How to develop out-of-the-box evidence collection strategies to boost approval rates
Enhanced evidence collection methodologies can improve approval rates and ensure reimbursement. Pharma companies should build an internal, cross-functional evidence team responsible for investigating new ways to collect and report clinical trial data
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- Cross-functional evidence teams must balance innovation and caution: New evidence sources should be combined with tested methodologies
- Internal data governance processes can ensure data quality is maintained: Engaging with regulatory bodies and health technology assessment (HTA) agencies early can help outline evidence expectations among stakeholders
- Companies should establish strong medical-commercial partnerships and use multiple health outcomes measures: Both approaches help ensure reimbursement by proving both the financial and clinical value of a drug to payers
- Patients should be involved in evidence planning: Partnerships with digital device providers can increase access to patient data, yet patients must consent to data sharing
Regulators are becoming increasingly receptive to new ways of collecting efficacy data. According to AbbVie’s Chris Boone, regulators have increased interest in observational studies and real-world evidence (RWE) to supplement clinical trial data.
Pharma companies should build an internal, integrated evidence team to investigate new forms of evidence collection. The team should be cross-representational and cross-functional. CSL Behring’s Debbie Drane pointed to a “Triple M” approach which involves marketing, medical and market access departments in new evidence collection strategies. Internal analytics, health outcomes and statistics experts should also be involved.
Evidence teams must find a balance between pushing for innovation and being cautious. While some data collection elements should continue using established methodologies, new approaches may provide more efficient ways to collect data and demonstrate an investigational drug’s value. To facilitate innovation, a change in mindset is crucial. Upskilling or reskilling internal departments may be necessary.
Data governance processes, led by an overarching governing body, can help guarantee data quality. These are particularly important when filtering through vast real-world datasets. Traditional data sources and new ones should be merged to thoroughly prove efficacy. Teams used to working with electronic health records (EHR) and registry data may require retraining to analyze RWE.
Collaboration with external stakeholders and service providers is needed to develop new evidence-building approaches. Engaging with regulators and HTA agencies early can help establish clear evidence expectations. Third-party service providers, such as ones that support data gathering via digital devices, can increase data quantity by supporting access to varied data sources. Evidence teams should engage with advisory boards to understand the market landscape in various diseases.
Evidence presented to payers should focus on both the clinical and financial value of different drugs and therapies. Even after a product is approved, payers can still opt against reimbursement. To address payer reservations, pharma companies should undertake integrated evidence planning. Through this, companies can collect patient-reported outcomes (PRO) and other health outcome measures to bolster a drug’s clinical value. Medical-commercial partnerships can also ensure a drug’s clinical and financial value is communicated effectively.
Involving patients during data collection design helps pharma companies gather more patient-centric data. Due to large-scale digitalization, patients can provide more data points if they consent to sharing the information collected by their personal devices. If patients are told the benefits of their individual data contribution, such as helping develop new treatments, they may be more likely to share their data. Once evidence is ready to be reported, the presentation should be tailored to various stakeholders’ needs. Patient-targeted communications should be clear, free of jargon, and available on demand.
Industry Experts Who Contributed:
- Debbie Drane, SVP, Global Commercial Development, CSL Behring
- Christopher Boone, VP, Global Head, Health Economics and Outcomes Research, AbbVie
- Dr Zsuzsanna Devecseri, VP, Head of Global Oncology Medical Affairs, Sanofi Genzyme
- Michael Aboud, VP, Global Franchise Medical Head, ViiV Healthcare
- Moderator: Todd Somsel, (formerly) Associate Principal, Real World Data Venture, ZS Associates