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Commercial Insight: Osteoporosis and HRT - Novel Osteoporosis Drugs Counter Generic Threat While HRT Players Regroup and Move Forward
Datamonitor, Oct 2004, Pages: 78
Page 39......
- no bisphosphonate treatment to be prescribed to postmenopausal women with osteoporosis who have not suffered a fracture;
- bisphosphonates only to be prescribed for postmenopausal women aged 65 years and older if they have a fracture with no need for DXA;
- bisphosphonate treatment for younger women with a fracture will also need to have very low BMD T-score confirmed by DXA below -3.2 SD or low BMD (T-score -2.5 SD) and a history of maternal hip fracture;
- teriparatide only to be prescribed for women over 70 years with multiple fragility fractures who have not responded adequately to bisphosphonates and have a T-score below -4.0 SD or a history of maternal hip fracture;
- raloxifene is not recommended for the treatment of postmenopausal osteoporosis.
These measures, if enforced, would restrict the choice of drugs available to treat osteoporosis as well as limit access to those patients who have already suffered a fracture, leaving those patients without fracture untreated and at greater risk. This is despite the fact that the cost of treating osteoporotic fractures in England and Wales is estimated to reach £2.0 billion by 2010. Given the recent large-scale HRT trials carried out in the US and the UK and the resulting updated guidelines for hormone therapy, the NICE proposals could leave thousands of women who are at risk of fracture, unprotected. HRT is no longer recommended to prevent and treat osteoporosis and the consideration of non-hormonal alternatives for treatment is advised. However, younger postmenopausal women in particular could have even those alternatives removed.
Heavy criticism, led by the NOS, in response to the draft guidelines during the consultation period included mobilizing the public to write to their MPs expressing their concerns over the implications of the proposal. This resulted in a parliamentary debate in the House of Commons on March 3, 2004 where NICE announced that it will reconsider its plans for the treatment of osteoporosis. Part of this reassessment involved dividing the appraisal into two parts, published separately. One of these will address primary prevention of osteoporotic fractures and the other will focus on secondary prevention.
In July 2004, the final NICE appraisal document on these two issues was issued. Key changes included the maintenance of choice of effective treatment for postmenopausal women with osteoporotic fractures. However, there remains a lack of provision for women under 65 years who also have fragility fractures. The NOS plans
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