PUBLIC SUMMARY DOCUMENT

Size: px
Start display at page:

Download "PUBLIC SUMMARY DOCUMENT"

Transcription

1 PUBLIC SUMMARY DOCUMENT Product: Budesonide with eformoterol fumarate dihydrate, powder for oral inhalation, fixed dose combination, 400 micrograms-12 micrograms per dose, Symbicort Turbuhaler 400/12 Sponsor: AstraZeneca Pty Ltd Date of PBAC Consideration: November Purpose of Application The submission sought a Restricted Benefit listing for the symptomatic treatment of patients with chronic obstructive pulmonary disease (COPD) who meet certain criteria. 2. Background The PBAC recommended the restricted benefit listings of budesonide with eformoterol Turbuhaler 200 micrograms/6 micrograms (March 2002 meeting) and 400 micrograms/12 micrograms (March 2004 meeting), on a cost-minimisation basis compared with the individual components, for the treatment of asthma in patients who meet certain criteria. Listing was effective 1 February 2003 and 1 August 2004, respectively. At the November 2004 meeting, the PBAC recommended the listing of budesonide with eformoterol Turbuhaler 100 micrograms/6 micrograms strength, and to broaden the restriction to include those patients with frequent episodes of asthma who are receiving treatment with optimal doses of budesonide. Listing was effective 1 April At the March 2007 meeting, the PBAC recommended amending the current restricted benefit listing for the 200/6 and 100/6 strengths to include single maintenance and reliever therapy (SMART) in patients who had frequent asthma symptoms while taking oral or inhaled corticosteroids. Full details in the March 2007 (PSD) available at: 3. Registration Status As at 15 October 2010, budesonide with eformoterol 400/12 Turbuhaler was TGA registered for the symptomatic treatment of moderate to severe COPD (FEV 1 less than or equal to 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use and/or a history of recurrent exacerbations. Symbicort Turbuhaler is not indicated for the initiation of bronchodilator therapy in COPD. It is also TGA registered for the treatment of asthma where use of a combination (inhaled corticosteroid and long acting beta-agonist) is appropriate. This includes patients who are symptomatic on inhaled corticosteroid therapy and patients who are established on regular long acting beta-agonist and inhaled corticosteroid therapy. Symbicort 400/12 should only be used in patients aged 18 years and over. The 400/12 strength should not be used for the Symbicort maintenance and reliever therapy regimen. 4. Listing Requested and PBAC s View Restricted Benefit The symptomatic treatment of moderate to severe chronic obstructive pulmonary disease (COPD) where the FEV 1 is less than or equal to 50% predicted normal in adults with frequent symptoms despite long acting bronchodilator use and/or a history of recurrent exacerbations. Page 1 of 8

2 NOTE: Budesonide with eformoterol is not indicated for the initiation of bronchodilator therapy in COPD For PBAC s view, see Recommendation and Reasons. 5. Clinical Place for the Proposed Therapy COPD is a progressive disease and lung function is expected to worsen over time. As such, treatment tends to be cumulative with more medications being required as the disease state worsens. Combined therapy with inhaled corticosteroids and long-acting beta 2-adrenoceptor agonists is used in patients with COPD who experience repeated exacerbations. The submission claimed that budesonide with eformoterol would provide an alternative therapy to fluticasone with salmeterol. 6. Comparator The submission nominated fluticasone with salmeterol (Seretide ) as the comparator. This was considered appropriate by the PBAC and is consistent with current guidelines where a long-acting beta 2-adrenoceptor agonists (LABA) is usually given with an inhaled corticosteroid (ICS). 7. Clinical Trials The submission presented an indirect comparison including a meta-analysis of four randomised trials comparing Symbicort with placebo in patients with COPD (Calverley et al 2003, SHINE, SUN, and Szafranski et al 2003), and a meta-analysis of seven randomised trials (Barnes et al 2006, Mahler et al 2002, SCO104925, SFCT01, TORCH, TRISTAN, and Zheng et al 2006) comparing Seretide with placebo in patients with COPD. The submission also presented a second indirect comparison including one randomised trial comparing Symbicort plus tiotropium with tiotropium monotherapy (CLIMB) and a metaanalysis of two randomised trials comparing Seretide plus tiotropium with tiotropium monotherapy in patients with COPD (Aaron et al 2007, Cazzola et al 2007). Publication details of the studies presented in the submission are in the table below. Trial ID / First Protocol title / Publication title author Common reference: placebo Symbicort vs placebo Calverly et al Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease Publication citation Eur Respir J, 2003, Dec; 22(6): SHINE Tashkin et al Efficacy and safety of budesonide and formoterol in one pressurized metered-dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease: results of a 6- month randomized clinical trial Drugs, 2008; 68(14): Page 2 of 8

3 SUN Rennard et al Szafranski et al Calverley et al Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metereddose inhaler in patients with chronic obstructive pulmonary disease: results from a 1-year randomized controlled clinical trial Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Relationship between respiratory symptoms and medical treatment in exacerbations of COPD Drugs, 2009; 69(5): Eur Respir J, 2003, 21: Eur Respir J, 2005, 26: Seretide vs placebo Barnes et al Antiinflammatory effects of salmeterol/fluticasone propionate in chronic obstructive lung disease Mahler et al Effectiveness of Fluticasone Propionate and salmeterol Combination Delivered via the Diskus Device in the Treatment of Chronic Obstructive Pulmonary Disease Am J Crit Care Med, 2006, 173: Am J Crit Care Med, 2002, 166: TORCH Calverley et al Celli et al Crim et al Ferguson et al Jenkins et al McGarvey et al 2007 Vestbo et al Vestbo et al TRISTAN Calverley et al Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebocontrolled TORCH study TORCH Clinical Endpoint C. Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee The TORCH (towards a revolution in COPD health) survival study protocol Adherence to inhaled therapy, mortality and hospital admission in COPD Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial N Engl J Med, 2007, Feb 22;356(8): Am J Respir Crit Care Med, 2008, Aug 15;178(4): Eur Respir J, 2009, Sep; 34(3): Chest, 2009, Dec; 136(6): Respir Res, 2009;10:59 Thorax, 2007, May; 62(5): Eur Respir J, 2004, Aug; 24(2): Thorax, 2009, Nov; 64(11): Lancet, 2003, Feb 8;361(9356): Page 3 of 8

4 Calverley et al Keene et al Keene et al Vestbo et al Vestbo et al Zheng et al The severity of airways obstruction as a determinant of treatment response in COPD Statistical analysis of exacerbation rates in COPD: TRISTAN and ISOLDE revisited. Analysis of exacerbation rates in asthma and chronic obstructive pulmonary disease: example from the TRISTAN study TRISTAN study g. Early onset of effect of salmeterol and fluticasone propionate in chronic obstructive pulmonary disease Gender does not influence the response to the combination of salmeterol and fluticasone propionate in COPD The efficacy and safety of combination salmeterol (50 microg)/fluticasone propionate (500 microg) inhalation twice daily via accuhaler in Chinese patients with COPD Int J Chron Obstruct Pulmon Dis, 2006; 1(3): European Respiratory Journal, 2008, July; 32(1):17-24 Pharm Stat, 2007, Apr- Jun; 6(2):89-97 Thorax, 2005, Apr; 60(4): Respir Med, 2004, Nov; 98(11): Chest, 2007, Dec; 132(6): Common reference: tiotropium; co-treatment with tiotropium Symbicort plus tiotropium vs tiotropium monotherapy CLIMB Welte et al 2009 Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease Seretide plus tiotropium vs tiotropium monotherapy Aaron et al Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial Am J Respir Crit Care Med, 2009, Oct 15; 180(8): Ann Intern Med, 2007, Apr 17;146(8): Aaron et al Cazzola et al The Canadian Optimal Therapy of COPD Trial: design, organization and patient recruitment A pilot study to assess the effects of combining fluticasone propionate/salmeterol and tiotropium on the airflow obstruction of patients with severeto-very severe COPD Can Respir J, 2004, Nov- Dec; 11(8): Pulm, Pharmacol, Ther, 2007; 20(5): Results of Trials The key outcomes presented in the submission were the rate of COPD exacerbations, mean change from baseline as measured by St George Respiratory Questionnaire (SGRQ) and mean change from baseline for pre- and post-dose Forced Expiratory Volume in one second (FEV 1 ). The results of the indirect comparisons are presented below. The results of the indirect comparison should be interpreted with caution due to the heterogeneity between the trials included in the analyses. Page 4 of 8

5 Rate of exacerbations The meta-analysis of rate ratios for Symbicort versus placebo showed a statistically significant reduction in the rate of COPD exacerbations in favour of Symbicort (0.72, 95% CI: 0.64 to 0.81). Similarly, meta-analysis of rate ratios for Seretide versus placebo showed a statistically significant reduction in the rate of COPD exacerbations compared to placebo (0.75, 95% CI: 0.70 to 0.80). The indirect comparison using placebo as common reference showed no statistically significant difference between Symbicort and Seretide (0.96, 95% CI: 0.84 to 1.10), and the upper 95% CI of the indirect comparison did not cross the Minimal Clinically Important Difference (MCID) of Symbicort plus tiotropium resulted in a statistically significantly lower rate of exacerbations compared to tiotropium alone (0.38, 95% CI: 0.25 to 0.57), while Seretide plus tiotropium did not result in a statistically significant lower rate of exacerbation compared to tiotropium alone (0.85, 95% CI: 0.65 to 1.11). The indirect comparison using tiotropium as the common reference suggested that Symbicort might be superior to Seretide, when used in combination with tiotropium (0.46, 95% CI: 0.27 to 0.73), however, the submission considered that the analysis needed to be interpreted with caution, as the trials were of different duration and patients enrolled in the Aaron trial were able to initiate pulmonary rehabilitation programs during the trial as well as oxygen therapy. St George Respiratory Questionnaire (SGRQ) The St George s Respiratory Questionnaire is a standardised self-completed questionnaire for measuring impaired health and perceived well-being ( quality of life ) in patients with disease of the airways. The submission presented indirect comparisons based on the change in SGRQ from baseline using placebo and tiotropium as common references. There was no statistically significant difference in change in SGRQ from baseline between Symbicort (with or without tiotropium) and Seretide (with or without tiotropium) in either indirect comparison (indirect mean difference [95% CI] [-1.5, 1.5] using placebo as common reference and 1.8 [-0.9, 4.6] using tiotropium as common reference). The treatments appeared to confer an average improvement which was less than the 4-unit difference considered in clinical guidelines to be the MCID, i.e. the trials do not provide evidence that either Symbicort or Seretide results in a clinically important improvement in SGRQ score, as monotherapy compared to placebo, or in combination with tiotropium compared to tiotropium alone. Pre and post dose FEV 1 The magnitude of change observed in FEV 1 from baseline depends on a number of factors including baseline lung function and severity of disease. The absolute change observed is less marked in patients with lower baseline lung function. The PBS listing for Seretide restricts use to patients with baseline FEV 1 less than 50% predicted normal; however unlike the Symbicort trials, the Seretide trial population included patients with baseline FEV 1 greater than 50% predicted normal. As such, to facilitate comparability, analysis of both pre Page 5 of 8

6 and post-dose FEV 1 only included those patients with baseline FEV 1 less than 50% predicted normal. Symbicort resulted in a statistically significant increase in pre-dose FEV 1 from baseline compared to placebo treatment; however, this increase of 0.09 L was below 0.12 L, which the submission considered the MCID. Similarly, Seretide resulted in a statistically significant increase in pre-dose FEV 1 (0.11 L), which was also below the MCID. There was no statistically significant difference between Symbicort and Seretide using placebo as common reference. When used in combination with tiotropium, neither Symbicort nor Seretide showed a statistically significant difference in pre-dose FEV 1 compared to tiotropium alone. There was no statistically significant difference between Symbicort plus tiotropium and Seretide plus tiotropium, using tiotropium as the common reference. Results from the indirect comparison based on change in post-dose FEV 1 from baseline showed that Symbicort resulted in statistically and clinically significant increases in postdose FEV 1, compared to placebo treatment. Seretide treatment resulted in statistically significant, but not clinically significant, differences in post-dose FEV 1. The submission claimed that there was a statistically significant difference with regard to the change in postdose FEV 1 in favour of Symbicort compared to Seretide, using placebo as common reference (indirect mean difference 0.10: 95% CI 0.07 to 0.13). The submission claimed that as the upper confidence interval crosses the upper threshold of the MCID of 0.12 L, Symbicort may result in a clinically relevant improvement compared to Seretide treatment. For PBAC s view of these results, see Recommendations and Reasons. The submission claimed that while there was an increase in adverse events when Symbicort was compared to placebo treatment, there were no statistically significant difference between Symbicort and Seretide, when the TORCH trial was excluded. The submission justified the exclusion of the TORCH trial, as this trial was of longer duration than the other studies included in the safety analyses. The submission claimed that there were no other differences in safety outcomes between Symbicort and placebo or Symbicort plus tiotropium and tiotropium as well as between Symbicort (with or without tiotropium) and Seretide (with or without tiotropium) as demonstrated by the indirect comparisons using either placebo or tiotropium as the common reference. The assessment of extended comparative harm did not reveal additional safety concerns. 9. Clinical Claim The submission claimed Symbicort as non-inferior in terms of comparative effectiveness and at least as effective in terms of comparative safety over Seretide. The PBAC considered that this was reasonable, despite the uncertainties raised with the indirect comparisons. 10. Economic Analysis The submission presented a cost minimisation analysis. The equi-effective doses were estimated as Symbicort 400/12 micrograms twice daily and Seretide 500/50 micrograms Page 6 of 8

7 twice daily, based on the recommended dose in the Australian Product Information (PI). The doses used for the claim of equi-effectiveness were similar to the doses used in the clinical trials. Each prescription of eformoterol with budesonide provides two months supply of this combination compared to the salmeterol with fluticasone combination currently PBS listed for COPD, which provides one month s supply. The submission claimed an incremental dispensed price for maximum quantity (DPMQ) saving per 2 months to the Government of $6.42 per prescription (equivalent to one pharmacy dispensing fee), as a result of the listing. 11. Estimated PBS Usage and Financial Implications The likely number of patients per year was estimated in the submission to be in the range of 10,000 to 50,000 in Year 4. This was considered to be uncertain. The submission estimated financial savings per year to the PBS of less than $10 million in Year 5 based on a weighted price. Upon request from the ESC, revised financial estimates based on the COPD price were provided in the sponsor s Pre-PBAC Response. This analysis estimated an overall net cost to the PBS of less than $10 million in Year 5 which resulted from a reduction in patient co-payments associated with Symbicort. For PBAC s view, see Recommendation and Reasons. 12. Recommendation and Reasons The PBAC recommended listing on a cost minimisation basis with equi-effective doses being salmeterol 50 micrograms with fluticasone 500 micrograms and eformoterol 12 micrograms with budesonide 400 micrograms, both agents administered twice daily. The PBAC stated that there should be no additional cost associated with this recommendation for the listing of budesonide with eformoterol on the PBS. The PBAC noted the results of the indirect comparison presented in the submission, agreeing with the concerns raised by ESC around the comparability of the clinical trials used in the indirect comparison. The PBAC noted that the pooled results for the change from baseline for the St George Respiratory Questionnaire and the pre-dose FEV 1 were not statistically significantly different from the reference therapy and that the point estimates were not greater than the Minimum Clinical Important Difference. The indirect comparison for post-dose FEV 1 showed a statistically significant difference in favour of budesonide with eformoterol, but these results may be uncertain because of the differences in the trials. Overall, on the totality of the evidence, the PBAC considered that the claim of non-inferiority of budesonide with eformoterol compared to fluticasone with salmeterol was reasonable. The PBAC noted that budesonide with eformoterol for COPD should be included in the PBS medicines for prescribing by nurse practitioners within collaborative arrangements. Recommendation: BUDESONIDE WITH EFORMOTEROL FUMARATE DIHYDRATE, powder for oral inhalation in breath actuated devices 400 micrograms-12 micrograms per dose (60 doses), 2 Extend the current restriction to include: Page 7 of 8

8 Restriction: Restricted Benefit Symptomatic treatment of chronic obstructive pulmonary disease (COPD), where the FEV 1 is less than 50% predicted normal and there is a history of repeated exacerbations with significant symptoms despite regular beta-2 agonist bronchodilator therapy. Maximum quantity: 1 Repeats: 5 NOTE: Budesonide with eformoterol fumarate dihydrate is not indicated for the initiation of bronchodilator therapy in COPD. 13. Context for Decision The PBAC helps decide whether and, if so, how medicines should be subsidised in Australia. It considers submissions in this context. A PBAC decision not to recommend listing or not to recommend changing a listing does not represent a final PBAC view about the merits of the medicine. A company can resubmit to the PBAC or seek independent review of the PBAC decision. 14. Sponsor s Comment AstraZeneca welcomes the recommendation by the PBAC to extend the listing for Symbicort, to provide access to an additional treatment option for patients with chronic obstructive pulmonary disease. Page 8 of 8

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler ) No. (450/08) GlaxoSmithKline 11 February 2008 The Scottish Medicines Consortium has completed its

More information

Indacaterol (Onbrez)

Indacaterol (Onbrez) 1 for chronic obstructive pulmonary disease (IN-da-CAT-er-ol) A once-daily beta 2 -agonist for chronic obstructive pulmonary disease Key points Once-daily dosing provides symptomatic relief in COPD Indacaterol

More information

Samer El Rayess, M.D. Internal Medicine, PGY3 29 January 2016

Samer El Rayess, M.D. Internal Medicine, PGY3 29 January 2016 Samer El Rayess, M.D. Internal Medicine, PGY3 29 January 2016 Case Scenario Mr. X., a 50 year old man heavy smoker 80 pack / year known to have -COPD on spiriva at home last exacerbation 9 months ago -Hypertension

More information

ONCE-DAILY TIOTROPIUM RESPIMAT ADD-ON TO ICS ± LABA IMPROVES CONTROL ACROSS ASTHMA SEVERITIES

ONCE-DAILY TIOTROPIUM RESPIMAT ADD-ON TO ICS ± LABA IMPROVES CONTROL ACROSS ASTHMA SEVERITIES SPIRIVA Respimat is approved for use in asthma in the EU, Japan, the USA and many other countries. The label varies by country. Please refer to the local product information ONCE-DAILY TIOTROPIUM RESPIMAT

More information

2. Background This drug had not previously been considered by the PBAC.

2. Background This drug had not previously been considered by the PBAC. PUBLIC SUMMARY DOCUMENT Product: Ambrisentan, tablets, 5 mg and 10 mg, Volibris Sponsor: GlaxoSmithKline Australia Pty Ltd Date of PBAC Consideration: July 2009 1. Purpose of Application The submission

More information

Asthma and COPD. Trends in Prescribing of Drugs for Asthma and COPD in General Practice in England (Chart 1)

Asthma and COPD. Trends in Prescribing of Drugs for Asthma and COPD in General Practice in England (Chart 1) Asthma and COPD This review will focus on the most recent evidence regarding the safety of currently recommended options for treating chronic asthma and exacerbations in chronic obstructive pulmonary disease

More information

Drugs Used in Asthma and COPD

Drugs Used in Asthma and COPD Drugs Used in Asthma and COPD Charts 1 and 2 show trends in prescribing for asthma and chronic obstructive pulmonary disease (COPD). Although the recorded prevalence of asthma is higher (5.4% of registered

More information

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

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

More information

Bronchodilators in COPD

Bronchodilators in COPD TSANZSRS Gold Coast 2015 Can average outcomes in COPD clinical trials guide treatment strategies? Long live the FEV1? Christine McDonald Dept of Respiratory and Sleep Medicine Austin Health Institute for

More information

2. Background This indication of rivaroxaban had not previously been considered by the PBAC.

2. Background This indication of rivaroxaban had not previously been considered by the PBAC. PUBLIC SUMMARY DOCUMENT Product: Rivaroxaban, tablets, 15mg and 20mg, Xarelto Sponsor: Bayer Australia Ltd Date of PBAC Consideration: March 2013 1. Purpose of Application The application requested the

More information

medicineupdate to find out more about this medicine

medicineupdate to find out more about this medicine medicineupdate Asking the right questions about new medicines Seretide for chronic obstructive pulmonary disease What this medicine is 1 What this medicine treats 2 Other medicines available for this condition

More information

Before prescribing for COPD management, the patient should have had appropriate assessment, including spirometry, as per NICE guidelines.

Before prescribing for COPD management, the patient should have had appropriate assessment, including spirometry, as per NICE guidelines. Formulary Guidance for Management of COPD patients Before prescribing for COPD management, the patient should have had appropriate assessment, including spirometry, as per NICE guidelines. For inhaler

More information

Prevention of Acute COPD exacerbations

Prevention of Acute COPD exacerbations December 3, 2015 Prevention of Acute COPD exacerbations George Pyrgos MD 1 Disclosures No funding received for this presentation I have previously conducted clinical trials with Boehringer Ingelheim. Principal

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

Summary of treatment of asthma in adults

Summary of treatment of asthma in adults Summary of treatment of asthma in adults Original article by: Michael Tam Resources Asthma Management Handbook 2006 (National Asthma Council Australia) [1.1 Mb] The management of asthma is clearly and

More information

The submission positioned dimethyl fumarate as a first-line treatment option.

The submission positioned dimethyl fumarate as a first-line treatment option. Product: Dimethyl Fumarate, capsules, 120 mg and 240 mg, Tecfidera Sponsor: Biogen Idec Australia Pty Ltd Date of PBAC Consideration: July 2013 1. Purpose of Application The major submission sought an

More information

Sponsor Novartis Pharmaceuticals

Sponsor Novartis Pharmaceuticals Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Generic Drug Name Indacaterol Therapeutic Area of Trial Chronic Obstructive Pulmonary Disease (COPD) Indication studied: COPD Study

More information

SmPC SYMBICORT pressurised inhalation, suspension Approved indications and posology given in Section 4. CLINICAL PARTICULARS

SmPC SYMBICORT pressurised inhalation, suspension Approved indications and posology given in Section 4. CLINICAL PARTICULARS Table VI-14 Risk miminisation by safety concern: off-label use of SYMBICORT pressurised inhalation, suspension for the treatment of asthma, in children, adolescents, or adults Safety concern Routine risk

More information

Combination Long-Acting Beta-Agonist Inhaled Corticosteroid: Summary of Clinical Evidence and Drug Utilization Evaluation

Combination Long-Acting Beta-Agonist Inhaled Corticosteroid: Summary of Clinical Evidence and Drug Utilization Evaluation Drug Use Research & Management Program DHS Division of Medical Assistance Programs, 500 Summer Street NE, E35; Salem, OR 97301-1079 Phone 503-947-5220 Fax 503-947-1119 Combination Long-Acting Beta-Agonist

More information

Product: Tazarotene, cream, 500 micrograms per g (0.05%) and 1.0 mg per g (0.1%), 30 g, Zorac

Product: Tazarotene, cream, 500 micrograms per g (0.05%) and 1.0 mg per g (0.1%), 30 g, Zorac PUBLIC SUMMARY DOCUMENT Product: Tazarotene, cream, 500 micrograms per g (0.05%) and 1.0 mg per g (0.1%), 30 g, Zorac Sponsor: Genepharm Australasia Ltd Date of PBAC Consideration: July 2007 1. Purpose

More information

Chronic obstructive pulmonary disease. Costing report. Implementing NICE guidance

Chronic obstructive pulmonary disease. Costing report. Implementing NICE guidance Chronic obstructive pulmonary disease Costing report Implementing NICE guidance February 2011 NICE clinical guideline 101 National costing report: chronic obstructive pulmonary disease 1 of 30 This costing

More information

INHALED CORTICOSTEROIDS FOR ASTHAMA IN ADULTS AND CHILDREN OVER TWELVE YEARS

INHALED CORTICOSTEROIDS FOR ASTHAMA IN ADULTS AND CHILDREN OVER TWELVE YEARS INHALED CORTICOSTEROIDS FOR ASTHAMA IN ADULTS AND CHILDREN OVER TWELVE YEARS In both adults and children over 12 inhaled corticosteroids are the most important treatment for chronic asthma. This is because

More information

Reslizumab for treating asthma with elevated blood eosinophils inadequately controlled by inhaled corticosteroids [ID872]

Reslizumab for treating asthma with elevated blood eosinophils inadequately controlled by inhaled corticosteroids [ID872] For public handouts Reslizumab for treating asthma with elevated blood eosinophils inadequately controlled by inhaled corticosteroids [ID872] 1 st Appraisal Committee meeting Clinical Effectiveness and

More information

28 April 2006 *S000001Q01* 000001 000 DR SAM SAMPLE 999 SAMPLE STREET SAMPLETOWN SAMPLE STATE 9999. Dear Dr Sample, 012282_3_1_LET/000001/000001/i

28 April 2006 *S000001Q01* 000001 000 DR SAM SAMPLE 999 SAMPLE STREET SAMPLETOWN SAMPLE STATE 9999. Dear Dr Sample, 012282_3_1_LET/000001/000001/i 28 April 2006 *S000001Q01* 000001 000 DR SAM SAMPLE 999 SAMPLE STREET SAMPLETOWN SAMPLE STATE 9999 Dear Dr Sample, 012282_3_1_LET/000001/000001/i PPR thirty three Prescribing Practice Review For Primary

More information

Topic: New Treatment = Better Outcome?

Topic: New Treatment = Better Outcome? Session on COPD: Novel Concepts and Promising New Drugs Topic: New Treatment = Better Outcome? Through a CME Grant sponsored by New Treatment = Better Outcome? Tim S. Trinidad, MD Disclosure Present: COPD

More information

Post-market review of COPD medicines. Joint submission from Lung Foundation Australia (LFA) and Thoracic Society of Australia and New Zealand (TSANZ)

Post-market review of COPD medicines. Joint submission from Lung Foundation Australia (LFA) and Thoracic Society of Australia and New Zealand (TSANZ) Post-market review of COPD medicines Joint submission from Lung Foundation Australia (LFA) and Thoracic Society of Australia and New Zealand (TSANZ) EXECUTIVE SUMMARY With the addition of new medicines

More information

A Mini-Sentinel Assessment of FDA Regulatory Policies for Long Acting Beta 2 Agonists

A Mini-Sentinel Assessment of FDA Regulatory Policies for Long Acting Beta 2 Agonists A Mini-Sentinel Assessment of FDA Regulatory Policies for Long Acting Beta 2 Agonists Melissa Butler, PharmD, MPH, PhD Center for Health Research Southeast Kaiser Permanente Georgia KP Center for Effectiveness

More information

Dr GH Kaye-Eddie Helen Joseph Hospital Pulmonology

Dr GH Kaye-Eddie Helen Joseph Hospital Pulmonology Dr GH Kaye-Eddie Helen Joseph Hospital Pulmonology Introduction Definitions Impact of Exacerbations Assessment of COPD Management of COPD Management of Acute Exacerbations Prevention of Exacerbations COPD

More information

Understanding the Risks and Benefits of Stepping Down Asthma MedicaDons

Understanding the Risks and Benefits of Stepping Down Asthma MedicaDons Understanding the Risks and Benefits of Stepping Down Asthma MedicaDons 4813 Workshop: Stepping Down Asthma MedicaDons: Benefits and Risks Monday March 3, 2014 4:45 pm to 6:00 pm AAAAI 2014 John B. Hagan,

More information

Respiratory Inhalers. Identification Guide Version 2

Respiratory Inhalers. Identification Guide Version 2 Respiratory Inhalers Identification Guide Version 2 230801 This booklet has been produced by NHS Greater Glasgow and Clyde together with the following companies, Almirall, AstraZeneca, Boehringer Ingelheim

More information

Guidance to support the stepwise review of combination inhaled corticosteroid therapy for adults ( 18yrs) in asthma

Guidance to support the stepwise review of combination inhaled corticosteroid therapy for adults ( 18yrs) in asthma Guidance to support the stepwise review of combination inhaled corticosteroid therapy for adults ( 18yrs) in asthma Important Complete asthma control needs to be achieved for at least 12 weeks before attempting

More information

Longitudinal Modeling of Lung Function in Respiratory Drug Development

Longitudinal Modeling of Lung Function in Respiratory Drug Development Longitudinal Modeling of Lung Function in Respiratory Drug Development Fredrik Öhrn, PhD Senior Clinical Pharmacometrician Quantitative Clinical Pharmacology AstraZeneca R&D Mölndal, Sweden Outline A brief

More information

1-844-FAX-A For more information, call Access 360 at ASK-A360, Monday through Friday, 8:00 AM to 8:00 PM ET.

1-844-FAX-A For more information, call Access 360 at ASK-A360, Monday through Friday, 8:00 AM to 8:00 PM ET. 1-844-ASK-A360 1-844-275-2360 1-844-FAX-A360 1-844-329-2360 www.myaccess360.com For more information, call Access 360 at 1-844-ASK-A360, Monday through Friday, 8:00 AM to 8:00 PM ET. SYMBICORT is indicated

More information

Role of dual bronchodilation in COPD

Role of dual bronchodilation in COPD Role of dual bronchodilation in COPD Canadian Respiratory Conference, Calgary, May 25 th, 2014 François Maltais Centre de Pneumologie IUCPQ Québec. Canada Disclosure Speaker bureau: Boehringer Ingelheim,

More information

Doncaster & Bassetlaw Medicines Formulary

Doncaster & Bassetlaw Medicines Formulary Doncaster & Bassetlaw Medicines Formulary Section 3.2: Corticosteroids Beclometasone 50, 100 and 250micrograms/dose Clickhaler Clenil Modulite (Beclometasone CFC free) 50, 100, and 250micrograms/dose MDI

More information

LMMG New Medicine Recommendation

LMMG New Medicine Recommendation LMMG New Medicine Recommendation Fluticasone furoate/vilanterol (Relvar Ellipta ) combination inhaler Chronic obstructive pulmonary disease in adults Recommendation: Fluticasone furoate/vilanterol (Relvar

More information

Asthma Prescribing Guidelines Adults and Children over 12 years

Asthma Prescribing Guidelines Adults and Children over 12 years South Staffordshire Area Prescribing Group Asthma Prescribing Guidelines Adults and Children over 12 years Inhaler choices in this guideline are different from previous versions produced by the APG. It

More information

Drug: mepolizumab (Nucala) Class: Interleukin-5 Receptor Antagonist Line of Business: Non-Medicare Effective Date: February 17, 2016.

Drug: mepolizumab (Nucala) Class: Interleukin-5 Receptor Antagonist Line of Business: Non-Medicare Effective Date: February 17, 2016. This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics

More information

4/12/2010 Update in the management of Asthma and COPD M. Shafick Gareeboo Consultant Chest Physician Consultant Chest 1

4/12/2010 Update in the management of Asthma and COPD M. Shafick Gareeboo Consultant Chest Physician Consultant Chest 1 Update in the management of Asthma and COPD M. Shafick Gareeboo Consultant Chest Physician 1 Content Current guidelines in asthma management Current guidelines in COPD management New treatment for COPD

More information

Inhaled Corticosteroid Audit

Inhaled Corticosteroid Audit Inhaled Corticosteroid Audit AIM To enable practices to review their prescribing of inhaled corticosteroids (ICS) for both asthma and / or COPD To step down the dose of ICS where clinically appropriate

More information

Hertfordshire Treatment Guidelines for COPD without Asthma Supporting Information (for COPD without asthma follow asthma guidelines)

Hertfordshire Treatment Guidelines for COPD without Asthma Supporting Information (for COPD without asthma follow asthma guidelines) Hertfordshire Treatment Guidelines for COPD without Asthma Supporting Information (for COPD without asthma follow asthma guidelines) This document provides further background information to support the

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

Acute Care of COPD: Gaps in our knowledge. Robert A. Wise, M.D. May 20, 2010

Acute Care of COPD: Gaps in our knowledge. Robert A. Wise, M.D. May 20, 2010 Acute Care of COPD: Gaps in our knowledge Robert A. Wise, M.D. May 20, 2010 Outline of talk Importance of COPD exacerbations Current treatments Areas for improvement Significant knowledge gaps Strategies

More information

Management of exacerbations in chronic obstructive pulmonary disease in Primary Care

Management of exacerbations in chronic obstructive pulmonary disease in Primary Care Management of exacerbations in chronic obstructive pulmonary disease in Primary Care Acute exacerbations of chronic obstructive pulmonary disease (COPD) are associated with significant morbidity and mortality.

More information

COPD and Asthma Differential Diagnosis

COPD and Asthma Differential Diagnosis COPD and Asthma Differential Diagnosis Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death in America. Learning Objectives Use tools to effectively diagnose chronic obstructive

More information

COPD PROTOCOL CELLO. Leiden

COPD PROTOCOL CELLO. Leiden COPD PROTOCOL CELLO Leiden May 2011 1 Introduction This protocol includes an explanation of the clinical picture, diagnosis, objectives and medication of COPD. The Cello way of working can be viewed on

More information

TECHNIQUE TRAINING ON INHALERS

TECHNIQUE TRAINING ON INHALERS TECHNIQUE TRAINING ON INHALERS Donna Huynh, PharmD, BCPS, MA Assistant Professor University of Maryland School of Pharmacy Optimizing Medication Safety in Maryland Assisted Living Facilities March 17,

More information

2. Background This was the fourth submission for everolimus requesting listing for clear cell renal carcinoma.

2. Background This was the fourth submission for everolimus requesting listing for clear cell renal carcinoma. PUBLIC SUMMARY DOCUMENT Product: Everolimus, tablets, 5 mg and 10 mg, Afinitor Sponsor: Novartis Pharmaceuticals Australia Pty Ltd Date of PBAC Consideration: November 2011 1. Purpose of Application To

More information

Scottish Medicines Consortium. erdosteine 300mg capsules (Erdotin ) No. (415/07) Edmond Pharma Sr.l/Galen Ltd. 5 October 2007

Scottish Medicines Consortium. erdosteine 300mg capsules (Erdotin ) No. (415/07) Edmond Pharma Sr.l/Galen Ltd. 5 October 2007 Scottish Medicines Consortium erdosteine 300mg capsules (Erdotin ) No. (415/07) Edmond Pharma Sr.l/Galen Ltd. 5 October 2007 The Scottish Medicines Consortium has completed its assessment of the above

More information

Asthma POEMs. Patient Orientated Evidence that Matters

Asthma POEMs. Patient Orientated Evidence that Matters ASTHMA POEMs Asthma POEMs Patient Orientated Evidence that Matters Developed by the Best Practice Advocacy Centre Level 8, 10 George Street PO Box 6032 Dunedin Phone 03 4775418 Fax 03 4772622 Acknowledgement

More information

Laboratorios Almirall, S.A. and Forest Laboratories, Inc. complete Phase III Studies in COPD

Laboratorios Almirall, S.A. and Forest Laboratories, Inc. complete Phase III Studies in COPD Laboratorios Almirall, S.A. and Forest Laboratories, Inc. complete Phase III Studies in COPD BARCELONA, July 7th: Laboratorios Almirall, S.A. and Forest Laboratories, Inc. (NYSE: FRX) have announced that

More information

NIH Asthma Guidelines. Versus. Asthma: Cost Beyond Non-Compliance

NIH Asthma Guidelines. Versus. Asthma: Cost Beyond Non-Compliance Asthma: Cost Beyond Non-Compliance WILLIAM CRAWFORD, MD OCTOBER 24, 2014 Outpatient Management of Asthma NIH Asthma Guidelines-Based Care Stepping Up Controller Therapy Newer Treatments for Severe Asthma

More information

Ambulatory Asthma Management

Ambulatory Asthma Management Ambulatory Asthma Management Summary of Recommendations Algorithm Patient presents with symptoms of asthma Establish diagnosis and determine level of severity by H and P and spirometry. (A) Consider alternative

More information

Position Statement from the Irish Thoracic Society on the treatment of Idiopathic Pulmonary Fibrosis

Position Statement from the Irish Thoracic Society on the treatment of Idiopathic Pulmonary Fibrosis BACKGROUND Position Statement from the Irish Thoracic Society on the treatment of Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF) is a rare, chronic and fatal disease characterised by

More information

Is it safe to use long acting β agonists in asthma and chronic obstructive pulmonary disease? Implications of recent trials and meta analyses

Is it safe to use long acting β agonists in asthma and chronic obstructive pulmonary disease? Implications of recent trials and meta analyses Review article Is it safe to use long acting β agonists in asthma and chronic obstructive pulmonary disease? Implications of recent trials and meta analyses Malcolm R. Sears Firestone Institute for Respiratory

More information

Inside. Managing COPD and preventing progression. Diagnose early and identify those at risk

Inside. Managing COPD and preventing progression. Diagnose early and identify those at risk Managing COPD and preventing progression Chronic obstructive pulmonary disease (COPD) caused over 5000 deaths in Australia in 2003. 1 About one-third of people with the disease reported severe disability

More information

Subsidised Inhalers for Asthma or COPD New Zealand March SABA Short-Acting Beta2 Agonists

Subsidised Inhalers for Asthma or COPD New Zealand March SABA Short-Acting Beta2 Agonists SALBUTAMOL 100mcg/puff SABA Short-Acting Beta2 Agonists TERBUTALINE SALBUTAMOL nebuliser solution 2.5mg/2.5mL nebule 5mg/2.5mL nebule Respigen SalAir Salamol Ventolin Bricanyl Turbuhaler Asthalin SAMA

More information

GSK Medicine: Study Number: Title: Rationale: Study Period: Objectives Indication: Study Investigators/Centers: Research Methods Data Source:

GSK Medicine: Study Number: Title: Rationale: Study Period: Objectives Indication: Study Investigators/Centers: Research Methods Data Source: GSK Medicine: Study Number: 08257 Title: OCSIGEN study Longitudinal follow-up of a cohort of patients with asthma treated with inhaled corticosteroids in primary care Rationale: In the Post-Licensing File

More information

Chronic obstructive pulmonary disease (COPD) is a

Chronic obstructive pulmonary disease (COPD) is a 390Clinical Pharmacist December 2010 Vol 2 For patients with chronic obstructive pulmonary disease, inhaled medicines are the mainstay of treatment COPD management By Hasanin Khachi, DipClinPharm, MRPharmS,

More information

Clinical Guideline. Recommendation 3: For stable COPD patients with respiratory symptoms

Clinical Guideline. Recommendation 3: For stable COPD patients with respiratory symptoms Clinical Guideline Diagnosis and Management of Stable Chronic Obstructive Pulmonary Disease: A Clinical Practice Guideline Update from the American College of Physicians, American College of Chest Physicians,

More information

RES/006/APR16/AR. Speaker : Dr. Pither Sandy Tulak SpP

RES/006/APR16/AR. Speaker : Dr. Pither Sandy Tulak SpP RES/006/APR16/AR Speaker : Dr. Pither Sandy Tulak SpP Definition of Asthma (GINA 2015) Asthma is a common and potentially serious chronic disease that imposes a substantial burden on patients, their families

More information

Clinical Guideline. Recommendation 3: For stable COPD patients with respiratory symptoms

Clinical Guideline. Recommendation 3: For stable COPD patients with respiratory symptoms Clinical Guideline Diagnosis and Management of Stable Chronic Obstructive Pulmonary Disease: A Clinical Practice Guideline Update from the American College of Physicians, American College of Chest Physicians,

More information

Determinants of Spirometry Use and Accuracy of COPD Diagnosis in Primary Care

Determinants of Spirometry Use and Accuracy of COPD Diagnosis in Primary Care MS #10217r1 Determinants of Spirometry Use and Accuracy of COPD Diagnosis in Primary Care Running title: Spirometry and COPD in primary care Min J Joo MD MPH 1,2, David H Au MD MS 3,4, Marian L Fitzgibbon

More information

New Australian asthma guidelines

New Australian asthma guidelines New Australian asthma guidelines The National Asthma Council 2014 Australian Asthma Handbook has important changes that every pharmacist should be aware of. Some of the key changes in the Australian Asthma

More information

Glucocorticoids, Inhaled Therapeutic Class Review (TCR)

Glucocorticoids, Inhaled Therapeutic Class Review (TCR) Glucocorticoids, Inhaled Therapeutic Class Review (TCR) July 31, 2015 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying,

More information

Asthma Update. Disclosure. Marium Mariko Yabe-Gill, MD, MBBS Assistant Professor Pediatric Pulmonology/Allergy. No conflict of interest.

Asthma Update. Disclosure. Marium Mariko Yabe-Gill, MD, MBBS Assistant Professor Pediatric Pulmonology/Allergy. No conflict of interest. Asthma Update Marium Mariko Yabe-Gill, MD, MBBS Assistant Professor Pediatric Pulmonology/Allergy Disclosure No conflict of interest Objective Asthma diagnosis and management ( National Asthma Education

More information

Differential effects of maintenance long-acting b-agonist and inhaled corticosteroid on asthma control and asthma exacerbations

Differential effects of maintenance long-acting b-agonist and inhaled corticosteroid on asthma control and asthma exacerbations Differential effects of maintenance long-acting b-agonist and inhaled corticosteroid on asthma control and asthma exacerbations Peter G. Gibson, MBBS(Hons), FRACP, a,b,d Heather Powell, MMedSci, a,d and

More information

Greater Manchester COPD Management Plan

Greater Manchester COPD Management Plan Greater Manchester COPD Management Plan Inhaler therapy options for patients with COPD Non-pharmacological options for ALL patients, consider at all stages (please see page 3): Inhaler technique Encourage

More information

Objectives. Internal Medicine Board Review Asthma. Emily DiMango, MD. Asthma Is Prevalent: Significant Morbidity and Mortality

Objectives. Internal Medicine Board Review Asthma. Emily DiMango, MD. Asthma Is Prevalent: Significant Morbidity and Mortality Internal Medicine Board Review Asthma Emily DiMango, MD Director John Edsall/John Wood Asthma Center Columbia University Medical Center Objectives Review asthma epidemiology Asthma pathophysiology/definition

More information

2008 New Jersey Academy of Family Physicians

2008 New Jersey Academy of Family Physicians Chronic Obstructive Pulmonary Disease: Using Spirometry to Diagnose COPD in the Family Physician Office An evidence-based CME program developed by the New Jersey Academy of Family Physicians 2008 New Jersey

More information

Diagnosis of COPD. COPD: Preventable and Treatable. Financial Disclosures. Lecture Outline. COPD: Defining Terms

Diagnosis of COPD. COPD: Preventable and Treatable. Financial Disclosures. Lecture Outline. COPD: Defining Terms COPD: Preventable and Treatable Christopher H. Fanta, MD Partners Asthma Center Pulmonary and Critical Care Division Brigham and Women s Hospital Harvard Medical School Financial Disclosures Christopher

More information

Leukotriene receptor antagonists: Montelukast and zafirlukast

Leukotriene receptor antagonists: Montelukast and zafirlukast Bulletin 61 February 2014 2.0 Leukotriene receptor antagonists: Montelukast and zafirlukast Across the PrescQIPP membership (20.2 million patients, November 2013), annual spend for the leukotriene receptor

More information

5 Relationship between asthma medication classes

5 Relationship between asthma medication classes 5 Relationship between asthma medication classes Key points Individuals who were dispensed more prescriptions for inhaled were also more likely to be dispensed more prescriptions for other classes of asthma

More information

An Update on the Management of Stable Chronic Obstructive Pulmonary Disease

An Update on the Management of Stable Chronic Obstructive Pulmonary Disease An Update on the Management of Stable Chronic Obstructive Pulmonary Disease Fei Wang, M.Sc., Pharm.D., BCPS, FASHP University of Connecticut School of Pharmacy Fei.wang@uconn.edu Learning Objectives 1.

More information

Chronic obstructive pulmon -

Chronic obstructive pulmon - Don D. Sin, MD, MPH, FRCPC Pharmacological management of stable chronic obstructive pulmonary disease Once the severity of a patient s COPD has been quantified by spirometry, appropriate agents including

More information

Classifying Asthma Severity and Initiating Treatment in Children 0 4 Years of Age

Classifying Asthma Severity and Initiating Treatment in Children 0 4 Years of Age Classifying Asthma Severity and Initiating Treatment in Children 0 4 Years of Age Components of Severity Symptoms Intermittent 2 days/week Classification of Asthma Severity (0 4 years of age) Persistent

More information

GSK Respiratory Committed to a brighter future for people with respiratory disease

GSK Respiratory Committed to a brighter future for people with respiratory disease GSK Respiratory Committed to a brighter future for people with respiratory disease First Mission Improve Alliance Leadership Community Medicines Impact Healthcare Patients Professional Partnerships Initiative

More information

In November 2005, the US Food and Drug

In November 2005, the US Food and Drug A W H I T E P A P E R O N I S S U E S I N A S T H M A M A N A G E M E N T This supplement to THE JOURNAL OF FAMILY PRACTICE is supported by a grant from Schering Plough. It was developed by the Primary

More information

Medicines Management of Chronic Obstructive Pulmonary Disease (COPD)

Medicines Management of Chronic Obstructive Pulmonary Disease (COPD) Medicines Management of Chronic Obstructive Pulmonary Disease (COPD) (Chronic & Acute) Guidelines for Primary Care Guideline Authors: Shaneez Dhanji (Wandsworth CCG) Samantha Prigmore (St George s Hospital)

More information

Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment Guidance for Industry

Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment Guidance for Industry Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions

More information

Confirming Diagnosis Through Spirometry

Confirming Diagnosis Through Spirometry Confirming Diagnosis Through Spirometry Shirley F. Jones, M.D., FCCP I have no conflicts of interest Instructional Objectives At the end of this session, learners will be able to: Select individual patients

More information

The effect of adding inhaled corticosteroids to tiotropium and long-acting beta 2 -agonists for chronic obstructive pulmonary disease (Review)

The effect of adding inhaled corticosteroids to tiotropium and long-acting beta 2 -agonists for chronic obstructive pulmonary disease (Review) The effect of adding inhaled corticosteroids to tiotropium and long-acting beta 2 -agonists for chronic obstructive pulmonary disease Karner C, Cates CJ This is a reprint of a Cochrane review, prepared

More information

CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION

CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION MEPOLIZUMAB (Nucala GlaxoSmithKline Inc.) Indication: Severe eosinophilic asthma Recommendation: The CADTH Canadian Drug Expert Committee (CDEC)

More information

Pharmacy Management Drug Policy

Pharmacy Management Drug Policy PAGE: Page 1 of 5 DESCRIPTION: Asthma is a heterogeneous syndrome that might be better described as a constellation of phenotypes, each with distinct cellular and molecular mechanisms, rather than as a

More information

Cost-effectiveness of Pirfenidone (Esbriet ) for the treatment of Idiopathic Pulmonary Fibrosis.

Cost-effectiveness of Pirfenidone (Esbriet ) for the treatment of Idiopathic Pulmonary Fibrosis. Cost-effectiveness of Pirfenidone (Esbriet ) for the treatment of Idiopathic Pulmonary Fibrosis. March 2013 1. Pirfenidone is indicated in adults for the treatment of mild to moderate Idiopathic Pulmonary

More information

PHARMAC responds on long-acting inhalers for COPD

PHARMAC responds on long-acting inhalers for COPD Vol 118 No 1225 ISSN 1175 8716 PHARMAC responds on long-acting inhalers for COPD Dr David Jones has recently written in the Journal (http://www.nzma.org.nz/journal/118-1222/1669) 1 about access to long-acting

More information

Progress in Treating Disease: The Case of Asthma

Progress in Treating Disease: The Case of Asthma 13TH EUROPEAN HEALTH FORUM CHRONIC RESPIRATORY DISEASES: A NEGLECTED EPIDEMICS GASTEIN 7 OCTOBER 2010 Progress in Treating Disease: The Case of Asthma Leonardo M. Fabbri Clinica di Malattie dell Apparato

More information

Drug therapy SHORT-ACTING BETA AGONISTS SHORT-ACTING ANTICHOLINERGICS LONG-ACTING BETA AGONISTS LONG-ACTING ANTICHOLINERGICS

Drug therapy SHORT-ACTING BETA AGONISTS SHORT-ACTING ANTICHOLINERGICS LONG-ACTING BETA AGONISTS LONG-ACTING ANTICHOLINERGICS Drug therapy 6 6.1 What is the role of bronchodilators in COPD? 52 SHORT-ACTING BETA AGONISTS 6.2 How do short-acting beta agonists work? 52 6.3 What are the indications for their use? 52 6.4 What is the

More information

STAYING ASTHMA FREE. All you need to know about preventers. www.spacetobreathe.co.nz

STAYING ASTHMA FREE. All you need to know about preventers. www.spacetobreathe.co.nz STAYING ASTHMA FREE All you need to know about preventers www.spacetobreathe.co.nz HELPING YOUR CHILD BREATHE MORE EASILY GETTING TO KNOW THE PREVENTER What is a preventer? When do you use it? How do they

More information

Bronchial thermoplasty for severe asthma

Bronchial thermoplasty for severe asthma Severe Refractory Asthma Meeting, Leuven, Belgium 20 th February 2014 Bronchial thermoplasty for severe asthma Professor Neil C Thomson Institute of Infection, Immunity & Inflammation University of Glasgow

More information

Global Strategy for the Diagnosis, Management and Prevention of COPD 2016 Clinical Practice Guideline. MedStar Health

Global Strategy for the Diagnosis, Management and Prevention of COPD 2016 Clinical Practice Guideline. MedStar Health Global Strategy f the Diagnosis, Management and Prevention of COPD 2016 Clinical Practice Guideline MedStar Health These guidelines are provided to assist physicians and other clinicians in making decisions

More information

Chronic obstructive pulmonary disease. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study

Chronic obstructive pulmonary disease. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study Eur Respir J 212; 4: 83 836 DOI: 1.1183/931936.225511 CopyrightßERS 212 Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study Paul W. Jones*, Dave Singh, Eric D. Bateman

More information

Update in ASTHMA: Clearing the Air What Works and What Doesn t? Blair Brooks MD Dartmouth Hitchcock Medical Center COOP Meeting Pre Workshop 2/04/05

Update in ASTHMA: Clearing the Air What Works and What Doesn t? Blair Brooks MD Dartmouth Hitchcock Medical Center COOP Meeting Pre Workshop 2/04/05 Update in ASTHMA: Clearing the Air What Works and What Doesn t? Blair Brooks MD Dartmouth Hitchcock Medical Center COOP Meeting Pre Workshop 2/04/05 Knowing is not enough: we must apply. Willing is not

More information

Severe asthma Definition, epidemiology and risk factors. Mina Gaga Athens Chest Hospital

Severe asthma Definition, epidemiology and risk factors. Mina Gaga Athens Chest Hospital Severe asthma Definition, epidemiology and risk factors Mina Gaga Athens Chest Hospital Difficult asthma Defined as asthma, poorly controlled in terms of chronic symptoms, with episodic exacerbations,

More information

Inhaled corticosteroid therapy for patients with persistent asthma: Learnings from studies of inhaled budesonide DO NOT COPY

Inhaled corticosteroid therapy for patients with persistent asthma: Learnings from studies of inhaled budesonide DO NOT COPY Inhaled corticosteroid therapy for patients with persistent asthma: Learnings from studies of inhaled budesonide Bradley E. Chipps, M.D. ABSTRACT Inhaled corticosteroids (ICSs) are recommended for patients

More information

To Air is Human, To Not Wheeze Divine

To Air is Human, To Not Wheeze Divine To Air is Human, To Not Wheeze Divine Obstructive Lung Disease in The Elderly Meyer Balter, MD, FRCPC Mount Sinai Hospital University of Toronto Disclosure Statements I have served on advisory boards for:

More information

TB and COPD 衛生福利部胸腔病院 張祐泟醫師

TB and COPD 衛生福利部胸腔病院 張祐泟醫師 TB and COPD 衛生福利部胸腔病院 張祐泟醫師 COPD is estimated to affect 65 million people worldwide COPD predicted to be third leading cause of death in 2030 3 million deaths annually 90 % of these deaths are in low-

More information

MEDICAL POLICY STATEMENT

MEDICAL POLICY STATEMENT MEDICAL POLICY STATEMENT Original Effective Date Next Annual Review Date Last Review / Revision Date 06/15/2011 02/15/2017 03/09/2016 Policy Name Policy Number Xolair/Nucala SRx-0013 Policy Type Medical

More information

Glucocorticoids, Inhaled Therapeutic Class Review (TCR) February 7, 2012

Glucocorticoids, Inhaled Therapeutic Class Review (TCR) February 7, 2012 Glucocorticoids, Inhaled Therapeutic Class Review (TCR) February 7, 2012 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying,

More information

Clinical Practice Guideline for the Management of Asthma in Children and Adults

Clinical Practice Guideline for the Management of Asthma in Children and Adults Clinical Practice Guideline for the Management of Asthma in Children and Adults Assessment: A critical aspect of the diagnosis and management of asthma is the precise and periodic measurement of lung function

More information