1. What are value added medicines?
Value Added Medicines are medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, health care professionals and/or payers.
2. What type of improvements can they deliver?
Relevant improvements include:
- A better efficacy, safety and/or tolerability profile;
- A better way of administration and/or ease of use;
- New therapeutic uses (indication/population);
3. How do value added medicines deliver these benefits?
The added value may be achieved through finding a new indication (drug repositioning), finding a better formulation or dosage (drug reformulation) or developing a new combined drug regimen, adding a new device or providing a new service (drug combination).
4. Can you give us more details and some examples?
- Drug Repositioning or repurposing is the process of finding a new therapeutic use for an already known medicine which had initially been developed for another indication.
Examples: A very famous and classical example of a repurposed drug is Sildenafil. Originally developed as an anti-hypertensive, Sildenafil was later repositioned for the treatment of erectile dysfunction and pulmonary arterial hypertension. Other examples include:
– Parkinson’s to Alzheimer’s (Memantine)
– Cardiovascular to Oncology (Propranolol)
– HIV infection to Oncology (Plerixafor)
– Parkinson’s to Diabetes type 2 (Bromocriptine)
- Drug Reformulation is the development of a different formulation for the same medicine, i.e. finding new ways to combine the different substances of a medicine, including the active ingredient, to produce a final medicinal product.
– From standard release to quick release of the active substance (Bromocriptine)
– From an intravenous to a subcutaneous injection (Trastuzumab)
– From an injectable solution to a ready-to- use prefilled syringe (Methotrexate)
– From a sublingual tablet to transdermal patches (Buprenorphine)
5. What type of R&D efforts are needed to develop value added medicines?
Different types of value added medicines require different R&D efforts.
- Developing a new device requires considerable R&D investment to optimize the administration of the active substance.
- Certain changes to a medicine require a clinical development programme in order to collect new clinical data which are necessary to assess the safety and efficacy of the value added medicine:
- New claims around safety or efficacy of the product such as different indications, an improved safety profile in case of repositioning or increased speed of onset in case of reformulation.
- A change in the blood concentration profile of the medicine. This situation occurs when there is a change:
- in dosing frequency,
- in the strength per dose,
- in the release profile,
- in the route of administration,
- for new formulations,
- where it is difficult to demonstrate the pharmacokinetic equivalence.
- A new combination product containing active substances that have not previously been used together
- In certain circumstances, to support safety/efficacy in children in accordance with the requirements of the European paediatric regulation.
6. Can you give an example of a therapeutic area where value added medicines can add benefit?
Taking the example of respiratory diseases: 68 million people in the EU suffer from common respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). Due to known risks, the management of asthma and COPD is associated with high healthcare and societal costs. Asthma and COPD are respectively responsible for 250,000 and 1.1 million annual hospital admissions and their estimated annual economic burden in terms of direct (healthcare) and indirect (lost production) costs amounts to €82 billion in total.
Despite the availability of efficacious molecules to treat asthma and COPD, evidence shows that low adherence to treatments contributes to poor patient outcomes associated with an increased risk of hospitalisations, medical visits, and administration of antimicrobials or oral corticosteroids.
 European Respiratory Society. European lung white book 2013. Available from http://www.erswhitebook.org
National Institute for Health & Care Excellence. Medicines Adherence. NICE Clinical guideline 2009. Available from: https://www.nice.org.uk/guidance/cg76
 Melani, AS, et al. Respir Med. 2011;105(6):930-8
7. What are their benefits for the healthcare community?
The benefits of value added medicines are expected to impact healthcare systems through increasing treatment options, preventing therapeutic escalation or increasing rational use of medicines. They will as a consequence reduce the use of healthcare resources and improve cost-effectiveness, and therefore contribute to the efficiencies of the healthcare system and better patient health and access.
8. What benefits will value added medicines bring to patients?
All patients differ and what works for one may not work as well for another. In a society where patients want to take responsibility for their own health, value added medicines can help empower patients to feel better with their treatment.
With this in mind, the Value Added Medicines Group is developing a framework to provide new opportunities to help patients in their healing process, offering more adapted medicines to those who need it.
9. What benefits will value added medicines bring to healthcare professionals?
Value added medicines provide healthcare professionals with unprecedented flexibility in therapy choices to target better outcomes for patients, whose needs remain unaddressed and unmet by existing therapies. Healthcare professionals will be able to choose from a wider range of treatment options using well known active substances, but allowing for a more tailor-made, patient centric approach, increasing patient and professional satisfaction.
Value added medicines offer a well-known safety and tolerability profile based on existing molecules, creating confidence in using alternatives which are more adapted to some patients’ lives and needs. Fewer side effects, better modes of administration, new dosage forms or easier to handle medicines are among the benefits that value added medicines offer to healthcare professionals so that patients can be treated more effectively without resorting to expensive next line therapies.
10. What benefits will value added medicines bring to payers?
Several healthcare inefficiencies are impacting the sustainability of healthcare budgets, such as suboptimal use of drugs The WHO has notably estimated that more than 50% of all medicines globally are prescribed, dispensed or sold inappropriately and that 50% of all patients fail to take their medication as prescribed or dispensed. The cost of non-adherence in Europe is estimated to cost European governments 125 billion euros per year.
Value added medicines provide an opportunity to tailor treatment to specific patient subgroups and therefore to reduce misuse of medicines which can lead to therapeutic failure and which are unnecessarily consuming resources for payers.
 WHO, Health systems financing: the path to universal coverage (2010)
 €125bn/year is an A.T. Kearney estimate based on US avoidable cost data
11. Why is our industry developing value added medicines?
Value added medicines represent a form of R&D, merging a pharmacological approach of known molecules with a well-known safety and tolerability profile together with more patient and/or healthcare professional insight, leveraging new technologies to transform existing molecules to address specific needs that could not have been tackled 20 years ago.
Working with proven compounds whose toxicity and other effects have been studied, the pharmaceutical industry can reduce development times, but considerable R&D investment and effort are still required to reposition, reformulate or combine new technologies with known molecules. Our aim is to bring innovation continuously through the entirety of a molecule’s lifecycle, particularly those molecules no longer protected by patent, without impacting patient access.
12. What objective is the Value Added Medicines Group aiming for?
Our aims are to establish, in collaboration with patients, healthcare professionals and payers, a sustainable market model that incentivises R&D, notably when the molecules come off patent, and to enable access to value added medicines in Europe.