COPD: KOL Insight

COPD: KOL Insight

Code: FW-21072016-28 | Published: Apr-2016 | Pages: 0 | FirstWord
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Is the COPD treatment market poised for a fundamental shift?
After years of dominance by a handful of brands, change is in the air for COPD treatment. Will deep set preferences finally be overturned, or will physicians need both cost and performance incentives to switch? How will device attributes impact future decision-making? Which are the key trials to watch and why?
Find out in FirstWord’s new report, COPD: KOL Insight Request sample pages now.
Covering 13 currently marketed brands and 5 Phase III drugs, this report examines today’s market, looks at future trends and reveals insight from 12 key opinion leaders (KOLs) in North America and Europe.
Discover why the ‘open versus closed’ triple therapy debate is set to intensify thanks to exciting new research. With IL-5 antibodies in Phase III development, targeted treatment could soon be a reality. Decide for yourself which brands will be the new ‘movers and shakers’ in COPD treatment – and find out how new studies look set to change entrenched habits.
Plus: Order the report and you’ll receive three quarterly FirstWord Therapy Trends Update Bulletins free!
“These are provocative results. It shows that for reasons that we don’t understand, long acting bronchodilators are quite effective in decreasing exacerbations. And they are equivalent to an ICS/LABA which suggests that we’re are overusing ICS.”

Expert insight into the COPD treatment

Recently Marketed Drugs
Long-acting muscarinic antagonists (LAMAs)

Spiriva (tiotropium; Boehringer Ingelheim): Is familiarity enough to keep Spiriva in the top position? Are physicians considering alternatives?
Eklira/Tudorza (aclidinium; AstraZeneca): Is patient preference for twice-daily dosing a trend to watch?
Seebri (glycopyrronium; Novartis): How does the efficacy of twice-daily US Seebri compare to the once a day EU version?
Incruse (umeclidinium; GlaxoSmithKline): Can Incruse beat Spiriva as the LAMA of choice now that comparative studies have revealed its superior lung function performance?
Arcapta/Onbrez (indacaterol; Novartis): What was behind the 25% drop in sales of Arcapta/Onbrez in 2015?
Striverdi (olodaterol; Boehringer Ingelheim): Find out why the FDA rejected Boehringer Ingelheim’s attempt to make Striverdi the first COPD brand with exercise endurance benefits.

LAMA/LABA combinations

Ultibro/Utibron (indacaterol/glycopyrronium; Novartis): Will the Ultibro FLAME trial redefine the treatment path for patients with exacerbations, with ICS added as a last resort?
Anoro (umeclidinium/vilanterol; GSK): Where next for Anoro? IF GSK’s companion triple ICS/LAMA/LABA is approved, will Anoro’s easy treatment sequencing trump all else?
Stiolto/Spiolto (tiotropium/olodaterol; Boehringer Ingelheim): If KOLs view all LAMA/LABAs as comparable, what is Stiolto/Spiolto’s differentiator?
Duaklir (aclidinium/formoterol; AstraZeneca): Will device differences between Duaklir and other AstraZeneca products create a drug sequencing issue?

ICS/LABA combinations

Symbicort (budesonide/formoterol; AstraZeneca): Can Symbicort catch up with Advair? Do KOLs favour MDIs or DPIs?
Advair/Seretide (fluticasone propionate/salmeterol; GSK): When are US generics expected? Will payers prefer low cost Breo/Relvar to generic Advair/Seretide?
Breo/Relvar (fluticasone furoate/vilanterol; GSK): Was pricing or clinical benefit behind the trebling of Breo/Relvar sales last year?

Pipeline Drugs
Anti-IL5 antibody

Benralizumab (AstraZeneca): Do KOLs believe the clinical benefit of benralizumab will be enough to justify the expected cost?
Mepolizumab (GSK): How important are eosinophil levels for patient selection? Will differing views about the minimum level be an issue for mepolizumab?

Closed triple (ICS/LAMA/LABA)

PT010 (AstraZeneca): Is improved lung function or reduced exacerbations the primary focus for current studies with PT010?
CHF5993 (Chiesi): KOLs say adherence is the key benefit of closed triples; will two separate 52-week studies for CHF5933 throw any more light on this issue?
FF/UMEC/VI (GSK): With so much at stake, what exactly does GSK hope to gain from extensive trials of its FF/UMEC/VI closed triple?

Top takeaways

Reluctance to switch: KOLs view all LAMAs and LAMA/LABAs as equivalent and still believe ICS are an important treatment option for recurrent exacerbations. Concerns about the unknown effect of withdrawal of ICS will prevent physicians from changing existing patient therapies. Will this slow the growth of LAMA/LABAs?
Potential overuse of ICS: The first comparative trial of LAMA/LABA versus ICS/LABA (the FLAME study) looks like a game-changer. GSK’s much anticipated IMPACT study may settle once and for all the optimal treatment approach. Will continuing uncertainty regarding asthma vs. COPD in primary care continue to prompt ICS use?
KOLs want earlier detection: Late presentation is common as early symptoms such as a cough can be missed in primary care settings. Diagnosis often follows exacerbations or significant loss of lung function. How will spirometry be leveraged in the future?
Belief that closed triples will simply improve adherence: With ICS/LAMA/LABA combinations expected to be approved in 2018, KOLs are focused on the benefits of a simplified treatment path rather than any clinical advantages. But will payers agree?
Unmet needs remain: Existing therapies reduce symptoms and exacerbations, but none slow the progressive decline in lung function or reduce mortality. Other needs such as improving drug adherence and identifying predictive biomarkers are being addressed to some degree. Where next for the treatment of COPD?

Themes Explored

The importance of the device: KOLs are uninspired by device choices. Although they recognise an impact on adherence, most do not have favourites; drug choice is the deciding factor. Triple combinations via one device could be a step forward. GSKs plans for consistency of device across the entire treatment pathway could have far-reaching implications.
Questions about established treatment pathways: GOLD guidelines provide little clarity. New studies are offering a different perspective on entrenched choices. LAMA/LABA combinations may prove to be more effective for some patients than ICS/LABA. Closed triples are simpler for patients. Eosinophils may be a promising biomarker.
Individual preference as a key driver: Are incremental benefits enough to challenge entrenched prescribing habits? KOLs also consider cost, adherence and patient preferences before switching. As none of the drug companies can yet promise to cure COPD, is symptomatic relief and reducing exacerbations the only choice on offer?

A report based on expert knowledge
Key Opinion Leaders Interviewed for This Report
North American KOLs

Prof Robert Wise, MD; Johns Hopkins Medical School, US
Prof David Mannino, MD; Head of Pulmonary Care, Critical Care, and Sleep Medicine, University of Kentucky in Lexington, KY
Prof Richard H Casaburi, MD; Chief, Division of Respiratory and Critical Care Physiology and Medicine, University of California at Los Angeles Medical Center
Prof James Donahue, MD; Professor of Medicine, UNC Chapel Hill Medical Center
Prof Nadia Hansel, MD; Associate Professor of Medicine, Johns Hopkins University School of Medicine
Prof Fernando Martinez, MD; Adjunct Professor, Department of Internal Medicine, Division of Pulmonary & Critical Care Medicine, University of Michigan

European KOLs
Prof Fan Chung, MD; Professor of Respiratory Medicine & Head of Experimental Studies, National Heart & Lung Institute, Imperial College London, UK
Professor Anoop Chauhan, MD; Consultant Physician in Respiratory and General Medicine, Portsmouth Hospitals NHS Trust, UK
Prof Stefano Centanni; MD; University Hospital Milan, Italy
Three anonymous German KOLs

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Table of Contents

1 Executive summary
2 Research objectives
3 Research focus
4 COPD market overview
4.1 Spiriva, Advair/Seretide and Symbicort are the top-selling treatments 5
4.2 A disease-modifying therapy is a key unmet need
4.3 Earlier detection of COPD is required
4.4 GOLD’s A to D patient quadrant is not fit for primary care
4.5 Guidelines recommend ICS for patients with exacerbations
4.6 ICS/LABAs are commonly used in primary care
4.7 The device is not a key factor in treatment selection
5 Long-acting bronchodilators
5.1 Spiriva benefits from a long period of clinical use
5.2 Eklira/Tudorza’s main advantage is twice-daily dosing
5.3 Seebri’s different US and EU dosing does not impact lung function efficacy
5.4 Incruse shares the same device as Anoro and Relvar/Breo
5.5 Arcapta/Onbrez has low US formulary coverage
5.6 Striverdi’s exercise endurance claim rejected by FDA
6 LAMA/LABA combinations
6.1 Ultibro FLAME results are a potential paradigm shifter
6.2 Anoro has high US formulary coverage
6.3 AstraZeneca’s Duaklir and Bevespi use different devices
6.4 Stiolto/Spiolto’s Respimat device is preferred by some
7 ICS/LABA combinations
7.1 Advair generics may be approved in 2017
7.2 Relvar/Breo is the lowest cost ICS/LABA
7.3 Symbicort late to US market
8 Phosphodiesterase-IV inhibitors
8.1 Poor tolerability limits Daliresp/Daxas use
9 R&D Pipeline
9.1 ICS/LAMA/LABA combinations may be approved in 2018
9.2 Antibodies have a role in specific patients
9.3 MABAs offer no advantages over current bronchodilators
9.4 Novel anti-inflammatories may treat acute exacerbations
10 Future treatment practice
10.1 LAMA/LABA uptake depends on place in national COPD guidelines
10.2 Stable patients on ICS/LABAs will not be switched to LAMA/LABAs
10.3 Triple combinations are a convenient treatment option
10.4 Eosinophils are currently the most promising biomarker
10.5 Key trials to watch
11 Appendix
11.1 Clinical endpoints
11.2 US formulary coverage of COPD drugs
11.3 KOL biographies

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