Patient Interest Groups Submission of Evidence Template. Version 1.1. Drug Name: _MAVENCLAD (Cladribine tablets) Date of Submission to NCPE:
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1 Patient Interest Groups Submission of Version 1.1 Drug Name: _MAVENCLAD (Cladribine tablets) Date of Submission to NCPE: Record of Updates Version Date Description of changes N/A Corrected typographical errors, included treatment indication and removed option to not be listed as a contributor Please Note: This document may be updated periodically, therefore please refer to the NCPE website to obtain the most recent version
2 Summary Cover Name of Organisation Multiple Sclerosis Society of Ireland Name Harriet Doig Information, Advocacy and Research Officer Address 80 Northumberland Road Ballsbridge Dublin 4 Telephone Number Address harrietd@ms-society.ie Product to which submission relates Product indication MAVENCLAD (Cladribine tablets) Adults with highly active relapsing multiple sclerosis Please Note: This document may be updated periodically, therefore please refer to the NCPE website to obtain the most recent version National Centre for Pharmacoeconomics Version of 8
3 Section 1: Submitting Patient Organisation Question 1: Name of Organisation The Multiple Sclerosis Society of Ireland Question 2: Alternative/Previous Names of Organisation MS Ireland Question 3: Date of Change NA Question 4: Organisation s main or registered address 80 Northumberland Road, Ballsbridge, Dublin 4 Question 5: Type of Organisation (please tick as appropriate) Type C (see Note:3 Question 6: Please provide details if you have ticked Other Question 7: Please provide a short description of the nature and purpose of your organisation The principal objectives for which MS Ireland exists are: to facilitate people with MS to control their lives and environment, to live with dignity and participate in the community to provide support for the families and carers of people with MS to co-operate with the medical, scientific, social and caring professions to promote scientific research into the cause of, cure for and management of MS, and the alleviation of medical and social symptoms to exchange and disseminate information relating to MS to provide an identifiable focal point by developing an efficient, effective and caring National Centre for Pharmacoeconomics Version of 8
4 organisation to serve the needs of PaMS Question 8: If you are a membership-based organisation, please indicate the number of members and geographical spread MS Ireland had 4,639 members as of 1 st January These are spread over the whole country. Question 9: Please list any pharmaceutical companies that are corporate members of your organisation NA Question 10: Please provide FULL details of any funding received from pharmaceutical companies within the last TWO years Please note that hyperlinks to other documents or websites will not be acceptable Pharmaceutical Company Perrigo Novartis Ireland Biogen IDEC Merck Serono (Ireland) Ltd Teva Pharmaceutical Ltd Sanofi Genzyme Ireland Ltd Roche Pharmaceuticals Amount of funding provided 45,000 in ,000 in ,730 in ,500 in ,000 in ,000 in ,000 in ,000 in ,000 in ,030 in ,000 in ,395 in ,000 in 2016 Purpose of funding Core funding for the MS Care Centre Roof and wifi for the MS Care Centre World MS Day and core funding My MS My Needs survey Core funding My MS My Needs survey Publications Core Funding and publications Access to Medicines Campaign Handbook Time Matters project on early treatment Participation in World vs MS project MS News magazine National Centre for Pharmacoeconomics Version of 8
5 Allergan Pharmaceutical Ireland 600 in 2015 Conference United Drug Regeneron Pharmaceuticals Grunenthal Pharma Alkermes Pharma Ireland Bemis Healthcare 500 in ,000 in ,740 in in in 2016 Conference Information publications Participation in My Pain Feels Like campaign Publications Publications Question 11: Please provide details of any individuals who have had a significant role in drawing up your submission and have interests to declare Name Role in P O Description of Interest Submission NA Y Merck have agreed to provide 3,600 towards the cost of producing a report of the results of our survey on DMTs. At the time of making the submission, this had been agreed but has not been received. Merck had no input into the design or content of the survey. MS Ireland plan to use these funds for graphic design and printing in order to produce a report of the survey results Section 2: Experience of patients, carers and their families Question 12: Please can you provide details of how you have gathered information about the experience of patients, carers and their families MS Ireland conducted a short, anonymous survey during September-October 2017, via MS Ireland s website and social media. The survey asked about the experiences of people with MS in accessing and taking disease modifying therapies (DMTs). The survey was completed by 236 people. A copy of the survey questions can be made available on request. We also have research reports available that look at the impact of MS on a range of life domains. Question 13: Please provide information about how this condition affects the day-to-day lives of patients, carers and their families National Centre for Pharmacoeconomics Version of 8
6 Research by MS Ireland shows that MS can have a substantial negative impact on quality of life. Our report Quality of Life of people living with MS in Ireland (2017) found that: Quality of life of people with MS is rated 32% less than for the general population 80% of people with MS experience pain and discomfort 78% struggle to do their usual activities 92% experience fatigue 60% experience anxiety or depression This report is available here: Furthermore, our report My MS My Needs (2017) found that: 35% of people with MS feel MS impacts on their family life a lot of the time Almost 25% said their MS impacted their participation in daily life very much This report is available here: Question 14: Which aspects of living with this condition, NOT MET by current treatments, do patients need most help with? As the results of the above surveys show, people with MS need treatments that will reduce the impact of the disease on their daily lives. Currently, in addition to the impact of symptoms as described above, people with MS also reported in our DMT survey that managing and administering their medication impacted on their daily life somewhat (48%), quite a lot (11%) or a great deal (4.5%). Therefore, there is definitely an unmet need for treatments that are easy to administer and have a low impact on daily life. Section:3 Views of the patients, carers and their families on the difference the new medicine may make Question 15: Please provide details of your sources of information about the new medicine As there were no clinical trial sites for Cladribine in Ireland, there are no patients in Ireland who have direct experience of taking the new medication. We are basing our responses on the information in our DMTs survey, which clearly shows a need for medications with reduced side effect profiles and easier administration methods, to reduce the burden and impact of taking MS treatments on the daily lives of people living with the condition. Question 16: Please advise us of the views of patients, carers and their families on what the advantages or disadvantages of the new medicine might be compared to existing treatments National Centre for Pharmacoeconomics Version of 8
7 Existing Treatment Advantages of new medicine Disadvantages of new medicine Side effects in our DMTs survey, nearly 75% of respondents reported experiencing side effects as a result of their DMT. Cladribine has a favourable side effect profile Administration in our survey, 48% of respondents reported that managing their medication impacted on their life somewhat, 11% reported it impacted on their daily life quite a lot and 4.5% reported it impacted on daily life a great deal. Nearly 13% said they found administering their current DMT either hard or very hard. In the qualitative data, a consistent theme emerged that injections are hard to manage, hard to administer, can be painful and can cause uncomfortable injection site reactions. Many others reported difficulties of managing their medication around their daily routine. Examples of the difficulties reported are: Cladribine is an oral, shortcourse treatment. Therefore it is likely to avoid or reduce much of the disruption to daily life and routine that people with MS have reported to us in the survey as a result of taking other DMTs (for those for whom it would be a medically suitable treatment). making sure they took the medication at a certain time so side effects didn t impact on work remembering to take medications at the right time difficulties of managing medication if travelling remembering to schedule monitoring appointments (e.g. blood tests) arranging meal times around taking tablets finding private spaces National Centre for Pharmacoeconomics Version of 8
8 to administer injections arranging childcare around hospital appointments (for those taking hospital-infusion medications) Question 17: To what extent will this new medication help to address the unmet needs you have previously highlighted in Q14? Cladribine could help reduce the impact of taking MS treatments on daily life due to its oral administration route, and the fact that it has a much shorter treatment course than existing oral therapies for MS. Section 4: Additional Information Question 18: In no more than 5 points please summarise the key aspects of your submission that you feel are most important In MS Ireland s recent survey of disease modifying therapy (DMT) usage in Irish people with MS, 48% of respondents reported that managing their medication impacted on their life somewhat, 11% reported it impacted on their daily life quite a lot and 4.5% reported it impacted on daily life a great deal. Nearly 13% said they found administering their current DMT either hard or very hard Therefore, there is definitely an unmet need for MS treatments that are easy to administer and have a low impact on daily life Problems reported with administering existing treatments include difficulty administering injections, difficulty remembering to take medications, difficulty fitting taking medications around meal times and difficulty planning medication routines around work Cladribine could help reduce the impact of taking MS treatments on daily life due to its oral administration route, and the fact that it has a much shorter treatment course than existing oral therapies for MS Question 19: Please provide any additional information which you believe would be helpful to the decision maker Cladribine also has the potential to reduce the costs associated with the prescribing and monitoring of MS medications, due to the short treatment course and the low monitoring requirements. Currently, according to MS Ireland s Societal Costs of multiple sclerosis in Ireland 2015 report, costs associated with MS medications are million per year and outpatient costs, a proportion of which will relate to medications monitoring, are million per year. This report is available here: National Centre for Pharmacoeconomics Version of 8
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