Access principle 2: affordability

We use a combination of approaches to help patients across the income pyramid access our medicines. We seek to price our medicines based on the value they deliver to patients, healthcare systems and society. We aim to implement tiered pricing for launches in our Pharmaceuticals and Oncology business units, taking into account income levels, local affordability barriers and economic realities, while maintaining the sustainability of our business. We also make our medicines available through patient support programs, as well as managed access and post-trial access programs.

Novartis access strategies

Our access strategies are adapted to the needs of people across income segments

Novartis access strategies

Value-based pricing

We aim to price our medicines according to the value they deliver to patients, healthcare systems and society. We believe this approach incentivizes healthcare systems to focus on interventions that deliver the most effective, efficient and sustainable outcomes.

In 2021, for example, we announced a world-first agreement with the UK’s public healthcare system to make Leqvio, our cholesterol-lowering medicine, available to patients in England through an innovative population health management approach. The agreement followed a positive recommendation by the UK’s National Institute for Health and Care Excellence, which determines whether medicines represent value-for-money to the country’s healthcare system.

Novartis was also one of the first pharmaceutical companies to enter into value-based contracting for medicines, linking pricing and reimbursement rates to specific outcomes – including for Zolgensma, our breakthrough gene therapy for patients with spinal muscular atrophy.

We consider the following elements in proposing the price of our innovative medicines:

Patient value: Do our medicines help increase patient quality of life and/or patient safety?

Healthcare system value: Do our medicines help increase efficiency and/or reduce costs elsewhere in the system, for example by preventing hospitalizations?

Societal value: Do our medicines have an impact beyond the immediate healthcare benefit, such as by helping to improve economic productivity?

A variety of approaches exist on how to measure the value of our medicines. We aim to generate transparent, real-world evidence to support the most accurate possible value assessment for our medicines.

While we take all of these factors into account in proposing the price of our medicines, in the majority of cases the final price is the result of a negotiation with payers. We stand ready to support and strengthen healthcare systems in the journey toward value-based healthcare, so the price of medicines overall can more closely and consistently align with our principles without limiting patient access to care.

For more information on our position on value-based pricing, please see www.novartis.com/affordability

Equitable commercial models

In 2014, Novartis introduced an emerging market brand (EMB) strategy to expand access to innovative medicines to people in LMICs, in a way that is sustainable for our business and supports governments in responding to unmet medical needs.

31%

Increase in patients reached

through emerging market brands (vs. 2020)

In 2021, we launched 26 EMBs in our Novartis Pharmaceuticals portfolio and five in Oncology. These launches helped Novartis reach 483 459 patients through EMBs, a 31% increase from 2020.

Entresto, our heart failure medicine, is a key contributor to our target to increase patient reach for our strategic innovative therapies. EMBs for Entresto, which number 42 overall, achieved a 39% increase in patient reach and 43% growth in sales compared with 2020.

We continue to narrow or eliminate the time lag between launches in Europe and in LMICs. For instance, we launched the EMB of our lung cancer treatment Tabrecta in India in November, at least six months ahead of expected first launch in Europe.

We launched the EMB of our lung cancer treatment Tabrecta in India in November, at least six months ahead of expected first launch in Europe

Novartis Access is our portfolio of medicines to address public health needs – in particular noncommunicable diseases – in lower-income countries. The program offers 15 on- and off-patent medicines, which in 2021 were provided to governments and public sector customers in 11 countries across Africa, Asia and Latin America. Since 2015, Novartis Access medicines have reached more than 5.4 million patients.

We also use social business models to reach patients in countries where Novartis has limited or no presence. In 2021, through a program called Global Health Markets, we reached patients in Cuba, Cambodia and Laos.

Our community solutions, known as Healthy Family programs, provide health education and strengthen healthcare infrastructure for populations living at the base of the income pyramid in India, Kenya, Uganda and Vietnam. In 2021, we expanded our geographical coverage in India and Vietnam, and we aim to launch the program in additional underserved markets. Since 2007, Healthy Family programs have delivered health education to more than 75 million people.

To drive access in sub-Saharan Africa (SSA), we established a dedicated Novartis SSA unit of about 700 employees that aims to expand the availability of our full portfolio of medicines, taking a high-volume, lower-price approach – with an aspiration to double patient reach in the region by 2022.

For example, we aim to bring affordable cancer treatments to 22 countries in SSA through our Cancer Access Partnership (CAP) with the Clinton Health Access Initiative. In 2021, we implemented the program in more than six countries, reaching patients with breast, prostate and cervical cancer through our CAP product line, which includes patented medicines and Sandoz generics. Medicines are offered at a competitive yet sustainable price, and we are working with partners to minimize markups on CAP products for patients purchasing their treatments out of pocket. Together with our partners, we aim to optimize the continuum of care across the patient journey, including through health system strengthening activities.

Patients reached with emerging market brands

(in thousands)

2021

2020

2019

Novartis Pharmaceuticals

464.6

355.1

302.6

Novartis Oncology

18.9

13.9

11.3

Zero-profit models

In 2021, we reached the milestone of 1 billion treatments of our antimalarial medicine Coartem delivered since 1999, with more than 90% supplied without profit. For more information, please see “One billion antimalarials delivered to patients” below.

One billion antimalarials delivered to patients

Antimalarial pill administered to child (Photo)

7.6 m

Lives saved since 2000
due to adopting ACTs as a first-line treatment for malaria, along with disease prevention efforts and better diagnostics, according to the WHO

For decades, Novartis has been involved in the fight against malaria, a disease that causes hundreds of thousands of deaths worldwide despite it being treatable and curable.

In 1999, Novartis launched the first fixed-dose artemisinin-based combination therapy (ACT). In 2001, in a landmark agreement with the WHO, we were the first healthcare company to commit to supply antimalarial treatments to the public sector of endemic countries without profit.

In 2021, we reached the milestone of 1 billion treatments of our ACT delivered since 1999, with more than 90% supplied without profit. More than 450 million were a pediatric formulation developed jointly with Medicines for Malaria Venture. The WHO estimates that adopting ACTs as a first-line treatment for malaria, together with prevention efforts and better diagnostics, have saved 7.6 million lives since 2000.

Malaria is still endemic in many countries. Moreover, increased temperatures and humidity due to climate change threaten to increase the number of insects that carry vector-borne diseases like malaria. We remain committed to finding solutions for patients: Alongside our access programs, Novartis is advancing the next generation of antimalarials, with several promising candidates in our development pipeline.

Donations

Through our donation programs, Novartis supports LMICs in their efforts to treat patients for neglected diseases or life-threatening conditions, and to provide medicines in areas impacted by the COVID-19 pandemic, natural disasters and extreme poverty.

One of our key programs is CMLPath to Care™, which connects people living with chronic myeloid leukemia (CML) with effective treatments made available at no cost, professional medical capabilities, trained physicians and hands-on support. The initiative is implemented in 67 countries that are most urgently in need of medicines, as identified by the Access to Medicine Index. In 2021, the program reached more than 29 300 patients.

For over 30 years, Novartis has been working with partners around the world to eliminate leprosy

For over 30 years, Novartis has been working with partners around the world to eliminate leprosy. Since 2000, Novartis has donated more than 68 million blister packs of multidrug therapy (MDT) valued at approximately USD 119 million through the WHO, helping to treat more than 7.3 million leprosy patients worldwide. In 2021, we extended our donation agreement with the WHO, and reached more than 75 000 patients. This was lower that the number of patients reached in 2020, primarily due to countries reducing their screening activities amid the COVID-19 pandemic.

The new five-year agreement with the WHO also covers the continuing donation of triclabendazole for the treatment of fascioliasis, a disease caused by parasites known as liver fluke. Novartis has been donating the drug to the WHO since 2005, helping to treat around 2 million fascioliasis patients in more than 30 countries.

Our Sandoz Division works with organizations including Americares, Operation Smile and Direct Relief to donate medicines to people affected by poverty and disaster. In 2021, Sandoz donated products worth approximately USD 900 000 to these organizations. Sandoz also collaborates with World Child Cancer, a charity that aims to improve diagnosis and access to treatment for children with cancer in LMICs. In the first half of 2021, the partnership reached 128 children with cancer and trained 506 healthcare professionals in the Philippines.

Donations

 

2021

2020

2019

Patients reached with donations (thousands)

 

 

 

Leprosy (WHO)1

75.3

245.4

168.6

Fascioliasis/Egaten2

159.0

132.8

154.7

CMLPath to Care™

29.3

30.3

14.4

Donations value (USD millions)3, 4

 

 

 

Emergency relief

1.4

2.5

2.8

1

In 2020, the leprosy program fully transitioned to the Global Health organization as one of the flagship programs. It is also included in data reported in the Novartis Global Health table.

2

Numbers of patients reached have been updated to reflect the new methodology used by the WHO and based on real-world evidence.

3

Monetary and product donations

4

Wholesale acquisition cost (WAC) plus logistics costs for some programs

Leqvio: integrated access in action

Doctor and patient discuss chart (Photo)

~300 000

Patients in the UK
at high risk of a second cardiovascular event are expected to be treated with Leqvio in the community setting over three years

Our cholesterol-lowering medicine Leqvio is a prime example of how we integrate innovative access strategies into the launch of our medicines.

Leqvio is approved in more than 50 countries to treat atherosclerotic cardiovascular disease, which accounts for over 85% of all cardiovascular disease (CVD) deaths. As part of our access strategy, we aim to introduce emerging market brands for Leqvio with tiered pricing in LMICs and upper-middle-income countries to address affordability challenges, based on local feasibility assessments. We also intend to minimize time lags between first launch in Europe and launches in LMICs.

We also partner with health systems to improve patient outcomes. In the UK, for instance, Leqvio is provided under a first-of-its-kind population health management approach through the National Health Service in England; it is expected to treat up to 300 000 patients at high risk of a second cardiovascular event in the community setting over three years. We are also exploring population health approaches in other markets. In Colombia, for example, we formed an alliance with the innovation chamber of the government and civil society stakeholders to help remove treatment barriers for more than 50 000 high-risk CVD patients.

Patient support programs

Our patient support programs help patients access medicines they could not afford due to financial hardship, lack of insurance, or inadequate reimbursement. They also help patients better manage their medication and disease outcomes through services including education, nurse programs and call centers.

One example is the Novartis Patient Assistance Foundation Inc. (NPAF), which provides medicines at no cost for individuals who are experiencing financial hardship and have limited or no prescription drug coverage in the US. In 2021, NPAF made medicines available to more than 127 000 patients.

Another program is Novartis Oncology Access, which shares the cost of medicines with government healthcare systems, charities and other payers, or directly with patients without healthcare coverage who are unable to pay the full cost. In 2021, more than 29 400 patients in seven countries benefited from the Novartis Oncology portfolio in multiple disease areas.

Other examples include the Vale Mais Saúde™ program in Brazil, which reached more than 1.7 million patients in 2021. The program provides discounts on Novartis therapies for chronic conditions and promotes disease awareness and treatment adherence. In China, meanwhile, we reached 31 000 Cosentyx patients through a program designed to support patients and healthcare professionals with medication adherence and disease awareness. Overall, our patient support programs helped more than 3.8 million patients in 2021.

Patients reached through support programs

(in thousands)

2021

2020

2019

Novartis Patient Assistance Foundation Inc. (US)1

127.4

107.2

87.2

Novartis Oncology Access

29.4

33.9

60.7

1

2020 figure corrected and restated

Managed access programs

Physicians sometimes seek access to medicines that are not yet approved or available in their country to treat patients with serious or life-threatening conditions. Novartis Managed Access Programs (MAPs) address this need by making certain investigational or unapproved treatments available to eligible patients.

13 000

Patients

receiving treatment through managed access programs

In 2021, we reviewed 8 559 MAP requests from physicians. We approved 95% of those requests from 95 countries and across 62 compounds. At the end of 2021, more than 13 000 patients were receiving treatment through MAPs.

We fulfilled our 2021 commitment to make Zolgensma, our one-time gene therapy to treat pediatric patients with spinal muscular atrophy, available to up to 100 patients via a global MAP. Further, Tabrecta was provided to 838 patients suffering from lung cancer.

Since 2017, Novartis has collaborated with an external Independent Bioethics Advisory Committee (IBAC), which provides analysis and recommendations on Novartis guidelines and policies for the ethical conduct of clinical research, and on selected ethical challenges that may arise in clinical trials, development programs, managed access programs and other areas across Novartis. The IBAC is made up of bioethicists, clinicians, healthcare practitioners, patient advocates and other experts appropriate to the problem at hand.

Post-trial access programs

Novartis has a comprehensive post-trial access (PTA) policy to ensure continuity of treatment for patients who have participated in a confirmatory, Novartis-sponsored clinical trial designed to demonstrate superiority versus a placebo or another drug. Patients who have derived clinical benefit from an investigational treatment can continue to receive it, free of charge, until it is commercially available and accessible locally.

Our PTA commitment applies regardless of the severity of the disease, the availability of alternative therapies, or the geographical location of the clinical trial. PTA commitments were incorporated in all in-scope trials approved in 2021.

We also convene a cross-functional consultation board to provide guidance on PTA activities and ensure a consistent approach across the company in accordance with our Commitment to Patients and Caregivers and the Novartis Position on Post-Trial Access.