4 Implementation

4 Implementation

4.1 Section 7(6) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication.

4.2 The Welsh Ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final appraisal document.

4.3 When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has osteoporosis and the doctor responsible for their care thinks that bisphosphonates are the right treatment, they should be available for use, in line with NICE's recommendations.

Clarification of implementation of this appraisal

Background

In light of the enquiries we've received about osteoporotic fracture risk and treatment thresholds, dual-energy X-ray absorptiometry (DXA) scans and the relationship between our technology appraisal guidance and clinical guideline on osteoporosis, we have produced the following clarification.

Putting this guidance into practice

Our technology appraisal guidance should be applied clinically in conjunction with:

  • NICE's guideline on osteoporosis (CG146), which defines who is eligible for osteoporotic fracture risk assessment.

  • NICE's quality standard on osteoporosis (QS149), which defines the clinical intervention thresholds for the 10-year probability of a major osteoporotic fracture in those patients who have undergone fracture risk assessment. These thresholds are based on the NICE-accredited National Osteoporosis Guideline Group guideline.

  • The individual person's circumstances, goals and informed preferences.

In this context, our technology appraisal guidance recommends oral bisphosphonates (alendronic acid, ibandronic acid and risedronate sodium) and intravenous bisphosphonates (ibandronic acid and zoledronic acid) as options for treating osteoporosis in adults providing 3 conditions are met:

  • the person is eligible for risk assessment as defined in recommendations 1.1 and 1.2 of NICE's clinical guideline on osteoporosis and in NICE's quality standard on osteoporosis and

  • the person has been assessed as being at higher risk of osteoporotic fragility fracture using the methods recommended in NICE's guideline on osteoporosis (recommendations 1.3 to 1.12) and NICE's quality standard on osteoporosis and

  • bisphosphonate treatment is appropriate.

We made this recommendation because we found oral bisphosphonates to be clinically and cost effective for people with at least a 1% risk of osteoporotic fragility fracture, irrespective of the assessment tool used. We also found intravenous bisphosphonates to be clinically and cost effective for people with at least a 10% risk of osteoporotic fragility fracture, and for those with at least a 1% risk of osteoporotic fragility fracture for whom oral bisphosphonates are not suitable, irrespective of the assessment tool used. This does not mean that oral and intravenous bisphosphonates should be routinely offered to all adults with these probabilities of osteoporotic fragility fracture alone. These are the risk levels at which bisphosphonates are cost effective, and are not intervention thresholds. We make it clear in the recommendations that, for the funding regulations to apply, a person must also be eligible for risk assessment as defined in recommendations 1.1 and 1.2 of our clinical guideline on osteoporosis, the person must have been assessed as being at higher risk of osteoporotic fragility fracture using the methods recommended in NICE guidance, and bisphosphonate treatment must be appropriate.

The probability of osteoporotic fragility fracture
The term 'osteoporotic fragility fracture' in the guidance means total osteoporotic fracture. This is 'clinical spine, forearm, hip or shoulder fracture' when using FRAX or 'any osteoporotic (hip, wrist, shoulder or spine) fracture' when using QFracture.

Bone mineral density (BMD) measurement
The NICE guideline on osteoporosis makes recommendations on measuring BMD using DXA. These recommendations should be considered when applying the technology appraisal guidance.

Practical application of this guidance
If the person is eligible for estimation of osteoporotic fragility fracture risk (see recommendations 1.1 and 1.2 of the clinical guideline), the first step is for the healthcare professional to discuss with them (and their families and carers if appropriate and the person agrees) the advantages and disadvantages of formal risk estimation. This discussion may well include the possible treatments available for osteoporosis, since if none of these would be acceptable or suitable for the person, formal risk estimation may not be appropriate.

If the person and their healthcare professional agree that a risk assessment would be worthwhile, and the 10 year probability of them having an osteoporotic fragility fracture is at least that stated in the technology appraisal, the next step is for the healthcare professional to discuss with them the advantages and disadvantages of bisphosphonate treatment, and the choice of medicine. We have produced a decision support aid to help support this discussion.

If the person wishes to try a bisphosphonate, they should be able to start treatment with the least expensive formulation, with no other local formulary or funding restrictions.

  • National Institute for Health and Care Excellence (NICE)