ICER says ‘marginal’ benefits for AbbVie’s new RA drug

AbbVie’s Rinvoq rheumatoid arthritis drug is an important part of the company’s strategy to replace lost sales as its mega-blockbuster Humira finally succumbs to cheaper biosimilar competitors over the coming years.

With Humira losing its US patent in 2023, and already facing copycats in Europe, sales are already sliding in some markets after annual sales peaked at almost $20 billion in 2018.

But according to the cost-effectiveness gurus at the US advisory body the Institute for Clinical and Economic Review (ICER), the benefits of Rinvoq compared with Humira are “marginal” despite the newcomer’s higher price tag.

Unlike England’s NICE, ICER’s decisions are not binding in the US health system, but the organisation is growing in influence as payers seek to ensure that novel drugs represent value for money at a time when drug prices are under intense scrutiny.

ICER has produced an evidence report that will be reviewed by its experts ahead of a public meeting on 9th December comparing the cost-effectiveness of Rinvoq with Humira.

According to ICER’s reckoning, AbbVie is charging around $15,000 too much for Rinvoq at its list price of $59,860.

Based on a clinical comparison of Humira plus another disease-modifying drug (DMARD) and Rinvoq plus a DMARD, ICER estimates that AbbVie should actually be charging between $44,000 and $45,000.

This discount of 25-25% from the list price is consistent with the rebates that ICER assumes AbbVie is offering for Rinvoq in the rather opaque US reimbursement system.

This is an updated report: ICER pulled an earlier version that said Rinvoq exceeded its cost-effectiveness threshold of $150,000 per QALY.

ICER withdrew that report, saying that it was re-evaluating its approach to assessments.

But even though the new document casts Rinvoq in a more favourable light, it’s hardly glowing with praise for the new drug.

Approved in August, Rinvoq is competing in a tough market where there are a range of new products such as Eli Lilly’s rival daily pill Olumiant (baricitinib).

In Rinvoq’s favour, ICER noted that it is taken as a daily tablet instead of as an injection like Humira and older anti-TNF drugs, which some patients may find more convenient.

Another problem affecting these JAK inhibitor class drugs is safety: the FDA has issued “black box” safety warnings for both drugs relating to risks of “serious infections, malignancy, and thrombosis”.

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