Postmenopausal Osteoporotic Patients Granted Treatment Options by the National Institute for Health and Clinical Excellence (NICE)

- Final Guidance Issued by NICE

Monday 27th October 2008: Procter & Gamble Pharmaceuticals (P&GP) acknowledges the publication of the new Technology Appraisal Guidance (TAG 160, for the primary prevention, and 161 for the secondary prevention, of osteoporotic fragility fractures in post-menopausal women) issued by NICE. Within the scope of this guidance NICE considered alendronate, risedronate, etidronate, strontium ranelate, raloxifene and teriparatide (secondary prevention only). P&GP welcomes the recommendation of risedronate and etidronate as the first alternative treatment options to alendronate for postmenopausal women who are unable to comply with the special administration instructions, have a contraindication to, or are intolerant (requiring discontinuation) of alendronate (and also meet certain criteria such as Bone Mineral Density T- scores, age and independent clinical risk factors for fracture)i,ii.

P&GP recognises that the NICE TAG 160 and 161 have not been widely accepted by the osteoporosis community as the guidance is viewed as difficult to implement, with a patient’s condition often having to deteriorate before gaining access to alternative treatments to alendronate. The National Osteoporosis Guideline Group (NOGG), chaired by Professor Juliet Compston (please see section “notes to the editors”), recently launched an alternative set of guidelines with the aim of providing broader and more manageable intervention thresholds for treating patients at risk of fracture in the UKiii. P&GP remain committed to helping clinicians provide the best possible care for osteoporosis patients.

Recommendations for treatment options within the NICE TAG 160 and 161 are not only based on the clinical efficacy of the therapies but also the acquisition cost of the available osteoporosis medicines and a summary of the stepwise process (as outlined in the table below)i,ii.

Table 1. Summarised Treatment Flow
Developed from NICE TAG 160 and 161 - see full guidance for details
Each step is dependent on the following:
Patients being unable to comply with the special administration instructions, have a contraindication to, or intolerance (requiring discontinuation) of the preceding treatments, age, T score, independent clinical risk factors for fracture, indicators of low BMD & in some cases clinically apparent fragility fractures or an unsatisfactory response to previous therapies.

What the final NICE TAG 160 and 161 means for physicians and postmenopausal osteoporotic patients
Initial draft versions of the NICE guidance recommended alendronate as the only treatment option for postmenopausal osteoporotic patients (please see section “notes to the editors”). However this decision was met with opposition from patient groups such as the National Osteoporosis Society (NOS). NICE has since revised the guidance to provide more treatment options. For patients who cannot take alendronate and meet certain criteria (see TAG 160 and 161 for full details), risedronate or etidronate are now recommended as the first alternative treatmentsi,ii. Once these options have been fully exhausted, other treatments including strontium ranelate, raloxifene and teriparatide are recommended.
In those women who are currently receiving treatment with one of the drugs covered by the TAG 160 and 161, but for whom treatment would not have been recommended according to the guidance criteria, patients should have the option to continue treatment until they and their clinicians consider it appropriate to stopi,ii.
The revised position of the NICE TAG 160 and 161 is particularly important for postmenopausal osteoporotic patients as NICE recognise that one third of participants in post-marketing studies of alendronate reported the occurrence of adverse gastrointestinal eventsi,ii.
Osteoporosis care should now better meet the needs of individual patients as alternative treatment options have been recognised by NICE for patients who cannot take alendronate (as described above).
Oral bisphosphonate treatment is the most common pharmacological intervention for osteoporosis, with risedronate and alendronate being the most frequently prescribed treatments in the UKiv. Managing osteoporosis involves a balance between choosing a treatment that best protects the individual from fracture, has an adequate tolerability profile, and makes best use of NHS resources. However, not all bisphosphonates covered by TAG 160 and 161 have the same tolerability profile and demonstrated fracture prevention. Primary Care Trusts (PCTs) in England and Wales will now be given three months to implement the TAG 160 and 161 by NICE