What are autoimmune disorders?
An autoimmune disorder is a condition in which the body’s immune system mistakenly attacks its own healthy cells and tissues. This can lead to a wide range of symptoms and health problems, depending on the specific disorder and the parts of the body affected.
What are the typical causes of autoimmune disorders?
The exact causes of autoimmune disorders are not fully understood, but they are thought to be multifactorial, involving a combination of genetic, environmental, and immunological factors. Some common triggers and risk factors include: genetics, infections, and environmental exposures.
Please provide brief medical details using RA as an example.
Rheumatoid arthritis (RA) is a chronic autoimmune disorder that primarily affects the joints, causing inflammation, pain, stiffness, and eventually joint damage. The immune system attacks the lining of the joints (synovium), leading to swelling and erosion of cartilage and bone. RA typically affects the hands, feet, and wrists symmetrically, but it can also involve other joints and organs.
What are the projections of the total number of patients in the U.S. with RA?
The prevalence of RA in the U.S. is estimated to be around 1.3 million adults, or about 0.6% of the population. The disorder is more common in women than men, and it typically develops between the ages of 30 and 60.
What is the nature of traditional treatments for autoimmune disorders?
Traditional treatments for autoimmune disorders have focused on suppressing the immune system and managing symptoms. These treatments can be broadly categorized into:
Non-steroidal anti-inflammatory drugs (NSAIDs): These medications help to reduce pain and inflammation.
Disease-modifying antirheumatic drugs (DMARDs): These drugs can slow the progression of the disease and help to prevent joint damage.
Biologics: These newer medications target specific parts of the immune system involved in the disease process.
Are traditional treatments for autoimmune disorders short-term or long-term?
The duration of treatment for autoimmune disorders depends on the specific disorder and its severity. In many cases, treatment is long-term or even lifelong, especially for chronic conditions like RA.
Which drugs provided the mainstay of treatments?
Before the advent of biologics, the mainstay of treatment for many autoimmune disorders was DMARDs, such as methotrexate, sulfasalazine, and hydroxychloroquine. These drugs are still used today, often in combination with biologics, to improve disease control and reduce symptoms.
What are the approximate treatment costs for traditional autoimmune disorder treatments?
The cost of traditional treatments for autoimmune disorders can vary widely, depending on the specific medications used and the duration of treatment. DMARDs can cost anywhere from a few dollars to several hundred dollars per month, while biologics can cost tens of thousands of dollars per year.
What is the timeline and history of the development of Humira, and which firms were involved?
1991: The Cambridge Antibody Technology Group develops technology for simplifying the discovery of human antibodies.
1994: BASF Pharma collaborates with the developers of the human antibody discovery technology.
1998: BASF Pharma releases positive results from a Phase I trial of D2E7 (now Humira) in rheumatoid arthritis.
2001: Abbott Laboratories acquires BASF Pharma’s business for 18.98 in sales, the highest-grossing drug of the year for the third in a row.
What were the costs of bringing Humira to the market?
The costs of bringing Humira to market are not explicitly stated in the provided text, however, it is mentioned that Humira has generated over 12.4 billion in U.S. sales for AbbVie.
Please provide a breakdown of the costs of bringing Humira to market.
A detailed breakdown of the costs of bringing Humira to market is not provided in the reference text.
What is the timeline of FDA approvals for Humira?
December 31, 2002: FDA Approves Humira (adalimumab) for Rheumatoid Arthritis
October 4, 2005: Humira Receives FDA Approval for Psoriatic Arthritis
July 31, 2006: Humira Receives FDA Approval for Treatment of Ankylosing Spondylitis
February 27, 2007: Humira (Adalimumab) Receives FDA Approval for Treatment of Crohn’s Disease
January 22, 2008: Abbott’s Humira (adalimumab) Receives FDA Approval for Moderate to Severe Chronic Plaque Psoriasis
February 22, 2008: Abbott Receives FDA Approval for Humira (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis
September 28, 2012: FDA Approves Humira to Treat Ulcerative Colitis
September 25, 2014: FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn’s Disease
September 11, 2015: FDA Approves Humira (adalimumab) for Moderate to Severe Hidradenitis Suppurativa
June 30, 2016: AbbVie’s Humira (adalimumab) Receives FDA Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis
March 30, 2017: FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie’s Humira (adalimumab) Prescribing Information
February 24, 2021: Humira (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis
What are the characteristics that defined Humira as the defining drug in this area of therapy?
Humira (adalimumab) is a fully human monoclonal antibody that specifically binds to TNF-alpha molecules, blocking their inflammatory effect. This reduces pain and inflammation in people with autoimmune diseases. Humira has been approved for the treatment of multiple diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, rheumatoid arthritis, and ulcerative colitis among others. The high price of Humira and its usage in multiple indications contribute to its strong market share.
What is the nature of innovation in Humira?
Humira is a fully human monoclonal antibody, which means that it is less likely to cause an immune response in patients compared to earlier biologic treatments that were derived from animal proteins. This innovation has led to improved tolerability and efficacy for many patients.
What is the timeline of cure/treatment using Humira?
Humira does not provide a cure for autoimmune diseases, but it can significantly reduce symptoms, induce remission, and slow the progression of joint damage in many patients. The timeline for response to treatment varies depending on the specific condition and its severity, but many patients experience improvement within a few weeks of starting treatment.
What are the approximate treatment costs for Humira?
Humira is one of the most expensive biotherapies on the market, with a typical patient cost between 2,600 per month.
Describe Abbott versus Pfizer as competitors to acquire Humira.
Abbott Laboratories acquired Knoll Pharmaceuticals in 2001, gaining full rights to Humira. Pfizer was reportedly interested in acquiring Knoll but was outbid by Abbott.
What were the main issues in Abbott versus Pfizer as competitors to acquire Humira?
The main issues in the competition between Abbott and Pfizer to acquire Humira were likely the potential blockbuster status of the drug and the desire to expand into the growing immunology market.
What was the motivation behind Abbott’s spin-off AbbVie?
Abbott Laboratories spun off its pharmaceutical business into AbbVie in 2013, primarily to separate its research-based pharmaceuticals from its diversified medical products business. This allowed each company to focus on its core strengths and pursue independent growth strategies.
Provide a stock market analysis and stock price changes over time for Abbott and AbbVie.
A detailed stock market analysis is not provided in the reference texts. However, several sources note that Humira has been a major contributor to AbbVie’s revenue and stock price performance since the spin-off.
What is the treatment price of Humira in the U.S.?
The price of Humira in the U.S. has increased significantly over time, from around 38,000 per patient per year in 2018.
Provide details about the costs and timeline of Humira treatment.
Humira is typically administered as a 40-milligram injection every other week. The cost of treatment can vary depending on insurance coverage and eligibility for discounts, but it can be a significant financial burden for many patients.
Provide international comparisons of Humira prices.
The price of Humira in the U.S. is significantly higher than in other developed countries. For example, in 2017, two kits of Humira Pen (40 mg) cost an average of 1,570 in Germany and $1,230 in Switzerland.
What are the implications of Humira’s pricing for healthcare markets?
The high price of Humira in the U.S. has several implications for healthcare markets, including:
Limited access for patients: The cost of Humira can be prohibitive for many patients, even those with insurance coverage.
Increased healthcare spending: The high cost of Humira contributes to rising healthcare expenditures in the U.S.
Potential for market distortions: The lack of price controls in the U.S. allows pharmaceutical companies to charge high prices for drugs like Humira, potentially distorting market dynamics.
What is the revenue generated by Abbvie from Humira?
AbbVie’s revenue from Humira has increased significantly over time, from around 21 billion in 2022.
What are the readings on Humira’s effectiveness?
Two relevant readings on Humira’s effectiveness are provided:
“2016 Humira RA Effectiveness Germany”
“2018 Humira AS Effectiveness Australia”
Using the main data presented, assess the benefits and costs of Humira.
Humira has been shown to be effective in reducing symptoms, inducing remission, and slowing the progression of disease in patients with various autoimmune disorders. However, the high cost of Humira can be a significant barrier to access for many patients.
Describe Humira Patents.
Humira is protected by a large number of patents, including patents on the drug itself, its manufacturing process, and its use in various indications. This “patent thicket” has been used by AbbVie to extend the drug’s market exclusivity and delay the entry of biosimilars.
What are the issues related to competition and entry by biosimilars?
The large number of patents surrounding Humira has made it difficult for biosimilar manufacturers to enter the market. Even after the expiration of the main patent on Humira in 2016, AbbVie has used its patent portfolio to delay the launch of biosimilars in the U.S. until 2023.
When was Amgen’s biosimilar entry?
Amgen’s biosimilar adalimumab-atto, Amjevita, was approved by the FDA in September 2016, but due to patent litigation and a settlement agreement with AbbVie, it was not launched in the U.S. until January 2023.
Briefly describe, with examples and numbers, the magnitude of the cost problems faced by the US healthcare system with Humira.
Humira is one of the most expensive drugs in the U.S., with a typical patient cost between 2,600 per month. The high cost of Humira has contributed to rising healthcare spending in the U.S., and has made it difficult for many patients to access this important treatment option.
Did the initial cost problems created by Humira for the US healthcare system change over subsequent years?
Yes, the cost problems associated with Humira have increased over time, as AbbVie has steadily raised the price of the drug. In 2012, Humira cost about 38,000 per year.
What are the main reasons for the changes in Humira’s cost over time?
The main reason for the increase in Humira’s cost over time is AbbVie’s pricing strategy, which has involved regular price hikes, often exceeding the rate of inflation. Additionally, AbbVie has used its patent portfolio to delay the entry of biosimilars, which could have helped to lower the price of the drug.