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Evidence-Based Oncology August 2017
Implementing an Oncology Precision Medicine Clinic in a Large Community Health System
Michael A. Thompson, MD, PhD; Jennifer J. Godden, PharmD; Scott M. Weissman, MS, CGC; Deborah Wham, MS, CGC; Amanda Wilson, MD; Antony Ruggeri, MD; Michael P. Mullane, MD; and James L. Weese, MD, FACS
Genetic Counselors Save Costs Across the Genetic Testing Spectrum
Joy Larsen Haidle, MS, CGC; Darci L. Sternen, MS, CGC; Jane A. Dickerson, PhD; Amelia Mroch, MS, CGC; Denise F. Needham, MS, CGC; Christine M. Riordan, MS, CGC; and Michele C. Kieke, PhD, MS, CGC
Patient Engagement Is Mandatory at Our Table
Bonnie J. Addario and Daryl Pritchard, PhD
Targeted Therapies: One Practice's Story
Barry Kaplan, MD, PhD
From "Magic Bullets" to Precision Medicine—Ensuring More Patient-Centered Cancer Care
Joseph Alvarnas, MD
Letter to the Editors
Eleanor M. Perfetto, PhD, MS
Q&A With Syapse CEO Ken Tarkoff
Surabhi Dangi-Garimella, PhD
The Newest Members of CancerLinQ's Community—FDA and NCI
Kevin Fitzpatrick
Currently Reading
Medical World News®, August 2017
AJMC Staff

Medical World News®, August 2017

AJMC Staff
An update on the latest developments in the world of oncology care: product approvals, clinical developments, health policy changes, and more.
CMS Proposes Payment Rate Change for 340B Program

Laura Joszt

Reform may be coming to the controversial 340B Drug Discount Program, a federal program that requires drug companies to provide discounts to hospitals, clinics, and covered entities that include freestanding cancer centers.

In January 2017, the Health Resources and Services Administration (HRSA) within HHS finalized a rule that would set the 340B ceiling price and allow HRSA to fine manufacturers up to $5000 for each incident of knowing and intentionally overcharging 340B hospitals for drugs purchased through the program. However, the rule was pulled back by the Trump administration.

Now, the new administration has proposed its own change to the payment rate for certain Medicare Part B drugs purchased by hospitals through the 340B program. According to CMS Administrator Seema Verma, “The proposed rule takes a critical step toward fulfilling President Trump’s promise to lower the cost of drugs, particularly for Medicare beneficiaries.”1

The proposal gained immediate support from the Community Oncology Alliance (COA), which has previously called out abuses taking place in the 340B program. The program was created with good intentions, COA has argued, but it has morphed into an opportunity for hospitals to make tremendous profits by buying deeply discounted drugs and selling them to patients at full price.

“Community oncology practices across the country will tell you that hospitals have been strong-arming them to sell or close because of the tremendous profits they make from the 340B program and higher billing rates,” said Jeff Vacirca, MD, president of COA and CEO of NY Cancer and Blood Specialists on Long Island, NY, in a statement.2

The proposal would implement a new payment methodology for Medicare Part B reimbursement for 340B drugs, which would cut reimbursement by close to 30%: entities would be allowed to purchase discounted 340B drugs at the average sales price (ASP) minus 22.5% rather than the ASP plus 6%. The Medicare Payment Advisory Commission estimated that this was the average minimum discount that eligible hospitals could receive for drugs purchased through the 340B program.

The comment period for the rule will be open through September 11, 2017, and the proposed rule will take effect January 1, 2018.

“We applaud HHS Secretary Price and CMS Administrator Verma for taking this bold step in curtailing hospital abuse of the 340B program and further addressing site payment parity,” said Ted Okon, MBA, executive director of COA. “These proposals represent a good first step, but the administration and Congress must take additional steps to address the alarming consolidation of cancer care that is fueling drug prices and driving up costs for seniors and taxpayers.”

REFERENCES

1. Joszt L. CMS proposes 2018 policy and rate changes for hospital outpatient, ambulatory surgical center payment systems. The American Journal of Managed Care® website. ajmc.com/newsroom/cms-proposes-payment-rate-change-for-340b-program. Published July 17, 2017. Accessed July 17, 2017.

2. CMS proposal a huge step in the right direction to curbing 340B hospital abuses, stopping cancer system consolidation, and reducing costs for seniors. Community Oncology Alliance website. communityoncology.org/blog/2017/07/17/july-17-cms-proposal-a-huge-step-in-the-right-direction-to-curbing-340b-hospital-abuses-stopping-cancer-system-consolidation-and-reducing-costs-for-seniors/. July 17, 2017.

Rural America’s High Cancer Mortality Rates Point to Growing Disparities

Christina Mattina

A recent analysis of cancer incidence and mortality rates across America found that while those in rural counties are less likely to get cancer, cancer-related mortality rates are higher than in more populous areas and this disparity is increasing over time.

The surveillance study, conducted by CDC researchers, was published in the Morbidity and Mortality Weekly Report.1 It used data from several national registries to calculate average annual age-adjusted incidence and death rates in 4 types of counties:
  • Nonmetropolitan rural
  • Nonmetropolitan urban
  • Metropolitan with population <1 million
  • Metropolitan with population ≥1 million
It also compared the trends in these rates in recent years among counties classified as nonmetropolitan or metropolitan. From 2004 to 2013, the incidence rates of cancers at all sites was lower in rural counties than in the other county types, but rural residents had higher rates of developing lung, colorectal, and cervical cancers. Overall incidence rates in nonmetropolitan counties decreased by about 0.8% per year during this period, while they decreased in metropolitan counties by 1% annually.

Cancer death rates were higher in nonmetropolitan rural counties than the others during 2011 to 2015. Although cancer mortality decreased nationwide from 2006 to 2015, death rates showed a steeper decline in metropolitan counties than in nonmetropolitan counties (1.6% decrease vs 1.0% decrease per year, respectively). To explain the findings, the researchers referenced prior studies showing that rural residents are more likely to have risk factors for cancer, such as cigarette smoking or obesity, and may have more difficulty accessing screening due to higher uninsurance rates.

“While geography alone can’t predict your risk of cancer, it can impact prevention, diagnosis, and treatment opportunities—and that’s a significant public health problem in the United States,” said Anne Schuchat, MD, acting director of the CDC, in a press release.2 “Many cancer cases and deaths are preventable, and with targeted public health efforts and interventions, we can close the growing cancer gap between rural and urban Americans.”

According to the study results, these interventions will need to use “evidence-based strategies to improve health-related behaviors, use of vaccinations that prevent infections with cancer-causing viruses, and use of cancer screening tests” among rural residents in particular.

A blog post by Robert T. Croyle, PhD, of the National Cancer Institute (NCI), explored the potential next steps toward reducing cancer disparities in light of both the CDC study and a recent NCI commentary that discussed the issue.3 He called for stronger outreach to rural community organizations and for a better understanding of the racial demographics in rural areas. Croyle also noted that the NCI will host a meeting in May 2018 to collaborate with researchers on potential solutions to reduce rural disparities.

“In the meantime, NCI will continue to work with the cancer community and others to refine and reinvigorate our cancer control efforts in rural areas across the country,” he concluded.

REFERENCES

1. Jane Henley S, Anderson RN, Thomas CC, Massetti GM, Peaker B, Richardson LC, Invasive cancer incidence, 2004-2013, and deaths, 2006-2015, in nonmetropolitan and metropolitan counties—United States. CDC website. cdc.gov/mmwr/volumes/66/ss/ss6614a1.htm?s_cid=ss6614a1_w#contribAff. Accessed July 10, 2017.

2. New CDC report shows deaths from cancer higher in rural America [press release]. Atlanta, GA: CDC; July 6, 2017. cdc.gov/media/releases/2017/p0706-rural-cancer-deaths.html. Accessed July 10, 2017.

3. Croyle RT. Improving cancer control in rural communities: next steps. National Cancer Institute website. cancer.gov/news-events/cancer-currents-blog/2017/rural-cancer-disparities-next-steps?cid=eb_govdel. Published July 7, 2017. Accessed July 10, 2017.

FDA Considers Label Changes for Some Immunotherapies Due to Potential Vision Loss

Alison Rodriguez

The FDA is considering adding the risk of ocular inflammatory conditions to labels for 3 immune checkpoint inhibitors due to sight-threatening complications. The drugs that could have label changes include Bristol- Myers Squibb’s Yervoy (ipilimumab) and Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab). The 3 labels currently list uveitis, a type of eye inflammation, as a potential immune-mediated adverse reaction, but the FDA’s postmarketing reviews have found further complications including retinal detachment and vision loss.1

Ocular inflammation resulting in vision loss was also observed in a study that treated metastatic melanoma with ipilimumab. The study involved a male patient that was diagnosed with melanoma that progressed during treatment. Eventually, he participated in a clinical trial for ipilimumab and received 3mg/ kg every 3 weeks for 3 doses.2

Following treatment, he experienced adverse effects (AEs), including a rash and diarrhea, which were treated with supportive therapy, and headaches that were resolved with steroids. However, 4 months after the initial treatment, the participant experienced acute vision loss in his left eye, followed by vision loss in his right eye after 5 months.

“High-dose steroid therapy stabilized the right eye vision, but the left eye vision never improved after initial presentation, again supporting a probable vascular cause for the left eye visual loss,” the study noted. “This may or may not have been secondary to an inflammatory/immune-mediated process (ie, local thrombosis related to inflammation/vasculitis).”

Furthermore, the steroids taken by the patient to treat the AEs from the ipilimumab treatment caused further complications. The FDA is considering labeling changes to emphasize the risks of these complications.

“Regulatory discussions are ongoing regarding PD-1 pathway–blocking antibodies in attempts to improve the consistency and effectiveness of the information regarding immune-mediated AEs provided in the labels,” explained Tralisa Colby, an FDA public affairs specialist, in a statement to Regulatory Focus. “Those labeling changes may include additional characterization of ocular inflammatory conditions; however, the current term, uveitis, should convey the severity and potential ocular complications to oncology physicians.”3

REFERENCES

1. Potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System (FAERS): January-March 2017. FDA website. fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ AdverseDrugEffects/ucm565425.htm. Updated June 30, 2017. Accessed July 17, 2017.

2. Wilson MA, Guld K, Galetta S, et al. Acute visual loss after ipilimumab treatment for metastatic melanoma. J Immunother Cancer. 2016;4:66. eCollection 2016. doi: 10.1186/s40425-016-0170-9.

3. Brennan Z. FDA considers label changes for Keytruda, Opdivo and Yervoy. Regulators Affairs Professionals Society website. raps.org/Regulatory-Focus/News/2017/07/12/28070/FDA-Considers-Label-Changes-for-Keytruda-Opdivo-and-Yervoy/. Published July 12, 2017. Accessed July 17, 2017.

FDA Advisory Committee Confirms Support for Biosimilars to Trastuzumab, Bevacizumab

Surabhi Dangi-Garimella, PhD

A 17-0 vote in favor of the Amgen/Allergan bevacizumab biosimilar candidate, ABP 215, and a 16-0 vote in favor of Mylan’s trastuzumab biosimilar candidate, MYL-1401O were the final tiles following voting by the FDA’s Oncologic Drugs Advisory Committee (ODAC) on the 2 pioneer biosimilar candidates for cancer treatment.

 
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