Drug pipeline 2024

Executive summary

Drug coverage is a core and valued component of benefit plans. In 2023, drug claims accounted for over a third of the benefits costs for Alberta Blue Cross^® private health and dental benefit plans. With this in mind, it is critically important to have insights into new drug therapies to support the health and wellness of our plan members, while also having a strong understanding of the associated costs to ensure the future sustainability of benefit plan offerings.

Alberta Blue Cross^® continuously monitors the Canadian drug pipeline, assessing more than 300 drugs currently under Health Canada review, to understand the major therapeutic areas and specific drug therapies that are likely to impact private drug plans. This report will provide an update on some of the notable developments, providing plan sponsors with insight into what’s to come.

Drug pipeline at a glance

Diabetes and weight loss

Diabetes continues to have an impact on private drug plans, typically ranking within the top 3 health conditions by spend. People with insulin dependent diabetes typically require daily insulin injections. Recently approved by Health Canada, the first once-weekly injectable basal insulin could improve adherence and convenience for these people.

It is anticipated that manufacturers of existing diabetes medications will continue to seek regulatory approval to use their drugs for health conditions beyond diabetes. Mounjaro (tirzepatide), which has been approved for diabetes in Canada, has received approval in the United States for weight loss. It is also being studied for other health conditions that benefit from weight loss (for example, for chronic heart failure and obstructive sleep apnea). Other new molecules are being studied for both diabetes and weight loss where early-stage clinical trials are showing greater weight loss effects than currently available therapies.

Migraine

In recent years, we have seen new injectable medications for migraine treatment and prevention, such as Aimovig, Emgality, Ajovy and Vyepti. In addition to these new injectable medications, new oral medications such as Qulipta, Ubrelvy and Nurtec ODT, now offer options for individuals averse to injectable therapies or unable to use conventional therapies like triptans.

Dermatology

The number of treatments for various dermatological conditions continue to increase with the introduction of two new biologics as well as 2 novel topical medications. The first and only treatment available for alopecia areata was recently approved by Health Canada in December 2023. Additionally, 2 innovative topical therapies are currently under review by Health Canada—1 for the treatment of plaque psoriasis and the other for both vitiligo and mild-moderate atopic dermatitis. These new topical treatment alternatives are expected to come with a higher price tag compared to other conventional topical therapies.

Neurology

A breakthrough treatment for Alzheimer’s disease, which slows disease progression and improves symptoms in individuals diagnosed early on, is currently under review in Canada. Newly targeted therapies for the treatment of generalized myasthenia gravis will make their way to the Canadian market. While these novel therapies may provide symptom improvement for those not effectively managed with conventional therapies, they will come with high price tags, placing pressure on private drug plans.

COVID treatments

Paxlovid, a 5-day treatment for mild to moderate COVID-19 infections, no longer has universal government funding and is now covered by private payers in the United States. We are closely monitoring Canadian developments to see if government funding will also stop in Canada.

Rare disease drugs

Advancements in drug treatments for rare diseases continue to expand, with many therapies currently undergoing review or receiving recent approval in Canada. While these drugs provide crucial therapeutic options for patients with rare conditions, they are accompanied by extremely high costs. The National Strategy for Drugs for Rare Diseases was announced by the federal government in March 2023; however, considering the number of rare disease drugs in the pipeline and the ultra-high cost of these therapies, newly allocated federal funding won’t be sufficient to provide universal coverage for rare disease drugs.

Generics and biosimilars

Generics and biosimilars continue to enter the market providing more affordable treatment options, and savings for benefit plans, which helps with drug plan sustainability. Biosimilars have recently been marketed for Stelara, a high-cost drug commonly utilized for various autoimmune disorders. The biosimilar pipeline is expanding to new therapeutic areas including bone health, infertility and asthma.

There are notable first entry generics coming to the Canadian market for a number of highly utilized diabetes medications and for Vyvanse, which is used for Attention-Deficit Hyperactivity Disorder (ADHD). Also, a generic for the specialty drug Mavenclad, an oral treatment for Relapsing Remitting Multiple Sclerosis (RRMS), is under review by Health Canada.

Notable drugs

Diabetes and weight loss

Insulin icodec

Health Canada has approved the first basal insulin designed for once-weekly administration. This dosing is unique as basal insulins on the market today require daily administration. A reduction in the frequency of basal insulin injections has the potential to enhance treatment acceptance and adherence, particularly among patients managing Type 2 diabetes.

Diabetes drugs with expanding uses

Based on recent developments in the United States, it is anticipated that there will continue to be the expansion of indications for existing diabetes medications. Numerous pharmaceutical companies are studying diabetes drugs for weight loss, as well as for health conditions that benefit from weight loss (for example, tirzepatide for chronic heart failure and obstructive sleep apnea). Although not currently submitted to Health Canada for review, we will take a deeper dive into some of the products we may soon see come down the Canadian pipeline.

• As mentioned in last year’s pipeline, Mounjaro (tirzepatide) has been approved in the United States and Canada for use in Type 2 diabetes. In November 2023, the Food and Drug Administration (FDA) approved tirzepatide’s use for chronic weight management in adults under the name Zepbound. Zepbound has not been submitted to Health Canada.
• In addition to Mounjaro, pharmaceutical company, Eli Lilly, has several other medications in their development pipeline being studied for obesity and diabetes. These include orforglipron and retatrutide. Retatrutide will be the first triple agonist targeting 3 hunger-regulating hormones, Glucose-dependent Insulinotropic Polypeptide (GIP) receptor, Glucagon-like Peptide-1 (GLP-1) receptor and glucagon receptor. Although there have not been any head-to-head studies conducted to date with other drugs, promising phase 2 results for retatrutide have demonstrated an average body weight loss of 24 per cent, representing the highest percentage of weight loss for any drug.
• Pharmaceutical company, Novo Nordisk, currently markets Wegovy, Ozempic, Rybelsus and Saxenda. Their new pipeline drug, CagriSema, is being studied for use in Type 2 diabetes and obesity. It is a new drug combination of an amylin analogue and semaglutide, which is the active ingredient of Ozempic and Wegovy. Anticipation builds for the clinical trial results as the study compares the efficacy and safety of CagriSema to Zepbound (Eli Lilly’s weight loss drug).

Weight loss drugs and diabetic drugs that promote weight loss will continue to have an impact on private drug plans considering the prevalence of obesity and diabetes in Canada. Approximately 30 per cent of adults in Canada are considered obese and 35 per cent are overweight, and according to recent findings from Diabetes Canada² the prevalence of diabetes in 2022 stands at 10.2 per cent, affecting more than 4 million Canadians³. The relationship between obesity and diabetes remains strong as an estimated 80 to 90 per cent⁴ of people with Type 2 diabetes are either overweight or obese. Prescribers are following evolving treatment guidelines suggesting treatment based on patient comorbidities. Costly second- or third-line therapies that positively impact weight loss are being initiated earlier, which contribute to the growth in diabetes claim expenditure, and we expect this trend to continue. Strong drug management will be imperative to control off-label use of these medications and maintain drug plan sustainability.

Migraine

Ubrelvy and Nurtec ODT

In recent years, there have been new injectable medications for migraine treatment and prevention, such as Aimovig, Emgality, Ajovy and Vyepti, with costs from $6,400 to $20,000 annually. In the past year, additional new oral therapies have been coming to market for those who are averse to using injectable therapies to treat their migraines. These oral treatments can also be an option for patients who have developed medication overuse headaches with other treatments, or are unable to use triptans, such as those with heart disease or stroke risk.

Qulipta was the first oral Calcitonin Gene-Related Peptide Receptor (CGRP) antagonist that entered the Canadian market for migraine prevention with an annual cost of $6,700. This was followed with the launch of Ubrelvy, which is another oral therapy used for migraine treatment, in May 2023. Ubrelvy’s Canadian pricing aligns closely with that of branded triptans like Axert and Imitrex; however, is considerably more expensive than generic triptans. For those treating a minimum of 4 migraines monthly, meeting the criteria for episodic migraine diagnosis, the estimated annual cost of Ubrelvy would be around $740. However, individuals experiencing 15 or more migraines monthly may face an annual cost just under $3,000.

Nurtec ODT, the third oral CGRP antagonist, was recently approved by Health Canada. Nurtec ODT differs from Ubrelvy in that it is an oral disintegrating tablet that is seeking approval for both acute migraine treatment, as well as migraine prevention. We anticipate the pricing for Nurtec ODT to be similar or slightly higher, reflecting its use for both prevention and treatment of migraines.

With an estimated migraine prevalence of 12 per cent in Canada, affecting almost 4.5 million Canadians⁷, we expect continued growth in both plan spend and claimants for migraine therapies.

Dermatology

Litfulo

A once-daily oral treatment, Litfulo is the first and only treatment approved by Health Canada for individuals 12 years of age and older with severe alopecia areata. Approximately 2 per cent¹¹ of the global population and an estimated 775,000 Canadians are affected by alopecia areata¹². Alopecia areata is an autoimmune disease where the immune system attacks the body’s hair follicles causing patchy to complete hair loss on the scalp, face and/or body. Litfulo is also being studied for the treatment of vitiligo, rheumatoid arthritis, Crohn’s disease and ulcerative colitis.

Lebrikizumab

Lebrikizumab is currently under review by Health Canada and if approved, will be the third, targeted biologic therapy for the treatment of moderate-to-severe atopic dermatitis. An extended study¹³ showed promising long-term results of sustained skin clearance, itch relief and reduced disease severity. The main competitors currently on the market will be Dupixent and Adtralza; however, lebrikizumab could have a dosing advantage of only once monthly compared to every 2 weeks.

Vtama

Vtama is a new chemical entity and first-in-class non-steroidal cream to be developed in the psoriasis space in 25 years. It has been marketed in the United States since June 2022. Recent phase 3 trials demonstrated a significant improvement in itch, which is the most prevalent symptom of atopic dermatitis. Vtama’s manufacturer, Dermavant Sciences, plans to submit the new indication for FDA approval in early 2024, and we can anticipate similar plans for Health Canada.

Opzelura

Opzelura has been approved in the United States to treat mild to moderate atopic dermatitis and nonsegmental vitiligo. Opzelura is currently the first and only Janus Kinase (JAK) inhibitor cream, and the first and only treatment to address repigmentation in patients with vitiligo. Patients with vitiligo suffer from the loss of skin colour affecting the skin on any part of the body.

These topical treatments offer new therapies for individuals whose condition is not effectively managed with current therapies, or where treatments did not exist previously; however, the annual expenses associated with these treatments will be significantly higher than currently available topical medications.

Neurology

Leqembi

Leqembi was approved by the FDA in January 2023 and is currently under review by Health Canada for the treatment of Alzheimer’s disease. The drug is not a cure for Alzheimer’s but has been shown to reduce cognitive decline in people living with early-stage disease, often still managing symptoms enough for patients to continue working. Leqembi is administered intravenously once every 2 weeks. The annual cost in the United States is approximately $26,000 USD; which is significantly higher than conventional oral Alzheimer’s disease therapies currently available in Canada ranging from $200 to $2,100 annually.

Vyvgart, Zilbrysq and Rystiggo

New targeted therapies for the treatment of Generalized Myasthenia Gravis (gMG) are making their way to the Canadian market. Vyvgart was recently marketed and 2 others are currently under review. gMG is a chronic, autoimmune disease characterized by unpredictable and debilitating symptoms that weaken the skeletal muscles, potentially leading to challenges in walking, swallowing and breathing.

Targeted therapies, referred to as complement inhibitors, will provide add-on treatment options for the estimated 15 per cent of patients who are inadequately managed with conventional therapies due to suboptimal effectiveness and/or safety concerns. These treatments not only improve symptom management, but also target the disease process without the broad immune suppression characteristic of conventional treatments. We can expect the pricing of Zilbrysq and Rystiggo to be in line with other complement inhibitors like Vyvgart, Ultomiris, and Soliris, costing hundreds of thousands annually.

COVID-19 treatment

Paxlovid was approved in 2022 by Health Canada to treat mild to moderate COVID-19 infections. Since coming to market, the 5-day treatment course has been publicly funded and available to eligible Canadians free of charge. In our April 2022 COVID-19 vaccine and drug pipeline report, we highlighted the possible shift towards private plans being asked to cover the expenses of COVID-19 outpatient treatments. This is the scenario currently happening in the United States.

In the United States, Paxlovid has been provided to the public free of charge since December 2021 when the FDA first authorized the treatment. However, beginning in 2024, Pfizer is now selling Paxlovid directly to health insurers, with a price of $1,390 per course, more than double what the United States government paid.

Private payors may soon see a similar development in Canada. Pfizer submitted Paxlovid for Canadian Agency for Drugs and Technologies in Health (CADTH) review in September 2023, which is likely a sign that universal provincial coverage will cease. At time of writing, the provinces are still providing the publicly funded Paxlovid supply. Alberta Blue Cross^® is monitoring this development closely.

Biosimilars

Biosimilars continue to enter the market providing more affordable treatment options, and savings for benefit plans, which helps with drug plan sustainability. Biosimilar transitioning policies by provincial governments have been implemented in 11 out of the 13 jurisdictions, with Manitoba and Nunavut remaining as the only jurisdictions in Canada without a biosimilar switch policy. The growing influence of emerging public payer biosimilar policies is shaping prescribing decisions and subsequently driving greater adoption of biosimilar drugs.

Biosimilars of Stelara are entering the Canadian market with 2 products currently under review, 1 approved, and 2 recently marketed. Stelara is used for several autoimmune disorders and is ranked within the top 10 drugs by spend on the Alberta Blue Cross^® book of business. Some of the biosimilars will have Health Canada approval for all Stelara indications including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Finlius, was approved by Health Canada in April 2023 and if marketed, will be a first of a kind biosimilar launch as this biosimilar is manufactured by the same company that makes the innovator product, Stelara.

The biosimilar pipeline is expanding to new therapeutic areas including bone health, infertility and asthma. The first biosimilars have been approved for Prolia and Xgeva, and biosimilars for Xolair (omalizumab) and Gonal-F (follitropin alfa) are in phase 3 clinical trials but have not been submitted to Health Canada. There are other notable biosimilars currently in phase 3 clinical trials for Simponi (golimumab), indicated for numerous autoimmune disorders, and Ocrevus (ocrelizumab), a treatment for multiple sclerosis.

A summary of the notable biosimilars currently under review with Health Canada or recently approved are outlined below.

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 benefit all our drug plans. 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