Published April 29th, 2020 by USA Rx
The recent approval of hydroxychloroquine by the Food and Drug Administration (FDA) for Emergency Use Authorization to treat patients who are hospitalized with COVID-19 has incited a rapid demand for the drug. Due to the pandemic, several existing drugs that are approved for other indications are now being investigated for their potential ability to treat COVID-19. Hydroxychloroquine is one of these drugs that has been at the forefront of potential candidates, and has received an immense amount of media attention due its promotion by President Trump and other high-profile celebrities who have praised it. What is the big deal with hydroxychloroquine? Is it a magical cure for COVID-19? The answer is that there is not currently enough data to draw a conclusion on whether this drug can effectively work to clear an infection due to COVID-19 in the human body. Before the FDA approves the use of a drug for a certain purpose, clinical trials are conducted to study whether the drug is beneficial to patients who have the medical affliction for which it is being studied. Clinical trials are now ongoing in the United States to study whether hydroxychloroquine is safe and effective in treating COVID-19, and the data from these trials will help answer this question. However, due to the lack of current treatment options for COVID-19, the FDA is allowing the use of hydroxychloroquine to treat patients who are hospitalized and cannot enroll in a clinical trial.
What is Hydroxychloroquine? Hydroxychloroquine is not a new prescription drug. It belongs to a well-studied family of anti-malarial drugs that are based on the compound, quinine, which has been used in some form or another for the treatment of malaria since the 1600s. What is hydroxychloroquine used for? The brand form of hydroxychloroquine, mainly known as Plaquenil, has been FDA-approved since the 1950s when clinical trials demonstrated its success in treating major autoimmune diseases like Lupus and Rheumatoid Arthritis. For years, hydroxychloroquine has been the first-line therapy for patients with Lupus. Patients who are diagnosed with Lupus most likely have to take the drug regularly for the rest of their lives. This means that the cost of the drug is a large factor in determining how much Lupus patients have to spend on healthcare per year. For a drug like hydroxychloroquine, the generic form has been available since 1995. In general, generic drugs that have been on the market for more than 20 years usually maintain a low and affordable cost. Hydroxychloroquine has been an exception in this trend though, and is known to be more expensive than other older generic drugs in its group. The relatively high cost of hydroxychloroquine has been a concern in the Rheumatology field, with doctors concerned that their Lupus and Rheumatoid Arthritis patients may not be taking their prescribed drug regularly because they cannot afford to purchase the drug. Taking regular medication is crucial for these patients to manage the symptoms of their disease and maintain their well-being.
What makes the cost of hydroxychloroquine so high compared to other generic drugs? To understand this, let’s take a look at the average price per pill of the drug over the years. Before 2013, drug manufacturers had priced hydroxychloroquine at $0.10 per pill. This is quite cheap for a generic drug, and for one that is as seasoned as hydroxychloroquine the price is not surprising. This price had also been stable without fluctuation for many years. But in 2017, the price of 60 tablets of 200 mg of hydroxychloroquine was on average $220, meaning that the average price per pill rose to $3.66 in just a few years. Interestingly, this steep increase in price was not a general trend for other generics that are as old as hydroxychloroquine. The hike in price of the drug could only be due to some factors that were specific to hydroxychloroquine. This year, the drug is priced more reasonably at an average of $40 for 50 tablets of 200 mg dosage, making the price per pill closer to $0.80. Although this price is much lower than when it was at its peak a few years ago, hydroxychloroquine is still considerably expensive compared to how cheap it was before 2013.
The biggest factor was market-based, in which there was a sudden shortage of the drug on the market. Ranbaxy Pharmaceuticals was one of the major manufacturers of hydroxychloroquine with a majority of the market share. In 2014, Ranbaxy faced regulatory issues with manufacturing certain drugs and hydroxychloroquine was one of them. The FDA prohibited Ranbaxy from distributing these drugs until the problem was corrected, and since Ranbaxy owned most of the market share for hydroxychloroquine, the result was a severe shortage of the drug. Due to the steady demand of the drug by Lupus patients who do not have any other option but to continue taking the drug, the price of the drug rose dramatically.
Most Americans use some form of health insurance to cover the cost of their prescription drugs. How much they have to pay for the drug out-of-pocket depends on their individual health insurance plan and premiums that come with these plans. This factor plays a big role in how expensive a drug can be to a patient. For example, during the hydroxychloroquine drug shortage by Ranbaxy in 2014, one of the major health insurance providers, Medicaid, dispensed most of its drug through this company. When the drug shortage happened, Medicaid could not access the drug leading to an inability of patients with this insurance fill their prescription. Subsequently, more drug manufacturers started producing hydroxychloroquine, which finally brought the cost of hydroxychloroquine back down. However, the price has not gone back to its original $0.10 per pill that was seen before 2013, making the current price of hydroxychloroquine still quite expensive for patients who must take it regularly. Additionally, hydroxychloroquine is a ‘Tier 2 generic drug’ according to the Medicare prescription drug coverage plan. This means that the drug will have a moderate co-pay, averaging between $15-$50 every time the prescription is filled. For patients that have to fill their prescriptions more than once a month on this insurance plan, costs of co-pay can add up.
Hydroxychloroquine is a drug that is commonly prescribed for indications that the FDA has not specified it should be used for. One example of this is the use of hydroxychloroquine to treat Sjögren’s Syndrome, a rare autoimmune disease that affects moisture- producing glands in the body. This disease does not have any other drugs that work to treat it, so physicians prescribe hydroxychloroquine even though clinical trial data has shown mixed results in whether or not it actually works to treat the disease. Off-label use of hydroxychloroquine can increase the amount it is prescribed, and this can contribute to the overall market cost of the drug.
Currently, there has been a recent surge in the demand of hydroxychloroquine due to COVID-19. Although it is not yet proven to be safe or effective in treating this disease, pharmacies across the nation are experiencing an increase in people trying to purchase hydroxychloroquine. In early January, Rising Pharmaceuticals, a major supplier of hydroxychloroquine doubled the price of hydroxychloroquine. However, once hydroxychloroquine was considered as a potential therapeutic agent for COVID-19, the company slashed the price of hydroxychloroquine to half of its original price before the price increase.
What is concerning about the sudden interest in hydroxychloroquine, is patients who desperately need the drug, often for life-saving reasons, are now facing a shortage again. The majority of these patients use hydroxychloroquine for FDA-approved indications like Lupus and Rheumatoid Arthritis. After experiencing a similar predicament in 2014, these patients are now facing this situation again. With the recent announcements by pharmaceutical companies that they will offer the drug for as low as $1 to make it readily available for the potential treatment of COVID-19, patients currently on the drug for its FDA-approved uses remain concerned that they will experience a prolonged shortage of the drug. More companies are starting to manufacture the drug though, so time will tell whether the cost will remain steady with the increased demand.
It is extremely important not to self-medicate with hydroxychloroquine as it is associated with some serious side effects like retinal toxicity and heart failure in some individuals. If you are prescribed hydroxychloroquine and need to purchase it, especially for a long-term condition like Lupus, finding ways to save on the drug will be a priority for you. Often, the cost of hydroxychloroquine is cheaper with a drug discount card or drug coupon than it is with insurance. You can save more than 50% on hydroxychloroquine by using the drug discount card offered by USA Rx. There are no restrictions to who can sign up for this free card. All you need to do is sign up for the card online and present it at your pharmacy to start saving. Even with an average savings of 52.5% through USA Rx, the cost of hydroxychloroquine varies between $42 to $137 for 50 tablets of 200 mg depending on the pharmacy. Without a discount, the price is much steeper. More information on how much hydroxychloroquine costs at your pharmacy can be found here. Taking your medication regularly and as prescribed is important, so don’t let the cost of hydroxychloroquine stop you from obtaining your medication.