Understanding treatment patterns, care pathways and the economic burden of migraine among adults in England: A retrospective cohort study.

Study type
Protocol
Date of Approval
Study reference ID
22_002459
Lay Summary

Migraine is a common and painful long-term condition of the brain affecting approximately 15% of the global population. Considered one of the main causes of disability, frequent migraine occurrences (episodes) result in reduced quality of life, negative impacts to mental health and increased burden on patients, families and society. An estimated total of 43 million days of work and education are lost each year due to migraine.

Migraine can be challenging to diagnose as it can cause symptoms associated with other types of headaches, so involvement of specialist physicians in the hospital setting is often required. Previous research suggests patients are less likely to be diagnosed with migraine by a general practitioner (GP), compared with a hospital specialist.

While there are no cures for migraine, several treatments for managing symptoms (acute medications) and preventing future migraines (preventative medications) are available. However, delays in diagnosis, lack of response to treatment and the development of headaches resulting from the over-use of medicines or painkillers make managing the condition difficult. As the choice of migraine treatment can be complex, taking into consideration previous treatments, existing health conditions, patients’ medical history and potential side effects, migraine management often requires collaborations across healthcare services.

This study aims to describe and better understand how migraine is managed by GPs and specialist physicians, and explore the care pathways of patients through the National Healthcare Service. Moreover, this study will describe use and cost of healthcare services compared to similar patients without a migraine diagnosis.

Technical Summary

Aim: To describe treatment and care pathways for adult patients with migraine in the UK. Findings will be used to address gaps in existing literature regarding the pharmacological treatment of migraine in clinical practice and how patients are managed across primary and/or secondary care settings, which may ultimately be used to inform physician decision-making for patients with migraine, and improve patient outcomes.

Objectives: To describe i) treatment patterns/sequencing of acute and preventative migraine treatments prescribed in primary care; ii) demographic and clinical characteristics of migraine patients; iii) annual prevalence rates of migraine; iv) healthcare resource use (HCRU) and associated direct medical costs (all-cause and migraine-related),(inc. comparison of all-cause HCRU/costs with matched general population controls); v) referral pathways for migraine patients between primary and secondary care.

Methods: A retrospective cohort study using UK primary care data (CRPD Aurum), with linkage to secondary care Hospital Episode Statistics (HES), death registration (Office for National Statistics [ONS]) and deprivation (2019 English Index of Multiple Deprivation [IMD]) datasets, of adult patients with an incident migraine diagnosis in primary or secondary care during the study indexing period (Jan-2017 to Mar-2019). Patient demographics and clinical characteristics will be described in the 12-months prior to index date (baseline), and outcomes assessed during a 12-month minimum follow-up period.

Exposures: Incident migraine diagnosis

Outcomes: Prescribing rates; treatment sequencing; neurologist/headache specialist involvement, sociodemographic and clinical characteristics; migraine-related and all-cause HCRU/costs; prevalence.

Data analysis: Analysis will be predominantly descriptive in nature. Frequencies and percentages will be reported for categorical variables. Counts, means, medians and SDs will be reported for continuous variables. Rates will be reported for endpoints measured over a variable time period. Each migraine patient (case) will be exact matched to a headache/migraine-free control on birth year, sex, socioeconomic status, GP region and baseline comorbidities for comparison of all-cause HCRU/costs.

Health Outcomes to be Measured

Prescribing rates of acute and preventative migraine treatments (at class level, except for triptans which will be reported at the product and formulation level); Treatment sequencing; Time to discontinuation of preventative treatment; Triptan use; Opioid use/ medication overuse headache (MOH); Neurologist/headache specialist involvement; Migraine-specific and all-cause HCRU/costs (primary care medication use, primary care consultations, outpatient appointments, hospitalisations, A&E attendances, total medical costs); Sociodemographic (age, sex, ethnicity etc.) and clinical (comorbidities, prior headache diagnoses etc.) characteristics.

Collaborators

Shuk-Li Collings - Chief Investigator - Pfizer Ltd - UK
Amisha Patel - Corresponding Applicant - Adelphi Real World
Aideen Ahern - Collaborator - Pfizer Ltd - UK
Elizabeth Hamson - Collaborator - Pfizer Ltd - UK
Hannah Gowman - Collaborator - Adelphi Real World
Lucy Massey - Collaborator - Adelphi Real World
Robert Pawinski - Collaborator - Pfizer Ltd - UK
Robert Wood - Collaborator - Adelphi Real World
Sarah Law - Collaborator - Adelphi Real World
Shazia Afridi - Collaborator - Guy's & St Thomas' NHS Foundation Trust

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;CCG Pseudonyms