Pharmaceutical assistance programs for cancer patients in the era of orally administered chemotherapeutics

2017 ◽  
Vol 24 (6) ◽  
pp. 424-432 ◽  
Author(s):  
Aaron Mitchell ◽  
Benyam Muluneh ◽  
Rachana Patel ◽  
Ethan Basch
Keyword(s):  
North Carolina ◽  
Cancer Patients ◽  
Care Delivery ◽  
Private Insurance ◽  
Standard Of Care ◽  
Drug Manufacturer ◽  
Cancer Drugs ◽  
Oral Agent ◽  
Assistance Programs ◽  
Oral Agents

Introduction The rising cost of cancer drugs may make treatment unaffordable for some patients. Patients often rely on drug manufacturer-administered Pharmaceutical Assistance Programs (PAPs) to obtain drugs and reduced or no cost. The overall usage of PAPs within cancer care delivery is unknown. Methods We included all cancer patients across an academically affiliated, integrated health system in North Carolina during 2014 ( N = 8591). We identified the subset of patients receiving PAP assistance to afford one or more cancer drugs, in order to calculate the proportion of patients receiving PAP assistance, and the retail value of the assistance. Results Among 8591 cancer patients, 215 unique patients submitted a total of 478 successful PAP requests for cancer drugs. 40% of PAP-utilizing patients were uninsured, 23% had Medicaid coverage, 20% had Medicare coverage, 2% were dual Medicare/Medicaid eligible, and 14% were commercially insured. Among all cancer patients who received medical treatment, 6.0% required PAP assistance, whereas 10.6% receiving an oral agent required PAP assistance. The proportion receiving PAP assistance varied substantially by drug, ranging from <1% of patients (e.g. carboplatin, methotrexate) to 50% of patients (e.g. ponatinib, temsirolimus). The majority of the retail value obtained was for oral agents, including $1,556,575 of imatinib and $1,449,633 of dasatinib, which were the two drugs with the highest aggregate retail value. Conclusions A substantial proportion of cancer patients receive private charitable assistance to obtain standard-of-care treatments. This includes patients with federal and private insurance, suggesting an inability of patients to meet cost-sharing requirements.

scholarly journals Pharmaceutical assistance foundations in the financing of cancer care.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 8-8
Author(s):  
Aaron Philip Mitchell
Keyword(s):  
North Carolina ◽  
Cancer Care ◽  
Kinase Inhibitors ◽  
Care Delivery ◽  
Private Insurance ◽  
Standard Of Care ◽  
Drug Manufacturer ◽  
Cancer Drugs ◽  
Assistance Programs ◽  
Patients With Cancer

8 Background: The rising cost of cancer drugs may make treatment unaffordable for some patients. Patients often rely on drug manufacturer-administered Pharmaceutical Assistance Programs (PAPs) to obtain drugs at reduced or no cost. The overall impact of PAPs on cancer care delivery is unknown. Methods: We identified all patients obtaining cancer drugs across an academically affiliated, integrated health system in the state of North Carolina during 2014. The proportion of patients receiving PAP assistance, and the retail value of the assistance, were quantified for each oncology drug. Cancer drugs were analyzed with respect to route of administration. Results: 215 unique patients submitted a total of 478 successful PAP requests for cancer drugs. The majority of the retail value of drugs obtained was for oral cancer drugs, particularly targeted therapies including tyrosine kinase inhibitors. Among all cancer patients who received medical treatment, 5.5% required PAP assistance, whereas 10.6% receiving an oral agent required PAP assistance (Table). The proportion receiving PAP assistance varied substantially by drug, ranging from <1% of patients (e.g., carboplatin, methotrexate) to 50% of patients (e.g., ponatinib, temsirolimus). Patients obtained a total of $1,556,575 of imatinib and $1,449,633 of dasatinib, which were the two drugs with the highest aggregate retail value. 40% of PAP-utilizing patients were uninsured, 26% had Medicaid coverage, 20% had Medicare coverage, and 14% were commercially insured. Conclusions: A substantial proportion of patients with cancer receive private charitable assistance through PAPs in order to obtain standard-of-care treatments. In particular, a disproportionate share of patients treated with orally-available cancer drugs require PAP assistance. This includes patients with federal and private insurance, suggesting an inability of patients to meet cost-sharing requirements. [Table: see text]

A comparison of chemotherapy use in stage IV pancreatic cancer.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 257-257
Author(s):  
Naomi Whittaker ◽  
Kristin Hueftle ◽  
Mary Warlaumont ◽  
Lauren Brin ◽  
David C. Olson ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Native American ◽  
Cancer Patients ◽  
Private Insurance ◽  
Stage Iv ◽  
Standard Of Care ◽  
Uninsured Patients ◽  
Asian Pacific Islander ◽  
Asian Pacific ◽  
To Receive

257 Background: Palliative chemotherapy is the standard of care for stage IV pancreatic cancer patients (SFPC). Methods: This study compares the amount of chemotherapy given for SFPC across insurance types using the National Cancer Database (NCDB), which contains 70% of U.S. cancer cases. Results: The NCDB reported 115,512 patients diagnosed with SFPC from 2000 to 2009. Overall, 38.3% of SFPC patients received chemotherapy. The VAH (28.3%) and Medicare (29.7%) provided significantly less chemotherapy to SFPC patients as compared to Managed Care (48.2%), Private Insurance (46.7%), Tricare/Military (42.8%), Medicaid (37.8%), Medicare Plus Supplement (35.5%), and Uninsured (34.4%). From 2000 to 2009, the rate of chemotherapy for SFPC increased for both VAH (22.9% to 34.3%) and non-VAH (31.1% to 44.1%). At time of diagnosis, the percent of patients less than 60 at the VAH was 32%, non-VAH was 25.5% and Medicare was 7%. From age 20 to 59, the rate of chemo was stable at approximately 49%, but each successive decade demonstrated a marked reduction in use of chemotherapy (from 44% for 60 to 69 years of age to 21% for 80 to 89 and 5% for >90). The VAH PC population diagnosed with PC included 71.1% whites (W), 21.1% blacks (B), 4.8% Hispanics (H), 0.8% Asian-Pacific Islander (API), and 0.6% Native American (NA). Among all insurance types, only Medicaid (25%* B, 14%* H, 6%* API) and Uninsured (20% B, 15%* H, 4%* API) had a greater percentage of minorities. Compared to the average of all patients treated for SFPC (38.3%), blacks (34.7%*) and Hispanics (35.7%*) received less chemotherapy and whites received more (39.1%*). Conclusions: This is the largest study to analyze the use of chemotherapy in stage IV pancreatic cancer. Patients treated within the VAH were less likely to receive chemotherapy compared to all other patients except those with Medicare, who tend to be older at time of diagnosis. As age increases above 59, chemotherapy treatment for SFPC decreases. VAH patients receive less chemotherapy than Medicaid and Uninsured patients, though Medicaid and Uninsured have a greater percentage of minorities, who tend to get less chemotherapy for SFPC.

A medication acquisition program to facilitate access to nonstandard targeted oncologic therapies.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13505-e13505
Author(s):  
Vicki Doctor ◽  
Maurie Markman ◽  
Ankur Rasik Parikh ◽  
Bellinda Conte
Keyword(s):  
Cancer Patients ◽  
Targeted Therapies ◽  
Insurance Coverage ◽  
Standard Of Care ◽  
Consecutive Series ◽  
Precision Oncology ◽  
Tumor Type ◽  
Assistance Programs ◽  
Off Label ◽  
Patient Assistance

e13505 Background: Precision oncology provides targeted approaches to cancer diagnosis and treatment, but also carries significant risks to reimbursement and patient access. A recent survey found that up to 60% of authorization denials are due to the therapy being off-label and experimental. The Cancer Treatment Centers of America's Medication Acquisition Program (CTCA-MAP) was initiated in October 2015 with the goal of helping patients successfully navigate a medication acquisition process following prior authorization denials for off-label therapy. Methods: A consecutive series of cancer patients who were non-responsive to standard-of-care, and for whom off-label targeted therapies have been matched to a potentially actionable genetic or molecular variant were enrolled into CTCA-MAP following the denial of payer preauthorization. The CTCA-MAP appeals payer denials, and simultaneously coordinates applications to patient assistance programs. Each payer appeal is customized to the patient's disease profile and unique tumor genomics and is based on any available evidence supporting the therapy’s use and safety in the patient’s tumor type. Results: A total of 825 patients (338 males and 487 females; median age 57 years) were enrolled into the program from October 2015 to October 2020. The most common tumor types were breast (n = 157), colorectal (n = 96), pancreas (n = 72), lung (n = 68), ovarian (n = 35) and prostate (n = 35). 682 (82.7%) patients were able to access therapy through patient assistance programs (n = 548), overturned payer appeals (n = 133) or conversion from patient assistance to insurance (n = 1) within a median of 16 days from the date of program referral. Only 5 (0.6%) patients were unable to access therapy through payer appeals or philanthropic programs. The remaining 138 (16.7%) patients could not complete the program due to disease progression or death. The overturned payer appeals led to insurance coverage for an estimated USD 7.95 million in drugs (calculated as the multiplication of drug cost per cycle and the number of cycles received). Conclusions: The CTCA-MAP provides a mechanism through which cancer patients with potentially actionable genetic variants can acquire access to existing off-label targeted therapies when standard-of-care is no longer effective, or when they are ineligible for a clinical trial. This program's outcomes to date demonstrate a need for a concerted advocacy effort to increase accessibility for cancer patients to these innovative targeted therapies.

Use of surgery and chemoradiation in stage II and III rectal cancer: A retrospective comparison of treatment modalities in major insurance types using the NCDB.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 64-64
Author(s):  
Mary Warlaumont ◽  
Lauren Brin ◽  
Timothy Fuller ◽  
Naomi Whittaker ◽  
Peter Silberstein
Keyword(s):  
Rectal Cancer ◽  
Cancer Patients ◽  
Private Insurance ◽  
Standard Of Care ◽  
Neoadjuvant Chemoradiation ◽  
Stage Ii ◽  
Treatment Modalities ◽  
Uninsured Patients ◽  
Treatment Practices ◽  
Using Data

64 Background: The standard of care (SOC) for stage II/III rectal cancer is neoadjuvant chemoradiation plus surgical resection. We aim to compare the treatment practices for patients with stage II and III rectal cancer in major insurance types. Methods: Using data from the National Cancer Database (NCDB), we analyzed the treatment patterns of 91,782 patients diagnosed with stage II/III rectal cancer from 2000 to 2009. The NCDB includes data from 70% of all U.S. cancer patients. This is the largest study of this kind to date. Results: In stage II/III rectal cancer, patients with private insurance received more SOC treatment (70.3%) than patients with VA Insurance (56.6%), Medicare (46.9%), Medicaid (66.5%), or no insurance (61.7%) (p<.0001). VA patients received less SOC treatment than Medicaid or noninsured patients (p<.0001). Medicare patients (26.9%) were treated with surgery alone more often than patients with private insurance (9.8%), Medicaid (10.4%), VAH (12.2%), or no insurance (9.4%) (p<.0001). VA (4.8%) and Medicare (4.3%) patients more often did not receive any “First Course Treatment” than patients with private insurance (1.3%) (p<.0001). Patients over 70 years old received less SOC treatment (42.2%) than patients under 70 years old (68.9%) (p<.0001) and received more surgery without chemotherapy or radiation (29.3%) than patients less than 70 years old (9.2%) (p<.0001). Conclusions: Stage II/III rectal cancer patients with private insurance received more SOC treatment than VA, Medicare, Medicaid or uninsured patients. VA patients received less SOC treatment than Medicaid or uninsured patients. [Table: see text]

scholarly journals Circulating regulatory T cells predict efficacy and atypical responses in lung cancer patients treated with PD-1/PD-L1 inhibitors

2021 ◽  
Author(s):  
Da Hyun Kang ◽  
Chaeuk Chung ◽  
Pureum Sun ◽  
Da Hye Lee ◽  
Song-I Lee ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Cancer Patients ◽  
Advanced Nsclc ◽  
Checkpoint Inhibitors ◽  
Standard Of Care ◽  
Treg Cells ◽  
University Hospital ◽  
X Rays ◽  
Lung Cancer Patients ◽  
National University

Abstract Background Immune checkpoint inhibitors (ICIs) have become the standard of care for a variety of cancers, including non-small cell lung cancer (NSCLC). In this study, we investigated the frequency of pseudoprogression and hyperprogression in lung cancer patients treated with ICIs in the real world and aimed to discover a novel candidate marker to distinguish pseudoprogression from hyperprogression soon after ICI treatment. Methods This study included 74 patients with advanced NSCLC who were treated with PD-1/PD-L1 inhibitors at Chungnam National University Hospital (CNUH) between January 2018 and August 2020. Chest X-rays were examined on day 7 after the first ICI dose to identify changes in the primary mass, and the response was assessed by computed tomography (CT). We evaluated circulating regulatory T (Treg) cells using flow cytometry and correlated the findings with clinical outcomes. Results The incidence of pseudoprogression was 13.5%, and that of hyperprogression was 8.1%. On day 7 after initiation of treatment, the frequency of CD4+CD25+CD127loFoxP3+ Treg cells was significantly decreased compared with baseline (P = 0.038) in patients who experienced pseudoprogression and significantly increased compared with baseline (P = 0.024) in patients who experienced hyperprogression. In the responder group, the frequencies of CD4+CD25+CD127loFoxP3+ Treg cells and PD-1+CD4+CD25+CD127loFoxP3+ Treg cells were significantly decreased 7 days after commencement of treatment compared with baseline (P = 0.034 and P < 0.001, respectively). Conclusion Circulating Treg cells represent a promising potential dynamic biomarker to predict efficacy and differentiate atypical responses, including pseudoprogression and hyperprogression, after immunotherapy in patients with NSCLC.

scholarly journals Effect of reasons for screen failure (RFSF) on standard of care in cancer patients screened for clinical trials

2018 ◽  
Vol 29 ◽  
pp. ix170-ix171
Author(s):  
C. Tiu ◽  
Z. Loh ◽  
C. Gan ◽  
J. Hakanson ◽  
H. Gan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Standard Of Care ◽  
Screen Failure

scholarly journals Non-pharmacological sleep interventions for pediatric cancer patients and survivors: a systematic review protocol

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Peter L. Stavinoha ◽  
Ineke M. Olsthoorn ◽  
Maria C. Swartz ◽  
Sara Nowakowski ◽  
Stephanie J. Wells ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sleep Quality ◽  
Cancer Patients ◽  
Pediatric Cancer ◽  
Sleep Disturbances ◽  
Sleep Onset ◽  
Standard Of Care ◽  
Sleep Diary ◽  
Pharmacological Interventions ◽  
Pediatric Cancer Patients

Abstract Background Sleep disturbances constitute a common complication in pediatric cancer patients and survivors and are frequently severe enough to warrant treatment. Suboptimal sleep has been associated with decreased emotional well-being and cognitive functioning and increased behavioral problems. Standardized guidelines for non-pharmacological sleep interventions for adults with cancer exist, but no standard of care intervention or standard guidelines are available to guide such intervention in pediatric cancer patients and survivors. Therefore, effective behavioral interventions for improving sleep quality need to be identified. The objective of the review is to evaluate the effect of non-pharmacological sleep interventions on sleep quality in pediatric cancer patients and survivors. Methods The review will consider studies that include children and adolescents between 0 and 18 years diagnosed with cancer or who have a history of cancer who have non-respiratory sleep disturbance. We will include experimental and quasi-experimental studies evaluating non-pharmacological interventions such as psychological interventions, technical/device interventions, interventions targeting physical activity, and complementary and alternative medicine interventions (e.g., yoga, massage, music). Interventions involving medications, ingestible supplements, products purported to work through absorption, and medical devices will be excluded. Primary outcome will be sleep quality as measured by methods including retrospective ratings, daily sleep diary, and validated questionnaires. Secondary outcomes will include total sleep time, sleep onset latency, wake after sleep onset, daytime sleepiness, and daytime sleep duration (naps) as measured by retrospective ratings, daily sleep diary, validated questionnaires, and/or actigraphy. Databases will include MEDLINE (Ovid), EMBASE (Ovid), Cochrane Library, CINAHL (Ebsco), and PsycINFO (Ovid) and will be queried from database inception to present. Two reviewers will independently screen all citations, full-text articles, and extract data. The study methodological quality will be assessed using Joanna Briggs Institute (JBI) critical appraisal tools. Data will be extracted and findings pooled and synthesized using a meta-aggregation approach via the JBI System for the Unified Management, Assessment, and Review of Information (SUMARI). If feasible, we will conduct random effects meta-analysis. Additional analyses will be conducted to explore the potential sources of heterogeneity (e.g., methodological quality, study design, outcome measures). Discussion This systematic review will synthesize and consolidate evidence on existing non-pharmacological interventions to improve sleep in pediatric cancer patients and survivors. Findings may help inform practitioners working with pediatric cancer patients and survivors experiencing sleep disturbances and is intended to identify gaps and opportunities to improve methodical quality of further non-pharmacological sleep intervention research in this population toward developing an eventual standard of care. Systematic review registration PROSPERO CRD42020200397.

The feasibility of same day pegfilgrastim-cbqv administration in breast cancer patients receiving myelosuppressive chemotherapy regimens at a northern Virginia cancer center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18687-e18687
Author(s):  
Maya Leiva ◽  
Angela Pennisi ◽  
Kathleen Kiernan Harnden ◽  
Patricia Conrad Rizzo ◽  
Lauren Ann Mauro
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Small Sample Size ◽  
Standard Of Care ◽  
Secondary Prophylaxis ◽  
Small Sample ◽  
Cancer Center ◽  
Breast Cancer Patients ◽  
Curative Intent ◽  
Myelosuppressive Chemotherapy

e18687 Background: The long-acting injectable G-CSF, pegfilgrastim and its biosimilars have historically been given to patients 24 hours following the administration of myelosuppressive chemotherapy for either primary or secondary prophylaxis of febrile neutropenia (FN). Previous literature has indicated that pegfilgrastim administration prior to 24 hours post chemotherapy, may result in a deepened and prolonged neutropenia due to the increase in circulating granulocytes exposed to chemotherapy. With the onset of the COVID-19 pandemic and to reduce potential SAR-CoV-2 exposure to cancer patients on therapy, we implemented same day administration of injectable pegfilgrastim-cbqv among select breast cancer patients receiving myelosuppressive chemotherapy regimens from March 2020 – February 2021. Methods: Utilizing retrospective EHR chart reviews, 55 patients among 4 medical oncologists in our breast cancer group were identified as meeting the criteria of same day pegfilgrastim-cbqv administration. Inclusion was based on completion of at least 2 consecutive cycles of same day pegfilgrastim-cbqv 6 mg subcutaneous injection for primary or secondary prophylaxis. The selected patient charts were reviewed for the incidence and severity of FN. Among the patients who had documented FN, further subgroup analyses were done regarding baseline characteristics, timing of neutropenia, regimens, regimen sequence, and reported ADRs associated with pegfilgrastim-cbqv. Results: 9 (16.4%) of the 55 patients experienced FN (Grades 3-4) and 6 (10.9%) patients were hospitalized. There were no Grade 5 events and none had therapy discontinued due to FN. 8 (88.9%) of the patients experienced FN between cycles 1 and 2. Of note, there were no cases of COVID-19 among the 9 patients who had an episode of FN. 52 (94.5%) of the 55 patients received treatment with curative intent and 3 (5.5%) had metastatic disease on a subsequent line of therapy. The median age was 49.1 years (range 29-71) and patients were 56.4% Caucasian, 18.1% Black or African American, 12.7% Asian, and 12.7% Hispanic/Latina. Conclusions: Based on the retrospective data analysis, same day pegfilgrastim-cbqv appears to be a safe and effective option in the primary and secondary prophylaxis of FN with myelosuppressive standard of care chemotherapy used in breast cancer treatment. Though our review was limited by a relatively small sample size and confined to younger (49.1 median age) breast cancer patients, this opens the door to further re-evaluation of same day pegfilgrastim-cbqv administration in other patient populations. In a post pandemic treatment world, this slight change in practice has the potential to reduce patient financial toxicity associated with multiple medical visits, provide an alternative to on-body injector formulations, and ensure treatment adherence.

scholarly journals Immunotherapy and prevention of breast cancer

2020 ◽  
Vol 7 (2) ◽  
pp. 58-70
Author(s):  
Neelam Thacker ◽  
Perianayagam Taneja
Keyword(s):  
Breast Cancer ◽  
Monoclonal Antibodies ◽  
Cancer Patients ◽  
Triple Negative ◽  
Standard Of Care ◽  
Breast Tumors ◽  
Cancer Death ◽  
Breast Cancer Patients ◽  
Conventional Chemotherapy ◽  
Prevention Of Breast Cancer

Breast cancer is the most commonly diagnosed cancer in women and is a leading cause of cancer death in women worldwide. Despite the significant benefit of the use of conventional chemotherapy and monoclonal antibodies in the prognosis of breast cancer patients and although the recent approval of the anti-PD-L1 antibody atezolizumab in combination with chemotherapy has been a milestone for the treatment of patients with metastatic triple-negative breast cancer, immunologic treatment of breast tumors remains a great challenge. In this review, we summarize current breast cancer classification and standard of care, the main obstacles that hinder the success of immunotherapies in breast cancer patients, as well as different approaches that could be useful to enhance the response of breast tumors to immunotherapies.

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