As pharmaceutical manufacturers face the threats of generic competition and increasing payer pressure, technology-enabled solutions are emerging as a smart way for companies to add genuine value and extend the life of their branded medicines.
In the respiratory space, pharmaceutical companies face losing their patent shields on their blockbusters, at which time they fall vulnerable to generic competition.
GlaxoSmithKline’s Advair (fluticasone/salmeterol) for COPD and asthma has been the mainstay of the drug major’s business for the best part of a decade and at its height was bringing in $5bn a year in the USA alone. Its US patent expired in 2010 and while an additional patent on the Diskus inhaler used to deliver the drug helped keep generics at bay until August last year, competitors have been knocking at the door.
It is not just GSK that is under pressure. The likes of AstraZeneca’s Symbicort (budesonide and formoterol), Merck & Co’s Dulera (formoterol and mometasone) and Teva’s Qvar (beclometasone) are also feeling the heat and companies are battling to protect their productive franchises. So how can pharmaceutical manufacturers maintain positioning and continue to demonstrate the value of their medicines to patients and payers when competing with a lower cost alternative?
Providing value ‘beyond the pill’
A key to doing this is adopting innovative ways to differentiate products. Approved drugs for asthma and COPD have a wealth of data behind them that support their clinical effectiveness but this is not enough in the face of less expensive generics.
They also need to come up with value-added services that benefit all stakeholders, going ‘beyond the pill’.
Moreover, despite the proven effectiveness of these respiratory medicines, real-world results are unfortunately suboptimal. As an example, 50% of asthma patients are uncontrolled, and studies have shown that two-thirds of the costs to treat asthma are due to poor control of disease.
Suboptimal real-world results are driven by a number of obstacles in the management of respiratory disease, with poor adherence at the top of the list. Adherence rates in asthma and COPD have been shown to vary from 78% down to a jaw-dropping 22%. As well as the human cost in terms of quality of life and avoidable deaths, the financial burden is considerable – about $92bn in the USA and 82bn euros in Europe. A COPD patient in the USA suffering from an acute exacerbation may require extensive treatment and an overnight stay, which can lead to a hospital bill in the thousands of US dollars.
A second hurdle is the reliance on patients to manually track and report medication utilisation and symptoms. This makes it very difficult for physicians to access objective data to make informed treatment decisions. If patients has an exacerbation, how do physicians reliably know if something has changed in the disease progression that they should respond to, or if the patients simply did not take their medication? Equally, how can physicians be sure that patients are providing an accurate or truthful report, or if the medicine is indeed working effectively?
The standard of care in respiratory medicine has remained largely unchanged for several decades. While we have seen the development of new delivery mechanisms and new combinations of existing molecules, the same old challenges persist. We need a new approach.
Technology is enabling the ordinary to become ‘smart’
While little has changed in the management of asthma and COPD, the world has been turned upside down by technology. The ‘Internet of Things’ has enabled ordinary items to become ‘smart’, by embedding technology to provide new and progressive capabilities.
Outside respiratory, other chronic diseases, for example diabetes, are incorporating such technologies. For example, Dexcom offers a mobile monitoring system that helps track and share glucose levels via a smart device. The platform includes a small sensor to measure glucose levels, a transmitter to send data to a compatible smart device via Bluetooth, an app and a cloud-based reporting system to display data and provide insights to patients and healthcare providers, such as highs, lows, daytime, night-time and best/worst days.
Mobile technology has the potential to solve many of the current challenges for asthma and COPD, and at the same time give pharmaceutical companies a way to distinguish their branded drugs from generics and drive continued brand loyalty among prescribers, patients and caregivers.
Smart inhalers, which are prominent in the new wave of digital technology washing over healthcare, have sensors that track medication use in real time.
Healthcare companies are increasingly exploring their use alongside platform technologies that engage patients, encourage compliance and provide real-time alerts to patients, caregivers and healthcare professionals. With retrospective and predictive data analytics capabilities built in, you have a powerful tool to provide an objective historic picture of patient adherence and engagement, and to inform future treatment decision.
Connected smart technology not only has the potential to improve patient experiences, outcomes and brand loyalty, but the information gained will help pharmaceutical manufacturers better understand the patients’ ecosystem and more effectively demonstrate the drug’s value to payers.
Picking the correct connected device is crucial
Already we have seen a number of ‘clip-on’ connected respiratory devices performing well on the market, but deploying a comprehensive, fully integrated smart inhaler that empowers pulmonary patients and the stakeholders that care for them will be most critical for global pharmaceutical companies.
Integrated devices incorporating both hardware and software, with no disruption to the medication delivery pathway, yield powerful data. The most optimal solutions for pharmaceutical companies to harness will be those that have been designed intuitively, to closely mirror the design and compact size of existing metered dose inhaler (MDI) devices.
With this, patients will find it easy to adopt and use the connected MDI, which will improve their visibility into medication persistence and adherence, in turn improving their engagement.
While technology permits companies to consider incorporating a number of features – from breath activation to shake confirmation – this should be balanced against consideration of the cost required to enable large volume global roll-out.
Pharmaceutical manufacturers would do well to adopt inhaler technology designed and developed for efficient, large-scale commercial supply. It makes sense to use a connected device that can be easily integrated into the company’s existing MDI process manufacturing, filling and packaging. The device should also incorporate a US Food and Drug Administration-approved mechanical dose counter, as this will allow pharmaceutical companies to transition their current products to connected devices more easily and in a stepwise manner.
Real-world data complements clinical excellence
Following these steps will ease regulatory and reimbursement pathways for pharmaceutical companies as they move forward with smarter add-ons to their products. They can go to regulators and payers not just with data from clinical trials but with objective real-world data on their established and clinically effective drugs.
H&T Presspart and Cohero Health recently unveiled the first market-ready metered dose inhaler connected to BreatheSmart, a respiratory care platform that can track adherence and measure lung function, and provide real-time alerts to patients, caregivers and healthcare professionals. For the first time, this allows the effects of preventer and rescue medication use on lung function to be tracked and analysed, giving a complete and objective picture of how a patient is responding to treatment, vital information for patients, physicians and payers.
While smart inhaler technology is revolutionising the treatment of asthma and COPD, it also offers potential usage with other medical conditions, notably cardiovascular disease and diabetes. As pharmaceutical companies
