July 10, 2018
On July 10, the National Cancer Institute (NCI) and the Department of Veterans Affairs (VA) announced the launch of the NCI and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE). NAVIGATE will be launching at 12 VA facilities across the country. As part of the agreement, NCI will provide infrastructure funding support needed for VA facilities to participate in NCI-sponsored clinical trials, and VA will manage organizational and operational activities within its national healthcare system to establish a network to focus on NCI trial goals. Read the full NIH press release here.
Posted 7/10/2018
July 3, 2018
In a report released on June 28, the Government Accountability Office (GAO) calls for improvement in federal oversight of compliance at 340B contract pharmacies. From 2010 to 2017, the number of pharmacies with which 340B covered entities have contracted increased from about 1,300 to almost 20,000. The 340B Drug Pricing Program is administered by the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS).
The GAO report describes:
1) financial arrangements selected covered entities have with contract pharmacies;
2) the extent that selected covered entities provide discounts on 340B drugs dispensed by contract pharmacies to low-income, uninsured patients; and
3) HRSA's efforts to ensure compliance with 340B Program requirements at contract pharmacies.
Among the report's seven recommendations for improving oversight are that HRSA audits assess for duplicate discounts in Medicaid managed care, and that HRSA require information on how entities determined the scope of noncompliance and evidence of corrective action before closing audits.
Read GAO recommendations .
Read full report .
Posted July 3, 2018
July 2, 2018
On July 2, 2018, CMS announced that participants in the Merit-based Incentive Payment System (MIPS) in 2017 could review their MIPS final score and performance feedback on the Quality Payment Program website . The payment adjustment received in 2019 is based on this final score. A positive, negative, or neutral payment adjustment will be applied to the Medicare paid amount for covered professional services furnished under the Medicare Physician Fee Schedule in 2019.
MIPS eligible clinicians or groups (along with their designated support staff or authorized third-party intermediary), including those who are subject to the APM scoring standard, may request for CMS to review their performance feedback and final score through a process called targeted review.
If you believe an error has been made in your MIPS payment adjustment calculation, you can request a targeted review until September 30, 2018 . The following are examples of circumstances in which you may wish to request a targeted review:
You can access your MIPS final score and performance feedback and request a targeted review by:
CMS has posted new resources on CMS.gov to help eligible clinicians and groups understand their Merit-based Incentive Payment System (MIPS) final score, performance feedback, and payment adjustment, as well as the targeted review process. The new resources include:
For more information, visit the Quality Payment Program Resource Library on CMS.gov to review new and existing Quality Payment Program resources, or contact the Quality Payment Program at QPP@cms.hhs.gov or 1-866-288-8292 (TTY: 1-877-715-6222).
Posted 7/2/2018
June 29, 2018
On June 29, the Centers for Medicare & Medicaid Services (CMS) announced that they would be advancing the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration, which would waive Merit-Based Incentive Payment System (MIPS) requirements for clinicians who participate sufficiently in certain Medicare Advantage plans that involve taking on risk. CMS seeks public comment on the information collection burdens associated with the demonstration, which is under consideration for formal approval. Read the full CMS press release here.
Posted 6/29/2018
June 27, 2018
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved encorafenib and binimetinib (Braftovi and Mektovi, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Read FDA announcement .
Posted June 27, 2018
June 20, 2018
On June 15, 2018, the Association of Cancer Care Centers submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's opening of a National Coverage Analysis (NCA) for CAR T therapies for cancer. Currently, two CAR T-cell therapies are approved the U.S. Food and Drug Administration, Kymriah® (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel). In comments its to the agency , ACCC urged that CMS:
Additionally, ACCC expressed concern that the outcome of the NCA process may be stifling to innovation of CAR T therapies in the pipeline. Read ACCC Comment Letter
Posted 6/20/2018
June 13, 2018
On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection.
Read the full FDA announcement here.
Posted 6/13/18
June 13, 2018
On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Read the full FDA press release here.
Posted 6/13/2018
June 13, 2018
At the 2018 ASCO Annual Meeting, we had the opportunity to connect with many ACCC members and engage a wide audience! Oncology Business Review, OncLive, and ASCO Post sat down with a number of ACCC advocates and leaders to discuss pressing issues in cancer care.
ACCC Treasurer Randall A. Oyer, MD , with an update on the ACCC Immuno-Oncology Institute:
ACCC Immuno-Oncology Institute Executive Committee Member Ivo Abraham, PhD, RN , speaks about value in cancer care:
ACCC Past President Jennie R. Crews, MD, MMM, FAC P , describes how care coordination in immunotherapy is engaging new providers with the cancer care team:
Dr. Abraham shares his perspective on hurdles to adoption of biosimilars in oncology:
Watch more from Dr. Abraham on:
Key features of a biosimilar- via OBR
Biosimilars approved and nearing approval for oncology- via OBR
Biosimilar pricing and reimbursement- via OBR
Dr. McBride Discusses financial toxicity in oncology with OncLive :
Lee S. Schwartzberg, MD, FACP, discusses how the ACCC Immuno-Oncology Institute is evolving to support integration of IO in the community through new working groups, resources for cross-specialty care coordination, and team education for this rapidly expanding field. - ASCO Post
Dr. Zibelman discusses managing immune-related adverse events with OncLive :
Posted 6/13/2018
June 11, 2018
On June 8, 2018, the Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
Read the full FDA announcement here.
Posted 6/11/2018
May 30, 2018
In response to increasing incidence in young and middle-aged populations, the American Cancer Society (ACS) has updated its colorectal cancer (CRC) screening guideline. The revised guideline now recommends that CRC screening should begin at age 45 for people at average risk.
Read the ACS press release here , and the updated guideline here .
Posted 5/30/2018
May 24, 2018
On May 23, the FDA approved abiraterone acetate (Yonsa, Sun Pharmaceutical Industries Ltd.) in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Read the Sun Pharma press release here .
Posted 5/24/2018
May 22, 2018
On May 22, The National Institutes of Health (NIH) released its Annual Report to the Nation on the Status of Cancer , a collaborative effort with the Centers for Disease Control and Prevention, the American Cancer Society, and the North American Association of Central Cancer Registries.
The report finds that from 1999 to 2015, overall cancer death rates decreased by 1.8 percent per year among men and by 1.4 percent per year among women. From 2011 to 2015, death rates decreased for 11 of the 18 most common cancer types in men and for 14 of the 20 most common cancer types in women. Over the same period, death rates for cancers of the liver, pancreas, and brain and other nervous system increased in both men and women; death rates for cancer of the uterus increased in women; and death rates for cancers of the oral cavity and pharynx and soft tissue increased in men.
Read the full report here .
Posted 5/22/2018
May 21, 2018
On May 18, 2018, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals, oncology clinical investigators, and the public about decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).
In two ongoing clinical trials (KEYNOTE-361 and IMVIGOR-130), the Data Monitoring Committees’ (DMC) early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy. There was no change in the adverse event profile of Keytruda or Tecentriq. Both Merck, manufacturer of Keytruda, and Genentech, manufacturer of Tecentriq, have stopped enrolling patients whose tumors have PD-L1 low status to the Keytruda or Tecentriq monotherapy arms per the DMCs’ recommendations.
The clinical trials compare platinum-based chemotherapy combined with Keytruda or Tecentriq to platinum-based chemotherapy alone. Both trials enrolled a third arm of monotherapy with Keytruda or Tecentriq to compare to platinum-based chemotherapy alone. The monotherapy arms remain open only to patients whose tumors have PD-L1 high status. The combination arms and the chemotherapy arms of both studies also remain open. The FDA is reviewing the findings of the ongoing clinical trials and will communicate new information as necessary.
Both Keytruda and Tecentriq are currently approved under accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma patients who are not eligible for cisplatin-containing chemotherapy, irrespective of PD-L1 status. Patients taking Keytruda or Tecentriq for other approved uses should continue to take their medication as directed by their healthcare professional.
Healthcare professionals should be aware that the populations enrolled in the ongoing clinical trials were eligible for platinum-containing chemotherapy, and therefore differ from those enrolled in the trials that led to the accelerated approvals of both Keytruda and Tecentriq in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. FDA recommends providers select patients for the treatment of locally advanced or metastatic urothelial cancer using the criteria described in Section 14 of each label. These criteria supported the approvals for Keytruda and Tecentriq for initial monotherapy in cisplatin-ineligible patients. Keytruda and Tecentriq are also currently approved by the FDA for the treatment of multiple types of other cancers.
Patients should talk to their doctor if they have questions or concerns about either drug.
Health care professionals and patients are encouraged to report any adverse events or side effects related to the use of these products and other similar products to FDA’s MedWatch Adverse Event Reporting program .
Keytruda Prescribing InformationTecentriq Prescribing InformationAccess FDA announcement .
Posted 5/21/2018
May 21, 2018
On May 21, 2018, the Food and Drug Administration approved avatrombopag (Doptelet, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Read the full FDA announcement here .
Posted 5/21/2018
May 18, 2018
On May 17, 2018, the American Urological Association (AUA) announced updates to its castration-resistant prostate cancer (CRPC) guideline. The guideline was updated to incorporate new published research related to the treatment of patients with asymptomatic non-metastatic CRPC. Read the newly amended guideline here .
Posted 5/18/2018
May 15, 2018
On May 15, 2018, the Food and Drug Administration approved epoetin alfa-epbx (Retacrit, Hospira Inc.) as a biosimilar to epoetin alfa (Epogen/Procrit, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
Read the FDA announcement here.
Posted 5/15/2018
May 14, 2018
On May 14, the Department of Health and Human Services (HHS) issued a formal request for information (RFI) regarding the Trump Administration’s proposed drug pricing blueprint . HHS seeks “all suggestions to improve the affordability and accessibility of prescription drugs, including reflections and answers to questions not specifically asked.” Questions specifically posed by HHS are:
ACCC will be submitting comments, but we also encourage our member programs to weigh in on this important document. Comments must be submitted on or before July 15, 2018. To submit electronically, go to http://www.regulations.gov .
Posted 5/14/2018
May 11, 2018
On Friday, May 11, President Trump and U.S. Department of Health and Human Services Secretary Alex M. Azar II announced the administration's plan to lower drug prices.
Access " American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs ."
ACCC is continuing to look at the policies' implications for our members and their patients. Stay tuned for updates.
Posted 5/11/2018
May 8, 2018
On May 8, 2018, the U.S. Preventive Services Task Force (USPSTF) released a final recommendation statement and evidence summaries on screening for prostate cancer. The USPSTF final recommendation provides clinicians and patients with important new information about the benefits and harms of prostate-specific antigen (PSA)-based screening.
For men 55 - 69 years of age, the USPSTF final recommendation calls for informed individual decision-making based on the individual's values and specific clinical circumstances. This is a C recommendation.
The USPSTF recommends against PSA-based screening for prostate cancer in men age 70 and older.
Read the USPSTF Recommendation Statement and access the evidence summary and FAQs .
Posted May 8, 2018
May 8, 2018
On May 7, 2018, the Food and Drug Administration approved daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT).
Read the Johnson & Johnson press release here.
Posted 5/8/2018
May 7, 2018
On May 4, 2018, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis Pharmaceuticals Corp.) and trametinib (Mekinist, Novartis Pharmaceuticals Corp.), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).
Read the full FDA announcement here.
Posted 5/1/2018
May 1, 2018
On May 1, 2018, Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication - the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
Kymriah is not indicated for the treatment of patients with primary central nervous system lymphoma. Read the company press release . Read FDA announcement .
Posted 5/1/2018
May 1, 2018
The Centers for Medicare & Medicaid Services (CMS) is hosting a webinar on Wednesday, May 9at 1:00 PM ET to provide an overview of participation criteria used to determine inclusion in the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs).
Attendees will learn about:
CMS will address questions from participants at the end of the webinar, as time allows.
Webinar DetailsTitle: Participation Criteria for Year 2 of the Quality Payment Program Date: Wednesday, May 9, 2018 Time: 1:00-2:15 p.m. ET Registration Link:https://engage.vevent.com/rt/cms/index.jsp?seid=1091
Posted 5/1/2018