FormalPara Key Summary Points

Migraine, a widespread neurological condition, involves calcitonin gene-related peptide (CGRP), a crucial 37-amino acid neuropeptide. Targeting the anti-CGRP pathway has transformed the landscape of migraine treatment.

A group of expert neurologists based in the United Arab Emirates (UAE) formed a task force to develop evidence-based consensus recommendations to guide the use of CGRP-based migraine treatments in clinical practice. All statements achieved consensus (≥ 60% agreement) through a voting process.

The proposed CGRP therapy consensus recommendations pertain to specification of patients, appropriate monitoring of responses, and standardization of treatment, and as these recommendations were primarily drawn from global studies, they are relevant worldwide.

These recommendations mark the UAE’s first consensus on utilizing CGRP-based therapies for migraine treatment and management.

Introduction

Migraine is a common neurological disorder that is characterized by recurrent attacks of headache, which vary in severity and duration [1]. Migraine is classified as either chronic or episodic on the basis of the frequency of monthly migraine days (MMDs) or monthly headache days (MHDs) [2]. The latter, in which individuals experience up to 14 MHDs, is the more common form of the condition [2]. In comparison, individuals with chronic migraine experience 15 MHDs or more, of which 8 must meet the criteria for migraine as described in the third edition of the International Classification of Headache Disorders [3, 4]. Moreover, prodromal symptoms precede the headache phase of migraine and may include symptoms such as lethargy, thirst, and cravings, as well as increased sensitivity to lights and sound [5].

In addition to the physical symptoms, migraine can have a significant impact on an individual’s social life, economic status, and quality of life, making it a burdensome disease [6]. In 2019, migraine was considered the second leading cause of years lived with disability (YLD) by the Global Burden of Diseases study and the first leading cause of YLD in women aged 15–49 years [7]. Disorders such as neck pain, depression, and anxiety, which are commonly comorbid with migraine, are also among the top leading causes of disability in the world, further emphasizing the focal position of migraine in global disability [8]. In 2022, migraine was estimated to represent 16% of workforce productivity loss in the USA, with an estimated annual cost of $240 billion [9]. Migraine affects over one billion individuals globally [10], with current prevalence in the general population of the Gulf region ranging between 2% and 32% [11].

The understanding of the pathophysiology of migraine as a disorder of the nervous system is rapidly progressing owing to advancement in the characterization and diagnosis of its clinical features [12]. Primarily, extensive evidence has indicated the significant role of the trigeminal sensory neuropeptide calcitonin gene-related peptide (CGRP) in mediating migraine [13]. The release of CGRP contributes to the pain in a migraine attack by activating mechanisms in both the peripheral and the central nervous system. CGRP is an important factor that catalyzes mechanisms such as the vasodilation of vasculature in the head and neck [14], release of inflammatory mediators from immune cells [15], and development of peripheral sensitization in nociceptive, or pain-mediating, neurons [16]. CGRP has been identified as a crucial molecule released during acute, episodic migraine attacks [17] and, according to several studies, its concentrations may be continuously elevated in patients experiencing chronic migraine [18, 19].

CGRP-based therapies may provide significant improvement over conventional drugs as they are specifically designed to target the trigeminovascular pathway and have greater specificity and a favorable adverse events profile [13].

Targeting ligands or receptors of the CGRP pathway, anti-CGRP monoclonal antibodies are utilized in the prevention of migraine in adults who suffer from either episodic or chronic migraine [20]. The four notable monoclonal antibodies targeting the CGRP pathway approved by the US Food and Drug Administration (FDA) are erenumab, fremanezumab, galcanezumab, and eptinezumab [21]. As these represent a relatively new class of migraine preventive medication, several studies and randomized clinical trials have shown that monoclonal antibodies targeting the CGRP pathway exhibit comparable, and probably superior, efficacy to current drugs [22]. A meta-analysis assessing the safety and tolerability of monoclonal antibodies targeting the CGRP pathway through treatment-emergent and serious adverse events observed no significant differences between active treatments and placebo, thereby supporting monoclonal antibodies targeting the CGRP pathway as a well-tolerated therapy option for migraine prevention [23]. Additionally, pharmaco-economic analyses have shown that erenumab is a cost-effective option when compared with no treatment or treatment with onabotulinumtoxinA for chronic migraine [24]. In the United Arab Emirates (UAE), prescribers currently have access to all the anti-CGRP monoclonal antibody therapies apart from fremanezumab (Table 1).

Table 1 FDA-approved CGRP-based therapies and their availability in the UAE [67, 71,72,73,74,75,76]
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On the other hand, gepants are small-molecule CGRP receptor antagonists utilized in the treatment of patients with episodic or chronic migraine as acute or preventive therapies [25]. The clinical development of the first generation of gepants was halted because of reported hepatotoxicity. However, all recent clinical trials support the newest generation of gepants as a well-tolerated and efficacious treatment option. Several unmet needs of current treatments with non-steroidal anti-inflammatory drugs and other analgesics [26] are addressed by gepants, owing to their universal efficacy, favorable side-effect profiles, the absence of vasoconstriction, and the need for less frequent dosing [27].

In 2022, the European Headache Federation (EHF) updated their recommendations on the use of monoclonal antibodies targeting the CGRP pathway for migraine prevention [28]. Various national headache societies have since published recommendations on the use of CGRP-based therapies for migraine [29,30,31]. In the UAE, as well as the wider Gulf region, there are no published regional or local recommendations for migraine management, which has led to inconsistent practices among healthcare providers, resulting in variations in patient care and outcomes. The objective of these expert-established consensus recommendations is to clearly define patient cohorts that may benefit from CGRP-based therapy and guide the optimization and standardization of the patient pathway in the UAE.

Methods

Assembly of Expert Task Force

A task force comprising nine neurologists who are members of the Emirates Neurology Society, UAE, and experts in the clinical management of migraine was established. The task force convened to develop evidence-based consensus recommendations to guide the use of CGRP-based therapies for the prevention of migraine in the clinical setting in the UAE.

Development of Consensus Recommendations

All consensus recommendations were jointly drafted by members of the established task force, who together represent the expert voting panel. Several consensus recommendations were largely congruent with the EHF guidelines on the use of monoclonal antibodies targeting the CGRP pathway for migraine prevention, which were updated in 2022 [32]. The scope of the consensus statements was expanded to include recommendations for the use of monoclonal antibodies targeting the CGRP pathway and recommendations on the use of gepants for migraine prevention in clinical practice. Additionally, modifications were made to specific EHF and American Headache Society (AHS) evidence-based recommendations to align them with local clinical practice, with consideration of the nuances of the patient population and healthcare infrastructure within the UAE. The expert task force also reviewed relevant published findings from various randomized controlled trials and observational studies during the development of the consensus recommendations. Following the development of all recommendations, each consensus statement was critically evaluated and modified during a meeting conducted on February 26, 2023. Members of the task force panel subsequently voted to “agree” or “disagree” with each statement. A consensus was considered if at least 60% of the voting panel voted in agreement with a particular recommendation.

Literature Review

Prior to the consensus meeting on February 26, 2023, the first three named authors (Taoufik Alsaadi, Deeb M Kayed, and Abubaker Al-Madani) conducted a literature review to identify pertinent treatment guidelines, recommendations, randomized controlled trials, and observational studies, which were presented to the wider group at the consensus meeting. Following the meeting, a comprehensive literature review was jointly conducted by the task force panel using the PubMed database. Multiple search strings were employed, incorporating keywords derived from the formulated consensus recommendations. This comprehensive search strategy was designed to identify publications that provided supporting evidence for the consensus statements, allowing for assessment of the level of evidence associated with each statement, and ensuring a robust, evidence-based foundation for the generated recommendations.

Ethical Approval

This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

Results

Expert Consensus

The task force convened to discuss and develop seven consensus recommendations based on a review of the relevant supporting literature for each recommendation (Table 2).

Table 2 Consensus recommendations and relevant supporting literature
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Consensus Recommendations

The task force reached a consensus on all recommendations (agreement level ≥ 60%) (Table 3). Recommendations were subsequently reviewed critically using the Oxford Levels of Evidence system to evaluate the quality of supporting evidence, and generate a score indicating the strength of the recommendation [33] (Table 3).

  1. 1.

    There is a need for the establishment of local consensus guidelines to ensure the appropriate and effective use of CGRP-based therapies for individuals with migraine in the UAE.

Table 3 Consensus recommendations 1–7 for CGRP-based therapies
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CGRP-based therapy has emerged as a promising novel treatment for migraine [34]. This emergence represents a significant advancement in the treatment and prevention of migraine and provides a new therapeutic option for millions of people who suffer from this debilitating condition.

Several studies have evaluated the efficacy, tolerability, and safety of CGRP-based therapies, including monoclonal antibodies and gepants, in the treatment of migraine. A long-term randomized controlled trial which was initially blinded and then open-label for the second half of the trial showed that using erenumab, a monoclonal antibody targeting the CGRP receptor, there was effective reduction in the frequency of migraine attacks and improvements in health-related quality of life in patients with episodic migraine [35]. In another retrospective cohort study, both erenumab and galcanezumab, monoclonal antibody agents targeting the CGRP ligand, improved patient-reported outcomes in patients with chronic and episodic migraine [36]. A study evaluating the use of fremanezumab, which functions through a mechanism similar to that of galcanezumab, a prevention therapy, demonstrated that it was effective in reducing the number of migraine days in patients with chronic migraine [37].

The expert panel unanimously agreed on the necessity of developing a local consensus statement on the use of novel CGRP-based therapies. The main goal was to enhance the health outcomes of patients with migraines in the UAE by reinforcing the significance of personalized treatment plans and regular follow-ups.

Local recommendations for the use of CGRP-based therapies in individuals with migraine in the UAE will be based on a comprehensive review of the available evidence and the expert opinion of a panel of specialists. These recommendations will consider the nuances of the healthcare infrastructure in the UAE, local epidemiological data, clinical practices, and available resources. They aim to provide a framework for healthcare professionals to make informed treatment decisions by providing recommendations for the appropriate use of these therapies to help promote standardized, evidence-based clinical practices, reduce variability in care, and ensure that patients receive the most appropriate and effective treatments. Guidelines can help to ensure that patients are appropriately screened and evaluated before treatment, receive appropriate doses of medication, and are monitored closely for any potential adverse effects, leading to improved safety and better treatment outcomes.

  1. 2.

    For individuals with migraine who require preventive treatment, monoclonal antibodies targeting the CGRP pathway should be considered as a first-line treatment option for migraine prophylaxis. Treatment should only be initiated by a neurologist after patients meet specific criteria that have been adapted from AHS criteria.

Monoclonal antibodies targeting the CGRP pathway should be considered as a first-line treatment option for migraine prophylaxis in individuals with migraine who require preventive treatment [32]. The statement also recommends this treatment option should be initiated by a neurologist only when specific criteria, modified from the AHS criteria, are met [38].

This consensus statement is supported by a large body of research. The CGRP pathway has been shown to play a key role in the pathophysiology of migraine [39]. Monoclonal antibodies that target this pathway have been shown to effectively prevent migraine attacks in clinical trials [39]. In fact, four such monoclonal antibodies have been approved by the FDA for migraine prevention: erenumab, fremanezumab, galcanezumab, and eptinezumab [40]. All these drugs, except fremanezumab, are available in the UAE. Additionally, the national health insurance policy fully covers CGRP-targeting monoclonal antibodies for the entire local population of the UAE. For expatriates, coverage varies as per individual reimbursement policies, with copayment structures mostly in the range of 10–35%.

Many current standard of care treatments for migraine have limitations, such as poor efficacy or intolerable side effects [2]. In contrast, CGRP-based therapies have been found to have high efficacy, a favorable safety profile, and are well tolerated by patients [39]. A double-blind randomized controlled trial compared the efficacy and tolerability of erenumab and topiramate for migraine prophylaxis in adults, and concluded that significantly more patients achieved a 50% or more reduction in MMDs from baseline with erenumab [41]. A study within the UAE itself demonstrated the efficacy and safety of eptinezumab in chronic and episodic migraine, finding that it was well tolerated and caused a significant reduction in MMDs over a period of 6 months [42]. As a result, they are considered a viable option for long-term use in preventing migraine. However, the decision to initiate CGRP-based therapy should be made on a case-by-case basis, considering the patient’s individual characteristics, medical history, and preferences.

The specific criteria for initiating monoclonal antibody treatment for migraine prophylaxis were modified from the AHS criteria, which recommend preventive treatment for individuals with migraine who experience at least four headache days per month or have migraine attacks that are severe or disabling despite acute treatment [38]. The modified criteria used in the consensus statement include the following:

  1. (a)

    At least four MMDs, or fewer if the attacks are severe or disabling based on the Migraine Disability Assessment (MIDAS) or Headache Impact Test-6 (HIT-6) scores

  2. (b)

    Inadequate response or intolerance to acute treatment

  3. (c)

    No contraindications to monoclonal antibody treatment

These criteria are intended to help neurologists identify individuals with migraine who are more likely to benefit from CGRP-based therapy and to ensure that this treatment is used appropriately. It is important for a neurologist to initiate treatment as they have specialized knowledge in determining whether a patient is a good candidate for CGRP-based therapy on the basis of their medical history, coexisting medical conditions, and potential drug interactions. They can also monitor the patient’s response to therapy and adjust the treatment plan accordingly.

  1. 3.

    In individuals with episodic or chronic migraine who have been on continuous treatment with monoclonal antibodies targeting the CGRP pathway for a minimum of 12 months, a pause in treatment may be considered unless continuation is deemed clinically necessary. If treatment is paused or discontinued and migraine worsens, restarting treatment should be considered.

The consensus statement recommends considering a pause in treatment with CGRP-based therapies in individuals with episodic or chronic migraine after a minimum of 12 months of continuous treatment [32]. If treatment is deemed clinically necessary, it can be continued for a longer period. Additionally, the statement suggests restarting treatment if the migraine worsens after treatment withdrawal [32].

This recommendation is based on the limited long-term safety data available for the use of CGRP-based therapies in the treatment of episodic and chronic migraine. Although short-term studies have demonstrated the safety and efficacy of these medications, there is a need for long-term data to fully understand the risks and benefits of continued use [43]. Further data can help healthcare providers and patients make informed decisions about initiating and continuing these therapies. Therefore, it is important to proceed with caution, monitor patients closely, and have professionals define medication stopping criteria while continuing to gather more long-term safety data on CGRP-based therapies [44].

The recommendation for a pause in treatment after 12 months is also based on the observation that some individuals with migraine experience a reduction in the frequency and severity of migraine attacks over time and may be able to manage their symptoms with non-pharmacological interventions such as diet modification and behavioral interventions [32, 45]. However, it is important to note that not all individuals with migraine will be able to manage their symptoms without continued medication. In cases where migraine worsens after treatment withdrawal, it may be necessary to restart CGRP-based therapy.

In general, pausing CGRP-based therapies after 12 months can assist in determining whether prolonged use is required for a patient. This strategy aligns with the aim of personalized treatment plans that strive to optimize therapy according to the individual characteristics and response of the patient. By regularly assessing the need for continued pharmacological intervention, healthcare professionals can ensure that patients receive the most appropriate and effective treatments while minimizing the risk of adverse events and unnecessary healthcare costs.

  1. 4.

    Assess the efficacy of monoclonal antibodies targeting the CGRP pathway in individuals with episodic or chronic migraine after an appropriate duration of therapy. For episodic migraine, a meaningful improvement is considered as a 50% or more reduction in pain burden, with evaluation after 3 months (6 months for eptinezumab). For chronic migraine, a meaningful improvement is considered as a 30% or more reduction in pain burden, with evaluation after 6 months.

Within clinical trials in patients with chronic migraine, CGRP-based therapies have been shown to lead to significant improvements in migraine frequency, severity, and quality of life in the first few months of treatment [46, 47]. Therefore, it is necessary for healthcare providers in the UAE to follow the recommended minimum duration of therapy before evaluating the efficacy of CGRP-based therapies for individuals with episodic or chronic migraine [32], as this allows adequate time for the medication to take effect. The specific medication for episodic migraine treatment should also be considered, with the recommended duration of treatment being 3 months for erenumab, galcanezumab, and rimegepant and 6 months for eptinezumab [32, 48, 49].

Moreover, healthcare providers in the UAE must be aware of what constitutes failure of CGRP-based therapy. Patients with episodic or chronic migraine are considered as having failed CGRP-based therapy if they do not achieve a meaningful reduction in pain burden after the recommended duration of treatment [32]. The panel of experts reached consensus that, in the case of episodic migraine, a significant improvement is defined as a 50% or more reduction in pain burden, following an evaluation as measured by MMDs, MHDs, MIDAS, HIT-6 or any equivalent test conducted after 3 months (or 6 months in the case of eptinezumab). In contrast, for chronic migraine, the expert panel agreed that a meaningful improvement is considered a 30% or more reduction in pain burden, following an evaluation after 6 months.

  1. 5.

    Consider monoclonal antibodies targeting the CGRP pathway for all individuals with migraine, including episodic and chronic migraine with or without medication overuse. Rimegepant, the only approved and available gepants in the UAE, may be considered a first-line treatment option only in patients with episodic migraine.

In 2022, the EHF released an updated consensus statement that recommends considering the use of monoclonal antibodies targeting the CGRP pathway for migraine prophylaxis [32]. Therefore, in line with the updated consensus statement of the EHF, the UAE consensus statement similarly recommends considering the use of monoclonal antibodies targeting the CGRP pathway for all individuals suffering from migraine.

The UAE consensus statement also suggests that rimegepant, the only approved and available gepants in the UAE, can be considered as a first-line treatment option specifically for patients with episodic migraine. Although atogepant is not yet available in the UAE, it may be used for all individuals with migraine, including those with chronic migraine, as it has been recently approved by the FDA for these indications [50, 51]. Additionally, for individuals with chronic and episodic migraine, any of the available monoclonal antibodies targeting the CGRP pathway can be considered while following all other recommended consensuses regarding CGRP-based therapies.

Monoclonal antibodies targeting the CGRP pathway have shown high efficacy and favorable safety profiles in clinical trials, with many individuals experiencing a significant reduction in migraine frequency and severity [35,36,37]. For individuals with medication overuse headache, monoclonal antibodies targeting the CGRP pathway can provide an alternative treatment option that does not carry the risk of further exacerbating medication overuse [52, 53]. Therefore, considering the potential benefits and safety of these medications, neurologists should consider monoclonal antibodies targeting the CGRP pathway as a first-line treatment option for all individuals with migraine, including episodic and chronic migraine, regardless of their medication overuse status.

It is important to note that the use of monoclonal antibodies targeting the CGRP pathway in the UAE is subject to approval by the UAE Ministry of Health and Prevention (MOHAP). MOHAP is responsible for ensuring the safety and efficacy of all medications available in the UAE, including monoclonal antibodies targeting the CGRP pathway. Healthcare providers in the UAE must adhere to the MOHAP guidelines and regulations when prescribing these medications to their patients. The approval process for medications can involve a rigorous review of clinical trial data as well as other factors such as manufacturing standards and quality control.

Rimegepant can be considered a first-line treatment option for the acute treatment of migraine because it has demonstrated efficacy in reducing migraine pain and associated symptoms, such as nausea and sensitivity to light and sound, in multiple clinical trials [20]. Additionally, it has a favorable safety profile and is well tolerated by patients [54]. However, it is important to note that its use as a first-line treatment option is recommended only in patients with episodic migraine, as at the current moment it is only available and approved for this.

  1. 6.

    Switching CGRP-based therapies can be considered in individuals with migraine who have an inadequate response to one antibody. Although there is insufficient evidence on the potential benefits of antibody switch, it may be an option to explore.

The consensus statement suggests that in individuals with migraine who have an inadequate response to one CGRP-based therapy, switching to another antibody can be considered [32]. This approach can be considered in individuals who experience a lack of response or loss of response to one CGRP-based therapy or who experience adverse effects that prevent them from continuing with the initial treatment; however, there are limited efficacy data supporting this approach [55].

Although there are limited supporting data, there are several potential advantages to antibody switch therapy [55,56,57]. In fact, a recent small study has suggested the feasibility and efficacy of antibody switching [58]. First, it allows for continued use of the CGRP pathway as a target for migraine prevention, while potentially addressing any limitations or adverse effects of the initial therapy. Second, it may provide an opportunity to optimize treatment on the basis of individual patient response, as different CGRP-based therapies may have varying efficacy and safety profiles in different patients. Finally, it may be a useful option for individuals who require long-term treatment for migraine prevention, as it allows for adjustments to be made over time.

Although antibody switching may have potential benefits in some cases, the lack of robust clinical evidence and potential risks of switching medications mean that this practice should be approached with caution and considered only on a case-by-case basis [55]. It is important to note that the decision to switch to another CGRP-based therapy should be based on individual patient needs, preferences, and clinical judgment. The safety and efficacy of the new therapy should also be carefully evaluated, and the potential risks and benefits should be discussed with the patient.

In the UAE, CGRP-based therapies have been approved as prophylactic treatments for migraine, and they are increasingly being used in clinical practice. Patients who do not achieve adequate relief with one antibody may benefit from switching to another. This decision is best made in consultation with a neurologist or headache specialist.

  1. 7.

    Avoid CGRP-based therapies in pregnant and nursing women, and those seeking pregnancy. Carefully review patients with vascular disease or cardiac risk factors before using CGRP therapy. Counsel patients with a history of constipation about the use of CGRP-based therapies for migraine. Do not use CGRP-based therapies in patients under 18.

The consensus statement recommends avoiding the use of CGRP-based therapies in certain patient populations because of potential risks and lack of sufficient evidence [32]. Specifically, the statement suggests avoiding CGRP-based therapies in pregnant women, women seeking pregnancy, and nursing women. This is because there are limited data on the safety of these therapies during pregnancy and lactation [59]. Therefore, it is recommended that women in these categories avoid CGRP-based therapies unless deemed necessary by their healthcare provider after a thorough evaluation of potential risks and benefits.

The statement also recommends careful review before using CGRP-based therapy in patients with vascular disease or cardiac risk factors. This is because CGRP plays a role in the regulation of blood vessels, and there is some concern that CGRP-based therapies may have cardiovascular side effects [60, 61]. This effect may be of particular interest in patients with preexisting vascular disease, such as Raynaud’s syndrome, or cardiac risk factors such as hypertension, coronary artery disease, or heart failure. Although studies have shown that CGRP-based therapies are generally well tolerated, there is a need for caution in patients with these conditions [62]. Healthcare providers should carefully review a patient’s medical history and perform a thorough cardiovascular evaluation before deciding to use CGRP-based therapies.

Patients with a history of constipation should also be counseled on the use of CGRP-based therapies. CGRP is involved in the regulation of gastrointestinal motility, and there have been reports of constipation associated with CGRP-based therapies [63]. Antibodies that target CGRP or its receptor can cause constipation by disrupting the normal function of CGRP in the small and large intestine, where CGRP plays an important role in regulating peristaltic motor activity, ion and water secretion, and intestinal transit [64]. Neurologists should counsel patients with a prior history of constipation about the use of CGRP-based therapies for migraine to help them understand the potential risk of constipation as a side effect of treatment.

Finally, the use of CGRP-based therapies is not recommended in patients under 18 years of age because there is limited data on the safety and efficacy of these therapies in this population [65, 66]. Clinical trials evaluating the use of CGRP-based therapies for migraine treatment have primarily included adult patients, and there is a scarcity of data specifically focusing on the effectiveness and safety of these therapies in children and adolescents. Therefore, it is important to exercise caution when considering the use of CGRP-based therapies in patients under 18 years of age.

It is important for healthcare providers in the UAE to carefully consider the use of CGRP-based therapies in these patient populations to ensure the safety and efficacy of treatment.

Discussion

Although various CGRP-based therapies are available in the UAE and the Gulf region, there is a lack of local and regional data from clinical trials and real-world experience regarding their use for the treatment and management of migraine. At the time of preparation of this consensus statement, only three published studies addressing the use of CGRP-based therapies, specifically erenumab and eptinezumab, were available from the UAE [42, 67, 68]. All these studies were retrospective and observational in nature. So far, none of the other MOHAP-approved CGRP-based therapies have been evaluated in the UAE or regionally, although such studies are expected. Additionally, there are limited guidelines advising on the use of such therapies in the treatment of migraine, both for the purpose of prevention and for acute therapy. On the basis of this observation, the panel of experts unified to provide consensus recommendations on the use of CGRP-based therapies in the UAE. Publishing consensus statements on the use of CGRP-based therapies can have several effects on real-world studies. Such statements can aid in creating a standardized approach, which reduces variability across studies, may influence study design based on recommended duration of therapy, and can inform selection or exclusion criteria.

The panel agreed that both forms of CGRP-based therapies, monoclonal antibodies targeting the CGRP pathway and gepants, should be addressed in the recommendations because evidence has shown both classes of drugs to be effective in the prevention and treatment of migraine and both have been approved for the same by regulatory agencies, such as the FDA [69, 70]. These treatment options are largely accessible in the UAE and are fully covered for the entire local population of the country by national insurance. Additionally, there are considerable differences between CGRP-based therapies, which are imperative to address in helping prescribers make an informed treatment decision, taking into consideration their patients’ characteristics, comorbidities, and medical history. Therefore, whereas the EHF recommendations primarily discuss migraine prevention using monoclonal antibodies targeting the CGRP pathway [32], the UAE expert consensus recommendations also include guidance on the use of gepants.

Despite this, the UAE consensus recommendations contain considerable similarities to those established by the EHF [32]. Key resemblances include (1) considering monoclonal antibodies targeting the CGRP pathway as a first-line treatment option, (2) assessing efficacy after three consecutive months of therapy for episodic migraine except in the case of eptinezumab, (3) considering a treatment pause after a minimum of 12 months, (4) avoiding CGRP-based therapy in certain populations such as pregnant women and proceeding with caution in those with cardiovascular disease or a history of constipation, and (5) switching monoclonal antibodies targeting the CGRP pathway if necessary. Although the consensus recommendations were tailored for the UAE, they relied heavily on international data because of the scarcity of robust regional data. Therefore, the consensus recommendations may be considered relevant and serve as a practical resource for healthcare providers worldwide.

Establishing consensus recommendations for the use of CGRP-based therapies in migraine treatment and management in the UAE may present certain challenges on a local and regional level that must be addressed. The adoption of such recommendations may have a significant impact on existing healthcare practices as many healthcare providers will have to modify their current treatment protocols and management strategies to align with the new guidelines. Consequences of this could involve altering medication selection, treatment duration, and timelines for the assessment of treatment efficacy. Additional challenges of implementing new guidelines within the region could include a lack of awareness or resource limitations. Future needs in the adoption of these guidelines will include further training and education for healthcare providers, to ensure they have the necessary knowledge and skills to implement these recommendations.

Subsequent steps would include monitoring the adoption of the consensus recommendations, as well as evaluating their impact on patient outcomes, which can be accomplished by collecting real-world data. Continuing research in the field of CGRP-based therapies, particularly in the UAE, is also an emphasized necessity, to further assess the efficacy, safety, and tolerability of these treatments. Moreover, it is important to note that consensus recommendations on the use of CGRP-based therapy in migraine treatment and management are not fixed and will require updates as the field of migraine research and treatment evolves. As new data and evidence emerge, healthcare providers in the field should continually revise the available guidelines to ensure that patients receive the most current and effective care.

Conclusion

The proposed consensus recommendations are the first regional consensus recommendations for the UAE and are based on the integration of clinical evidence and clinical expertise, aiming to enhance decision-making in the use of CGRP-based therapies in patients with migraine. The consensus recommendations can have a significant impact on regional treatment practices by providing definitive, evidence-based guidelines for healthcare providers to adhere to. Their primary goal is to provide a framework for appropriate use of CGRP-based therapy, while simultaneously encouraging future initiatives, attentive patient care, and research that produces meaningful outcomes. Although they were developed specifically for the UAE, the consensus recommendations were formulated predominantly on the basis of international data because of the scarcity of robust regional data. As a result, these statements have the potential to be widely applicable and can serve as guidelines for healthcare providers globally.