Incremental drug innovation means more therapeutic options with “great impact” on patients’ lives and on the healthcare system

Farmaindustria presents in Barcelona the update of the study that analyses the scientific evidence of medicines that offer therapeutic opportunities to groups of patients with unmet needs.

There is inadequate recognition of these therapeutic improvements by funding decision-makers, which may discourage their development, the report concludes.

Incremental innovation in medicines is innovation that includes additional developments on existing medicines, such as new dosage forms or formulations, combinations of medicines, changes in dosage or in the amount of active substance, and new uses of the medication. All of these are particularly important improvements for the elderly, the chronically ill, the polymedicated and children.

A large volume of biomedical innovation is currently represented by this type of innovation. Around 40% of the drugs that have reached the market in the last decade have come from incremental innovation and it is evidence that the innovative pharmaceutical industry is developing both new drugs resulting from radical innovation and improved existing products resulting from this innovation.

Incremental innovation can bring about significant developments with respect to the original medicine, having “a major impact on patients’ lives and, consequently, on society and the healthcare system”. Incremental innovation is key both in the maintenance and adaptation of essential medicines and in the personalisation of medicine and plays a central role for the European Medicines Agency (EMA), as reflected in its strategy for evaluation agencies. However, today, “there is often a lack of adequate recognition of such therapeutic improvements by funding decision-makers, which may discourage their development”.

These are the main conclusions of the study presented this Wednesday in Barcelona and carried out by the consultancy firm Axentiva for Farmaindustria under the name La innovación incremental del medicamento. Generating value for the patient and the health system, which is an update of the one presented in 2023, to which striking examples of medicines that represent incremental innovation have been added, ranging from ways of administering medicines and formulations that are better received by patients to combinations of medicines that lead to significant improvements in health outcomes.

“Following the publication of the report on incremental innovation last May, this edition contains an expanded compendium of cases, which aims to provide a more holistic view of the relevance of incremental innovation as a strategy that enhances the value of the medicine. Thus, both the range of therapeutic areas included and the time frame have been expanded and, although the global approach and the balance between the different areas of value already present in the initial report have been maintained, special emphasis has been placed on incremental innovation in our country”, explained Carlos Crespo, CEO of Axentiva Solutions, yesterday.

The availability of multiple therapeutic options provides flexibility in “choosing the treatment that best suits the individual characteristics of each patient” and can also facilitate treatment delivery, and provides “therapeutic opportunities for groups of patients with unmet needs”, he added.

Some life-changing examples

For example, the study describes the case of a new nanocrystal dosage form for schizophrenia patients that allows for sustained release and, consequently, six-monthly administration. Or patches for Alzheimer’s patients that allow twice-weekly application and have comparable effectiveness to the daily formulation. Or an inhaler combining two active ingredients for the treatment of patients with persistent asthma that reduces the drop-out rate and improves adherence to treatment.

Or the case of a new skin foam formulation for people with psoriasis, which, in addition to improving the condition and severity of the disease compared to the gel version, improves disease-related quality of life and reduces sleep loss associated with itching. Or the introduction of a dispensing device that delivers personalised doses for Parkinson’s disease.

These are just a few of the examples included in the study that have a positive impact on the patient’s quality of life, which ultimately represents an advance in the quality of care in the health system. But also in its efficiency. The incremental improvement within a therapeutic class of drugs often leads to a reduction in the cost associated with the disease, both direct and indirect, derived from factors such as lower rates of adverse effects, improved efficacy, reduced patient absenteeism, etc., with the consequent health savings. Overall, “this drug development strategy can translate into reduced costs and increased efficiency of healthcare management, while attracting the attention and support of patients and healthcare professionals due to its inherent characteristics,” the report concludes.

Types of incremental innovation

Specifically, the report analyses five types of incremental drug innovation: changes in the amount of active substance, changes in dosage formulation, new formulations or dosage forms, new uses and incorporation of delivery devices, including digital technologies, and combinations of medicines.

In addition, the review of the scientific evidence analysed in the report finds other parameters that are positively affected by incremental drug development, such as patient convenience and compliance with treatment, adherence, reduction in the economic burden associated with a disease, addressing an unmet need, or adaptation to certain patient groups or individualisation, many of which are interrelated.

For example, “an improvement in the patient’s quality of life could have a positive impact on their productivity at work, also reducing absenteeism, which reduces the indirect cost of the disease”. In the same vein, improved adherence can lead to lower expenditure of healthcare resources thanks to the appropriate use of medication, which “generates the desired clinical effect and avoids acute episodes of the disease, which cause high costs to the health system,” the report says.

However, the perception of the added value of incremental innovation by regulators and payers differs from that of patients and healthcare professionals. The former focus on efficacy, tolerability and safety outcomes and cost-effectiveness of the drug, often without valuing the advances in terms of patient experience and social environment or the individualisation of medicine, which the end-user of the treatment considers essential.

“The paradox is that, although patients are well aware of the benefits of incremental innovation, national pharmaceutical legislation does not recognise or value this innovation,” said Farmaindustria’s deputy director general, Javier Urzay, at the study’s presentation. “The lack of consideration of these real benefits, not only clinical, that incremental innovation generates is an obstacle to patient access to these medicines which, at the end of the approval and pricing process, are either not included in the public pharmaceutical provision or, if they are, it is at such low prices that their launch and production is of no interest to the pharmaceutical company that has invested time and money in their development,” he added.

The conference Incremental drug innovation: An updated view was also attended by Jordi Aguasca, Director of the Technological Transformation Unit of the Department of Business and Employment of the Catalan Government; Vicente Plaza Moral, Director of the Pneumology and Allergy Service of the Hospital de la Santa Creu i Sant Pau (Barcelona); Montserrat Ginés, Vice-President of Acción Psoriasis; Fabiana d’Aniello, Pharmaceutical R&D, Portfolio and Drug Development of the Ferrer Group, and Meritxell Cortés, Medical, Quality & Market Access Director of Laboratorios Gebro Pharma.