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20/78 Pharmacological treatment and prevention of chronic migraine

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research question

What is the clinical and cost-effectiveness of pharmacological treatments for patients with chronic migraine?      

  1. Intervention: Pharmacological treatments (singular and in combination) for the treatment and prevention of chronic migraine – to be defined and justified by applicants. 
  2. Patient group: Adults with chronic migraine.
  3. Setting: Community and any other suitable setting.
  4. Comparator: Any appropriate comparator.
  5. Study design: An evidence synthesis to determine the effectiveness and cost-effectiveness (with economic modelling if appropriate) of pharmacological interventions to prevent and treat chronic migraine.
  6. Outcomes: Headache/Migraine days, quality of life, acute treatment use, headache intensity and duration, adverse events, health service activity, days lost from usual activities, cost-effectiveness and research recommendations. Subgroup analyses should be carried out as/if appropriate.

Rationale

Migraine is defined as a condition causing headaches, often accompanied by nausea and vomiting. Migraines typically present on one side of the head, and the pain is described as moderate or severe. Migraines may also be accompanied by a range of other symptoms including altered vision, poor concentration, sweating, sensations of hot/cold, and nausea or abdominal pain. There are 3 common types distinguished by the presence of a headache and/or aura. Where an aura is involved the symptoms above are preceded by a warning sign such as visual disturbances, numbness and pins and needles, speech difficulties, and sometime strange smells, food cravings and other odd sensations. Chronic migraine is defined by NICE/SIGN as headaches on more than 15 days a month, with more than 8 days of those being classified as migraine. Chronic migraine has been found be a very costly contributor to worldwide disability and has been estimated to cost the UK  around £3 billion per year in terms of healthcare, loss of productivity and disability.

Recent SIGN guidance on migraines has highlighted the need for further research into the pharmacological management of chronic migraines, with several recommendations issued to stimulate research. SIGN state that ‘most of the available evidence is based on studies of a patient population with episodic migraine rather than chronic migraine. There is limited data to make specific treatment recommendations for patients with chronic migraine.’ Since the publication of the SIGN guidance, there have been several publications around the treatment and prevention of chronic migraine and following discussions with SIGN, the HTA programme wants to commission an evidence synthesis to investigate pharmacological interventions alone and in combination, for the treatment and prevention of chronic migraines. The work could include newer research in chronic migraine, and also, if appropriate, extrapolation from the existing evidence base on episodic migraine.

The Programme Oversight Committee has estimated that the cost of this work will be around £200,000.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 23rd September 2020. Applications will be considered by the HTA Funding Committee at its meeting in November 2020.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in March 2021.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared. 

Should you have any queries please contact us

Email:   

htagb@nihr.ac.uk