38-39 - It’s time to make non-clinical differentiation a strategic priority

As a society, we are in the fortunate position where many common disease areas have now been satisfied.

We have treatments for conditions that, just decades ago, would have been life-limiting, or even life ending. But what does this progress mean for the industry? It means pharma on the triumvirate of efficacy, safety and affordability, to differentiate itself in the market. We need a new model.

One approach has been the development of non-clinical offerings and services. Non-clinical differentiation, affectionately known as ‘Beyond the Pill’, isn’t exactly a new kid on the block. In fact, the patient benefits of ‘beyond clinical’ services are now accepted across the life sciences. And yet, even while acknowledging the clear advantages to patients and HCPs, pharma companies have repeatedly failed to make non-clinical offerings a strategic priority.

So, how can non-clinical solutions help companies adapt to this new drug provision landscape? How can we strategically leverage its benefits while delivering genuine value to patients and payers? What will it take to transform Beyond the Pill from optional industry extra to essential market opportunity?

Patient support programmes (PSPs) and supplemental services include financial support and reimbursement, disease education and awareness programmes, and field services. Traditionally, these services only came into play at the end of a drug’s life cycle. A ‘last chance saloon’ when all clinical features had been exhausted.

Now, companies are waking up to their myriad benefits. They offer a competitive advantage in a saturated market. They entice patient buy-in. They support long-term commitment, meaning a patient is more likely to stay on a prescribed drug. Comprehensive PSPs also help pharma firms position themselves as companies who care. This is particularly important for patients with terminal and chronic conditions with more complicated care requirements. Abbvie for example, have established themselves as market leaders in patient service leaders with their Humira support programme.

For non-clinical strategies to succeed, it’s vital that pharma companies change their mindset as well as their approach. That means positioning themselves as a provider of services as well as a dispenser of products. They must also be more proactive with the development of their PSPs, pursuing them as essential opportunity not last resort.

Rather than rely on revenue from traditional drug development cycles, more companies are channelling their R&D efforts into targeted therapies for the most complex diseases. Breakthrough treatments in the biotech space, for example, are boasting strong patient outcomes and improved overall quality of life. And, from an HCP perspective, effective one-off treatments such as gene therapy can reduce both the cost and labour burden of long-term care.

But, with the combination of substantial R&D investment and relatively small market size, these therapies come with a heavy price tag. Right now, the cost of gene therapy ranges from $300,000 to $2 million per treatment. As payers battle to balance efficacy and expense, these groundbreaking treatments remain out of reach to many.

It’s a problem without a quick solution. For such therapies to become widely available to patients, the entire fee-for-service model needs to be reworked. As key decision makers steadily embrace the inevitable transition from volume to value-based care, pharma companies must also realign their strategy. That means as well as convincing payers of the efficacy and clinical value of new therapies, they must also prioritise value and access through robust PSPs, such as reimbursement, educational materials, transportation, or dedicated support nurses.

Healthcare is no longer something that just happens inside surgeries and hospitals. An entire digital health ecosystem has emerged, giving patients more autonomy and control over their care. These technologies range from basic wellness management to prescription-based therapies, such as MindMaze’s VR environment for neurorehabilitation and Pfizer’s LivingWith app.

At the beginning of 2020, the move from organisation-centric to patient-centric care was already an established trend. But when the pandemic hit, it became an immediate necessity. Healthcare systems had to reinvent themselves overnight. Extended lockdowns and social distancing have accelerated the demand for remote patient monitoring (RPM) tools, digital technologies and telehealth solutions at an unprecedented rate.

The pandemic highlighted, beyond question, the long-term benefits of digital services and RPM tools. It proved their ability to boost patient engagement, adherence and monitoring. In a recent trial, more than 85 percent of patients that used an RPM solution indicated they would use it again if it was made available. With many reimbursement policies for RPM and telehealth programmes set to expire after the pandemic, companies must push to ensure they remain an industry standard.

Purpose
On a fundamental level, the pandemic limelight forced Big Pharma to confront probing questions about its purpose: Is our objective to deliver drugs, or improve health? If the latter, moving forward pharma companies must focus less on speed of access to market, and more on impact of access to patients. That means treating non-clinical services and PSPs as much more than convenient ornamentation. These services are a crucial aspect of any patient- centric approach to healthcare. They can help pharma companies better position themselves as strategic partners to health systems, rather than just vendors.

Partnerships
It’s unlikely that traditional pharmaceutical manufacturers will be willing or able to invest in their own digital and RPM patient services soon. The future of integrated digital PSPs therefore likely relies on their collaboration with established healthcare technology players. Rather than reinvent the wheel, companies can meet mounting pressure to diversify by pursuing third-party partnerships for existing portfolio products. This approach will allow pharma to unlock added value without radically redefining its own market position.

Provability
The true impact of a PSP can be difficult to measure. But, as they become more widespread within the healthcare landscape, payers will demand evidence of their value, and pharma companies must be ready to provide it. This means more than paying lip service to patient-centricity. For non-clinical strategies to really have impact, they must provide fundamental, not ornamental, value to patients and HCPs.

Patients and Payers
When implemented well, non-clinical strategies and PSPs have the power to uplift the entire health ecosystem. For payers, this means more value for investment, better patient commitment to treatments, and a reduced healthcare burden. PSPs and non-clinical solutions can also support with cost containment, particularly for chronic conditions requiring long-term care. For patients, the growth of Beyond the Pill signals more than a symbolic gesture towards patient-focus. It offers a tangible impact on medication access, outcomes and experience. Tailored support packages and specialised pathways provide a personalised standard of care. Support services and communication channels help patients feel more informed, and more empowered, to manage their conditions.

Whether digital, financial or care-based, non-clinical services drive better patient outcomes and benefit the whole health ecosystem. By learning the key lessons of the pandemic and embracing value-led trends, pharma companies can develop a differentiation strategy that enables payer negotiations and improves patient access and adherence. For this holistic model to function, it’s vital that each strand collaborates and communicates effectively throughout the pipeline. For pharma, that means engaging entire rows of stakeholders as early as possible in the development process, including regulators, industry consortia, payers and patients. Above all, it must deliver genuine value to patients. Without it, a non-clinical strategy becomes nothing more than an empty marketing ploy.