Innovation that’s unaffordable is not truly innovative

Innovative disruption in her view was about a fundamental shift in the way in which we addressed an identified gap or need – put simply it was about doing something that was radically different to what went before thus replacing a product or service with something new, more efficient and worthwhile, Eimear Caslin, General Manager of GSK Ireland Pharmaceuticals, told the conference.

Eimear Caslin
Eimear Caslin

She said this was the seventh year that GSK had been associated with the HMI and the annual conference.

“The relationship with the HMI is one that we value and it fully aligns with our ambition to help support a dynamic and progressive health care system in Ireland,” she said.
Ms. Caslin said that as a leading global pharmaceutical company, GSK innovation was at the heart of GSK’s mission to bring new medicines to patients.

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Instead of taking a medicine, a tiny electrical device would be implanted in the body and this could modify electrical signals that pass along the nerves in the body including irregular or altered impulses that occur in many illnesses.

“Our £3.6 billion annual investment in R&D attests to the commitment to discover and manufacture new medicines. We have 20-30 new assets or drugs in development with data expected next year and over 14 candidate vaccines in early, mid and late stage development against a range of diseases. The 1,500 partnerships that we have with academic institutions, biotechs, public-private partnerships and pharmaceutical companies all underpin our ambition around innovation.

“Similarly, we employ some of the most disruptive technologies in health care. With the pace of technological change, we can say with absolute certainty that the shape of the pharmaceutical sector will be radically different in ten years’ time from the one that we are familiar with today. Personalised medicines, preventative care and increased life expectancy are just three factors that will dramatically change the way that we produce medicines.

“ Recognising the pace of change, GSK along with Verily Life Sciences (formerly Google Life Sciences), has created a company, Galvani Bioelectronics, which aims to use bioelectronics to fundamentally change the way chronic conditions are treated. To put it at its simplest, instead of taking a medicine, a tiny electrical device would be implanted in the body and this could modify electrical signals that pass along the nerves in the body including irregular or altered impulses that occur in many illnesses. The hope is that this technology will treat chronic conditions such as arthritis, diabetes and asthma. By any measure, I think this is innovative disruption. Not alone is it transformative technology; it is highly disruptive in terms of replacing a tried and tested product.”

Our last three respiratory products to be reimbursed by the HSE were all launched at or below the medicines that they sought to replace.

Ms. Caslin said GSK was investing in a new technology that fundamentally changed the way they researched and made medicines? In the main, it had to do with medical need but there was also an economic dimension to such innovation. For some time, health policy experts in Europe and the US had questioned the long-term financial sustainability of our health care systems. The financial burden on Governments and individuals arising from the cost of health care was high and was going in one direction.

“One frightening statistic that I read recently is that one quarter of all personal bankruptcies in the US are as a direct result of health care bills. It would be disingenuous of me to suggest that the price of medicines have no role to play to in that cost burden. We know that specialist medicines are costly and the sustainability of a commercial model that is dependent on governments and insurance companies paying six figure sums for individual medicines is extremely limited.

“When we develop and commercialise an innovative product, there is a responsibility on us to demonstrate the efficacy of that product in the first instance and then to prove the cost effectiveness of that product to payers. In GSK, we take that responsibility seriously. What do I mean by that? Well, in the case of my business, our last three respiratory products to be reimbursed by the HSE were all launched at or below the medicines that they sought to replace. So we place great store on innovation but we must make it affordable. There’s a quote that our former CEO was fond of using and it think it’s very appropriate, ‘innovation that’s unaffordable is not truly innovative.’

“So we have a responsibility to assist governments and health systems to control costs. Nobody doubts the need for cost containment whether that’s in pharmaceutical spend, elective procedures or procurement of any product or service within the healthcare system. But cost containment should be only one dimension to the prism that is medicines policy. I believe there should be an ambition and desire to make the most innovative and cost effective medicines available to Irish patients. This is rarely discussed or if it is, it’s usually in the context of failure of a patient or group of patients to access a lifesaving medicine. As a country, I think it’s a legitimate ambition to have access to medicines that are available in other EU countries. In return, as an industry, we need to be more innovative in how we balance risk with public health systems.

I believe there should be an ambition and desire to make the most innovative and cost effective medicines available to Irish patients.

“We are still at the very early stages of collating and using real world data gathered from patients treated for chronic and other conditions. Traditionally, our industry was solely dependent on clinical trials that took place prior to licensing and regulatory approval. Now we have the opportunity to demonstrate in a real world setting the impact and value of a medicine.

“The Salford Lung Study, which read out two weeks ago, is a great example of the value of an effectiveness study. Recruitment of the trial commenced on Nov 12, 2012, and the last visit was completed on Dec 16, 2016. The trial recruited patients with a documented diagnosis of symptomatic asthma made by a General Practitioner across 74 general practice clinics in Salford and South Manchester. There were 4,725 patients enrolled and 4,233 randomly assigned to initiate treatment for a once a day treatment for asthma. The results, which were very positive from a GSK perspective, allows us to talk with a much higher degree of certainty about the efficacy and value of our medicines.

“That is very powerful from a clinical but also from an economical perspective. It paves the way for a new conversation with payers about cost and value. And like all innovative disruptions we need to be brave in our approach and be prepared to explore risk sharing mechanisms and other means of linking price to health outcomes. So what I am trying to say to the Minister and all health managers is that we in GSK very much value our relationship with you and we want to work with you to create an environment which promotes innovation and enables Irish patients to access new products in a financially sustainable way.