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An evaluation of the NICE guidance for the prevention of osteoporotic fragility fractures in postmenopausal women

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Abstract

Summary

The National Institute for Health and Clinical Excellence (NICE) in the UK issued guidance based on a health economic assessment of interventions for the primary and secondary prevention of osteoporosis. The recommendations in the guidance are unworkable in clinical practice and the foundation on which they are based is insecure.

Introduction

The NICE in the UK recently issued final appraisal documents on the health economic assessment of interventions for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. The majority of interventions were considered to be cost-ineffective except at very low T scores for bone mineral density (BMD). Concerns have been raised with respect to the construct and assumptions that populate the model used by NICE and the feasibility of implementing the subsequent guidance.

Results

The application of the NICE guidance to primary care is problematic. Intervention thresholds are based on a complex array that includes the agent to be used, age, T scores and the presence of different categories of risk factors. Alendronate is the first-line treatment, but women who cannot take or tolerate alendronate may have to wait till their T score deteriorates before they qualify for treatment. The guidance takes no account of women with a T score > −2.5 SD, of glucocorticoid-induced disease or of men. Newer interventions, such as ibandronate and zoledronic acid, are not included. The development of guidelines by the National Osteoporosis Guideline Group (NOGG) avoids many of these problems and unlike the NICE guidance, can be used with FRAX®, the WHO-supported fracture risk assessment tool. NOGG provides intervention thresholds based on fracture probabilities computed from clinical risk factors for fracture with or without information on BMD that are readily accessed by primary care physicians for the assessment of all postmenopausal women and men over the age of 50 years. The NICE guidance is based on a health economic assessment of several interventions. The model used to assess cost-effectiveness is based on Gaussian regression functions which were derived from an individual state transition model. Since the source individual state transition model is not available, the Gaussian functions cannot be evaluated. Moreover, neither the internal nor external validity of the model is established, and the model is not accessible for such an evaluation. Although the NICE model incorporates the clinical risk factors (CRFs) used in FRAX, it neglects the impact of CRFs on the death hazards giving estimates of fracture probability that differ from those using FRAX®. The estimates of cost-effectiveness differ from reference models for reasons that relate in part to the model construct and in particular to the assumptions used to populate the model.

Conclusions

The guidance provided by NICE is cumbersome and cannot be readily used in the setting of primary care. The model on which the guidance is based is opaque. The authors do not support the view of NICE that there are no issues which cause it to doubt the validity of the model or that raise justifiable doubts about the appropriateness of the use of the model to inform its guidance.

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Abbreviations

BMI:

Body mass index (computed as kg/m2)

BMD:

Bone mineral density (in this report at the femoral neck measured by dual energy X-ray absorptiometry)

CRFs:

Clinical risk factors

DSU:

Decision support unit

FAD:

Final appraisal document

FRAX®:

Algorithms that assess the probability of fracture related to any combination of clinical risk factors with or without BMD

HTA:

Health technology assessment

ICER:

Incremental cost-effectiveness ratio

NICE:

National Institute for Health and Clinical Excellence

NOGG:

National Osteoporosis Guideline Group

QALY:

Quality-adjusted life years

RCP:

Royal College of Physicians, London

ScHARR:

School of Health and Related Research, University of Sheffield, UK

T score:

The deviation in SD units of measured BMD from the mean of the young adult female reference range

WHO:

World Health Organization

WTP:

Willingness to pay

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Acknowledgements

We are grateful to Professors Juliet Compston and Cyrus Cooper for their review of the manuscript and constructive comments.

Conflicts of interest

This review is an adaptation of a more extensive report commissioned by Servier for use in their response to consultation documents issued by NICE in 2009. Servier Laboratories provided financial support for the original report. Servier had no role in study design, in the collection, analysis, and interpretation of data and in the writing of the report or this review. JAK, BJ, EM, AC, OS and FB act as advisors to and have received funding from many pharmaceutical companies involved in marketing products for treatment of osteoporosis. JAK was a member of the NICE Osteoporosis GDG, and was asked by NICE to leave the GDG in 2006. He is also a member of NOGG. JAK is President of the International Osteoporosis Foundation and FB serves on its Committee of Scientific Advisors. AC is a member of NOGG. OS collaborates with the Osteoporosis Guideline Group of the Swedish National Board of Health and Welfare.

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Authors and Affiliations

  1. WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK

    John A. Kanis

  2. Academic Unit of Bone Metabolism, Northern General Hospital, Sheffield, UK

    Eugene V. McCloskey

  3. i3 Innovus, Stockholm, Sweden

    Oskar Ström & Fredrik Borgström

  4. Stockholm School of Economics, Stockholm, Sweden

    Bengt Jonsson

  5. Crawley Fracture Liaison Service, Crawley, UK

    Alun Cooper

  6. Medical Management Centre, Karolinska Institute, Stockholm, Sweden

    Oskar Ström & Fredrik Borgström

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  1. John A. Kanis
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  2. Eugene V. McCloskey
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  3. Bengt Jonsson
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  4. Alun Cooper
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  5. Oskar Ström
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  6. Fredrik Borgström
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Correspondence to John A. Kanis.

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Kanis, J.A., McCloskey, E.V., Jonsson, B. et al. An evaluation of the NICE guidance for the prevention of osteoporotic fragility fractures in postmenopausal women. Arch Osteoporos 5, 19–48 (2010). https://doi.org/10.1007/s11657-010-0045-5

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