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Evidence-Based Oncology December 2017
EHR Documentation and the Patient–Physician Visit
Sheree Starrett, MD, MS
How Technology, Social Media Are Changing the Way Clinical Trials Connect With Patients
Mary Caffrey
Halt and Catch Fire: Can the Digital Revolution Empower the Move Toward Value-Based Cancer Care?
Joseph Alvarnas, MD
Q&A With Dr Thomas LeBlanc: The Value of ePROs in Oncology
Surabhi Dangi-Garimella, PhD
High-Impact Workflow Changes for Value-Based Care Success
Charles Saunders, MD; Charles Alcorn, MS; Catherine Cowan, MSN, RN; and Maria Fabbiano
Lending the Patient Voice to Oncology Quality Measurement
Surabhi Dangi-Garimella, PhD
Navigating the Quality Landscape in Oncology: Pitfalls and Lessons Learned
Surabhi Dangi-Garimella, PhD
Stakeholders Weigh in on Payment Reform in Cancer Care
Surabhi Dangi-Garimella, PhD
The Commercial Payer OCM Experience: Year 1
Surabhi Dangi-Garimella, PhD
Will 2-Sided Risk Be a Reality in the OCM?
Kelly Davio
How Has the OCM Evolved? Year 1 Provider Updates
Surabhi Dangi-Garimella, PhD
AJMC®tv Interviews, December 2017
Produced by Laura Joszt and The Center for Biosimilars®
Currently Reading
Medical World News®, December 2017
AJMC Staff

Medical World News®, December 2017

AJMC Staff
Key drug approvals; alcohol cancer link.
The expansion now adds patients to the following study arms to TAPUR:
  • Patients with ovarian cancer with KRAS, NRAS, and BRAF wildtype variants treated with cetuximab
  • Patients with breast cancer with a high tumor mutation burden treated with pembrolizumab
  • Patients with colorectal cancer with a BRAF V600E mutation treated with vemurafenib plus cobimetinib
  • Patients with non–small cell lung cancer with CDKN2A deletion or mutation treated with palbociclib as monotherapy
The following study cohort, however, will be permanently closed:
  • Patients with pancreatic cancer with CDKN2A loss or mutation treated with palbociclib as monotherapy
TAPUR, which provides patients access to drugs at no cost, is designed to evaluate FDA-approved targeted agents for indications other than those on the drug’s label, with the objective of using real-world evidence to identify alternative options for patients with advanced disease.

According to the ASCO press release, 510 participants are enrolled in the TAPUR Study, which is available at 83 clinical sites in 20 states. The study now includes a

new drug combination, nivolumab plus ipilimumab, an immunotherapy treatment that boosts the immune system to target tumor cells. With this addition, there are a total of 19 drugs yielding 16 different targeted therapy options (some drugs are used in combination).

“The TAPUR trial gives us the chance to [apply] the technology and the science, and apply it to patients in real time, with everybody agreeing that they’re going to have access to the medicine, that they’re going to have payment for the treatments, and that the data are going to be available,” according to Leonard Lichtenfeld, MD, deputy chief medical officer, American Cancer Society.

Reference: 

ASCO expands TAPUR study enrollment after promising initial treatment outcomes seen [press release]. Alexandria, VA: American Society of Clinical Oncology; November 16, 2017. asco.org/about-asco/press-center/news-releases/asco-ex- pands-tapur-study-enrollment-after-promising-initial. Accessed November 29, 2017.

Study to Explore Link Between Diabetes, Pancreatic Cancer

Mary Caffrey

A 3 -YEAR STUDY will investigate the link between new-onset diabetes and pancreatic cancer, with the hope of finding ways to detect pancreatic cancer early, when it is at a curable stage.

Richard Frank, MD, director of clinical cancer research for the Western Connecticut Health Network (WCHN), will lead the $2.7 million study, which will ask participants to undergo annual magnetic resonance imaging of the pancreas for 3 years under a protocol developed by network radiologists Ronald Lee, MD, and James Bauman, MD. A gastroenterologist will examine suspicious lesions using endoscopic ultrasound to determine whether cancer is present.

Study participants will also give a blood sample every 6 months to create a serum blood bank, which may later allow investigators to find a biomarker for pancreatic cancer; none currently exists.

Overtaking other types of cancer in overall death rate, pancreatic cancer is projected to be the second-leading cause of cancer death by 2020. A challenge with pancreatic cancer is that it is often detected only at a late stage, when it is difficult to treat.

Rising rates of diabetes and obesity have been linked to increases in pancreatic cancer. Type 2 diabetes is associated with a 1.5- to 2.0-fold increase in pancreatic cancer risk. Although the connection is not fully understood, insulin resistance, in ammation, and resulting hyperglycemia have been implicated in the mechanisms that cause cell proliferation in diabetes-related pancreatic cancer.

In 2012, Donghui Li, PhD, reported in Molecular Carcinogenesis1 that results from animal studies suggest islet cell turnover, associated with insulin resistance, triggers the initial growth of pancreatic cancer cells. Because the failure of islet beta cells is the hallmark of the onset of obesity-associated type 2 diabetes, it would make sense to closely follow patients with new-onset diabetes for early signs of pancreatic cancer.

Patients in the trial will not have to pay for any tests, as all have been covered by private donations, according to a statement from WCHN. The actor James Naughton and his family raised more than $1 million for pancreatic cancer research in honor of his late wife, Pamela, who died of pancreatic cancer in 2013.

Reference:

Li D. Diabetes and pancreatic cancer. Mol Carcinog. 2012;51(1):64-74. doi: 10.1002/mc.20771.

Fiber Intake Associated With Lower Mortality in Patients With Colorectal Cancer

Jaime Rosenberg

HIGHER FIBER INTAKE after the diagnosis of nonmetastatic colorectal cancer (CRC) is associated with lower CRC-specific and overall mortality, according to a study published in JAMA Oncology.

CRC is the third most common cancer and third-leading cause of cancer death in the United States. While high dietary fiber intake has previously been associated with a lower risk of CRC, there is no known benefit of fiber intake for CRC survivors.

“Due to lack of data on post-diagnostic diet and CRC survival, most dietary recommendations for CRC survivors are primarily based on incidence studies,” wrote the authors. “Therefore, identifying prognostic dietary factors is needed to improve CRC survivorship.”

Authors of the study analyzed 1575 healthcare professionals with stages I to III CRC from the Nurses’ Health Study (NHS) and Health Professionals Follow-up Study (HPFS). Participants were mailed a questionnaire focusing on medical history and lifestyle factors at baseline and every 2 years after.

Dietary data were collected and updated every 4 years using Food Frequency Questionnaires (FFQs). The baseline for NHS was 1980, and the baseline for HPFS was 1986. The study was conducted between December 23, 2016, and August 23, 2017.

Dietary fiber intake data collected by the FFQs inquired about how often, on average, the participant consumed each food of a specific serving size in the prior year. Authors calculated the daily intake for each nutrient by multiplying the reported frequency of consumption by its nutrient content and then summing across all foods.

CRC-specific and overall mortality was determined after adjusting for other potential predictors for cancer survival.

Results showed that high fiber intake was associated with lower mortality. The multivariable hazard ratio per 5-g increase in intake per day was 0.78 for CRC-specific mortality and 0.86 for all-cause mortality. The benefit of increasing fiber intake capped at approximately 24 g/d. Patients who increased their fiber intake after diagnosis had a lower mortality rate, with each 5-g/d increase in intake linked to an 18% lower CRC-specific mortali- ty and 14% lower all-cause mortality.

There was no substantial association between fiber intake and tumor subsite or stage.

With respect to specific sources of fiber:
  • Cereal fiber was associated with lower CRC-specific mortality and all-cause mortality.
  • Vegetable fiber was associated with lower all-cause mortality but not CRC-specific mortality.
  • Whole grain intake was associated with lower CRC-specific mortality.  
  • No association was found for fruit fiber.
“Our present study adds to the existing literature and suggests that the effect of high fiber intake may extend beyond protection against cancer incidence and contribute to better prognosis after cancer is established,” concluded the authors.

Reference:

Song M, Wu K, Meyerhardt JA, Ogino S, et al. Fiber intake and survival after colorectal cancer diagnosis [published online November 2, 2017]. JAMA Oncol. doi: 10.1001/jamaoncol.2017.3684.

Do Oral Parity Laws Reduce OOP Spending for Patients?

Surabhi Dangi-Garimella, PhD

ACCORDING TO A NEW ANALYSIS by Stacie Dusetzina, PhD, and colleagues, state oral parity laws—devised to equate out-of-pocket (OOP) spending for patients, irrespective of whether their treatment is an oral agent or an infusion—are not consistent with reducing patient OOP costs for oral anticancer agents.

The medical versus pharmacy benefit equation has shifted for these oral agents. John Fox, MD, MHA, senior medical director and vice president of medical affairs, Priority Health, explained during a panel discussion hosted by The American Journal of Managed Care® that more than 60% of patients on the commercial side

of their plans have significant deductibles and coinsurance. “There is less cost sharing on the pharmacy benefit for an oral cancer drug than on the medical benefit, but an unintended consequence of this is that oral prices may increase for patients.”1

For the present study, published in JAMA Oncology,2 investigators at the University of North Carolina, Harvard Medical School, and Brigham and Women’s Hospital analyzed claims data from 3 insurance plans for the period between 2008 and 2012, aggregated by the Health Care Cost Institute. The nearly 64,000 adults in the study lived in 1 of 16 states that passed the oral parity laws during the study period and had received anticancer treatment for which an oral option was available. Primary outcomes being evaluated were:
  • Anticancer medication use
  • OOP spending
  • Total healthcare spending
The use of oral anticancer agents, measured as a percentage of overall anticancer treatment, rose from 18% to 22% during the study period, in the months prior to and after parity. Prescription fills for oral therapies without a co-pay rose from 15.0% to 53.0% among plans subject to parity, compared with a 12.3% to 18.0% increase in plans not subject to parity (P<.001).

Additionally, patients with monthly OOP spends of over $100 increased from 8.4% to 11.1% in plans subject to parity, while those not subject to parity saw

a slight decline: 12.0% to 11.7% (P = .004). Importantly, patient monthly OOP spending varied based on the actual OOP amount after parity:
  • Spending decreased by $19.44 at the 25th percentile.
  • Spending decreased by $32.13 at the 50th percentile.
  • Spending decreased by $10.83 at the 75th percentile.
  • Spending increased by $37.19 at the 90th percentile.
  • Spending increased by $143.25 at the 95th percentile.
  • The 6-month total spending did not change post parity for oral or any anticancer therapy users.
Based on their results, the authors concluded that, despite the slight financial protection, “parity laws may not be sufficient to ensure that patients are protected from high out-of-pocket medication costs.”

References: 

1. Oral parity laws and patient cost sharing. The American Journal of Managed Care®. ajmc.com/peer-exchange/ oncology-stakeholder-summit-fall-2015/oral-parity-laws-and-patient-cost-sharing. Published January 28, 2016. Accessed November 13, 2017.

2. Dusetzina SB, Huskamp HA, Winn AN, Basch E, Keating NL. Out-of-pocket and health care spending changes for patients using orally administered anticancer therapy after adoption of state parity laws [published online November 9, 2017]. JAMA Oncol. doi: 10.1001/jamaoncol.2017.3598.

Incidence Rates of Early-Stage Breast and Colorectal Cancers Increased Following Enactment of ACA

Jaime Rosenberg

THE INCIDENCE RATES of early-stage breast and colorectal cancers increased after the initiation of the Affordable Care Act (ACA), according to a study published in JAMA Oncology.

In addition to expanding insurance coverage, the ACA puts emphasis on preventive care. Through the ACA, cost sharing for services given an A or a B grade by the US Preventive Services Task Force (USPTF) is eliminated.

 
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