How VAMs increase access to healthcare - Addressing unmet medical needs (7 min read)
Nick Warwick, Chief Medical Officer at Sandoz, explains what value added medicines (VAMs) are, how they are developed, and which benefits they bring not only to patients.
نوفمبر 05, 2018
„While not many people may be familiar with the term ‘value added medicines,’ patients are familiar with problems they have when they use existing medicines. This is why I usually describe a VAM as a better version of the best available existing generic medicine – for example, by making it easier and less complicated to take, by changing the side effect profile or by combining two effective medicines into one. Another example is when a generic medicine used for one medical condition can be shown – through generation of appropriate data – to also benefit patients with a separate, unrelated medical condition (so-called ‘repurposing’ or ‘repositioning’). But to achieve these things, we first have to really understand patients’ needs and use this knowledge to best improve our products, so these needs can be met. This is the underlying concept of value added medicine development.
Discovering candidates for enhancement
There are several ways we can discover new candidates for value added medicines. One way is to view our existing portfolio of products with an external mindset. We typically do that through advisory boards with doctors, pharmacists and patient representatives. We listen to the problems they are having with their current medication and to their ideas for improving the product. Another very exciting way to identify potential candidates for VAMs is by gaining an in-depth understanding of how a particular medicine works to benefit patients with a specific condition – and then looking to see if that therapy could be extended to treat patients with other conditions. Here, we can increasingly use big data and digital technologies, including artificial intelligence and machine learning, to identify ways of repurposing drugs from treating patients with one disease type to another. This can be done by sifting through large amounts of data like patient records, clinical trial data and publications. Other data sources – from publicly available and proprietary databases, conference reports, abstracts and the like – can also be reviewed to recognize patterns of a medicine’s characteristics and usage. We also receive fantastic ideas from our community of Sandoz associates and their families, among which are scientists, technicians, researchers and other trained healthcare professionals.
We are getting closer. This is the most compelling and important work I’ve ever done.
Developing VAMs requires a hybrid approach
Once we have an idea for an enhanced generic medicine, our Product Development team sets out to translate it into a drug ready for patients’ usage. The efforts to do that sit somewhere between developing a ‘standard’ generic product and developing ‘new chemical entity’ medicines. Developing a typical generic medicine usually takes about three to four years and an investment of single-figure millions of dollars. Conversely, it takes many years and billions of dollars of investments to develop completely new pharmaceuticals. Value added medicines sit somewhere in-between, which means there is still a substantial amount of research and investment involved. When developing a VAM,the amount of data we need to generate is very different to that required for standard generic products – this is because of the differentiating features of a VAM as compared to a standard generic. For example, we will need to conduct clinical studies to better understand how the body handles the VAM. Plus, of course, we’ll also need to understand the effect of the drug on the body - either as part of healthy volunteer studies, or studies in patients, and this may entail large Phase III trials. We may also need to look at doing patient experience studies in the post-marketing setting, and studies especially designed to characterize the ‘value added’ nature of the drug. Our development approach needs to be specifically tailored for each VAM, and the type of approach we take very much depends on what change or modification is needed to add value to a medicine.
Reducing waste and inefficiency
For therapies to be effective, patients typically need to take their medication at a certain dosage, sometimes at the exact same time of a day, and continue to do so as long as prescribed. This is especially important for patients with chronic conditions. However, 50 % of patients fail to take their medication as prescribed, according to WHO.1 For me, this number is shocking. At the same time, it motivates me in my work in the VAMs field because I believe that anything we can do to improve existing generic products to increase treatment compliance will be good for patients and our society at large.
Addressing universal healthcare
By developing enhanced generic (value added) medicines, I believe we also can help address some of the key barriers to universal healthcare coverage, a concept well-established and actively promoted by WHO. I believe it is a fundamental right that we get healthcare at a cost that is not going to cause significant or undue financial hardship. The top three leading causes of global healthcare inefficiency include underuse of generic products, use of substandard medicines (with associated quality issues) and inappropriate and ineffective use of medicines. I believe VAMs can really make a difference in this area. As indicated by an analysis from the IQVIA Institute for Human Data Science, responsible use of medicines could help save almost USD 500 billion worldwide.2 This would allow a more efficient use of healthcare budgets, helping countries in the effort to provide universal access to medicines without endangering financial sustainability.3 For me, this makes VAM development all the more relevant, and rewarding.”