There is a lot of buzz in the pharmaceutical and healthcare industry right now around the concept of ‘Patient Centricity’.
The term can mean many different things to a lot of different factions within the healthcare space. With high profile headlines about drug pricing in the market, the industry is coming around to the enlightening thought that it ought to be more overtly focused on the patient. This is now borne out in many facets of the business.
Pipeline development is one leading indicator of where the industry’s focus resides. Market factors have driven pharmaceutical and biotech companies to pursue therapies in increasingly specialised therapeutic areas. With the advent of priority review programs by the FDA, companies are increasingly focusing on areas such as oncology, as well as diseases where there is long unmet or underserved need. These areas are attractive for pharmaceutical companies due to the expedited and largely assured regulatory approval, as well as attractive premium pricing and patent protection.
It is interesting to follow the role of patient advocacy groups for these rare diseases, as evidenced recently in the approval of a prominent muscular dystrophy drug, where patient testimony seemingly played a substantial role in the ultimate approval of the drug, despite reservations from the FDA review panel regarding its perceived effectiveness. Regardless of one’s perspective, it was clearly a win for the patients who, up until that point, faced no current available treatment and potentially life-limiting prospects.
In the drug development space, we are seeing Patient Centricity borne out in formulation development and drug delivery. For oral solid delivery forms, the advent of more patient-friendly technologies can offer a more palatable, increasingly biologically-effective and better, faster acting product. Technologies such as soft gels, liquid gels and liquid-filled capsules, rapid release or quick dissolve formulations, dissolvable thin strips, as well as multilayered or multi-formulated tablets for drug combinations to reduce pill burden, all bring smarter and more consumer-friendly solutions to the patient. For parenteral delivery forms, we are increasingly seeing technologies to reduce the complexity of drug delivery.
Traditional vials and syringes are making way for advanced pre-filled syringes with refined safety technologies, as well as the advance of highly engineered and even multi-use auto-injectors. Further developments are seen in topical deliveries, transdermal technologies, inhaled therapies and even discreet wearable infusions and electronics. As a shining example, while it took many years and considerable persistence to reach the market, the novelty and convenience of MannKind’s Afrezza inhaled insulin product has brought a significant step-change for patients suffering from diabetes.
Integral to drug delivery is drug packaging. Often maligned due to the encumbrance brought on by the need for child resistant protections, drug companies have made considerable strides in commercialising medicines with more Patient Centric approaches to the packaging that delivers the therapy. Providing patients with medicines that are packaged not only for protection, but also for discretion and convenience, is a notable pivot for the industry. FDA has helped inch the industry along with its requirements for Human Factors studies, forcing companies to take the time and effort to engage focus groups and ensure the voice of the customer is reflected in the ultimate packaging.
Patient compliance and adherence is another element of Patient Centricity that is increasingly an area of focus for the industry. Holistic adherence programs engage patients in a variety of ways such as patient enrolment and support programs, physician and pharmacist engagement, follow-on remote monitoring, nursing engagement and intervention, patient education, and many other touch points to encourage positive health outcomes.
Within the packaging segment, published studies have identified that simple unit dose calendarisation has considerable impact on both patient adherence as well as persistence, supporting patients to take medication consistently and effectively, engendering patient behaviours resulting in staying on therapy longer and reducing fall-off.
Increasingly, pharmaceutical companies are leveraging this methodology and also addressing other elements of non-adherence through packaging by incorporating tools for cost mitigation and reimbursement instruction, patient education and disease state education, side effect education, lifestyle tips, goal setting tools, and many others in a coordinated adherence strategy that leverages packaging as the primary ‘direct to patient’ channel.
Such Patient Centric design is evidenced in the Vertex Pharmaceuticals Orkambi Cystic Fibrosis treatment, a recipient of the Healthcare Compliance Packaging Council’s (HCPC) Compliance Package of the Year in 2016. Considerable research and patient feedback helped guide the development and commercialisation of the product and its outstanding packaging, clearly reflected in the consumer-friendly design.
For many years, industry focus in clinical trials was concentrated all around the data. As the industry has evolved, so has the realisation that the quality of the data is contingent upon the patient’s engagement with the investigational drug product. If the patient fails to take the medication properly, ultimately the success of the drug product is compromised and generates false or unusable trial data.
Worse yet, non-adherent patients are lost, at significant expense to financial and trial duration goals. Increasingly, sponsor companies are utilising packaging and adjacent technologies to facilitate patient engagement and feedback, in addition to spurring effective adherence, ultimately leading to better data capture and analysis.
Specifically for packaging, sponsor companies are opting not to take the traditional ‘just throw it in a bottle’ approach, but devoting the resource to develop packaging that helps facilitate a positive user experience and supports adherence. This may actually include packaging that captures information about when patients dose their medication, or may even potentially provide some level of interactivity such as a prompt to the patient to take their medication; prompt for a response as to how they feel or what they are experiencing; or further connecting the patient to interactive communication tools as part of the study.
Similarly, the structure of the study itself may be more Patient Centric in its logistical approach. As the name implies, Direct-to-Patient studies offer a way to engage study participants and reduce the burden for participants to travel frequently to clinics. These new logistical models provide a different dynamic to bringing focus to the patient, their needs and lifestyle realities, and ultimately a better and more effective treatment.
In the developed world, patients rarely ponder whether they are receiving authentic or unadulterated medicines. However, in less developed countries, the reality of receiving ineffective, improper or even harmful medicines is a daily reality. Studies have demonstrated that in some Latin American or African countries, counterfeit medicines can comprise an estimated 30-70% of the supply. This has led to new authentication technologies to assure everyday patients that they can be confident in the medicines they are taking, increasingly leveraging the prominent use of cellular connectivity.
In the United States and Europe, major effort has been undertaken to provide Serialised medicines that in principle should help authenticate the security of the pharmaceutical supply chain. Technologies are being implemented to provide registered data that can be monitored and verified. Furthermore, anti-counterfeiting technologies contained within the packaging help provide a robust and multilayered strategic approach to ensuring that the drug and its packaging are authentic and also not adulterated. These initiatives will provide a foundation for extending product assurance to emerging markets and developing countries in a patient-focused approach.
With the rapid advances in consumer technology, one has to wonder how these breakthroughs will find their way into the healthcare continuum in a way that is truly Patient Centric. Published news has shown promise in interesting applications such as smart pills, providing real-time information as they travel through the body.
Technologies such as these may not be Patient Centric in the eyes of many people, however, who may find the idea of ingesting a small robot disturbing. Conversely, the broad appeal of Fitbit style technologies and Apple smart watches demonstrate that health technology can be engaging to the patient when it has a perceived value or benefit to them.
Technologies such as these can drive very positive patient behaviours – including diet and exercise, adherence to medication, real-time health monitoring and potentially data sharing if incentivised by healthcare providers, employers and insurers. Continued development in virtual reality or augmented reality opens a whole new horizon for people to manage their health, if done in a way that demonstrates value to them as the patient.
What is clear is that when companies take a measured and focused approach to understanding the patient, their needs and their circumstances, positive outcomes are realised. The industry is changing and we should be encouraged by its focus on driving positive and sustained change towards a Patient Centric outcome.