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Pollen allergies, sublingual immunotherapy and drug shortages

Tetsuya Tanimoto, M.D.

Researcher, Medical Governance Research Institute, Tokyo, Japan

The Japanese government convened a cabinet meeting concerning pollen allergies countermeasures on May 30, 2023. According to reports, measures were outlined to disseminate sublingual immunotherapy more widely, intending to expand the supply of therapeutic medicine from the current volume, sufficient for 250,000 people, to a volume four times greater, sufficient for 1 million people, within five years. Sublingual immunotherapy for hay fever is a comparatively new treatment method. Initially, a liquid medicine for cedar pollen sufferers aged between 12 and 65 years was covered by insurance in 2014. Subsequently, 'CedarCure', the current tablet form, was released in 2018, extending its applicability to those aged between 5 and 65 years.


Torii Pharmaceutical Co., Ltd. is the sole manufacturer of this cedar pollen-specific sublingual immunotherapy. Potentially influenced by governmental policy, its share price has risen from 2,898 yen at the beginning of the year to 3,455 yen as of May 30th. According to their 2022 financial report, their gross revenue has increased by 2 billion yen from the previous year, amounting to approximately 49 billion yen. If we consider only the product sales of CedarCure and MiteCure, another allergy medication, they have seen an increase of 2.5 billion yen, totaling around 18.5 billion yen. Simple calculations suggest that revenue from these allergy-related products alone could exceed 70 billion yen within five years. I am not involved with Torii Pharmaceutical's shares, but the company's performance indicates a promising growth trajectory.


The widespread adoption of CedarCure is likely due not only to the wide recognition of its efficacy and safety but also to the sales efforts of Torii Pharmaceuticals. In fact, upon researching Torii Pharmaceuticals in the Pharmaceutical Money Database, operated by the Medical Governance Research Institute, data from the latest fiscal year of 2019 shows that around 280 million yen was spent on academic research grants, and approximately 150 million yen was spent on honorariums for 1,721 physicians. It is plausible that a portion of this expenditure is also utilized in relation to CedarCure.


While I do not receive any research funding or honorariums from Torii Pharmaceuticals, as an internist, I am in a position to prescribe CedarCure. One recent issue is a shortage of CedarCure due to its popularity. In industry parlance, this is called shipment adjustment; the company has been unable to stably supply the medication due to an overflow of orders that exceeded Torii Pharmaceuticals' projections. Given its unique nature, the drug cannot be instantly mass-produced, even in response to increased demand.


CedarCure is not an immediate panacea that works instantly after a single dose; rather, it is a medication that gradually changes one's constitution throughout 3 to 5 years of diligent daily usage. As such, when a drug shortage occurs, those taking it previously are prioritized, and those who wish to start anew may be delayed if they cannot secure sufficient medication. At our clinic, we have been able to reserve a certain amount for new patients. However, it may not suffice if the number of aspirants increases in the future.


Nonetheless, CedarCure is a therapeutic agent specifically for pollen allergies. It is not the type of commodity that would incite a state of panic in the event of a shortage. Particularly from the viewpoint of a general practitioner devoid of any financial interest, Cedar Cure is far from being a magic bullet; it can occasionally elicit severe allergic reactions, such as anaphylaxis, and incurs an annual expense of around 30,000 yen. Since numerous instances can be effectively treated with conventional anti-allergy drugs, my prevailing strategy when conferring with patients involves offering CedarCure as one of several potential treatments. I usually suggest that they might consider trying it if they are interested and then ask for their opinion on the matter.


A question here is the degree of attention the government is placing on sublingual immunotherapy. Upon examining the draft of the comprehensive pollen allergy measures compiled by the inter-ministerial conference on pollen allergies, it is apparent that there is a high level of interest in this topic. The document, which is emphasized with bold and underlining, states, "For the commencement period of allergen immunotherapy (including sublingual immunotherapy), appropriate information dissemination and concentrated publicity will be conducted in medical institutions, among other places [Ministry of Health, Labor and Welfare]."


I am concerned about this attitude of the government. If a medicine is truly effective, it typically increases in prescriptions and sales naturally, without government intervention. For instance, there was a case where Opdivo, an expensive cancer drug, sold too well and sparked discussions of potential national bankruptcy, leading to a rushed and unusual price reduction. When establishing governmental policy, caution must be exercised to ensure that favoring a particular company's product excessively is truly beneficial for the entire Japanese population.


Concerns were also raised about the legitimacy of the emergency approval for Shionogi & Co., Ltd.'s Ensitrelvir (brand name: Xocova) during the COVID-19 pandemic. Currently, a similar favoritism may be taking place in the area of sublingual immunotherapy. A fair and balanced evaluation of sublingual immunotherapy is necessary, considering its effectiveness, safety, cost-effectiveness, and patient selection compared to other anti-allergy drugs. Of course, policies that support Japanese companies may be acceptable, but as a frontline physician, all one can do is hope that each patient's benefits will not be compromised on scientific grounds.


This article is a translation of Japanese MRIC published on Jun 2, 2023

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