Market Access for nebulisers in asthma – UK payer insights

Dr Joanna Entwistle and Julia Glover

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GfK Bridgehead

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As pharmaphorum’s market access themed month commences, Dr Joanna Entwistle and Julia Glover explore market access barriers to nebulisers for asthma in the UK.

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Asthma is an inflammatory disease of the airways characterised by chronic inflammation associated with airway hyper-responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing1. This can lead to widespread, variable, and often reversible airflow limitation.

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Figure 1: Asthma severity breakdown in the UK, 2012 (Datamonitor 2011)

Based on the GINA guidelines for definition of severity, one analyst report suggested that the UK has over 2 million children and adults with severe persistent asthma2.

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A review of the literature shows that there is no evidence of clinical superiority of nebulisers over standard metered dose inhalers (pMDIs) in terms of bronchodilator delivery despite the fact that the cost may be several times higher. Hence, in terms of the cost-effectiveness pMDIs are often favoured by clinicians when deciding upon the most effective and efficient treatment option for a patient3.

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Figure 2: Example of a nebuliser in use

A total of 23 studies in adults found equivalence for the main pulmonary and secondary outcomes, in children, three trials compared different devices and demonstrated no evidence of clinical superiority of nebulisers over inhaler devices in bronchodilator delivery. The cost-effectiveness evidence therefore favours pMDIs (or the cheapest inhaler device) as first-line treatment in all patients with stable asthma unless other specific reasons are identified4.

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This can lead to challenges for developers of nebulisers that need to be overcome when considering market access and reimbursement.

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One of the most important aspects to build a strong case for market access in all areas is clinical data and cost effectiveness. Within the relatively crowded asthma space, clinicians are increasingly requesting real-world data to highlight what cost savings could potentially be made through improved management of asthma patients.

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“…clinicians are increasingly requesting real-world data to highlight what cost savings could potentially be made through improved management of asthma patients.”

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Recent research (conducted in 2012 with 12 payers and KOLs) has found that payers do not often restrict reimbursement of nebulisers, despite there often being a lack of clinical-effectiveness data. The main reasons why payers currently do not impose restrictions on nebulisers include:

•&nbsp,&nbsp,&nbsp,&nbsp, The number of requests they receive is very low and therefore their budget impact is minimal

o&nbsp,&nbsp,&nbsp,&nbsp, If a greater number of requests were put forward limitations may be imposed

•&nbsp,&nbsp,&nbsp,&nbsp, When they are requested by clinicians there is clinical justification for their use, for example in patients unable to effectively use pMDIs

•&nbsp,&nbsp,&nbsp,&nbsp, Patients considered suitable candidates for nebulised therapy are known to be severe asthmatics who have a life-threatening disease and are likely to require significant healthcare resources

o&nbsp,&nbsp,&nbsp,&nbsp, Therefore utilisation of a nebuliser may, in these cases, reduce future healthcare costs.

It was noted by two payers, that 10–15 years ago there was a rise in the numbers of nebulisers requested because if a patient was considered to require nebulised therapy they were automatically eligible for increased incapacity benefits5. This led to an overuse of nebulisers and although this ruling does not seem to be in place now, it has resulted in added caution for physicians to recommend their use.

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Switching to a new nebuliser from a current nebuliser is not seen as problematic. Providing there is minimal impact on the budget and the clinical benefit is proven to be the same or better than the current technology then respiratory nurses may be able to simply switch patients to a new model.

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Figure 3: The route of gaining access to nebulisers is highly variable involving many different departments although is usually initiated via a respiratory specialist

“…payers do not often restrict reimbursement of nebulisers, despite there often being a lack of clinical-effectiveness data.”

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Nebulisers are often initially loaned on a short-term basis from the hospital and purchased from their equipment budget, funding may later be picked up in primary care once the short-term loan from the hospital has ended via a community respiratory team engaging the use of the community equipment service. Home healthcare companies may be employed to provide nebulisers to patients which may either be organised by a community nurse, hospital pharmacy or directly with the PCT. Local risk sharing agreements are employed in some areas between the manufacturers and the hospitals – if the patient doesn’t achieve the required (agreed) improvement then the hospital doesn’t have to pay for the device.

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In terms of evidence requirements, proving a reduction in unplanned hospital admissions is one of the most valuable outcomes to payers whereas reducing side effects and oral systemic corticosteroids use is most valued outcome by KOLs. Payers in the UK note the preference for the health economic aspects to be analysed, either in the form of economic or budget impact model. The desire from both parties, however, is often to understand how the product performs in the real world rather than in the clinical trial setting. Generally this data follows on after approval of the product, but in an attempt to address these data needs GSK has performed pre-registration real-world effectiveness studies to investigate the potential effects of Relovair™ (the product in development) versus the standards of care in asthma and COPD6.

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Device manufactures /developers need to consider the requirements for economic data during the development process and may wish to consider the potential for employing novel risk share approaches to lower market access barriers.

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References

1. GINA. Global Strategy for Asthma Management and Prevention. 2011

2. Epidemiology: Asthma, Datamonitor, September 2011

3. Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature. D Brocklebank et al. NHS R&amp,D HTA Programme Health Technology Assessment 2001, Vol. 5: No. 26 Review

4. Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature. D Brocklebank et al. NHS R&amp,D HTA Programme Health Technology Assessment 2001, Vol. 5: No. 26 Review

5. One based in England and the other in Northern Ireland

6. http://us.gsk.com/html/media-news/pressreleases/2012/2012-pressrelease-840722.htm Accessed April 2013

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About the authors:

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About Joanna Entwistle

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Jo Entwistle joined GfK Bridgehead in 2000 having completed her PhD in molecular chaperones and their role in protein secretion in Aspergillus niger at the University of Nottingham. Since becoming a Senior Consultant for GfK Bridgehead, Jo has worked on and managed a variety of projects in diverse areas including oncology, cardiac disease, infectious diseases and respiratory disease.

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In recent years Jo has focussed on medical device and diagnostic technology, as well as keeping up to date with changes in the wider pharmaceutical markets. The projects she has managed and completed have included pricing and reimbursement strategy as well as technical and commercial evaluations for Expert’s reports and funding reviews. Jo’s work has included modelling and budgetary impact of novel products, pharmaceuticals and medical devices involving creating the value proposition for these products to be shared with payers and clinicians.

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About Julia Glover

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Julia Glover joined GfK Bridgehead in 2006 and has experience working in both Market Access Strategy and Technical and Commercial Evaluation and Strategy Consulting.

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Since joining the company she has worked across all the major global markets and has been involved many types of projects including the creation of core reimbursement dossiers, budget impact modelling and facilitating multi-national advisory boards. Projects she has been involved with cover a hugely varied rage of indications including oncology, infectious disease, respiratory disease, cardiovascular disease and orphan indications. Julia has experience in pharmaceuticals, medical devices and diagnostics.

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What market access challenges do you see in the Asthma space?