Appendix A: Prescription Medication Table for COPD1- 4

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'ƵŝĚĞůŝŶĞƐΘWƌŽƚŽĐŽůƐĚǀŝƐŽƌLJŽŵŵŝƩĞĞ Appendix A: Prescription Medication Table for COPD 1- 4 Generic Name Cost per Device Usual Adult Daily PharmaCare Trade Name Approx. cost per Therapeutic Considerations Dose Coverage Dosage Forms and Strengths usual daily dose SHORT-ACTING RELIEVER MEDICATIONS Short-Acting Beta 2 Agonists (SABA) Salbutamol Acute relief: $6.48 Regular • Potential adverse eects: tremor Ventolin®, Airomir™, 1 to 2 pus prn $0.13 to $0.26 Coverage (particularly in the hands, usually generics Prevention: (1 to 2 pus QID) disappears as treatment continues), cardiac arrhythmias (more likely in pMDI: 100 mcg/pu 1 to 2 pus QID susceptible patients), tachycardia, 200 doses restlessness, headache, muscle cramps, Salbutamol Acute relief: $12.50 No Coverage and nervousness. Ventolin® Diskus® 1 inhalation prn $0.62 to $0.83 • Use cautiously in patients with Diskus: 200 mcg/inhalation Prevention: (3 to 4 inhalations/day) cardiovascular disorders (e.g., coronary insu!ciency, arrhythmias, hypertension). 60 doses 1 inhalation q4-6 hour (maximum 3-4 • Paradoxical bronchospasm is unusual inhalations daily) and may be related to the propellant and Terbutaline Acute relief: $8.52 Regular in which case a dry powder formulation may be eective. An alternative therapy, Bricanyl® Turbuhaler® 1 to 2 inhalations $0.51 (6 inhalations/day) Coverage such as a SAMA, may also be considered. prn (maximum Turbuhaler: 0.5 mg/inhalation 6 inhalations daily) 100 doses Short-Acting Muscarinic Antagonist (SAMA) or Short Acting Anticholinergic Ipratropium bromide 40 mcg (2 actuations) $21.05 Regular • Potential adverse eects: headache, Atrovent® TID to QID $0.63 to $0.84 Coverage throat irritation, cough, dry mouth, pMDI: 20 mcg/pu Maximum: 240 mcg (2 actuations TID to QID) GI motility disorders, dizziness, bitter/ (12 actuations) daily, metallic taste. 200 doses (minimum 4 hours • Use cautiously and monitor for worsening between doses) urinary retention in patients with pre-existing urinary tract obstruction. • Use cautiously in patients with narrow- angle glaucoma. • Avoid spraying the mist into the eyes (ocular complications have been reported). • A SAMA and a LAMA should not be used concurrently. Combination product: SABA and SAMA Ipratropium bromide 1 inhalation QID 31.00 Regular • Similar therapeutic considerations salbutamol sulfate Maximum: $1.03 (1 inhalation QID) Coverage as SABAs and SAMAs (see above). Combivent® Respimat® 6 inhalations/ Inhalation solution via Respimat: 24 hours 20 mcg/100 mcg salbutamol 120 doses BCGuidelines.ca: Chronic Obstructive Pulmonary Disease (COPD): Diagnosis and Management: Appendix A (2017) 1 Generic Name Cost per Device Usual Adult Daily PharmaCare Trade Name Approx. cost per Therapeutic Considerations Dose Coverage Dosage Forms and Strengths usual daily dose LONG-ACTING MEDICATIONS Long-Acting Beta 2 Agonists (LABA) Indacaterol maleate 75 mcg once daily $50.22/30 capsules Limited • Potential adverse eects: cough, Onbrez® Breezhaler® by oral inhalation $1.67 (1 inhalation daily) Coverage headache, palpitations, tachycardia, tremor, muscle spasms, upper respiratory Inhalation powder capsules tract infection. via Breezhaler: 75 mcg Boxes of 10 or 30 capsules • Use cautiously in patients with cardiovascular disorders (e.g., coronary Salmeterol 50 mcg BID $61.20 Limited insu!ciency, arrhythmias, hypertension). SereVent® Diskhaler® $2.04 (50 mcg BID) Coverage • Monitor for hyperglycemia in diabetic Disks of dry powder patients when initiating therapy. for inhalation: 50 mcg • LABAs are not typically used to treat 60 doses acute bronchospasm (rapid onset, short acting bronchodilator should be used to treat acute symptoms). Salmeterol 1 inhalation BID $62.41 Limited • When initiating treatment with LABA, SereVent® Diskus® $2.08 (1 inhalation BID) Coverage discontinue the use of any regularly Diskus: 50 mcg/inhalation scheduled SABA and transition to PRN 60 doses use of the SABA. Formoterol 6 or 12 mcg Q12 6 mcg: $36.35 No Coverage • Do not use more often or at higher doses Oxeze® Turbuhaler® hour $1.21 (1 inhlation Q12 h) for COPD than recommended. Maximum: (Limited Turbuhaler: 6 mcg, 12 mcg 12 mcg: $48.39 48 mcg/day Coverage 60 doses $1.61 (1 inhalation Q12 h) bene"t for NOTE: not ocially indicated for asthma) the treatment of COPD in Canada Formoterol 12 mcg BID via oral $54.58 No Coverage Foradil® inhalation $1.82 (1 inhalation BID) for COPD May increase to (Limited Inhalation powder Coverage capsules 24 mcg BID via oral inhalation, bene"t for via inhaler: if required asthma) 12 mcg Maximum: Boxes of 60 capsules 48 mcg/day Long-Acting Muscarinic Antagonists (LAMA) or Long Acting Anticholinergics Aclidinium bromide 400 mcg BID 57.35 Limited • Potential adverse eects: headache, dry Tudorza® Genuair® $1.91 (1 inhalation BID) Coverage mouth, urinary retention, metallic taste, nasopharyngitis. DPI: 400 mcg 60 doses • Use cautiously and monitor for worsening urinary retention in patients with Glycopyrronium 50 mcg once daily $57.35/30 capsules Limited pre-existing urinary tract obstruction bromide Seebri® by oral inhalation $1.91 (1 inhalation daily) Coverage (e.g., prostatic hyperplasia). Breezhaler® • Use cautiously in patients with Inhalation powder narrow-angle glaucoma. capsules via Breezhaler: • Do not use LAMAs to treat acute 50 mcg bronchospasm (rapid onset, short acting Boxes of 6 or 30 capsules bronchodilator should be used to treat acute symptoms that occur despite the Tiotropium bromide 18 mcg once daily $56.06/30 capsules Limited regular use of a long acting medication). Spiriva® by oral inhalation $1.87 (1 inhalation daily) Coverage • When initiating treatment with a LAMA, Inhalation powder capsule discontinue the use of any previous via HandiHaler: 18 mcg scheduled short acting bronchodilator. Boxes of 10 or 30 capsules • Use SABA as a rescue medication PRN Tiotropium bromide 5 mcg (2 actuations) $56.06/60 actuations Limited and do not prescribe a SAMA. Spiriva® Respimat® once daily by oral $1.87 (2 actuations daily) Coverage • Avoid spraying the mist into the eyes inhalation (ocular complications have been Inhalation solution reported). via Respimat: 2.5 mcg per actuation 60 actuations 2 BCGuidelines.ca: Chronic Obstructive Pulmonary Disease (COPD): Diagnosis and Management: Appendix A (2017) Generic Name Cost per Device Usual Adult Daily PharmaCare Trade Name Approx. cost per Therapeutic Considerations Dose Coverage Dosage Forms and Strengths usual daily dose Umeclidinium bromide 62.5 mcg once daily $54.00/30 doses Limited Incruse™ Ellipta® $1.80 (1 inhalation daily) Coverage DPI: 62.5 mcg 30 doses Combination: Inhaled Corticosteroid (ICS) and LABA Budesonide/ formoterol 400 mcg / 200 mcg: $92.22 Non-Bene"t • Potential adverse eects: palpitations, fumarate 12 mcg BID $3.07 (400 mcg/ for COPD oropharyngeal candidiasis, headache, Symbicort® Turbuhaler® 12 mcg BID) (Limited tremor, throat irritation, coughing, Coverage hoarseness. DPI: 100 mcg/6 mcg, bene"t for 200 mcg/6 mcg • Risk of oropharyngeal candidiasis and asthma) 120 doses hoarseness can be reduced by using a spacer with pMDI AND by rinsing mouth Fluticasone furoate/vilanterol 100 mcg/25 mcg $88.78 Limited and throat after each use (and cleansing Breo® Ellipta® once daily $2.96 (100 mcg/ Coverage dentures if applicable). DPI: 100 mcg/25 mcg, 25 mcg daily) • ICS is associated with an increased risk of 200mcg/25mcg pneumonia, particularly at higher doses. 30 doses Fluticasone propionate/ 125/25 mcg or 125/25 mcg: $105.23 Limited salmeterol 250/25 mcg: $3.51 (2 inhalations BID) Coverage 2 inhalations BID Advair® 250/25 mcg: $149.38 MDI: 125/25 mcg and $4.98 (2 inhalations BID) 250/25 mcg 120 inhalations Fluticasone propionate/ 250/50 mcg: 1 250/50 mcg: $105.23 Limited salmeterol inhalation BID $3.51 (1 inhalation BID) Coverage Advair® Diskus® 500/50 mcg: 1 500/50 mcg: $149.38 inhalation BID DPI via Diskus: 100/50 mcg, $4.98 (1 inhalation BID) 250/50 mcg, and 500/50 mcg 60 inhalations NOTE: 100/50 mcg DPI is not indicated for use in COPD Combination: LAMA and LABA Aclidinium/formoterol 400/12 mcg BID $64.80 Limited • Potential adverse eects: throat irritation, fumarate $2.16 (1 inhalation BID) Coverage cough, in#uenza, upper respiratory Duaklir™ Genuair® tract infection, tooth abscess, headache, tremor, dry mouth. DPI: 400/12 mcg 60 doses • Do not administer a combination LAMA and LABA product concurrently with Indacaterol/glycopyrronium 100 mcg/50 mcg $86.84 Limited other products containing LABA or LAMA. Ultibro® Breezhaler® once daily by oral $2.89 (1 inhalation daily) Coverage • Similar therapeutic considerations as inhalation Inhalation powder LABAs and LAMAs (see above). capsules via Breezhaler: 100 mcg/50 mcg Boxes of 30 capsules Tiotropium/olodaterol 5 mcg/5 mcg $65.78 Limited Inspiolto™ Respimat® (2 inhalations) $2.19 (2 inhalations daily) Coverage once daily Inhalation solution via Respimat: 2.5/2.5 mcg 60 actuations Umeclidinium/vilanterol 62.5 mcg/25 mcg $87.48 Limited Anoro™ Ellipta® once daily $2.92 (1 inhalation daily) Coverage DPI: 62.5/25 mcg 30 doses BCGuidelines.ca: Chronic Obstructive Pulmonary Disease (COPD): Diagnosis and Management: Appendix A (2017) 3 Generic Name Cost per Device Usual Adult Daily PharmaCare Trade Name Approx. cost per Therapeutic Considerations Dose Coverage Dosage Forms and Strengths usual daily dose Inhaled Corticosteroids NOTE: the following single agent ICS products are NOT ocially indicated, as monotherapy, for the treatment of COPD; however, these products are commonly used in conjunction with
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    NBEO Drug List (SORTED BY TRADE WITH GENERIC EQUIVALENT) Trade Generic Trade Generic Abilify aripiprazole Avandia rosiglitazone Accolate zafirlukast Avastin bevacizumab Accupril quinapril Azasan azathioprine Achromycin tetracycline AzaSite azithromycin Aciphex rabeprazole Avodart dutasteride Actos pioglitazone Azopt brinzolamide Acular ketorolac Bactrim trimethoprim-sulfamethoxazole Acuvail ketorolac Bactrim DS trimethoprim-sulfamethoxazole Advair fluticasone propionate Baquacil polyhexamethylene biguanide Advil ibuprofen Beconase AQ beclomethasone AeroBid flunisolide Benadryl diphenhydramine Afrin oxymetazoline Bepreve Bepotastine besilate Aggrenox aspirin and dipyridamole Besivance besifloxacin Alamast pemirolast Betadine povidone-iodine Alaway ketotifen Betagan levobunolol Aldactone spironolactone Betasept chlorhexidine topical Aleve naproxen sodium Betaseron interferon beta-1b Allegra fexofenadine Betimol timolol Allegra-D fexofenadine-pseudoephedrine Betoptic S betaxolol Alluvia lopinavir Biopatch chlorhexidine topical Alocril nedocromil Blephamide sulfacetamide-prednisolone Alomide lodoxamide Botox onabotulinum toxinA Alphagan P brimonidine Brolene propamidine isethionate Alrex loteprednol 0.2% Bromday bromfenac Ambien zolpidem Calamine zinc oxide and iron oxide Amicar aminocaproic acid Calan verapamil Amoxil amoxicillin Calgon Vesta chlorhexidine topical Amphocin amphotericin B Capoten captopril Anectine succinylcholine Carafate sucralfate Ansaid flurbiprofen Carbocaine mepivacaine HCl injection Antivert meclizine Cardizem diltiazem
  • FDA Briefing Document Pulmonary-Allergy Drugs Advisory Committee Meeting

    FDA Briefing Document Pulmonary-Allergy Drugs Advisory Committee Meeting

    FDA Briefing Document Pulmonary-Allergy Drugs Advisory Committee Meeting August 31, 2020 sNDA 209482: fluticasone furoate/umeclidinium/vilanterol fixed dose combination to reduce all-cause mortality in patients with chronic obstructive pulmonary disease NDA209482/S-0008 PADAC Clinical and Statistical Briefing Document Fluticasone furoate/umeclidinium/vilanterol fixed dose combination for all-cause mortality DISCLAIMER STATEMENT The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office. We have brought the supplemental New Drug Application (sNDA) 209482, for fluticasone furoate/umeclidinium/vilanterol, as an inhaled fixed dose combination, for the reduction in all-cause mortality in patients with COPD, to this Advisory Committee in order to gain the Committee’s insights and opinions, and the background package may not include all issues relevant to the final regulatory recommendation and instead is intended to focus on issues identified by the Agency for discussion by the advisory committee. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered