SASKATCHEWAN
TAKHZYRO is covered by the Saskatchewan Drug Formulary (Exception Drug Status Program)
Eligibility
For TAKHZYRO to be eligible for coverage by the Saskatchewan Drug Formulary, prescribers must submit a request 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 Saskatchewan for your hereditary angioedema (HAE) patients who meet the following criteria:
For the routine prevention of attacks of HAE in patients 12 years of age or older with HAE Type I or II diagnosed by a specialist physician experienced in the diagnosis and management of HAE, who:
- Have experienced at least three HAE attacks within any four-week period before initiating lanadelumab therapy that required the use of an acute injectable treatment.
- Applications must include the baseline number of attacks requiring acute injectable treatment in the three months prior to initiation of lanadelumab.
- Will not be using lanadelumab in combination with other medications used for long-term prophylactic (LTP) treatment of angioedema (e.g., C1 esterase inhibitor); and
- Will not use a dose of lanadelumab that is more than 300 mg every two weeks.
Initial approval duration: 3 months.
Renewal criteria – approval duration 6 months
Renewal requests may be considered:
- After treatment with lanadelumab for three months if there has been a 50% or more reduction in the number of HAE attacks where acute injectable treatment was received in the first three months of treatment with lanadelumab compared to the rate of attacks observed before starting lanadelumab.
OR - For patients with continued response defined as maintenance of 50% or more reduction from baseline with no increase in the number of HAE attacks for which acute injectable treatment was received compared with the number of attacks observed prior to starting treatment with lanadelumab.
AND - Patients must continue to:
- Be under the care of a specialist experienced in the diagnosis and management of angioedema, and
- Not use lanadelumab in combination with other LTP angioedema treatments (e.g., C1 esterase inhibitor), and
- Not use a dose larger than 300 mg every two weeks even in cases of inadequate response or loss of response.
Notes
- A definitive diagnosis of HAE Type I and II requires testing C1 esterase level and activity, as well as C1q levels (to rule out acquired angioedema for which lanadelumab is not indicated).
- To determine which patients would be eligible for reimbursement of lanadelumab, the current attack rate may be used for patients who are not receiving LTP treatment and a historical attack rate may be used for those who are already receiving LTP treatment and intend to transition to lanadelumab.
- Patients on LTP treatment will continue to require access to on-demand treatments that are used in the management of acute attacks.
- Coverage will be discontinued for patients who no longer meet the renewal criteria.
