WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR OMVOH?: CADTH recommends that Omvoh be reimbursed by public drug plans for the treatment of moderately to severely active ulcerative colitis (UC) if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Omvoh should only be covered for patients who are eligible for the reimbursement of other advanced drugs for the treatment of moderately to severely active UC (i.e., biologics and Janus kinase [JAK] inhibitors) based on the criteria used by each public drug plan. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Omvoh should only be reimbursed if prescribed by a physician experienced in the diagnosis and management of UC but should not be reimbursed if used in combination with biologic therapies or JAK inhibitors for UC. For ongoing treatment to keep UC under control, Omvoh should only be reimbursed if initial treatment reduces the severity of UC after 24 weeks. Patients should be reassessed every year for renewal. The cost of Omvoh should not exceed the drug program cost of treatment with the least costly biologic reimbursed for the treatment of UC. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from 2 clinical trials demonstrated that treatment with Omvoh improved symptoms and reduced severity of UC; this treatment effect with Omvoh was maintained for up to 52 weeks compared with placebo. Additionally, fewer patients needed to use corticosteroids with Omvoh compared with placebo; this outcome was identified as important to patients and clinicians. Omvoh appears to meet some of the needs identified by patients, including a need for additional treatment options that would help them gain control of UC symptoms and keep them under control. Based on CADTH’s assessment of the health economic evidence, Omvoh does not represent good value to the health care system at the public list price. The committee determined that there is not enough evidence to justify a greater cost for Omvoh compared with other biologics reimbursed for the treatment of UC. Based on public list prices, Omvoh is estimated to cost the public drug plans approximately $15 million over the next 3 years. However, the actual budget impact is uncertain due to limitations with the sponsor-submitted model.
WHAT IS UC? UC is an inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine and rectum. Signs and symptoms include blood in stool, frequent diarrhea, loss of appetite, the strong urge to use the bathroom without necessarily having a bowel movement, abdominal pain, and rectal bleeding. It is estimated that the prevalence of UC in Canada will be 0.44% of the population in 2030. UNMET NEEDS IN UC: Patients have found it difficult to obtain adequate symptom relief with the currently available treatment options. Patients have also noted that treatment response varies across patients and that response to treatment may stop after prolonged use. Thus, patients have identified a need for additional treatments that reduce the severity of symptoms and keep the symptoms under control, demonstrate long-term safety and tolerability, and improve quality of life and work productivity. HOW MUCH DOES OMVOH COST? Treatment with Omvoh is expected to cost between $7,124 and $14,248 per patient during the 12- to 24-week initiation phase and $30,977 per patient in the maintenance phase (i.e., per year).
