Earlier this month, GlaxoSmithKline (GSK) and a number of collaborators announced an innovative new study pertaining to Relovair, the company’s once-a-day combination of corticosteroid (fluticasone furoate) and long-acting beta agonist (vilanterol trifenatate), under development for the treatment of asthma and chronic obstructive pulmonary disorder (COPD).
The year-long Salford Lung Study, anticipated to enrol around 4,000 COPD patients and 5,000 asthma patients in Salford, England, is the first prospective, large-scale, “real-world” trial to be focused on one geographical setting and conducted prior to marketing authorisation.
Salford Lung Study — Leveraging the Locale
The Salford Lung Study will see GSK work with North West e-Health, Salford Royal NHS Foundation Trust, NHS Salford, GPs and community pharmacists, and the University of Manchester. The COPD portion of the study, for which recruitment is expected to begin this month, is an open-label Phase III programme, where half the patients will be randomised to Relovair and half will receive their existing therapies.
Salford’s existing infrastructure for electronic patient records (which integrate both primary and secondary care) will be utilised to assess safety and effectiveness in actual clinical practice. The primary endpoint will be mean annual rate of moderate and severe exacerbations; secondary endpoints include time to discontinuation of therapy and to addition of further therapies, time to first moderate/severe exacerbation, and such real-world measures as number of contacts with healthcare professionals across the continuum of care (for respiratory-related concerns or otherwise), number of hospital admissions, days in hospital, and quality-of-life outcomes.
Relovair — A Payer’s Dream Come True
This study treads new ground to the extent that GSK is investing in comparative, real-world effectiveness data prior to licensing – meaning that, by the time Relovair is subjected to health technology assessments within the UK, decision-makers should have an emerging evidence base on the therapy’s added value that is country and healthcare system-specific – what more could payers ask for?
Of course, the onus is on GSK to demonstrate this value in the first place. The announcement of the Salford Lung Study comes on the heels of disappointing top-line Phase III data for the asset in January of this year.
But Don’t Hold Your Breath…
There are a number of factors unique to the therapeutic area and geography in question for the Salford study that help to explain GSK’s investment, including:
However, it is debatable to what extent this study is a harbinger of things to come, whether from GSK or other manufacturers – GSK’s move toward real-world and comparative effectiveness data at this stage is also a reflection of just how high the stakes of the game are for the company in the respiratory space.
Relovair is a follow-on to GSK’s Seretide/Advair (fluticasone+salmeterol), which has ranked in the top three products by global sales in recent years. Seretide/Advair’s patent expired in 2010 in the US and is good until 2013 in most European markets –although it has been revoked in a number of countries, including the UK. So far, there has been no generic competitor to Seretide/Advair, due to challenges not only with establishing the bioequivalence of inhaled medicines, but also development of an alternative inhalation device (the original is covered by a separate patent). However, generic competition is expected in the upcoming years.
So, it may be premature to envision widespread creep of effectiveness considerations into development strategy more broadly speaking. Still, at least this time round, there will be some fresh air for payers in the UK.