ONTARIO

TAKHZYRO is available in Ontario with restrictions through the Exceptional Access Program (EAP)

Eligibility

For TAKHZYRO to be eligible for coverage by the Ontario EAP, prescribers must submit a request for special authorization and approval must be granted before the patient fills the prescription. Deductibles may apply. For more information concerning the reimbursement process, contact OnePath^®.

Reimbursement Criteria

We are pleased to inform you that TAKHZYRO (lanadelumab injection) is reimbursed in Ontario for your hereditary angioedema (HAE) patients who meet the following criteria:

For the routine prevention of attacks of HAE in patients meeting ALL the following criteria:

Is at least 12 years of age; AND
Has HAE Type I or II; AND
Has experienced at least three HAE attacks within any four-week period requiring treatment with an acute injectable therapy (e.g., icatibant, C1 esterase inhibitor); AND
Must be prescribed by physicians (e.g., immunologists, allergists or hematologists) with experience in the diagnosis and management of HAE.

NOTE:

For patients who are already on long-term prophylactic treatment of angioedema (e.g., C1 esterase inhibitor) and intend to transition to lanadelumab, please provide historical HAE attack rates and treatment details.

Discontinuation criteria

Reimbursement will be discontinued in patients who either respond inadequately or exhibit loss of response, defined as follows:

Inadequate response: No reduction in the number of HAE attacks that require treatment with an acute injectable therapy during the first three months of treatment with TAKHZYRO.
Loss of response: An increase in the observed number of HAE attacks requiring acute injectable treatment compared to the number before initiating treatment with lanadelumab.

Exclusion criteria

Patient is using lanadelumab with other medications used for the long-term prophylactic treatment of angioedema (e.g., C1 esterase inhibitor).

Renewal criteria

Renewals will be considered in patients who do not meet the discontinuation criteria.

NOTES:

An assessment of a response to treatment should be conducted three months after initiating treatment with lanadelumab.
Following the initial three-month assessment, patients should be assessed for continued response to lanadelumab every six months.

Recommended dose

300 mg administered subcutaneously (SC) every two weeks. The dose should not be escalated to more than 300 mg every two weeks in cases of inadequate response or loss of response. Dosing interval of 300 mg SC every four weeks may be considered if the patient is well-controlled (e.g., attack free) for more than six months.

Approval duration of initials and renewals

4 months initial, 6 months first renewal, 12 months subsequent renewals.

Case-by-case consideration

For patients not meeting the requirement of three HAE attacks in the initiation criteria but with HAE attacks associated with significant functional impairment and risk of mortality (e.g., laryngeal attacks).