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
May 1, 2018
The National Academies of Sciences, Engineering, and Medicine (NASEM) has published the proceedings of several new workshops , including a workshop held by the National Cancer Policy Forum on long-term cancer survivorship care.
Long-Term Survivorship Care After Cancer Treatment summarizes the proceedings of a July 2017 workshop held in Washington, D.C., to examine progress made in cancer survivorship care since the publication of the 2006 consensus study report From Cancer Patient to Cancer Survivor: Lost in Transition . Workshop participants highlighted potential opportunities to improve the planning, management, and delivery of cancer survivorship care.
The Global Forum on Innovation in Health Professional Education also published the proceedings of their Improving Health Professional Education and Practice Through Technology workshop held in November 2017. Participants explored effective use of technologies as tools for bridging identified gaps within and between health professions education and practice in order to optimize learning, performance and access in high-, middle-, and low-income areas while ensuring the well-being of the formal and informal health workforce.
Posted 5/1/2018
May 1, 2018
On April 30, 2018, the Food and Drug Administration granted regular approval to dabrafenib (Tafinlar, Novartis Pharmaceuticals Corp.) and trametinib (Mekinist, Novartis Pharmaceuticals Corp.) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Read the full FDA announcement here.
Posted 5/1/2018
April 25, 2018
On April 24, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System.
Among the proposed changes, CMS seeks to overhaul the Medicare and Medicaid EHR Incentive Programs to “focus on interoperability, improve flexibility, relieve burden and place emphasis on measures that require the electronic exchange of health information between providers and patients,” according to the agency’s fact sheet. To reflect this new focus, CMS proposes to change the EHR incentive program name from the “Meaningful Use” program to “Promoting Interoperability.”
In addition to payment and policy proposals, CMS is releasing a Request for Information (RFI) to gain stakeholder input on the possibility of revising Conditions of Participation related to interoperability as a way to increase electronic sharing of data by hospitals.
The deadline for submitting comments on the proposed rule and the RFI is June 25, 2018.
Read the full rule here , and access the CMS fact sheet here .
Posted 4/25/2018
April 24, 2018
Earlier this week, the Centers for Medicare & Medicaid Services (CMS) announced the release of the more than 1,000 comments the agency received in response to its “New Direction” RFI for the Innovation Center. In a statement, the agency said that it is sharing the feedback “to promote transparency and facilitate further discussion” on ways to move the Innovation Center in a new direction. Learn more .
CMS also opened a new RFI for a “potential model in the area of direct provider contracting” as a next step. The agency is seeking input on a possible direct provider contracting care model between payers and primary care or multispecialty groups.The model might be tested within the Medicare fee-for-service (FFS) program (Medicare Parts A and B), Medicare Advantage program (Medicare Part C), and Medicaid. Read more on the RFI .
Posted 4/24/2018
April 23, 2018
On April 22, the White House stated that President Donald Trump's planned speech on lowering drug costs has been postponed. Originally planned for April 26, the speech has been postponed to an undetermined date in the "near future," according to Hogan Gidley, deputy White House press secretary.
Source: Bloomberg BNA
Posted 4/23/2018
April 18, 2018
On April 17, 2018, the U.S. Food and Drug Administration (FDA) approved fostamatinib disodium hexahydrate tablets (Tavalisse, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Read FDA announcement . 4/18/18
April 16, 2018
On April 16, 2018, the Food and Drug Administration granted approval to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk previously untreated advanced renal cell carcinoma.
Read the full press release here.
Posted 4/16/2018
April 13, 2018
On April 6, Secretary of Health and Human Services (HHS) Alex Azar announced that Adam Boehler would assume leadership of the Center for Medicare & Medicaid Innovation (CMMI) on the week of April 9. Boehler, the founder and chief executive officer of Landmark Health, replaced acting leader Amy Bassano as the head of CMMI, the office responsible for testing Medicare and Medicaid payment innovations. Read more here.
Posted 4/13/2018
April 11, 2018
The American Cancer Society Cancer Action Network (ACS CAN) has released a report detailing the barriers to patient enrollment in therapeutic clinical trials for cancer. In its report, ACS CAN compiles all relevant evidence for clinical trial barriers in one place and discusses them in relation to each other, addressing each component’s contribution to the problem as a whole. ACS CAN also provides a complementary set of 23 recommendations for overcoming clinical trial barriers in numerous areas, including provider and institutional barriers, patient barriers, trial-design barriers, and disparities.
Posted 4/11/2018