Unnecessary treatments, redundant medicines, or ill-advised decisions?
The ongoing discussion about initiatives that can counteract and reduce unnecessary treatments and treatments with low value is also relevant for new medicines. One of the dilemmas here is the weighing of the relationship between the clinical significance of a drug and the costs of treatment with the drug.
Concrete examples of over-treatment, as referenced in the recommendations of the Robusthedskommissionenfrom September 2023 include, for instance, the fact that 39 percent of patients visiting an acute healthcare facility receive antibiotics, and that patients with an oxygen saturation level above 94 percent receive oxygen therapy. It should be a relatively simple task to adhere to the clinical guidelines in such areas.
However, there are areas where it is much more challenging to specify and implement the recommendations from the Robusthedskommissionen for reducing the extent of inappropriate treatment – simply because there isn’t always a shared understanding of when a treatment is appropriate.
For many types of existing surgical and medical interventions, there isn’t sufficient evidence that they provide value for patients – and it is often pointed out, including by Medical Associations, that society does not conduct enough research and testing of existing clinical practices to ensure evidence for the given treatments.
Clinical significance vs. economics
When it comes to new medicines, one would assume that regulatory authorities have reviewed the clinical evidence for safety and efficacy – and found it sufficient – prior to approval. However, hints in the media from the Danish Medicines Council that it is often very difficult to assert with certainty that medicine benefits patients, even if it is approved by the EMA (European Medicines Agency), unfortunately do not contribute to this perception. And this is problematic.
A significant challenge is that we do not always agree on what provides value for the patient. One of the dilemmas is the understanding and weighting of the relationship between the clinical significance of a medicine and the costs associated with its use.
An EMA-approved medicine can indeed be of great benefit to an individual patient, even if it is not recommended by the Danish Medicines Council or another HTA body. Conversely, an EMA-approved medicine that is also recommended by the Danish Medicines Council or another HTA body may be unnecessary, redundant, or even harmful to the individual patient. Whether a medicine is appropriate in a given situation often depends on clinical judgment and the patient’s preference, but strict guidelines on which medicines must or should be used within different indications limit the possibilities. The decisions – and thus the priorities – are centralized based on defined criteria.
Drug development for patients who can afford it
One possible consequence of this will be that investments in the development of new medicines may go toward those expected to be recommended by relevant HTA bodies or those intended for patients and/or markets beyond the influence of the respective HTA bodies. More specifically, this could drive drug development towards indications where patients can afford self-payment and away from areas where it is difficult in advance to speculate about the relationship between future clinical significance and the costs of the potential medicine.
It will also hinder the development of innovative medicines that will “only” lead to minor improvements compared to established treatments, even though many of the effective and new generations of medicines available today have been developed based on sequential and gradual improvements.
Furthermore, it may limit the innovation of medicines for rare diseases if the same requirements for weighing the relationship between clinical significance and costs are applied to these conditions. Not to mention the development of new medicines aimed at complex and/or multifactorial disease spectrums, such as lower back problems and mental disorders. Common to these conditions is that it is difficult, or in some cases impossible, for drug developers to establish clear and attractive business models, despite the significant associated health economic burdens.
Regardless, it is in everyone’s interest to target healthcare resources toward medicines, technologies, and initiatives that provide the most possible health for the money. The question is whether consensus can be reached on what constitutes necessary, redundant, appropriate, and inappropriate treatments, medicines, and decisions. A consensus that will be biased by the eyes that see.