(Sept. 27, 2017) A recent Iranian law that in effect removes all foreign medications from the list of drugs covered by insurance organizations reportedly endangers the health of a large percentage of the country’s thalassemia patients and subjects them to heavy financial burdens. (Law Creating Hurdles for Thalassemia Patients, FINANCIAL TRIBUNE (July 26, 2017).) The Law on the Sixth Development Plan, passed in March 2017, provides that only drugs from the government’s official list of Iranian generic drugs are eligible for insurance coverage. (Law on the Sixth Development Plan of the Islamic Republic of Iran (Mar. 4, 2017), art. 74(f), Agricultural Research, Education and Extension Organization website (in Persian).) The Law also charges the Ministry of Health and Medical Education (MHME) with supporting the production and prescribing of Iranian generic medicines. (Id. art. 74(j).)
Thalassemia describes a group of anemia-producing genetic blood disorders primarily afflicting particular ethnic groups, with Iran being a major center of Beta thalassemia (25,000 patients) in the eastern Mediterranean region. (Thalassemia, in Gale Encyclopedia of Medicine (2008), Free Dictionary website; Gholam Hasan Khodaei et al., Frequency of Thalassemia in Iran and Khorasan Razavi, 1(1) INTERNATIONAL JOURNAL OF PEDIATRICS (Iran) 46–47 (Dec. 2013).) Intermediate to severe forms of the disease often require regular blood transfusions and expensive iron-chelation therapy to remove the excess iron in the blood produced by the transfusions. (How Are Thalassemias Treated?, NATIONAL INSTITUTES OF HEALTH: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (last updated July 3, 2012).
Complications Stemming from Use of Generic Drugs
The President of Iran’s Thalassemia Association, Dr. Majid Arasteh, alleges that 60% of the country’s thalassemia patients have used imported medications for decades and that the sudden shift to domestically produced drugs, which he considers to be of lower quality than the foreign-made drugs, has created many physiological and psychological complications for these patients. (Life-Threatening Risk for 60% of Thalassemia Patients, SHARGH (July 25, 2017) (in Persian); The Exclusion of Thalassemia Drugs from Insurance Coverage: The Lives of Most Patients Are at Risk, SHABTAB NEWS (July 24, 2017) (in Persian).) Moreover, the Association’s executive director, Mohammad Reza Mashhadi, says the problem for many thalassemia patients is they do not tolerate the Iranian generic iron-chelation medications, which cause digestive problems, in the same way as the foreign brand-name medications. (Concern over Exclusion of Vital Medicines for Thalassemia Patients from List of Thalassemia Insurance, ISNA (July 23, 2017) (in Persian).)
Drug Prices and Quality Control
According to Mashhadi, insurance covers 100% of the cost of Iranian-produced generic thalassemia medications, but patients’ share of costs for nongeneric thalassemia medications can be as much as 400,000 tomans (about US$121) monthly. Without insurance coverage for the cost of nongeneric medicines under the new Law, patients would have to pay an average of two million tomans (about US$603) per month for these medications – an increase of about 400%. (Id.) Mashhadi notes that a new foreign oral drug that does not cause digestive problems will come on the market in October of this year, but because even the current effective foreign drugs have been excluded from insurance coverage, patients will not be able to afford the new drug either. (Id.)
Production Vagaries and Drug Shortages
According to Mashhadi, Association representatives and doctors have complained to the MHME that the market availability and production quality of domestic thalassemia drugs are erratic and “some pharmaceutical companies have been inconsistent and changed the source of effective constituents of medicines, which has caused side effects in patients.” (Id.) Arasteh declared that “these drugs were not produced [in Iran] in the second half of last year and Thalassemia patients have had to cope with a shortage of the drugs for five months.” (Law Creating Hurdles for Thalassemia Patients, supra.) In Arasteh’s view, “[i]f pharmaceutical companies are going to follow the law, they absolutely must meet the standards of foreign meds and ensure constant production; they can’t just stop making drugs for a while.” (Id.) The problem of the domestic shortage is further complicated by the existence of a shortage of the foreign medicines as well. (The Exclusion of Thalassemia Drugs from Insurance Coverage, supra.)
Response of Iranian FDA
A month after Arasteh and Mashhadi’s statements to the media, Farzad Pirouyan, deputy director of Planning and Programs at the Iranian FDA, responded to the concerns about the removal of the thalassemia drugs from insurance coverage, saying that while mandating insurance coverage only for generic drugs “is now the generally accepted trend,” an exception would be made for some medicines for particular chronic and difficult-to-treat conditions, including thalassemia. (The Reaction of the Food and Drug Administration to Some Concerns About Insurance Coverage of Different Drugs, EBTEKAR NEWS (Aug. 26, 2017) (in Persian).) Pirouyani stated that because, unsubsidized, the cost of these foreign drugs is too steep to allow patients with chronic conditions to procure them, the Iranian FDA has drawn up a memorandum of understanding with insurance organizations approving the continuation of long-term subsidized coverage of these drugs. (Id.) However, at present, no further details about the extension of this coverage have been reported.