What science can do

Science can deliver value to patients, payers and society

One of the approaches we are adopting to payment for our medicines is the implementation of Innovative Value Strategies, which link payment for a medicine to its effectiveness and the outcomes it achieves for patients, payers and society. For example, in the US we have entered into 37 agreements that span across each of our main therapy areas.

Scientific advances have led to a new era of medicines that have the potential to be used across different disease areas and patient populations. Value delivered by a medicine may differ across different indications and may not align to a single price. Additive pricing of combinations may also present an access challenge for health systems.

As part of our Innovative Value Strategies, we are working with payers and healthcare systems to introduce indication-based pricing (IBP) which aligns payment to value at the indication level. This development is part of our commitment to working with all stakeholders to improve patient health and adding value to the health system through innovative personalised medicines that are both accessible and affordable.

IBP requires three elements: a system of value assessment at the individual indication level; appropriate evidence that allows usage per indication to be linked to payment; and an ability to implement confidential commercial agreements that recognise the different value of individual indications. A number of countries have already implemented various IBP approaches, including the US, Australia, Italy and Switzerland.

Science can improve the diagnosis and treatment of cancer

AstraZeneca has pioneered the use of circulating tumour DNA (ctDNA) for the detection of biomarkers in cancer. Pieces of DNA are shed from a tumour and circulate in the bloodstream where they can be analysed to give genetic information about a patient’s tumour. The world’s first ctDNA diagnostic test was associated with Iressa for specific mutations in the epidermal growth factor receptor (EGFR), namely Exon 19 deletions and L858R in patients with non-small cell lung cancer. It is an approach that allows healthcare professionals to determine the right treatment for a patient using a minimally invasive blood test in place of a biopsy, a more invasive method that can ‘fail’ in some 30% of cases. AstraZeneca is partnering with world-leading diagnostic developers to deliver complete disease profiling with a single ctDNA test continuing to improve outcomes for patients.

Circulating tumour DNA also has an important role to play if we are to realise our ambition of eliminating cancer as a cause of death. We believe it has the potential to improve drug development by identifying patients who are at risk of relapse and enabling rapid changes in therapy to address this. For example, in early-stage lung cancer, the majority of patients are cured by surgery and chemoradiation therapy. The key to improving overall survival in these stages is to identify those patients at high risk of early relapse and an emerging potential way to do this is by detecting the failure to clear ctDNA from the blood once curative intent treatment has been completed. Investigating the clinical utility and validity of ctDNA in this setting is an active area of research. For example, for these high risk patients, we can test in a minimally invasive manner whether three months’ intervention with investigational compounds removes residual disease as evidenced by the clearance of ctDNA, and whether this ultimately impacts long-term outcomes.

Science can deliver complete disease management in China

Opened in 2017, and jointly developed with partners from government, industry and academia, as well as with research and medical institutions, our China Commercial Innovation Centre in Wuxi in Jiangsu Province is designed as a showcase for innovative ideas in healthcare. It uses the Internet of Things (IoT), big data, artificial intelligence and other digital technologies to meet the needs of patients in disease prevention, screening, diagnosis, treatment and rehabilitation.

We collaborate with companies who use advanced technologies to make diagnosis more precise, effectively combine drugs with medical devices for better treatment, and integrate online and offline healthcare resources to make information more accessible. In this way, we can develop complete disease management solutions that deliver better outcomes for patients, make healthcare more accessible, and improve the understanding and management of diseases.

We currently have eight models for disease management which continue to be rolled out, not only across Wuxi, but across the whole of China:

• Chronic disease management – 42 centres
• China chest pain – 783 centres
• Metabolic management – 200 centres
• Gastrointestinal cancer – 66 centres
• Integrated centre for lung cancer treatment – 20 centres
• Integrated centre for prostate cancer diagnosis and treatment – 200 centres
• Paediatric nebulisation – 15,000 centres, including 4,200 smart centres
• Pulmonary and critical care medicine – 593 centres

Science can help find a cure for ovarian cancer

There is a critical unmet need in the treatment of advanced ovarian cancer: only 20% of women will be cured and more than 70% will relapse within three years following their initial therapy. The best opportunity to achieve sustained remission, with potential for a cure, is to treat patients when they are newly diagnosed. However, current treatment options only provide a modest improvement in time to relapse. Once a patient relapses their disease is considered incurable and, for the majority of women, they go on to receive multiple lines of treatment.

By using Lynparza maintenance therapy earlier in the treatment pathway, the SOLO-1 trial results show that 60% of newly-diagnosed patients with a BRCA mutation remain progression-free at three years compared to 27% of patients receiving placebo. At 41 months, the median progression-free survival (PFS – the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse) had not been reached for patients treated with Lynparza, compared to 13.8 months for patients treated with placebo, indicating that there may be a group of patients who continue to remain progression-free for a long time or, perhaps, are cured.

Since the initial approval of Lynparza four years ago, the ovarian cancer and overall PARP inhibitor environment has become increasingly competitive but, with SOLO-1, AstraZeneca and MSD have the potential to transform the standard of care for women with advanced BRCA-mutated ovarian cancer, while reinforcing the importance of testing for BRCA mutations at the time of diagnosis.

Science can advance our understanding of the repair and regeneration of tissues

For the estimated 26 million people worldwide with heart failure, recent scientific progress in blood vessel and heart muscle regeneration may lead to new ways of treating their disease. Not so long ago, we assumed that heart failure was an almost inevitable consequence of damage to or death of cells in the heart’s main pumping chamber, the left ventricle, caused by lack of oxygen due to an impaired blood supply. However, we now know that there may be ways to help regeneration of blood vessels around heart muscle cells that are damaged by a heart attack, by high blood pressure or other cardiovascular problems that occur as people get older.

Our pioneering research is based on:

• Advances in understanding of vascular biology and the biological action of vascular endothelial growth factor A (VEGF-A) in stimulating formation of new blood vessels and helping to repair damaged heart muscle.
• Developments in messenger ribonucleic acid (mRNA) technology to boost production of VEGF-A in areas of the heart (mRNA is an essential part of the process by which genes in the form of DNA are decoded to make proteins).

The vascular and cardiac regeneration initiative brings together the complementary skills and expertise of scientists from AstraZeneca and Moderna. This important collaboration, which began in 2013, is advancing the science of tissue regeneration for cardiovascular and metabolic diseases and in other therapy areas. It is rapidly translating laboratory findings into clinical trials of novel therapeutic modalities, for example patients undergoing coronary artery bypass graft surgery (AZD8601).

Achieve Scientific Leadership – 2018 Highlights

During 2018, we had:

• 23 approvals of new molecular entities (NMEs) or major life-cycle management (LCM) projects in major markets

-   13 Oncology approvals for Imfinzi, Lumoxiti, Lynparza and Tagrisso

-   6 CVRM approvals for Bydureon, Bydureon BCise, Lokelma and roxadustat

-   3 Respiratory approvals for Bevespi and Fasenra

-   1 Other approval for Nexium

• 28 NME or major LCM regulatory submissions in major markets
• 19 Phase III NME investment decisions
• 9 Phase II starts
• Accelerated reviews included

-   1 Breakthrough Therapy designation

-   3 Orphan Drug designations

-   3 Priority Review designations

• 18 projects discontinued

Return to Growth – 2018 Highlights
 

• Product Sales of $21,049 million (up 4% at actual rate of exchange; 4% at CER) and Externalisation Revenue of $1,041 million (down 55%; 55% at CER), resulting in Total Revenue of $22,090 million (down 2%; 2% at CER)
• Growth Platforms revenue of $18,464 million, up 13% (12% at CER)

-   Emerging Markets: Sales growth of 12% (13% at CER) to $6,891 million. China sales in the year grew by 28% (25% at CER), supported by the launches of new medicines

-   Respiratory: Sales grew by 4% (3% at CER). Symbicort sales declined by 9% (10% at CER), Pulmicort sales rose by 9% (8% at CER) and Fasenra performed well in the countries where it had been launched

-   New CVRM: Sales growth of 12% (12% at CER). Strong performances from Farxiga and Brilinta, with sales of each exceeding $1.3 billion in 2018

-   Japan: Sales decline of 9% (11% at CER). The impact of generic Crestor was felt faster than expected and the biennial price reduction also impacted sales

-   Oncology: Sales growth of 50% (49% at CER). Sales of Tagrisso reached $1,860 million to become AstraZeneca’s largest-selling Oncology medicine

• US revenue was up by 11% to $6,876 million; Europe was down by 6% (10% at CER) to $4,459 million; and Established Rest of World was down by 8% (9% at CER) to $2,823 million
  
• 81% increase in New Medicines revenue (81% at CER), contributing 30% of Total Revenue (New Medicines include Tagrisso, Imfinzi, Lynparza, Calquence, Lumoxiti, Brilinta, Farxiga, Lokelma, Bevespi and Fasenra)

Be a Great Place to Work – 2018 Highlights
 

• Encouraging improvements in scores in our employee survey (Pulse)
• Continued development of women and increase in the representation of women in senior roles
• Published new Global Standards on inclusion and diversity, sexual harassment and bullying, reinforced by training
• Continued focus on workforce planning to attract critical capabilities and manage retention risks
• Maintained listing in Pharmaceuticals, Biotechnology and Life Sciences industry group of Dow Jones Sustainability Index
• Materiality assessment reaffirmed focus and used to refine our sustainability priorities
• Sustainability Advisory Board met twice in 2018 to guide, recommend opportunities and provide external feedback
• Continued progress towards our target to source 100% renewable power by 2025