1 Recommendations

1 Recommendations

The purpose of this technology appraisal was to establish at what level of absolute fracture risk bisphosphonates are cost-effective. Please note that because of the reduction in prices for oral bisphosphonates over the last few years, the absolute risk level at which these drugs are cost-effective is now very low. The absolute risk level at which oral bisphosphonates are recommended as treatment options in this guidance are therefore not clinical intervention thresholds. This technology appraisal guidance should be applied clinically in conjunction with:

  • NICE guideline on assessing the risk of fragility fractures (CG146), which defines who is eligible for osteoporotic fracture risk assessment.

  • NICE quality standard on osteoporosis (QS149), which defines the clinical intervention thresholds for the 10-year fracture 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.

Further information is in the implementation section.

1.1 Oral bisphosphonates (alendronic acid, ibandronic acid and risedronate sodium) are recommended as options for treating osteoporosis in adults only if:

  • the person is eligible for risk assessment as defined in NICE's guideline on osteoporosis (recommendations 1.1 and 1.2) and

  • the 10‑year probability of osteoporotic fragility fracture is at least 1%.

1.2 Intravenous bisphosphonates (ibandronic acid and zoledronic acid) are recommended as options for treating osteoporosis in adults only if:

  • the person is eligible for risk assessment as defined in NICE's guideline on osteoporosis (recommendations 1.1 and 1.2) and

  • the 10‑year probability of osteoporotic fragility fracture is at least 10% or

  • the 10‑year probability of osteoporotic fragility fracture is at least 1% and the person has difficulty taking oral bisphosphonates (alendronic acid, ibandronic acid or risedronate sodium) or these drugs are contraindicated or not tolerated.

1.3 Estimate the 10‑year probability of osteoporotic fragility fracture using the FRAX or QFracture risk tools, in line with NICE's guideline on osteoporosis.

1.4 The choice of treatment should be made on an individual basis after discussion between the responsible clinician and the patient, or their carers, about the advantages and disadvantages of the treatments available. If generic products are available, start treatment with the least expensive formulation, taking into account administration costs, the dose needed and the cost per dose.

1.5 These recommendations are not intended to affect treatment with alendronic acid, ibandronic acid, risedronate sodium and zoledronic acid that was started in the NHS before this guidance was published. Adults having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Alendronic acid, ibandronic acid, risedronate sodium and zoledronic acid are bisphosphonates, licensed for treating osteoporosis. Currently clinicians offer bisphosphonates to people with osteoporosis who are eligible for risk assessment and who have a high fracture risk.

To simplify the criteria for treatment and bring the guidance into line with NICE's guideline on osteoporosis, the evidence on bisphosphonates has been reviewed. A new network meta-analysis confirms that bisphosphonates are more effective at reducing the risk of fracture than placebo.

Risk assessment tools are used in clinical practice (FRAX and QFracture), in line with NICE's guideline on osteoporosis. These tools measure risk differently and can give different levels of risk in the same person.

Oral bisphosphonates are recommended because new analyses show they are cost effective for people with at least a 1% risk of osteoporotic fragility fracture, irrespective of the assessment tool used. Similarly, intravenous bisphosphonates are recommended because they are cost effective for people with at least a 10% risk of osteoporotic fragility fracture, irrespective of the risk assessment tool used.

For some people with a 1% risk of osteoporotic fragility fracture, oral bisphosphonates may be contraindicated or not tolerated, or taking them might be difficult or impossible. For these people intravenous bisphosphonates are recommended.

  • National Institute for Health and Care Excellence (NICE)