As more CAR-T products come to market with similar clinical profiles in the same indications, the non-clinical differentiators will become increasingly important. Given the novelty of the class of products and the complexity of the manufacturing and delivery process, we find ourselves in a time of ‘writing the rules of engagement’. This process is surrounded with uncertainty about what regulators, payers, and patients will be receptive to.

Considering the unique costs, risk, intensity and benefits of CAR-T, the strategy behind the products must be as innovative as the treatments themselves. A good grasp of the commercial landscape is essential to striking the right balance between level of investment versus ROI.

Product Launches Aren’t Just About the Product – A Comprehensive End-to-End Solution is Required

In CAR-T, your traditional product launch strategy needs to go hand in hand with your non-clinical offering. This is related to the level of risk to the patient. It would be unethical to test a new high-risk therapy in the kind of large-scale trials that we see for other indications. The lack of head-to-head trial comparability data complicates decision-making for HCPs as there is no clear cut ‘winner’. Thus, HCPs have to take multiple factors into account when deciding which product to prescribe.

In this space, an enhanced patient services offering could be the differentiator. As such, the key players in the market are doubling down on their service offerings. In the CAR-T space, there are Gilead’s Kite Connect and Novartis’s Kymriah Cares. These programs support patients with deceptively simple things that make a big difference to their lives, like travel and accommodation. Other non-clinical differentiation services can include anything from at-home nurse support to helping patients navigate their complex healthcare insurance to solicit reimbursement.

Thinking Beyond Service and Product – Innovative Payment Models

Additional care-based services have clear benefits, but the reality is, one of the first things on the minds of many patients and providers is cost. ‘Value-based healthcare’ can take many forms, but the key principle is that instead of paying providers for the amount of care services delivered, value is determined by measuring health outcomes against the cost of delivering the outcomes. For example, a payer only pays the full drug list price if the product has the desired effect. Risk-sharing agreements are also on the rise in the field of oncology, particularly when it comes to innovative treatments.

The success of any payment model will naturally depend on the market in which you are operating. In the US, patients are much more actively involved in the process of sourcing their own treatment than in the EU. This is why your strategic approach must be adaptable depending on the market you are trying to access. If your messaging is off or doesn’t connect with the right decision-makers, your product will be dead in the water.

Out with the Old, In with the New

Developing efficient non-clinical processes benefits everyone. It improves patient experience, drives costs down and makes CAR-T more accessible. It is up to pharmaceutical companies to step out of their comfort zone and develop innovative approaches that serve today’s market and look to the future. Getting to grips with these strategies will determine who comes out on top.