Proposal to list cinacalcet (Sensipar) on the Pharmaceutical Schedule for parathyroid carcinoma and calciphylaxis

Medicines Consultation Closed

Cinacalcet is a treatment used to reduce the production of parathyroid hormone in people with disorders of the parathyroid gland and calcium dysregulation.

PHARMAC is seeking feedback on a proposal to list cinacalcet (Sensipar) on the Pharmaceutical Schedule through a provisional agreement with Amgen Australia Pty Limited from 1 May 2016 for:

  • patients with parathyroid carcinoma with symptomatic hypercalcaemia resistant to bisphosphonates and sodium thiosulfate, subject to Special Authority criteria;
  • patients with symptomatic calciphylaxis after failure of bisphosphonates and sodium thiosulfate, subject to Special Authority criteria.

Please note that there are several other indications for cinacalcet that have been considered for PHARMAC funding, including primary, secondary and tertiary hyperparathyroidism. These are not included in the current proposal for reasons explained in the Background section.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Tuesday 29 March 2016 to:

Geraldine MacGibbon
Senior Therapeutic Group Manager/ Team Leader
PHARMAC
PO Box 10 254
Wellington 6143

Email: geraldine.macgibbon@pharmac.govt.nz
Fax:      04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld.  PHARMAC will give due consideration to any such request. 

Details of the proposal

  • Cinacalcet (Sensipar) 30 mg tablets would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 May 2016 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical

Brand

Presentation

Pack size

Proposed price and subsidy

Cinacalcet

Sensipar

Tab 30 mg

28

$403.70
  • Cinacalcet would be listed in Section B of the Pharmaceutical Schedule subject to the following restrictions:

Initial application only from a nephrologist or endocrinologist. Approvals valid for 6 months for applications meeting the following criteria:

Either:

  1. All of the following:
    1. The patient has been diagnosed with a parathyroid carcinoma (see Note); and
    2. The patient has persistent hypercalcaemia (serum calcium ≥3 mmol/L) despite previous first-line treatments including bisphosphonates and sodium thiosulfate; and
    3. The patient is symptomatic; or
  2. All of the following:
    1. The patient has been diagnosed with calciphylaxis (calcific uraemic arteriolopathy); and
    2. The patient has symptomatic (e.g. painful skin ulcers) hypercalcaemia (serum calcium ≥3 mmol/L); and
    3. The patient’s condition has not responded to previous first-line treatments including bisphosphonates and sodium thiosulfate.

Renewal only from a nephrologist or endocrinologist. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Both:

  1. The patient’s serum calcium level has fallen to < 3mmol/L; and
  2. The patient has experienced clinically significant symptom improvement.

Note: this does not include parathyroid adenomas unless these have become malignant.

  • The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

Background

Cinacalcet belongs to a class of medications called calcimimetics. It works by signaling the body to produce less parathyroid hormone in order to decrease the amount of calcium in the blood.

PHARMAC has received a significant number of Named Patient Pharmaceutical Assessment (NPPA) funding applications for cinacalcet for individual patients with a range of parathyroid conditions over the past few years and the frequency of these applications is increasing. Principle 3 of the NPPA Policy is that “the NPPA Policy is designed for individual assessment”. Given the number and frequency of NPPA applications, it now appears to PHARMAC that the Pharmaceutical Schedule is a more appropriate pathway to consider the funding of cinacalcet.

Please see PHARMAC’s website for more information on the NPPA Policy.

Accordingly, PHARMAC sought updated advice on the funding of cinacalcet from its clinical advisors. The most recent review was by the Pharmacology and Therapeutics Advisory Committee (PTAC) in November 2015. The November 2015 PTAC minute and the history of PHARMAC’s consideration of a Pharmaceutical Schedule listing for cinacalcet can be found via the Application Tracker on PHARMAC’s website at:

https://connect.pharmac.govt.nz/apptracker/s/global-search/cinacalcet(external link)

In summary, PTAC has made the following recommendations for funding:

Indication/patient group

PTAC recommendation

Non-malignant parathyroid disorders (any cause) without symptomatic hypercalcaemia

decline

Primary hyperparathyroidism with hypercalcaemia but not contraindicated for surgery

decline

Non-malignant secondary hyperparathyroidism with or without hypercalcaemia

decline

Tertiary hyperparathyroidism with hypercalcaemia

decline

Parathyroid carcinoma with symptomatic hypercalcaemia resistant to bisphosphonates and sodium thiosulfate

fund with medium priority

Symptomatic calciphylaxis after failure of bisphosphonates and sodium thiosulfate

fund with medium priority

This proposal to list cinacalcet on the Pharmaceutical Schedule for the indications of parathyroid carcinoma and calciphylaxis is in line with the recommendations from PTAC.

Please note that PHARMAC has recently received two funding submissions relating to the use of cinacalcet in patients with secondary hyperparathyroidism, which will be reviewed by PTAC at its next meeting in May 2016. Further advice will also be sought from PTAC at that meeting regarding the use of cinacalcet in patients with primary hyperparathyroidism contraindicated for surgery.

This proposal would have no impact on the funding of cinacalcet for patients with current NPPA approvals.