August 27, 2018
On August 27, AbbVie announced that the FDA has approved ibrutinib (Imbruvica) (Pharmacyclics, LLC) plus rituximab for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). This approval represents the first and only chemotherapy-free combination treatment specifically indicated for the disease. Read the full AbbVie corporate press release here.
Posted 8/27/2018
August 20, 2018
On August 17, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.
Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product. Read the full FDA announcement here.
Posted 8/20/2018
August 20, 2018
On August 16, 2018, the Food and Drug Administration updated the prescribing information for pembrolizumab (Keytruda, Merck & Co., Inc.) and atezolizumab (Tecentriq, Genentech, Inc.) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq.
On August 16, 2018, the FDA approved the Dako PD-L1 IHC 22C3 PharmDx Assay (Dako North America, Inc.) as a companion diagnostic to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Keytruda. The 22C3 assay determines PD-L1 expression by using a combined positive score (CPS) assessing PD-L1 staining in tumor and immune cells.
On July 2, 2018, the FDA approved the Ventana PD-L1 (SP142) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic test to select patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Tecentriq. The SP142 assay determines PD L1 expression in immune cells. Read the full FDA announcement here.
Posted 8/20/2018
August 17, 2018
On August 17, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Read the BMS press release here.Read the FDA announcement her e .
Posted 8/17/2018
August 17, 2018
On August 16, 2018, the Food and Drug Administration approved lenvatinib (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC. The trial demonstrated that lenvatinib was non-inferior but not statistically superior to sorafenib for overall survival. Read the full FDA press release here.
Posted 8/17/2018
August 14, 2018
The HealthWell Foundation has opened a new fund to provide copayment and premium assistance to Medicare patients living with gastric cancer. Through the new fund, HealthWell will provide up to $10,000 in financial assistance for a 12-month grant to eligible patients who have annual household incomes up to 400 percent of the federal poverty level.
To determine eligibility and apply for financial assistance, visit HealthWell's Gastric Cancer Fund page. Read the full HealthWell press release here .
August 9, 2018
On August 9, the National Comprehensive Cancer Network (NCCN) announced the publication of a new set of guidelines for gestational trophoblastic neoplasia (GTN), also known as gestational trophoblastic disease (GTD), a group of rare cancers that can affect women during pregnancy. GTN can occur when tumors develop in the cells that would normally form the placenta during pregnancy. It affects approximately 1 out of every 1,000 pregnancies in the United States and is more common in many Asian and African countries. The NCCN Guidelines for GTN detail treatments for several variations of the disease.
Read the full NCCN press release here , and download this new guideline here .
Posted 8/9/2018
August 8, 2018
On August 8, the Food and Drug Administration (FDA) approved mogamulizumab-kpkc (Poteligeo, Kyowa Kirin, Inc.) for adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. Approval was based on a randomized, open-label, multicenter trial in patients with active MF or SS after at least one prior systemic therapy. The trial randomized 372 patients to either mogamulizumab-kpkc or vorinostat; progression-free survival (PFS) was statistically significantly longer in the mogamulizumab-kpkc arm. Read the full FDA press release here.
Posted 8/8/2018
August 7, 2018
Starting January 1, 2019, the Centers for Medicare & Medicaid Services (CMS) is giving Medicare Advantage (MA) Plans the option to utilize step therapy for Part B drugs. For example, in 2019, MA Plans may now require that a beneficiary who is newly diagnosed with a condition begin treatment with the plan's most preferred, most cost-effective drug therapy before progressing to a more costly drug therapy if the initial treatment is ineffective. This change will only apply to newly prescribed medications.
As part of the policy announced on August 7, 2018, Medicare Advantage plans that also offer a Part D benefit will be able to cross-manage across Part B and Part D.
Medicare Advantage plans that choose to offer this approach to enrollees in 2019, must explicitly communicate this to beneficiaries through the Annual Notice of Change and Evidence of Coverage documents. Patients that do not want to participate in a plan that elects to adopt this step therapy approach will have the option to select a different plan.
The ACCC policy team is currently analyzing this policy change and will provide an update to members.
Read CMS memo to Medicare Advantage plans .
Read CMS fact sheet on Medicare Advantage Plans and step therapy for Part B drugs.
Posted 8/7/2018
August 3, 2018
On August 3, the Food and Drug Administration issued a warning against the long-term use of the antibiotic azithromycin (Zithromax, Pfizer Inc.) to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. The FDA is reviewing additional data and will communicate its conclusions and recommendations when its review is complete.
The serious lung condition for which long-term azithromycin was being studied, called bronchiolitis obliterans syndrome, is caused by inflammation and scarring in the airways of the lungs, resulting in severe shortness of breath and dry cough. Cancer patients who undergo stem cell transplants from donors are at risk for bronchiolitis obliterans syndrome.
Azithromycin is not approved for preventing bronchiolitis obliterans syndrome; there are no known effective antibiotic treatments for prophylaxis of bronchiolitis obliterans syndrome. Health care professionals should not prescribe long-term azithromycin for prophylaxis of bronchiolitis obliterans syndrome to patients who undergo donor stem cell transplants because of the increased potential for cancer relapse and death. Read the full FDA warning here.
Posted 8/3/2018
August 2, 2018
On August 22, join the Centers for Medicare & Medicaid Services (CMS) for a listening session on the CY 2019 Physician Fee Schedule (PFS) proposed rule.
During this listening session, CMS experts will briefly cover three provisions from the proposed rule and address clarifying questions to help formulate written comments for formal submission:
Participants are encouraged to review the proposed rule prior to the call, as well as the following materials on the provisions to be covered:
This listening session will take place from 1:30 - 3:00 PM ET . Click here to register for this listening session as well as other Medicare Learning Network events.
Posted 8/2/2018
August 1, 2018
On July 31, the Food and Drug Administration approved lusutrombopag(Mulpleta, Shionogi Inc.) for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Approval was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2, NCT02389621) involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count less than 50 x 10 9 /L. Read the full FDA announcement here.
Posted 8/1/2018
July 31, 2018
On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site, and require systemic anticancer therapy. This is the first FDA-approved drug for this use.
Pheochromocytomas are rare tumors of the adrenal glands. These glands are located right above the kidneys and make hormones including stress hormones called epinephrines and norepinephrines. Pheochromocytomas increase the production of these hormones, leading to hypertension (high blood pressure) and symptoms such as headaches, irritability, sweating, rapid heart rate, nausea, vomiting, weight loss, weakness, chest pain or anxiety. When this type of tumor occurs outside the adrenal gland, it is called a paraganglioma. Read the FDA announcement .
Posted 7/31/2018
July 25, 2018
On July 25, 2018, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule for calendar year 2019. The deadline for submitting comments on the proposed rule is September 24, 2018.
ACCC is currently analyzing the rule and will provide an update to members soon.
Read the CMS fact sheet .
View the proposed CY 2019 OPPS rule .
Posted 7/25/2018
July 25, 2018
On July 18, the Government Accountability Office (GAO) issued a report that compares characteristics of hospitals participating in the 340 Drug Pricing Program with those not participating in the 340B Program. The report focuses on three types of hospitals that made up more than 95 percent of 340B participants in 2016.
The report examines the effects of Medicaid expansion on 340B participation and other characteristics such as rates of charity care provided.
Because for certain types of hospitals 340B eligibility is partially based on the number of Medicaid patients served, the report finds that 340B participation increased for those particular hospitals in states that expanded Medicaid. Read the report summary . View the full report .
Posted 07/25/18
July 24, 2018
On July 23, the House of Representatives passed four Energy and Commerce Committee bills to authorize critical health workforce programs:
Posted 7/24/2018
July 23, 2018
On July 20, the Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym, Pfizer Inc.) for the treatment of chemotherapy-induced febrile neutropenia, acute myeloid leukemia (AML), patients with cancer receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment, and severe chronic neutropenia. This is the second approved biosimilar for filgrastim (Neupogen, Amgen) following the approval of filgrastim-sndz (Zarxio, Sandoz) in 2015. Read the Pfizer corporate press release here.
Posted 7/23/2018
July 20, 2018
The Centers for Medicare & Medicaid Services (CMS) will be hosting two "Office Hours" sessions over the next few weeks to provide a brief overview of the Merit-based Incentive Payment System (MIPS 2017) performance feedback and targeted review, answer frequently asked questions, and highlight available resources on performance feedback and targeted review. The two webinars will be held at the following times:
If you are interested in submitting a question to be considered, please email CMSQualityTeam@ketchum.com . This email address is only for office hours questions; do not use this to submit a targeted review request. Space for these sessions is limited; register now to reserve your spot. The audio portion of the sessions will be broadcast through the web. Questions? Contact the Quality Payment Payment program at qpp@cms.hhs.gov .
CMS is also hosting a series of webinars on the MIPS Performance Categories for Year 2 (2018) of the Quality Payment Program. The webinars will provide an overview on the Cost, Improvement Activities, and Quality performance categories for Year 2. CMS subject matter experts will cover topics including category requirements, scoring details, and data submission mechanisms. Below are details for these webinars:
MIPS Cost Performance Category for Year 2 (2018) Overview Webinar
MIPS Improvement Activities Performance Category for Year 2 (2018) Overview Webinar
MIPS Quality Performance Category for Year 2 (2018) Overview Webinar
The audio portion of these webinars will be broadcast through the web; you can listen to the presentation through your computer speakers. CMS will open the phone line for the Q&A portion, but if you are unable to hear audio through your computer speakers, please contact CMSQualityTeam@ketchum.com .
Posted 7/20/2018
July 20, 2018
On July 20, the Food and Drug Administration (FDA) approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test. It is the first FDA-approved therapy for patients with R/R AML and an IDH1 mutation. Read the Agios corporate press release here.
Posted 7/20/18
July 18, 2018
On July 18, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corp.) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
The FDA also approved ribociclib in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy. Read the full FDA press release here.
Posted 7/18/18
July 16, 2018
On July 16, the Association of Community Cancer Centers (ACCC) submitted comments to the Request for Information (RFI) included in the administration's Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs . The plan was released in May.
In its comments , ACCC expresses support for the overarching goal to "bend the cost curve by improving care, providing the right care at the right time, reducing over-treatment and under-treatment, and reducing hospital admissions and readmissions." However, ACCC cautions that "any policy solution to rein in drug costs must preserve patients' access to—and ability to afford—quality cancer care and, relatedly, mitigate any impact on already reduced payment rates for cancer providers."
In brief, ACCC comments on the following concerns:
Read the ACCC Comment letter for a full discussion of these issues.
Posted 7/16/2018
July 16, 2018
On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).
This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC. Read FDA announcement .
Posted 7/16/2018
July 12, 2018
On July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) released the CY 2019 Medicare Physician Fee Schedule (PFS) proposed rule . Included are proposals to update payment policies, payment rates, and quality provisions for services furnished under the Medicare PFS on or after January 1, 2019.
The agency's proposals for Year 3 of the Quality Payment Program (QPP) are incorporated under the CY2019 PFS proposed rule .
Comments on the proposed rule are due by September 10, 2018.
ACCC is currently analyzing the proposed rule and will provide an in-depth analysis for membership.
Read the CMS fact sheet on the 2019 PFS proposed rule .
Read the CMS fact sheet on proposed QPP changes .
On Tuesday, July 17 from 1:00 - 2:30 PM ET, CMS will host a webinar on the proposed rule for Year 3 (2019) of the Quality Payment Program. CMS subject matter experts will:
Register here .
Posted 7/12/2018
July 10, 2018
In an effort to refocus nationwide efforts in oncology care, the American Cancer Society (ACS) has begun to outline its vision for cancer control in the 21st century through a series of articles. The first article in this series , published July 1, addresses trends in cancer mortality and disparities in cancer outcomes. ACS found that one area of critical disparity in cancer outcomes was socioeconomic status, indicated by educational attainment. Future articles in the series will focus on areas such as prevention, screening and early detection, cancer care and treatment, and research. Read the full ACS press release here.
Posted 7/10/2018