Wainua.ca | Coverage

Information about provincial coverage for WAINUA in Alberta

WAINUA (eplontersen injection) is indicated for the treatment of polyneuropathy associated with stage 1 or stage 2 hereditary transthyretin-mediated amyloidosis (hATTR) in adults.⁸

Provincial coverage for WAINUA in Alberta is available for the treatment of polyneuropathy in adult patients with a confirmed genetic diagnosis of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in patients who meet the following criteria:¹

Patients are symptomatic with early-stage neuropathy, defined as polyneuropathy disability (PND) stage I to ≤IIIB or familial amyloidotic polyneuropathy (FAP) stage I or II, and
Do not exhibit severe heart failure symptoms (defined as New York Heart Association [NYHA] class III or IV), and
Have not previously undergone a liver transplant.

Note:¹

For coverage, this drug must be prescribed by a specialist with experience in the diagnosis and management of hATTR.
Initial coverage may be approved for 45 mg administered subcutaneously once a month for a period of nine months.
Patients will be limited to receiving one dose of eplontersen per prescription at their pharmacy.
For renewal of coverage, patients must show continued benefit from treatment with eplontersen and must NOT be:
- Permanently bedridden and dependent on assistance for basic activities of daily living, nor
- Receiving end-of-life care.
Continued coverage may be approved for 45 mg once a month for a period of six months.
Coverage cannot be provided for use in combination with other interfering ribonucleic acid drugs or transthyretin stabilizers used to treat hATTR.

Please refer to the listing for complete details.

Information about provincial coverage for WAINUA in British Columbia (BC)

BC PharmaCare has added WAINUA to its list of Expensive Drugs for Rare Diseases (EDRDs), making it eligible for exceptional funding.²

Please refer to the listing for complete details.

Information about provincial coverage for WAINUA in Nova Scotia

WAINUA (eplontersen injection) is indicated for the treatment of polyneuropathy associated with stage 1 or stage 2 hereditary transthyretin-mediated amyloidosis (hATTR) in adults.⁸

Patients in Nova Scotia have access to provincial coverage for WAINUA based on the following initiation criteria:³

For the treatment of polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR) who meet all of the following criteria:
- Confirmed genetic diagnosis of hATTR.
- Symptomatic with early-stage neuropathy, defined as polyneuropathy disability stage I to IIIB or familial polyneuropathy stage I or II.
- Does not have New York Heart Association class III or IV heart failure.
- Has not previously undergone a liver transplant.

Discontinuation criteria:³

The patient is permanently bedridden and dependent on assistance for basic activities of daily living.
OR
The patient is receiving end-of-life care.

Claim notes:³

The patient must be under the care of a physician with experience in the diagnosis and management of hATTR.
Combination therapy with other interfering ribonucleic acid drugs or transthyretin stabilizers used to treat hATTR will not be reimbursed.
Initial Approval: 9 months.
Renewal Approval: 12 months. Confirmation of continued response is required.

Please refer to the listing for complete details.

Information about provincial coverage for WAINUA in Ontario

Coverage for WAINUA is available in Ontario through request to the Exceptional Access Program (EAP).⁴

Please refer to the listing for complete details.

Information about provincial coverage for WAINUA in Quebec

WAINUA (eplontersen injection) is indicated for the treatment of polyneuropathy associated with stage 1 or stage 2 hereditary transthyretin-mediated amyloidosis (hATTR) in adults.⁸

WAINUA is covered on the RAMQ* based on the following initiation criteria:⁵

The person:

must have received genetic confirmation of hATTR; and
must have a Neuropathy Impairment Score (NIS) of 5 to 130 points; and
must have an ambulatory condition corresponding to stage 1 or 2 on the Functional Ambulation Performance (FAP) scale or a stage 1, 2, 3a or 3b on the polyneuropathy disability (PND) scale; and
must not have cardiomyopathy that corresponds to class III or IV of the New York Heart Association (NYHA) Functional Classification.

Authorizations are given for a maximum dose of 45 mg of eplontersen once a month.

The maximum duration of each authorization is six months.

When requesting continuation of treatment, the prescriber must confirm that the patient has not reached stage 3 on the FAP scale or stage 4 on the PND scale. Renewal will not be authorized in presence of a stage 3 FAP or stage 4 PND disease.

It must be noted that eplontersen is not authorized in combination with another disease modifying drug used in the treatment of transthyretin amyloidosis.

*Official Mark of the Régie de l’assurance maladie du Québec.

Please refer to the listing for complete details.

Information about provincial coverage for WAINUA in Saskatchewan

WAINUA (eplontersen injection) is indicated for the treatment of polyneuropathy associated with stage 1 or stage 2 hereditary transthyretin-mediated amyloidosis (hATTR) in adults.⁸

WAINUA is covered under the Saskatchewan formulary (Exception Drug Status) based on the following initiation criteria:⁶

For the treatment of adult patients with a confirmed genetic diagnosis of hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN), where patients are symptomatic with early-stage neuropathy as defined by ONE of the following:
- Polyneuropathy disability [PND]* stage I to ≤IIIB, or
- Familial amyloidotic polyneuropathy [FAP]^† stage I or II.
Patients must be under the care of a specialist with experience in the diagnosis and management of hATTR-PN.

Exclusion criteria (at therapy initiation):⁶

Patients exhibiting severe heart failure symptoms (defined as NYHA class III or IV); or
Patients who have previously undergone a liver transplant; or
Patients receiving other interfering ribonucleic acid drugs (such as patisiran or vutrisiran) or transthyretin stabilizers (such as tafamidis); or
Patients who are permanently bedridden and dependent on assistance for basic activities of daily living, or who require end-of-life care.^‡

Initial approval duration: Nine (9) months.⁶

Discontinuation criteria:⁶

Treatment with eplontersen should be reviewed 9 months after the initial approval, and then at least every 6 months thereafter, to determine the continued clinical benefit for the patient. Coverage will be discontinued if the patient is:
- Permanently bedridden and dependent on assistance for basic activities of daily living, or
- Receiving end-of-life care.^‡
After the initial 9-month approval, renewal requests not meeting the discontinuation criteria will be considered for a 6-month approval duration.

NYHA: New York Heart Association.

* PND stage I to ≤IIIB defined as: sensory disturbances but preserved walking capability (I); impaired walking capacity but ability to walk without a stick or crutches (II); walking with the help of one stick or crutch (IIIA); walking with the help of two sticks or crutches (IIIB).⁶

† FAP stage I or II defined as: unimpaired ambulation and mostly mild sensor, motor, and autonomic neuropathy in the lower limbs (I); assistance with ambulation required, mostly moderate impairment progression to the lower limbs, upper limbs, and trunk (II).⁶

‡ End-of-life care defined as: care in the late stages of a terminal illness, where life expectancy is measured in months, and treatment aimed at cure or prolongation of life is no longer deemed appropriate, but care is aimed at improving or maintaining the quality of remaining life (e.g., management of symptoms such as pain, nausea and stress).⁶

Please refer to the listing for complete details.

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Coverage for WAINUA is available in multiple provinces across Canada (with conditions)^1-6

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WAINUA®

Coverage

Coverage for WAINUA is available in multiple provinces across Canada (with conditions)1-6

Get more information about provincial coverage for WAINUA in:

Alberta

British Columbia

Nova Scotia

Ontario

Quebec

Saskatchewan

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WAINUA^® Important Safety Information

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Coverage for WAINUA is available in multiple provinces across Canada (with conditions)^1-6