Wendy Pigg Practice support Pharmacist/Independent Prescriber What’s new in asthma Wendy Pigg Practice support Pharmacist/Independent Prescriber

NICE Quality standards Qs25 Launched in February 2013 Provides best clinical practice statements for a health topic Statement 1. People with newly diagnosed asthma are diagnosed in accordance with BTS/SIGN guidance. Statement 2. Adults with new onset asthma are assessed for occupational causes. Statement 3. People with asthma receive a written personalised action plan. Statement 4. People with asthma are given specific training and assessment in inhaler technique before starting any new inhaler treatment. Statement 5. People with asthma receive a structured review at least annually. Statement 6. People with asthma who present with respiratory symptoms receive an assessment of their asthma control. Statement 7. People with asthma who present with an exacerbation of their symptoms receive an objective measurement of severity at the time of presentation. Statement 8. People aged 5 years or older presenting to a healthcare professional with a severe or life-threatening acute exacerbation of asthma receive oral or intravenous steroids within 1 hour of presentation. Statement 9. People admitted to hospital with an acute exacerbation of asthma have a structured review by a member of a specialist respiratory team before discharge. Statement 10. People who received treatment in hospital or through out-of-hours services for an acute exacerbation of asthma are followed up by their own GP practice within 2 working days of treatment. Statement 11. People with difficult asthma are offered an assessment by a multidisciplinary difficult asthma service. Ref :http://guidance.nice.org.uk/QS25 Recently launched and covers both primary and secondary care of asthma . They will be reflected in the new Clinical Commissioning Group Outcome Indicator Set (CCGOIS) and will inform payment mechanisms and incentive schemes such as the Quality and Outcomes Framework (QOF). I thought it was useful to present this to show that some of the work done with the asthma Les has preempted some of these standards. The action plans , structured review , assessment tools of asthma control. There are some things that Worcestershire has worked on with the Asthma LES already such as Asthma action plans , the need for inhaler technique training and assessment of asthma control using

New licensing for Fostair® The product license for the pMDI Fostair® (beclometasone and formoterol) dose inhaler (pMDI) has been updated with a new indication to allow use as maintenance and reliever therapy. Dose is 1 inhalation of the inhaler regularly twice daily for maintenance and then take up to 6 additional inhalations as needed in response to symptoms. Symbicort® DPI are already licensed in this way (SMART). The license extension for Fostair® now provides a patients choice of delivery device (pMDI or DPI). Patients must be carefully selected and patient education is key to the success of the regime which in the studies can provide an overall lower steroid load to patients. The product license for the pMDI Fostair® (beclometasone and formoterol) dose inhaler (pMDI) has been updated with a new indication to allow use as maintenance and reliever therapy. Dose is 1 inhalation of the inhaler regularly twice daily for maintenance and then take up to 6 additional inhalations as needed in response to symptoms. Symbicort® DPI are already licensed in this way (SMART). The license extension for Fostair® now provides a patients choice of delivery device (pMDI or DPI). Patients must be carefully selected and patient education is key to the success of the regime which in the studies can provide an overall lower steroid load to patients.

New Inhalers - Flutiform®

New Inhalers - Flutiform® Combination MDI inhaler containing fluticasone and formoterol Available in 3 strengths, with a dose schedule of two puffs twice daily. (120 dose) Flutiform 50 mcg/5 mcg and 125 mcg/5 mcg are licensed for use in adults and adolescents aged > 12 years. Flutiform 250 microgram/10 microgram is licensed for use only in adults. Aerosol combination inhaler with fluticasone as steroid. Offer a cost effective choice for prescribers with Seretide inhalers as offer a range of low to high dose steroid potency . Important to note the high dose inhaler provides more LABA per dose and licensed in adults > 18 only. NICE reviewed the evidence for its use and there are 2 inferiority studies indicating the combination is non inferior to the sames doses in single inhalers or to fluticasone/salmeterol combination in terms of lung function (measured as FEV1) – whilst this evidence is not on patient orientated outcomes such as excaberbation rates, asthma control score and SABA use we have evidence of this with the individual components.

Expected no inhalers/yr Combined inhalers BDP equivalence (note the dose of long acting bronchodilator (LABA) may vary) BDP equivalence Daily dose Licensed for use in COPD Cost for 30 days Expected no inhalers/yr Fostair® (BEC + formeterol) 100/6 MDI 1pBD (120 dose) 400-500mcg no £14.66 7 Flutiform® ( FLU + formeterol) 50/5 MDI 2pBD (120 dose) 400mcg £18.00 13 Seretide® (FLU+ salmeterol) 50/25 MDI (2pBD - must use 2 puff to get full dose of LABA) £18.20 Seretide® (FLU+ salmeterol) 100/50 ACCUHALER 1pBD (only 1 puff needs to get full dose of LABA) (60 dose) 400mg Symbicort® (BUD + formeterol) 200/6 1pBD (120 dose) £19.00 Symbicort ® (BUD + formeterol) 100/6 2pBD (120 dose) £33   Fostair® (BEC + formeterol) 100/6 MDI 2pBD (120dose) 800-1000mcg £29.32 Symbicort® (BUD + formeterol) 400/12 1pBD (60 dose) 800mcg yes £38 Symbicort® (BUD + formeterol) 200/6 2pBD (120 dose) Flutiform®( FLU + formeterol) 125/5 2pBD (120 dose) 1000mcg £29.26 Flutiform® ( FLU + formeterol) 250/10 MDI 1pBD (120 dose) £22.78 Seretide® (FLU+ salmeterol) 125/25 MDI 2pBD (120 dose) £35 Seretide ® 250/50 ACCUHALER 1P BD (60 dose) 1000mg Flutiform® ( FLU + formeterol) 250/10 MDI 2pBD (120 dose) 2000mg £45.56 Seretide® 500/50 ACCUHALER 1p BD (60 dose) £40.92 Seretide® (FLU+ salmeterol) 250/25 MDI 2P BD (120 dose) 2000mcg £59.48 Symbicort® (BUD + formeterol) 400/12 2pBD (60 dose) 1600mcg £76 25 Fostair and Flutiform are now the most cost effective inhalers of choice for an MDI device. This should be used for new starters if the device is appropriate – as per NICE guidance and can also be considered for patients where a step down to a less potent steroid is required.

Worcestershire Spend on ICS- Cost effective prescribing N.I.C.E states to use the combination inhaler that is least costly that is suitable for that patient. All new starters for pMDI ICS/LABA inhalers should be on Fostair®/Flutiform® Switching can be an option in suitable patients now we have a fluticasone pMDI alternative to Seretide® Switching 50% of patients from Seretide® 250 evohaler to Flutiform® 250 could save £183,249 Switching 50% of patients from Seretide® 125 evohaler to Flutiform® 125 could save £62,313 Switching can be an option in suitable patients now we have a fluticasone pMDI alternative to Seretide® Although recognise this is a switch that needs to take place with full patient cooperation Switching 50% of patients from Seretide® 250 evohaler to Flutiform® 250 could save £183,249 Switching 50% of patients from Seretide® 125 evohaler to Flutiform® 125 could save £62,313 Lets remember those figures for later

Worcestershire Spend on ICS- YTD Dec 2012 The volumes of combined ICS is increasing year on year 59% (49% in 2010) of total inhaled corticosteroid inhalers (ICS) prescribing is for combination inhalers . (Step 3 or more of BTS guidelines for asthma or COPD FEV1 <50%) This equates to a spend of £4,490,521 £2.2 million is spent on Seretide® 250 Evohaler/Seretide® 500 Accuhalers  high dose inhaler ??Why ?? More patients moving from step 2 –to step 3 of BTS guidelines too early ? Patients started on step 3 of BTS guidelines with higher dose steroid than needed ? Patient started on higher dose steroids to gain control but not stepped down when stable More COPD patients on triple therapy LAMA + ICS/LABA ? - limited evidence base for use So what’s happening in Worcester regarding step down of high dose ICS in asthma . Nearly 60% of prescribing is for combination inhalers , this has been steadily increasing since 2010 . That is £4.4 million spent so far and a half of this - 2.2 million spent on a high dose Seretide 250 accuhaler/evohaler . We do not know if this is spent in COPd or asthma though , but prevalence of asthma is still higher than COPD . Why is there large volumes of high dose ICS ? .

Q.I.P.P –High dose Inhaled corticosteroids in Asthma QIPP – Quality, Innovation, Productivity and Prevention High dose = high cost = increased risk of side effects Numbers of patients with serious side effects may be small but Cost of fracture to the NHS Lifetime cost of a diabetic Cataract surgery cost QIPP – Quality, Innovation, Productivity and Prevention – is a large scale transformational programme to improve quality of care whilst making £20billion efficiency savings to reinvest. ICS is one of the medicine management issues that can deliver savings and improvement in quality for asthma patients. How to ? Sound easy but this is where we made need to think how to we could do this differently in the future . How do we access non attenders – pharmacy?? How do we achieve active review in practice – managed partnerships with drug industry

Worcestershire ICS Volume - Changes so far This graph shows the changes in types of inhalers prescribed over the last 2 years. The data is not linked to disease state so this is difficult to truely interupt as cannot tell what prescribing is for COPD or asthma. There has been a large growth in Fostair as its was still relatively new in 2010 and appears to be from new prescribing – there has been a drop in Seretide 250 evohalers/accuhaler but this is counteracted by a larger increase in Seretide 500 . This deomonstrates the message about using the licensed COPD dose has generated changes to prescribing and may also indicate more COPD patients are being treated with combination inhalers. There has been a drop in the moderate potency Seretide 125 and 100 inhalers but a large increase in Seretide 50 – maybe not much stepping down but stepping up patients to a more apporiate dose ? Symibcort has seen growth in the lower strength and higher strength which is licensed COPD dose . Again are we treating more COPD patients but with the a lower potency steroid

BTS guidelines – Optimising Step 2 of treatment ? Are we ensuring step 2 of BTS guidelines are followed with optimisation of ICS first before adding LABA . Impact Project in Bristol found adequate inhaler training and education for these patients meant they gained control without need to step up. In asthma reviews look at prescription ordering history – are patients actually using their ICS ? Is stepping down ICS dose discussed and documented at every asthma review ? (is it on your templates ?) Is inhaler technique actually checked every time ? Where else can we bring costs down and improve quality of patient care.

Number of HCP's who demonstrated all 7 steps correctly &/ or correct inspiratory flow rate using the In-Check Dial. The Group included hospital doctors, hospital nurses, general practitioners, pratice nurses, hospital and community pharmacy staff. Each professional was marked against a standard set by the manufacturer and Education for Health UK.1Of 150 HCP tested only 7% could demonstrate all 7 steps correctly &/ or correct inspiratory flow rate using the In-Check Dial. Baverstock M et al. Thorax 2010;65:A117-A118

BTS guidelines – Step 3 of treatment Ensure patient using at least 400mcg BDP equivalent before adding LABA No need to increase steroid when LABA added – therefore should be using low dose combined ICS inhalers which are more cost effective and lower doses of steroids. Fostair®/Flutiform 50®/Sertide 50®/Symbicort® Step down when asthma control is achieved to reduce long term side effects of steroids.

BTS guidelines – Stepping up and stepping down Stepping down 25% of patients from Seretide® 250 Evohaler  Seretide® 125 Evohaler = £161,133 Seretide® 250 Evohaler Flutiform® 125 Evohaler = £198,908 Seretide® 125 Evohaler  Seretide®/Flutiform® 50 Evohaler = £92,276 Seretide® 250 Accuhaler  Seretide® 100 accuhaler = £91,000 This in total is nearly quarter a million pounds to free back to the health economy plus the long term benefits to the patient in side effect reduction from steroids. Switching 50% of patients from Seretide® 250 evohaler to Flutiform® 250 could save £183,249 Switching 50% of patients from Seretide® 125 evohaler to Flutiform® 125 could save £62,313

Key messages Asthma is a variable disease so patients can be over treated or undertreated. In stable asthma with no symptoms consider step down in treatment every three months , decreasing dose by 25-50% at a time . Scottish study in 259 stable asthma patients on high dose ICS (>1200 BDP) had 50% reduction in dose and in 1 year no difference in exacerbation rate, GP attendance or health status SGRQ If inhaler technique not correct – treatment is in vain. Hawkins et al BMJ 2003:325:1115