Health Economics of the Use of Ferrous Iron Salts in Primary Care in the UK.

NCT ID: NCT02300428

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 406902 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-12-31

Brief Summary

Iron deficiency anaemia (IDA) affects approximately 4.7 million of people in the UK, with children and pre-menopausal women being at higher risk (1). Each year more than 6.8 million prescriptions for oral iron are filled in England alone (NHS Information Centre data). However, gastrointestinal symptoms limit adherence in 10-30% of otherwise healthy patients (2-4) and in up to 50% of patients with gastrointestinal disorders (5). Simple ferrous iron salts constitute the vast majority of currently prescribed oral iron because these are cheap and well absorbed. However, they are also poorly tolerated and thus, we believe, are expensive to the NHS.

Funded by the Medical Research Council, we have developed an alternative oral iron supplement, that we name IHAT (iron hydroxide adipate tartrate), as an efficacious therapy for IDA with minimal side-effects.

In the study proposed here we aim to assess the total health cost associated with current oral iron supplements and, hence, define the clinical unmet need for alternative treatments. We will use Clinical Practice Research Datalink (CPRD) GOLD data to (i) estimate the pattern of prescribing to oral iron in primary care in the general population and (ii) develop a health economics model in pre-menopausal women. These data will provide evidence for the total health system costs associated with current oral iron treatment. Furthermore, this study will provide data from which the cost-effectiveness and total health system costs of alternative effective and treatments with minimal side-effects could be estimated.

Detailed Description

Our research objective is to gather evidence for the unmet clinical need for safe, low-side-effect oral iron in the UK.

To achieve this objective we aim to determine:

1. Pattern of prescribing to oral iron in primary care in GP practices in England: estimate prescription rates, efficacy and intolerance of treatment with all forms of currently prescribed oral iron.

2. Health economics of the use of ferrous iron salts in primary care: estimate patterns of individual response to treatment; determine the costs of ferrous iron (sulphate, fumarate and gluconate) therapy in pre-menopausal women in primary care, and develop a cost-effectiveness model for alternative treatments with minimal side-effects.

Conditions

Anemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

1-year cohort

Patients with at least 1 prescription of any oral iron preparation in the last 2 years and who have at least 1 year of follow up data post-prescription.

It is anticipated that ca. 123,000 patients in CPRD fulfil this criteria.

oral iron

Intervention Type: DIETARY_SUPPLEMENT

BNF code for section 9.1.1.1 (Oral iron preparations for iron-deficiency anaemias)

10-year cohort

All pre-menopausal women (18-45 years old) with at least 1 prescription of one ferrous iron salt (i.e. sulphate, fumarate and gluconate) since January 2000.

It is anticipated that ca. 299,000 patients in CPRD fulfil this criteria.

oral iron

Intervention Type: DIETARY_SUPPLEMENT

BNF code for section 9.1.1.1 (Oral iron preparations for iron-deficiency anaemias)

Interventions

oral iron

BNF code for section 9.1.1.1 (Oral iron preparations for iron-deficiency anaemias)

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Dried ferrous sulphate tablets 200mg; Ferrous fumarate tablets 210mg; Ferrous gluconate tablets 300mg; Ferrous fumarate tablets 322mg (incl. Fersaday); Ferrous fumarate capsules 305mg (incl. Galfer); Dried ferrous sulphate MR tab 325mg (incl. Ferrograd)

Eligibility Criteria

Inclusion Criteria

• patients prescribed oral iron in primary care practices included in the UK CPRD database

Exclusion Criteria

• N/A

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

Bangor University

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

dora pereira

OTHER_GOV

Sponsor Role: lead

Responsible Party

dora pereira

Senior Investigator Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dora Pereira, PhD

Role: PRINCIPAL_INVESTIGATOR

MRC Human Nutrition Research

Locations

MRC Human Nutrition Research

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

Other Identifiers

6531

Identifier Type: -

Identifier Source: org_study_id