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Many more eligible for bisphosphonates after NICE lowers threshold to 1%



GPs should consider patients with lower risks of osteoporotic fracture for bisphosphonate treatment as the drugs are ‘clinically effective’ at this level, recommends a new NICE appraisal.

New advice from the NICE technology appraisal on bisphosphonates for treating osteoporosis suggests that patients with a 10 year osteoporotic fracture risk of 1%, calculated using a risk tool such as QFracture or FRAX, should be considered for primary prevention with oral bisphosphonates.

This is in contrast to the National Osteoporosis Guideline Group’s recommendation that primary prevention with bisphosphonates should being at around 7% 10-year risk in those aged 40 years, rising to a 20% risk threshold in the over 70s. 

The SIGN osteoporosis guidelines, which say that patients with a 10 year risk of greater than 10% should have a DXA scan and receive treatment with bisphosphonates after that if appropriate, also contrast with NICE recommendations.

NICE cautions that this does not mean that every patient at low risk should receive treatment and that doctors need to use their clinical judgement.

The guideline says: ‘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.’

The National Osteoporosis Society said of the new advice: ‘With growing concerns about possible rare long term effects of bisphosphonate treatments, we want to make sure that people are only given a treatment when the benefits of treatment outweigh the risks.

‘Health professionals, especially non-specialists like GPs, may need some additional guidance to support their decisions about which patients should be offered a bisphosphonate.’

The appraisal reasons that the threshold for prescribing the drugs is low as they are shown to be both clinically effective and cost effective at this level.

Drug recommendations in the technology appraisal will apply to both women and men for the first time. It also states that IV bisphosphonates should only be given without trying oral bisphosphonates first if the 10 year risk is 10% or greater.

Dr Sally Hope, a GP and a hospital clinical assistant in osteoporosis, said: ‘So what has really changed since the initial NICE guidelines is the generic cost of bisphosphonates. They are now very cheap drugs, so it is cost effective to treat lots more people to reduce fracture risk.’

The appraisal can be used as the basis for NICE guidance on bisphosphonates in osteoporosis following a period during which consultees can appeal against it.

Technology appraisal in full

Consider oral bisphosphonates if:

Consider intravenous bisphosphonates if:

  • The patient is eligible for risk assessment, as described in NICE’s osteoporosis guideline
  • Their 10 year osteoporotic fracture risk is at least 10% or
  • Their 10 year osteoporotic fracture risk is at least 1% and they cannot take oral bisphosphonates due to contraindication, intolerance or difficulty taking oral medication

Use the QFracture or FRAX tools to estimate 10 year risk

Decide whether to treat based on the individual patient’s needs and after a discussion of risks and benefits of the treatments available

Source: NICE