19 minute read
FEATURE: MIGRAINE MEDICATION
MAI Advocating for Better Access to Care and Medication in Ireland
One of The Migraine Association of Ireland’s goals at the start of 2021 was to open the discussion for better ‘Access to Care’ in Ireland for those living with migraine in conjunction with the European Migraine and Headache Association (EMHA). Unfortunately, Ireland lags way behind in the medication approval process as well as the market availability compared to our neighbouring countries in the UK and Europe. We strongly believe migraine patients in Ireland should have the same medications available to them as other countries across the pond do, and that the standard wait time for medications to be approved should be reduced significantly. MAI’s Board Member, Jeff Smith M.D. delved into this in detail at the EMHA 2021 #TogetherTalks on the 16th of June where he showed the staggering difference compared to other countries and what we could do as a nation to improve wait times. This event came off the back of the EMHA ‘Access to Care’ global survey which ran over a 6-week period asking participants to take part to tell them ‘How they felt the access to care and cost of care was in their country’. Following on from this The Migraine Association of Ireland created a survey to ask migraine patients multiple questions on ‘How they viewed the access to care and medication in Ireland’. A total of 83 participants took part in the MAI survey. We asked 7 questions in total around access to care, treatments and medications available in Ireland compared to other countries. Questions were targeted at those suffering from episodic and chronic migraine. We also wanted to gain feedback from migraine sufferers, therefore, we left some questions open to comment, while also having scored questions to gain a consensus to how those living with migraine feel about
Written by Hazel Breen, Communications and Information Officer, Migraine Association of Ireland
access to care in Ireland overall. The results are as follows…
- 44% stated they have episodic migraine, 56% suffer with chronic migraine. - When asked how you would rate treatment options available in Ireland (1 being the lowest, 10 being the highest), most participants scored 5.
The second highest score was 1, the remaining high scores all fell under 5 showing a lack of satisfaction overall.
- When asked how you would rate medication options available in Ireland, most participants scored 5. The second highest scores were 3 and 4. Again, most of the high scores were on the lower side of the scale. - When asked how you wouldrate treatment options for migraine in Ireland compared to other countries, most participants scored 5. Second to thathigh score was 2. - When asked do you think Ireland is far behind other countries in relation to treatment/medication for migraine, 82% said yes. - When asked what needs to happen to improve treatment options in Ireland, we had an array of responses suggesting better access to care, treatments, and medication options. Multiple participants stated they had to travel the UKfor treatment, more access to Anti-CGRP drugs, more regular clinic times, more access to medications overall as it can be trial and error for those living with migraine to see what works for them and more access to devices to name a few. - Lastly, we asked if there were any further comments our participants may like to add. Most said there needs to more awareness around how debilitating migraine is, GPs should be further educated in this area, chronic migraine should be put on the disability list and to quote one participant, “I honestly feel Ireland is way behind the rest of the western world in the acknowledgement and treatments available for migraine sufferers.
The conclusion from this survey is mostparticipants view Ireland’s access to care for migraine as lacking in much needed resources, medical professionals specialising in migraine, GPs with a full understanding of migraine, facilities nationwide and options for kids as well as adults. In addition, most feelwaiting lists are too long, and this has a huge impact on their life overall.The word ‘MORE’ was used in nearly every answer
- Lastly, we asked if there were any further comments our participants may like to add. Most said there needs to more awareness around how debilitating migraine is, GPs should be further educated in this area, chronic migraine should be put on the disability list and to quote one participant, “I honestly feel
Ireland is way behind the rest of the western world in the acknowledgement and treatments available for migraine sufferers. The conclusion from this survey is most participants view Ireland’s access to care for migraine as lacking in much needed resources, medical professionals specialising in migraine, GPs with a full
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understanding of migraine, facilities the #TogetherTalks online webinar on nationwide and options for kids as well ‘Better Access to Care’. As mentioned as adults. In addition, most feel waiting previously, Jeff Smith M.D. spoke at this lists are too long, and this has a huge event after his in-depth research into impact on their life overall. The word Irelands access to medications process. Jeff ‘MORE’ was used in nearly every answer is a physician by training and has worked which further proves that migraineurs for pharmaceutical companies for the last in Ireland feel they do not have enough thirty years, most recently with Alder options when it comes to care and Biopharmaceuticals who have developed medication to have the quality of life they one of the anti-CGRP medications. The deserve. The consensus is that Ireland is company was recently taken over by significantly behind other countries in Lundbeck which led to Jeff’s retirement relation to treatment options and access to from the company, and he is now a Board medication for Migraine. member of MAI. The talk was moderated by Sadhbh Armstrong, MAI Regional It is vital to note that we had a lot of Development Officer.
positive feedback from participants about
migraine clinics, specialists, GPs, and Jeff wasted no time in stating the facts pharmacists in Ireland stating that they and gave a highly engaging presentation felt supported and have learned so much covering all areas taking Ireland v-s from them on how to try to manage Belgium for example. In Ireland, the actual their migraine. medication approval process takes just under 550 days, whereas Belgium’s actual After the results were in for both surveys medication approval process takes just the EMHA in conjunction with MAI held over 200 days from start to finish.
IQVIA - Median Time to Availability 2015-2018
1000 900 800 700 600 500 400 300 200 100 0
Germany Switzerland Denmark Netherlands Sweden Finland Austria England Turkey Belgium Spain Scotland Italy Iceland Greece Croatia Slovenia Norway Albania Hungary Latvia Ireland France Estonia Slovakia Bulgaria Czech Macedonia Bosnia Portugal Serbia Poland Romania Lithuania
NCPE Rapid Review and NCPE HTA takes 242 days HSE price discussions and drugs review and approval takes 307 days Totalling 549 days
Belgium’s medication approval process timeframe is broken down as follows:
INAMI-RIZIV Assessment, CRM/CTG Assessment, Minister Recommendation and Post-minister Recommendation takes 210 days in total. Granted, this is an example of a highly efficient approval process in Belgium’s case, but Ireland falls way behind most EU countries in the approval process. In an IQVIA study on the ‘Median time to availability 2015-2018’ which included the UK at the time, Ireland is as low as 13 on the list of the number of days for medication approval. See the graph on previous page.
The current drugs available for migraine in Ireland are:
Acute Treatment – Triptans, Analgesics (e.g., Aspirin, Paracetamol, Non-steroid anti-inflammatory drugs (e.g., ibuprofen) Prevention of migraine – Beta blockers (e.g., Propranolol), Anti-depressants (e.g., Amitriptyline), Anti-epileptics (e.g., topiramate), Calcium channel blockers (e.g., nicardipine), Serotonin reuptake inhibitors (e.g., fluoxetine), Botulinum toxin.
Anti-CGRPs and other drugs waiting for approval and to be made available in Ireland are:
Erenumab – By Novartis Fremanezumab (Ajovy) – By Teva Galcanezumab – By Eli Lilly Eptinezumab – By Lundbeck Gepants and Ditans
What is CGRP and what does it do?
• It is a substance that is released in the trigeminal nerve. • It spikes during migraine. • CGRP dilates blood vessels. • Degrades mast cells (cells which control inflammation during allergic reactions) • Creates an inflammatory fluid in the blood vessels.
There are 2 main approaches for targeting CGRP in migraine: large molecule monoclonal antibodies given by injection to prevent attacks and small molecule absorbable tablets for acute and possibly preventative treatment. Medications act by either blocking a receptor called the calcitonin gene-related peptide receptor (CGRP-R), or binding to the substance (CGRP) and not allowing it to reach the nerve. For more information see Prof. Peter Goadsbys Interview from the European Academy of Neurology Congress 2016 on our website www.migraine.ie Several pharmaceutical companies are involved in the manufacture of anti-CGRP and other drugs. The main ones are Amgen/Novartis Inc, Teva, Eli Lilly, Lundbeck, Allergan and Biohaven Pharmaceuticals.
Erenumab – By Novartis
The Marketing Authorisation was granted in Ireland in the Summer 2018 and Novartis is currently awaiting the results of the Health Technology Assessment for the Irish licensing application. The Migraine Association wrote the supporting patient organisation document as part of this process. Current Access: Erenumab was available on a managed access programme, but this was closed to new patients in June 2019. NCPE Verdict: The National Centre for Pharmacoeconomics (NCPE) has recommended Erenumab for chronic migraine only – we are still awaiting the HSE verdict.
Fremanezumab (Ajovy) – By Teva
Teva’s version of anti-CGRP medication, Fremanezumab (Ajovy) became available on a ‘Free of Charge’ or ‘Compassionate Grounds’ programme, which is like the managed access programme, from July 2019. New patients can only access Fremanezumab through their Neurologists. Teva is also awaiting the results of the Health Technology Assessment for the Irish licensing application. The Migraine Association wrote the supporting patient organisation document as part of this process also. Current Access: Patients can only access Fremanezumab through their Neurologist as explained above, after having failed three or more preventative medications. Other criteria may also apply. NCPE Verdict: The NCPE has recommended Fremanezumab for both Episodic and Chronic Migraine – we are still awaiting the HSE verdict.
Galcanezumab – By Eli Lilly
Eli Lilly’s Galcanezumab is next, but we have no news as to its availability yet. Galcanezumab has been granted FDA approval in the US to treat episodic Cluster Headache in adults. So far it is the only one of the new treatments to be approved for Cluster Headache. NCPE Verdict: They are currently awaiting submissions of HTAs which will be looking at the efficacy of the medication and cost effectiveness against current treatments.
Eptinezumab – By Lundbeck
Eptinezumab (Yvepti) by Lundbeck has yet to be submitted to the NCPE for evaluation and authorisation.
Gepants and Ditans
Gepants are ‘cousins’ of Erenumab, Fremanezumab, etc., they are small molecule drugs which block the CGRP receptor and are effective at relieving migraine. They are currently only available in the US and as acute treatments. Gepants rapidly penetrate the brain so work quickly. Studies on the preventative properties of Gepants are ongoing. The FDA in the US has authorised two Gepants, but they have not arrived in Ireland yet. These are: • Utopgepant (Ubrelvy) • Rimegepant (Nurtec ODT) Lasmiditan (Reyvow) by Eli Lilly, is not an anti-CGRP medication but the first of a new group of headache medicines that are called a “Ditan”. It is an Antagonist at the 5-HT 1F serotonin receptor, whereas Triptans work on the 5-HT 1B and 5-HT 1D receptors. Like a Triptan, Lasmiditan can stop a migraine when taken at the appropriate time, but unlike a Triptan, it is thought to decrease stimulation of the trigeminal system and treat migraine pain without causing vasoconstriction so may be helpful for people for whom Triptans are contraindicated due to cardiovascular problems. Lasmiditan is not available in Ireland yet. For further information and updates on the latest information on the availability of the new Anti-CGRP medications in Ireland keep an eye on our website. For general updates you can go to https://www.cgrpforum.org/. While we understand that many other factors come into play when it comes to medication approvals and better access to care, it is simply not acceptable for Ireland to be so far behind neighbouring countries and to not have the same options available to those suffering with migraine. Currently there is no law for medication approval in Ireland, whereas in the UK if a medication is not approved by the said deadline, the parties are held accountable and fined. This type of process helps push approval along faster for obvious reasons. The Migraine Association of Ireland would like to see a positive change in the process overall that will reduce the timeframe for medication approval and availability in Ireland significantly and in turn help those living with migraine have a better quality of life. For more information, visit migraine.ie
Sunlight and Diet Key Factors for Eye Health
A new study reports on sunlight and nutrition as being key contributors to eye health. This research was published by a team led by Dr Marina Green from The Nutrition Research Centre Ireland in Waterford Institute of Technology.
It is the first study of its kind to describe macular pigment and its determinants for the Mexican population. Additionally, this research investigated the impact of environmental and nutritional factors on macular pigment. The level of macular pigment present in the human eye enhances visual function in a variety of ways. Low levels of macular pigment have been proposed to be a risk factor for Age-related Macular Degeneration, Professor John Nolan and Dr Marina Green, The Nutrition Research Centre Ireland, Waterford Institute of Technology
the leading cause of significant vision loss usually found in those over the age of 55. Macular pigment also absorbs harmful blue light, protecting the retina from damage. Dr Green’s study has discovered that those with high sunlight exposure during the day have significantly higher Macular Pigment. Interestingly, macular pigment and serum concentrations of the carotenoids lutein and zeaxanthin were significantly higher in the Mexican study sample compared with an Irish sample, but this difference was not reflected when the dietary analysis was carried out. This finding sheds light on the importance of nutrition and dietary patterns on macular pigment, and consequently, on eye health.
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As we grow older our eye health comes under increasing pressure and in particular the macula.
Macular health is an increasing concern as AMD is the No.1 cause of sight loss in Ireland over 50’s. The macula pigment comprises of three carotenoids: Lutein, MesoZeaxanthin and Zeaxanthin. The body does not produce Lutein and Zeaxanthin. The macular pigment can therefore become severely depleted in those with a poor diet lacking in the right foods. Hence, why it could be advantageous to use supplementations such as MACU-SAVE® .
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High Quality Reporting
A review by RCSI University of Medicine and Health Sciences in collaboration with the HSE National Quality Improvement Team has found that quality improvement (QI) studies in Ireland over a five-year period conformed to high reporting standards and enhanced multiple elements of healthcare quality.
The review showed an increasing trend in the frequency of publication of QI studies in Ireland, with 43 studies published during the period 2015–2020.
Key findings from the review showed that most QI studies were conducted in hospitals and aimed to improve the effectiveness (65%), efficiency (53%), timeliness (47%) and safety (44%) of care. Fewer aimed to improve patientcentredness (30%), value for money (23%) or staff well-being (9%).
The review found that costs and healthcare outcomes were understudied and require increased attention to support better decision-making about resource allocation in healthcare. No study aimed to increase equity.
Dr Siobhán McCarthy, the study's first author and lecturer at the RCSI Graduate School of Healthcare Management, commented, "The review has, for the first time, profiled the characteristics of QI studies published in Ireland. It is encouraging to see that the studies meet high reporting standards with a focus on internationally recognised elements of healthcare quality.
“It is also pertinent that the review findings align with current international discussion about the need to promote equity-focused quality improvement work.
"It is becoming increasingly acceptable to discuss costs in healthcare and the review points to an existing awareness of costs among QI practitioners in Ireland. Approximately half of studies discussed costs but did not quantify these sufficiently, highlighting the need to provide greater guidance to QI practitioners on performing cost analysis in healthcare. With appropriate educational guidance and resources, this awareness can be fine-tuned to support informative QI cost analyses."
Hypothyroidism: What it looks like and Treatment Options
Hypothyroidism in the general population is suspected to range anywhere from 10-15%. For this reason it is vital that we understand and utilise every strategy at our disposal to ensure proper medical management of this condition. The most common form of hypothyroidism is Hashimoto’s thyroiditis, making up over 90% of all hypothyroid cases not just in Ireland but worldwide. Being so prevalent in society means you’ll be dispensing medication or fielding questions about the medications the person is taking. established as the gold standard in medical management.
Even with the introduction and extensive use of levothyroxine there still remain a sizeable population that do not seem to respond to the conventional therapy. As anecdotal evidence, in my practice I have been witnessing a very high rate of poor symptom response to just levothyroxine treatment only. These patient’s usually exhibit the worst of the hypothyroid symptoms: - Excessive, almost crushing, fatigue - Crippling brain fog - Severe constipation - Systemic joint or muscle pains that incapacitate them
Written by Dr. Shandeep Momi, MRCGP Founder of Functional Thyroid Care www.functionalthyroidcare.com Facebook: @functionalthyroidcare Instagram: @functionalthyroidcare
Those who suffer from hypothyroidism have exceedingly varied degrees of symptoms. This in of itself, isn’t a particular problem for clinicians to identify and treat as we have long known the collective symptoms that make up the hypothyroid condition. Classic symptoms are usually hair loss, fatigue, constipation, ‘brain fog’, and weight gain, among many more less common symptoms. The tricky thing about hypothyroidism is the treatment itself, which is not always a straight line to improvement. At present the accepted and only mainstream management for hypothyroidism, regardless of its origins, is the use of levothyroxine. This monotherapy has been the mainstay approach of the modern medical world since its commercial release of levothyroxine in the 1950s. At the time of its introduction, it made treatment of hypothyroid symptoms much more reliable and safe compared to the previous method of using natural desiccated thyroid (NDT) medication. NDTs contain a large dose of T4, some T3, and a small amount of T2, T1, and calcitonin. As technology and standards improved so did the reliability of NDT medications but by that time, levothyroxine had been firmly - Unrelenting weight gain
- Debilitating anxiety/panic attacks - Infertility or recurrent miscarriages - Among other symptoms In my search for an answer I came upon the earliest treatment method of the hypothyroidism which was NDT. Nowadays NDTs are better regulated and much more consistent, compared to its earlier counterparts however there are still issues with production that make it less than ideal for a lot of patients. Anecdotally, only a very small portion of my patients respond favourably to this form of monotherapy. For those patients that do not respond well to just levothyroxine or NDT alone, the addition of liothyronine is a game changer. When given with levothyroxine, my patients almost universally reported an improvement in all observable metrics. The degree of improvement is dose dependent and also relies heavily on improving the supporting systems of the thyroid. Once those supporting systems are improved, the patient usually notices a subtle, yet sustained, improvement in their symptoms. One of the most effective ways of getting good relief from patients taking both levothyroxine and liothyronine is multidosing. While levothyroxine is designed to be taken once daily, due to longer half-life, liothyronine should ideally be given in multiple doses, specifically because of its much shorter half life. Most patients need to start with three times a day dosing and as their symptoms stabilise, are able to take it twice a day.
With the dissemination of medical knowledge through the internet, more and more patients are taking their health into their own hands and are looking for answers. As a result many patients are self medicating and self treating with over the counter thyroid preparations from foreign countries. To keep thyroid management safe and effective for our patients, GPs, Endocrinologists, and pharmacists should be looking at all these treatment options and tailoring them to the patient’s needs. I hope that this provides some insight into where and how the alternative treatments for hypothyroidism can be utilised and when.
