In previous blogs, we’ve examined the Cell and Gene Therapy (CGT) landscape and the complexities involved in manufacturing and pricing. Complex and time-consuming manufacturing processes impact CGT pricing with a knock-on effect on therapy accessibility. This blog introduces CGT support solutions, discussing how these can be framed to improve the experience of HCPs, patients and carers.
Resourcing pressures and operational insufficiencies within healthcare systems have led to a situation where the treatment centres and hospitals are only able to support evolution in therapy options, with intervention and support from the industry. In an era of healthcare staffing shortages and increasing demand for patient management, the high costs of CGTs can only be justified if they can be delivered seamlessly. CGT support solutions are already challenging for Pharma to deploy effectively, and this burden is expected to increase further, as such therapies are scaled up to more prevalent disease indications.
Within the CAR-T space, we can already see a differential in the breadth and depth of support solutions provided by CGT developers. There are essential service components that form the “permission to play” blueprint, but beyond that, and looking into the future, where should the line be drawn? Will the pharma industry continue to be responsible for supporting the transition of HCPs and patients onto more innovative therapies as an unavoidable prerequisite of understaffed healthcare systems?
Learnings From In-market Experience: Tickets to Entry & Going Beyond the Minimum Viable Offering
CGTs have been on the market for a few years, presenting a clear opportunity to absorb learnings from real-world experiences to support pipeline therapies. While the following elements could be considered essential for CAR-T deployment in the average treatment centre, pharma players have addressed each with varying levels of investment reflecting an experimental approach towards differentiation in a space that lacks stakeholder consensus on what constitutes the winning formula.
- Online platform: Deployment of CAR-Ts requires real-time coordination between many stakeholders across treatment centres, labs, cell storage facilities and even patients’ homes. An interactive portal customised for the stakeholders within the hospital and lab setting is the minimum requirement to manage these complex logistics. Some competitors differentiate by providing a ‘personalised experience’ through their portals, potentially over-compensating for support that hospitals are not prepared/trained to provide yet.
- Real-time cell tracking: CAR-Ts long vein-to-vein time remains a challenge, especially when orders are delayed. Cell tracking not only helps address this issue, but also aligns closely with the chain of custody – a tracing system to ensure that the right cells are received, processed, labelled, stored, and returned to the correct patient. Some online platforms have been proactively designed to incorporate features for real-time tracking, however, adapting these technologies to individual hospital IT systems is a challenge. Conversely, some pharma players opted to retain the human interaction, whereby cell tracking is managed through email communication between case managers and HCPs.
- Scheduling: Pharma companies support all the back-end processes of the treatment, including scheduling apheresis appointments, as well as cell collections and deliveries. The more tech-savvy players enable the scheduling of patient visits through their online platform, yet not all treatment centres are sufficiently equipped to support such technology solutions. To address this, some players have also resorted to providing company-designated scheduling teams on the ground.
- Reimbursement & Claims: While this is not considered a ticket to entry in most EU countries, in the US, it is essential to on-board and support hospital staff with benefits investigations, claims, appeals information, and potential sources of support for patients who are eligible for treatment but are un- or underinsured. A well-versed team in reimbursement support is key to driving a quality HCP experience, but also ensuring wider accessibility of the treatments, where healthcare systems and governments are lagging.
- Housing & Transport: This is a major burden for the patient across healthcare systems, as government support is not extended to cover travel costs, nor accommodation of family/carer throughout the treatment and follow-up period. As such, to make treatments more accessible, pharma companies provide resources and guidance to patients and their families. Some therapies have even secured their own dedicated ‘travel funds’ to relieve eligible patients, bridging serious gaps in the national healthcare systems.
- Post-treatment follow-up: For best practice, some CAR-T companies continue their support after treatment completion, to monitor patients, check for any adverse reactions, and collect real-world data. In cases where data privacy is not restrictive, follow-ups are conducted through phone calls; alternatively, some CAR-T players have invested in monitoring apps to collect robust post-treatment data. Companies with innovative solutions to overcome data privacy and compliance challenges will reap the benefits of collecting valuable information to optimise their future therapies and services.
In addition to the above, other nice-to-have initiatives are being provided by some players to further uplift patient and HCP experience. For example, some CAR-T players focus on improving the patient experience through Mentor Match schemes, while others strive to support HCPs through 24/7 direct points of contact and dedicated teams on-site for continuous training. Notwithstanding, the real incentive continues to be ‘financial support’ for patients and ‘work-load relief’ for HCPs.
Invest Smartly in Technology
With enough built-in flexibility, an online platform should accommodate options for expansion to avoid spending valuable resources reinventing its capabilities down the line. For example, during the initial stages of certifying a new treatment centre, the onboarding process must be digitalised in a robust manner to align with regional data security measures. Moreover, the scalability of the platform to newer therapies should be a central consideration during the initial design. But is that enough?
Currently, the development, validation, and maintenance of these complex clinical information systems comes at a technology and labour cost to pharma, which is being absorbed considering the limited reach of these therapies. Looking into the future, the technology underpinning these online platforms should have the capacity to include extra patients, facilities and territories; however, if treatment centres fail to develop their IT systems and support teams at a fast enough pace, we may face a scenario where tech tools are available but cannot be effectively deployed unless the gaps continue to be bridged by pharma at an ever-increasing cost burden. Moreover, the inherent diversity in the IT capabilities of different treatment centres begs the question of how far pharma will push the envelope to build digital tools that can be customised to specific hospital requirements and workflows.
Improve Accessibility Options Proactively
Existing patient support programmes may already include some degree of assistance for travel and accommodation. However, investing in travel-related patient support will be a key consideration for a pharma company wishing to increase accessibility and uptake by normalising these expensive treatments compared to out-of-class therapies. Ethically, such schemes may be considered an inducement which draws a fine line between the level of support pharma should provide and where new payer models need to be advanced.
Field Force Evolution
Currently, the teams assisting HCPs and patients on the ground play a crucial role in managing support services effectively. It is, therefore, extremely valuable when companies set up integrated and dynamic internal training programmes for their corpus.
Building a highly-skilled support team that will give companies a competitive edge, requires active, targeted research into the most relevant training for managing CGT pipelines. Cutting-edge technology may achieve a reduction in human involvement, allowing teams on the ground to be servicing an expanded patient and HCP pool.
Focus on Preparing, not Repairing
Developing support solutions differentiating a CGT offering requires more than simply addressing technology, training programmes and travel-related costs. There are holes in how healthcare systems have evolved, which require a more collective drive for change. From the HCP perspective, as treatments get more complicated to manage, being the simplest to prescribe and coordinate provides a huge advantage. Hence, companies have a choice between continuing to fill the void yet still having their services and therapies hostage to the abysmal state of healthcare, or refocusing their resources on the development of simpler therapies that can be successfully deployed through the available but modest infrastructure.
With these options at hand, ambitious pharma players may want to change the rules of the game altogether and set up CAR-T treatment centres of excellence, dedicated to providing end-to-end support directly to the patients. However, this will, once again, leave biotech companies yearning for acquisition by companies that have the resources to become entrenched in the system.
In a vigorously growing space, the future is exciting, with early-stage decision-makers currently steering the wheel.
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