COMMENTARY

'Revolutionary' Biologics for Asthma--Big Benefit, Big Price

Gary J. Stadtmauer, MD

Disclosures

July 24, 2018

Exciting, but Costly

The cytokine- and antibody-targeted drugs for various asthma phenotypes are nothing short of revolutionary. Entire journal editions[1] have been devoted to these biologic therapies. The excitement surrounding these medications is tempered only by their cost—and that cost is not so transparent. Published prices are not necessarily those paid by insurers, and the cost of biologic drugs can also vary greatly depending on the agent and the patient's weight.[2] Drug costs presented herein are estimates only and will change over time owing to many factors, including insurance contracts.

Anti-Immunoglobulin E Monoclonal Antibody

The cost of Xolair per patient is variable and depends on the patient's weight and immunoglobulin E (IgE) level. This can vary from a small patient with a low IgE level requiring a single monthly 150-mg vial of Xolair, with an annual average wholesale price (AWP) of $12,586,[3] to a patient who is heavier and/or with a higher IgE level receiving 375 mg every 2 weeks, equating to a cost (on the high end) of approximately $81,809 annually.

Anti-Interleukin 5 Monoclonal Antibody

Mepolizumab (Nucala®) is a 100-mg monthly subcutaneous injection for all patients. On the basis of AWP, the annual price is $37,080.[4]

Reslizumab (Cinqair®) is a monthly intravenous infusion and weight-based at 3 mg/kg. The AWP for one vial is $1032.[5] For example, two vials for a 66-kg patient cost about $24,768 annually, whereas three vials for a heavier patient cost about $37,512 annually.[5]

Benralizumab (Fasenra™) is dosed at 30 mg subcutaneously every 4 weeks for three doses and then every 8 weeks thereafter. Benralizumab costs about $38,000 in the first year only, and then has maintenance costs of about $28,000-$33,000 per year.[6]

Other Biologics

Dupilumab, an anti-interleukin 4 and anti-interleukin 13 monoclonal antibody, is on the market for atopic dermatitis and is under review by the US Food and Drug Administration (FDA) for asthma. Once approved by the FDA, it will be the only biologic therapy for asthma that may be self-administered at home. Dosed for atopic dermatitis (eczema), the drug costs about $37,000 annually.

When Should Biologics Be Considered?

These drugs clearly have the potential to transform patients' lives, but at a substantial price. It is up to us, as specialists, to optimize care before proceeding to biologics. I say this not only because of the expense but also because once patients are on these medications, stopping them may not be easy.

In my opinion, even if the patient may benefit from a biologic therapy, alternatives, including triple therapy with an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta 2-adrenergic agonist in a single inhaler, should be considered.

Other options include a combination of a high-dose combination inhaler with a small-particle hydrofluoroalkane inhaled corticosteroid, which I wrote about in a previous blog. I have used this option to get some patients off of low-dose oral steroids. If a patient is well controlled on a combination inhaler plus very-low-dose oral steroids (eg, methylprednisolone 2 mg every other day) and does not have contraindications to oral steroids, should we prescribe a biologic?

Alternatively, there are reasons to consider starting the biologics sooner rather than later, especially in asthmatics with polypoid eosinophilic chronic rhinosinusitis. These patients are often dependent on oral steroids for both the polyps and the asthma. Preliminarily, the biologics demonstrate efficacy in this subset of chronic sinus patients.[7] The reduced cost of both asthma and sinus care may justify the higher expense of these medications in this group. The unanswered question regarding the patient with severe eosinophilic asthma/nasal polyp is whether the biologic should be started before or after a first surgery.

Other patients in whom to consider using these drugs earlier include those who should not take inhaled corticosteroids (eg, central serous retinopathy) and perhaps some patients with glaucoma, severe osteoporosis, or brittle diabetes, who may be sensitive to the effects of higher-dose inhaled steroids.

The decision to start a biologic must be a clinical decision, with apparently separate indications for anti-IgE therapy and anti-cytokine therapy for various severe asthma phenotypes.[8] That being said, when the case can be made for one, the least expensive biologic should be considered.

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