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ICER Warns of ‘Short-Term Budget Challenges’ with Novo’s Rybelsus

ICER Warns of ‘Short-Term Budget Challenges’ with Novo’s Rybelsus

Compared to injectable GLP-1 receptor agonists and other classes of diabetes drugs, Rybelsus demonstrated equal, if not superior, efficacy. However, the ICER advisory committee felt the drug provided only intermediate long-term value for its money.

If a patient with diabetes has the option to take their medication by needle versus an oral pill, they are most likely to choose the pill. But what if the price of the pill was so high that it might be more cost-effective for patients to use the needle?

This is what researchers at the Institute for Clinical and Economic Review (ICER) concluded in their new report.

The pill is none other than Rybelsus, the first-ever oral semaglutide to hit the US market less than three months ago. The glucagon-like peptide 1 (GLP-1) receptor agonist can be taken once a day to increase insulin production and modulate blood sugar levels in adults with type 2 diabetes.

While it was clear from the outset that Novo Nordisk’s latest creation would be a patient favorite, questions loomed over how Rybelsus would stack up against market leaders like Januvia (Merck) and Jardiance (Boehringer Ingelheim) in terms of safety, efficacy and cost-effectiveness.

The report, which was reviewed by the New England Comparative Effectiveness Public Advisory Council, found that adding oral semaglutide to background therapy led to an overall “positive net health benefit,” slightly outperforming Januvia (sitaligliptin), a dipeptidyl peptidase-4 inhibitor, on reducing blood sugar, weight, major adverse cardiovascular events and probably kidney disease.

But when it came to long-term cost-effectiveness, the committee felt that the drug only provided intermediate long-term value for its money.

RELATED: FDA Clears First-Ever Oral Semaglutide Tablet for Type 2 Diabetes

“People with Type 2 diabetes who would like to use a GLP-1 receptor agonist have had no oral options until oral semaglutide, which appears to have similar efficacy to that of the injectable GLP-1s,” said Dr. David Rind, ICER’s chief medical officer. “However, oral semaglutide’s estimated net price is much higher than that of the oral SGLT-2 inhibitors like empagliflozin (Jardiance) that appear to have similar benefits with fewer common side effects, making SGLT-2 inhibitors a more cost-effective ‘next’ therapy for many people with [type 2 diabetes].”

ICER’s calculations place Rybelsus’ net price at $6,103 per year, which falls within the value-based price benchmark range of $6,000 to $6,400 per year that would ensure the health benefits are not outweighed by costs. Compared to ICER estimates of competitor drugs, Rybelsus may be out of reach for a significant proportion of diabetics who need it.

The report states, “…at oral semaglutide’s estimated net price, despite meeting common lifetime cost-effectiveness thresholds, only approximately seven percent to 14 percent of eligible US patients could be treated in a given year before crossing ICER’s potential budget impact threshold of $819 million.”

In other words, the amount of added healthcare costs associated with Rybelsus may be difficult for the US healthcare system to absorb in the short-term — despite the drug’s long-term value — when it exceeds $819 million.

In light of these findings, ICER issued an Access and Affordability Alert which warned of such short-term budgetary challenges to the US healthcare system based on their assessments. In a roundtable discussion, stakeholders recommended that drug developers aim for lower list prices to come out on top in the crowded diabetes drug market.

ICER also recommends robust head-to-head comparisons of new diabetes drugs based on the PIONEER trials of oral semaglutide as new treatments approach commercialization.