Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice)

Size: px
Start display at page:

Download "Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice)"

Transcription

1 Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) This drug has been reviewed because it is a product that may be prescribed in primary care. Medicine Roflumilast (Daxas, Nycomed) Document status Reviewed at NHS Suffolk Drug and Therapeutics Committee meeting July 15 th 2010 Date of last revision September 2010 Traffic light decision Blue initiated in Primary Care Clinical priorities Double Red- not to be prescribed in NHS Suffolk. group decision Prescribers rating Judgement reserved-the committee postpones its judgement until better data and a more thorough evaluation of the drug are available Mechanism of action Licensed indication Roflumilast is a long-acting selective phosphodiesterase-4 (PDE4) inhibitor which relieves the underlying symptoms of Chronic Obstructive Pulmonary Disease (COPD) through an anti-inflammatory effect. It acts by inhibiting the synthesis of leukotriene B4 and reactive oxygen species in neutrophils, as well as inhibition of TNF-α release by mononuclear cells. Roflumilast also inhibits T-cell proliferation, cytokine production, and cell infiltration of the lungs. (1,2) Roflumilast has been submitted for an EU license for the treatment of COPD. In April 2010, the committee for Medicinal Products for Human Use (CHMP) recommended that roflumilast be granted marketing authorisation for the maintenance treatment of severe COPD (FEV1 post-bronchodilator <50% predicted) associated with chronic bronchitis in adult patients as an add-on to bronchodilator treatment. (3) In the USA in April 2010, an advisory panel to the FDA voted 10-5 against recommending the approval of roflumilast for COPD see points for consideration section. (4) Dosage 500mcg orally ONCE a day (1,2,3) Treatment alternatives Inhaled bronchodilator therapy - Short-acting beta 2 agonist e.g.salbutamol - Short acting antimuscarinic e.g. ipratropium - Long-acting beta 2 agonist e.g. salmeterol - Long acting antimuscarinic e.g. tiotropium Theophylline slow release formulations

2 Place in therapy Future alternatives Evidence for use Corticosteroids - Inhaled corticosteroid (ICS) e.g. beclometasone dipropionate not licensed for use alone in COPD Or a combination of the above. (1) The place of roflumilast in the management of patients with COPD is uncertain. Further studies are required to establish whether roflumilast (in addition to inhaled bronchodilator treatment) offers any meaningful advantages as an alternative, or in addition, to an ICS. (1) Roflumilast has not been considered in the updated NICE COPD clinical guideline, due for publication in June 2010, but is included in the list of proposed technology appraisals. (2) None known at present There have been 4 key clinical trials (see appendix 1 for details). (5,6) AURA and HERMES were one-year randomised, double-blind clinical trials (total N=3,091), in symptomatic patients with mainly severe or very severe COPD. Roflumilast reduced the number of moderate-to severe exacerbations compared to placebo and improved lung function (increasing FEV1 by 48mL). Long-acting anti-cholinergics and inhaled corticosteroids (ICS) were not allowed during these trials. (5) In two 24-week randomised, double blind trials (EOS N=933, and HELIOS N=742) of patients with moderate to severe COPD, roflumilast combined with either salmeterol or tiotropium improved FEV1 compared to placebo plus either salmeterol or tiotropium (by 49mL and 80mL, respectively). (6) Critical Appraisal (2) The focused selection criteria of the patients enrolled in the studies restricts the generalisability of the results of these studies. The functional benefits of the improvements in lung function or the patients' health status were not addressed in either paper. The design of the studies (i.e. addition of roflumilast to salmeterol or tiotropium), does not allow a direct comparison of the two long-acting bronchodilators when administered with roflumilast. There is no information available about the efficacy of

3 roflumilast when added to inhaled corticosteroids and longacting bronchodilators. Cautions / side effects NNT/NNH Costs Costs of alternatives for 28 days treatment (MIMS, June 2010) Potential number of patients in NHS Suffolk If roflumilast is not more efficacious than inhaled corticosteroids (when added to long-acting inhaled bronchodilators) in reducing COPD exacerbations, the side-effect profile will need to be weighed against the increased risk of pneumonia when inhaled corticosteroids are used in patients with COPD. From the pooled AURA/HERMES trial results, more roflumilast patients reported adverse events, compared to placebo (67% vs. 62%, p value not quoted). Diarrhoea and weight loss were more common in roflumilast patients 14% of roflumilast and 11% of placebo patients withdrew from treatment due to adverse events (mainly diarrhoea, nausea and headache). These were more likely to occur in roflumilast patients in the first 12 weeks. (2,5) In EOS, adverse events were reported by 63% of patients in the salmeterol plus roflumilast arm compared to 59% of patients in the salmeterol plus placebo arm. In HELIOS, 46% of tiotropium plus roflumilast patients patients and 41% of tiotropium plus placebo patients reported adverse events (p values not quoted). (5) Weight loss, nausea and diarrhoea were more common in patients who received roflumilast. The NNH for withdrawal due to an adverse event was approximately 15 in EOS and 29 in HELIOS, over 24 weeks. (2, 6) NNT=5 to prevent one exacerbation over one year NNH 35 over one year for withdrawal due to an adverse event. The cost of roflumilast is not yet known but expected to be similar to the cost of tiotropium. (2) Drug / device (dose) Cost (30 days) Salmeterol (Serevent Accuhaler) µg twice daily Tiotropium (Spiriva Handihaler) 18µg once daily (Respimat) 5mcg Refill Fomoterol 12mcg twice daily (dry powder or aerosol) An average GP practice of 6,600 patients is likely to have about 100 patients on its COPD disease register. The manufacturer of roflumilast estimates that approximately 25% of COPD patients would meet the anticipated licence criteria. (2) With approximately 600,000 people in NHS Suffolk, there may be about 9000 people with COPD. Of these 2250 people may be eligible for treatment with roflumilast.

4 Points for consideration (1) The manufacturer estimate a budget impact of 4,491 per 100,000 in 2010 and 8,981 in Therefore given the population of NHS Suffolk of 581,797, the budget impact is estimated to be 26,129 in 2010 and 52,251 in The proposed indication for roflumilast is the maintenance treatment of severe COPD (FEV1 <50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. In the trials 'bronchotic symptoms' referred to chronic cough and sputum production. Therefore, only these specific patients should be considered if roflumilast reaches the market. There is no standard definition of an exacerbation. Change in FEV1 should be a minimum of 120ml to be clinically significant These studies do not inform about whether roflumilast (in addition to inhaled bronchodilator treatment) provides any significant benefit when used instead of, or in addition to, an ICS [inhaled corticosteroid] the current NICE recommended treatment option. It is not possible to extrapolate the results of these trials to patients in the real world. Many patients in the trials were already receiving an ICS prior to enrolment, which was discontinued. Trials of longer duration are necessary to assess long-term efficacy and safety. Oral, once daily, treatment may have advantages in terms of ease of use and compliance. Further studies are required to establish whether roflumilast offers any meaningful advantages as an alternative, or in addition to an inhaled steroid. There is insufficient evidence to justify the use of roflumilast ahead or instead of inhaled corticosteroids, for those people who remain symptomatic or suffer exacerbations on optimal bronchodilator therapy (long acting beta-agonists and or tiotropium). Any possible benefits of roflumilast have to be balanced against the possibility of adverse effects. An advisory panel to the FDA voted in April 2010 against recommending approval of roflumilast for COPD. They did

5 Decisions sought from other bodies Decision review date acknowledge that the drug appears safe and effective but concluded the company had provided insufficient evidence to support approval of the drug in the US. The FDA reviewers said roflumilast produced only a modest improvement in lung function and urged the panel to weigh that against concerns about severe diarrhoea, weight loss, cancer, psychiatric problems and suicides among people who took roflumilast in studies. The company said there was no evidence that the drug caused the suicides or raised the risk of cancer and the other risks were manageable. (4) Cambridgeshire JPG not assessed Norfolk TAG not assessed IHT not assessed WSH not assessed SMC not assessed AWMSG not assessed TBC This review is based on the NPC Review published in March 2010 (2) References 1. National Horizon Scanning Centre, University of Birmingham, August Roflumilast (Daxa) for chronic obstructive pulmonary disease. Available via 2. Roflumilast for chronic obstructive pulmonary disease (COPD). On the Horizon Future Medicines, March Available via 3. Daxas. Roflumilast. Summary of positive opinion. European Medicines Agency 22 April 2010 EMA/CHMP/159861/2010 Committee for medicinal products for human use (CHMP). Available via 4. Advisory panel votes against approving roflumilast for COPD in the United States: PharmaTimes, Reuters Health. Available via 5. Calverly P at al. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet 2009;374: Fabbri L et al. For the M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with long acting bronchodialtors: two randomised clinical trials. Lancet 2009:374: Prescribing Impact Resource Template for Roflumilast (Daxas) for Chronic Pulmonary Disease (COPD). A resource for NHS Budget Holders. Received from Nycomed Medical Information June 2010

6

7 Appendix 1; Key Clinical Trials Trial Trial Design Trial Population M2-124 HERMES (HERMES) N=772 M2-125 roflumilast (AURA) (5) 2 Phase II international, multi-centre, randomised, placebo-controlled trials of 52 weeks duration. Identical designs in 2 different geographical locations. Analysis was by intention to treat and allocation was concealed. Stratified according to smoking status and treatment with long acting beta 2 agonists. N= 796 placebo AURA N=765 roflumilast N= 758 placebo Patients were aged over 40 years, with severe airflow limitation, bronchotic symptoms, and a history of exacerbations. Treatment Roflumilast 500µg daily or placebo Primary Outcomes The primary endpoints were change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) and the rate of exacerbations that were moderate (glucocorticosteroid-treated) or severe. The primary outcomes; effects on exacerbation rates and pulmonary function (FEV1) were achieved. In pooled analysis, pre-bronchodilator FEV1 increased by a modest 48mL with roflumilast vs. placebo ([95% CI 35mL to 62mL] (p<0.0001). Individual results for AURA and HERMES were 39mL and 58mL respectively. There was a mean reduction in the rate of moderate (i.e. requiring oral corticosteroids or parenteral corticosteroids) or severe (i.e. resulting in hospital admissions or death) from 1.37 per year to 1.14 per year (rate ratio RR 0.83; 95% CI 0.75 to 0.92; p = ) with roflumilast a reduction of 0.23 exacerbations per year. (NNT 5 to prevent 1 exacerbation in a year). The rate of exacerbations that were moderate or severe per patient year was 1.14 with roflumilast and 1.37 with placebo (reduction 17% [8-25]; p<0.003). AEs were more common with roflumilast (1040 [67%]) than with placebo (963 [62%]). 219 (14%) patients on roflumilast vs. 177

8 (12%) on placebo discontinued treatment because of AEs. M2-127 (EOS) M2-128 (HELIOS) (6) 2 supporting randomised controlled trials of 24 weeks duration. Patients were randomised after a 4 week run in. N = 933 (M2-127) N = 742 (M2-128) Patients were aged over 40 years, with moderate to severe COPD already being treated with salmeterol or tiotropium Roflumilast 500mcg daily or placebo This was in addition to salmeterol (M2-127) or tiotropium (M2-128). The difference in weight change during the study between the roflumilast and placebo group was kg. The primary outcome was change in pre-bronchodilator FEV1 and rates of exacerbations in order to confirm the efficacy of roflumilast when used with standard bronchodilator therapies. Compared with placebo, roflumilast consistently improved mean prebronchodialtor FEV1 by 49 ml (95% CI 27 71; p<0.0001) in patients treated with salmeterol, and 80ml (95% CI ; p<0.0001) in those treated with tioproium. Similar improvement in post-bronchodilator FEV1 was noted in both groups. Patients in the HELIOS study were more symptomatic than in EOS, and used more as-needed medication. The salmeterol plus roflumilast trial involved 466 patients on roflumilast and 467 on placebo; in the tiotropium plus roflumilast trial, 371 patients received Nausea, diarrhoea, weight loss and to a lesser extent, headache were more frequent in patients in the roflumilast group. Discontinuations due to adverse events were more common with roflumilast than placebo (significant in AURA HERMES and EOS).

9 roflumilast and 372 placebo. Grids used to assist the NHS Suffolk PCT Drug & Therapeutics Committee in reaching a decision about new medications For many years scientists have recognised two types of research: Primary: original studies, based on observation or experimentation on subjects. Secondary: reviews of published research, drawing together the findings of two or more primary studies. In biomedical science there is general agreement over a hierarchy: the higher up a methodology is ranked, the more robust and closer to objective truth it is assumed to be. The orthodox hierarchy looks something like this- Rank: Methodology Description 1 Systematic reviews and meta-analyses Systematic review: review of a body of data that uses explicit methods to locate primary studies, and explicit criteria to assess their quality. Meta-analysis: A statistical analysis that combines or integrates the results of several independent clinical trials considered by the analyst to be "combinable" usually to the level of re-analysing the original data, also sometimes called: pooling, quantitative synthesis. Both are sometimes called "overviews." 2 Randomised controlled trials (finer distinctions may be drawn within this group based on statistical parameters like the confidence intervals) Individuals are randomly allocated to a control group and a group who receive a specific intervention. Otherwise the two groups are identical for any significant variables. They are followed up for specific end points. 3 Cohort studies Groups of people are selected on the basis of their exposure to a particular agent and followed up for specific outcomes.

10 4 Case-control studies "Cases" with the condition are matched with "controls" without, and a retrospective analysis used to look for differences between the two groups. 5 Cross sectional surveys Survey or interview of a sample of the population of interest at one point in time 6 Case reports. A report based on a single patient or subject; sometimes collected together into a short series 7 Expert opinion A consensus of experience from the good and the great. 8 Anecdotal Something a bloke told you after a meeting or in the bar. Adapted from Systematic reviews, What are they and why are they useful? ScHARR 2008 To Decide if a Medication Is To Be Used In Suffolk Criterion to be measured Tends to poor 2 Medium 4 Tends to good Quality of evidence in the papers reviewed Magnitude of effect inferred from trials reviewed Low x Medium High Are trial end-points surrogate markers or clinical outcomes? Clinical outcomes Clinical usefulness of trial end-points x Known Side Effect Profile High Medium Low Known Interactions High Medium Low Concern re Possible Side Effects Not Yet Uncovered High x Medium Low Balance of Benefit To Harm (side effects toxicity interactions etc) Poor Medium Good NNT High x Medium Low Comparison Of Effectiveness With Other Medicines In Use For The Poor Medium Good Same Condition Severity of Condition to be Treated Trivial Medium Severe Novel drug or member of existing class Uptake (estimated proportion of people with this condition likely to be prescribed the medication under consideration maximum and minimum uptake) Is the drug to be used in Suffolk? Member of existing class 10 to 20% of COPD patients yes

11 Prescriber s Rating Definitions Bravo! -The drug is a major therapeutic advance in an area where previously no treatment was available. A real advance - The product is an important therapeutic innovation but has certain limitations. Offers an advantage - The product has some value but does not fundamentally change present therapeutic practice. Possibly Helpful - The product has minimal additional value, and should not change prescribing habits except in rare circumstances. Judgement reserved - The Committee postpones its judgement until better data and a more thorough evaluation of the drug are available. Nothing New - The product may be a new substance but is superfluous because it does not add to the clinical possibilities offered by previous products available. In most cases these are me-too products. Not acceptable - Product without evident benefit over others but with potential or real disadvantages. (With acknowledgement to Prescrire) To Decide Where A Medication Is To Be Used In Suffolk Skills of the prescriber Criterion Red Amber Green Blue Experience Of The Condition Specific Specific Specific General Diagnosis Specific Specific Specific General Monitoring Progress Of Treatment Difficult Specific General General Therapy Patient Selection Difficult Specific Specific Easy Initiation Of Treatment Difficult Difficult Easy Easy Dose Titration Difficult Specific Easy Easy Monitoring Of Side Effects Complex Easy Easy Easy Method Of Administration Complex Normal Normal Normal Discontinuation Of Treatment Complex Complex Easy Easy References Jonsen A. Bentham in a box: Technology assessment and health care allocation. Law Med. Health Care. 1986;14: Suffolk Drug & Therapeutics Committee Responsibility for prescribing, Hospital Trust or GP Attached as Appendix 1 & Appendix 2 Grids used to assist the NHS Suffolk PCT Drug & Therapeutics Committee in reaching a decision about new medications

12 For many years scientists have recognised two types of research: Primary: original studies, based on observation or experimentation on subjects. Secondary: reviews of published research, drawing together the findings of two or more primary studies. In biomedical science there is general agreement over a hierarchy: the higher up a methodology is ranked, the more robust and closer to objective truth it is assumed to be. The orthodox hierarchy looks something like this-

NHS Suffolk Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice)

NHS Suffolk Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) NHS Suffolk Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) This drug has been reviewed because it is a product that may be prescribed in primary

More information

Roflumilast (Daxas) for chronic obstructive pulmonary disease

Roflumilast (Daxas) for chronic obstructive pulmonary disease Roflumilast (Daxas) for chronic obstructive pulmonary disease August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended

More information

roflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd

roflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd roflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd 06 August 2010 (Issued 10 September 2010) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product

More information

Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice)

Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) This drug has been reviewed because it is a product that may be prescribed in primary

More information

Medicine Review. Medicine / Trade name Azelastine and fluticasone / Dymista Manufacturer

Medicine Review. Medicine / Trade name Azelastine and fluticasone / Dymista Manufacturer East & South East England Specialist Pharmacy Services East of England, London, South Central & South East Coast East Anglia Medicines Information Service Medicine Review Medicine / Trade name Azelastine

More information

Lead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984]

Lead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984] Lead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984] 1 st Appraisal Committee meeting Background & Clinical Effectiveness John McMurray 11 th January 2016 For

More information

Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and futher notice)

Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and futher notice) Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and futher notice) This drug has been reviewed because it is a product that may be prescribed in primary care.

More information

Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice)

Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) This drug has been reviewed because it is a product that may be prescribed in primary

More information

aclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A.

aclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A. aclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A. 05 October 2012 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and

More information

Sitagliptin. Agreed by Clinical Priorities Group

Sitagliptin. Agreed by Clinical Priorities Group New Medicine Report Document Status Sitagliptin Agreed by Clinical Priorities Group Traffic Light Decision Blue- Primary Care Prescriber s Rating Offers an advantage - The product has some value but does

More information

Suffolk PCT Drug & Therapeutics Committee New Medicine Report

Suffolk PCT Drug & Therapeutics Committee New Medicine Report Suffolk PCT Drug & Therapeutics Committee New Medicine Report This drug has been reviewed because it is a product that may be prescribed in primary care. Medicine Nalmefene (Selincro, Lundbeck) Document

More information

TORCH: Salmeterol and Fluticasone Propionate and Survival in COPD

TORCH: Salmeterol and Fluticasone Propionate and Survival in COPD TORCH: and Propionate and Survival in COPD April 19, 2007 Justin Lee Pharmacy Resident University Health Network Outline Overview of COPD Pathophysiology Pharmacological Treatment Overview of the TORCH

More information

umeclidinium/vilanterol, 55/22 micrograms, inhalation powder (Anoro ) SMC No. (978/14) GlaxoSmithKline

umeclidinium/vilanterol, 55/22 micrograms, inhalation powder (Anoro ) SMC No. (978/14) GlaxoSmithKline umeclidinium/vilanterol, 55/22 micrograms, inhalation powder (Anoro ) SMC No. (978/14) GlaxoSmithKline 04 July 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product

More information

Roflumilast for the management of severe chronic obstructive pulmonary disease

Roflumilast for the management of severe chronic obstructive pulmonary disease Roflumilast for the management of severe chronic obstructive pulmonary disease Issued: January 2012 guidance.nice.org.uk/ta244 NICE has accredited the process used by the Centre for Health Technology Evaluation

More information

Roflumilast for the management of severe chronic obstructive pulmonary disease

Roflumilast for the management of severe chronic obstructive pulmonary disease Roflumilast for the management of severe chronic obstructive pulmonary disease Issued: January 2012 www.nice.org.uk/ta244 NHS Evidence has accredited the process used by the Centre for Health Technology

More information

Re-Submission. roflumilast, 500 microgram, film-coated tablet (Daxas ) SMC No 635/10 AstraZeneca UK Ltd. Published 11 September

Re-Submission. roflumilast, 500 microgram, film-coated tablet (Daxas ) SMC No 635/10 AstraZeneca UK Ltd. Published 11 September Re-Submission roflumilast, 500 microgram, film-coated tablet (Daxas ) SMC No 635/10 AstraZeneca UK Ltd 4 August 2017 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product

More information

umeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline

umeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline umeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline 07 November 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product

More information

CEDAC FINAL RECOMMENDATION

CEDAC FINAL RECOMMENDATION CEDAC FINAL RECOMMENDATION ROFLUMILAST (Daxas Nycomed Canada Inc.) Indication: Chronic Obstructive Pulmonary Disease Recommendation: The Canadian Expert Drug Advisory Committee (CEDAC) recommends that

More information

Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice)

Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) This drug has been reviewed because it is a product that may be prescribed in primary

More information

glycopyrronium 44 micrograms hard capsules of inhalation powder (Seebri Breezhaler ) SMC No. (829/12) Novartis Pharmaceuticals Ltd.

glycopyrronium 44 micrograms hard capsules of inhalation powder (Seebri Breezhaler ) SMC No. (829/12) Novartis Pharmaceuticals Ltd. glycopyrronium 44 micrograms hard capsules of inhalation powder (Seebri Breezhaler ) SMC No. (829/12) Novartis Pharmaceuticals Ltd. 07 December 2012 The Scottish Medicines Consortium (SMC) has completed

More information

New Medicine Report (Adopted by the CCG until review and further

New Medicine Report (Adopted by the CCG until review and further New Medicine Report (Adopted by the CCG until review and further DEXIBUPROFEN notice) Document Status Decision made at Suffolk D&TC 7 th September 2006 Traffic Light Decision Double Green Prescriber s

More information

Suffolk PCT Drug & Therapeutics Committee New Medicine Report

Suffolk PCT Drug & Therapeutics Committee New Medicine Report Suffolk PCT Drug & Therapeutics Committee New Medicine Report This drug has been reviewed because it is a product that may be prescribed in primary care. Medicine Prolonged release (PR) oxycodone & PR

More information

Turning Science into Real Life Roflumilast in Clinical Practice. Roland Buhl Pulmonary Department Mainz University Hospital

Turning Science into Real Life Roflumilast in Clinical Practice. Roland Buhl Pulmonary Department Mainz University Hospital Turning Science into Real Life Roflumilast in Clinical Practice Roland Buhl Pulmonary Department Mainz University Hospital Therapy at each stage of COPD I: Mild II: Moderate III: Severe IV: Very severe

More information

Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice)

Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) Suffolk PCT Drug & Therapeutics Committee New Medicine Report (Adopted by the CCG until review and further notice) This drug has been reviewed because it is a product that may be prescribed in primary

More information

BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE

BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE December 2014 Review Date: December 2017 Bulletin 206 : DuoResp Spiromax 160 / 4.5 and 320 / 9 budesonide & formoterol dry powder inhaler JPC Recommendations

More information

NHS Dumfries & Galloway Triple therapy in COPD patients over 16 years

NHS Dumfries & Galloway Triple therapy in COPD patients over 16 years Title of Project: NHS Dumfries & Galloway Triple therapy in COPD patients over 16 years 1 Reason for the review Respiratory prescribing is long term and can be costly. Appropriate choice and use of inhaled

More information

Medicine Review (Adopted by the CCG until review and further notice) Medicine

Medicine Review (Adopted by the CCG until review and further notice) Medicine East & South East England Specialist Pharmacy Services East of England, London, South Central & South East Coast East Anglia Medicines Information Service Medicine Review (Adopted by the CCG until review

More information

Roflumilast for the treatment of respiratory disease: review of the Phase II and III trials

Roflumilast for the treatment of respiratory disease: review of the Phase II and III trials Roflumilast for the treatment of respiratory disease: review of the Phase II and trials Clin. Invest. (2011) 1(10), 1413 1419 Roflumilast (Daxas [EU], Daliresp [USA]) is the first phospho diesterase 4

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

More information

fluticasone furoate / vilanterol 92/22, 184/22 micrograms inhalation powder (Relvar Ellipta ) SMC No. (966/14) GlaxoSmithKline UK

fluticasone furoate / vilanterol 92/22, 184/22 micrograms inhalation powder (Relvar Ellipta ) SMC No. (966/14) GlaxoSmithKline UK fluticasone furoate / vilanterol 92/22, 184/22 micrograms inhalation powder (Relvar Ellipta ) SMC No. (966/14) GlaxoSmithKline UK 09 May 2014 The Scottish Medicines Consortium (SMC) has completed its assessment

More information

They are updated regularly as new NICE guidance is published. To view the latest version of this NICE Pathway see:

They are updated regularly as new NICE guidance is published. To view the latest version of this NICE Pathway see: bring together everything NICE says on a topic in an interactive flowchart. are interactive and designed to be used online. They are updated regularly as new NICE guidance is published. To view the latest

More information

This is the publisher s version. This version is defined in the NISO recommended practice RP

This is the publisher s version. This version is defined in the NISO recommended practice RP Journal Article Version This is the publisher s version. This version is defined in the NISO recommended practice RP-8-2008 http://www.niso.org/publications/rp/ Suggested Reference Chong, J., Karner, C.,

More information

Surveillance report Published: 6 April 2016 nice.org.uk. NICE All rights reserved.

Surveillance report Published: 6 April 2016 nice.org.uk. NICE All rights reserved. Surveillance report 2016 Chronic obstructive pulmonary disease in over 16s: diagnosis and management (2010) NICE guideline CG101 Surveillance report Published: 6 April 2016 nice.org.uk NICE 2016. All rights

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Brand Name: Daliresp. Generic Name: roflumilast. Manufacturer: Forest Pharmaceuticals, Inc.

Brand Name: Daliresp. Generic Name: roflumilast. Manufacturer: Forest Pharmaceuticals, Inc. Brand Name: Daliresp Generic Name: roflumilast 3, 4, 5 Manufacturer: Forest Pharmaceuticals, Inc. 1, 2,4,5,7 Drug Class: Second Generation Phosphodiesterase 4 (PDE 4) inhibitor Labeled Uses: prophylaxis

More information

Roflumilast for Management of Chronic Obstructive Pulmonary Disease

Roflumilast for Management of Chronic Obstructive Pulmonary Disease Roflumilast for Management of Chronic Obstructive Pulmonary Disease Submission to National Institute for Health and Clinical Excellence Single Technology Appraisal (STA) May 2011 Manufacturer MSD Ltd 1

More information

AWMSG SECRETARIAT ASSESSMENT REPORT. Glycopyrronium bromide (Seebri Breezhaler ) 44 micrograms inhalation powder as hard capsules

AWMSG SECRETARIAT ASSESSMENT REPORT. Glycopyrronium bromide (Seebri Breezhaler ) 44 micrograms inhalation powder as hard capsules AWMSG SECRETARIAT ASSESSMENT REPORT Glycopyrronium bromide (Seebri Breezhaler ) 44 micrograms inhalation powder as hard capsules Reference number: 1455 FULL SUBMISSION This report has been prepared by

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Co-Primary Outcomes/Efficacy Variables:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Co-Primary Outcomes/Efficacy Variables: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Suffolk PCT Drug & Therapeutics Committee New Medicine Report

Suffolk PCT Drug & Therapeutics Committee New Medicine Report Suffolk PCT Drug & Therapeutics Committee New Medicine Report This drug has been reviewed because it is a product that may be prescribed in primary care. Medicine Fentanyl citrate oral and intranasal preparations

More information

AWMSG SECRETARIAT ASSESSMENT REPORT. Aclidinium bromide (Eklira Genuair ) 322 micrograms inhalation powder. Reference number: 938 FULL SUBMISSION

AWMSG SECRETARIAT ASSESSMENT REPORT. Aclidinium bromide (Eklira Genuair ) 322 micrograms inhalation powder. Reference number: 938 FULL SUBMISSION AWMSG SECRETARIAT ASSESSMENT REPORT Aclidinium bromide (Eklira Genuair ) 322 micrograms inhalation powder Reference number: 938 FULL SUBMISSION This report has been prepared by the All Wales Therapeutics

More information

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 15 December 2010

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 15 December 2010 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 15 December 2010 HIROBRIZ BREEZHALER 150 micrograms, inhalation powder, hard capsules B/10 with inhaler (CIP code:

More information

New Medicine Report (Adopted by the CCG until review and further

New Medicine Report (Adopted by the CCG until review and further New Medicine Report (Adopted by the CCG until review and further GRASS ALLERGEN TREATMENT notice) Document Status Decision following Suffolk D&TC meeting Traffic Light Decision Red for 2007 with review

More information

What is COPD? COPD Pharmacotherapy. COPD Mortality Is Increasing

What is COPD? COPD Pharmacotherapy. COPD Mortality Is Increasing COPD Pharmacotherapy Chronic Bronchitis What is COPD? 75% 17.5% Emphysema Laura C. Feemster, MD, MS Assistant Professor University of Washington Division of Pulmonary & Critical Care April 23,2015 COPD

More information

Asthma Treatment Guideline for Adults (aged 17 and over)

Asthma Treatment Guideline for Adults (aged 17 and over) Asthma Treatment Guideline for Adults (aged 17 and over) Sharon Andrew MLCSU January 2019 (Review date 0 January 2022) VERSION CONTROL. Please access via the LMMG website to ensure that the correct version

More information

Clinical Policy: Roflumilast (Daliresp) Reference Number: CP.PMN.46 Effective Date: Last Review Date: 08.18

Clinical Policy: Roflumilast (Daliresp) Reference Number: CP.PMN.46 Effective Date: Last Review Date: 08.18 Clinical Policy: (Daliresp) Reference Number: CP.PMN.46 Effective Date: 11.01.11 Last Review Date: 08.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium montelukast 10mg tablets (Singulair ) No. (185/05) Merck, Sharp & Dohme Ltd (MSD) New indication: for asthmatic patients in whom montelukast is indicated in asthma, montelukast

More information

Treatment Responses. Ronald Dahl, Aarhus University Hospital, Denmark

Treatment Responses. Ronald Dahl, Aarhus University Hospital, Denmark Asthma and COPD: Are They a Spectrum Treatment Responses Ronald Dahl, Aarhus University Hospital, Denmark Pharmacological Treatments Bronchodilators Inhaled short-acting β -Agonist (rescue) Inhaled short-acting

More information

COPD. Breathing Made Easier

COPD. Breathing Made Easier COPD Breathing Made Easier Catherine E. Cooke, PharmD, BCPS, PAHM Independent Consultant, PosiHleath Clinical Associate Professor, University of Maryland School of Pharmacy This program has been brought

More information

Treatment. Assessing the outcome of interventions Traditionally, the effects of interventions have been assessed by measuring changes in the FEV 1

Treatment. Assessing the outcome of interventions Traditionally, the effects of interventions have been assessed by measuring changes in the FEV 1 58 COPD 59 The treatment of COPD includes drug therapy, surgery, exercise and counselling/psychological support. When managing COPD patients, it is particularly important to evaluate the social and family

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

Study No.: Title: Rationale: Phase: Study Period Study Design: Centres: Indication: Treatment: Objectives : Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period Study Design: Centres: Indication: Treatment: Objectives : Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) TREATMENT GUIDELINES

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) TREATMENT GUIDELINES CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) TREATMENT GUIDELINES Document Description Document Type Service Application Version Guidelines All healthcare professionals(hcps) caring for patients with asthma

More information

Supplementary appendix

Supplementary appendix Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Calverley P M A, Anzueto A R, Carter K, et

More information

THEOPHYLLINE WITH INHALED CORTICOSTEROIDS (TWICS) TRIAL SELF MANAGMENT / ACTION PLANS GENUAIR INHALERS: POTENTIAL SAFETY ISSUE

THEOPHYLLINE WITH INHALED CORTICOSTEROIDS (TWICS) TRIAL SELF MANAGMENT / ACTION PLANS GENUAIR INHALERS: POTENTIAL SAFETY ISSUE I S S U E 4 M A R C H / A R P I L 2 0 1 6 Endorsed December 2014 I N S I D E T H I S I S S U E : Theophylline with Inhaled Corticosteroids (TWICS) Trial Genuair Inhaler: Potential Safety Issue 1 Self Management

More information

Aclidinium bromide/formoterol Endpoint category. RR Endpoint. [95% CI 2 ] Study. with event

Aclidinium bromide/formoterol Endpoint category. RR Endpoint. [95% CI 2 ] Study. with event Resolution by the Federal Joint Committee on an amendment to the Pharmaceutical Directive (AM-RL): Appendix XII Resolutions on the benefit assessment of pharmaceuticals with new active ingredients, in

More information

DR REBECCA THOMAS CONSULTANT RESPIRATORY PHYSICIAN YORK DISTRICT HOSPITAL

DR REBECCA THOMAS CONSULTANT RESPIRATORY PHYSICIAN YORK DISTRICT HOSPITAL DR REBECCA THOMAS CONSULTANT RESPIRATORY PHYSICIAN YORK DISTRICT HOSPITAL Definition Guidelines contact complicated definitions Central to this is Presence of symptoms Variable airflow obstruction Diagnosis

More information

omalizumab 150mg powder and solvent for injection (Xolair ) No. (259/06) Novartis Pharmaceuticals UK Ltd.

omalizumab 150mg powder and solvent for injection (Xolair ) No. (259/06) Novartis Pharmaceuticals UK Ltd. Scottish Medicines Consortium Re-Submission omalizumab 150mg powder and solvent for injection (Xolair ) No. (259/06) Novartis Pharmaceuticals UK Ltd. 8 December 2006 The Scottish Medicines Consortium (SMC)

More information

Type of intervention Treatment. Economic study type Cost-effectiveness analysis.

Type of intervention Treatment. Economic study type Cost-effectiveness analysis. Cost-effectiveness of salmeterol/fluticasone propionate combination product 50/250 micro g twice daily and budesonide 800 micro g twice daily in the treatment of adults and adolescents with asthma Lundback

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

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium budesonide/formoterol 100/6, 200/6 turbohaler (Symbicort SMART ) No. (362/07) Astra Zeneca UK Limited 9 March 2007 (Issued May 2007) The Scottish Medicines Consortium (SMC)

More information

Long-acting bronchodilators: their properties and place in treatment

Long-acting bronchodilators: their properties and place in treatment Long-acting bronchodilators: their properties and place in treatment Steve Chaplin MSc, MRPharmS and Paul Walker BMedSci (Hons), MD, FRCP Steve Chaplin and Dr Paul KEY POINTS Walker provide an overview

More information

Algorithm for the use of inhaled therapies in COPD

Algorithm for the use of inhaled therapies in COPD Berkshire West Integrated Care System Representing Berkshire West Clinical Commisioning Group Royal Berkshire NHS Foundation Trust Berkshire Healthcare NHS Foundation Trust Berkshire West Primary Care

More information

Not available 100/6mcg 2 BD formoterol (Fostair MDI) 100/6mcg 33

Not available 100/6mcg 2 BD formoterol (Fostair MDI) 100/6mcg 33 COMMISSIONING POLICY RECOMMENDATION TREATMENT ADVISORY GROUP FLUTICASONE FUROATE/VILANTEROL COMBINATION INHALER - ASTHMA Policy agreed by Vale of York CCG (date) Drug, Treatment, Device name Fluticasone

More information

Algorithm for the use of inhaled therapies in COPD Version 2 May 2017

Algorithm for the use of inhaled therapies in COPD Version 2 May 2017 Algorithm for the use of inhaled therapies in COPD This document has been revised by the Berkshire West Respiratory Network to support clinicians in selecting the most appropriate, cost effective treatments

More information

Cost-effectiveness of telephone or surgery asthma reviews: economic analysis of a randomised controlled trial Pinnock H, McKenzie L, Price D, Sheikh A

Cost-effectiveness of telephone or surgery asthma reviews: economic analysis of a randomised controlled trial Pinnock H, McKenzie L, Price D, Sheikh A Cost-effectiveness of telephone or surgery asthma reviews: economic analysis of a randomised controlled trial Pinnock H, McKenzie L, Price D, Sheikh A Record Status This is a critical abstract of an economic

More information

VA/DoD Clinical Practice Guideline Management of COPD Pocket Guide

VA/DoD Clinical Practice Guideline Management of COPD Pocket Guide VA/DoD Clinical Practice Guideline Management of COPD Pocket Guide MODULE A: MAAGEMET OF COPD 1 2 Patient with suspected or confirmed COPD presents to primary care [ A ] See sidebar A Perform brief clinical

More information

Study population The study population comprised a hypothetical cohort of poorly reversible COPD patients with a history of exacerbations.

Study population The study population comprised a hypothetical cohort of poorly reversible COPD patients with a history of exacerbations. Development of an economic model to assess the cost-effectiveness of treatment interventions for chronic obstructive pulmonary disease Spencer M, Briggs A H, Grossman R F, Rance L Record Status This is

More information

Clinical Policy: Roflumilast (Daliresp) Reference Number: CP.PMN.46. Line of Business: Medicaid

Clinical Policy: Roflumilast (Daliresp) Reference Number: CP.PMN.46. Line of Business: Medicaid Clinical Policy: (Daliresp) Reference Number: CP.PMN.46 Effective Date: 11/11 Last Review Date: 08/17 Line of Business: Medicaid See Important Reminder at the end of this policy for important regulatory

More information

Breathtaking science. Developing respiratory drugs to improve health and quality of life. H.C. Wainwright Global Life Sciences Conference April 2018

Breathtaking science. Developing respiratory drugs to improve health and quality of life. H.C. Wainwright Global Life Sciences Conference April 2018 Breathtaking science Developing respiratory drugs to improve health and quality of life H.C. Wainwright Global Life Sciences Conference April 2018 www.veronapharma.com Forward-Looking Statements This presentation

More information

RESPIRATORY CARE IN GENERAL PRACTICE

RESPIRATORY CARE IN GENERAL PRACTICE RESPIRATORY CARE IN GENERAL PRACTICE Definitions of Asthma and COPD Asthma is due to inflammation of the air passages in the lungs and affects the sensitivity of the nerve endings in the airways so they

More information

Presented by UIC College of Nursing

Presented by UIC College of Nursing Presented by UIC College of Nursing Describe COPD. Identify red flags for a COPD exacerbation. Identify COPD triggers or risk factors. Differentiate between long-acting inhalers and emergency use inhalers.

More information

Chronic Obstructive Pulmonary Disease 1/18/2018

Chronic Obstructive Pulmonary Disease 1/18/2018 Presented by UIC College of Nursing Describe COPD. Identify red flags for a COPD exacerbation. Identify COPD triggers or risk factors. Differentiate between long acting inhalers and emergency use inhalers.

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE 1 Guideline title SCOPE Chronic obstructive pulmonary disease: the management of adults with chronic obstructive pulmonary disease in primary and secondary

More information

Combination inhaled steroid and long-acting beta -agonist in

Combination inhaled steroid and long-acting beta -agonist in Combination inhaled steroid and long-acting beta 2 -agonist in addition to tiotropium versus tiotropium or combination alone for chronic Karner C, Cates CJ This is a reprint of a Cochrane review, prepared

More information

Evidence Review for Prescribing Clinical Network

Evidence Review for Prescribing Clinical Network Summary page Evidence Review for Prescribing Clinical Network Treatment: LABA/LAMA Combination devices in COPD Anoro Ellipta, Ultibro and Duaklir Genuair Prepared by: Noreen Devanney Topic Submitted by:

More information

Pharmacotherapy for COPD

Pharmacotherapy for COPD 10/3/2017 Topics to be covered Pharmacotherapy for chronic treatment Pharmacotherapy for COPD Dr. W C Yu 3rd September 2017 Commonly used drugs Guidelines for their use Inhaled corticosteroids (ICS) in

More information

Suffolk PCT Drug & Therapeutics Committee New Medicine Report

Suffolk PCT Drug & Therapeutics Committee New Medicine Report Suffolk PCT Drug & Therapeutics Committee New Medicine Report This drug has been reviewed because it is a product that may be prescribed in primary care. Medicine Cinacalcet (Mimpara, Amgen) Document status

More information

GREEN. Ropinirole Other PD treatments Benzodiazepines Opioids low potency Anticonvulsants Clonidine

GREEN. Ropinirole Other PD treatments Benzodiazepines Opioids low potency Anticonvulsants Clonidine New Medicine Report (Adopted by the CCG until review and futher notice) Document Status Traffic Light Decision PRAMIPEXOLE For restless legs syndrome Post Suffolk D&TC GREEN Prescribers Rating Possibly

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium levetiracetam, 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra ) No. (394/07) UCB Pharma Limited 10 August 2007 The Scottish Medicines Consortium

More information

Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease 0 Chronic obstructive pulmonary disease Implementing NICE guidance June 2010 NICE clinical guideline 101 What this presentation covers Background Scope Key priorities for implementation Discussion Find

More information

Respiratory Subcommittee of PTAC Meeting held 4 March 2015

Respiratory Subcommittee of PTAC Meeting held 4 March 2015 Respiratory Subcommittee of PTAC Meeting held 4 March 2015 (minutes for web publishing) Respiratory Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology and

More information

Wirral COPD Prescribing Guidelines

Wirral COPD Prescribing Guidelines Wirral COPD Prescribing Guidelines (To be read in conjunction with the Wirral COPD Supplementary Information) STEP 1: Assess symptoms COPD Assessment Test (CAT) [Link for CAT-test Online] is a patient-completed

More information

ASTHMA TREATMENT GUIDE (ADULTS)

ASTHMA TREATMENT GUIDE (ADULTS) ASTHMA TREATMENT GUIDE (ADULTS) The BTS/SIGN guideline provides a wide range of information and guidance on the treatment of patients with asthma. https://www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-guideline-2016/

More information

Respiratory Subcommittee of PTAC meeting held 5 February (minutes for web publishing)

Respiratory Subcommittee of PTAC meeting held 5 February (minutes for web publishing) Respiratory Subcommittee of PTAC meeting held 5 February 2010 (minutes for web publishing) Respiratory Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology

More information

รศ. นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทยศาสตร มหาว ทยาล ยขอนแก น

รศ. นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทยศาสตร มหาว ทยาล ยขอนแก น รศ. นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทยศาสตร มหาว ทยาล ยขอนแก น COPD Guideline Changing concept in COPD management Evidences that we can offer COPD patients better life COPD Guidelines

More information

Cost effectiveness of fluticasone and budesonide in patients with moderate asthma Steinmetz K O, Volmer T, Trautmann M, Kielhorn A

Cost effectiveness of fluticasone and budesonide in patients with moderate asthma Steinmetz K O, Volmer T, Trautmann M, Kielhorn A Cost effectiveness of fluticasone and budesonide in patients with moderate asthma Steinmetz K O, Volmer T, Trautmann M, Kielhorn A Record Status This is a critical abstract of an economic evaluation that

More information

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

COPD: A Renewed Focus. Disclosures

COPD: A Renewed Focus. Disclosures COPD: A Renewed Focus Heath Latham, MD Assistant Professor Division of Pulmonary and Critical Care Medicine Disclosures No Business Interests No Consulting No Speakers Bureau No Off Label Use to Discuss

More information

COPD in primary care: reminder and update

COPD in primary care: reminder and update COPD in primary care: reminder and update Managing COPD continues to be a major feature of primary care, particularly in practices with a high proportion of M ori and Pacific peoples. COPDX clinical practice

More information

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 25 May 2011

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 25 May 2011 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 25 May 2011 Examination of the file for the proprietary medicinal product included for a period of 5 years by the

More information

Kirthi Gunasekera MD Respiratory Physician National Hospital of Sri Lanka Colombo,

Kirthi Gunasekera MD Respiratory Physician National Hospital of Sri Lanka Colombo, Kirthi Gunasekera MD Respiratory Physician National Hospital of Sri Lanka Colombo, BRONCHODILATORS: Beta Adrenoreceptor Agonists Actions Adrenoreceptor agonists have many of the same actions as epinephrine/adrenaline,

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 Synopsis 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

More information

The Journal Club: COPD Exacerbations

The Journal Club: COPD Exacerbations 252 The Journal Club: COPD Exacerbations Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation Journal Club The Journal Club: COPD Exacerbations Ron Balkissoon, MD, MSc, DIH, FRCPC 1 Abbreviations:

More information

COPD Update. Plus New and Improved Products for Inhaled Therapy. Catherine Bourg Rebitch, PharmD, BCACP Clinical Associate Professor

COPD Update. Plus New and Improved Products for Inhaled Therapy. Catherine Bourg Rebitch, PharmD, BCACP Clinical Associate Professor COPD Update Plus New and Improved Products for Inhaled Therapy Catherine Bourg Rebitch, PharmD, BCACP Clinical Associate Professor Disclosure The presenter has nothing to disclose concerning possible financial

More information

Advances in the management of chronic obstructive lung diseases (COPD) David CL Lam Department of Medicine University of Hong Kong October, 2015

Advances in the management of chronic obstructive lung diseases (COPD) David CL Lam Department of Medicine University of Hong Kong October, 2015 Advances in the management of chronic obstructive lung diseases (COPD) David CL Lam Department of Medicine University of Hong Kong October, 2015 Chronic obstructive pulmonary disease (COPD) COPD in Hong

More information

CDEC FINAL RECOMMENDATION

CDEC FINAL RECOMMENDATION CDEC FINAL RECOMMENDATION (FLUTICASONE FUROATE/VILANTEROL) (Breo Ellipta GlaxoSmithKline) Indication: Chronic Obstructive Pulmonary Disease Recommendation: The Canadian Drug Expert Committee (CDEC) recommends

More information

April 10 th, Bond Street, Toronto ON, M5B 1W8

April 10 th, Bond Street, Toronto ON, M5B 1W8 Comprehensive Research Plan: Inhaled long-acting muscarinic antagonists (LAMAs; long-acting anticholinergics) for the treatment of chronic obstructive pulmonary disease (COPD) April 10 th, 2014 30 Bond

More information