WIREDGOV

Postmenopausal women who are at increased risk1 of osteoporotic fractures should be treated with denosumab if treatment with currently available oral bisphosphonates is unsuitable, according to draft guidance published today (Friday 18 June) by NICE.

Denosumab (Prolia, Amgen) is a newly-licensed treatment for women at increased risk of osteoporotic fractures, given by injection twice a year. It works by reducing bone breakdown and increases bone mass and strength.

Most postmenopausal women at increased risk of osteoporotic fractures are treated with oral bisphosphonates, but for some women these drugs may be unsuitable. Reasons for unsuitability are that a woman is unable to comply with the special instructions for the administration of oral bisphosphonates (for instance she may not be able to remain standing or sitting upright for half an hour after taking the drugs), or has a contraindication to or is intolerant of bisphosphonates. Denosumab should be an option for these women if they are judged to be at increased risk of fractures, according to the NICE draft guidance.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “Our independent Appraisal Committee felt that there was good quality evidence to show that denosumab is a useful addition to the treatment options available to prevent a first fracture in women at increased risk and also at preventing further fractures in women who have already experienced one. We hope that older women at increased risk of osteoporotic fractures who cannot take oral bisphosphonates will be considered for this drug in order to help prevent the misery of breaking a bone, and we are now opening a consultation on this preliminary decision.”

This is not final NICE guidance. Draft guidance has been issued for consultation.Comments received during the consultation will be considered by the Committee and following this meeting the next draft guidance will be issued. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.

Notes to Editors

About the guidance

• The appraisal consultation document (ACD) will be available at http://guidance.nice.org.uk/TA/Wave20/75 from Friday 18 June 2010. Consultation will take place between 18 June and 9 July 2010. The next committee meeting will be held on 27 July. NICE expects to publish final guidance on denosumab later this year.
• The appraisal consultation document published today (18 June) states:

1.1 Denosumab is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures:

• who are unable to comply with the special instructions for the administration of oral bisphosphonates, are intolerant of oral bisphosphonates or for whom treatment with oral bisphosphonates is contraindicated and
• who also have a combination of T-score2, age and number of independent clinical risk factors for fracture (see section 1.3) as indicated in the following table:

T-scores (SD) at (or below) which denosumab is recommended when oral bisphosphonates are unsuitable

1.2 Denosumab is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures:

• who are unable to comply with the special instructions for the administration of oral bisphosphonates, are intolerant of oral bisphosphonates or for whom treatment with oral bisphosphonates is contraindicated

1.3 For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.

• Denosumab is administered as a single subcutaneous injection into the thigh, abdomen or the back of the arm. The recommended dosage is 60mg once every six months.
• Each dose costs £183, which means that the annual cost of treatment with denosumab is £366. Costs may vary in different settings because of negotiated procurement discounts.

About NICE

• The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
• NICE produces guidance in three areas of health:
  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

1 ‘Increased risk’ is defined by a combination of low bone mineral density, age and a number of other clinical risk factors such as parental history of hip fracture, high alcohol intake and rheumatoid arthritis.

2 T-score relates to the measurement of bone mineral density (BMD) using central (hip and/or spine) DXA scanning, and is expressed as the number of standard deviations (SD) below peak BMD.