Today, Payers are implementing access barriers at unprecedented levels to mitigate budget challenges. To prepare, manufacturers must adopt a market access mindset from the very beginning of the clinical trial process to anticipate potential obstacles, and incorporate measures that allow access for all appropriate patient segments.
Clinical trials are designed years before commercial launch, so it’s not surprising that Payer perspectives and clinical practice bandwidth considerations are not paramount when developing endpoints and measures. However, the measures utilized in clinical trials are often adopted by Payers once the medicine is approved. If not considered carefully, these can unexpectedly impair access, leading to
An example of unexpected obstacles derives from selecting trial endpoints or measures that are not achievable for all patients, thereby leading to Payer exclusions. Citing a real-world example, a clinical trial for a medicine to improve respiratory, cardiac and metabolic systems might require patients to be able to exercise for a defined time period (e.g., 6-minute walk test). Measures like this can lead to selection bias and Payer exclusions of important patient segments (e.g., non-ambulatory patients). Measures need to be considered carefully to be viable for ALL appropriate patient groups.
Another example involves selecting outcomes that are difficult or expensive to measure in everyday clinical practice. Once the medicine is approved, these make it difficult for clinics and patients to comply with re-authorization requirements and thereby impair Payer coverage. Case in point: a medicine requiring recurring muscle biopsies can be expensive, time-consuming, and invasive for patients. An AMA study in 2018 found that the average specialty drug required 2.7 reauthorizations per year, so the expenses and time associated with frequent, clinically non-vital measurements can add up to create significant treatment burdens for clinics and patients, thereby creating access barriers.
Navigating commercialization dynamics is challenging. Those with knowledge of the complex market access landscape can bring valuable input to ensure that clinical trial measures are viable in the commercial world, and maximize access for all patients that can derive benefit.
If you would like assistance integrating market access considerations in your clinical trial strategy, please contact us at info@A3Access.com.