Two weeks ago, the Food and Drug Administration approved Xolair (omalizumab) for immunoglobulin E-mediated food allergy in certain adults and children one year or older for the reduction of allergic reactions. Xolair’s sponsors Roche and Novartis have been working on getting coverage for the product in the new indication. Given the high price of the drug and its need to be used indefinitely it can be a challenge to convince insurers.
Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure. Importantly, this includes reducing the risk of anaphylaxis that may occur with accidental exposure to one or more foods.
According to the Centers for Disease Control and Prevention, approximately 17 million people in the U.S. in 2021 had a food allergy. For some, exposure to the particular food(s) to which they are allergic can lead to a potentially life-threatening allergic reaction. In cases of anaphylaxis, prompt administration of epinephrine is necessary.
The product Xolair has a history that goes back several decades. It was originally approved in 2003 for the treatment of moderate to severe asthma. The drug was subsequently granted marketing authorization to treat chronic spontaneous urticaria and rhinosinusitis with nasal polyps in certain patients.
For its new indication, Xolair’s safety and efficacy in reducing allergic reactions in patients with food allergies were established in a multi-center, double-blind, placebo-controlled study of 168 pediatric (older than one year) and adult subjects who were diagnosed as allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut or walnut.
The full study results were published last week in the New England Journal of Medicine. Detailed findings from the Phase 3 OUtMATCH study showed treatment with Xolair increased the amount of peanuts, tree nuts, egg, milk and wheat that people as young as one year could consume without experiencing an allergic reaction.
Of those who were treated with Xolair, 68% of study participants were able to eat a single dose of peanut protein without moderate to severe allergic symptoms, which include whole body hives, persistent coughing and vomiting, compared to 6% who received a placebo.
While these results are statistically significant, 17% of subjects taking Xolair had no meaningful change in the amount of peanut protein they could tolerate. Consequently, people who are prescribed Xolair must continue to avoid the foods that can cause reactions, such as peanuts, cashews, hazelnuts, walnuts, milk products and eggs.
Will Xolair Be Covered for Food Allergies?
Xolair has been used off-label to treat food allergies. Off-label uses of a drug generally encounter difficulties in getting covered by insurers. But with the FDA’s approval of a supplemental indication, it’s more likely that insurers will reimburse Xolair for food allergies.
Nevertheless, it’s not a given. The list price for Xolair ranges from about $2,900 a month for children to $5,000 a month for adults. While the net price is less and could diminish over time with the arrival, for example, of omalizumab biosimilars, a drug priced at several thousand dollars a month which must be used indefinitely and doesn’t offer guaranteed success constitutes financial exposure that insurers will want to carefully consider.
And even when payers decide to reimburse, it’s very likely they will institute prior authorization protocols to ensure appropriate prescribing to those who have IgE-mediated food allergies, detected through blood or skin tests.
There is precedent for widespread coverage of Xolair, as most patients are currently covered by insurance for its asthma, urticaria (hives) and rhinosinusitis approvals. The drug’s sponsors have said they will work with payers to pursue similar coverage for food allergy patients.
Moreover, Genentech and Novartis have a co-payment program in place for patients taking Xolair for asthma, chronic spontaneous urticaria and rhinosinusitis with nasal polyps. Eligible patients with commercial insurance may not have to pay anything per treatment after patient assistance kicks in. Co-payment assistance of up to $15,000 can be provided per calendar year. It’s presumed that such assistance would also apply to the food allergy indication.
As the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure, Xolair represents an advance. For most patients, however, access will depend on insurer coverage which isn’t assured following FDA approval.
