428
To increase bone mass in postmenopausal females with osteoporosis who meet the following criteria:
High risk* for fracture; and
Failed other available osteoporosis therapy (i.e. fragility fracture OR evidence of a decline in bone mineral density below pre-treatment baseline levels) despite adherence for one year.
429
To increase bone mass in postmenopausal females with osteoporosis who meet the following criteria:
High risk* for fracture; and
For whom oral bisphosphonates are contraindicated due to hypersensitivity OR abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes.
515
To increase bone mass in males with osteoporosis who meet the following criteria:
High risk* for fracture; and
Failed other available osteoporosis therapy (i.e. fragility fracture OR evidence of a decline in bone mineral density below pre-treatment baseline levels) despite adherence for one year.
516
To increase bone mass in males with osteoporosis who meet the following criteria:
High risk* for fracture; and
For whom oral bisphosphonates are contraindicated due to hypersensitivity OR abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes.
687
To increase the bone mass in postmenopausal females with osteoporosis who are at high risk* for fracture who have failed, had intolerance to, or are unable to take a bisphosphonate therapy.
688
To increase the bone mass in males with osteoporosis who are at high risk* of fractures who have failed, had intolerance to, or are unable to take a bisphosphonate therapy.
*High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool.
319
For the treatment of Paget's disease.
436
For the treatment of osteoporosis in postmenopausal females who meet the following criteria:
High risk* for fracture; and
For whom oral bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes.
523
For the treatment of osteoporosis in males who meet the following criteria:
High risk* for fracture; and
For whom oral bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes.
*High fracture risk is defined as either:
a prior fragility fracture AND a moderate 10-year fracture risk (10% to 20%) based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool; OR
a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR
where a patient's 10-year fracture risk based on the CAROC or FRAX tool is less than the thresholds defined above, a high fracture risk based on evaluation of clinical risk factors for fracture
Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors.
676 (Forteo / Teva-teriparatide)
For the treatment of osteoporosis in patients at a high risk of fragility fractures who meet ALL the following criteria:
65 years of age or older; AND
Has a documented bone mineral density [BMD] T-score of less than or equal to 3; AND
Has a history of prior fragility fracture(s); AND
Has used an anti-resorptive agent for osteoporosis which resulted in osteonecrosis of the jaw and/or an atypical femur fracture.
Note: The maximum lifetime exposure to teriparatide for an individual patient is 24 months
635 (Osnuvo)
For the treatment of osteoporosis in patients at a high risk of fragility fractures who meet ALL the following criteria:
65 years of age or older; AND
Has a documented bone mineral density [BMD] T-score of less than or equal to 3; AND
Has a history of prior fragility fracture(s); AND
Has used an anti-resorptive agent for osteoporosis which resulted in osteonecrosis of the jaw and/or an atypical femur fracture.
For the treatment of osteoporosis in postmenopausal women meeting ALL the following criteria:
History of osteoporotic fracture; AND
Is at a high risk for future fracture, defined as a 10-year fracture risk greater than or equal to 20% as defined by the Fracture Risk Assessment (FRAX) Tool; AND
Treatment naive to osteoporosis medications, except for calcium and/or vitamin D.
Exclusion criteria: Romosozumab will not be funded as combination therapy with other osteoporosis medications, except for calcium and/or vitamin D.
Recommended dose: 210 mg subcutaneously once every month for 12 doses
Approval duration: 12 months (A maximum of 12 monthly doses will be reimbursed.)
Renewals will not be considered.
Note: Requesting prescriber must include a copy of the FRAX assessment.
Initiation Criteria:
For the treatment of perinatal/infantile, childhood, or juvenile-onset hypophosphatasia (HPP) in patients who meet the following criteria:
Diagnosis is confirmed by genetic testing (i.e. documented tissue-nonspecific alkaline phosphatase gene mutations); AND
Serum alkaline phosphatase (ALP) level is below the age-adjusted normal range(1) using age and gender adjusted norms; AND
Plasma pyridoxal-5-phosphate (PLP) above the upper limit of normal; AND
Radiologically confirmed HPP-related skeletal abnormalities; AND
Diagnosis occurred before the patient’s 12th birthday with documented onset of signs/symptoms(2) of HPP prior to their 12th birthday; AND
Patient is younger than 18 years of age at the time the treatment is initiated; AND
Patient does not have odonto- or pseudo- HPP (i.e. craniosynostosis alone, premature loss of deciduous teeth alone and vitamin D deficiency to be ruled out); AND
The patient’s treatment plan and goals of therapy is provided prior to the initiation of therapy; AND
Patient is under the care of a metabolic specialist with expertise in the diagnosis and management of HPP.
Approval duration for initial requests: 6 months
Renewal Criteria:
Renewals of reimbursement will be considered in patients meeting the following criteria:
Patient continues to be under the care of a metabolic specialist; AND
Patient has demonstrated compliance to the treatment and monitoring schedule: AND
Pre-specified goals(3) based on the patient’s clinical status at initiation of treatment are met and the patient is deemed to continue to benefit from treatment. (Note: The request must include information about the treatment responses and milestones)
First renewal: 6 months
Subsequent renewals: 1 year
Stopping Criteria:
• Discontinuation to be considered after growth is completed based on objective measure of height, weight and closure of bone growth plates as confirmed radiologically.
• Babies with perinatal/infantile HPP who fail treatment trials of 6 months
• If pre-specified goals are not met at reassessment, the treatment should not be continued.
Notes:
(1) Normal range as informed by the Canadian Laboratory Initiative on Paediatric Reference Intervals (CALIPER) can be used as a reference for this information. Below upper limit of normal refers to 2 or lower standard deviations above the mean.
(2) Incoming Requests should address the following;
baseline skeletal symptoms including age and dates of for those assessments • abnormalities of skeletal mineralization
fracture history
growth plate irregularities and bone and skeletal growth
description of growth and developmental milestones
Signs, symptoms, and history of seizures
respiratory function including need for ventilator support
Activity and mobility
Laboratory markers that include vitamin D levels, calcium levels
Assessments such as the Radiographic Global Impressive of Change (RGIC) score and/or the Thacher score for evaluating rickets may be provided at baseline and at the time of renewal of coverage (as applicable) as a measure of response and benefit from therapy.
(3) Specific patient treatment goals should be developed on a case-by-case basis and may include some of the following; Healing of rickets, improved bone mineralization, fewer fractures, reduced pain, improved growth, mobility, improvement in respiratory status, attainment of age-appropriate growth milestones, improvement in gait or deformities, improved quality of life measures.
Documentation of improvement from baseline is to be provided at the time of renewal.