New inhaled drugs for asthma & COPD: integration into UK practice

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1 New inhaled drugs for asthma & COPD: integration into UK practice Hasanin Khachi Lead Pharmacist - Respiratory Medicine Joint Chair UKCPA Respiratory Group Barts Health NHS Trust 30 th September 2014

2 Outline Do we follow guidelines? Current Management of Asthma & COPD Inhalers: the old world Inhalers: the new world New inhalers, new paradigm? Implications for Practice

3 Are we following national guidance..?

4 NICE Treatment Algorithm June 2010

5 Moderate COPD 10 GP practices 314 patients Results: ICS used in 75% 22% on mono ICS* 70% who had no exacerbations in preceding 12months were on ICS preparation *ICS monotherapy is not licensed in COPD

6 % of Patients prescribed each drug class by COPD severity (Lung Health - National UK) Drug Mild % Moderate % Severe % v. Severe % SABA SAMA LABA LAMA LABA/ICS LABA/ICS (as DPI) NB: The only licensed ICS / LABA treatments are those available in DPI form. Seretide is licensed for patients with an FEV1<60% and Symbicort is licensed for patients with an FEV1<50%. Both are outside the NICE classification of mild COPD - IMPRESS Guide to the relative value of COPD interventions.

7 % of Patients prescribed each drug class by COPD severity (Lung Health - National UK) Drug Mild % Moderate % Severe % v. Severe % SABA SAMA LABA LAMA LABA/ICS LABA/ICS (as DPI) NB: The only licensed ICS / LABA treatments are those available in DPI form. Seretide is licensed for patients with an FEV1<60% and Symbicort is licensed for patients with an FEV1<50%. Both are outside the NICE classification of mild COPD - IMPRESS Guide to the relative value of COPD interventions.

8 % of Patients prescribed each drug class by COPD severity (Lung Health - National UK) Drug Mild % Moderate % Severe % v. Severe % SABA SAMA LABA LAMA LABA/ICS LABA/ICS (as DPI) NB: The only licensed ICS / LABA treatments are those available in DPI form. Seretide is licensed for patients with an FEV1<60% and Symbicort is licensed for patients with an FEV1<50%. Both are outside the NICE classification of mild COPD - IMPRESS Guide to the relative value of COPD interventions.

9 What about international guidance.?

10 GOLD COPD Guidelines GOLD 4 GOLD 3 C LABA+ICS or LAMA LABA and LAMA D LABA+ICS or LAMA LABA+ICS and LAMA or LABA+ICS and PDE4-inh or LABA and LAMA or LAMA and PDE4-inh 2 or > 1 leading to hospital admission Exacerbations per Year GOLD 2 GOLD 1 A LABA or SAMA prn LABA or LAMA or SABA and SAMA B LABA or LAMA LABA and LAMA 1 (not leading to hospital admission) 0 mmrc 0 1 mmrc 2 CAT <10 CAT 10 Adapted from GOLD Available from:

11 Percentage of patients COPD prevalence by GOLD Group Prevalence varies according to whether symptoms are evaluated by CAT or mmrc scores 1 60 Evaluated by CAT Evaluated by mmrc Group A Group B Group C Group D Data were drawn from the Adelphi Respiratory Disease Specific Programme, a large multinational (France, Germany, Italy, Spain, UK, USA) cross-sectional survey generating real-world data based on actual clinical practice. N= ,2 CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; GOLD, Global Initiative for Chronic Obstructive Lung Disease; mmrc, modified Medical Research Council. References. 1 Small M Thorax 2012; 2 Small M COPD

12 Despite recommendations & product licenses, ICS used often in early-stage COPD ICS plus LABA recommended for use only in patients in Groups C and D 1 However, many patients in Groups A and B are treated with ICS 2,3 GOLD Group C GOLD Group D 13 patients 54% using ICS 604 patients 51% using ICS GOLD Group A GOLD Group B 152 patients 33% using ICS 739 patients 38% using ICS Data were drawn from the Adelphi Respiratory Disease Specific Programme, a large multinational (France, Germany, Italy, Spain, UK, USA) cross-sectional survey generating real-world data based on actual clinical practice. N=1508 2,3 ICS inhaled corticosteroid; LABA, long-acting β 2 agonist. References. 1 GOLD Small M Thorax Higgins M COPD

13 Are we any better with following asthma guidelines.?

14 BTS/SIGN May 2008

15 Inhalers: the old world It all used to be so simple

16

17 Inhalers: the new world

18

19 Asthma & COPD: Increasing Complexity Bronchodilators Corticosteroids SABAs ICS Salbutamol (7+ devices) Beclometasone (3 devices) Terbutaline (1 device) Beclometasone extra-fine SAMAs (1 device) Ipratropium (2 devices) Budesonde (3 devices) LABAs Fluticasone propionate Formoterol (3 devices) (2 devices) Salmeterol (2 devices) Fluticasone furoate Indacaterol (1 device) (planned 1 device) Olodaterol (1 device) ICS/LABA Vilanterol (planned 1 device) Bufomix (planned 1 device) LAMAs DuoResp (1 device) Aclidinium (1 device) Fostair (2 devices) Glycopyrronium (1 device) Relvar (1 device) Tiotropium (2 devices) Seretide (2 devices) Umeclidinium (1 device) Symbicort (planned 2 LABA/LAMAs devices) Anoro (umeclidinium/vilanterol) (1 device) Duaklir (aclidinium/formoterol) (1 device) Ultibro (glycopyrronium/indacaterol) And don t forget future generics (1 device)

20 The LAMA/LABA paradigm

21 Breathlessness in COPD Despite current therapies, 50% of patients continue to experience significant breathlessness with daily activities 1 Visits to the GP for breathlessness cost the NHS more per patient per year than exacerbation management (community and hospital costs) 2 1. Müllerová H, Lu C, Li H, et al. PLoS One 2014; 9: e Punekar YS et al. Int J Chron Obstruct Pulmon Dis 2014; 9: 65 73

22 Exacerbations/year Frequent Exacerbator Phenotype 71% of frequent exacerbators in Years 1 and 2 were frequent exacerbators in Year 3 74% of patients with no exacerbations in Years 1 and 2 had no exacerbations in Year 3 Year 2 Year 3 Percentage Percentage Year 1 Percentage Percentage Percentage Data are for 1679 patients with COPD who completed the study Reference. Hurst JR N Engl J Med 2010.

23 Duaklir Genuair Aclidinium bromide 340 mcg / formoterol 12 mcg Dosage: 1 puff BD ACLIFORM (n=1729) and AUGMENT (n=1692): Both randomised, multicentre parallel-group trials comparing: Aclidinium/formoterol combination Vs aclidinium, formoterol & placebo Statistically significant improvements Peak & trough FEV1 TDI SGRQ

24 FEV1 improvement Vs Form at 1yr Make et al. Efficacy and tolerability of aclidinium bromide/formoterol fumarate fixed-dose combination in patients with COPD: a 1-year study. ERS 2014

25 TDI at 1 yr D Urzo et al. One-year efficacy of aclidinium/formoterol fixed-dose combination in COPD patients: the AUGMENT COPD extension trial. ERS 2014

26 TDI: ACLIFORM & AUGMENT at 24 wks Jones et al. Effect of aclidinium/formoterol fixed-dose combinations on respiratory symptoms in COPD patients. ERS 2014

27 FEV1: ACLIFORM & AUGMENT at 24 wks Singh et al. Lung function improvements with twice-daily aclidinium/formoterol fixed-dose combination in two 24-week studies in patients with COPD. ERS 2014

28 QoL - SGRQ at 24 wks > 4-point improvement from baseline SGRQ in both trials However difference Vs placebo in ACLIFORM was not clinically significant due to unusually high placebo response. Jones et al. Effects of aclidinium bromide/formoterol fumarate fixed-dose combination on health status in COPD. ERS 2014

29 Anoro Ellipta Umeclidinium bromide 55mcg / Vilanterol 22mcg Dosage: 1 puff OD 3 x trials Vs Tio 18mcg OD: ZEP (N=905), DB (N=843) & DB (N=869) Both randomised, multicentre parallel-group trials comparing: Aclidinium/formoterol combination Vs aclidinium, formoterol & placebo Statistically significant improvements Peak & trough FEV1 TDI SGRQ

30 FEV1 at D169 Vs Tio 18mcg Decramer et al. Lancet Resp Med 2014 ; Vol 2 No. 6 pp

31 TDI at D169 Vs Tio 18mcg Decramer et al. Lancet Resp Med 2014 ; Vol 2 No. 6 pp

32 SGRQ at D169 Vs Tio 18mcg Decramer et al. Lancet Resp Med 2014 ; Vol 2 No. 6 pp

33 FEV1, TDI & SGRQ Vs Placebo at D169 TDI Vs Placebo 1.2 improvement at D169 Trough FEV1 Vs Placebo 167ml improvement at D169 SGRQ Vs Placebo 5.5 improvement at D169

34 LAMA in Asthma

35 Tiotropium Respimat in Asthma Licensing: add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with: maintenance combination of ICS/LABA ( 800mcg budesonide/day or equivalent) and who experienced one or more severe exacerbations in the previous year Licence extension not applicable to Tio 18mcg HandiHaler Dose: 5mcg OD License approval based on Phase III PrimoTinA-asthma study: 24 week; Vs placebo

36 Tio in Asthma - Respimat: Phase III PrimoTinA-asthma FEV1: 110ml and 93ml improvement in peak & trough FEV1 (95% CI: to litres, p<0.0001) (95% CI: to litres, p<0.0001), respectively. Delayed the time to first severe asthma exacerbation (282 days versus 226 days) Risk of severe exacerbation by 21% (HR: 0.79; 95% CI, ; p=0.03) Delayed the time to first episode of asthma worsening (315 days versus 181 days) Risk of experiencing asthma worsening by 31% (HR: 0.69; 95% CI, ; p<0.001)

37 New ICS/LABAs Fostair MDI (COPD) Fostair NEXThaler (asthma) Relvar: asthma and COPD Duoresp: asthma & COPD

38 Cost Data

39 Cost Data LABA & LAMA LAMA NHS Price Aclidinium 322mcg Genuair 1 puff Twice daily Glycopyrronium 44mcg Breezhaler 1 puff Once daily Tiotropium 2.5mcg Respimat 2 puffs Once daily Tiotropium 18mcg HandiHaler 1 puff Once daily Umeclidinium 55mcg Ellipta 1 puff Once daily LABA NHS Price Formoterol 6mcg/12mcg Turbohaler 12mcg Twice daily Formoterol 12mcg Easyhaler 1 puff Twice daily Indacaterol 150mcg/300mcg Breezhaler 1 puff Once daily Olodaterol 2.5mcg Respimat 2 puffs Once daily Salmeterol pmdi / Accuhaler 50mcg Twice daily LABA/LAMA NHS Price Anoro (Umeclidinium/Vilanterol) Ellipta 1 puff Once daily Duaklir (Aclidinium/Formotero) Genuair 1 puff Twice daily tbc Ultibro (Indacaterol/Glycopyrronium) Breezhaler 1 puff Once daily tbc NHS List Price (July 2014)

40 Cost Data ICS/LABA - DPIs ICS/LABA NHS Price Fostair 100/6 Nexthaler 2 puffs Twice daily Symbicort 100/6 Turbohaler 2 puffs Twice daily Symbicort 200/6 Turbohaler 2 puffs Twice daily Symbicort 400/12 Turbohaler 1 puff Twice daily DuoResp 200/6 Spiromax 2 puffs Twice daily DuoResp 400/12 Spiromax 1 puff Twice daily Relvar 92/22 Ellipta 1 puff Once daily Relvar 184/22 Ellipta 1 puff Once daily Seretide 100 Accuhaler 1 puff Twice daily Seretide 250 Accuhaler 1 puff Twice daily Seretide 500 Accuhaler 1 puff Twice daily NHS List Price (July 2014*)

41 Cost Data ICS/LABA - MDIs ICS/LABA NHS Price Fostair 100/6 MDI 2 puffs Twice daily Flutiform 50/5 MDI 2 puffs Twice daily Flutiform 125/5 MDI 2 puffs Twice daily Flutiform 250/10 MDI 2 puffs Twice daily Seretide 50 MDI 2 puffs Twice daily Seretide 125 MDI 2 puffs Twice daily Seretide 250 MDI 2 puffs Twice daily NHS List Price (July 2014*)

42 Implications for practice & Summary How do we support HCPs to follow guidelines? Which guidelines? COPD: NICE or GOLD How can we optimise value based interventions: Non-pharmacological: e.g. PR, self management Smoking cessation Adherence Inhaler technique How can we simplify local guidelines? Should we review guidelines now? Wait until the dust settles? What about generics?

43 Questions

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