Strengthening product launches
In our commercial operations, we aim to consistently deliver successful launches to support our financial performance and enable broad and rapid access to our medicines.
In 2021, launch brands and medicines we consider our key growth drivers1 contributed 52% of net sales in our Innovative Medicines Division, compared with 44% in 2020. By 2026, we expect approval of more than 20 pipeline assets with the potential to become blockbuster medicines with sales of more than USD 1 billion.
By 2026, we expect approval of more than 20 pipeline assets with the potential to become blockbuster medicines
We have developed a launch roadmap to codify best practices. For example, we start to prepare early – more than three years before the anticipated launch date in many cases – including talking with patients, physicians and payers to better understand their perspectives and needs. In our Novartis Pharmaceuticals business unit, for example, around 80% of investment in medical affairs is now focused on the pre-launch stage.
For Kesimpta, our treatment for multiple sclerosis (MS), we focused pre-launch investment on three key markets: the US, Germany and China. We deployed an unbranded digital information platform that reached up to 2 000 physicians in the US. We also worked with patient advocacy groups to ensure their views were integrated into our launch preparations, and we talked to payers to understand their needs.
The preparations paid off: In the six months after launch in the US, we had reached 85% of our target customer base, most of them virtually, while around 20% of patients received Kesimpta as their first-ever treatment for MS and more than 50% of patients received it as their first-line treatment. Kesimpta is approved in more than 60 countries worldwide.
Another example is Zolgensma, our gene therapy for spinal muscular atrophy (SMA) that reached USD 1.4 billion in sales in 2021. Early patient identification through newborn screening programs and treatment awareness are critical for SMA patients. We work closely with stakeholders such as payers to highlight the importance of early treatment, and provide disease awareness programs for parents, physicians and other health professionals to spot the signs and symptoms of SMA. In 2021, around 85% of new births in the US underwent screening for SMA, and we anticipate that the EU will have SMA screening in place for all new births by 2025.
Our pre-launch preparations also found that achieving sustainable access to a one-time gene therapy like Zolgensma in diverse markets such as Argentina and Egypt requires a menu of options to address the needs of stakeholders. For example, our early access and “Day One” access agreements offer customizable options for payers – including retroactive rebates, deferred payments, installment options and outcome-based rebates – and are designed to ensure that access is available to patients even before regulatory approval and formal national reimbursement agreements are in place. In 2021, we had early access agreements in place in six markets, and pay-for-performance agreements in place in 16 markets. The therapy was commercially available in over 40 countries.
Meanwhile, in our Oncology business unit we leveraged more than 20 years of experience in chronic myeloid leukemia (CML) to launch Scemblix, a new treatment option for patients that was approved in the US in 2021 for treatment of CML in two distinct indications.
Despite tremendous advances in CML treatment over the past decades, some patients struggle to meet treatment goals due to intolerance or inadequate response. Before launch, we took steps to raise awareness of remaining unmet needs for CML patients. Additionally, at the time of launch we estimate that more than 80% of US healthcare providers who treat CML were aware of the compound and/or its unique mechanism of action – known in scientific literature as a STAMP inhibitor. We anticipate approval in Japan and Europe during 2022.
We are also preparing for other launches in our oncology pipeline. For example, we plan to enter the growing checkpoint inhibitor field with VDT482 (tislelizumab), an anti-PD-1 monoclonal antibody that we in-licensed in 2021 as part of an agreement with an affiliate of BeiGene, Ltd. We anticipate launch of VDT482 in second-line esophageal squamous cell carcinoma – the most common type of esophageal cancer globally – in the US in mid-2022. Looking further ahead, the need to extend survival for more patients with different tumor types still exists. We believe VDT482 has the potential for synergistic combinations with other Novartis medicines to help address these unmet needs, and we have initiated three combinations in clinical trials and aim to advance several more within the next years.
1 Launch brands include Zolgensma, Kesimpta, Mayzent, Beovu, Luxturna, Leqvio, Enerzair, Atectura, Piqray, Adakveo, Tabrecta and Scemblix. Growth drivers include Cosentyx, Entresto, Xolair, Ilaris, Xiidra, Aimovig, Promacta/Revolade, Tafinlar + Mekinist, Kisqali, Lutathera, Kymriah and Jakavi (marketed by Novartis outside the US).