Lawyers to Help with Gene Therapy Drug Insurance Denials
Gene therapy may truly feel like a lifeline for those with serious diseases, yet when they receive a gene therapy drug insurance denial, that lifeline feels as though it has been jerked away. If you or a loved one have been told by your doctor that gene therapy could offer the hope for treatment and recovery you need, yet your insurance company denies payment for the treatment, attorney Scott Glovsky can help.
Scott understands how discouraging—not to mention potentially damaging to your health—it can be to spend years paying health insurance premiums only to have your legitimate claim denied. At the Law Offices of Scott Glovsky, we fight for your rights so you can receive the medical treatment you need. When your health and your future are at stake, choosing a highly experienced insurance bad faith attorney like Scott Glovsky can make all the difference.
Attorney Scott Glovsky knows every tactic used by insurance companies—delay, deny, underpay. The consequences of these tactics can range from inconvenient to catastrophic. Having Scott on your side after your insurance company has denied your doctor’s request for gene therapy can change your life from disheartening to hopeful once again. If you are in California, call the Law Offices of Scott Glovsky immediately. We have offices in Claremont and Pasadena and can help residents across the state of California.
What is Gene Therapy?
Medical techniques that use genes to treat or prevent disease are known as gene therapy. The theory of gene therapy is that doctors can treat a disorder by inserting a gene into the patient’s cells rather than using surgery or drugs. There are several approaches to gene therapy, including the following:
- When a mutated gene is functioning improperly, doctors use gene therapy to inactivate or knock out the malfunctioning gene.
- A healthy copy of the gene can replace a mutated gene that is currently causing disease.
- A new gene can be introduced into a body to assist in fighting disease.
Gene therapy is currently being tested for diseases for which there are no known cures. Gene therapy is promising on several fronts, including specific viral infections, certain types of cancers, and some inherited disorders.
What are the Goals of Gene Therapy and How Does It Work?
The goal of gene therapy is to introduce genetic material into a patient’s cells. This genetic material is introduced in an attempt to compensate for abnormal genes or to produce a beneficial protein. In some cases, a mutated gene can cause a necessary protein in the body to be flawed or to be missing altogether.
When a normal gene copy is introduced, the function of the necessary protein can potentially be restored. Genes are not introduced directly into a cell, because they do not function in this manner. Certain viruses may be used as the “vector” for introducing a gene into the body, as it then has direction and magnitude.
When genes are introduced via a virus vector, the virus is modified to avoid causing disease. Some types of viruses (like retroviruses) introduce the new gene into a chromosome in the human cell. Adenoviruses introduce DNA into the nucleus of the cell. The vector virus may be administered via IV into a specific tissue in the body.
Individual cells “take up” the gene. The patient’s cells may also be removed, exposed to the vector in a laboratory setting, then returned to the patient’s body. In this instance, when the gene therapy is successful, the new gene will create a properly functioning protein. The goal of gene therapy is to find better ways to deliver genes as well as better ways to target the genes to particular cells.
How Does Gene Therapy Help Patients?
Patients that have a certain disease could potentially be helped by replacing the mutated or defective gene with a healthy copy of the gene. Mutated genes that are not functioning properly, therefore causing disease in the body, can potentially be “fixed,” by turning the mutated gene off, or by introducing healthy genes that help the body fight the disease. Gene therapy can also work by exposing diseased cells to the immune system.
In some cases, the body fails to recognize cells that are a threat and can cause disease, so gene therapy “trains” the immune system to recognize these intruders. For patients who suffer from complex genetic disorders, gene therapy could truly be the light at the end of the tunnel. The gene therapies up for approval over the course of the next few years are largely focused on cancer treatments, while the others are meant to treat rare inherited genetic disorders.
Some of those inherited genetic disorders include:
- Oncological disorders
- Retinal disorders
- Musculoskeletal disorders
- Hematology/blood disorders
Are There Gene Therapy Drugs Currently Approved by the FDA?
Some forms of gene therapy have been approved by the FDA while others are available primarily in a research setting. There are hundreds of clinical trials currently underway that are testing gene therapy for use as a cancer treatment, genetic conditions, and even HIV/AIDS. If you are interested in taking part in a clinical trial that uses gene therapy, you can search online at ClinicalTrials.gov. The FDA website has an entire list of gene therapy drugs that have been approved by the FDA. The approved gene therapy drugs include:
- ABECMA (idecabtagene vicleucel) – Celgene Corporation, a Bristol-Myers Squibb Company
- ADSTILADRIN (nadofaragene firadenovec-vncg) – Ferring Pharmaceuticals A/S
- ALLOCORD (HPC, Cord Blood) – SSM Cardinal Glennon Children’s Medical Center
- BREYANZI – Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- CARVYKTI (ciltacabtagene autoleucel) – Janssen Biotech, Inc.
- CLEVECORD (HPC Cord Blood) – Cleveland Cord Blood Center
- Ducord, HPC Cord Blood – Duke University School of Medicine
- GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) – Organogenesis Incorporated
- HEMACORD (HPC, cord blood) – New York Blood Center
- HEMGENIX – CSL Behring LLC
- HPC, Cord Blood – Clinimmune Labs, University of Colorado Cord Blood Bank
- HPC, Cord Blood – MD Anderson Cord Blood Bank – MD Anderson Cord Blood Bank
- HPC, Cord Blood – LifeSouth – LifeSouth Community Blood Centers, Inc.
- HPC, Cord Blood – Bloodworks – Bloodworks
- IMLYGIC (talimogene laherparepvec) – BioVex, Inc., a subsidiary of Amgen Inc.
- KYMRIAH (tisagenlecleucel) – Novartis Pharmaceuticals Corporation
- LAVIV (Azficel-T) – Fibrocall Technologies
- LUXTURNA – Spark Therapeutics, Inc.
- MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane) – Vericel Corp.
- PROVENGE (sipuleucel-T) – Dendreon Corp.
- RETHYMIC – Enzyvant Therapeutics GmbH
- SKYSONA (elivaldogene autotemcel) – bluebird bio, Inc.
- STRATAGRAFT – Stratatech Corporation
- TECARTUS (brexucabtagene autoleucel) – Kite Pharma, Inc.
- YESCARTA (axicabtagene ciloleucel) – Kite Pharma, Incorporated
- ZYNTEGLO (betibeglogene autotemcel) – blubird bio, Inc.
- ZOLGENSMA (onasemnogene abeparvovec-xioi) – AveXis, Inc.
Why Would Insurance Deny Gene Therapy?
Despite the fact that amazing breakthroughs have recently occurred in the gene therapy field, these treatments can be expensive, causing many insurance companies to deny the treatment. That being said, insurance companies are slowly beginning to change their policies, thus allowing more people to receive these potentially life-saving treatments. Like many new treatments, gene therapy was once considered largely experimental, so it is taking time and information for insurance companies to reverse their policies regarding gene therapy treatments.
Currently, some insurance companies will approve gene therapy, but usually only for illnesses with no other known cures or treatments. One such disease is spinal muscular atrophy, a genetic disorder characterized by atrophy of skeletal muscles. When spinal muscular atrophy occurs, the nerve cells that control movement are lost, worsening over time, and significantly shortening a person’s lifespan.
Gene therapy may also be approved—depending on your insurance company—to treat a rare genetic vision disorder in children and adults. Luxturna was approved by the FDA in 2017 for treating this vision disorder by targeting vision loss caused by gene mutations. Zolgensma is another gene therapy treatment drug that treats children under the age of two with genetically linked spinal muscular atrophy (SMA). Zolgensma targets and repairs missing or non-functioning genes responsible for SMA. In the case of Zolgensma, the treatment must be administered as quickly as possible, before damage from SMA accumulates and is irreversible.
What Happens Following a Gene Therapy Drug Insurance Denial?
While it is not particularly unusual for insurers to deny certain claims, or refuse to cover a test, procedure, or service that your doctor has ordered, these decisions can definitely be appealed. Medicare claim denials can also be appealed. Once a claim is denied, you might ask for more information from a case manager or customer service rep before making a formal appeal. This information will also help your gene therapy drug insurance denial attorney fight the decision.
Your insurance company is required by law to tell you why your doctor’s request for a gene therapy drug insurance was denied and to tell you how long you have to file an internal appeal. In some cases—although gene therapy is unlikely to be one of these cases—you can re-submit your claim with a copy of your denial letter and information from your doctor that supports the treatment to have it coded differently.
If an internal appeal is unsuccessful, your next step is a formal appeal. It can be difficult to go through all the proper steps of a formal appeal if you are not familiar with the process. Having an experienced insurance denial attorney like Scott Glovsky on your side can truly make all the difference in the final outcome. Make sure you keep every piece of correspondence from your insurance company, as well as a log of dates, names, and conversations you have had regarding the denial.
How the Law Offices of Scott Glovsky Can Help with a Gene Therapy Drug Insurance Denial
If you or a loved one in California have had a gene therapy drug insurance denial, attorney Scott Glovsky understands the urgency of the situation and that this gene therapy could be your only hope for recovery. Scott helps clients with health insurance denials based on experimental or investigational treatments and will work to examine the reasons your claim was denied, investigate relevant case law, file the appropriate appeals, and go to court on your behalf. With offices in Claremont and Pasadena, we can help residents across the state of California fight insurance denials. Contact the Law Offices of Scott Glovsky today to get the help you need and deserve for a brighter future.