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Scientific and digital development has created a ‘new build’ surge across the pharma landscape. Bold structures are appearing at a whirlwind pace, towering above the pre- pandemic skyline with their promise and ambition.

The high-rise promise of cell and gene therapy is the new architecture, gleaming with patient-centric potential and transformative intent.

But, as with every construction boom, the correct materials need to be in place.

Patient support programmes (PSP) are the foundations that will make pharma’s new era function and thrive.

As R&D continues to reach skyward, PSPs are integral to therapy design and patient outcomes. They are the multipurpose building blocks that improve patient safety, pharmacovigilance, trial enrolment and retention, disease management, adherence, market share and quality of life for patients. They have proliferated in recent years and are becoming increasingly adept at tailoring content for individual patients to cope with complex regimens and engaging with diverse and hard-to-reach communities.

Aaron Hall, Associate Creative Director (Healthcare Copy) at Purple Agency, the international marketing agency, a part of HH Global, highlights that technology is playing a critical role in the growth of PSPs and their ability to connect pharma, healthcare professionals (HCPs) and patients, and energise remote monitoring and data generation.

“Technology has definitely transformed what is possible from the healthcare system perspective with vast improvements in how HCPs can interact with pharma and patients. We should not underestimate the value of HCPs being able to continually monitor a patient on medication,” he said.

“This empowers and supports patients but also generates clinical and scientific data that can be used to develop better care programmes.”

Collaboration boosts potential

Hall believes the best PSPs are those that liberate HCPs’ time by reducing clinic and hospital visits while also amplifying the patient voice in consideration of how therapies are designed, trialled and delivered.

“There are a range of benefits from a good PSP,” he added. “The knowledge they generate can act as a spur for R&D, particularly in rare disease areas where there are limited patient populations. They also unite those patients to give them a louder voice while providing HCPs and pharma with real-world evidence.

“Research has shown that they also lead to greater adherence – and less complications – which improves outcomes and helps with healthcare system economics.

“Collaborating does lead to greater things and it is exciting to see what developments in cell and gene therapy can achieve if they are matched with a strong PSP.”

PSPs are by nature bespoke and vary in their intention, components, pharma involvement and mode of operation, which makes evaluation problematic, but a systematic review of 49 PSPs earlier this year, published in Patient, underpinned the benefit by stating that they ‘play a key role in promoting treatment effectiveness, clinical outcomes, and satisfaction’.

Hall cites one PSP that he worked on where the pharmaceutical company responded to patient feedback to develop a new drug delivery device that improved patient adherence.

“That kind of outcome is something we champion. It had connectivity from everyone looking after the patients, but busy HCPs sometimes still need reminding that PSPs are available and that they are effective,” he added.

“We also need to be aware that some patients find it difficult to access technology or struggle with the design functions on smart phones and tablets,” said Hall. “PSPs should be designed to win awards on usability, not style. We have to make sure everyone can benefit from what is a crucial part of healthcare.”

The need to evaluate

Finding metrics that evaluate that benefit is complex, costly and has rarely been attempted. “I have been involved in more than 50 PSPs but none have had a full economic evaluation,” said Christina Jackson, a behavioural psychologist and partner and founder at Sprout Health Solutions, an agency that works with pharma across the drug development pathway to deliver evidence-based insights, behaviour change programmes and Clinical Outcome Assessment (COA) strategies.

“We must find ways to overcome pharma’s internal barriers to thoroughly evaluating patient support programmes. Additionally, the industry is missing out on their value as there is rarely standardisation so there is less opportunity to learn and understand across functions and disease areas,” she added. “Having a standardised approach to the development of programmes would enable companies to get more data and a greater understanding and as there is a greater interest from payers in adopting value-based pricing, it also makes sense to invest in an economic evaluation.

“We also need to have increased focus on implementation of PSPs so that more patients can benefit from them. While the successful implementation of healthcare innovation brings myriad challenges, we find that applying knowledge and strategies from the growing field of Implementation Science helps us make sure that PSP roll-out leads to maximum uptake from HCPs and patients.

“But these areas for improvement should not detract from the massive opportunities PSPs present.”

Jackson, who was at the vanguard of deploying behavioural psychology to influence healthcare outcomes, said: “The potential benefit for patients with unmet needs is vast.

“Most of the time they are living with or managing their long-term condition alone, so there is a real opportunity for programmes to provide support for the 363 days a year they are not seeing a doctor.

“When developed in collaboration with our subject-matter experts, PSPs can address issues such as adherence to medications, depression, anxiety and fatigue management, reducing workloads for HCPs by supporting challenges they either don’t have the time for or are not trained to deal with, making PSPs vital partners in delivering improved health outcomes.”

Jackson added: “For example, a frequent aim of patient support programmes is to improve adherence to medication, but the reasons for non-adherence vary between individuals and over time, and HCPs rarely discuss adherence in routine consultations. We design PSPs that can uncover an individual’s barriers to adherence (and how they change over time) and tailor the content to counter specific barriers using evidence-based behaviour change techniques.

“We’ve shown that you can overcome psychological barriers through PSPs.

“The other clear benefit is that HCPs are generally pleased to have content that does something different from what they can do and goes beyond information leaflets to support people to adapt their behaviour.”

Jackson believes going beyond lip service and truly embedding evidence-based health behaviour change strategies will play an increasingly central role in both PSPs and healthcare delivery, as systems around the world wrestle with demands from growing populations living with co-morbidities.

Dynamic PSPs drive step changes

Max Noble, CEO and founder of VISFO, a healthcare agency specialising in generating insights from granular patient data and experiences to transform care, wants to see more dynamic PSPs driving step changes in treatment and evidence generation.

He believes they can reach way beyond their current mission and be the agents of a paradigm shift in healthcare, facilitating earlier diagnoses and more holistic treatment plans that deal with the entire person rather than a single condition.

“Many of them are great but they can go a lot further,” said Noble. “There has been a drive for pharmaceutical companies to create PSPs, but many fall down by not working with people living with the disease. They create things pharma think patients want rather than what they need. There’s a big mismatch.

“The big challenges with all drugs are adherence and compliance, so improving that generally modulates the disease and improves their quality of life and mental health. Now, if you can track that and show how those things are improving, that’s the gold [standard].”

Valuing patient data

VISFO, which has health economists, medics, data scientists, immunologists and software engineers on its teams, is creating its own PSP, free from industry investment, for the autoimmune disease lupus. The agency is convinced it will demonstrate a higher level of efficacy and create a strong business model based on its data science and health economic evaluation.

It is a bold new approach, particularly as organisations tend to invest in PSPs that are closely tied to single drugs.

“Take someone with rheumatoid arthritis. They may be on several medications yet one company will only support through their drug,” said Noble.

“There has to be a better way.

“Drug companies will always make PSPs because they know their drug, the therapy area and what they are trying to achieve, but there are barriers to uptake, such as trust.

“In the lupus project, we are able to dig deeper with patients and, rather than ask them a ‘one- size-fits-all’ set of questions, we have developed technology to allow people to build their own dynamic patient-reported outcome measures. This allows true personalised decision support and monitoring of key characteristics such as flares, headaches, light sensitivity, GI symptoms, sleeping patterns, cognitive changes or mental health and sharing that with their HCPs, through longitudinal tracking visualisations to improve their disease management and, of course, pharmacotherapy.

“It is a far richer use of patient data, held under military grade security, and it puts natural histories, real-world evidence and insights to greater use, which is where the commercialisation comes in.

“Being able to identify key characteristics that will benefit from certain treatments, and the impact of nutrition and lifestyle changes, generates a valuable resource for the pharmaceutical industry. This opens up the opportunity to run a really targeted clinical study and get strong outcomes, which lifts a drug’s chances of succeeding through the regulatory process and reimbursement.”

He added: “We should be doing much better with PSPs and be more ambitious about the role people can play in healthcare.”

Reports by analysts Deloitte underscore the value of PSPs as industry pivots to outcomes- based reimbursement models and emphasise the potential from AI, analytics and data. Realising it takes investment in resources, digital competencies and cloud-based systems.

But, significantly, it will also involve a deeper understanding and evaluation of their performance to spread awareness of programmes across healthcare, argued Charlotte Maule, director at healthcare public relations agency, Anthem.

“There is work to be done here because there is a lack of traction with some HCPs and there may be a disconnect in multidisciplinary teams where one person might know of a PSP but others have no knowledge of it. This limits their reach and efficacy,” she said. “We need to better communicate the benefits, as I think it is a lack of awareness rather than reluctance that is holding some HCPs back.

“Awareness among patients is also key, as they are the ones that will go to HCPs and ask about PSPs.”

Putting patients at the centre

She identifies a concern from HCPs about pharma funding of PSPs, as well as concerns about long- term commitment as barriers to more widespread involvement.

“Sometimes there is a big launch of a PSP but then activity may begin to dwindle or even discontinue after just a couple of years and patients rightly question a pharma company’s motives,” she added. “It is important that these initiatives last because they are so critical to the future of healthcare, particularly as we move towards more remote monitoring and home care.

“They are also really powerful ways for pharma to build trust with stakeholders and to help healthcare systems fill gaps in their services.”

Anthem, a company that crafts high quality content and ignites credible health conversations to develop best-in-class stakeholder relationships, believes PSPs should be celebrated and the patients firmly positioned at the centre of their care.

“Most patients want to take ownership of their illness and want to be involved in making their health, and that of their communities, better. PSPs are a great way of empowering them to do that,” added Maule. “I’m really passionate about the fact that patients should be involved from the start and should be true co-creators of these programmes. Pharma talks about being patient-centric and although that is happening, it is not happening fast enough. Getting patients involved at the start of the journey helps you create a PSP that is really effective, because you are able to understand all the nuances of how a condition impacts their physical health and their lives.

“We can see that patients have become more involved over recent years, but levels need to increase.”

She cautions that the lure of digital capabilities should not obscure the needs of a significant group of people that struggle with technology and respond better to more human contact.

“The approach needs to be tailored, and the beauty of that is that we have the capabilities to target support,” added Maule. “There is so much to be gained all round from a well-planned and constructed PSP with patients at its heart.

“We run these programmes to create a better patient experience – that is the ultimate goal. Patients have to be involved because they are the experts in their condition and should be treated as such.

“PSPs will continue to grow and those that listen to patients from the start, understand the condition on all levels and have long-term commitment, will be the most successful and forge genuine advances.”