The Pharma industry is under a great deal of pressure to deliver better dividends to shareholders, and to deliver better, more effective treatment to patients at lower cost. Healthcare costs are escalating at an alarming rate and it is well reported that some of these costs are due to ineffective usage and wastage of drugs1. This is particularly true in inhaled products where we know for example, that a large proportion of patients cannot co-ordinate breathing with the actuation of a pMDI or do not adequately adhere to treatment which is then less effective than it could be2. Furthermore, patients sometimes simply do not do what you expect them to and for a variety of reasons do not take their medication when they should…’I felt better, I only take it when I am feeling unwell...it was sports today so I missed my dose, I forgot’ etc. etc. However, we must not lay the blame at the patient’s door; indeed, the pharmaceutical and device industry must assume a large proportion of the responsibility if current drug delivery solutions are not as good as they might be. So is the solution better technology? Yes, in the future, advanced technology will be part of the solution but it is not the total answer, not the magic bullet in itself. We still need to provide better useability through design, more patient education, more training, more liaison, monitoring and support but these are out of scope for this paper which concentrates on the technology element and what the future might hold.
Of course if we ask ourselves “can we do more?” The answer will be “yes”; quickly followed by “but who is going to pay?” Here lies the main complication in the current thinking and commercial model. The cost of poor drug delivery, poor compliance and adherence is borne by all; it is an ownership cost. The result of ‘ineffective delivery’ of inhaled therapy is wasted drugs, more devices than necessary ‘consumed’, more frequent GP visits, increased exacerbations, more emergency room visits, greater hospitalisation, poorer patient health and increased mortality – and if that isn’t enough, the financial burden is becoming crippling. Yet when we look for solutions in ‘delivery’ we just look at the device and drug cost, seek to minimise these and in doing so, largely fail to address most of the consequential costs of providing an incomplete and frankly, woefully inadequate solution. A more holistic solution that seeks to have greater impact on this total, consequential cost might require a slightly more expensive device but it is likely to greatly reduce total healthcare costs. So can we afford to stay with ‘cheapest is best’ or is there another way? A technology enabled way. Do we only have the polarised options or are there gradations in between? In some instances eg in third world infrastructures there will be no choice but to keep with low cost less effective methods since the alternative is to go without completely and that is unacceptable. However, the escalating healthcare costs we are experiencing in the developed world cannot continue to rise at the rate they are and more cost effective solutions aiming to reduce total health costs must be found.
In targeting more effective delivery of drugs and higher value platforms, ‘the industry is considering different commercial models based on a range of drivers such as the future ‘threat’ of payment by results (PbR). However, many see PbR as an opportunity; a way of differentiating products in both the eyes of the ‘payers’ but also in the eyes of the patient (or more realistically the consumer). Further evidence that change is happening is seen in new entrants bringing both add-on devices and applications (apps) to the landscape to enhance the user experience, encourage and ensure adherence and make it easier to monitor and measure treatment effectiveness (diagnostics). The convergence of technology will require changes in clinical organisation3. So if technology could provide smarter and more effective drug delivery solutions, how far should we go? What level of technology do we need and might we see in inhalation in the future?
PA Consulting Group believes that the technology enabled route has the potential to significantly reduce total healthcare costs if a more holistic view is taken. Thus, the drivers of PbR and the need to prove or demonstrate efficacy could be one of the elements that rather than being a threat, actually stimulates companies to invest in technology and real time diagnostics. In this way future products have the potential to provide better drug delivery systems that are demonstrably more efficacious and enable more patients to achieve better treatment and quality of life both with existing drugs and new/emerging therapies/NCEs.
So what might the future hold? At the 2012 Respiratory Drug Delivery Conference in Arizona we conducted a survey to establish where inhalation professionals think technology might be heading with respect to inhalation.
PA Consulting Group asked the question: - “Where will inhalation technology be in ten years?”
However, to stimulate discussion and tease out views on the factors affecting the uptake of technology, PA Consulting Group provided reference levels of technology one might expect in the future. Participants were asked to vote for the level of technology they believed would be on the market, within an inhaler, in 2022. The technology levels were selected based on examples of technology that already exist or are in development in other sectors of healthcare.
Respondents included representatives from pharmaceutical and device companies, suppliers, regulators and academics. Views were wide ranging, however, the spread was skewed towards more inclusive technology rather than basic user aids and opinion was that technology will play a stronger role in inhalation in the future decade. Analysis of respondents’ views and PA’s current experience reveals a range of benefits, drivers and barriers to technology evolution. These are discussed further below.
Increased technology in inhalation products has the potential to have positive impact and provide benefits in a number of areas:
Reduced healthcare cost through:
Improved clinical outcomes, less exacerbations and fewer hospital visits/relapses
Increased revenues for pharmaceutical companies
Notably, much of the value of the above is embedded in complex calculations that describe service (rather than product) benefits. What is clear is that the whole healthcare model must change if we are to manage and contain escalating costs and realise the benefits technology can enable.
A range of drivers are influencing the consideration of inclusive technology as discussed below:
Improve clinical outcomes: Improving patient adherence through intervention can improve adherence4 and potentially reduce the significant cost of non-adherence or of ineffective delivery1. Compliance monitors and reminders are clinically proven to help achieve improved adherence with intervention in poorly adhering patients improving clinical outcomes. Feedback from advanced devices enables better estimation of what is being delivered to the lung, providing better design inputs to next generation inhalers. Improved technique through better feedback (from awareness of poor adherence) results in improved response to therapy.
Improved product safety: Similarly technology can be a route to improving product safety. Poor outcomes often result in an escalation of the dose or medication. In cases where the poor outcome results from poor technique the escalation is not addressing the problem and can result in increased side effects and compromised patient safety. Awareness of poor technique through improved monitoring coupled with feedback that helps patients develop better technique is likely to improve patient safety. Furthermore, more advanced technology has the potential to improve consistency of delivery, reduce patient critical errors, improve useability and ultimately through improved patient health, gain increased patient acceptance and even better adherence.
IP Capture: With the IP landscape for inhalers becoming increasingly crowded companies are looking wider to secure future products. Convergence in the healthcare industry between drugs, devices, diagnostics and even ‘well-being’ products means that IP outside that of a company’s core skill area is becoming more attractive. The modern pharmaceutical company must look beyond its comfort zone as companies such as Nestlé, Sony and Ford move into healthcare. A recent study by CambridgeIP found that up to 89% of new medical device patents involve wireless technology but less than 8% of ~11,000 inhaler patents included wireless5.
Lifecycle management and differentiation in the marketplace: This can apply to both off-patent and proprietary products. There is significant potential for branded generic drug developers to differentiate their products from other similar products eg Teva’s Easi-breathe BAI achieved this more than 18 yrs ago. Larger pharmaceutical companies that can afford the investment have the opportunity to add value to off-patent products and line extensions with added technology as well as improving delivery of well tested and perfectly adequate generic drugs. If they don’t, add-on products will continue to emerge and claim the higher value revenue.
With all the potential benefits and drivers outlined, what is holding back the flood of new products?
Legislation: The inability of regulatory bodies to keep up with technological development was cited by many respondents as the main barrier to approval of technology enhanced products. In development now are combinations of drugs, medical device hardware and software, diagnostics and even consumer products that quickly reach the limit of experienced regulators’ ability to define the optimum regulatory pathway. An example here is that Ford, working with Medtronic, has developed a prototype system that allows Ford SYNC® to connect via Bluetooth to a Medtronic continuous glucose monitoring device and share glucose levels and trends through audio alerts and visual displays. It can also be linked to an iPhone asthma management system6. Does this make a car a medical device? What is the regulatory pathway here?
Furthermore, the spread of liability across healthcare networks implicates a regulatory landscape beyond that of the FDA and EMEA. PA’s own work with the GSMA5 has found that the main challenge lies in finding the right balance between very different regulatory motivations and the resulting dynamics of the communications and healthcare industries. Medical approaches to regulation result in closed, integrated solutions where the provider has control of the architecture. To support innovation and serve a mass consumer market, mobile health needs the sort of common standards and interoperable approaches that allowed the telecommunication industry to thrive.
Cost of development: The cost of developing a technology laden product and its associated service is inevitably high. However, the extension to providing a service based product requires a larger leap of faith that the downstream value (savings) created can be shared upstream through initial cost increases. In essence such a model is more that of a business than a product and at the outset the business case must be developed against this precept. The value chain is likely to involve a number of new players in strategic partnerships and their margins must form part of the proposition. It is likely that currently only large Pharma can afford integrated healthcare solutions and undoubtedly some already have inhaled telehealth solutions in development. In the current climate they cannot afford not to.
Payers and reimbursement: Whilst many products can have technology applied, the business case for doing so in a manner that satisfies healthcare payers is complex. This is particularly true when the case rests on ‘managing’ a condition rather than real prevention or cure. In many cases business propositions where healthcare providers need to pay more for increased benefit will not be acceptable if the providers do not share some of those downstream benefits. However, technology enhanced products could initially be available to users who are prepared to pay for it themselves risking that this will initially result in a two tier system. A recent positive move has been that in the UK the National Institute for Clinical Excellence (NICE) is considering offering advice to venture capital firms on the type of evidence needed for NICE technology assessments. This is reflective of the shift in emphasis of technology developers from primarily clinical and regulatory considerations to considerations of how to demonstrate efficacy and the value of holistic solutions in healthcare systems.
Competencies: The multidisciplinary nature of combination product development is already experienced by pharmaceutical companies that develop drug-device combinations, even if they are purely mechanical solutions. However, the development of the technology described in the survey levels ventures well outside the core competency of pharmaceutical companies, and even traditional drug delivery device developers. Partnerships will be essential..
Examining the patient care cycle and mapping onto this the emerging technology levels used in the survey demonstrates that, by adding technology to inhalation therapy, control over the whole care cycle can be achieved.
Through the use of technology pharmaceutical companies, whether knowingly or not, are moving from a product-based to a disease management and service-based model. Pharmaceutical companies will need to assume more responsibility (some already are) for the clinical outcomes beyond those proven in traditional clinical trials. Payers are moving to assessment of drug products not only on their clinical results but on the value they bring to the whole care pathway (savings in total healthcare costs) and the quality of life.
As developers of inhaled products we are in a unique position in that whilst it is a drug that is prescribed, the patient is actually presented with a device. This device can provide a ‘gateway’ to treatment, in much the same way as we see other everyday mobile devices as our gateway to the world. Future products must move beyond that of a drug delivery device to being serviced based, incorporating features such as user-preferred settings, dose and adherence monitoring, condition-related lifestyle aids, integrated diagnosis and web-based disease management. Once we see the device in this system context then new possibilities emerge.
Phil Seeney is an expert in healthcare management at PA Consulting Group
1. P Trueman, D taylor et al. (2010) Evaluation of the Scale, causes and costs of Waste Medicines
2. PricewaterhouseCoopers report, Healthcare Unwired: New Business Models Delivering Care Anywhere, 2010
3. Clinica, Medtech Intelligence: Megatrends that will impact the future of medtech, 23 November 2012, Brian D Smith
4. Philips, T. Dyche, DDL Dec 2010, J. Pritchard, RDD Berlin May 2011