Decision to list icatibant (Firazyr) in the Pharmaceutical Schedule
PHARMAC is pleased to announce the approval of an agreement with Shire Australia Pty Limited to list icatibant in the Pharmaceutical Schedule for funded use in both the community and DHB hospitals.
The decision means that icatibant will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule for the treatment of hereditary angioedema (HAE) as soon as practicable following registration. Prior to listing, clinicians could continue to make NPPA funding applications for icatibant for their patients.
Details of the decision
Following Medsafe approval, icatibant (Firazyr) will be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:
|Chemical||Presentation||Brand||Pack size||Price and subsidy|
|Icatibant||inj 10 mg per ml, 3 ml prefilled syringe||Firazyr||1||$2,668.00|
- Confidential rebates will apply to Firazyr which will reduce the net price of the treatment to the Funder.
- Firazyr will be listed as soon as practicable following Shire’s notification to PHARMAC that Medsafe has granted registration.
- Firazyr will be listed subject to the following Special Authority criteria in the community and restrictions in the Hospital Medicines List.
Initial application from a clinical immunologist or relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:
- Supply for anticipated emergency treatment of laryngeal/oro-pharyngeal or severe abdominal attacks of acute hereditary angioedema (HAE) for patients with confirmed diagnosis of C1-esterase inhibitor deficiency; and
- The patient has undergone product training and has agreed upon an action plan for self-administration.
Renewal from any relevant practitioner. Approvals valid for 12 months where the treatment remains appropriate and the patient is benefiting from treatment.
- Firazyr will have subsidy and delisting protection until 1 July 2018.
- Prior to a listing on the Pharmaceutical Schedule, doctors can apply for funding for icatibant via the Named Patient Pharmaceutical Assessment (NPPA) policy for patients who would meet the icatibant access criteria.
- The net pricing in the agreement will apply to any individual patient funding applications approved via the Named Patient Pharmaceutical Assessment (NPPA) Policy.
We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 4 August 2015 were considered in their entirety in making a decision on the proposed changes. All responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:
|Diagnosis should be confirmed by laboratory testing as there may be overuse of icatibant.||The Special Authority criteria require that patients have confirmed diagnosis of C1-esterase inhibitor deficiency.|
|It would be easier if General Practitioners could apply for renewals.||Any relevant practitioner may apply for a renewal of a Special Authority for icatibant, and this includes General Practitioners.|
|Some emergency department clinicians considered icatibant would be useful for the treatment of ACE-inhibitor induced angioedema in severe cases.||Icatibant is not registered for use in this indication and funding for this purpose would need to be considered separately. An application for funding would be required.|
|Supportive of the proposal. HAE attacks are unpredictable and having access to use icatibant at home would be life changing for patients as it would reduce hospital admissions and allow freedom from the need to be close to a hospital.||Noted|
If you have any questions about this decision, you can email us at email@example.com.