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 cost effective as treatment options does not represent a clinical intervention threshold. This 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 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) and intravenous bisphosphonates (ibandronic acid and zoledronic acid) are recommended, within their marketing authorisations, as options for treating osteoporosis in adults:

  • who are eligible for risk assessment as defined in NICE's guideline on osteoporosis (recommendations 1.1 and 1.2) and NICE's quality standard on osteoporosis and

  • who have 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

  • when bisphosphonate treatment is appropriate, taking into account their risk of fracture, their risk of adverse effects from bisphosphonates, and their clinical circumstances and preferences.

1.2 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.

1.3 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 and intravenous bisphosphonates are recommended because new analyses show they are cost effective for people who have been assessed as being at higher risk of osteoporotic fragility fracture using the methods recommended in NICE's guideline on osteoporosis and NICE's quality standard on osteoporosis.

  • National Institute for Health and Care Excellence (NICE)