agents Ertapenem No No anti-infective for systemic use Etanercept No Yes antineoplastic and immunomodulating agents Ethinyl estradiol/etonogestrel No No genitourinary system and sex hormones Etravirine No No anti-infective for systemic use Everolimus No No antineoplastic and immunomodulating agents Exemestane No No antineoplastic and immunomodulating agents Exenatide Yes No alimentary tract and metabolism Ezetimibe Yes No cardiovascular system Febuxostat No No musculoskeletal system Fexofenadine No No respiratory system Fingolimod Yes No antineoplastic and immunomodulating agents Fluticasone No No respiratory system Fondaparinux Yes No blood and blood-forming agents Formoterol No No respiratory system Fosaprepitant No No alimentary tract and metabolism [4] HEALTHCARE POLICY Vol.12 No.2, 2016

5 How Safe and Are First-in-Class Drugs Approved by Health Canada: A Cohort Study Frovatriptan No No nervous system Fulvestrant Yes No antineoplastic and immunomodulating agents Gadobenate No No not listed Galantamine No No nervous system Ganirelix Yes No systemic hormonal preparations, excluding sex hormones and insulins Gatifloxacin No No anti-infective for systemic use Gefitinib Yes No antineoplastic and immunomodulating agents Gemifloxacin No No anti-infective for systemic use Glatiramer Yes No antineoplastic and immunomodulating agents Glimepiride No No alimentary tract and metabolism Golimumab No No antineoplastic and immunomodulating agents Grepafloxacin No No anti-infective for systemic use Histrelin No No antineoplastic and immunomodulating agents Ibandronate No No musculoskeletal system Ibritumomab Yes No various Icodextrin No No not listed Idursulfase Yes No alimentary tract and metabolism Imatinib Yes Yes antineoplastic and immunomodulating agents Imiglucerase No Yes alimentary tract and metabolism Indacaterol No No respiratory system Infliximab Yes Yes antineoplastic and immunomodulating agents Insulin detemir No No alimentary tract and metabolism Insulin glulisine No No alimentary tract and metabolism Interferon beta-1a No Yes antineoplastic and immunomodulating agents Ipilimumab Yes No antineoplastic and immunomodulating agents Irbesartan No No cardiovascular system Irinotecan No Yes antineoplastic and immunomodulating agents Lacosamide No No nervous system Lanreotide No Yes systemic hormonal preparations, excluding sex hormones and insulins Lanthanum No No various Lapatinib No No antineoplastic and immunomodulating agents Laronidase Yes Yes alimentary tract and metabolism [5] HEALTHCARE POLICY Vol.12 No.2, 2016

6 Joel Lexchin Latanoprost Yes No sensory organs Leflunomide Yes No antineoplastic and immunomodulating agents Lenalidomide No Yes antineoplastic and immunomodulating agents Letrozole No No antineoplastic and immunomodulating agents Levetiracetam No No nervous system Linagliptin No No alimentary tract and metabolism Linezolid Yes No anti-infective for systemic use Liraglutide No No alimentary tract and metabolism Lisdexamfetamine No No nervous system Lopinavir/ritonavir No No anti-infective for systemic use Loteprednol No No sensory organs Lurasidone No No nervous system Maraviroc Yes No anti-infective for systemic use Meloxicam No No musculoskeletal system Memantine Yes No nervous system Mequinol/tretinoin No No dermatologicals Methylnaltrexone Yes Yes alimentary tract and metabolism Micafungin No No anti-infective for systemic use Miglustat Yes No alimentary tract and metabolism Mirtazapine No No nervous system Modafinil Yes Yes nervous system Montelukast No No respiratory system Moxifloxacin No No anti-infective for systemic use Naratriptan No No nervous system Natalizumab Yes No antineoplastic and immunomodulating agents Nateglinide No No alimentary tract and metabolism Nebivolol No No cardiovascular system Nelfinavir No No anti-infective for systemic use Nepafenac No No sensory organs Nesiritide Yes No cardiovascular system Nevirapine Yes No anti-infective for systemic use Nilotinib No No antineoplastic and immunomodulating agents [6] HEALTHCARE POLICY Vol.12 No.2, 2016

7 How Safe and Are First-in-Class Drugs Approved by Health Canada: A Cohort Study Ofatumumab No No antineoplastic and immunomodulating agents Olmesartan No No cardiovascular system Omalizumab Yes No respiratory system Orlistat Yes No alimentary tract and metabolism Oseltamivir No No anti-infective for systemic use Oxaliplatin No No antineoplastic and immunomodulating agents Oxcarbazepine No No nervous system Palifermin Yes Yes various Paliperidone No No nervous system Palivizumab Yes No anti-infective for systemic use Palonosetron No No alimentary tract and metabolism Panitumumab No No antineoplastic and immunomodulating agents Pantoprazole No No alimentary tract and metabolism Paricalcitol No No systemic hormonal preparations, excluding sex hormones and insulins Pazopanib No No antineoplastic and immunomodulating agents Pegaptanib Yes Yes sensory organs Pegfilgrastim No No antineoplastic and immunomodulating agents Peginterferon alfa-2a No No antineoplastic and immunomodulating agents Peginterferon alfa-2b No No antineoplastic and immunomodulating agents Pegvisomant Yes No systemic hormonal preparations, excluding sex hormones and insulins Pemetrexed No Yes antineoplastic and immunomodulating agents Penciclovir No No anti-infective for systemic use Perindopril No No cardiovascular system Pimecrolimus No No dermatologicals Pioglitazone No No alimentary tract and metabolism Plerixafor Yes No antineoplastic and immunomodulating agents Posaconazole No Yes anti-infective for systemic use Pramipexole Yes No nervous system Prasugrel No No blood and blood-forming agents Pregabalin No No nervous system Quetiapine No No nervous system Rabeprazole No No alimentary tract and metabolism [7] HEALTHCARE POLICY Vol.12 No.2, 2016

8 Joel Lexchin Raloxifene Yes No genitourinary system and sex hormones Raltegravir Yes Yes anti-infective for systemic use Ranibizumab No Yes sensory organs Rasagiline No No nervous system Rasburicase Yes No various Recombinant-methionyl interferon consensus 1 No No antineoplastic and immunomodulating agents Repaglinide Yes No alimentary tract and metabolism Rilpivirine No No anti-infective for systemic use Riluzole Yes Yes nervous system Risedronate No No musculoskeletal system Rituximab Yes Yes antineoplastic and immunomodulating agents Rivaroxaban No No blood and blood-forming agents Rivastigmine No No nervous system Rizatriptan No No nervous system Rofecoxib No No musculoskeletal system Roflumilast Yes No respiratory system Romiplostim Yes No blood and blood-forming agents Ropinirole No No nervous system Rosiglitazone No No alimentary tract and metabolism Rosuvastatin No No cardiovascular system Rufinamide No No nervous system Sapropterin Yes Yes alimentary tract and metabolism Saxagliptin No No alimentary tract and metabolism Sevelamer No No various Sibutramine Yes No alimentary tract and metabolism Sildenafil Yes Yes genitourinary system and sex hormones Silodosin No No genitourinary system and sex hormones Sirolimus Yes No antineoplastic and immunomodulating agents Sitagliptin Yes No alimentary tract and metabolism Sodium oxybate No Yes nervous system Solifenacin No No genitourinary system and sex hormones Sorafenib Yes No antineoplastic and immunomodulating agents [8] HEALTHCARE POLICY Vol.12 No.2, 2016

9 How Safe and Are First-in-Class Drugs Approved by Health Canada: A Cohort Study Sunitinib No Yes antineoplastic and immunomodulating agents Tadalafil No No genitourinary system and sex hormones Tamsulosin No No genitourinary system and sex hormones Tapentadol No No nervous system Tegaserod Yes No alimentary tract and metabolism Telaprevir No Yes anti-infective for systemic use Telbivudine No No anti-infective for systemic use Telithromycin Yes No anti-infective for systemic use Telmisartan No No cardiovascular system Temozolomide No No antineoplastic and immunomodulating agents Temsirolimus Yes No antineoplastic and immunomodulating agents Tenecteplase No No blood and blood-forming agents Tenofovir No No anti-infective for systemic use Ticagrelor No No blood and blood-forming agents Tigecycline Yes No anti-infective for systemic use Tiotropium No No respiratory system Tipranavir No No anti-infective for systemic use Tirofiban No No blood and blood-forming agents Tizanidine Yes No musculoskeletal system Tocilizumab Yes No antineoplastic and immunomodulating agents Tolcapone Yes No nervous system Tolterodine No No genitourinary system and sex hormones Tolvaptan No No cardiovascular system Topiramate No No nervous system Topotecan Yes No antineoplastic and immunomodulating agents Tramadol No No nervous system Trastuzumab Yes No antineoplastic and immunomodulating agents Travoprost No No sensory organs Treprostinil No No blood and blood-forming agents Triptorelin No No antineoplastic and immunomodulating agents Trospium No No genitourinary system and sex hormones Trovafloxacin No No anti-infective for systemic use [9] HEALTHCARE POLICY Vol.12 No.2, 2016

10 Joel Lexchin Ustekinumab Yes No antineoplastic and immunomodulating agents Valdecoxib No No musculoskeletal system Valsartan No No cardiovascular system Vandetanib No No antineoplastic and immunomodulating agents Vardenafil No No genitourinary system and sex hormones Varenicline Yes No nervous system Vemurafenib Yes Yes antineoplastic and immunomodulating agents Verteporfin Yes Yes sensory organs Voriconazole No No anti-infective for systemic use Vorinostat Yes No antineoplastic and immunomodulating agents Zafirlukast Yes No respiratory system Zaleplon No No nervous system Zanamivir Yes No anti-infective for systemic use Zoledronic acid No No musculoskeletal system Zolmitriptan No No nervous system [10] HEALTHCARE POLICY Vol.12 No.2, 2016