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Drug Use Research & Management Program
Oregon State University, 500 Summer Street NE, E35
Salem, Oregon 97301-1079
Phone 503-947-5220 | Fax 503-947-2596
Asthma/COPD Drug Class Prior Authorization Update
Date of Review: December 2020 Date of Last Review: October 2020
Current Status of PDL Class:
See Appendix 1.
Purpose for Prior Authorization Update:
In September 2020 Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) was approved for the maintenance treatment of asthma in patients 18 years and
older, which necessitates changes to the prior authorization (PA) criteria to allow a pathway for obtainment.1
Summary of Approval:
The approval of the three drug product (inhaled corticosteroid [ICS]/long-acting muscarinic antagonist [LAMA]/ long-acting beta-agonist [LABA]), Trelegy Ellipta,
was based on a double-blind, parallel-group, randomized controlled trial of 2,436 patients with asthma who were not controlled on ICS/LABA maintenance
therapy in a study lasting 24 to 52 weeks.1 The primary endpoint was change in trough forced expiratory volume in 1 second (FEV1) at week 24. Trelegy Ellipta at
the dose of fluticasone furoate 100 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg was found to increase trough FEV1 more than fluticasone furoate 100
mcg/vilanterol 25 mcg by a least squares mean change (LSMC) of 110 mL (95% CI, 66 mL to 153 mL; P<0.001).1 An FEV1 change of 100 mL or more is considered
clinically meaningful.2 Comparison of Trelegy Ellipta at the dose of fluticasone furoate 200 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg reported a larger
change in trough FEV1 compared to fluticasone furoate 200 mcg/vilanterol 25 mcg (LSMC 92 mL (95% CI, 49 mL to 135 mL; P<0.001).1 Trial results served as
evidence for a new approved dose of Trelegy Ellipta (fluticasone Furoate/umeclidinium/vilanterol 200 mcg/62.5 mcg/25 mcg).1
Recommendations:
No changes to the preferred drug list (PDL) are recommended.
Modify ICS/LABA/LAMA PA criteria with updated indication for Trelegy Ellipta.
References:
1. Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) [package insert]. Research Triangle Park, NC: GlaxoSmithKline, September 2020.
2. Cazzola, M, Macknee W, Martinez F, et al. Outcomes for COPD Pharmacological Trials: From Lung Function To Biomarkers. Eur Respir J. 2008;31:416-469.
Author: K. Sentena December 2020
Appendix 1: Current Preferred Drug List
LABA/LAMA Combination, Inhalers
Generic Brand Form PDL
tiotropium Br/olodaterol HCl STIOLTO RESPIMAT MIST INHAL Y
umeclidinium brm/vilanterol tr ANORO ELLIPTA BLST W/DEV Y
aclidinium brom/formoterol fum DUAKLIR PRESSAIR AER POW BA N
fluticasone/umeclidin/vilanter TRELEGY ELLIPTA BLST W/DEV N
glycopyrrolate/formoterol fum BEVESPI AEROSPHERE HFA AER AD N
indacaterol/glycopyrrolate UTIBRON NEOHALER CAP W/DEV N
budesonide/glycopyrrol/form fum BREZTRI AEROSPHERE MIST INHAL N
Beta-agonists, Inhaled Long-acting
Generic Brand Form PDL
salmeterol xinafoate SEREVENT DISKUS BLST W/DEV Y
arformoterol tartrate BROVANA VIAL-NEB N
formoterol fumarate PERFOROMIST VIAL-NEB N
indacaterol maleate ARCAPTA NEOHALER CAP W/DEV N
olodaterol HCl STRIVERDI RESPIMAT MIST INHAL N
Anticholinergics, Inhaled
Generic Brand Form PDL
ipratropium bromide ATROVENT HFA HFA AER AD Y
ipratropium bromide IPRATROPIUM BROMIDE SOLUTION Y
ipratropium/albuterol sulfate IPRATROPIUM-ALBUTEROL AMPUL-NEB Y
tiotropium bromide SPIRIVA CAP W/DEV Y
aclidinium bromide TUDORZA PRESSAIR AER POW BA N
glycopyrrol/nebulizer/accessor LONHALA MAGNAIR STARTER VIAL-NEB N
glycopyrrolate SEEBRI NEOHALER CAP W/DEV N
glycopyrrolate/neb.accessories LONHALA MAGNAIR REFILL VIAL-NEB N
ipratropium/albuterol sulfate COMBIVENT RESPIMAT MIST INHAL N
revefenacin YUPELRI VIAL-NEB N
tiotropium bromide SPIRIVA RESPIMAT MIST INHAL N
umeclidinium bromide INCRUSE ELLIPTA BLST W/DEV N
Corticosteroids, Inhaled
Generic Brand Form PDL
budesonide PULMICORT FLEXHALER AER POW BA Y
Author: Sentena December 2020
fluticasone propionate FLOVENT DISKUS BLST W/DEV Y
fluticasone propionate FLOVENT HFA AER W/ADAP Y
mometasone furoate ASMANEX AER POW BA Y
beclomethasone dipropionate QVAR REDIHALER HFA AEROBA N
budesonide BUDESONIDE AMPUL-NEB N
budesonide PULMICORT AMPUL-NEB N
ciclesonide ALVESCO HFA AER AD N
fluticasone furoate ARNUITY ELLIPTA BLST W/DEV N
mometasone furoate ASMANEX HFA HFA AER AD N
fluticasone propionate ARMONAIR DIGIHALER INHAL PWD N
Corticosteroid/LABA Combination, Inhalers
Generic Brand Form PDL
BUDESONIDE-FORMOTEROL
budesonide/formoterol fumarate
FUMARATE HFA AER AD Y
budesonide/formoterol fumarate SYMBICORT HFA AER AD Y
fluticasone propion/salmeterol ADVAIR DISKUS BLST W/DEV Y
fluticasone propion/salmeterol ADVAIR HFA HFA AER AD Y
fluticasone propion/salmeterol FLUTICASONE-SALMETEROL BLST W/DEV Y
fluticasone propion/salmeterol WIXELA INHUB BLST W/DEV Y
mometasone/formoterol DULERA HFA AER AD Y
fluticasone propion/salmeterol AIRDUO RESPICLICK AER POW BA Y
fluticasone propion/salmeterol FLUTICASONE-SALMETEROL AER POW BA N
fluticasone/vilanterol BREO ELLIPTA BLST W/DEV N
Fluticasone propion/salmeterol AIRDUO DIGIHALER AER PW BAS N
Miscellaneous Pulmonary Agents
Generic Brand Route Form PDL
montelukast sodium MONTELUKAST SODIUM PO TAB CHEW Y
montelukast sodium MONTELUKAST SODIUM PO TABLET Y
montelukast sodium SINGULAIR PO TAB CHEW Y
montelukast sodium SINGULAIR PO TABLET Y
benralizumab FASENRA SQ SYRINGE N
benralizumab FASENRA PEN SQ AUTO INJCT N
mepolizumab NUCALA SQ AUTO INJCT N
mepolizumab NUCALA SQ SYRINGE N
mepolizumab NUCALA SQ VIAL N
montelukast sodium MONTELUKAST SODIUM PO GRAN PACK N
montelukast sodium SINGULAIR PO GRAN PACK N
Author: Sentena December 2020
omalizumab XOLAIR SQ SYRINGE N
omalizumab XOLAIR SQ VIAL N
reslizumab CINQAIR IV VIAL N
roflumilast DALIRESP PO TABLET N
zafirlukast ACCOLATE PO TABLET N
zafirlukast ZAFIRLUKAST PO TABLET N
zileuton ZILEUTON ER PO TBMP 12HR N
zileuton ZYFLO PO TABLET N
Appendix 2: Prior Authorization Criteria
Long-acting Muscarinic Antagonist/Long-acting Beta-agonist (LAMA/LABA) and
LAMA/LABA/Inhaled Corticosteroid (LAMA/LABA/ICS) Combinations
Goals:
To optimize the safe and effective use of LAMA/LABA/ICS therapy in patients with asthma and COPD.
Step-therapy required prior to coverage:
o Asthma and COPD: short-acting bronchodilator and previous trial of two drug combination therapy (ICS/LABA, LABA/LAMA
or ICS/LAMA). Preferred LAMA and LABA products do NOT require prior authorization.
Length of Authorization:
Up to 12 months
Requires PA:
All LAMA/LABA and LAMA/LABA/ICS products
Covered Alternatives:
Current PMPDP preferred drug list per OAR 410-121-0030 at www.orpdl.org
Searchable site for Oregon FFS Drug Class listed at www.orpdl.org/drugs/
Approval Criteria
1. What diagnosis is being treated? Record ICD10 Code
Author: Sentena December 2020
Approval Criteria
2. Will the prescriber consider a change to a preferred Yes: Inform prescriber of No: Go to #3
product? preferred LAMA and LABA
products in each class
Message:
Preferred products are reviewed for comparative
effectiveness and safety by the Oregon Pharmacy and
Therapeutics (P&T) Committee.
3. Does the patient have a diagnosis of asthma or reactive Yes: Go to #9 No: Go to #4
airway disease without COPD?
4. Does the patient have a diagnosis of COPD, mucopurulent Yes: Go to #5 No: Pass to RPh. Deny;
chronic bronchitis and/or emphysema? medical appropriateness.
Need a supporting diagnosis. If
prescriber believes diagnosis is
appropriate, inform prescriber of
the appeals process for Medical
Director Review. Chronic
bronchitis is unfunded.
5. Does the patient have an active prescription for an on- Yes: Go to #6 No: Pass to RPh. Deny;
demand short-acting bronchodilator (anticholinergic or beta- medical appropriateness.
agonist)?
6. Is the request for a LAMA/LABA combination product? Yes: Go to #7 No: Go to #8
7. Is there a documented trial of a LAMA or LABA, or Yes: Approve for up to 12 No: Pass to RPh. Deny;
alternatively a trial of a fixed dose combination short-acting months. Stop coverage of all medical appropriateness.
anticholinergic with beta-agonist (SAMA/SABA) (i.e., other LAMA and LABA inhalers
ipratropium/albuterol), or ≥ 2 moderate exacerbations or ≥ or scheduled SAMA/SABA
1 leading to a hospitalization? inhalers (PRN SABA or SAMA
permitted).
Author: Sentena December 2020
Approval Criteria
8. Is the request for a 3 drug ICS/LABA/LAMA combination Yes: Approve for up to 12 No: Pass to RPh. Deny;
product and is there a documented trial of a LAMA and months. Stop coverage of all medical appropriateness.
LABA, or ICS and LABA or ICS and LAMA? other LAMA, LABA and ICS
inhalers.
9. Does the patient have an active prescription for an on- Yes: Go to #10 No: Pass to RPh. Deny;
demand short-acting acting beta-agonist (SABA) and/or for medical appropriateness.
ICS-formoterol?
10. Is the request for Trelegy Ellipta (ICS/LAMA/LABA) Yes: Approve for up to 12 No: Pass to RPh. Deny;
combination product and is there a documented trial of an months. Stop coverage of all medical appropriateness.
ICS/LABA? other LAMA, LABA and ICS
inhalers.
P&T Review: 12/20 (KS), 10/20 (KS), 5/19 (KS); 1/18; 9/16; 11/15; 9/15; 11/14; 11/13; 5/12; 9/09; 2/06
Implementation: 3/1/18; 10/13/16; 1/1/16; 1/15; 1/14; 9/12; 1/10
Author: Sentena December 2020
