Value-added medicines (VAMs) can offer a transformative opportunity to improve patients’ experience and outcomes by enhancing existing treatments to address unmet medical needs.1 While repositioning, reformulating, or combining known molecules to make VAMs can deliver relevant improvements for patients, healthcare professionals, and payers, significant challenges remain.1 As a member of the VAM group at Medicines for Europe, we at Colonis Pharma Ltd give an overview of key opportunities and challenges for VAMs.
How VAMs help patients: Tailoring treatment to diverse needs
VAMs shift the focus from a “one-size-fits-all” approach to a model that considers the practical realities of different patient groups:2
- Patients with swallowing difficulties (dysphagia): As many as one in five older patients struggle to swallow tablets and capsules.3 In cases where no alternative formulations are available, caregivers may resort to crushing tablets – a practice that can lead to increased toxicity due to dose dumping, medication errors, or reduced efficacy.3
- Paediatric patients: Many existing medicines lack age-appropriate formulations for children.4 VAMs can come in the form of flavoured liquids that improve palatability and support children to complete their treatment.4
- Polypharmacy patients: Many patients, particularly the elderly, have to take multiple medications and face a high ‘pill burden’, which can lead to medication errors.3,5 VAMs can combine different products into a single fixed-dose combination, reducing the number of daily doses which may improve adherence.5
- Patients with limited access to suitable options: VAMs allow for the repositioning of well-known products to treat other indications, for which tailored medicines were previously unavailable.5
Cost efficiency and sustainable healthcare
VAMs can also offer a sustainable approach to managing limited healthcare budgets.6
Evidence suggests that reallocating resources from new chemical entities toward existing products and services could have generated approximately 1.25 million more years of life in full health (quality-adjusted life-years [QALYs]) for the UK population during the 2000–2020 period.6
Because they are designed to combat treatment-related barriers, Medicines for Europe state that VAMs can “improve the cost effectiveness and efficiency of the healthcare system, either in terms of improved outcomes, reduced medication errors or improved patient adherence”.2
VAMs can also help reduce research and development costs as they utilise off-patent molecules with known safety profiles, meaning they typically have shorter development timelines compared to new chemical entities.5,7,8
The regulatory landscape: EU vs US
Europe still has significant regulatory hurdles that can cause challenges in bringing VAMs to market.8
Currently, the EU lacks a single, dedicated VAM pathway, which forces pharmaceutical companies to navigate multiple, often complex, regulatory routes.8 This added complexity can lead to wasted resources and additional costs.8
In comparison, the US has one combined pathway – the 505(b)(2) pathway. This provides a more streamlined approach that specifically addresses the changes VAMs make to existing medicines, simplifying and speeding up the approval process compared to Europe.8 This could be a contributing factor to the US’s prevalence in the VAM market, accounting for 62% of global VAM sales in Q2 2025.9
BRIC, Brazil, Russia, India, China; ROW, rest of world; US, United States.
Looking to the future of VAMs
The future of VAMs must involve a more harmonised approach if they are to fulfil their potential benefits. To achieve this, a “core evaluation framework” has been developed which is designed to help EU regulators and payers assess VAMs across five main categories: health gain, unmet medical needs, patient-reported outcomes, and the reduced burden on both the healthcare system and households.7 An important step forwards is Article 84, an amended framework proposed by the EU Commission, which includes a data protection period of four years for a repurposed medicine.10
At Colonis Pharma Ltd, we believe that VAMs are essential for the future of sustainable healthcare. We identify unmet needs and work to reposition and reformulate existing generic medicines into innovative alternative options. By developing products that support improved adherence, we can help improve outcomes for patients and healthcare systems alike.
References
- Medicines for Europe. Value added medicines. Home. Available from: https://www.medicinesforeurope.com/value-added-medicines/ [Accessed March 2026].
- Medicines for Europe. Our 5 pillars. Available from: https://www.medicinesforeurope.com/value-added-medicines/our-5-pillars [Accessed March 2026].
- Taylor S and Glass BD. Aust Prescr. 2018;41:191–193.
- Batchelor HK and Marriot JF. Br J Clin Pharmacol. 2013;79:405–418.
- Toumi M and Rémuzat C. J Mark Access Health Policy. 2017;5:1264717.
- Naci H et al. The Lancet. 2025;405:50–60.
- Petykó ZI et al. Cost Eff Resour Alloc. 2021;19:57.
- DCAT Value Chain Insights. Value-Added Medicines: A Call in the EU for a New Drug Class. Available from: https://www.dcatvi.org/features/value-added-medicines-a-call-in-the-eu-for-a-new-drug-class/ [Accessed March 2026].
- IQVIA EMEA Thought Leadership; IQVIA MIDAS MAT Q2 2025.
- Medicines for Europe. Pharmaceutical Directive – Article 84: Repurposed medicinal products. Available from: https://www.medicinesforeurope.com/wp-content/uploads/2024/04/Medicines-for-Europe-Position-Paper-Repurposing-v2.pdf [Accessed March 2026].
Colonis Pharma Ltd is an independent entity under the Clinigen Group.
March 2026 | GB-CPL-0-381
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