CSL Ltd Annual Report 2019

For Seqirus, the focus this year was transforming pharmacovigilance and associated risk management (PVRM) into a smart, innovative, results-focused function in line with our strategic direction. A number of internal audits were conducted to oversee the maintenance and continuous improvement of the Seqirus global pharmacovigilance system, ensuring it is compliant, of the highest quality and fit for purpose. Targeted, industry-leading, good vigilance practice (GVP) compliance has been maintained throughout the year at the desired level. Value and access CSL invests in programs to develop and supply innovative vaccines and therapies that protect public health, and extend the lives of people living with serious and rare diseases. The value our products provide to patients and society is enormous. Our therapies save lives, improve clinical outcomes and quality of life, and our vaccines prevent life-threatening illnesses, each contributing to the reduction of overall healthcare costs around the world. We are proud of these contributions and work diligently to ensure that patients and communities have access to our lifesaving vaccines and therapies. CSL engages in a number of initiatives to help improve access to our products. We work with governments and health insurance payers to support timely market entry and access, as both play a critical role in the development of reimbursement frameworks and patient access regimes. We articulate and communicate comprehensive evidence on the value of our innovations to inform access and reimbursement decisions. And, we provide patient assistance programs and support advocacy efforts that improve access to care. In 2018/19, CSL’s investment for humanitarian access programs and product support initiatives totalled US$21.7 million* (see page 37 for examples of our humanitarian access programs). In the US, access programs are critical to patients who are uninsured, underinsured or who cannot afford therapy. We are also committed to pricing practices that reflect the value our products bring to patients and society. To that end, we evaluate real-world and clinical trial data that demonstrate the benefit they deliver relative to alternative treatments and the cost savings they provide to overall healthcare. We also consider patient preferences and the improvements they provide to patients’ quality of life and productivity. As a leader in our space, we are committed to dialogue with all interested stakeholders on how best to ensure continued patient access and affordability of medicines, and to preserve an ecosystem that sustains medical innovation for patients today and in the future. In 2018/19, there were no findings against CSL relating to a breach of any fair trading or competition laws. * Indicator externally assured by Ernst & Young. Collaboration Our values We are stronger together Irina Staxen, Manufacturing Sciences and Technologies, Holly Springs, US. US$21.7 million supporting product access across the world.* CSL Limited Annual Report 2019 27