Impact of COVID on Humira: An Analysis
Sir William Osler, one of the co-founders of the Johns Hopkins Hospitals, had once correctly said, “Medicine is a science of uncertainty and an art of probability”.
The gravity of the statement is realized every passing day, especially when mankind is battling with a threatening virus COVID-19. While it has turn around our lifestyle for good, it has also brought with it a baggage of complexities with it that seem to have no solution at sight.
One such dilemma is the Humira (scientific name adalimubab) , US’s №1 selling drug. This is where Osler’s ‘science of uncertainty’ gets clearer. Humira was designed to eliminate a number of chronic disorders, but at this time when COVID is already beating human immunity, Humira’s role in ‘healing’ people is being countered for more than one reasons.
As per Statista.com, it is said to have generated a revenue of 20 billion dollars for the company AbbVie (a subsidiary of Abbott) in 2018 alone. The upward movement of the sales graph was unstoppable since, until in 2019 when it witnessed a slight drop in revenues (nothing insignificant though); The reason unknown. We cannot yet link it to COVID, which had made onset in the Asian countries like China and Japan in early November 2019 and which are the top consumers of the medicine after the United States. However, we cannot even deny its role at all! Here’s why?
The deadly concoction- Humira and COVID
Humira, when administered, suppresses the immune system, which exposes consumers to more deadly viruses and bacteria. Some of the most common side effects of the medicine are tuberculosis (TB), invasive fungal infection, and lymphomas (cancer of the immune system). On the contrary, the only prescribed way to combat COVID is enhancing the immune system.
Rumoured reports of COVID death caused due to Thrombosis or clotting of blood merely adds up to the dilemma of using the medicine, especially because blood reactions and worsening congestive heart failure are some of the other side effects of Humira. Now, how complicated could that be?
The scale and adversity can be gauged by the following numbers as provided by the FDA.
Between 2013 and 2017, Humira was directly connected to more than 209,000 adverse event reports, which surprisingly included more than 4,200 deaths. In the year 2014, Humira ranked №1 in the number of total reports reaching the FDA and was ranked №2 for reports causing serious injuries occurring in the United States. The FDA received 46,937 reports of adverse events, which included 1,125 cases of deaths and 12,270 serious injuries. Interestingly, three-quarter of these reports came from consumers.
However, that did not deter its prescription rate, which is evident from the jump it projected from 1.5 million in 2011 to 2.4 million in 2015, as per data from the IMS Health (provided in MEDPAGE TODAY).
Humira’s status in the US
Humira is the top selling prescription drugs in the US. This, in context of the number of people using prescription drugs in the States is rather alarming. According to a 2019 report by Bloomberg ‘Nearly One in Two Americans Takes Prescription Drugs: Survey’, close to 46% of the US population have been using one or more prescription drugs in 30 days.
The trend of using prescription drugs and the fact that Humira is used prevalently among the older age groups suffering from Rheumatoid Arthiritis, Psoriatic Arthiritis, Ankylosing Spondilitis, Adult’s Chron’s disease, Ulcerative Colitis, and Plaque Psoriasis (Source: FDA.gov), may face a double dilemma of whether or not its administration be continued in the face of COVID.
It is noteworthy that the United Nations, in its policy brief ‘The Impact of COVID-19 on older persons’, stated that people dying from COVID above 80 years are five times than the average rate. Almost 66% of the people above 70 have one underlying condition, which places them at high risk of contamination. And, the United States is already struggling with its growing older population. According to the National arthritis prevalence statistics provided by CDC.gov, between 2013–2015, an estimated 54.5 million US adults above the age of 18, accounting for 22.7% annually have been told by a doctor that they had some form of arthiritis, rheumatoid arthritis, lupus, gout, or fibromyalgia. Arthiritis.org corroborates, further elaborating that in rural US, one in three adults have arthiritis. For the age group over 65, the numbers are much worse.
According to a report by IQVIA.com, the need for treatment of rheumatoid arthiritis will only go up in 2020 and that there will be more competition in the biosimilar market for the same, which forms a large part of therapeutic medicines; This, when spending on the drug alone in the US as an anti-inflammatory drug triple from $4.5 billion, implying Humira is more than likely to be continued to be prescribed.
Going further, Lymphoma comprises 4% of all cancers in the United States and it is considered to be the 7th most common cancer in both men and women. As elaborated by Cancer.net, in 2020 an estimated 77,240 people will be diagnosed with the disease. Adults above the age of 65 are more prone to the disease and the risk increases with age. In fact, over half of the patients are age 65 or older when diagnosed.
Forget arthiritis, it is equally frightening when we come across the fact that close to 1.3% of the US population, irrespective of the age group, suffer from the Chron’s disease, which again requires the administration of Humira in severe cases.
Similarly, according to Centers for Disease Control and Prevention up to 13 million people in the US live with latent TB infection. 9,025 people were confirmed TB cases in 2018. It is also noteworthy that presently more than 8 million people are suffering from painful psoriasis, which has Humira as the only means of treatment.
It is definite death for these populations as COVID is here to stay for the next 2 years, at least and so is Humira, given the medical complications and the ageing population that the United States is likely to witness in the coming years. But does that really justify the slight dip in the sales of the drug?
Let’s dive deeper.
Joining the dots
The number-crunching is a mere exercise of connecting the dots that can lead us to the destiny of Humira and the love-hate scenario it might be facing right now. We really cannot make any direct implications since prescription medicines, especially those used for long-term therapies have various conjoining factors working at the background. For instance, the tolerance level of the patients to the drug, their recovery from less-invasive medicines before being prescribed the medicine, and most of all their purchasing power.
All said, even if we assume that the drug is less likely to be given to everyone suffering from the afore-mentioned clinical conditions, how many people can actually buy it? If that is the case, how is it still the most sold prescription drugs in the US? Here’s an interesting twist- the Pricing.
Humira comes in three forms- as a single-dose pen, a single-dose pre-filled syringe, and a single-dose vial of liquid solution. According to MedicalNewsToday, the price of Humira (2 pens of 40 mg/0.8 ml single carton) could be varying, but costs approximately $5678, which is a fair price that patients may get after medical assistance and insurance coverages or with the use of Humira Complete Savings Card. One can imagine how much it may cost without these. According to a Fortune report, the US list price of the standard 40 mg Humira injectible pens, which is used in the treatment of rheumatoid arthritis was priced more than triple its original price in 2006, amounting to $58,612 in 2017. This was deduced by the AARP Public Policy Institute and the University of Minnessota’s PRIME institute.
As per an article by the Washington Post, Humira’s manufacturers priced it at an excess of 7% , which followed the price hike of 19% during 2017 and 2018, as per a survey by the Institute of Clinical and Economic Review (ICER). Interestingly, the organization deemed the rise unjustified basing on the “inclusion criteria of new information on benefits and/or harms within the indications and account for greater than 10% of use”; An indication of a long forsaken investment on research and development and inclination of the pharmaceutical giant manufacturing it toward advertisement and marketing.
Another deterrent when it comes to buying the drug, especially when people are already paying a high price for recovering (or otherwise) from COVID.
This lands us in a hypothetical situation where Humira is no longer the champion product of Abbvie, taking down its market value in the United States and the rest of the world.
Humira and the world market
According to a 2019 Fortune report, the drug alone brought in approximately $20 billion in global sales in 2018. The drug earned AbbVie a whopping $32.8 billion in 2018, giving the company a winning spot of No 381 on that year’s Global 500 in terms of revenue growth. The drug gradually took over maximum of the company’s revenue share at 60% in 2018, beating all the other drugs it marketed. Now, here comes an interesting catch. Humira gained achieved this fete 2 years after its patent with AbbVie expired.
The same magazine report explains how the company decided to function to protect its legacy of marketing Humira. It not just bought every patent that came in the market and won 75 of them in this course, but also sued anyone who came any closer, thus retaining its position as the world leader in the drug sale.
But this position is not easy to be maintained because it required constant vigilance for competition, which AbbVie has been able to ward off with its own complex patenting processes. Albeit the furious retaliation by other competition drug companies launching biosimilars and the grocer’s union, which raised voice against the unprecedented price hikes, AbbVie really has nothing to worry about.
All said, the company and its biosimilar competitors might have reasons to worry now. They all might have to think out of the “black precaution box” that lists the number of side effects they may have on patients. They all have to evolve, waking up to the present pandemic scenario. This is not withstanding the competition Humira is facing in Europe and the rest of the world, leading to a drop in sales in the first quarter of 2019 to 5.6%.
While other drug companies may have a plan ‘B’, will Humira survive the crashing demands of COVID? If yes, how? Because it has not been showing any inclination toward revolutionizing the medicine as per the changing complexities of virology. And if Humira is indeed stubbed by COVID survivors or sufferers, how will it run the brand legacy?
Of course, it has some of its own patented drugs to fall back on, but they have equal competition in the market, have sufficient pricing options, and better research standing in some cases. To sum it up, AbbVie really cannot have a reliable Plan ‘B’. More so, because its “Blockbuster model” is no longer supporting the ideas of “medicine for health”, but following the much-criticized “medicine for profit” model.
Add to it the mistakes it has been making in identifying the right acquisitions. Its acquisition of Stemcentrx for its much-acclaimed lung cancer treatment called Rova-T and its own Venetoclax for blood cancer multiple myeloma, both had disappointing results in the clinical trials.
The bins spilt, the investors in the company are no longer interested in it. While the med seems to have already lost a global battle, it still rides high in the US market because of its sole legacy. However, already struggling with its sales in the other domains because of lack of R&D, it remains to be seen how Humira manages to ride the COVID tide in US (which to date has 2,837,612 cases) and outside it. Needless to say, when the numbers are increasing.
So, can we bid Humira goodbye for good?
AbbVie should let its guards down for a change
“It is better to burn out than fade away”
To survive, AbbVie has to:
· Stop being the lone ranger in the therapeutic medicine market. It has to stop winning every patent and let competitors in.
· Be a little lenient on the pricing, which would be an indirect reaction to the patent war or the lack of it.
· Increase its investments in the R&D, which was the sole motto of the company created by Abbott. In other words, it has to go back to its roots for which the company has been earning public priority.
· Evolve Humira to meet the present virology situation and could add components that help fight COVID rather than increasing the chances of infection.
· Make SCM tech- and eco-friendly and make details accessible for public view.
While all the first four options have already been discussed in the essay, the last one holds the trump card for Humira’s destiny, especially in the times of COVID when pharma manufacturing companies are looking forward to bringing a significant change in their SCM, involving iOS-enabled engineering and contact-less operations.
Technology in the manufacturing of Humira would require particular attention.
Can technology help Humira stand the test of time?
Unlike other drugs that are chemically synthesized, Humira is a ‘biologic’ derived from actual biological material, which adds to the complexity of its manufacturing.
Clinically testing drug is time consuming, which pans over years involving an investment of billions of dollars. AbbVie could use technologies like Machine Learning and Artificial Intelligence to see what researchers cannot see at the inception stage of an evolution. This is particularly helpful if the company decides to work on the COVID-inclusive treatment model for Humira.
Technology can identify the pain points of a research and tell whether the end product will be workable at all, in many cases before even the compound even goes for clinical testing. This allows researchers to change compounds or ingredients to maintain the therapeutic effects, or scratch the entire process if there’s no hope at the end of the production line. This not just saves time, but also money, thus impacting the end price of the drug.
Big Data is said to be another factor that helps in launching new medicines in the market sooner because data mining for researchers is easier who need references and peer-reviewed biomedical journals to avoid unnecessary experimenting. Researchers can also check if a drug could be repurposed for multiple benefits, which is the demand of the time.
Coming to the packaging and distribution of the drugs, AbbVie can use the Rapid Scanning technology for cashless stocking, picking, inventory management, and delivery reducing the chances of viral contamination.
Many companies that perform tracking, such as TrackTraceRX and Axway, have come up with innovative ideas to speed up the supply chain management at various levels to fight counterfeit drugs. TrackTraceRx, for instance, has taken extra care in understanding the pain points of various levels of the supply chain management, being the first among its competitors to integrate the Fishbowl technology to their systems so that tracing is easy and contact-less at every juncture.
Availing the help of these technologies will only add to the brand value of AbbVie and its end-users may start relying on it yet again; Thus, making the company’s target of reaching $15.23 billion (as per Pharma Manufacturing) by the year 2024 achievable. AbbVie can still mint money on its brand name, which has a worldwide preference over other brands. But if that is an ethical way of serving the healthcare industry is something that the company has to decide and act upon.
