Background
The brand team at a top ten pharmaceutical company contracted with KMK Consulting to perform an analysis of the market and patient issues leading to poorer-than-anticipated performance of their recently-launched medicine treating anemia in patients suffering with myelodysplastic syndromes (MDS) blood disorders. Once these factors were identified, the goal was to assist the forecasting team in refining their forecast model assumptions to help set realistic expectations for the brand. The client once again turned to KMK as a proven resource in understanding analytics and business needs, and helping to develop appropriate solutions.
The Challenge
The client’s medication is delivered via injection by a medical professional. Patients start with a 1 milligram (mg)/ kilogram (kg) dose administered once every 3 weeks. This dosage would be subject to change based on how the patient responds to the treatment.
Initially, after launch, the client saw an increase in the monthly doses administered. The client expected this trend to continue through an increase in patients taking the drug and by increasing the average duration of therapy (DoT) across all patients. However, this trend did not continue, and utilization remained below pre-launch expectations.
The analytics team at KMK was tasked to take a deep dive into the claims-based real-world data (RWD) to determine the MDS patient types being treated with the medication, and to identify factors preventing them from increasing their dosage according to original expectations. By learning why patients were not adhering to this protocol, the client could develop best practices to overcome this result.
The KMK Solution
Data source selection was our critical first step . For this assignment, we chose to work with IntrinsiQ, an EMR database with a uniquely high capture rate, and which collects data on administrations versus prescriptions, thus imparting the most confidence.
Starting with the monthly average dosing trend from IntrinsiQ data, we took a deeper look at dosing by cycle and year, and found that the 2022 cohort patients appeared to have lower starting doses compared with patients in 2021. We also observed that 2022 cohort patients represented a large proportion of the total MDS patient population, and was likely driving underperformance in dosing.
This finding led us to believe that the lower starting dose could be a key driver for the lower monthly continuing dose. To verify this assumption, we explored the data to profile MDS cohort patients in order to better understand the relationship between starting dose and such key metrics as gender, age, and prior treatment.
These crosstabs allowed us to generate important insights into the 2022 cohort’s utilization of our client’s medication.
To validate these insights, we triangulated MEDALIST (clinical trial data) and secondary data sources such as Symphony Source to conduct a deep dive into patient demographics. In this analysis, we considered all MDS patients, not just those using our client’s product. We discovered that the shift we observed towards proportionally more female patients in 2022 IntrinsiQ data was also seen in Symphony Source. (Hypothetically, COVID could have been a factor in this result as there was a higher death rate from COVID for males than females, potentially leading to a higher concentration of females in the cohort population.) However, the demographic shifts driving our client’s dose decline from 2021 to 2022 were specific to their medication, and were not observed in ESA patients or total MDS patients, which led us to further investigate these phenomena. Our final step was to examine the relationship between starting dose, dose escalation and duration of therapy.
This analysis helped us guide the client’s understanding of the underperformance in 2022 average dose per patient, when duration of therapy was at or above expected levels. To do this, we leveraged trends in persistency curves by gender/by year. Our findings demonstrated that our client’s female patients had better persistency than male patients, and female patients had better dose titration vs. their male counterparts. We also confirmed that there was a strong relationship between dosage titration and improved persistency, since female and younger patients were more likely to have two titrations and tended to have a higher persistency leading to a better outcome. Unfortunately, when leveraging a market research report on physician behavior regarding dosage, we uncovered that the dosing escalation for most HCPs was far less than indicated in the MEDALIST study. As a result, they were not regularly prescribing titrations and few patients were experiencing a notable change in their dosage prior to discontinuing the medication. This HCP behavior was contributing to less-than-optimal patient outcomes and perpetuating the lack of needed titrations and lower persistency.
Results
Answered key business questions regarding why there was dosage underperformance in the client’s medication usage
More feasible and reasonable growth expectations for the brand team and other key stakeholders by adjusting and evolving the dose assumptions in the forecasting model
Helped influence product and business strategies by identifying performance issues, finding growth opportunities, and presenting actionable insights to senior leadership
Based on our comprehensive and insightful analytics of the issues in this patient population, we were able to answer key business questions regarding why there was dosage softness in the client’s medication usage. Building on these insights, the forecasting team decided to adjust and evolve the dosing assumptions in the forecast model to set feasible and more reasonable growth expectations for the brand team and other key stakeholders. Additionally, we identified performance issues, found growth opportunities, and presented actionable insights to senior leadership, which greatly helped influence product and business strategies. The client was able to recognize that although it would be hard to change the patient type at this time, it was important that they understand the current experience of HCPs with their medication and to identify the factors influencing their dosing behaviors ultimately preventing them from increasing dosage. In doing this, the client could work to improve HCP education to ensure that MDS patients achieve the best possible outcomes by titrating to the maximum dose as needed.
