J&J's Xarelto, Amarin's Vascepa are cost-effective, not budget friendly — ICER
ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.
J&J’s Xarelto, known chemically as rivaroxaban, is a blood thinner that was originally approved to prevent deep vein thrombosis in patients undergoing major orthopedic surgery and is widely used in the management of atrial fibrillation and venous thromboembolic disease. Last year, it was cleared for use in combination with aspirin as a treatment to reduce the risk of major cardiovascular (CV) events in patients with chronic coronary or peripheral arterial disease — on the basis of the pivotal COMPASS trial that indicated that the combination spurred a 24% reduction of the risk of major CV events in the patient population.
Amarin’s Vascepa, known chemically as icosapent ethyl, is an omega-3 fatty acid derived from fish oil that was originally endorsed by the US regulator as a treatment for elevated triglycerides. However, it is now under FDA review for an expanded label after a landmark trial — REDUCE-IT — showed the pill triggered a 25% reduction in the risk for the first occurrence of a major cardio event, and a 26% reduction for 3-point MACE, a composite of cardiovascular death, nonfatal heart attack and nonfatal stroke. The regulator is set to make its decision by December.
At current prices, both drugs fall within the value-based price benchmark range set by ICER:
Xarelto’s annual list price of $5,457 falls within ICER’s value-based price benchmark range of $5,200-$7,600 per year — in fact, the drug’s estimated net price of $2,215 per year is significantly lower than the ICER benchmark. Clinical experts at ICER’s public meeting suggested they would consider using the drug in approximately 30% of eligible patients — but at the current price — only roughly 6% of eligible patients could be treated in a given year without crossing the potential ICER threshold of $819 million annually. Last year, Xarelto generated nearly $2.5 billion in global sales.
In the case of Vascepa, the drug’s annual list price of $3,699 and estimated net price of $1,625 are both significantly lower than ICER’s value-based price benchmark range of $6,300-$9,200 per year. Experts at ICER’s public meeting suggested they would like to prescribe the drug, if approved for the new indication, to the majority of eligible patients — but only about 4% of eligible patients could be treated in a given year without crossing the ICER threshold of $819 million annually. In 2018, Vascepa generated roughly $229 million in sales.
ICER’s budget threshold is based on calculations that suggest that the US health care system, in the short term, may not be equipped to absorb the therapies’ expected adoption if costs exceed $819 million per drug, per year — without sidelining other drugs/services or contributing to a rapid uptick in insurance costs.
In terms of long-term effectiveness, ICER found that both therapies provided gains in overall survival above and beyond the current arsenal of cardiovascular therapies. However, reviewers did highlight some sources of uncertainty.
Although treatment with Xarelto lowered the risk of CV events, there was a surge in bleeding, reviewers noted. For Vascepa, it is unclear whether the therapy would be effective in patients not treated with statins — and the mineral oil placebo used in the REDUCE-IT trial may not have been biologically inert, they said. In addition, although the REDUCE-IT trial tested a higher dose of Vascepa, prior negative results testing different formulations of omega-3 fatty acid derived from fish oil “have led some to worry that these new results could be wrong by chance.”
“(D)espite the report’s positive conclusion that Vascepa is cost-effective, we believe that it understates the true value of Vascepa,” Amarin’s chief medical officer Craig Granowitz said in a statement on Thursday.
“For example, the report’s base-case analyses reflect only the costs of heart attack, stroke and cardiovascular death and exclude other high costs associated with other cardiovascular events demonstrated to be lowered by Vascepa in the REDUCE-IT cardiovascular outcomes study (e.g., revascularization procedures and hospitalization for unstable angina) as well as lower rates of recurring cardiovascular events in patients treated with Vascepa during the study.”
J&J said it had expected ICER to find Xarelto cost-effective in its new indication.
“However, we do not endorse the use of cost-per-QALY or cost-per-life-year-gained analysis as the sole or primary basis of decision making,” the company said in a statement to Endpoints News.
Cancer may have eclipsed cardiovascular disease in the developed world — although CDC estimates suggest it still kills 610,000 in the United States every year (that’s 1 in every 4 deaths).