Why ‘reduce, reuse, and recycle' medicine is the future
The ultimate raison d’être of any medicine is to benefit patients.
At its very core, value-added medicine (VAM) is taking established treatments and finding new ways of revitalising and re-purposing them into new indications and formats. This process is often referred to as ‘incremental innovation’, which ultimately results in one or more of the following: a clinically relevant advantage, a major contribution to patient care, and significant improvement in use in a clinical setting. It’s about reducing the over-reliance on new scientific inventions by reusing existing and well-established medicines and giving them a new lease of life by renovating them, just like you would with a classic car, to make it fit for modern driving.
Sounds simple, right? On face value, it is – but behind every successful VAM is a complex process to ensure that the end product adds incremental value to patients, prescribers, healthcare providers, and regulators.
VAMs showed their value in the pandemic, but will they just remain pandemic life-savers?
VAMs have been around for a while; in fact, according to estimates by IQVIA, global sales are around $34.7 billion, two-thirds of which are from the US market alone.1 But it wasn’t until the global pandemic that VAMs were really thrust into the public consciousness, when an anti-inflammatory steroid, typically used to treat skin conditions and allergies, was re-purposed, as it was shown to relieve symptoms of COVID-19 for thousands of patients worldwide.2
Global pandemics aside, we’re seeing the repurposing of a number of existing medicines for the treatment of other, unrelated health conditions. Even planned but modest adjustments to existing medicines that were formulated years ago can often provide a better patient experience, while improving health outcomes. By partnering with new technology companies, new administration formats such as patches, films, and nasal sprays can be bolted onto existing medicines, and used alongside or instead of tablets, liquids, and injections to make medicines easier to use. New formulation approaches to excipients can also lower known side effects.
Going back to the classic car analogy, older molecules are also better understood than brand new ones. They come with a significant safety data record, which means that reformulations often do not require full phase III clinical trials. This lowers the safety risk, reduces the costs, and increases the speed of getting the medicine to patients who need it - just as a fully restored classic car with a complete service record is more likely to last for the long-term and retain its value.
Patient-centric design is key
Gone are the days of one size fits all, as we move towards an era of personalised medicine. Approaching medicines from a product lifecycle development perspective enables a more holistic approach to addressing patient needs. By truly understanding patient-centric insights, from symptoms to treatment barriers, this real-world evidence tells us so much more than clinical data alone and plays a pivotal role in informing how medicines can be reformulated or re-designed.
If we think about this on a larger, societal scale, these insights can also help tackle major public health concerns, like treatment adherence. According to studies, only around 50% of all patients living with a chronic disease adhere to their treatment instructions,3,4 which can severely affect a patient’s health, as well as add to the overall burden on healthcare systems. In patients where multiple medications are required to manage a chronic condition, such as cardiovascular disease, adherence is especially low. Studies have shown that if certain treatments are combined into a fixed-dose regimen, adherence, and therefore drug effectiveness, is improved.5 This is just one example of a simple ‘tweak’ that can add real value to patients. With an ageing population in many countries, including the UK, we need to maximise the potential of drug re-purposing across other chronic conditions, in order to reduce the pressure on our healthcare system and build a more sustainable industry and society.
Greater incentives are needed to ensure a more sustainable healthcare system for Europe
We’ve seen that there is clearly a huge social impact in reconditioning well-known and efficacious legacy medicines to ensure improvement for patients, prescribers, and payers, while not costing the earth. So, why are we not seeing more VAMs being used and made available across Europe? One of the reasons is that the regulatory pathway for VAMs is complex, with a lack of clarity on what evidence is necessary to prove the value of these treatments. As a result, incremental innovation is currently difficult to evidence and, by today’s definitions, falls short of delivering true value to patients in need across Europe.
The other reason is price. Focusing on a medicine’s price in isolation – without addressing and acknowledging the crucial issues of improving outcomes by rewarding genuine innovation – may make for instantaneous and lucrative savings on medicine costs. However, this approach fails to deal with the very real challenges that are facing health systems across Europe.
Innovative value-added medicines not only promote improved patient outcomes, but also offer value at an affordable cost to both health systems and wider society, compared to new chemical or biological entities. All of these elements must be considered in pricing and reimbursement decisions.
But change is happening: we’re seeing several initiatives from industry bodies across Europe and the US to support new regulatory pathways for VAMs, helping to cut the red tape for researchers, developers, and manufacturers. It’s encouraging to see things moving in the right direction, but we must come together as an industry to do more in helping all stakeholders understand and recognise the true potential of VAMs. My hope is that, one day soon, VAMs will be as appreciated as a newly restored classic car and we will see the health industry embracing a ‘reduce, reuse, and recycle’ mentality.
- VALUE ADDED MEDICINES ONLINE SUMMIT Webinar Report [Internet]. Medicines for Europe Value Added Medicines Sector Group; 2021 [cited 17 March 2023]. Available from: https:// www.medicinesforeurope.com/wp-content/ uploads/2021/04/FINAL%202021%20VAM%20 webinars%20writeup%20(1).pdf
- N Engl J Med 2021; 384:693-704 DOI: 10.1056/NEJMoa2021436
- Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9. PMID: 21389250; PMCID: PMC3068890.
- Naderi SH, Bestwick JP, Wald DS. Adherence to drugs that prevent cardiovascular disease: meta-analysis on 376,162 patients. Am J Med. 2012 Sep;125(9):882-7.e1. doi: 10.1016/j.amjmed.2011.12.013. Epub 2012 Jun 27. PMID: 22748400.
- Tsioufis K, Kreutz R, Sykara G, van Vugt J, Hassan T. Impact of single-pill combination therapy on adherence, blood pressure control, and clinical outcomes: a rapid evidence assessment of recent literature. J Hypertens. 2020 Jun;38(6):1016-1028. doi: 10.1097/HJH.0000000000002381. PMID: 32371789; PMCID: PMC7253190.
About the author
James Burt, CEO of Pharmanovia, joined the company in October 2021. Previously, he was the EVP EMENA at Accord Healthcare, and oversaw branded and generic pharmaceutical activities across 65 markets. Before that, he served as VP Hospital Business at Actavis, where he was responsible for the strategic direction of secondary-care activities worldwide. Burt holds a PhD in Chemical Engineering from the University of Birmingham, with a particular focus on biopharmaceutical manufacturing. He is also vice chair of the Medicines for Europe, Value Added Medicines Sector Group.