Canadian Journal of Health Technologies

Olaparib (Lynparza)

CADTH — Thu, 25 Apr 2024 00:00:00 -0700

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.
The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses olaparib (Lynparza), 100 mg and 150 mg tablet, administered orally.
Indication: Olaparib is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA mutated metastatic castration resistant prostate cancer in whom chemotherapy is not clinically indicated. BRCA mutation must be confirmed before olaparib treatment is initiated.

Sacituzumab Govitecan (Trodelvy)

CADTH — Wed, 24 Apr 2024 00:00:00 -0700

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.
The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses sacituzumab govitecan (Trodelvy), 180 mg lyophilized powder for solution for injection, for IV use.
Indication: For the treatment of adult patients with unresectable, locally advanced or metastatic, HR-positive, human epidermal growth factor receptor 2-negative (immunohistochemistry [IHC] 0, IHC 1+ or IHC 2+/in situ hybridization-negative) breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.

Glofitamab (Columvi)

CADTH — Tue, 23 Apr 2024 00:00:00 -0700

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.
The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses glofitamab (Columvi), concentrate for solution for infusion, 2.5 mg/2.5 mL vial and 10 mg/10 mL vial, IV infusion.
Indication: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy.

Evinacumab (Evkeeza)

CADTH — Wed, 17 Apr 2024 00:00:00 -0700

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.
The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses evinacumab (Evkeeza), 150 mg/mL (345 mg/2.3 mL and 1,200 mg/8 mL) solution in single-dose vials for IV infusion.
Indication: As an adjunct to diet and other low-density lipoprotein cholesterol–lowering therapies for the treatment of adult and pediatric patients aged 5 years and older with homozygous familial hypercholesterolemia.

Efgartigimod Alfa (Vyvgart)

CADTH — Thu, 04 Apr 2024 00:00:00 -0700

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.
The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses efgartigimod alfa (Vyvgart), 20 mg/mL solution, 10 mg/kg administered as an IV infusion over 1 hour once weekly for 4 doses (i.e., weeks 0 to 3). For patients weighing 120 kg or more, the recommended dose of efgartigimod alfa is 1,200 mg (3 vials) per infusion.
Indication: For the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

Ibrutinib (Imbruvica)

CADTH — Tue, 02 Apr 2024 00:00:00 -0700

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.
The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses ibrutinib (Imbruvica), 140 mg capsule, oral.
Indication: For the treatment of adult patients with:
- Waldenström macroglobulinemia (WM) as a monotherapy or in combination with rituximab
- Previously untreated active chronic lymphocytic leukemia (CLL), including patients with 17p deletion
- CLL who received at least one prior therapy, in combination with bendamustine and rituximab
- Relapsed or refractory mantle cell lymphoma (MCL)
- marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy
- Steroid-dependent or refractory chronic graft vs. host disease (cGVHD)

Calaspargase Pegol (Asparlas)

CADTH — Tue, 02 Apr 2024 00:00:00 -0700

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class.
The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec.
This review assesses calaspargase pegol (Asparlas), 3,750 units/5 mL (750 units/mL), concentrate for solution for IV infusion
Indication : As a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 year to 21 years

Teclistamab (Tecvayli)

CADTH — Wed, 24 Apr 2024 00:00:00 -0700

CADTH recommends that Tecvayli (teclistamab) be reimbursed by public drug plans for the treatment of adults with relapsed or refractory (r/r) multiple myeloma (MM) who have received at least 3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (mAb), and who have demonstrated disease progression on the last therapy if certain conditions are met.
Tecvayli should only be covered to treat adults with MM who have received at least 3 prior treatments, have disease that has not responded to their last treatment, and are in relatively good health. Tecvayli should not be reimbursed to treat those whose MM is affecting their brain or spinal cord or those showing signs that the tissue layers protecting the brain and spinal cord are affected by MM. It also should not be reimbursed in those with amyloidosis (a buildup of a protein, amyloid, in organs) that is not secondary to MM, and those with plasma cell leukemia.
Tecvayli should only be reimbursed if it is prescribed and administered by health professionals at treatment centres with adequate medical resources and personnel.

Drospirenone (Slynd)

CADTH — Thu, 04 Apr 2024 00:00:00 -0700

CADTH recommends that Slynd should be reimbursed by public drug plans for conception control in adolescent and adult women if certain conditions are met.
Slynd should be covered for conception control in adolescent and adult women provided that Slynd is listed in a similar way to other oral contraceptive pills currently reimbursed by public drug plans for the prevention of pregnancy.
Slynd should only be reimbursed if the cost does not exceed that of other progestin-only pills (POPs) for contraception.

Inebilizumab (Uplizna)

CADTH — Tue, 02 Apr 2024 00:00:00 -0700

CADTH recommends that Uplizna be reimbursed by public drug plans for the treatment of neuromyelitis optica spectrum disorder (NMOSD), if certain conditions are met.
Uplizna should only be covered to treat adult patients who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive and who have had at least 1 NMOSD relapse episode (also known as an “attack”) in the 1 year before initiation, or 2 NMOSD relapse episodes in the 2 years before initiation. Patients must have an Expanded Disability Status Scale (EDSS) score of 8 points or less.
Uplizna should only be reimbursed if it is prescribed by neurologists with expertise in treating NMOSD and the cost of Uplizna is reduced to be no greater than the least costly comparator currently reimbursed for the treatment of NMOSD. Uplizna should not be initiated during a NMOSD relapse episode or when used in combination with rituximab, satralizumab, eculizumab, or ravulizumab.

Ravulizumab (Ultomiris)

CADTH — Tue, 02 Apr 2024 00:00:00 -0700

CADTH recommends that Ultomiris be reimbursed by public drug plans for the treatment of neuromyelitis optica spectrum disorder (NMOSD) if certain conditions are met.
Ultomiris should only be covered to treat adult patients with anti–aquaporin 4 (AQP4) antibody–positive NMOSD. Patients must have had at least 1 relapse (also known as an “attack”) of NMOSD in the 12 months before initiation. Patients must have an Expanded Disability Status Scale score of 7 points or less.
Ultomiris should only be reimbursed if prescribed by a neurologist with expertise in treating NMOSD and if the price is reduced by at least 73%. Ultomiris should not be initiated during an NMOSD relapse episode or when used in combination with rituximab, satralizumab, eculizumab, or inebilizumab.

Renal Denervation for Uncontrolled Hypertension

CADTH — Mon, 08 Apr 2024 00:00:00 -0700

What Is the Issue?

It is estimated that 23% of adults in Canada have hypertension. About 1/3 of this population have uncontrolled hypertension, a condition in which (BP) blood pressure levels continue to remain high despite treatment. People with high BP despite being prescribed 3 or more blood pressure-lowering (antihypertensive) medicines are considered to have uncontrolled resistant hypertension.
Renal denervation is a therapy that involves disrupting activity in the sympathetic nerves in the renal artery using a minimally invasive catheter-based procedure to treat high BP.
We wanted to know if renal denervation would effectively and safely reduce BP in people with uncontrolled hypertension.

What Did We Do?

We identified and summarized the literature comparing the clinical effectiveness and safety of renal denervation in individuals with uncontrolled hypertension to help guide decisions on the use of this intervention.
An information specialist searched for peer-reviewed and grey literature sources published between January 1, 2019, and February 5, 2024. The search was limited to English-language documents. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings.

What Did We Find?

The evidence for this report was based on 2 systematic reviews and 3 randomized controlled trials (RCTs).
Renal denervation could lead to a reduction in BP compared to sham in adults with uncontrolled nonresistant hypertension.
It is uncertain if renal denervation is an effective treatment for resistant hypertension and suspected hypertensive heart disease due to the methodological limitations of the included studies.
Serious side effects of renal denervation were rare.

What Does This Mean?

Our findings agree with evidence-based guidelines and real-world evidence that suggest renal denervation can be considered a treatment option for patients with uncontrolled nonresistant hypertension. Other factors, including costs and resources, equity, acceptability, and patient selection, should be considered when implementing renal denervation in Canada, where it remains an emerging medical technology.
Future research should assess important patient outcomes, such as quality of life.

Viewpoint: Model Validation Tool

Karen M. Lee — Tue, 16 Apr 2024 00:00:00 -0700

Validating economic models is important to ensure that the modelling results address decision-making needs, measure intended outcomes, and are accurate.
Through a targeted literature search, and in consultation with other health economists, CADTH developed a tool that will assist researchers and decision-makers to ensure economic models are fit for purpose and function properly.
The tool is not intended to address concerns related to the quality of model inputs, but rather to ensure that the process of model validation is consistent and reproducible.