Hesitancies in primary headaches treatments

KEYWORDS:

• Awareness
• education
• preventative drugs
• primary headaches
• public health

1. Introduction

Primary headaches represent a global health priority, with an estimated global prevalence of active disorders of 52%, of which migraine accounts for 14%, Tension-Type Headache 26%. On a monthly basis, 4.6% of the global population has headaches for more than 15 days, while on a daily basis 15.8% of all mankind suffer from it [1]. Noteworthy, three out of four people suffering from migraine are women. It is therefore necessary to hypothesize an effective large-scale strategy including risk factor control, such as obesity, cardiovascular diseases, psychiatric diseases, to address this important aspect of clinical medicine. It is important to point out that the majority of migraines can be appropriately managed at a general practitioner’s level, applying pharmacological and non-pharmacological strategies, including neuromodulation.

The acknowledgment that this immense group of people with migraine needs appropriate consideration, that stakeholders and policy makers must adequately take in charge this emerging problem, are the yet open challenges that must be faced without further hesitation.

2. Body

Facing this immense public health priority, many decades have passed without an adequate social perception of the personal, social and economic consequences that this pathology produces. The analysis of the risk originating from this unpreparedness of the NHS has highlighted the need for dedicated and certified health structures for the control of this class of pain disorders [2,3].

It should be considered that in the face of these socio-health impact data, scientific research has not been able to build a model useful for the creation of a class of prevention drugs, until the identification of CGRP as a key step in a new pathophysiological mechanism. Monoclonal antibodies (MoAbs) for CGRP and its receptor (CGRP (r)) have filled this gap [4], first approved by the FDA and then filed and approved with a physiological delay by EMA.

It should also be noted that there are embarrassing approval asymmetries between FDA and EMA for non-fungible drugs, such as Galcanezumab for the prophylaxis of devastating cluster headaches [5].

Many factors have slowed down the effective and applicative diffusion of this new pharmacological class, and among them it can be firstly included the need for the NHS to address the COVID-19 pandemic as a priority. Then, disparities in prescription rules across EU, the spending review for potentially non- deadly diseases, as well as non-prioritizing headache disorders among chronic non-communicable CNS diseases [6,7].

Other barriers that slow down the effectiveness in controlling headache disorders are the small number of headache subspecialty experts who, even feeling the need to change with the previous Standard of Care (SoC), implement it smoothly or combinedly which, together with the long consequent waiting lists, favors the natural progression of primary headaches toward the chronicization complicated by medication overuse [8].

Another step forward is the full involvement of GPs in the early management of primary headaches, starting from the use of SoCs and then sending for referral to Headache Centers only clinically refractory or resistant patients [9], relieving the pressure on the EDs of patients with low therapeutic response [10,11].

A further step to be taken is represented by the education of pharmacists in the screening of patients requesting OTC drugs delivery without indication to individuals with migraine in needing of prevention (i.e. >4 migraine days/month), or to help guard against narcotic usage and at the same time educate individuals with cluster headache to a fully informed decisions on the available approved drugs [12,13].

A further problem that must be addressed, to optimizing the availability of new drugs for migraine, is the homogenization of reception, pricing and authorization times by national stakeholders, to make them identical across the EU. This problem will arise again shortly due to the EMA post-authorization availability of the new pharmacological classes of gepants and ditans, drugs that will soon be available in the EU and which, having an advantageous delivery route – oral compared to the subcutaneous – should be able to be used on a wider group of individuals with migraine, both in prevention compared to CGRP MoAbs and in acute therapy compared to triptans because of their greater safety [8].

What solutions can be taken to overcome these hesitancies in primary headaches management.

Awareness public campaign on chronic headache as costly diseases [14].

Motivate GPs to take responsibility for low/medium frequency headache patients [14].

Narrow the choice to access to Headache Centers to just chronic/resistant/refractory patients favoring tele-healthcare.

These solutions are urgently needed for 52% global population individual with primary headaches [1], and among these, tele-healthcare can represent an ideal way, above all, for the necessary follow-up after the first phase of clinical and instrumented diagnostics when necessary [15]. It is also important to educate patients with primary headache and their families to minimize the social impact of this disease.

3. Conclusions

Concluding, pathologies with a large impact in the global population such as primary headaches, acknowledged as relevant in the various Global Burden of Diseases, producing an enormous biopsychosocial burden in one billion affected individuals (1), although with differentiated relevance between a medium (<15 days/month – H15-) or high impact (> days/month – H15 +), cannot continue to be considered a priority only by big pharma and remain unrecognized and neglected on the tables of decision makers of the various NHS, preventing or slowing down a full applicability of pharmaceutical products resulting from the most recent basic and clinical research [8]. It seems now defined that CGRP(r) MoAbs will be able to act as ‘game-changers,’ taking on the function of migraine disease course-modifying drugs, with an effect comparable to specific MoAbs used in the treatment of other chronic inflammatory diseases [16].

The success of the Global Campaign against Headache, which began 18 years ago, after achieving the goal of an adequate awareness on the disease and its social recognition, it is still hesitating today while facing an insufficient education of physicians, considering that apart from the specialists in this field there is the necessity to permeate of skills all doctors who during their daily practice see individuals affected also from primary headache disorders and hesitate to take charge of them.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.