Drug pipeline

Executive summary

Well into our second year of the COVID-19 pandemic, most new drug submissions publicly highlighted during this unprecedented time often focused on COVID-19 treatments and vaccines. As these products have been covered by government funding thus far, there has been no impact to Canadian private payers. However, non-COVID drug submissions to Health Canada during this time continue to be made up of drug products that will put cost pressures on private drug plans. This page highlights some of the notable developments within the Canadian drug pipeline to provide plan sponsors with insight into what’s to come for their members and drug plans.

Drug pipeline at a glance

Migraine

Biologic therapies for migraine prevention were introduced in 2018 and have continued to grow since. However, this year, Quilipta, a new oral formulation targeting the same protein known as calcitonin generelated peptide (CGRP) was recently approved by Health Canada. It is set to compete with the existing four injectable migraine prevention biologics which cost from $6,400 to $30,375 annually.

Weight loss and diabetes

The World Health Organization (WHO) has designated obesity as a chronic disease that is a risk factor for other serious, costly chronic conditions. Diabetes is one of these health conditions and was the top condition by spend on Alberta Blue Cross^® private plans in 2021. Drugs coming to the Canadian drug market to treat these two conditions are touted to be more effective than currently available treatments. Wegovy, a once-weekly injection, is set to compete against another medication in the same class, Saxenda. In the diabetic space, a new injectable drug, Mounjaro, is being heavily compared to Ozempic, which has achieved great success amongst diabetic drug therapies.

Cardiovascular

Drug therapies treating cardiovascular conditions have high utilization on any drug plan. A new drug therapy coming to the Canadian drug market treats symptoms of heart failure, aiming to prevent hospital readmission of recently discharged patients. Another notable drug recently approved is the first medication to treat a genetically inherited cardiovascular condition, hypertrophic cardiomyopathy. Existing drug therapies for this condition only treat the symptoms; this is the first to treat the underlying disease.

Plaque psoriasis

Moderate to severe plaque psoriasis can be treated with both biologic therapies and oral therapies. Medications for this health condition continue to expand, seeing an additional biologic as well as an oral medication coming to market to compete with the existing comparator therapies. This space currently has drug therapies with annual costs ranging from $12,250 to $31,300.

Macular degeneration

Coming to the market are treatment options for agerelated macular degeneration (AMD) and diabetic macular edema (DME) that are more convenient in dosing than existing therapies. Current standard of care for AMD and DME are Eylea and Lucentis, both of which are covered by the Government of Alberta if criteria are met.

Rare disease drugs

In the past two decades, research and development for rare disease drugs have grown exponentially. In 2021 alone, there were over 350 rare disease drugs in phase 3 clinical trials; the last phase before submission for drug approval. Historically, once approved, most rare disease drugs proceed to be covered by government funding. However, given the growth in this category and their associated ultra high price tags (some in excess of $1 million annually), government funding may not be reliable or consistent in the future. This will likely result in additional pressure for rare disease drug coverage on private plans.

Generics and biosimilars

While high cost drugs continue to push drug spend up year over year, biosimilar and generic products coming to market help temper this growth in drug spend. Coming to the market soon are biosimilars and generic products for drug molecules that have significant impact on most drug plans. This includes biosimilars and generic products used in treatment of inflammatory conditions, diabetes and attentiondeficit hyperactivity disorder (ADHD).

Notable drugs

Migraine

Qulipta

In 2018, a new class of medication targeting the protein that causes migraines, calcitonin gene-related peptide (CGRP), quickly cemented its position in the management of this prevalent condition. To date, CGRP antagonists are administered by injection and soon, Canadians may be able to take this class of medication orally once Qulipta is available. The recently approved submission is for the prevention of episodic migraines. However, to compete with the injectable drugs of the same therapeutic class (for example, Aimovig, Emgality, Ajovy and Vyepti), the drug manufacturer will need to submit for the prevention of chronic migraine as well.

Canadian pricing of Qulipta has not been determined yet but it will be competing with other injectable migraine prevention medications (Aimovig, Emgality and Ajovy, which can cost from $6,400 to $7,500 annually) and with the newest injectable CGRP antagonist (Vyepti, which depending on dosing can range from $10,125 to $30,375 annually).

Weight loss and diabetes

Wegovy

Obesity is designated as a chronic disease by WHO and is a major risk factor for other serious conditions including type 2 diabetes, cardiovascular disease, hypertension, stroke and certain forms of cancer. Existing approved therapies in Canada cost around $2,000 to $4,100 annually, with glucagon-like peptide 1 (GLP-1) agonists as the most utilized type of therapy. This class of medication has been successful in managing diabetes at lower doses and results in weight loss at higher doses. Liraglutide, a once-daily GLP-1 agonist injection, at a lower dose is marketed as Victoza, for the management of diabetes, and Saxenda, for the management of obesity, at a higher dose. The manufacturer of Ozempic (semaglutide), a drug used for diabetes has used this same marketing approach and rebranded the higher dose semaglutide product as Wegovy to compete in the anti-obesity drug category. Clinical trials so far have shown Wegovy to be superior to other weight loss medications on the market.

Mounjaro

Diabetes is a top treated health condition on any drug plan and is only expected to impact drug plans further with its increasing prevalence. Ozempic, a GLP-1 agonist, experienced tremendous success since its arrival on the Canadian drug market and is now a mainstay in managing type 2 diabetes—propelling it to the top diabetic drug by spend on 2021 Alberta Blue Cross’s^® private drug plans. Mounjaro, a newly approved medication, works as a GLP-1 agonist as well, but is the first diabetic medication to also activate the receptor for another hormone, gastric inhibitory polypeptide (GIP), to further regulate blood sugar levels. In one of its clinical trials, 50 per cent of Mounjaro patients in the early stages of diabetes went into remission. With these promising results, remission of type 2 diabetes is being discussed as the potential new goal of diabetes management, a result that no other diabetes medication has achieved. In addition, clinical trials comparing Mounjaro against Ozempic has shown that Mounjaro is more effective in lowering A1C levels, a marker indicating how well diabetes is managed. In the United States, Mounjaro has the same annual cost, $12,666 USD, at any strength. Its Canadian pricing is not yet available but it would be competing with Ozempic which has a price range of $2,600 to $5,300 annually.

In clinical trials, Mounjaro with its dual GIP/GLP-1 receptor agonist action, also demonstrated its strong potential as a weight loss medication. Based on this, the manufacturer will likely submit for approval as a weight loss drug in the future.

Cardiovascular

Verquovo

Heart failure is the third most common reason for hospitalization in Canada. It is often referred to as a “revolving door” condition because 1 in 5 heart failure patients will need to be readmitted to the hospital within a month of being discharged. Verquvo is the first chronic heart failure drug to be indicated specifically for patients who recently received intravenous treatment, usually while hospitalized, due to worsening heart failure symptoms. In clinical trials, Verquvo, an add-on oral therapy, has shown to reduce deaths and hospital admissions due to heart failure symptoms. The annual cost of Verquvo in the United States is approximately $7,100 USD.

Camzyos

Heart disease is most recognized as a chronic condition with modifiable risk factors; however, approximately 1 in 500 people are affected by a genetically inherited heart disease called hypertrophic cardiomyopathy (HCM). Many cases of HCM, the most common genetic heart disease, are asymptomatic but some can have symptoms as serious as sudden death. Existing treatments such as beta blockers only treat symptoms of the chronic condition; Camzyos is the first drug to treat the underlying disease. The annual cost for Camzyos is $89,500 USD in the United States.

Plaque psoriasis

Bimzelx

Plaque psoriasis can already be treated by select biologics available on the Canadian drug market, however, a new biologic, Bimzelx, was approved in February 2022. Bimzelx touts improved skin clearance when compared with 3 other commonly used biologics for psoriasis. Adalimumab, ustekinumab and secukinumab range in annual cost from $12,250 (adalimumab) to $31,300 (usetekinumab maximum dose). Bimzelx is dosed according to patient weight and costs between $21,125 and $42,240 annually.

Sotyktu

Soyktu is a new oral class of medication that is an improvement on JAK inhibitors, a medication class that is used to treat inflammatory conditions. Although JAK inhibitors are approved in Canada for many inflammatory conditions such as rheumatoid arthritis and ulcerative colitis, none of the JAK inhibitors are approved in Canada for treatment of plaque psoriasis. In the United States, drugs in this medication class have been approved for treatment of plaque psoriasis. Soyktu belongs to a new class of medication that is more selective than JAK inhibitors, potentially avoiding the risk of significant adverse events like heart attacks and strokes due to blood clots. These adverse events have resulted in black box warnings for JAK inhibitors Xeljanz, Olumiant and Rinvoq in the United States. Soyktu is set to compete against first-in-class oral drug, Otezla, which costs approximately $13,800 annually.

Macular degeneration

Vabysmo and Susvimo

Age-related macular degeneration (AMD) and diabetic macular edema (DME) rank as the top 2 causes of vision loss in adults. Eylea and Lucentis are the current standard of care and are administered through monthly eye injections. Susvimo is a port delivery system that administers the same active ingredient as Lucentis, ranibizumab. Susvimo is a one-time surgical implant which delivers ranibizumab continuously and only needs to be refilled every 6 months.

Vabysmo has a more flexible dosing regimen than the existing therapies for AMD and DME. Depending on the patient’s vision outcomes and anatomy, Vabysmo has the potential for less frequent dosing than current therapies, making it a more convenient and less costly alternative.

Eylea and Lucentis are currently funded by the Government of Alberta if criteria are met. Given this, there is potential that Vabysmo and Susvimo may also be government-funded in the future.

Biosimilars

Many emerging public payer biosimilar policies are driving prescribing decisions and as a result, there is an increase in the uptake of biosimilar drugs leading to savings for patients and drug benefit plans.

Health Canada-approved biosimilars for Humira, Enbrel and Remicade have been marketed for a few years, yet additional biosimilar versions of these biologics are still coming to the Canadian drug market. Simlandi and Yuflyma are the first adalimumab biosimilars for the high concentration formulation (100mg/mL), the most commonly used formulation in the United States.

Byooviz has become the first Lucentis biosimilar, a biologic used to treat retinal vascular disorders, including AMD, one of the leading causes of blindness in Canada. Funding for Lucentis is available through provincial government funding in Alberta if criteria are met, and likely will apply to Byooviz as well.

Additional insulin biosimilars have recently been approved for NovoRapid and Lantus insulins. In the drug pipeline, a Lantus biosimilar is pioneering legislation changes to biosimilar insulin products in the United States. Semglee was recently approved by the United States Food and Drug Administration (FDA) as an interchangeable biosimilar, allowing pharmacists to substitute Lantus for Semglee without intervention of the prescriber. In Canada, however, interchangeability decisions rest with provincial or territorial governments. At this time, no biosimilars are deemed interchangeable with their innovator biologic anywhere in Canada; this requires a patient to get a new prescription when switching between biologic products.

Alberta Blue Cross^® drug management strategy

Drug plan management at Alberta Blue Cross^® starts with a solid unique foundation built on systems and management processes that all our drug plans benefit from. In addition, we offer numerous optional plan management features that mitigate rising drug costs and ensure plan sustainability.

Foundational drug plan management

Optional drug plan management strategies