Dr Somali Burgess on Translating Patient-Reported Outcomes Into Clinical, Pharmaceutical Decisions

Somali Burgess, PhD, senior director, Xcenda, discusses how patient-reported outcomes (PROs) help advance patient care and challenges with translating PROs into clinical and pharmaceutical decisions.

Transcript

How does the incorporation of patient-reported outcomes help advance patient engagement and care?

I describe something called the 3 pillars, and the first pillar represents the registration, 1 represents reimbursement, and 1 represents brand. So, if you look at registration, patient-reported outcome (PRO) measures are included in clinical studies for registration, and so that is a direct benefit to the patient once that drug has been approved.

With reimbursement, formulary decisions are being made based on PRO data, so once that drug is put on the formulary based on that PRO data, or it’s being reimbursed, that’s another benefit to the patient because a drug is only as good as its reimbursement policy.

With the third pillar, which is brand, while it may not directly impact or prove beneficial to a patient, it is in an indirect way benefitting the patient because you do real-world studies. So, perspective studies and collecting real-world data, which is showing the burden of illness, or its showing what is happening post-approval that is going to impact patient care and patient involvement in the end.

But these are not the only ways that it can be impacted, because you’ve got studies on compliance and adherence, which are all patient reported, or measures that are used in clinical practice settings that are helping to improve patient care based on the data being generated.

Are there challenges with translating patient-reported outcomes into clinical and pharmaceutical decisions?

Yes, there’s both benefits and challenges. So, when a PRO measure is being included in a clinical trial for approval, to me that’s a direct link and a benefit, because the moment the drug is getting approved the patient is the one that’s going to be benefitting from a new drug being available, and that added value that PRO data will show. The pharmaceutical manufacturer at that point has already made the decision to include a PRO measure in a clinical study, so that is being pushed forward and really the pharmaceutical decision has been made.

But I feel like patient reported outcomes data needs to be shared more consistently with formularies and coverage decision-makers to make sure that they are showing their understanding, and therefore, making a decision based on that added value of a drug. Until the inclusion of PRO data becomes as standardized and as regular as clinical efficacy, safety, tolerability, or other economic data, we are not going to see that added value. I think the push is towards that, but it’s not there yet.