Untapped Sources of Data, Evidence and Insights

January 23, 2019

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Specialty pharmaceutical data has many faces. It can track clinical outcomes, explore competitive pricing strategies, and zoom in on prescriber habits, to name just a few. We’ve already established the why of collecting it: to support best practice for prescribers, fair pricing decisions for payers, and better access for patients. But where do we get it, and how do we ensure all parties buy in?

As it happens, the specialty drug ecosystem has the people and processes required for meaningful, disease-specific data collection. Observational studies, compassionate access programs, phase 4 surveillance systems, patient registries, and patient support programs (PSPs)—an offering accompanying many specialty drugs—can all serve as rich data sources.

While PSPs exist primarily to guide patients through treatment, adherence and access, they can also track key clinical parameters—from liver enzymes to disease markers, joint erosion to tumour progression. As integrated support systems for patients with a common disease, PSPs also serve as ideal vehicles for collecting patient-reported outcome measures (PROM)—an increasingly recognized means of assessing treatment success—such as quality of life and patient satisfaction.9

This data engine can feed back to clinicians, allowing them to gather information on disease scores, adherence, and persistence, and use it to better meet their patients’ needs. Pharmacists, who interact with both clinicians and patients, have a front-line perspective on patient behaviours. As the first point of contact for many patients, they can both document and influence adherence.

To earn stakeholders’ trust, the data must be free of bias. We need the expertise to understand and “clean up” the biases that creep into real-world data, such as differences in record keeping or in physician prescribing patterns.10 Patient-reported data, arguably most vulnerable to bias, may require third-party oversight and validation to pass muster. Above all, trust in the data will depend on establishing a dialogue in which all stakeholders have a say.

Patients, for their part, may fear that their medical data will get into the wrong hands, employers being a common concern. Fortunately, modern medical data collection has robust mechanisms for deidentifying patient data to avoid privacy leaks.

In an ideal world, stakeholders will not only collect the data but aggregate it into evidence and insights: how patients, prescribers, and payers are behaving, and why. These insights, in turn, will drive a fairer system for all players. Forward-thinking payers will have a basis for negotiating outcomes-based agreements (OBAs), which limit their financial responsibility for poorly performing drugs. Manufacturers will make better strategic decisions for existing and pipeline medications. And patients will get better care. For all this to happen, we need to decide who will take the initiative to obtain and interpret the data—and who will pay for it.

The bottom line: new specialty drugs are coming to market every day and patients are anxious to use them. Prescribers need to know which medications work best, and data from RCTs doesn’t provide the full picture. Real-world data already exists, PSPs can capture a lot more, and policymakers recognize the need to take action.

So what are we waiting for?


References

9. Insight Series: Value of patient support programs for specialty medications in Canada. May 17, 2018. Accessed at https://www.innomar-strategies.com/insights/insight-series-value-of-patient-support-programs

10. Stone A. Rid yourself of dirty data. Eyeforpharma, Oct. 11, 2018.

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