Redesigning medicines: New options for patientcentric treatments (5 min read)
Value added medicines (VAMs) are an increasingly significant way to provide broader access to innovative treatment options. VAMs are generic medicines that have been enhanced in a variety of ways to better address patients’ needs – and improve patients’ lives.
نوفمبر 05, 2018
A crying toddler, sick with pneumonia, needs a dose of antibiotics. His mother has the medication – but first she has to prepare it. This means adding water to a gritty-tasting powder in a bottle, then extracting the liquid mixture at a precise amount into a syringe. Now she has to try to get the liquid into the mouth of the feverish, cranky child. Already uncomfortable, the child jerks away from the syringe coming at him – and the antibiotic ends up spilled all over his shirt. Now imagine the benefit for the young patient, and the relief for his mother, when this medicine is available as a small, quickly dissolving tablet that can be placed under the boy’s tongue. A user-friendly formula like this is one example of value added medicines, or VAMs.
Value added medicines, according to Medicines for Europe – the official trade association for the European generic, biosimilar and value added pharmaceutical industries – are defined as “medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers.”1 Because VAMs are based on known molecules, the basic ingredient is already there. To use an analogy, you could compare the known molecule – a generic medicine – to a bicycle. Then think of a VAM like a bike equipped with a small electric motor. On an e-bike, riders can go faster and travel longer distances with less effort. Or, parts of the bike can be added or replaced to make it more comfortable, convertible or safer. Similarly, medicines can be “upgraded” in different ways – to create tailored therapies for patients.
Reformulation, combination and repositioning
For a normal bicycle, a small motor surely is an upgrade. This means the rider will struggle less to go up a hill, for example, so he is more likely to continue. Similarly, in medicines, changes in dosage, strength, release characteristics or mode of administration can make it easier for patients to take them. Making a change like one of these is known as reformulation, and it can be done with established generic products. With the example of treating a sick child, a powder antibiotic requiring reconstitution can be converted into tablets that dissolve in the mouth. Not only does that reformulation make the medicine easier for the child to receive, but it also means that reconstitution is not necessary, and, because the dissolvable tablet is more stable, refrigeration is not needed. These latter factors are especially important when insufficient access to clean water and refrigeration can hinder the use of antibiotics, whether it be due to travel, lack of infrastructure or even after a natural disaster.
Another way to add value to existing medicines is by combining multiple medicines into one pill. The approach of combining can be especially important in cases where people need to take multiple medicines several times a day. Here, there is a risk that patients neglect to take them all or forget a dose. However, when two medications are combined (whether, for example, in tablet or inhaler form), patients usually find it easier to adhere to their treatment. As an example, patients with asthma and chronic obstructive pulmonary disease (COPD) tend to have low adherence to treatment, and this correlates with a higher risk of hospitalization.2 Ready-to-use combination inhalers help them continue their treatment regimen and can greatly improve their health and quality of life.
Increasingly, technology is also helping patients stick with their therapies. New and exciting ways of combining medicines and medical devices – such as digital apps or digital therapeutics – are on the rise. For instance, in the case of antidepressants, the medicine can be supplemented with an app delivering cognitive behavioral therapy. Such combinations can make the overall therapy more effective.
In addition to reformulating and combining treatments, new therapy options open when a medicine that was developed for one condition can be used to treat another. This approach is known as repositioning. Repositioning entails either retrieving existing data, or generating new data, to support the use of a drug for a new indication or in a new treatment population – and it is an attractive alternative to the lengthy and expensive process of developing new medicines.3 Someone who can speak to the great possibilities of repositioning is Nick Warwick, Chief Medical Officer at Sandoz, and part of a team responsible for the development of value added medicines. “I am very excited about the possibilities that utilizing big data, including real world evidence, can bring in the area of repurposing medicines. If we can avoid exposing patients to unnecessary clinical trials, and take a fresh look at the data that we have, then this has got to be a great thing.” (See interview with Nick Warwick, Chief Medical Officer at Sandoz)
Benefits of VAMs for PATIENTS Improvements:
efficacy; tolerability; safety
quality of life
reduction in therapeutic escalation
more efficient use of healthcare resources
rational use of medicines
more options for tailor-made therapies
increased therapy success
greater patient satisfaction
Adding value – receiving benefits
It is not only current patients who benefit from these new developments. By creating VAMs, existing medicines can be made safer for future patients and less likely to cause adverse effects. On another level, VAMs enable the development of safer ways to administer these medicines, so physicians lower the potential for accidents not only for patients but themselves. This risk is particularly relevant when physicians administer oncology treatments. Frequently, healthcare professionals need to reconstitute freezedried powders in vials before they can give them to patients. During this multiple-step process, the risk of a needle injury, or the contents squirting out of the vial, is high. Reformulating existing medicines to provide ready-to-use chemotherapy saves time, reduces the risk of injuries and simplifies medicine handling.4
The ease and convenience of handling medicine also plays a lifesaving role when it comes to antibiotics. Worldwide, some 700,000 deaths per year can be attributed to antibiotic-resistant bacteria, a growing global health threat. One reason for this development is insufficient compliance with a doctor’s prescription. To be effective, patients need to take the full course – until the package is empty. When patients abandon their treatment midway, it can be compared to going only half the distance of a planned bike tour. The rider is left in the middle of nowhere – not yet at his destination, but with resources significantly depleted. Similarly, if patients do not take their medicine as prescribed, the level of antibiotics in the body is not sufficient to continue inhibiting bacteria. Thus, resistant strains can develop more easily. But when antibiotics are easy to use, such as through reformulation, patients take them more consistently. This way, therapy is likely to be more effective, and collectively, this is also likely to have a positive impact on reducing global bacterial resistance.
Offering a strategy against antimicrobial resistance is just one way that VAMs can support healthcare systems, says Warwick. Because VAMs are based on existing generic products, they can offer a cost-effective alternative to certain treatments while, at the same time, provide access to high-quality therapy for patients. Although the cycle of VAM development is still in the early stages, Warwick is convinced of their potential. “Value added medicines allow us to focus on the needs of individual patients and enable a more patient-centric and personalized therapeutic approach. I believe that VAMs are one way to improve access to healthcare for patients, now and in the future.”