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East Kent Prescribing Group

Inhaled therapy for Chronic Obstructive Pulmonary Disease (COPD) These recommendations consist of 5 sections 1. Decision support tool for the use of inhaled therapy in COPD 2. Expanded version of Step 5 from the Decision support tool, showing pharmacological agents within the class. 3. Primary Care Respiratory Society-UK (PCRS-UK) recommendation on Stepping Down Triple therapy in COPD 4. Summary of devices for inhaled therapy in COPD 5. Table of costs and formulary status

1 Decision support tool Please note the treatment of COPD does NOT follow a step up process (as seen in asthma). Prescribers must be clear on the aim of treatment when reviewing, initiating or changing therapy. Prescribers should be aware of the potential risk of developing side effects (including non-fatal pneumonia) in people with COPD treated with ICS and be prepared to discuss with patients.

Non –pharmacological measures such as smoking cessation, vaccination (influenza and pneumococcal) pulmonary rehab and physical activity must be considered (where appropriate) at each consultation. Inhaler technique must be checked at each consultation

2 Expanded version of Step 5 from the Decision support tool, showing pharmacological agents within the class

3 PCRS-UK Practice Improvement Worksheet - Stepping Down Triple therapy in COPD The PCRS-UK have produced a number of practice improvement worksheets and have agreed to provide access to one of these tools free of charge for practices within East Kent to download for a fixed period of time. This is on the agreement that practices provide feedback on the tool via a short 5-minute survey available at https://www.surveymonkey.com/s/EKPG before using within their practice. A number of members of staff will already be PCRS-UK members and have access. An image of the tool is provided herewith but for best effect the tool should be utilised online as it includes a number of links to additional material. To access the online version click HERE

This Improvement Worksheet contains the following recommendation which is off license; however this is provided to support a pragmatic method of review for patients who are currently already being prescribed off license preparations (i.e. ICS/LABA without a history of repeated exacerbations) and has been agreed by the EKPG If no history of asthma and no history of exacerbation prior to commencing ICS, consider one month treatment at 50% of the ICS/LABA dose then stop  If patient on Seretide 500 change to 1 month of Seretide 250 then change to Serevent  If patient on Symbicort 400, change to 1 month of Symbicort 200 and then change to Formoterol

4 Summary of devices for inhaled therapy in COPD Only those preparations currently on local formulary are included. A number of additional devices are due to complete the national and local review processes early in 2015 and an update to this table will be published once the review are completed.

5 Table of costs and formulary status This contains costs and formulary status on all preparations used in COPD- Please note some use is off license

Approved by: East Kent Prescribing Group (Representing Ashford CCG, Canterbury and Coastal CCG, South Kent Coast CCG and Thanet CCG) Date: Address: Medicine Management, 81 Station Road, Ashford, Kent, TN23 1PP Page 1 of 7 Contact: T: 01233 618140 | F: 01233 618195 | E: [email protected] Decision Support tool for the use of inhaled therapy in COPD EKPG Date MMYYY

Step 1- Assess dyspnoea. If results indicate more than one group, choose the highest risk Step 2- assess patients exacerbation risk using exacerbation history and severity of airflow

group limitation (based on post-bronchodilator FEV1) in patients with FEV1/FEC<0.70) Medical Research Council dyspnoea score COPD Assessment Tool (CAT) If results indicate more than one group, choose the highest risk group (MRC) Severity of airflow limitation Exacerbation risk Exacerbation history ≥80% predicted Grade 1-2 <10 Low risk 0-1 exacerbations Less symptoms Between 80% and 50% predicted

Between 50% and 30% predicted ≥2 or More symptoms < 30% predicted ≥1 leading to hospital ≥10 admission Grade≥3 High risk

Step 3- Allocate a group from assessments in step 1 and 2 Step 4 Before starting or changing treatment consider the following If results indicate more than one group, choose the highest risk group (D=highest) Consider the aims of treatment: GOLD category Group C Group D For reducing symptoms, consider a bronchodilator. Step 1 Assess dyspnoea Less symptoms More symptoms For reducing risk of exacerbations, consider an ICS/LABA Step 2 Assess exacerbation risk High Risk High Risk DO NOT automatically add an ICS/LABA for breathlessness Check patient understanding of current treatment as well as technique. GOLD category Group A Group B Ensure a spacer is used and cleaned correctly. Step 1 Assess dyspnoea Less symptoms More symptoms Consider if an ICS/LABA should be continued especially if there is no exacerbation history. Step 2 Assess exacerbation risk Low Risk Low Risk Only add a new medicine to repeat status after effectiveness has been assessed. Consider using similar inspiratory flow devices e.g. a pMDI with spacer or a dry powder device; use those with same daily regimen and similar technique

Step 5 selection of pharmacological agent Glossary Gold Recommended first Alternative choice Other possible CAT-COPD assessment tool pMDI-pressurised metered dose inhaler Catergory choice treatments** ICS- inhaled corticosteroid PRN-when required A SAMA prn or SABA prn LAMA* or LABA Theophylline LABA-long acting beta agonist SABA-short acting beta agonist or LAMA-long acting Muscarinic antagonist SAMA-short acting muscarinic antagonist SAMA+SABA MRC-British Medical Research Council dyspnoea scale SPC-summary of product characteristics B LAMA or LABA LAMA* + LABA SABA and/or SAMA Theophylline PCRS-UK have produced a number of practice improvement worksheets and have agreed to provide C LAMA LAMA* + LABA SABA+/-SAMA access to one of these tools free of charge for practices within East Kent to download for a fixed or Theophylline period of time on the agreement that practices provide feedback on the tool ICS/LABA A PDF version is provided here for information but the links which provide access to additional D ICS/LABA ICS/LABA+LAMA* Carbocysteine resources are only available when logged in the web based version. Medicine management teams and/or Or SABA and/or SAMA will be able to provide log in details. LAMA LAMA*+LABA Theophylline This Improvement Worksheet contains a recommendation which is off license use, however this is *Stop SAMA when LAMA Prescribed provided to support a pragmatic method of review for patients who are currently receiving already ** Medication in this column can be used alone or in combination with other options in being prescribed off license use (i.e. ICS/LABA without a history of repeated exacerbations) and has recommended first choice and alternative choice been agreed by the EKPG Expanded version of Step 5 from the Decision support tool, showing pharmacological agents within the class. Preparations are shown in alphabetical order and not necessarily in order of preference Gold Recommended first Other possible Alternative choice Category choice treatments** A SAMA prn or SABA prn LAMA* or LABA or SAMA+SABA Theophylline ipratropium aclidinium; formoterol; salbutamol prn; A ipratropium prn or glycopyrronium; or indacaterol; or and theophylline terbutaline prn tiotropium salmeterol salbutamol; terbutaline SABA and/or SAMA B LAMA or LABA LAMA* + LABA Theophylline aclidinium; glycopyrronium; Salbutamol: aclidinium; formoterol; tiotropium terbutaline B glycopyrronium; or indacaterol; and and/or tiotropium salmeterol formoterol; ipratropium indacaterol; theophylline salmeterol SABA+/-SAMA C LAMA or ICS/LABA LAMA* + LABA Theophylline aclidinium; glycopyrronium; Salbutamol; aclidinium; beclometasone/formoterol; tiotropium terbutaline C glycopyrronium; or budesonide/formoterol; and +/- tiotropium fluticasone/salmeterol; formoterol; ipratropium indacaterol; theophylline salmeterol and Carbocysteine ICS/LABA D /or LAMA ICS/LABA+LAMA* or LAMA*+LABA SABA and/or SAMA Theophylline carbocysteine beclometasone/formoterol; and aclidinium; beclometasone/formoterol; aclidinium; theophylline D budesonide/formoterol; /or glycopyrronium; budesonide/formoterol; or glycopyrronium; salbutamol; fluticasone/salmeterol; tiotropium fluticasone/salmeterol; tiotropium terbutaline +/- ipratropium + formoterol; indacaterol; salmeterol *Stop SAMA when LAMA Prescribed ** Medication in this column can be used alone or in combination with other options in recommended first choice and alternative choice

Summary of devices for inhaled therapy in COPD on East Kent Formulary. (Due for revision March 2015)

Class Drug Brand & strength Brand & strength Maintenance dose Cost per30 *Comment pMDI + spacer Dry Powder days or per inhaler for ‘PRN’ dose Salbutamol as generic + £1.50/200 appropriate spacer doses Salbutamol Ventolin Accuhaler £3.00/60 Short SABA doses acting Easyhaler salbutamol £3.31/200 broncho doses -dilators Bricanyl Turbohaler 500mcg £6.92/100 Terbutaline doses Atrovent + £5.56/200 SAMA Ipratropium AeroChamber Plus doses Atimos Modulite® One inhalation £18.03-£36.07 Atimos fits (12mcg)+ AeroChamber twice daily + AeroChamber Plus Plus or Volumatic* additional doses and Volumatic but up to 4 puffs daily this is off license use Foradil® (12mcg) One inhalation £23.38 Formoterol twice daily Oxis® Turbohaler (6 & One inhalation £12.40-£24.80 12mcg) once or twice LABA daily Easyhaler Formoterol One inhalation £23.38 twice daily Onbrez Breezhaler® (150 One inhalation £29.26 Indacaterol & 300mcg) (150 or 300mcg) once daily Serevent® Evohaler® Two inhalations £29.26 Long (25mcg) + Volumatic twice daily Salmeterol acting Serevent® Accuhaler® One inhalation £29.26 broncho (50mcg) twice daily -dilators Eklira Genuair® (400mcg) One inhalation £28.60 No adjustment Aclidinium twice daily required in reduced renal function Seebri Breezhaler® One capsule £27.50 Caution when Glycopyrronium (50mcg) inhalation daily eGFR <30 ml/min Spiriva HandiHaler® One capsule 30 doses Caution when (18mcg) inhalation daily =£34.87; eGFR ≤ 50 ml/min Refill = £33.50 LAMA Spiriva Respimat® Two inhalations £35.50 Caution when (2.5mcg)* once daily eGFR ≤ 50 ml/min Tiotropium [Currently restricted use MHRA alert use on EK formulary, non- with caution in formulary for EKHUFT- patients with known under review] cardiac rhythm disorders

ICS/LABA is not an automatic step up for treatment of breathlessness in COPD. Please refer to the Decision support tool for the use of inhaled therapy in COPD to ensure aim of treatment is in line with recommendations Class Drug Brand & strength Brand & strength Maintenance dose Cost *Comment pMDI + spacer Dry Powder per 30 days Beclo- Fostair 100/6* (100 Two inhalations twice £29.32 Licensed for use in severe COPD metasone/ micrograms of BDP daily (FEV1 < 50% + history of repeated formoterol extrafine in Fostair ≡ exacerbations + significant symptoms