- On 1 February 2020, cinacalcet (Pharmacor Cinacalcet), a calcimimetic medicine, was listed on the PBS
It was listed for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving dialysis.
- Pharmacor Cinacalcet was listed on the PBS S100 Highly Specialised Drugs Program and PBS General Schedule
Listing on the General Schedule allows medical and nurse practitioners to prescribe cinacalcet for continuing treatment, improving patient access and continuity of care.
- Cinacalcet (Sensipar) was previously listed on the PBS from 2008 until 2015
It was listed for the treatment of sustained hyperparathyroidism in patients with CKD on dialysis not responsive to conventional therapy.
- Cinacalcet (Sensipar) was found to be not cost-effective in 2014
It was subsequently delisted from the PBS in 2015.
- In 2019, a submission for PBS listing by the sponsor for cinacalcet (Pharmacor Cinacalcet) was considered by the PBAC
The PBAC found a moderate unmet clinical need for a calcimimetic medicine to be made available on the PBS.
- PBAC considered that cinacalcet (Pharmacor Cinacalcet) was non-inferior compared to Sensipar, given the TGA considered them to be bioequivalent
It considered cinacalcet would be cost-effective if priced equivalent to the lowest effective price of Sensipar before its delisting.
On 1 February 2020, cinacalcet (Pharmacor Cinacalet) was listed on the PBS for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) who are currently on dialysis, as the following listings:1
- Authority Required on the S100 – Highly Specialised Drugs Program (Public and Private Hospital) for initial treatment
- Authority Required (Streamlined) on the S100 – Highly Specialised Drugs Program (Public and Private Hospital) for continuing treatment
- Authority Required (Streamlined) on the General Schedule (Section 85) for continuing treatment only.
See the PBS website for complete details for each item.
Why were the changes made?
Cinacalcet (Sensipar) was listed on the PBS from 1 July 2008 to 31 July 2015 for the treatment of SHPT in patients with CKD on dialysis not responding to conventional therapy.2
SHPT is one of the principle manifestations of CKD and is associated with increases in cardiovascular events, pathological fractures and overall mortality.2
Cinacalcet is a calcimimetic medicine that reduces parathyroid hormone levels, as well as serum calcium and phosphorus levels, in patients with CKD receiving dialysis.2
The PBAC recommended the 2008 listing based on a meta-analysis of biomarker randomised controlled trials, which suggested that treatment with cinacalcet was associated with changes in intact parathyroid hormone (iPTH) levels and subsequent reductions in cardiovascular-related hospital admissions, pathological fractures and parathyroidectomy rates when compared to placebo.2,3
However, the PBAC also recommended a risk-sharing arrangement (RSA) which required the sponsor to provide all ongoing data to the Commonwealth on the efficacy and cost-effectiveness of the drug.2 RSAs are used to address multiple types of risks that may be associated with listing particular medicines on the PBS (such as uncertainty in estimating the overall cost to the PBS).4
In November 2013, new evidence was provided to address the requirements of the RSA. This included a large international randomised double-blind trial which demonstrated that there was no statistically significant difference in the primary outcome (time to death or non-fatal cardiovascular event)5 and a higher rate of adverse events with cinacalcet compared with placebo.2 The only benefit with cinacalcet was a reduction in parathyroidectomy.2
Therefore, the PBAC made a new recommendation that cinacalcet (Sensipar) was not cost-effective at the current price based on this new evidence, and the price reduction offered by the sponsor was not sufficient to restore cost-effectiveness of cinacalcet (Sensipar).3
The medicine was subsequently delisted from the PBS on 1 August 2015.2
More information about the delisting of Sensipar is available in a previous RADAR article.
Cinacalcet has been relisted on the PBS
At its July 2019 meeting, the PBAC made a recommendation for Pharmacor Cinacalcet to be listed on the PBS for the treatment of SHPT in patients with CKD on dialysis.2
The PBAC accepted that Pharmacor Cinacalcet was non-inferior in terms of safety and efficacy when compared to Sensipar, given that the TGA considered Sensipar and Pharmacor Cinacalcet to be bioequivalent.2
The PBAC was also satisfied that there was a moderate unmet clinical need in the target population, as there was no suitable alternative PBS-listed calcimimetic medicine.2
If standard treatment for SHPT fails (including management of the underlying cause and potential deficiencies in vitamin D6), parathyroidectomy is the next treatment option, but is not appropriate for all patients and is associated with adverse outcomes, such as rehospitalisation with hypocalcaemia.2
The PBAC noted that the claim of an increase in parathyroidectomy rates due to the unavailability of cinacalcet was reasonable.2
The PBAC recommendation for listing was based on, as well as clinical considerations, its assessment that cinacalcet would be considered cost-effective if it were priced equivalent to the lowest effective price of Sensipar before delisting on 1 August 2015.2
Will the changes affect current prescribing/health services?
While cinacalcet has multiple TGA-approved indications, the PBS-approved listing only relates to secondary hyperparathyroidism in patients with CKD on dialysis.1,7
The PBAC considered it was appropriate for cinacalcet to be listed on the S100 Highly Specialised Drugs Program for commencing initial treatment. It was considered that a nephrologist would be the appropriate prescriber for initiating cinacalcet treatment as patients commencing dialysis would be in a hospital setting.2
The listing of cinacalcet for continuing treatment on the General Schedule was also considered appropriate, as this would allow medical and nurse practitioners to prescribe cinacalcet, improving patient access and continuity of care.2
The Authority Required (Streamlined) listing of cinacalcet on the General Schedule means that prescribers do not need telephone or written approval from Services Australia (previously known as the Department of Human Services) or Department of Veterans’ Affairs (DVA) prior to prescribing. For more information about prescribing of Streamlined Authority medicines, see the PBS website.
Listing on the General Schedule will allow easier access for patients in rural areas. The sponsor of cinacalcet (Pharmacor) noted that there is a high proportion of patients on dialysis in Aboriginal and Torres Strait Islander communities who are less likely to receive a kidney transplant compared to non-Indigenous Australians who are on dialysis.2
Additionally, the relisting of cinacalcet is likely to reduce the rates of parathyroidectomy.2
What else should health professionals know?
Cinacalcet is not indicated for use by patients with CKD who are not receiving dialysis, as they are at an increased risk of hypocalcaemia with this medicine.7
Cinacalcet is contraindicated for use by people with hypocalcaemia because it has the potential to lower serum calcium concentrations. Life-threatening events and fatal outcomes associated with hypocalcaemia have been reported in patients being treated with cinacalcet, such as QT prolongation potentially resulting in ventricular arrhythmias.7
Regular monitoring of serum calcium concentrations is required with use of cinacalcet for patients with secondary hyperparathyroidism. Monitoring is recommended at baseline, within one week of starting treatment or changes to the dose and also at monthly intervals after a maintenance dose has been established.8
Cases of gastrointestinal bleeding (mostly relating to the upper gastrointestinal tract) have occurred with use of calcimimetics, including cinacalcet. Patients with risk factors for upper gastrointestinal bleeding (such as gastritis, oesophagitis, ulcers or severe vomiting) may be at increased risk of gastrointestinal bleeding when receiving treatment with cincalcet.7
What should patients know?
Patients should inform their prescribing doctor if they start or stop smoking tobacco. Tobacco smoking can increase the clearance of cinacalcet which may warrant a dose adjustment if a patient’s smoking status changes.8
Pharmacor Cinacalcet should be taken with or soon after food and swallowed whole, not divided.9
Discuss the Pharmacor Cinacalcet Consumer Medicine Information (CMI) leaflet with the patient.
- Pharmaceutical Benefits Scheme. PBS Schedule: Summary of changes (February 2020). Canberra: Australian Government Department of Health, 2020 (accessed 10 January 2020).
- Pharmaceutical Benefits Scheme. Public Summary Document: Cinacalcet (July 2019 PBAC meeting). Canberra: Australian Government Department of Health, 2019 (accessed 10 January 2020).
- Pharmaceutical Benefits Scheme. Public Summary Document: Cinacalcet (March 2014 PBAC meeting). Canberra: Australian Government Department of Health, 2014 (accessed 10 January 2020).
- Pharmaceutical Benefits Scheme. What are Deeds of Agreement? Canberra: Australian Government Department of Health, 2017 (accessed 22 January 2020).
- Pharmaceutical Benefits Scheme. Public Summary Document: Cinacalcet (November 2013 PBAC meeting). Canberra: Australian Government Department of Health, 2013 (accessed 22 January 2020).
- Bone and Metabolism Expert Group. Therapeutic Guidelines: Secondary and tertiary hyperparathyroidism. West Melbourne, Victoria: Therapeutic Guidelines Ltd, 2019 (accessed 17 January 2020).
- Pharmacor Pty Limited. Cinacalcet (Pharmacor Cinacalcet) product information. Chatswood, NSW: Pharmacor Pty Ltd, 2018 (accessed 10 January 2020).
- Australian Medicines Handbook. Cinacalcet. Adelaide: AMH Pty Ltd, 2020 (accessed 10 January 2020).
- Pharmacor Pty Limited. Cinacalcet (Pharmacor Cinacalcet) consumer medicine information. Chatswood, NSW: Pharmacor Pty Ltd, 2018 (accessed 17 January 2020).