Role of Yosprala™ in At-Risk Patients Requiring Low-Dose Aspirin

Devada Singh-Franco, PharmD

Disclosures

March 27, 2018

Cost

A review of the average wholesale price for aspirin, omeprazole, and Yosprala(Table 2) shows that if a patient purchases a single bottle of 120 EC-ASA 81 mg or 100 tablets of EC-ASA 325 mg and 2 boxes of enteric-coated 20 mg tablets of omeprazole (taking 2 tablets a day to equal 40 mg), the estimated cost is $42 per month, whereas a 30-day supply of Yosprala is $180.[17,18,19]

However, nonadherence to aspirin and a gastroprotective agent resulting in events leading to increased morbidity and mortality is concerning. In a pharmacoeconomic study where factors such as efficacy, rates of adherence/discontinuation, drug costs, cost of ulcers/GI bleeds and management, secondary CVD and management, and cost of death were included in a Markov model, it was estimated that a US payer of a plan with 1 million members could save between $81 and $191 per plan member per year with the addition of Yosprala into the plan.[20]

Table 2. Average Wholesale Prices of Aspirin, Omeprazole, and Yosprala

Product Quantity AWP AWP Per Unit
Aspirin 81-mg tablet[18]
Chewable 36 $1.65 $0.0458
Enteric-coated 120 $2.55 $0.0213
Bayer enteric-coated 32 $2.36 $0.0738
Aspirin 325-mg enteric-coated tablet 100 $2.90 $0.029
Omeprazole[17]
Delayed-release capsule 20 mg
(20.6 [20 base] mg omeprazole magnesium)
14 $9.18 $0.656
Enteric-coated tablet 20 mg 28 $19.21
Prilosec OTC® enteric-coated tablet 20 mg 28 $20.14 $0.719
Yospralatablet[19]
Delayed-release aspirin 81 mg or 325 mg /
immediate-release omeprazole 40 mg
30 $180.00 $6.00
AWP = average wholesale price

Summary

Yosprala is a single-pill coordinated delivery tablet available for use in patients at risk for adverse CV and GI events.

Based on results of a pooled analysis,[12] 19 patients would have to be treated with Yosprala for 6 months to prevent 1 additional patient from experiencing a gastric ulcer. Despite these results, Yosprala has not been shown to reduce the risk for aspirin-induced GI bleeds, per the drug label. In clinical research, two participants receiving Yosprala had upper GI bleeds, two had lower GI bleeds, and one had a small bowel obstruction. In study subjects receiving EC-ASA, one had a duodenal ulcer hemorrhage and one an intestinal hemorrhage.[6] With regard to safety, three quarters of participants experienced a treatment-emergent adverse event, and a small proportion discontinued treatment due to adverse events in a 12-month safety study.[16] Overall, additional research on the long-term safety and efficacy, adherence rates, and costs will further clarify the role of Yosprala in chronic LDA users.

While PPIs can reduce the risk for ulcers, they do not prevent lower GI bleeds. Both patients and prescribers may also be reluctant to use PPIs due to adverse events currently being reported in the literature.[21,22] Therefore, a discussion between LDA users and healthcare providers about the benefits and risks of PPI co-therapy, financial concerns, and the need for monitoring to detect bleeds is encouraged.

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