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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300428
• Other study ID #: 6531
• Status: Completed
• First received: November 24, 2014
• Last updated: March 20, 2018
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Medical Research Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406902
• Est. completion date: December 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Anemia

Intervention

Dietary Supplement:
• oral iron
BNF code for section 9.1.1.1 (Oral iron preparations for iron-deficiency anaemias)

Locations

Country	Name	City	State
United Kingdom	MRC Human Nutrition Research	Cambridge	Cambridgeshire

Sponsors (4)

Lead Sponsor	Collaborator
dora pereira	Bangor University, University of Cambridge, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prescription rate	number of prescriptions of iron supplements issued at the patient level in the year	12 months
Primary	Health Economics Modelling	In this analysis we will determine the following to parameterise the model that will be based on the cohort study over a 10 years period: i) Frequency of repeat oral iron prescriptions, ii) Number of hospital admissions, i) Incidence of gastrointestinal side-effects, ii) Treatment cessation rate iii) Haemoglobin changes; The basis for the model will be the above data extracted from the CPRD, further informed by publicly available clinical trial data.	10 years
Secondary	Efficacy	increase in Hb of at least 2 g/dL or to >12 g/dL	12 months
Secondary	Gastrointestinal intolerance	At least one event of i. change in product; ii. reduction in dose; iii cessation of treatment with no improvement in Hb during the 12 months	12 months