AbbVie's blockbuster hopeful Orilissa shouldn't be first in line for endometriosis treatment: ICER

The $845-per-month list price AbbVie set for its just-approved endometriosis drug Orilissa is reasonable enough, a U.S. cost-effectiveness watchdog figures. But payers should consider requiring women to try other treatments first.

The Institute for Clinical and Economic Review (ICER) issued an affordability and access alert in a final report (PDF) published Friday. The reason? At Orilissa's current price, only a quarter of eligible patients could get the drug without exceeding ICER’s healthcare burden threshold.

Plus, by ICER’s standard measures, Orilissa is only cost-effective for endometriosis when pitted against no treatment at all. Under that comparison, Orilissa’s annual price of $10,140 fits right in. But when it comes to head-to-head with other treatments, the watchdog said it doesn't yet have enough clinical evidence to judge.

To achieve its cost-effectiveness threshold of $150,000 per quality-adjusted life year gained, ICER figured Orilissa’s annual price should not exceed $12,800. At $10,140, it does not exceed that upper limit—only when compared to no treatment at all.

"We have been thoughtful and responsible in our approach to pricing Orilissa to optimize patient access. Our WAC price falls within the value-based benchmark prices recommended in the ICER report," said AbbVie in a statement to FiercePharma.

According to ICER, many patients will likely choose Orilissa despite the availability of other treatments for endometriosis pain. As a GnRH antagonist, Orilissa acts fast to suppress ovarian hormones to achieve clinical relief. In contrast, widely used GnRH agonists need about 10 to 14 days because they first stimulate female hormones and can result in an initial worsening of symptoms. Moreover, Orilissa’s oral form could be convenient for administration, while GnRH agonists are given by injection or intranasally.

Combine that with an estimated disease prevalence of 6.1% in the U.S., ICER figures about 270,000 patients could use Orilissa annually over five years. That’s good news for AbbVie but bad for overall healthcare costs.

When applied to the drug’s list price, the per-patient impact of Orilissa compared to no active treatment is about $6,800, or about $4,800 at an assumed 27% discount off net price.

"At the WAC and assumed net price, only 18% and 25% of the eligible population cohort could be treated each year before the budget exceeded the ICER annual budget impact threshold of $915 million," said ICER in the report.

ICER also looked at the efficacy of Orilissa, which is currently approved for use up to 24 months at the 150 mg daily dose and up to six months at 200 mg. An expert panel who reviewed ICER’s report recently voted unanimously that currently, available clinical evidence is not enough to distinguish the health benefit of Orilissa from other treatments such as GnRH agonist and hormonal contraceptive. Head-to-head trials of Orilissa against other therapies were small in sample sizes and short in duration, argued ICER.

What’s more, ICER also noted lack of certainty around Orilissa’s long-term safety and efficacy profile. "Until more is understood about the long-term effects, it would be reasonable for payers to consider prior authorization criteria to ensure prudent use of the therapy, such as requirements for previous treatment with other options, specialist prescribing, and clinician attestation of clinical improvements while using the therapy," said Dan Ollendorf, Ph.D., ICER’s chief scientific officer, in a statement.

The FDA had previously postponed its decision on Orilissa, as it took more time to understand the liver safety results. So, when the agency handed down the green light in July without black-box warnings, Goldman Sachs analyst Jami Rubin said it "should fully de-risk" the AbbVie drug. As she saw it at the time, Orilissa was "well positioned to hit management expectations of >$2bn by 2025." 

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