Coverage rules for the drug Omalizumab (Xolair) in Canada

Dernière mise à jour : 12 juil.


Sélectionnez votre province parmi celles soulignées:

NOC | BC | AB | SKMBONQCNBNFPEIYK | NIHB

 

Alberta:

Exception Drug Status - effective April 1, 2018

"For the treatment of adults and adolescents (12 years of age and above) with moderate to severe chronic idiopathic urticaria(CIU), defined as having a baseline Urticaria Activity Score over 7 days (UAS7) of greater than or equal to 16, who remain symptomatic (presence of hives and/or associated itching) despite optimum management with available oral therapies. Oral therapies should include a therapeutic trial with H1 antihistamines, unless contraindicated or not tolerated.

For coverage, the drug must be initiated and monitored by a Specialist in Dermatology, Clinical Immunology or Allergy.

Coverage may be approved for a period of 24 weeks at a maximum dose of 300 mg every 4 weeks.

Patients will be limited to receiving a one-month supply of omalizumab per prescription at their pharmacy.

Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

Continued coverage of a further 24-week treatment period may be considered if the patient has experienced:

  • complete symptom control (i.e., UAS7 of 0) for less than 12 consecutive weeks; OR

  • partial symptom control, with a reduction in baseline UAS7 of greater than or equal to 9.5 points.

Treatment cessation should be considered for patients who experience complete symptom control for at least 12 consecutive weeks at the end of a 24-week treatment period.

In patients where treatment is discontinued due to temporary symptom control, treatment re-initiation should be considered should CIU symptoms reappear."

All requests (including renewal requests) for omalizumab for Chronic Idiopathic Urticaria must be completed using the Omalizumab for Chronic Idiopathic Urticaria Special Authorization Request Form (ABC 60056).


Saskatchewan:

Exception Drug Status - effective Jan 1, 2017

Criteria:

For the treatment of adults and adolescents (12 years of age or older) with moderate to severe chronic idiopathic urticaria (CIU) who remain symptomatic (presence of hives and/or associated itching) despite optimal management with H1 antihistamines.

Notes:

  • Document the baseline urticaria activity score over seven days (UAS7) on the initial request.

  • Prescribed by a specialist (allergist, immunologist, dermatologist, etc.) or other authorized prescriber with knowledge of CIU treatment.

  • Initial approval will be granted for a period of 24 weeks at a maximum dose of 300mg every 4 weeks.

  • Treatment cessation could be considered for patients who experience complete symptom control for at least 12 consecutive weeks at the end of a 24 week treatment period.

  • Extension requests:

Continued coverage may be authorized if the patient has achieved:

  • complete symptom control for less than 12 consecutive weeks; or

  • partial response to treatment, defined as at least a ≥ 9.5 point reduction in baseline urticaria activity score over 7 days (UAS7)

Re-initiation requests:

  • In patients where treatment is discontinued due to temporary symptom control, treatment re-initiation may be considered should CIU symptoms reappear.

Manitoba:

Exception Drug Status (EDS) - effective April 20, 2017

Criteria:

For the treatment of adults and adolescents (12 years of age or older) with moderate to severe chronic idiopathic urticaria(CIU) who remain symptomatic (presence of hives and/or associated itching) despite optimum management with available oral therapies.

Criteria Notes:

Initial approval period of 24 weeks at a maximum dose of 300mg every 4 weeks

Continued coverage will be authorized if the patient has achieved:

o complete symptom control for less than 12 consecutive weeks; or

o partial response to treatment, defined as at least a > 9.5 point reduction in baseline urticariaactivity score over 7 days (UAS7)

Request for coverage must be made by a specialist in allergy, immunology or dermatology with knowledge of CIU treatment.

Treatment cessation could be considered for patients who experience complete symptom control for at least 12 consecutive weeks at the end of a 24 week treatment period.

In patients where treatment is discontinued due to temporary symptom control, treatment re-initiation could be considered should CIU symptoms reappear.”

Ontario:

Exceptional Access Program - effective April 27, 2017

For the treatment of moderate to severe chronic idiopathic urticaria (CIU) when prescribed by a specialist (i.e. an allergist, an immunologist, a dermatologist) in patients who meet ALL the following criteria;

(i) Patient must be 12 years of age or older; AND

(ii) Patient must remain symptomatic despite optimum management with available oral therapies.

Approved regimen: Up to 300 mg every 4 weeks

Duration of Approval: 24 weeks

Renewals will be considered for patients who demonstrate one of the following responses to treatment;

i) Patient has had a trial of stopping omalizumab treatment after having achieved symptom control for at least 12 weeks while on therapy but who experience symptom relapse during the stoppage period; OR

ii) Patient has demonstrated improvement but has not been able to achieve complete symptom control for more than 12 consecutive weeks; OR

iii) Patient has demonstrated a partial response to treatment defined as at least a greater than or equal to 9.5 point reduction in the baseline urticaria activity score over 7 days (UAS7).

Approved regimen: Up to 300 mg every 4 weeks

Prince Edward Island:

High Cost Drug Program - effective June 2022

For the treatment of patients 12 years of age and older with moderate to severe chronic idiopathic urticaria (CIU) who remain symptomatic (presence of hives and / or associated itching) despite optimal management with H1 antihistamines.

Initiation Criteria:

- Documentation of the most recent Urticaria Activity Score over 7 days (UAS7) to be provided on the submitted request.

- Approvals will be for a maximum dose of 300mg every four weeks.

- Initial approval period : 24 weeks.

Renewal Criteria:

- Requests for renewal will be considered if the patient has achieved:

- Complete symptom control for less than 12 weeks; or

- Partial response to treatment, defined as at least 9.5 point reduction in baseline UAS7

Clinical notes:

  1. Moderate to severe CIU is defined as UAS7 greater or equal to16

  2. Treatment cessation could be considered for patients who experience complete symptom control for at least 12 consecutive weeks at the end of a 24 weeks treatment period,

  3. In patients who discontinue treatment due to temporary symptom control, re-initiation can be considered if CIU symptoms reappear.

  4. Optimal management is defined as H1 antihistamines at 4 times the standard daily dose.


Québec:

Medicament d'exception - effective May 26th, 2022

Pour le traitement des personnes souffrant d’urticaire chronique idiopathique modérée à grave, dont le score

selon l’échelle Urticaria Activity Score 7 (UAS7) est égal ou supérieur à 16 malgré l’utilisation d’antihistaminiques à doses optimisées

Lors de la demande pour la poursuite du traitement, le médecin doit fournir la preuve d’une réponse complète d'une durée inférieure à 12 semaines ou d’une réponse partielle. On entend par réponse complète, l’atteinte d’un score UAS7 inférieur ou égal à 6, alors qu’une réponse partielle correspond à une réduction d'au moins 9,5 points du score UAS7 par rapport à celui de départ sans atteindre une valeur inférieure ou égale à 6.

Lorsque le patient présente une réponse complète depuis 12 semaines ou plus, le traitement doit être arrêté. Lors d’une demande subséquente, le médecin doit fournir les données démontrant une rechute. Cette dernière est définie par l’atteinte d’un score UAS7 qui est égal ou supérieur à 16 à la suite d’une réponse complète.

Les autorisations sont accordées pour une durée maximale de 24 semaines à raison d’une dose maximale de 300 mg toutes les 4 semaines

Nouveau-Brunswick :

Exceptional Access Program - effective June 28, 2017

Criteria:

For the treatment of patients at least 12 years of age with moderate to severe chronic idiopathic urticaria (CIU) who remain symptomatic (presence of hives and/or associated itching) despite optimum management with H1/ antihistamines.

1- Initial Request : Documentation of the most recent urticaria activity score over 7 days (UAS7)must be provided on the submitted request.

2- Renewal request will be considered if the patient has achieved:

- complete symptom control for less than 12 consecutive weeks;

- or partial response to treatment, defined as at least a 9.5 point reduction in baseline urticaria activity score over 7 days (UAS7)

Clinical Notes:

1. Moderate to severe CIU is defined as a UAS7 ≥16.

2. Treatment cessation could be considered for patients who experience complete symptom control for at least 12 consecutive weeks at the end of a 24 week treatment period.

3. In patients who discontinue treatment due to temporary symptom control, re-initiation can be considered if CIU symptoms reappear.

Claim Notes:

• Approvals will be for a maximum dose of 300mg every four weeks.

• Initial approval: 24 weeks

Newfoundland :

For the treatment of patients ≥ 12 years of age with moderate to severe chronic

idiopathic urticaria (CIU) who remain symptomatic (presence of hives and/or associated

itching) despite optimum management with H1 antihistamines.

Requirement for Initial Requests:

• Prescribed by a specialist (allergist, immunologist, dermatologist, etc.) or other

authorized prescriber with knowledge of CIU treatment.

• Documentation of the most recent urticaria activity score over 7 days (UAS7)

must be provided on the submitted request.

Renewal Criteria:

• Requests for renewal will be considered if the patient has achieved:

- complete symptom control for less than 12 consecutive weeks; or

- partial response to treatment, defined as at least a ≥ 9.5 point reduction in

baseline urticaria activity score over 7 days (UAS7)

Clinical Notes:

1. Treatment cessation could be considered for patients who experience complete

symptom control for at least 12 consecutive weeks at the end of a 24 week treatment period.

2. In patients who discontinue treatment due to temporary symptom control, reinitiation

can be considered if CIU symptoms reappear.

3. Optimum management for H1 antihistamines is defined as at up to 4 times the standard daily dose.

Claim Notes:

• Approvals will be for a maximum dose of 300mg every four weeks.

• Initial approval: 24 weeks

Nova-Scotia :

Exception status - effective Dec 1, 2016

Criteria:

For the treatment of adults and adolescents (12 years of age or older) with moderate to severe chronic idiopathic urticaria (CIU) who remain symptomatic (presence of hives and/or associated itching) despite optimum management with available oral therapies.

Notes:

- Prescribed by a specialist or other authorized prescriber with knowledge of CIU treatment.

- Initial approval period of 24 weeks at a maximum dose of 300 mg every 4 weeks.

- Treatment cessation could be considered for patients who experience compete treatment period.

- Continued coverage will e authorized if the patient has achieved complete symptom control for less than 12 consecutive weeks; or partial response to treatment, defined as at least a 9.5 point reduction in baseline urticaria activity score over 7 days.

Yukon:

Exception status - effective Dec 9, 2016

Criteria:

For patients with moderate to severe chronic idiopathic urticaria(CIU) who remain symptomatic (presence of hives/or associated itching) despite optimum management with available oral therapies defined as

-H1 antihistamines at up to 4 times the standard daily dose

-montelukast

Specialist's consult required

Initial approval period of 24 weeks at a maximum dose of 300mg every 4 weeks.

Continued coverage will be authorized if the patient has achieved;

-complete symptom control for less than 12 consecutive weeks; OR

-partial response to treatment, defined as at least a ≥ 9.5 point reduction in baseline urticaria activity score over 7 days (UAS7)

Treatment cessation should be considered for patients who experience complete symptom control for at least 12 consecutive weeks at the end of a 24 week treatment period.

In patients where treatment is discontinued due to temporary symptom control, treatment re-initiation should be considered should CIU symptoms reappear.

Non-Insured Health Benefits (NIHB) - First Nations and Inuit Health Branch:

Limited Use - effective May 2017

Limited use benefit (prior approval required).

Coverage is provided for an initial period of 24 weeks at a maximum dose of 300 mg every 4 weeks (6 injections over a 24 week period).

1. For the treatment of adults and adolescents (12 years of age or older) with moderate to severe chronic idiopathic

urticaria (CIU) who remain symptomatic (presence of hives and/or associated itching) despite optimum management with

H1 antihistamines; AND

Prescriber is experienced in the treatment of CIU (Allergist, Dermatologist, Immunologist, OR other authorized prescriber

experienced in the treatment of CIU).

Treatment cessation could be considered for patients who experience complete symptom control (UAS-7 = 0) for at least12 consecutive weeks at the end of a 24-week treatment period.

Renewal coverage is provided for 24 weeks at a maximum dose of 300 mg every 4 weeks (6 injections/24 weeks).

2. For the treatment of adults and adolescents (12 years of age or older) with moderate to severe chronic idiopathic

urticaria (CIU);

AND

Patient stopped omalizumab after achieving complete symptom control (UAS-7 = 0) for at least 12 weeks while on treatment, but has experienced symptom relapse; OR

Patient achieved complete symptom control, but for a period of less than 12 consecutive weeks; OR

Patient achieved a partial response to treatment, defined as a ≥ 9.5-point reduction in baseline urticaria activity score over 7days (UAS-7).

In patients where treatment is discontinued due to temporary symptom control, treatment re-initiation may be considered should CIU symptoms reappear.

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