The Institute for Clinical Effectiveness and Research (ICER) released its report on biologic treatment of rheumatoid arthritis on April 10th, and it wasn’t pretty. The group, which assesses the value of therapies based on effectiveness and cost, found that none of the available immunomodulators approach the cost-effectiveness threshold of $100,000 to $150,000 per quality-adjusted life-year (QALY).
Of course, the price of this drug class plays a large role in ICER’s calculation, utilizing a discounted wholesale acquisition cost (WAC) that reflected rebates and discounts. The base WAC was the price obtained from the February 2017 Red Book. Although this figure may not be accurate for individual payers, the conclusion of the study was that Humira® wou
ld have to be sold at roughly half its quoted $40,415 annual cost to reach an acceptable level of cost effectiveness. At the current net price used and when used as monotherapy, its cost per QALY was $232,644. AbbVie’s Humira adalimumab originator took the brunt of the heat in the study, because it was considered the most costly anti-TNF inhibitor. However, even Janssen’s Remicade® (infliximab), the least expensive anti-TNF inhibitor cited (at $28,906 per year), was not deemed cost effective, at $202,824 per QALY.
Of any biologic used to treat rheumatoid arthritis, Genentech’s interleukin-6 inhibitor Actemra® (tocilizumab, subcutaneous injection) was deemed to have the best monotherapy cost per QALY, at $168,660.
One issue for the immunomodulator class is that a major component of the calculation‑the number of QALYs over the time horizon (the lifetime of the patient‑was closely bunched. They ranged from 12.95 for adalimumab to 13.35 for tocilizumab IV, compared with 10.75 for conventional DMARDs. These figures were slightly lower when the immunomodulators were added onto conventional DMARD therapy (although drug costs were somewhat lower).
Although the calculation did not consider the real issues of dose escalation for certain medications, a sensitivity analysis showed that virtually under all scenarios, the biologic drugs failed to meet the ICER threshold for cost effectiveness. However, it should be pointed out that ICER’s evidence of efficacy was based on patients achieving a fairly low standard: 20% improvement in American College of Rheumatology scores. Therefore, the actual cost to treat patients to a higher standard of improvement should be greater.
The evaluation was done by the New England Comparative Effectiveness Public Advisory Council, an ICER group. According to ICER’s value-based benchmark prices for these targeted immunotherapies, WAC discounts must be slashed from 29% (for tocilizumab subcutaneous) to 55% (for adalimumab) to reach the $150,000 cost per QALY level. In other words, for a biosimilar of Humira to be deemed cost effective by today’s reckoning, it would have to require a WAC discount (or net cost through rebating) of 55% below that of February’s Humira pricing.
This magnitude of reduction in net costs would effectively bend the specialty cost curve in the US. However, without several biosimilar competitors for the same drug, this is unlikely for the monoclonal antibodies. Cost reductions of 50% or more have been seen in certain European countries for first-generation biosimilars, but this would represent an alarming “race to the bottom” for US manufacturers and might dissuade future biosimilar development.
