Cinacalcet Hydrochloride (Sensipar®)
Highly Specialised Drugs Program Declaration Form*
| Patient's Name: | ____________________________________ |
| Medical Record Number: | ____________________________________ |
| Medicare Number: | ____________________________________ |
I certify that the above patient meets the Pharmaceutical Benefits Advisory Committee's criteria for funding under Section 100 of the National Health Act, 1953.
Criteria
-
Management, including initiation and stabilisation, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism with iPTH of at least 50 pmol per L, not responding to conventional therapy.
NOTE:
During the titration phase, intact PTH should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated, between 30 and 180 mg per day according to the patient's response and tolerability, until an appropriate iPTH concentration is achieved.
During the maintenance phase, intact PTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
"Sustained" means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.
- Management, including initiation and stabilisation, by a nephrologist, of a patient with chronic kidney disease on dialysis who has sustained secondary hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L AND an (adjusted) serum calcium concentration at least 2.6 mmol per L, not responding to conventional treatment.
NOTE:
During the titration phase, intact PTH should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated, between 30 and 180 mg per day according to the patient's response and tolerability, until an appropriate iPTH concentration is achieved.
During the maintenance phase, intact PTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
"Sustained" means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.
Specialist Prescriber
| Signature: | ____________________________________ |
| Name: | ____________________________________ |
| Date: | ____________________________________ |
*To be completed by the specialist or authorised prescriber initiating drug treatment, and retained by the hospital Pharmacy Department.
July 2008