NICE draft guidance recommends treatments for fractured vertebrae
The National Institute for Health and Care Excellence (NICE) has today (2 November 2012) opened a consultation on draft guidance which provisionally recommends the use of two treatments for fractured bones in the spine (vertebrae) caused by osteoporosis.
The draft guidance says that percutaneous vertebroplasty and percutaneous balloon kyphoplasty are recommended as options for treating osteoporotic vertebral compression fractures only in people:
- who have severe ongoing pain after a recent vertebral fracture (within 6 weeks) despite optimal pain management and
- in whom the pain has been confirmed to be at the level of the fracture (by physical examination and imaging).
Vertebral compression fractures normally occur when the front of the vertebra collapses, and may be caused by trauma, cancer or osteoporosis. When this type of fracture is due to osteoporosis, it can cause the spine to become curved and can also cause loss of height. This can result in pain, difficulties in breathing, gastrointestinal problems and disturbed sleep. Vertebral fractures are more common in women, and the prevalence increases with age. The prevalence of osteoporotic vertebral compression fractures is difficult to estimate as many of these fractures do not cause lasting symptoms, so are not identified. However, those fractures which are symptomatic, are associated with an increase in mortality.
Vertebroplasty involves injecting bone cement into the solid part of the vertebra, to provide pain relief for people with painful fractures and to strengthen the bone to prevent future fractures. Kyphoplasty without stenting is a variation of vertebroplasty involving inserting a balloon-like device into the solid part of the vertebra and slowly inflating it until it restores the normal height of the bone. When the balloon is deflated, the space is filled with bone cement. Kyphoplasty aims to reduce curvature of the spine.
Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said: "Osteoporotic vertebral compression fractures can have a major impact on quality of life, and can be painful and disabling. There can also be significant adverse effects caused by the high doses of analgesics used to treat the pain, which can add to the distress and loss of self-esteem caused by the symptoms. We're therefore pleased to provisionally recommend vertebroplasty and kyphoplasty, two treatments that can help to strengthen fractured bone and reduce pain.
"NICE has previously published interventional procedures guidance which set out that vertebroplasty and kyphoplasty were safe enough to be considered for use in the NHS. This draft technology appraisal guidance highlights that as these procedures are very cost effective, providing benefits to patients and value for money, they ought to be offered to the people specified. We welcome comments on these draft recommendations as part of the consultation."
This is draft guidance: NICE has not yet issued final guidance to the NHS.
Notes to Editors
About the draft guidance
1. The draft guidance 'Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures' is available from 2 November 2012 at: http://guidance.nice.org.uk/TA/Wave22/18.
2. The Committee concluded that the ICERs established for both kyphoplasty and vertebroplasty were generally at the lower end of what is usually considered to be cost effective.
3. Several bone cements are available for vertebroplasty. The acquisition cost of the high-viscosity Confidence Spinal Cement System (Johnson and Johnson) is based on the number of vertebrae being treated. The average cost of the kit is £1472. Low-viscosity cements are available and, based on list prices provided by 2 manufacturers (Cook and Stryker), the Assessment Group estimated a cost of £800 per low-viscosity cement vertebroplasty procedure.
4. The Kyphon BKP kit (Medtronic) is available in the UK for kyphoplasty. Kyphon BKP is a CE-marked, single-use sterile pack with a list price of £2600.50 and includes 2 Kyphon Xpander inflatable bone tamps (balloons) and Kyphon ActivOs bone cement with hydroxyapatite.
5. Adverse reactions from vertebroplasty and kyphoplasty related primarily to cement leakage, particularly for vertebroplasty. The Committee heard that leakage could be intradiscal or intravascular, with intravascular leaks increasing the risk of cement pulmonary embolism. The Committee concluded that cement leakage associated with vertebroplasty and kyphoplasty was manageable if a skilled clinician with specialised training in these procedures performs the operation.
6. NICE has already recommended a range of drug treatments to help prevent primary and secondary osteoporotic fractures: Osteoporosis - primary prevention (TA160), Osteoporosis - secondary prevention including strontium ranelate (TA161) and Osteoporotic fractures - denosumab (TA204) .
7. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
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This page was last updated: 01 November 2012