Novartis AG
Rank
2
Rank 3 in 2016
Score
3.21
Performance
Rises 1 place to 2nd position. The company has launched a new approach to access, embodied by the Novartis Access Principles, which aims to expand access planning across the company’s pipeline.
Management
Holds 1st place. Refreshed access strategy underpinned by the Novartis Access Principles, with CEO remuneration linked to access performance.
Compliance
Rises 13 places to 2nd. Improved performance compared to peers in its internal controls and transparency, including financial support made to patient groups.
R&D
Rises to 3rd place for its new approach to considering access planning for all new medicines.
Pricing
Holds 3rd place, with an above-average performance across all pricing metrics but outperformed by leaders.
Patents
Falls 6 places to 16th. Despite a greater level of transparency around its patents, it falls due to an incident regarding the IP around imatinib (Glivec®) in Colombia.
Capacity
Falls 2 places to 3rd, but holds strong against new metrics for good practice, notably in health system strengthening.
Donations
Rises two places to 3rd, achieving a comparatively wide geographic coverage for its leprosy programmes which aim to eliminate the disease in 49 countries.
Opportunities
Apply Novartis Access Principles to increase access across its entire late-stage pipeline. Novartis can work to ensure that its Access Principles are successfully applied to establish access plans for all new medicines in late-stage development regardless of disease scope. As the Novartis Access Principles were recently implemented in 2018, early success is critical to proving that access can be considered across the pipeline and successfully executed.
Expand equitable pricing strategies to cover all priority countries. Novartis' nilotinib (Tasigna®) for the treatment of cancer (leukaemia), is an on-patent product on the 2017 WHO Model List of Essential Medicines (WHO EML) and a first-line treatment. While equitable pricing strategies apply in some priority countries, the company could expand its scope to include all countries where need is the highest, including Egypt, Arab Rep., Kosovo, Kiribati, Micronesia, Fed. Sts., São Tomé and Principe and Tonga. Novartis has developed a new tool, Potential Affordability by Decile, to determine price segmentation in countries in scope. Novartis could apply this tool to address the affordability of products including valsartan (Diovan®) for hypertensive heart disease and ischaemic heart disease in low- and middle-income countries.
Expand access to more manufacturers through voluntary licensing. Novartis can actively identify generic medicine manufacturing partners for the non-exclusive voluntary licensing of products for high-burden diseases. Possible products could include nilotinib (Tasigna®) listed on the WHO EML for imatinib-resistant chronic myeloid leukaemia.
Change since 2016
- Established Novartis Access Principles to systematically integrate access strategies for all new products and Sandoz biosimilar launches beginning as early as Phase II.
- Reiterated its commitment to the control of non-communicable diseases with the Novartis Access Programme, expanding to new countries, such as Pakistan.
- Adapted the SMS for Life platform for stock management; the new, enhanced SMS for Life 2.0 has been launched in four countries since mid-2016.
- Launched the Better Hearts Better Cities initiative in May 2017 to improve cardiovascular health in low-income urban populations.
- Discloses publicly the patent statuses for small molecules in scope via the Pat-INFORMED platform.
- Published its expanded post-trial access policy to provide access to investigatory treatments for clinical trial participants that meet certain criteria after trials have concluded.
- Divests antibacterial and antiviral research.
Pipeline and Portfolio
for diseases and countries in scope
Pipeline
Comparatively large pipeline: 117 R&D projects (all medicines) for diseases in scope.
Clinical candidates: 40, including three clinical candidates for the treatment of Plasmodium falciparum malaria.
Regulatory approvals: 6, erenumab (Aimovig™), a novel once-monthly self-injection for the prevention of migraines.
R&D focus: non-communicable diseases (cancer and COPD) and communicable diseases (malaria).
Access provisions: for 17 projects, most commonly registration and equitable pricing strategies.
Portfolio
Largest portfolio: 127 products for diseases in scope (126 medicines; 1 contraceptive method).
Portfolio focus: non-communicable diseases (hypertensive heart disease and cancer) and communicable diseases (lower respiratory infections).
Essential medicines: 72% of Novartis' medicines are currently listed on the 2017 WHO Model List of Essential Medicines (WHO EML).
First-line treatments: 66% of Novartis' medicines have first-line indications for diseases in scope.
Business context
Three divisions: Innovative Medicines; Alcon; and Sandoz (generic medicines and biosimilars). Its Innovative Medicines division has two business units: Novartis Pharmaceuticals; and Novartis Oncology. Novartis Pharmaceuticals unit focuses on six therapeutic areas: ophthalmology; immunology; dermatology; neuroscience; respiratory; and cardiometabolic diseases. Novartis Oncology focuses on two therapeutic areas: cancers and rare diseases.
M&A news: 2018 sale of 36.5% stake in consumer healthcare joint venture to GSK. 2018 acquisition of cancer drugmaker Endocyte.
Presence in emerging markets: In 2018, Novartis reports sales in 95 countries in scope; 18 more countries than in the 2016 Index. It is the company with sales in the highest number of countries in scope. It reports that just over 20% of its sales in 2017 came from the Asia, Africa and Australia region.
* Neglected Tropical Diseases, while also communicable, are highlighted separately throughout the Index. See Appendix II.
**See Appendix IV for definition.