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COVID-19 is no obstacle to Expanded Access

29 Jan 2024 | By Expanded Access

The COVID-19 pandemic has had a profound effect on humanity. Societies have been locked down for months and the global economy has taken an unprecedented hit.

The COVID-19 pandemic has had a profound effect on humanity. Societies locked down for months and the global economy has taken an unprecedented hit. Even now, nine months after the virus first got a jump on attempts to pin it down in Hubei Province, nations are struggling to establish a workable balance between public health and dislodging the spanner from the economic works.

Nonetheless, it would be a mistake to assume the coronavirus’ impact is evenly spread. Yes, some industries, such as commercial aviation, have been particularly badly affected. But, equally, there are many examples of companies, indeed, entire segments escaping relatively unscathed. Just look at Amazon’s Q2 profits.

So, where does that leave expanded access programs (EAPs)? With, as an absolute minimum, several months of hard work ahead of us in suppressing it, does this cruel virus necessarily hamper the pharmaceutical industry’s ability to provide patients with unmet medical needs safe and timely access to emerging therapies?

Having worked in this area for 10 years, my answer to that question is an emphatic no.

Expanded Access Programs vs. clinical trials in a post-2020 world

It’s fair to say that clinical trial programs throughout the world haven’t fared well in 2020. Trial upon trial has been stopped or suspended. Many directly involve individuals potentially very vulnerable to COVID-19, so, if we are to abide by the principle of ‘first, do no harm’, limiting trials is a necessary evil.

What’s more, in a worrying development for pharmaceutical organizations looking to test the efficacy of their latest discoveries, research conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) indicates that the proportion of people saying they would be willing to take part in a clinical trial dropped alarmingly from 85% in 2019 to just 49% today.

That represents a serious setback to our industry. Not only has the development of hundreds of vital therapies and medicines been delayed for the foreseeable future but, it would appear, public trust in clinical trials has been eroded significantly.

Counterintuitive as it is to think that people have lost faith in clinical trials, while the frantic hunt for a vaccine that might alleviate a once-in-a-century global pandemic is on, countless non-COVID patients could suffer further down the line because we cannot conduct – and people are unwilling to participate in – clinical trials.

EAPs are a different matter

So, with clinical trials in the doldrums, it would be reasonable to think that expanded access programs are compromised by the same dynamics. Surely, with uncertainty serving up the prospect of sporadic locking and unlocking of restrictions, the coronavirus throws too many obstacles in front of anyone contemplating running an EAP during this delicate period, right?

Again, it’s a no. For me, clinical trials and EAPs are two entirely different animals. And there is every reason an EAP can overcome the hurdles and see to it that patients with unmet needs gain access to the therapies they require.

In fact, so strong are those reasons, not only has COVID-19 and the widespread absence of clinical trials made EAPs more relevant than ever but they also present real opportunities for pharmaceutical companies in four key areas.

Patient Access in Expanded Access Programs

The coronavirus is unforgiving. It doesn’t give a free pass to those with pre-existing conditions. Indeed, often it poses them a greater threat but, regardless, their unmet medical needs remain. They still suffer debilitating or life-threatening illnesses and, without access to a therapy that could benefit them, their anguish will continue.

Clinical trials, when they are available, can be valuable to those who qualify and who are able to take part. But they come with practical strings attached. Quite rightly, there are a number of controls in place to ensure the conclusions drawn are rock solid. And that militates against flexibility.

EAPs, on the other hand, can be designed to accommodate patients who would otherwise be excluded from clinical trials by geography or their inability to meet strict clinical inclusion criteria. With fewer, if any, requirements for physical clinic visits and the ability to monitor patients virtually, the constraints on broadening patient access to a treatment are largely removed.

EAPs can even be coordinated to allow patients continued access to therapies they first received during clinical trials, many of which are, sadly, now suspended. It would be a positive to think that, although product development might be curtailed, access could continue unabated in pursuit of better patient outcomes.

Using your Expanded Access Program as commercial opportunity

There are the brass tacks to think about, too. Aside from the altruistic desire to extend your early access program as far and wide as is practically possible, there are commercial benefits to running an EAP. The opportunities are hard to ignore.

A well-designed EAP program gets the word out on your product, informing relevant patient communities and putting it in the hands of healthcare professionals. That kind of awareness and familiarity engages KOLs and can be extremely valuable in breathing momentum into a nascent commercialized therapy.

Synergy with clinical trials around the same product is also worth bearing in mind. Data and insights, drawn from an EAP and potentially more indicative of real-world scenarios, complement those gathered from clinical trials and can add significant value in terms of product development and planning.

And, as is increasingly the case, sponsors and regulators include real‐world data from EAPs in the efficacy profiles of treatments and it is accepted as evidence by regulators, when collecting data in controlled settings is unfeasible or the target population is small.

Early Access Program design and delivery

With the right partner in place, the inherent flexibility of an EAP means you can design and optimize a program that meets the needs of every connected stakeholder. Even in today’s novel circumstances.

With “no contact” delivery methods and tech-enabled remote data collection and follow-ups, underpinned by dedicated and experienced teams with in-depth knowledge of the vagaries of regulations in different territories, the whole program can be managed accurately, efficiently and flexibly from afar.

Moreover, engaging an EAP partner with full control over its physical warehousing infrastructure at the global level, rather than outsourcing storage to a third-party provider, ensures you have a grip on certain COVID-related risks and decision-making. You have direct visibility, for instance, and greater input into supply chain continuity plans, when and if the virus, as seems likely, once again becomes more prevalent.

Expanded Access Program ecosystem connectivity

Technology has the capacity to bring people together. In the throes of the pandemic, it’s been something of a savior for many of us at both the personal and professional levels. And, now more than ever, it can add real value to an EAP.

Boosting all-round engagement throughout a program’s life cycle has been among the biggest objectives in the sphere for a long time. But the industry has, to date, fallen short.

However, valuable digital platforms are emerging. Uniphar’s own online portal, uniphi, is a case in point. It offers pharmaceutical organizations the ability not only to engage all connected stakeholders actively, but to enable them to make their own contributions to a program.

Patients, for example, are empowered to record their own progress, so they can take an active role in managing their own health and reassuring them that their input is valued by the sponsor.

And, by aggregating patient and caregiver reported outcomes with healthcare provider (HCP) recorded data, the platform can enable a deeper and more accurate collective understanding of how a therapy is performing outside the controlled clinical environment.

That, in turn, furnishes the pharmaceutical company in question with vital Real-World Data that, like is often the case with a well-designed and implemented EAP, illuminates their decision-making around how they can further optimize their product for the marketplace.

While EAPs will never replace clinical trials, they can certainly complement them in a number of ways. The pharmaceutical company benefits from insights that can go beyond those obtained under the tight strictures of a trial and add to the weight of approval and reimbursement applications. It can also use a program to drive stakeholder engagement with, and ground level awareness of, a product ahead of its launch to the market.

But, perhaps most importantly during this difficult period for us all, an EAP can play a vital role in addressing the unmet medical needs of people who were suffering long before they saw January’s initial TV reports from Wuhan.

So, despite the misperceptions of some, rather than acting as an obstacle to EAPs, COVID-19 makes expanded access more pertinent as an opportunity to deliver improved patient and commercial outcomes than it was even this time last year.