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What are Patient Reported Outcomes


During the last webinar, ‘Patient-Reported Outcomes’ organized by ISHEO into its Access matters webinar series, Davide Integlia, CEO of ISHEO, interviews Linda Abet Webb, CEO of P-COA, focusing on how Patient-Reported Outcomes are becoming increasingly crucial for Market Access. They are an essential tool to invest in for assessing the quality of life with data that comes directly from patients.

What are Patient-Reported Outcomes Assessments? 

The main goal is to understand the real value of the drug or medical device. Additionally, we use PROs to differentiate a product against its comparators. PROs are part of the Patient-centred Outcome Assessment, and they point out the importance of the patient’s perspective. We use Patient-Reported Outcomes (PRO) increasingly in studies and clinical settings to investigate treatment outcomes in the ‘real world’ and from the patient’s point of view. This type of investigation helps clinicians to understand the patient experience that would not be detectable through other types of examinations or evaluations. It enables us to study many factors related to symptoms, HRQL, the impact of treatment, impact of pain. Hence, when we talk about market access in clinical trials, we cannot focus only on identifying classic utility measures or QUALYs. Instead, it is also necessary to measure the improvement in the patients’ quality of life through PROs.


Understanding how to administer PROs the second step to understand them better. Which types of PROs Administration exist?

  1. Recall period: Diary (24hrs-12hrs-event-driven), weekly recall, 2-week recall, 4-week recall. 
  2. Mode of Administration (Electronic – Pen/Paper – interviews by phone or facetime)

One advantage is that PROs can assess patient progress, even when they are no longer clinically observed. PROs can be used in a variety of areas. For example, they can be included on label claims, likely to be considered for regulatory decisions, or they can be considered for pricing and reimbursement decisions. It depends on which PRO is used and for which indication. Although there are different market access stakeholders, they share many of the same concerns, and PROs can be the key to address some of these concerns:

The medical importance of disease and therapeutic value of the product, Benefits over existing treatments, value for money, and affordability PROs can consequently add value and influence to your market access strategy and obtaining reimbursement. Payers state the importance of validated PROs data:

  1. 65% of payers globally suggest that PRO data in a peer-reviewed publication is more important to decision-making than PRO in the label (intended as clinician-reported outcomes)
  2. PRO validation in the targeted population, along with clinical data, are the most important traits 
  3. Payers predicted that PRO data will become even more critical to decision-making.

PRO can play an important role in preparing the market – patient experience is the key to adherence – PROs help assess and communicate experience, and, get the patient’s voice heard.

PROs in Your  Market Access Strategy 

Regulators, payers, and consumers need PROs to understand disease and treatment effects for many conditions: can be used to demonstrate various important messages.

Key aspects for success in your Access Strategies:

  1. Engage early within the development programme
  2. Identify the key concepts of interest
  3. Talk to patients, using “One-size-fits-all” strategy is not going to meet everyone’s needs
  4. Validate and publish.

Therefore, the PROs are considered an effective method for assessing health-related quality of life (HRQOL), treatment assessment, and symptom reduction. Additionally, Regulatory Bodies consider these aspects more frequently nowadays when reviewing innovative value propositions as they take into account what helps patients in their daily lives.