Prescription therapies to treat patients with food allergies have long been an unmet need. This has notably been the case with the potentially life-threatening allergic reactions some people have to peanuts. The most-common food allergy reported in children, peanuts represent approximately 29% of all food allergies.1 Studies have estimated that food allergies are responsible for $4.3 billion in direct medical costs in the U.S. every year, with hospitalizations accounting for $1.9 billion of that total.1
For a long time, the primary approach to treating peanut allergy was simple: strictly avoid peanuts. In case of accidental exposure, allergic persons relied on epinephrine injections to stop serious anaphylactic reactions.
There is an estimated $4.5 billion global market for drugs to treat peanut allergies.
More recently, researchers have examined use of immunotherapy to treat peanut allergy. The concept is straightforward: treat an individual with gradually escalating amounts of peanut proteins in order to desensitize them in case of future exposure.2 There are several methods of immunotherapy, each with pros and cons (see chart below). Some allergists have been using these techniques informally for years. However, an immunotherapy agent approved the U.S Food and Drug administration has been lacking.3
This changed in early 2020 when the FDA approved Palforzia™, a peanut-derived oral immunotherapy drug for patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy. Palforzia, manufactured from defatted peanut flour, is mixed into soft foods and administered in very small quantities over time. The treatment is administered in 3 sequential phases; Initial Dose Escalation, Up-Dosing, and Maintenance; with each increasing dose during the Up-dosing phase administered under observation in a physician’s office.4
A large market
Palforzia was developed in response to calls from patient advocacy organizations, clinical and academic physicians, and government health officials. Collectively, they concluded that there was a significant unmet need for a standardized approach to immunotherapy for peanut sensitivity.5
For reasons that remain unclear, the number of people diagnosed with a peanut allergy has risen markedly in the past few decades. Although food allergies can also develop in adults, most begin in childhood. Over time, only 1 out of 5 of children with peanut allergy will naturally acquire a tolerance to peanut.6
It is now estimated 2.5% of the pediatric population in the U.S. (approximately 1 million children) experience allergic symptoms when exposed to peanuts.7
Therefore, beyond its method of action, the most notable thing about a peanut allergy immunotherapy is the size of the potential market. Given the minimal treatment options and large patient population, there is an estimated $4.5 billion global market for drugs to treat peanut allergies.8
In trials, Palforzia was found effective compared to placebo. A total of 67.2% of patients treated with Palforzia were able to consume a standard dose of peanut protein (defined as 600 mg of peanut protein, roughly equivalent to 2 peanut kernels) with no more than mild allergy symptoms. Only 4% of the patients treated with the placebo could do so.9
Risk and benefits
It’s significant that the FDA approval did come with conditions to address safety concerns, in the form of a restricted program called the Palforzia Risk Evaluation and Mitigation Strategy (REMS). To reduce the risk of severe allergic reactions including anaphylaxis, the FDA is requiring that Palforzia only be available through specially certified healthcare providers, health care settings, and pharmacies. Palforzia users must be monitored at a health care setting certified to manage anaphylaxis during Initial Dose Escalation and with the first dose of each Up-Dosing level. Patients will also need to continue to avoid peanuts in their diet, and have injectable epinephrine on hand for immediate use.4
The manufacturer of Palforzia, Aimmune, set the list price of Palforzia at $890 per month, or nearly $11,000 per year.10
Going forward, while Palforzia is the first immunotherapy for peanut allergy on the market, there are others in the pipeline.11 One investigational therapy, with an FDA decision expected in mid-2020, aims to accomplish a de-sensitizing effect to peanut allergy by delivering peanut antigen through a patch worn on the skin.12
As with all new drugs, OptumRx is closely monitoring new entrants into the market for treatment of food allergies. Our independent OptumRx Pharmacy and Therapeutics Committee will evaluate these new technologies using rigorous evidence-based clinical evaluations in order to ensure their most effective use. Based on their recommendations, OptumRx offers a wide range of management tools and strategies to control costs.
- The American Journal of Managed Care. “The Economic Impact of Peanut Allergies.” Accessed at: https://www.ajmc.com/journals/supplement/2018/managed-care-perspective-peanut-allergy/the-economic-impact-of-peanut-allergies
- The New England Journal of Medicine. “Oral Desensitization to Peanuts.” Accessed at: https://www.nejm.org/doi/full/10.1056/NEJMe1813314
- The Journal of Allergy and Clinical Immunology. “Allergist-reported trends in the practice of food allergen oral immunotherapy.” Accessed at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4291536/#
- FDA. “FDA approves first drug for treatment of peanut allergy for children.” Accessed at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treatment-peanut-allergy-children
- Aimmune Therapeutics. “The Power of a Shared Vision.” Accessed at: https://www.aimmune.com/about/history/
- Current Treatment Options in Allergy. “Desensitization for Peanut Allergies in Children.” Accessed at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5193471/
- American College of Allergy, Asthma & Immunology. “New study suggests 21 percent increase in childhood peanut allergy since 2010.” Accessed at: https://acaai.org/news/new-study-suggests-21-percent-increase-childhood-peanut-allergy-2010
- GlobalData. “Peanut Allergy: Opportunity Analysis and Forecasts to 2027.” Accessed at: https://store.globaldata.com/report/gdhc088poa--peanut-allergy-opportunity-analysis-and-forecasts-to-2027/
- The New England Journal of Medicine. “AR101 Oral Immunotherapy for Peanut Allergy.” Accessed at: https://www.nejm.org/doi/full/10.1056/NEJMoa1812856
- Wall Street Journal. “FDA Approves First Drug for Peanut Allergy.” Accessed at: https://www.wsj.com/articles/fda-approves-first-drug-for-peanut-allergy-11580510666
- Institute for Clinical and Economic Review. “Peanut Allergy: Final Evidence Report and Meeting Summary.” Accessed at: https://icer-review.org/material/peanut-allergy-final-evidence-report-and-meeting-summary/
- Drug Topics. “Investigational Immunotherapy for Peanut Allergy Shows Long-Term Clinical Benefit.” Accessed at: https://www.drugtopics.com/new-products/investigational-immunotherapy-peanut-allergy-shows-long-term-clinical-benefit
STATEMENT REGARDING FINANCIAL INFLUENCE:
This article is directed solely to its intended audience about important developments affecting the pharmacy benefits business. It is not intended to promote the use of any drug mentioned in the article and neither the author nor OptumRx has accepted any form of compensation for the preparation or distribution of this article.