Overview of Biologic Drugs
2023 Update: We filed this case against UnitedHealthcare that resulted in the insurer overturning its denial of medically necessary ulcerative colitis biologic medications.
Medical therapies that are derived from living organisms (microorganisms, animals, plants, and humans) are referred to as “biologics.” More traditional prescription drugs are non-biologic, in that they are synthesized in the lab without using parts of living things. Insulin was one of the first drug therapies to use biologics but since the 1990s, the number of biologics on the market has greatly increased. To ensure safeguards in the production of biologics, Congress passed the Biologics Control Act in 1902. This gave the government the first control over the process used to make biologics, as well as ensuring the safety of Americans.
Different biologics work differently. As an example, Actemra, a biologic used to treat rheumatoid arthritis, belongs to a class of biologics known as monoclonal antibodies. This type of antibody does not fight infection like the antibodies your body makes naturally but has been formulated to specifically target autoimmune conditions like rheumatoid arthritis. IL-6 is a cytokine that binds cells and sends signals, increasing inflammation and worsening conditions like rheumatoid arthritis.
Actemra and other tocilizumab monoclonal antibodies partially block the IL-6 receptor, decreasing symptoms. Monoclonal antibodies begin with the production of mice antibodies. Scientists modify those antibodies, replacing large portions with antibodies from humans. These “hybrid” antibodies are then given to patients to help their bodies respond to IL-6. Biologics are much more expensive than non-biologic drugs because the manufacturing process is complex. Overall, biologic drugs are much more targeted.
As an example, methotrexate is a non-biologic drug used in the treatment of rheumatoid arthritis. When methotrexate is given to a patient with rheumatoid arthritis, it can affect many different areas of the patient’s immune system. In contrast, biologic therapies for rheumatoid arthritis block very specific receptors, decreasing the likelihood of certain side effects. Most biologics are given by injection or infusion because they are heat and light-sensitive.
How Are Biologic Drugs Made?
Biologic therapies are not simple laboratory mixtures like conventional drugs, rather they use living organisms like cells, tissues, bacteria, and yeast in a highly complex manufacturing process. As an example, a biologic used to treat rheumatoid arthritis would have a piece of DNA put into a living cell then that DNA would instruct the cell to produce a large amount of a specific molecule (usually a protein). That molecule is then isolated, getting rid of the living cells and other materials, with only the desired molecules remaining. These molecules become the active ingredient in a biologic drug. Unlike “traditional” drugs, the molecules in a biologic drug are lacking in uniformity and have weak chemical bonds that can degrade when exposed to rapid temperature changes. Even minute differences in manufacturing, packaging, storage, and administration of biologic drugs can affect the drug’s effectiveness. Since biologics are so difficult to characterize, FDA approval is based solely on the manufacturing process, ensuring consistency.
How Do Doctors Use Biologic Drugs for Treatment?
The most commonly used biologics are for autoimmune diseases in which the immune system attacks its own tissues. Rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and psoriatic arthritis are just a few of these autoimmune diseases. Because biologics are expensive and difficult to administer, they are often given after other, non-biologic drugs have been tried. One biologic therapy for autoimmune diseases is the TNF blocker. TNF blockers include Enbrel, Humira, and Remicade—all drugs that block the inflammatory effects of an immune molecule known as TNF-alpha. Biologic therapies are used to treat cancer—sometimes as a first line of treatment, others used after first-line treatments have failed or in more advanced cancer cases. Biologics are also being used to treat rare genetic diseases such as hemophilia, Gaucher disease, sickle cell disease, and other genetic immune disorders.
How Are Biologic Drugs Different from Other Drugs?
As noted, the manufacturing process is entirely different in biologic drugs than in traditional drugs. Most drugs are chemically synthesized, and their structure is known whereas biologics are much more complex mixtures that are not easily characterized or even identified. Biologics are extremely vulnerable to heat and are much more likely to be contaminated by microbials than traditional chemically synthesized drugs. Traditional drugs like penicillin and aspirin, or even a statin like Lipitor, are small molecule drugs. They have dozens of atoms and are made in bulk in a chemistry lab. Biologics contain large proteins with hundreds of thousands of atoms and are made inside living cells. Because DNA in those living cells is altered, biologics are difficult to manufacture. After a specific number of years of exclusivity, traditional drugs must yield the way to generics which drive down spending on a specific class of drugs. There are no generic versions of biologics, allowing drug companies to continue to bring in profits years after losing patent protection because there is virtually no incentive for lowering the cost. This at least partially explains why a single prescription for a biologic drug that treats rheumatoid arthritis can cost as much as $3,000.
What Conditions Are Biologic Drugs Used to Treat?
There are many classes of biologics, including:
- Antitoxins to treat snakebites
- Steroid hormone therapies
- Blood and platelets
- Recombinant proteins used for insulin
- Interleukins used to treat cancers and certain infections
- Gene therapies for genetic conditions
- T cells to treat cancer
- Stem cell therapies for cancers and genetic diseases
- Monoclonal antibodies to treat autoimmune diseases and cancer
- Tendons, ligaments, and other transplant materials.
Currently, the primary use of biologics is to treat autoimmune diseases like rheumatoid arthritis and Lupus.
What Are the Top Biologic Drugs and What Are They Approved to Treat?
The top biologics currently being used in the United States include:
- Humira, used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, Uveitis, polyarticular juvenile arthritis, and hidradenitis suppurativa
- Rituxan, used for rheumatoid arthritis, chronic lymphocytic leukemia, non-Hodgkin’s lymphoma, granulomatosis, and pemphigus vulgaris
- Enbrel, used for psoriatic arthritis, plaque psoriasis, rheumatoid arthritis, ankylosing spondylitis, and polyarticular juvenile arthritis
- Herceptin, used for HER2+ breast cancer and HER2+metastatic gastroesophageal adenocarcinoma
- Avastin, used for cervical cancer, hepatocellular cancer, colorectal cancer, renal cell carcinoma, epithelial ovarian cancer, fallopian tube cancer, and non-squamous non-small cell lung cancer
- Remicade, used for rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and ulcerative colitis
- Lantus, used to treat diabetes
- Neulasta, used for cancer chemotherapy
- Avonex used for multiple sclerosis
- Lucentis, used to treat age-related macular degeneration and diabetic retinopathy
What Are the Anticipated Biologic Drugs and What Will They Treat?
There are a number of new biologics that will be released within the next few years. Some of the more promising biologics include:
- Donanemab to treat Alzheimer’s disease, expected by 2024-2026
- Gantenerumab, also used to treat Alzheimer’s and is also expected by2024-2026
- Deucravacitinib, used for plaque psoriasis, will possibly launch in 2022 or 2023
- Adagrasib, used to treat non-small cell lung cancer, is possibly set to release in late 2022 or 2023
What Are Biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs)?
Disease-modifying antirheumatic drugs are a class of drugs used for ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis. DMARDs may also be used to treat lupus, Sjogren syndrome, and connective tissues diseases as well inflammatory bowel disease, uveitis, myositis, vasculitis, and certain types of cancer. DMARDs can be “conventional,” or biologic. Conventional DMARDs include methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine. Biologic DMARDs include tofacitinib, tocilizumab, rituximab, abatacept, rituximab, etanercept, adalimumab, and infliximab.
DMARDs interfere with critical inflammatory pathways with biologics being very selective in how they work. Biologics interfere with cytokine function or production, inhibit the “second signal” required for T-cell activation, or deplete B-cells or inhibiting factors that activate B-cells. Traditional DMARDs help prevent joint damage and deformity from rheumatoid arthritis with the drug methotrexate being the “gold standard.”
Biologics are a more targeted approach to rheumatoid arthritis and are truly a godsend for those who need more than traditional DMARDs. They do, however, come with a much higher price. Many doctors are using DMARDs in combination with each other—pairing a traditional DMARD with a biologic. Only one biologic is prescribed at a time, but if a drug like methotrexate is not working, the doctor may add a biologic, switching to different biologics until the best results are achieved.
What Do I Do When My Insurance Company Won’t Approve Biologic Drug Prescriptions?
What do you do when your doctor prescribes a biologic that he or she believes will greatly improve the symptoms of your rheumatoid arthritis or other autoimmune disease, but your insurance company refuses to pay for the drug?
These drugs are expensive and may especially be denied by your insurance company when prescribed in combination. In fact, biologics account for less than 3% of prescriptions but almost half of US drug spending. While your doctor is trying to find the combination of drug therapies that gives you the most relief for your symptoms with the fewest side effects, the insurance company can put a halt to this by refusing to pay for the biologics.
Some insurance companies will disallow all biologics until the patient has gone through a “step procedures,” others will refuse to allow the drugs in combination with one another, while still others will flat out deny the drugs you need for your disease. Health insurance companies often deny DMARD biologics like Stelara, Remicade, Enbrel, Entyvio, and Humira even though many patients with severe autoimmune diseases can benefit greatly from them.
The insurance companies may have medication policies that determine when medications will be authorized for certain diseases. These policies may indicate that Stelara, Remicade, Enbrel, Entyvio, and Humira are not medically necessary, but these decisions are often wrong, and the drugs are medically necessary. Some of the insurers who commonly deny these drugs include:
- Anthem Blue Cross
- Blue Shield of California
- Heath Net
- Kaiser Permanente
- OSCAR Health Plan
- Magellan Healthcare
- Molina Healthcare
- Regal Medical Group
If you have received a biologic drug denial or your insurance company won’t approve biologic drug prescriptions, you need immediate help. The Law Offices of Scott Glovsky is ready to fight for the drugs you need for your medical disorder or disease. Contact Scott today for a completely free case evaluation. We believe that insurance companies should honor their contract to safeguard your health, and we will always go the extra mile to be your advocate.
How The Offices of Scott Glovsky Can Help You Following a Biologic Drug Denial
When your health insurer issues a biologic drug denial, you may feel desperate and unsure of where to turn. Your doctor is telling you that a specific drug can help you feel better and allow you to live your day-to-day life, yet your insurance company won’t approve the biologic drug prescription. These denials are frustrating and even frightening. How do you fight a big insurance company, and how will you get by without the prescription? Inappropriate drug denials are simply wrong and require an attorney who is not afraid to go toe to toe with a huge insurance company. That attorney is Scott Glovsky, and the firm is The Law Offices of Scott Glovsky.
Attorney Scott Glovsky has been helping people like you for over two decades—people who do not know where to turn for the help they need. Many insurers deny expensive biologics as a matter of course, without even considering the ramifications. If a drug is medically necessary, then your insurance company should pay for the drug, yet many do not. You may be asked to go through the step process where you take a less expensive drug for sixty days to see if it helps your conditions, then step up from that drug and so on. You may have to go through many different drugs that do not work nearly as well as the initial biologic drug prescribed by your physician. The process can be grueling as you watch your health decline because you cannot receive the drug you need.
Attorney Scott Glovsky is a seasoned, experienced, knowledgeable, highly-skilled attorney who has helped change the lives of many by forcing an insurance company to change its denial decision. Scott is personally involved in every case, so when you hire the firm, you hire Scott. While Scott has a great support team, he is the lead attorney on every case. This is extremely beneficial for his clients because your lawyer should know you and your case inside and out. Scott will get to know you, your family, and your story in ways most attorneys simply do not. At The Law Offices of Scott Glovsky, we really care about our clients. We take fewer cases so we can devote the necessary time and effort necessary to represent each client. If you have been denied a prescribed biologic by your insurer, contact The Law Offices of Scott Glovsky today for a free case evaluation.