Novo Nordisk A/S
Rank 10 in 2016
Rises 4 places to 6th. Novo Nordisk focuses on one disease covered by the Index: diabetes. It has strong management structures for access and exhibits robust performance in the application of good practice in both capacity building initiatives and donation programmes.
Falls 3 places to 5th, but remains in the first quartile, due to the reassignment of board-level responsibility for its access-to-medicine approach.
Falls 4 places to 6th, as its internal control framework does not meet the same criteria as leading peers.
Rises 6 places to 9th with a new publicly available policy for post-trial access.
Falls 2 places to 7th. Solid registration performance, but outperformed in the degree to which socioeconomic factors are used to determine affordable prices.
Falls 1 place to 13th. Static performance compared to 2016, as it reports no instances of sharing IP during the period of analysis.
Rises 3 places to 4th. Strong performance in capacity building with 11/13 initiatives meeting all good practice standards.
Rises 8 places to 2nd with a high-quality programme for paediatric diabetes, that considers longer-term access once the programme ends.
Expand access to insulin by supporting local manufacture. Novo Nordisk reports manufacturing capacity building initiatives in Bangladesh, India, Iran, and Egypt. The company can leverage this expertise and look to work with other insulin manufacturers (e.g., on the African continent, and in Latin America) to build capacity to produce high-quality insulin and help to stabilise local supply.
Expand Base of the Pyramid to more countries in scope. An evaluation from University College London demonstrated that Novo Nordisk’s Base of the Pyramid has been successful in sustainably increasing access to care and diagnosis, raising awareness and providing a stable supply of insulin in Kenya. The programme currently reaches Ghana, Kenya, Nigeria and Senegal. The positive evaluation shows that shared value can be achieved and scalability is possible. Additional countries in need of access to diabetes care can be brought within the ambit of this programme.
Establish access plans during development that go beyond registration. Novo Nordisk currently focuses on registration strategies for its pipeline. It can also plan for equitable pricing strategies and (where possible) WHO prequalification. By addressing multiple barriers to access, it can help make critical therapies not only available for purchase but also at an affordable price in low- and middle-income countries. This is especially true of its oral GLP-1 agonist semaglutide (Ozempic®), which is currently in Phase III of clinical development and could address the heat-stability issues that have reduced the utility of other GLP-1 agonists in low- and middle-income countries in the past.
Expand access to more diabetic children with no access to insulin. Over the period of analysis, Novo Nordisk reported that the Changing Diabetes in Children (CDiC) Programme reached over 2,000 additional children. Programmes such as these fill an important gap, especially where diagnosis and treatment of type 1 diabetes in children is not yet achieved through Universal Health Coverage. CDiC continues to successfully expand, and should seek to include additional countries where children at risk live.
Change since 2016
- Improved its governance structure by anchoring its responsibility and accountability for its global access to diabetes care strategy at the highest level within Novo Nordisk in 2017.
- Founding member of the new global multi-stakeholder partnership, the Defeat-NCD Partnership, which was formally launched in September 2018. The initial focus will be on hypertension and diabetes.
- Launched the Partnering for Change - Chronic Care in Humanitarian Crises initiative in April 2018 which aims to ensure basic healthcare and improve supply of insulin in humanitarian settings.
- Novo Holdings launched the REPAIR Impact Fund in February 2018 with $165 million USD to invest in early-stage drug development projects targeting antimicrobial resistant microorganisms.
- Expanded its Changing Diabetes® in Children programme in 2016, newly including Cambodia, Ivory Coast, Myanmar, Senegal and Sudan.
- Launched its Access to Insulin commitment in 2017, helping to ensure availability of low prices for insulin in the poorest parts of the world.
Pipeline and Portfolio
for diseases and countries in scope
Smallest pipeline: 10 R&D projects (all medicines) for diseases in scope.
Clinical candidates: 5, including a beta-cell preservation treatment for patients with newly diagnosed type I diabetes mellitus and oral semaglutide for type II diabetes mellitus.
Regulatory approvals: 2, including a faster-acting insulin aspart (Fiasp®) for the treatment of diabetes mellitus.
R&D focus: non-communicable diseases (diabetes mellitus).
Access provisions: for 2 projects, both of which have registration strategies.
Smallest portfolio: 12 products for diseases in scope (all medicines).
Portfolio focus: non-communicable diseases (diabetes mellitus).
Essential medicines: 17% of Novo Nordisk's medicines are currently listed on the 2017 WHO Model List of Essential Medicines (WHO EML).
First-line treatments: 75% of Novo Nordisk's medicines have first-line indications for diseases in scope.
Two business units: Diabetes and Obesity Care; and Biopharmaceuticals. The company also operates in two other therapeutic areas (haemophilia; and growth disorders).
M&A news: 2018 acquisition of Ziylo Ltd, a biotechnology company with a glucose binding molecule platform. Parts of Ziylo's research were also spun out to a new company (Carbometrics).
Presence in emerging markets: In 2018, Novo Nordisk reports sale in 81 countries in scope; 2 more countries than in the 2016 Index.
* Neglected Tropical Diseases, while also communicable, are highlighted separately throughout the Index. See Appendix II.
**See Appendix IV for definition.