Ferris State University College of Pharmacy MPA CE Symposium 2016 Paul Thill, PharmD, BCPS Objectives Categorize the new asthma and COPD inhalers in to existing or newly created categories Discuss the inherent benefits and drawbacks of the new devices approved by the FDA and apply them to patient scenarios Predict the changes likely to occur in payor formulary inhaler selection over the next few years 1
Inhaled Drug Delivery Trends Moving away from metered dose inhalers Moving toward platforms for drug delivery Higher technology built into devices/formulations New combinations of different drug classes New molecules for same old targets Rapid increases in price Treatment Inhaled Medications Study chart and use for PSL and AL Device determinants of delivery Respirable particles: 1 5 microns Lung deposition Pharmacokinetics Patient determinants of delivery Technique vital for optimal drug delivery & txpeutic effect Up to 30% cannot master MDI technique Recurrent teaching helps Rinse mouth after inhaled corticosteroids (ICS) < 4 yo usually need face mask/spacer for MDI 2
Spacer or No Spacer? Qvar data Moving away from MDIs New platforms 3
New Platforms: Respimat (B I) Respimat considerations Complicated assembly Multiple steps to deliver # of puffs/dose varies by product (Combivent vs. others) 1.8 second long puff Locks when it is empty Can go off spontaneously if cap open while twisting 4
New Platforms: Ellipta (GSK) Dry powder inhaler Intuitive; patient consistency All products in platform are 1 puff daily Patient driven; no timing issues Powder load is somewhat larger than other DPIs New Platforms: Respiclick (Teva) Dry powder inhaler ProAir Respiclick only one so far Open cap until it clicks; inhale, close Two other agents coming Fluticasone propionate Fluticasone/salmeterol Patient driven; no timing issues ProAir has low powder load (<3 mg) Indicated down to 4 yo 5
New Platforms: Pressair (Almirall) Dry powder inhaler Easy instructions; difficult inhalation Green/red indicator Small dose count estimator Patient driven; no timing issues Given twice a day New Platforms: Neohaler (Novartis) Dry powder inhaler; capsule device Difficult process; manual dexterity Significant powder load Patient driven; no timing issues Given twice a day 6
High tech solutions: Aerosphere Suspends drug particles Phospholipid particle Avoids physical incompatibilities Stays suspended; no need to shake Fixed particle size Mixes with lung surfactant Only used in Bevespi so far www.cosuspensiontechnology.com ICSs SABAs & short acting bronchodilators LABAs LAMAs 7
SABAs ProAir Ventolin Proventil Xopenex ICSs (Inhaled Corticosteroids) SABAs & Short acting bronchodilators LABAs Atrovent Vaponephrine Primatene Asthmanephrine Albuterol, (levalbuterol) Ipratropium EpinephrineLAMAs Tiotropium Spiriva DuoNeb Combivent MDI Aclidinium Tudorza Combivent Respimat Umeclidinium Incruse Glyclopyrronium 8
ICSs (CONTROLLERS!) ICSs (Inhaled Corticosteroids) SABAs & Short acting bronchodilators Qvar Flovent LABAs (FP) Arnuity (FF) Beclomethasone Fluticasone (FP & FF) BudesonideLAMAs Mometasone Ciclesonide Asmanex Asmanex HFA Pulmicort Alvesco 9
SABAs & Short acting ICSs (Inhaled LABAs (Long acting bronchodilators Corticosteroids) beta 2 agonists) Serevent Foradil LABAs Perforomist Brovana Salmeterol Formoterol IndacaterolLAMAs Vilanterol Olodaterol????? Arcapta Striverdi 10
SABAs & Short acting ICSs (Inhaled LAMAs (Long acting bronchodilators Corticosteroids) muscarinic antag) Spiriva LABAs Tudorza Tiotropium Aclidinium Glyclopyrronium LAMAs Umeclidinium Incruse Seebri 11
Combinations ICSs (Inhaled Corticosteroids) Beclomethasone Fluticasone (FP & FF) Budesonide Mometasone Ciclesonide LABAs Salmeterol Serevent Formoterol Foradil Indacaterol Arcapta Vilanterol Olodaterol Striverdi LAMAs Tiotropium Spiriva Aclidinium Tudorza Umeclidinium Incruse Glycopyrrolate Combinations Dulera Symbicort ICSs (Inhaled Corticosteroids) Beclomethasone Fluticasone (FP & FF) Budesonide Mometasone Ciclesonide Breo LABAs Salmeterol Serevent Formoterol Foradil Indacaterol Arcapta Vilanterol Olodaterol Striverdi Anoro Utibron LAMAs Tiotropium Spiriva Aclidinium Tudorza Umeclidinium Incruse Glycopyrrolate Bevespi Stiolto 12
Drug Developments on the Horizon New medications and combinations Triple inhaler (umeclidinium, vilanterol, fluticasone) in Ellipta device Submission to FDA by end of 2016 Inhaled SGRM, inhaled p38 inhibitor Muscarinic Antagonist β 2 Agonist (MABA) Generics Teva Flovent and Advair Not the same mcg strength inhalers Built on Respiclick platform New indications for differential efficacy Glycopyrrolate/indicaterol over fluticasone/salmeterol Formulary Issues Outpatient Payors will be more assertive Step therapy Higher copays Absolute NF Medicaid unified formulary (Preferred Drug List PDL) COPD agents often require PA (LABA/LAMAs, LABAs) Popular asthma inhalers require a PA (Pulmicort, Ventolin) Market basket choices Payor picks winners and losers More frustration 13
Formulary Issues Inpatient Spend is escalating Stays are short; inhalers typically month supply Minimal patient benefit from continuation Options: Go to nebs labor cost is an issue Get authorization to hold non essential inhalers Have patients bring in home supply Common canister Auto sub: pick most efficient product for each category 14
Anticholinergics LABA/LAMAs ICS/LABA Combo LABAs Inhaled Corticosteroids (ICS) SABAs Inhaled Asthma & COPD Medications 2016 Albuterol 0.63 mg per 3 ml 1.25 mg per 3 ml Pre mixed unit dose (3 ml); this low dose usually not recommended Generic, Accuneb Nebulization 2.5 mg/3 ml (0.083%) Pre mixed unit dose (3 ml); add 0.5 ml to other agents or NS for neb Albuterol ProAir, Proventil & 90 mcg per puff; Note: ProAir & Ventolin are the MDI; should be used with a spacer; shake 5 seconds; 4 primes to start; reprime after 2 wk without use or if Ventolin HFA only SABAs with dose counters dropped; expires 6 mo after opening: ProAir comes in both MDI and Respiclick DPI Levalbuterol Xopenex HFA & Neb 45 mcg per puff (200); MDI: Shake 5 seconds; 4 primes to start; reprime after 3 days without use; 0.31, 0.63 or 1.25 mg per unit dose Unit dose for neb; must use as soon as foil wrapper is opened Beclomethasone Qvar HFA 40 or 80 mcg per actuation (122) MDI; recommended to be used without spacer; no shaking required; 2 primes to start; reprime after 10 days without use Budesonide Pulmicort DPI 90 mcg per puff (60); 180 mcg per puff (120) Counter increments of 10; moves every 5; twist to the right, then left to load; do not tip once loaded Pulmicort Respules 0.25, 0.5 or 1 mg per unit dose nebulzer vial Deliver with mask if <3 yo; older child may use a mouthpiece; expires 2 wks after open Flovent Diskus DPI; 50, 100, 250 mcg per inhalation (60) No priming; do not tip once loaded; avoid humidity & moisture Fluticasone Flovent HFA 44, 110 or 220 mcg per inhalation (124) MDI; shake for 5 seconds; 4 puff priming; reprime after 7 days w/o use or if dropped Arnuity Ellipta DPI 100 or 200 mcg/puff (30) 1 puff daily; Fluticasone propionate; different mcg dosing from furoate above; only indicated in asthma Mometasone Asmanex DPI; 220 mcg (30, 60, 120); 110 mcg per puff (30) for Has dose counter; no priming; do not tip once loaded; avoid humidity & moisture; may give once daily in Asmanex HFA peds 4 11 yo; 100 mcg & 200 mcg HFA (124) evening; HFA Ciclesonide Alvesco HFA 80 or 160 mcg per inhalation (60) 1 puff 2x/day; shaking not required; 3 puffs to prime; reprime 10d unused; counter moves every 10 puffs Flunisolide Aerospan HFA 80 mcg per inhalation (120) Has a built in non valved, extremely low volume spacer ; This is the only ICS without a dose counter Salmeterol Serevent Diskus DPI 50 mcg per actuation (60) No priming; do not tip once loaded; avoid humidity; expires 6 wk after open Foradil DPI & 12 mcg per capsule (72 or 360) Asthma & COPD indications, but MUST be used along with an ICS for asthma. Formoterol Perforomist Neb 20 mg nebulization COPD indication only Arformoterol Brovana Neb 15 mcg ampule COPD Olodaterol Striverdi Respimat 2.5 mcg/puff (60) 2 puffs/dose; 60 dose inhaler; see Combivent respimat for device specifics Indicaterol Arcapta DPI 75 mg inhaled capsule COPD; Basically same device as formoterol Fluticasone/ Advair Diskus DPI 100/50, 250/50 or 500/50 mcg per puff (60) Same as Serevent DPI except expires one month after opening Salmeterol Advair HFA 45/21, 115/21 or 230/21 mcg per puff (124) Same as Flovent HFA except reprime @ 4 wk without use or if dropped Fluticasone/ Vilanterol Breo Ellipta DPI 100 mcg/25 & 200/25 mcg per puff (30) 1 puff daily; Indicated for COPD (only 100/25 dose) and asthma ( 12 yr old) Budesonide/ MDI; use with spacer; shake 5 seconds; 2 primes to start, reprime after 7d without use; do not use more Symbicort HFA 80/4.5 or 160/4.5 mcg per inhalation (120) Formoterol than BID; expires 90 days after opening Mometasone/ MDI; use with spacer; shake 5 seconds; 4 primes to start, reprime after 5d without use; do not use more Dulera HFA 100 mcg/5 mcg, 200 mcg/5 mcg (120) Formoterol than BID; expires 90 days after opening Umeclidinium/ Vilanterol Anoro Ellipta DPI 62.5 mcg/25 mcg per puff (30) LAMA/LABA combo for COPD; 1 puff daily; technique same as other Ellipta inhalers Tiotropium/ Olodaterol Stiolto Respimat 2.5 mcg/2.5 mcg/puff (60) LAMA/LABA combo for COPD; 2 puffs/dose; 1 dose daily; same as other Respimat devices Glycopyrrolate/ LABA/LAMA combo for COPD; 1 capsule inhaled twice a day via neohaler device; (similar to Spiriva Utibron Neohaler DPI 15.6 mcg/27.5 mcg/ capsule indicaterol handihaler) Glycopyrrolate/ formoterol Bevespi MDI 9 mcg/4.8 mcg/puff (120) LAMA/LABA combo for COPD Ipratropium Atrovent MDI/Neb 17 mcg/puff (200); Nebulization 0.5 mg/3ml SAMA; Prime x2 at first and if unused >3 days; counter goes down q5 7 puffs Ipratropium/albut Duoneb Neb 0.5 mg/3mg per 3 ml nebulization SAMA/SABA; given via nebulizer; can be used in acute asthma, but mostly for COPD. Ipratropium/albut Combivent Respimat 20/100 mcg; 120 puffs (counter); typical dose 1 Discard 3 mo after open; if unused 3 days, reprime 1 puff; 21 days, full reprime; locks when counter puff q6h prn; mist sprays over almost 2 seconds; reaches 0 ; MDI is not being sold anymore. Tiotropium Spiriva DPI; Respimat 18 mcg DPI; 2.5 mcg and 1.25 mcg/puff MDI(60) LAMA; 2 puffs/dose; 1 dose per day; Do not swallow capsule; Use Handihaler to pierce capsule; inhale x2 and listen for vibrating sound while inhaling; dump capsule directly in trash; Respimat same as others Umeclidinium Incruse Ellipta DPI 62.5 mcg/puff (30 puffs/inhaler) 1 puff/day LAMA; 1 puff daily; Ellipta instructions same as other Ellipta products Aclidinium Tudorza DPI 200 mcg/puff (60 puffs/inhaler) LAMA; 1 puff twice a day; Dose window tells user Pressair inhaler is ready and if the dose was given. Glycopyrrolate Seebri Neohaler DPI 15.6 mcg/capsule DPI LAMA; 1 capsule inhaled twice a day via neohaler device; (similar to Spiriva handihaler)