Catch Your Breath Updates in Asthma and COPD Pharmacotherapy

CATCH YOUR BREATH UPDATES IN ASTHMA AND COPD PHARMACOTHERAPY Hanna Raber, PharmD, BCPS, BCACP Assistant Professor (Clinical), University of Utah College of Pharmacy Objectives

■ Describe updates to the GINA/GOLD guidelines for asthma/COPD management ■ Compare and contrast dry powder, metered dose, and soft mist inhaler types ■ Discuss new inhaler products recently approved by the FDA ■ Recommend medication access options for patients who need assistance affording inhalers GUIDELINE UPDATES Patient Case

■ A 19-year-old female presents to your family medicine clinic to establish care and f/u on her asthma diagnosis. The patient reports she was diagnosed with asthma several years ago and has since used albuterol as needed to control her symptoms. ■ Patient reports she typically uses her inhaler about 2x monthly to control her symptoms. She is currently out of her medication and needs a new prescription.

What pharmacotherapy treatment would you consider for this patient? Asthma Guideline Updates – GINA 2019

Major Updates 2019

SABA-only no Updated Step Add-On longer Therapy Tiotropium recommended

Global Initiative for Asthma (GINA) 2019. Global Strategy for Asthma Management and Prevention. Mild Asthma Moderate Severe Asthma Asthma Step 1 Step 2 Step 3 Step 4 Step 5

Controller Preferred PRN low Low dose ICS Low dose ICS- Medium dose High dose Options dose ICS- LABA ICS-LABA ICS-LABA + formoterol Refer for add- on treatment Alternative - Low dose -LTRA -Med dose ICS -High dose ICS -Low dose Options ICS taken -Low dose ICS -Low dose ICS -Add OCS whenever taken whenever +LTRA tiotropium SABA is SABA is taken -Add LTRA taken Reliever Preferred PRN low dose ICS-formoterol Options Alternative As-needed SABA Options

Global Initiative for Asthma (GINA) 2019. Global Strategy for Asthma Management and Prevention. Mild Asthma Moderate Severe Asthma Asthma Step 1 Step 2 Step 3 Step 4 Step 5

Global Initiative for Asthma (GINA) 2019. Global Strategy for Asthma Management and Prevention. Asthma Guideline Updates – GINA 2019

■ Step 1 Preferred Controller: PRN low dose ICS-formoterol – “SABA-only treatment no longer recommended” – For patients with symptoms < 2x/monthly and no risk factors ■ Concerns – Insurance coverage – Limited to budesonide-formoterol

Global Initiative for Asthma (GINA) 2019. Global Strategy for Asthma Management and Prevention. Mild Asthma Moderate Severe Asthma Asthma Step 1 Step 2 Step 3 Step 4 Step 5

Global Initiative for Asthma (GINA) 2019. Global Strategy for Asthma Management and Prevention. Asthma Guideline Updates – GINA 2019

■ High dose ICS-LABA treatment limited to Step 5 – Limit use to 3-6 months – Little additional benefits from medium  high dose – Increased risk of side effects

Global Initiative for Asthma (GINA) 2019. Global Strategy for Asthma Management and Prevention. Mild Asthma Moderate Severe Asthma Asthma Step 1 Step 2 Step 3 Step 4 Step 5

Global Initiative for Asthma (GINA) 2019. Global Strategy for Asthma Management and Prevention. Asthma Guideline Updates – GINA 2019

■ Step 4: Tiotropium as add-on therapy – Patients aged 6 years and older – Modestly improves lung function – Modestly reduces exacerbations

Global Initiative for Asthma (GINA) 2019. Global Strategy for Asthma Management and Prevention. Patient Case

■ A 67 year old Caucasian male with a PMH significant for diabetes, hypertension, gout, and tobacco use (1ppd x 20 years) presents to your family medicine clinic with a chief complaint of dyspnea and chronic cough ■ Spirometry is completed and confirms diagnosis of COPD ■ Patient has no history of exacerbations and his CAT™ assessment score is 12

What pharmacotherapy treatment would you consider for this patient? COPD Guideline Updates – GOLD 2019

Major Updates 2019

Streamlined Management Initial EOS for ICS Cycle Treatment

Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease: 2019 Report COPD Guideline Updates – GOLD 2019 Initial Treatment: Group D: > 2 moderate exacerbations or >1 Group C: LAMA or leading to LAMA LAMA + LABA* or *Consider if highly hospitalization symptomatic (e.g. ICS + LABA** CAT >20) **Consider if eos > 300 0 or 1 moderate Group A: exacerbations (not Group B: leading to hospital Bronchodilator admission) LABA or LAMA

mMRC 0-1 CAT <10 mMRC > 2 CAT > 10

■ Consider blood eosinophil count to determine if inhaled steroids should be included – Consider inhaled steroids if eosinophils >300 cells/uL – Less benefit if eosinophils <100 cells/

Management Cycle Review Symptoms Exacerbations

Adjust Assess Escalate Inhaler technique Switch inhaler device or molecules Adherence De-escalate Non-pharm approaches

LABA or LAMA **Consider de- escalation of ICS or ** switch if: LABA + LAMA ** LABA + ICS -Pneumonia -Lack or response -Inappropriate use

-Switch inhaler device LABA + LAMA+ ICS or medication - R/O other causes of dyspnea

Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease: 2019 Report COPD Guideline Updates – GOLD 2019 Follow-Up Treatment (EXACERBATIONS): *Consider if eos ≥ LABA or LAMA 300 or eos ≥ 100 * and ≥ 2 moderate exacerbations/1 ** hospitalization LABA + LAMA ** LABA + ICS **Consider de- escalation of ICS or switch if: -Pneumonia LABA + LAMA+ ICS -Lack or response -Inappropriate use

Roflumilast Azithromycin FEV1 <50% and chronic bronchitis In former smokers Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease: 2019 Report INHALER REVIEW Inhaler review

■ Up to 80% of community patients have poor inhaler technique ■ Inhaler misuse associated with: – ↑ Risk of Hospitalizations – ↑ Emergency Room Visits – ↑ Oral Steroid Use – ↑ Antimicrobial Use ■ Many healthcare providers unable to correctly demonstrate inhaler use

Global Initiative for Asthma (GINA) 2019. Global Strategy for Asthma Management and Prevention. Inhaler Review

Dry Powder Metered Soft Dose Mist

Inhaler Types

S. P. Newman. European Respiratory Review Dec 2005, 14 (96) 102-108 Metered Dose Inhalers (MDI)

■ Examples: – Advair® HFA, QVAR Redihaler ®, Symbicort® ■ MDI Tips – Shake before use – Prime? – Inhale deeply and slowly – Spacer

S. P. Newman. European Respiratory Review Dec 2005, 14 (96) 102-108 Spacers

■ For use with MDI only ■ Improves delivery – ↓ Velocity = ↓ Medication deposited in throat ■ Reduces side effects (corticosteroids)

2019 Global Initiate For Asthma Strategy for Asthma Management and Prevention Dry Powder Inhalers (DPI)

■ Examples: – Flovent Diskus ®, Arnuity Ellipta ®, Spiriva HandiHaler ® ■ DPI Tips: – Load dose – Do not shake – Do not prime – Inhale deeply and quickly

S. P. Newman. European Respiratory Review Dec 2005, 14 (96) 102-108 Soft Mist Inhalers (SMI)

■ Examples: – Combivent Respimat ®, Spiriva Respimat ® ■ SMI Tips – Hold the inhaler upright – No shaking – Prime – Inhale deeply and slowly

S. P. Newman. European Respiratory Review Dec 2005, 14 (96) 102-108 Selecting an Inhaler

Inhaler Pros Cons Type MDI Small size Breath/actuation coordination Easy preparation Upper airway deposition

DPI Easy administration Breath force needed to aerosolize Complicated preparation steps

SMI Slow-moving mist Complicated preparation steps Canister difficult to turn Inhaler Tips

■ Consider a spacer for all patients with MDIs ■ Try to streamline inhaler types ■ Check and recheck inhaler technique – Errors often recur within 4-6 weeks – Show me, don’t tell me ■ Utilize placebo demo devices

Global Initiative for Asthma (GINA) 2019. Global Strategy for Asthma Management and Prevention. NEW INHALER UPDATES Trelegy Ellipta®

■ Combination of Fluticasone, Umeclidinium, and Vilanterol ■ FDA approved in September 2017 – Indication: maintenance treatment of COPD ■ Place in therapy ■ Benefits – Once-daily dosing – One copay

Trelegy Ellipta (fluticasonefuroate, umeclidinium, and vilanterol) Prescribing Information. Accessed January 2019. Duaklir Pressair®

■ Combination Aclidinium Bromide and Formoterol Fumerate ■ FDA approved in March 2019 – Indication: maintenance treatment of COPD ■ Place in therapy ■ Benefits: – Color-controlled window – Audible click to confirm proper dose

Duaklir Pressair (aclidinium bromide/formoterol fumerate) Prescribing Information. Accessed January 2019. AirDuo Digihaler®

■ Fluticasone Propionate and Salmeterol ■ FDA approved in April 2019 – Indication: maintenance treatment of COPD ■ Place in therapy ■ Benefits – Communicates with smart phone app via bluetooth ® – Usable without technology

Airduo Digihaler (fluticasone propionate and salmeterol) Prescribing Information. Accessed January 2019. New Generic Inhalers

■ Generic Xopenex (Levalbuterol) ■ Generic AirDuo (Fluticasone Propionate and Salmeterol) ■ Generic Ventolin (Albuterol) ■ Generic Proair (Albuterol) ■ Generic Advair Diskus (Wixela, Fluticasone Propionate and Salmeterol) MEDICATION ACCESS Inhaler Affordability

■ $3,266 Annual Per-Person Cost of Asthma: – $1,830 prescription costs – $640 office visits – $529 hospitalizations – $176 hospital-based outpatient visits – $105 emergency room visits

The Economic Burden of Asthma in the United States, 2008-2013. AnnalsATS Volume 15 Number 3, March 2018 Inhaler Affordability

Government Private Insurance Uninsured Insurance

Manufacturer Patient Check Formulary Prior Authorization Assistance Programs

Manufacturer Low Income Generic Inhalers Coupons Subsidy (Medicare) Conclusions

■ For asthma: – As needed combination ICS-formoterol is now preferred step 1 therapy – High dose ICS-LABA is now limited to step 5 therapy ■ For COPD: – Consider blood eosinophil count to help guide inhaled corticosteroid use – Utilize management cycle to adjust therapy based on symptoms and exacerbation risk ■ Inhaler use: – Use patient preference and affordability to guide inhaler selection

CATCH YOUR BREATH UPDATES IN ASTHMA AND COPD PHARMACOTHERAPY Hanna Raber, PharmD, BCPS, BCACP Assistant Professor (Clinical), University of Utah College of Pharmacy