Notification of decision to fund cinacalcet (Sensipar) for parathyroid carcinoma and calciphylaxis

Medicines

Decision

PHARMAC is pleased to announce a decision to list cinacalcet (Sensipar) on the Pharmaceutical Schedule through an agreement with Amgen (New Zealand) 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.

This was the subject of a consultation letter dated 11 March 2016 that can be found on PHARMAC’s website.

The proposal was approved as consulted on with no changes except that the wastage rule will be applied to the listing of cinacalcet from 1 May 2016.

Details of the decision

  • Cinacalcet (Sensipar) 30 mg tablets will 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 will 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:

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 will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 29 March 2016 were considered in their entirety in making a decision on the proposed changes. The following issues were raised in relation to specific aspects of the proposal:

Theme Comment
Several responders requested that cinacalcet be funded for other indications, including primary, secondary and tertiary hyperparathyroidism contraindicated to surgery (or where surgery has failed). We will be taking further advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) on these indications in May 2016. The consultation responses from these responders will be provided to the Committee.
One responder requested that the original pack or wastage rule be applied to the listing of cinacalcet, given the high pack price and likely low patient numbers. Cinacalcet will be subject to the wastage rule.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz