Advice

in the absence of a submission from the holder of the marketing authorisation:

cinacalcet hydrochloride granules in capsules for opening (Mimpara®) is not recommended for use within NHSScotland.

Indication under review:
Secondary hyperparathyroidism (HPT)

  • Treatment of secondary HPT in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy
  • Treatment of secondary HPT in children aged 3 years and older with ESRD on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy

Parathyroid carcinoma and primary HPT in adults

  • Reduction of hypercalcaemia in adult patients with:
    - parathyroid carcinoma
    - primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated

The holder of the marketing authorisation has not made a submission to SMC regarding this product in these indications. As a result we cannot recommend its use within NHSScotland.

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Medicine details

Medicine name:
cinacalcet hydrochloride (Mimpara)
SMC ID:
SMC2275
Indication:

Secondary hyperparathyroidism (HPT)

  • Treatment of secondary HPT in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
  • Treatment of secondary HPT in children aged 3 years and older with ESRD on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy.

Parathyroid carcinoma and primary HPT in adults

  • Reduction of hypercalcaemia in adult patients with:
    - parathyroid carcinoma
    - primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by   relevant treatment guidelines), but in whom
    parathyroidectomy is not clinically appropriate or is contraindicated
Pharmaceutical company
Amgen Ltd
Submission type
Non submission
Status
Not recommended
Date advice published
09 March 2020