Lawyer to Help with New Cancer Drug Insurance Denials
Insurance companies seem to be denying claims for medical treatments or necessary prescribed drugs more and more often. This can be incredibly disheartening for those who pay their premiums faithfully, then need a specific cancer drug and find their insurance company has issued a new cancer drugs insurance denial. New, targeted therapies for the treatment of cancer are being developed almost daily. Unfortunately, there can be a significant lag between when these cancer drugs become available, and when an insurance company will recognize the drugs as more than experimental.
Since virtually all health insurance policies implement exclusions for experimental treatments, even if your doctor tells you a new cancer drug could potentially save your life, your insurance company may deny payment. As an example, one highly promising type of radiation known as proton beam therapy (PBT) is often challenged by insurance companies as being experimental. PBT can target radiation into tumors much more effectively than traditional radiation, damaging fewer surrounding tissues. While medical acceptance of this protocol is fairly widespread, insurance companies often deny the treatment, still considering it experimental.
Some forms of cancer treatment drugs can be denied under the guise of being “not medically necessary.” Even though insurance companies maintain they do not practice medicine, they routinely question the judgment of doctors regarding treatment. Not coincidentally, the denied treatments are often those that are more expensive—even when they have been shown to be more effective than less expensive treatments.
It can be totally disheartening to find that the company you paid to protect you has turned its back on you when you need help the most. Don’t give up! All you need is one person who cares enough about you and your future to fight on your behalf. That person is attorney Scott Glovsky. The Law Offices of Scott Glovsky has helped hundreds of individuals just like you who had reached their breaking point.
Scott Glovsky forces insurance companies to change their behavior—including their process of reviewing requests for medically necessary treatment, including a new cancer drug insurance denial. If you are in LA County—or anywhere throughout the state of California, for that matter—we can help. We have offices in Claremont and Pasadena for your convenience.
Cancer Drugs Subject to New Cancer Drugs Insurance Denial
While many drugs can be subject to an insurance denial, there are some specific cancer drugs that could be even more likely to be denied by your insurance company. These cancer drugs include:
- Rolvedon (eflapegrastim) is used to decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. This drug was approved for use on 9/9/2022 by the FDA.
- Pluvicto (lutetium (177Lu) vipivotide tetraxetan) is used to treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies. This drug was approved for use on 3/23/2022 by the FDA.
- Zynlonta is a prescription medication used to treat adults who have been diagnosed with specific types of large B-cell lymphoma that have either returned or did not respond to prior cancer treatments. Zynlonta is the first and only CD19-targeted antibody drug used for large B-cell lymphoma. Zynlonta is manufactured by ADC Therapeutics and was just approved by the FDA in spring 2021. Based on the overall response rate to Zynlonta, accelerated approval was obtained by the FDA. Zynlonta meets a prior unmet need for treating adults with large B-cell lymphoma (DLBCL) that have had little success with other treatments. DLBCL is the most common type of non-Hodgkin lymphoma in the United States. It is an aggressive disease that progresses quickly. Zynlonta brings hope to many who had no success with other treatments. In fact, more than 40 percent of first-line DLBCL treatments fail, resulting in a poor prognosis. Because Zynlonta is expensive and new, insurance companies may deny requests by doctors for this drug.
- Jemperli (dostarlimab) received accelerated FDA approval as a drug to treat recurrent or advanced dMMR endometrial cancer. A GARNET study represented the largest dataset for an anti-PD-1 monotherapy treatment among women with endometrial cancer, showing an overall response rate of 42 percent. Jemperli is manufactured by GlaxoSmithKline, indicated for patients with dMMR recurrent or advanced endometrial cancer who have progressed on or are currently following prior treatment. During the clinical trials, Jemperli was shown to have a high response rate and durability of response. Since about one in four women with endometrial cancer experience a recurrence, or are initially diagnosed with an advanced case, Jemperli may be a true game-changer. GlaxoSmithKline is currently studying Jemperli for use as an earlier treatment, as well as in combination with other treatments for women with advanced solid tumors or metastatic cancers. Despite its success in clinical trials, insurance companies may deny payment for Jemperli because of its relative newcomer status.
- Fotivda (tivozanib) gained FDA approval on March 10, 2021, to be used in adults with relapsed or refractory advanced renal cell carcinoma after two prior systemic therapies have failed to work. Fotivda is a kinase inhibitor, evaluated in a large clinical trial that resulted in a median progression-free survival of 5.6 months compared with those treated with a different drug. Median overall survival was 16.4 months, with an objective response rate of 18 percent. For those for whom other treatments failed to work, Fotivda could significantly increase the survival and response rates for those with relapsed or refractory advanced renal cell carcinoma. Fotivda received FDA approval three weeks ahead of goal.
- Pepaxto is an FDA approved drug used in combination with the steroid dexamethasone for the treatment of adults with relapsed or refractory myeloma. Patients for whom Pepaxto is approved are those who have received at least four prior lines of another type of therapy. The disease of these patients must be refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one CD38-directed monoclonal antibody. Pepaxto is the first anticancer peptide drug conjugate that garnered FDA approval. Pepaxto is expensive ($9,500 for a 20 mg vial) making it more likely insurance companies may deny the cancer drug despite significant evidence of efficacy. In the clinical trials, the overall response rate for patients taking Pepaxto was 23.7 percent. The median duration of response was 4.2 months.
- Cosela (trilaciclib) is a cancer drug approved by the FDA in February 2021. Cosela is a first line therapy that reduces the frequency of chemotherapy-induced bone marrow suppression in adults receiving chemotherapy for extensive stage small cell lung cancer. Cosela has been found to protect bone marrow cells from the damage chemotherapy can cause by inhibiting an enzyme known as cyclin-dependent kinase. When bone marrow is protected by Cosela, chemotherapy is safer, allowing more patients to complete their course of chemotherapy treatment according to their doctor’s plan. Chemotherapy drugs kill cancer cells, but they can also damage healthy tissue, particularly bone marrow. When bone marrow is damaged, it produces fewer red and white blood cells and platelets. This increases the level of fatigue, infection, and bleeding among those undergoing chemotherapy treatment. Over the course of three studies, patients receiving Cosela had a significantly lower chance of developing severe neutropenia compared to those who received a placebo. Among those who had severe neutropenia, those taking Cosela had it for a significantly shorter period of time.
- Ukoniq is a drug used to treat adult patients with relapsed or refractory marginal zone lymphoma (MZL). The MZL patients prescribed the drug must have received at least one prior anti-CD20 based regimen or, patients with relapsed or refractory follicular lymphoma (FL) must have received at least three prior lines of systemic therapy. Ukoniq is the first and only oral inhibitor of phosphoinositide 3 kinase and casein kinase epsilon. Accelerated FDA approval was granted for Ukoniq in February 2021, based on the overall response rate. Despite treatment advances, MZL and FL remain incurable diseases with limited treatment options until Ukoniq. Ukoniq is now offering a new treatment option for these diseases and new hope for the outcome.
- Tepmetko is an oral kinase inhibitor approved to treat patients with metastatic non-small cell lung cancer (NSCLC). Tepmetko is the first and only FDA approved MET inhibitor with once-daily oral dosing. Tepmetko was developed by Merck, a German-based pharmaceutical company. Non-small cell lung cancer is the most common type of cancer across the globe, with more than two million new cases each and every year. In the United States in 2020, there were 228,000 new cases of NSCLC. Symptoms of NSCLC include chronic cough, chest pain, decreased appetite, chronic lung infections, unexplained weight loss, wheezing, and a cough that produces blood. About 85 percent of all lung cancers are NSCLC. The FDA granted accelerated approval for Tepmetko in February 2021.
- Elrexfio garnered FDA accelerated approval and was introduced to the United States in the first week of August 2023. Elrexfio is approved for relapsed or refractory multiple myeloma and is manufactured by Pfizer. Multiple myeloma is an aggressive, currently incurable blood cancer affecting bone marrow plasma cells that make antibodies to help the body fight infection. There are more than 35,000 new cases of multiple myeloma diagnosed in the U.S. each year, making it the second most common type of blood cancer. Even those who are “successfully” treated will almost certainly relapse at some point, often becoming resistant to the three primary classes of treatment. Elrexfio can give these patients a renewed chance to extend their lives and have an improved quality of life. Elrexfio is a fixed-dose subcutaneous drug; after 24 weeks of weekly treatments, Elrexfio can be administered every other week for long-term dosing. Elrexfio is a type of immunotherapy that binds to B-cell maturation antigens (BCMA) on myeloma cells and CD3 on T-cells. The drug then brings the T-cells and myeloma cells together, activating the T-cells to kill the myeloma cells. Current data showed the objective response rate to be about 61 percent, with those who continued every other week dosing after the initial 24 weeks achieving better outcomes than those who discontinued the drug.
- Talvey is another new drug used to treat relapsed or refractory multiple myeloma among patients who have received at least four prior therapies. Talvey received FDA approval just days before Elrexfio, on August 9, 2023. Like Elrexfio, the prior treatment regimens likely include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Multiple myeloma that is not responding to other treatments or that has recurred may respond to Talvey, given via an injection under the skin, usually in the abdomen or thigh. Talvey, manufactured by Janssen Biotech, Inc., was also granted accelerated approval by the FDA. The most common side effects seen in clinical trials included changes in sense of taste, muscle and joint pain, fatigue, weight loss, and dry mouth. Talvey was generally well-tolerated by patients involved in the clinical trials. Talvey belongs to the bispecific antibody drug class that has transformed how certain cancers are treated. Bispecific antibodies target the G protein-coupled receptor Class C group 5 member D expressed on the surface of multiple myeloma cells, along with the CD3 receptor on the surface of T-cells. Talvey bridges the gap between T-cells and malignant myeloma cells by binding to those proteins.
- Vanflyta gained FDA approval on July 20, 2023, to be used as a part of a treatment regimen for those with newly diagnosed acute myeloid leukemia that meets specific criteria. Acute myeloid leukemia is an aggressive blood cancer; Vanflyta may be combined with chemotherapy among those diagnosed with AML who have a specific change in the FLT3 gene. About one-quarter of all those diagnosed with AML will have these FLT3 genetic mutations. In clinical trials, those with the FLT3 gene who received Vanflyta along with chemotherapy lived more than twice as long as those who received only chemotherapy. Vanflyta is only the second FDA-approved FLT3-targeted drug approved as a first-line treatment for those diagnosed with AML. The trials for Vanflyta were especially noteworthy, as they included many people over the age of 60 diagnosed with AML. As one of the most aggressive forms of leukemia, AML with the FLT3 mutation is even more aggressive, therefore, more deadly—and less likely to respond to traditional treatments. The QuANTUM-First trial, funded by Daiichi-Sankyo, the manufacturer of Vanflyta, had 539 participants. Forty percent of those participants were over the age of 60. Those who responded well to Vanflyta continued taking the drug for up to three years as maintenance therapy to prevent the disease from returning.
- Columvi is a new cancer medicine approved by the FDA on June 15, 2023. Columvi is used to treat diffuse large B-cell lymphoma or large B-cell lymphoma arriving from follicular lymphoma after the patient has tried two or more other types of therapy. Columvi treats this blood cancer among those who are not responding to traditional treatments or those whose cancer has returned. Columvi is manufactured by Genentech as a part of its portfolio of T-cell-engaging bispecific antibody treatments. Columvi gained accelerated FDA approval, based on the response rate seen in clinical trials. Genentech believes Columvi could change the manner in which aggressive lymphoma is treated, offering hope to those with the disease, along with an improved quality of life. Diffuse large B-cell lymphoma is an aggressive cancer that is known to be difficult to treat. DLBCL is the most common form of non-Hodgkin’s lymphoma in the United States. Patients with DLBCL who are unresponsive to traditional treatment as well as those who relapse and/or experience a rapid progression of the disease can significantly benefit from taking Columvi.
- Posluma, is used with positron emission tomography imaging in some patients with prostate cancer, gaining FDA approval on May 25, 2023. For men with prostate cancer with suspected metastasis, or those with recurrence, based on PSA levels, Posluma is used to detect and locate prostate cancer during PET scans. The imaging agent in Posluma is designed to bind to Prostate-Specific Membrane Antigens on prostate cancer cells, allowing physicians to accurately identify and locate those cells within the body. Common side effects of Posluma include increased blood pressure, injection site pain, and diarrhea. More severe, but less common side effects include blurry or tunnel vision, fast, irregular, or pounding heartbeats, loss of coordination, tremors, severe headache, and stiff muscles. Posluma may interact with other therapies that target the androgen pathways, such as androgen receptor antagonists. The manufacturer of Posluma is Blue Earth Diagnostics; Posluma is the first and only FDA-approved PSMA-targeted imaging agent with radiohybrid technology. Posluma became available in early June 2023, and is expected to become more available across the United States in the coming months. Two Blue Earth Diagnostics-sponsored Phase 3 trials provided the data for the FDA to approve Posluma. Results from these trials demonstrated high specificity in the detection of pelvic lymph nodes, and high detection rates even when PSA numbers were relatively low.
- Epkinly was approved by the FDA on May 19, 2023, as a cancer drug that treats relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma after two or more lines of systemic therapy have not produced the desired effects. Epkinly was not tested on children and is only approved for adults. Epkinly has some potentially serious side effects, including cytokine release syndrome, that can be serious or life-threatening. Because of this risk, Epkinly is only administered on a “step-up” dosing schedule, which includes smaller dosages of the drug on days one and eight during the first cycle of treatment. Prior to each dose in cycle one, you will receive medications that will help reduce the risk of CRS. Epkinly can also cause serious neurologic problems that can be life-threatening. Because of the potential risks, you will be hospitalized for 24 hours after receiving the first full dose of Epkinly on day 15 of cycle 1 so that you can be carefully monitored for symptoms of neurologic problems and CRS. Infections, low blood cell counts, and anemia may also occur among those taking Epkinly. Epkinly is manufactured by Abbvie and Genmab.
- Zynyz was approved by the FDA on March 22, 2023, to treat metastatic or recurrent locally advanced Merkel cell carcinoma. Zynyz is considered a “programmed death receptor-1 blocking antibody” for adults with recurrent locally advanced or metastatic Merkel cell carcinoma. Merkel cell carcinoma is a rare disease in which malignant cells form in the skin. Those with a weakened immune system, and those with chronic sun exposure have a higher risk of Merkel cell carcinoma. A single, painless lump on sun-exposed skin is usually the first indication of Merkel cell carcinoma. Merkel cells are those found in the top layer of skin that are very close to the nerve endings that receive the sensation of touch. The head and neck, arms, legs, and trunk are areas most likely to develop Merkel cell carcinoma. Merkel cell carcinoma tends to grow quickly and has a high rate of metastasis. This leads to an overall poor prognosis—a five-year survival rate of only 14 percent among those diagnosed with metastatic MCC. The likelihood of being diagnosed with MCC is about 1 in 100,000 in the United States, although this number is rising, especially among adults over the age of 65. Zynyz is manufactured by Incyte who found that more than a third of all patients diagnosed with metastatic MCC will have high rates of mortality. Zynyz offers a first-line treatment option that may offer extended life expectancy as well as a higher quality of life for patients with difficult-to-treat metastatic MCC.
- Jesduvroq gained FDA approval in February 2023. Jesduvroq treats anemia caused by chronic kidney disease for adults who have been on kidney dialysis for at least four months. Anemia is common among those with chronic kidney disease as the kidneys do not make enough erythropoietin which the body needs to make red blood cells. Anemia is common among those on dialysis and can occur even before the kidneys fail. Those on kidney dialysis may become anemic due to a diet low in iron, or from blood loss during hemodialysis. At the end of each hemodialysis treatment, a small amount of blood is left behind in the artificial kidney. Over time, this can be a source of iron loss, causing anemia. Jesduvroq is the only oral HIF-PHI approved in the United States specifically for adults who have been receiving dialysis for at least four months and who have developed anemia as a result. Jesduvroq is the first innovative medicine for this type of anemia treatment in more than three decades. Chronic kidney disease affects 700 million patients across the globe. About one in seven patients with chronic kidney disease will develop anemia as a result of kidney dialysis.
- Jaypirca gained FDA approval on January 27, 2023, as a treatment for relapsed or refractory mantle cell lymphoma in adults who have already tried a BTK inhibitor as well as another line of systemic therapy. Mantle cell lymphoma is a rare form of lymphoma that originates from the mantle zone of the lymph node. This is an aggressive form of non-Hodgkin’s lymphoma that often occurs in an advanced stage with swelling of the lymph nodes. Some side effects seen among those involved in Jayprica drug trials included infections. Those at an increased risk of infection may receive other medications to decrease the risk of infection during treatment with Jaypirca. Jaypirca is considered the first medication of its kind to treat relapsed mantle cell lymphoma. Eli Lilly is the manufacturer of Jaypirca.
Promising New Drugs for Cancer Treatment
There are a number of new cancer drugs that have received FDA approval during the first few months of 2023. Because they are new—no matter how promising the research—many insurance companies may refuse to pay for these drugs, even when a doctor believes the drug gives a cancer patient the very best chance of a future. If your insurer refuses to pay for a cancer drug that your physician believes you need, attorney Scott Glovsky can help. Some of the newer cancer drugs include:
- The FDA approved pembrolizumab (Keytruda) for non-small cell lung cancer on January 26, 2023. Keytruda is also FDA-approved for the treatment of melanoma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and other types of cancer including as a post surgical treatment for resectable kidney cancer.
- The FDA approved the drug sacituzumab govitecan-hziy for HR-positive breast cancer on February 3, 2023.
- On March 3, 2023, the FDA approved abemaciclib for the treatment of early breast cancer that has a high risk of recurrence.
- The FDA approved dabrafenib (Tafinlar, Novartis) for pediatric patients over a year old with low-grade glioma on March 22, 2023.
- On March 22, 2023, the FDA granted accelerated approval for retifanlimab-dlwr (Zynyz, Incyte Corporation) is used for adult patients with metastatic or recurrent advanced Merkel cell carcinoma.
Potential Oncology Drugs and Treatments We’ll See in 2023
According to the American Association for Cancer Treatment, there are many exciting developments in oncology that we may see as early as 2023. One of these is known as “circulating biomarkers,” which is the dynamic monitoring of the entire cancer journey—from detection to interception to monitoring. These ultra-sensitive technologies can detect and measure microscopic residual disease among those who have been through cancer treatments, allowing earlier interception strategies and better overall outcomes. “Precision immune-oncology,” is another exciting area in cancer research that will allow us to use immunotherapy in the most precise manner.
One oncology drug of particular interest is ADCs (antibody drug conjugates), which combine cancer-killing cytotoxic drugs and monoclonal antibodies, resulting in dramatic anti-tumor activity. If you or a loved either currently has cancer or develop cancer in the future and your insurer refuses to pay for a drug your doctor believes will make a difference, you want an attorney like Scott Glovsky on your side. Scott works tirelessly every day to ensure you and others in the same situation get the medical treatments you need.
How the Law Offices of Scott Glovsky Can Assist with New Cancer Drugs Insurance Denial
Even though your insurer essentially agreed to pay for any medical treatment necessary to save your life or that of a loved one—or to increase their quality of life—insurance companies often make decisions as to whether the treatment is medically necessary. Despite the success of many of these new cancer drugs and despite the fact that they all have FDA approval, many insurance companies still refuse to approve these life-saving drugs.
As noted, insurers routinely claim that there is a lack of medical necessity for a drug, or assert that a cancer drug is “investigational” or “experimental,” to avoid paying for a treatment that could potentially save a life. There should be a definition of the term “medical necessity” in your health insurance policy, so it could be beneficial to look it over. The language may claim the drug is not necessary for or appropriate to the diagnosis, treatment, or relief of your illness or that it is not within the generally accepted standards of medical care in your community.
It could also say that the cost-effectiveness of the drug is not proven, or that there are alternative (cheaper) drugs to treat your illness. Attorney Scott Glovsky deals with these types of denials on a regular basis, fighting hard to make the insurer re-evaluate the situation, always with the goal of getting the denial reversed.
A letter detailing why the drug is medically necessary for your type of cancer is important in this fight, whether your insurer is claiming the drug is not medically necessary or whether your insurer is claiming the drug is experimental or investigational. Such a letter, along with a strong attorney like Scott Glovsky, who will never give up when the fight gets difficult, provides you with your best chance of a denial reversal.
Scott Glovsky will fight for you and your right to receive potentially life-saving drug therapy. We will work with you to examine your medical needs, evaluate the case law dealing with your situation, and determine the best path forward to challenge your insurance company’s new cancer drugs insurance denial. Contact the Law Offices of Scott Glovsky today in LA County or across the state of California.