Technology Appraisal Guidance No. 117
Source: National Institute for Health and Care Excellence
1.1 Cinacalcet is not recommended for the routine treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy.
1.2 Cinacalcet is recommended for the treatment of refractory secondary hyperparathyroidism in patients with end-stage renal disease (including those with calciphylaxis) only in those:
- who have ‘very uncontrolled’ plasma levels of intact parathyroid hormone (defined as greater than 85 pmol/litre [800 pg/ml]) that are refractory to standard therapy, and a normal or high adjusted serum calcium level, and
- in whom surgical parathyroidectomy is contraindicated, in that the risks of surgery are considered to outweigh the benefits.
1.3 Response to treatment should be monitored regularly and treatment should be continued only if a reduction in the plasma levels of intact parathyroid hormone of 30% or more is seen within 4 months of treatment, including dose escalation as appropriate.
The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA117
An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing firstname.lastname@example.org and quoting reference number N1184. It is also available on the Internet at http://guidance.nice.org.uk/TA117/quickrefguide/pdf/English
This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
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Cinacalcet for the Treatment of Secondary Hyperparathyroidism in Patients with End-Stage Renal Disease on Maintenance Dialysis Therapy.
Issue Date: January 2007
Review Date: December 2009