AstraZeneca gets FDA nod for Calquence
SILVER SPRING, Md. — The Food and Drug Administration has approved a new lymphoma treatment from AstraZeneca. The company announced this week that its Calquence (acalabrutinib) had been approved to treat patients with mantle cell lymphoma in patients who have received at least one prior therapy.
Mantle cell lymphoma makes up 3-in-10 new non-Hodgkin lymphoma diagnoses in the United States, according to the National Cancer Institute. The drug works by blocking an enzyme that cancer needs to multiply and spread, the FDA said. The regulatory agency approved the drug under its accelerated approval pathway based on its overall response rate, AstraZeneca said.
“The accelerated approval of Calquence is a landmark moment for our company,” AstraZeneca CEO Pascal Soriot said. “It provides an exciting new treatment option for patients with mantle cell lymphoma and marks the first approval of a medicine that will be the cornerstone of our presence in hematology. Furthermore, today's approval demonstrates our commitment to scientific leadership in Oncology and reinforces our progress towards returning to growth.”
Calquence is set to be dispensed by a limited group of specialty pharmacies, which include Diplomat Pharmacy and Avella Specialty Pharmacy
“Calquence is a needed alternative to treat a life-threatening blood cancer for patients who might not be responding to therapy or whose cancer has relapsed,” Diplomat president Joel Saban said.
CVS Pharmacy offers free Houston health screenings
HOUSTON — CVS Health is bringing its annual Project Health screenings in an effort to continue to support the Houston area as it recovers from Hurricane Harvey. The screenings, to be held Nov. 2 through Feb. 18 in select locations in the greater Houston area, were originally slated to take place in September, but was postponed in the aftermath of the hurricane.
"Even as the residents of Houston have begun to recover and rebuild their lives following Hurricane Harvey, we know the impact this type of stress can place on a person's health and wellness," CVS Pharmacy area vice president Jeff Schmidt said. "Our free health screenings can help identify health concerns or other risk factors for participants who may not have access to care otherwise, as well as provide referrals to local doctors and information on low-cost health insurance options."
The walk-in screenings will include such comprehensive health assessments as blood pressure, body mass index, glucose and total cholesterol screenings, the company said. Bilingual nurse practitioners or physician assistants will be on hand to analyze results and refer patients to their primary care physician or no- and low-cost medical facilities.
To encourage participation, CVS Health said it is working with the YMCA in Houston to drum up patients.
“Health screenings are the first step in recognizing opportunities for improving one's health," YMCA of Greater Houston association director of community health Lharissa Jacobs said. "Screenings, like those provided at Project Health, provide people with valuable information to make important decisions in reclaiming their health for the long run, and the Y is so pleased to encourage people to live their healthiest life."
CVS Health said the Houston screenings are part of Project Health efforts in 10 cities that will host 450 wellness events to more than 887,000 people.
Opioid commission issues 56 policy suggestions in final report
WASHINGTON — The President’s Commission on Combating Drug Addiction and the Opioid Crisis has issued its final report with 56 recommendations on how to address prescription drug abuse and misuse. The report, issued at the commission’s final meeting Wednesday, includes such recommendations as providing federal funding and programs to target opioid abuse and misuses, addiction prevention efforts and prescription drug management program enhancements, among others.
Besides calling for block grant funding from Congress for opioid-related state activities and a wide-ranging media campaign, the report outlines recommendations for prescribing guidelines. Suggestions include policies to ensure informed consent from patients about opioid prescriptions for chronic pain, a screening program to help prescribers identify at-risk patients and the requirement of a continuing education program for prescribers who want to be relicensed to prescribe opioids.
With regard to pharmacy, the report calls for pharmacist training to help them assess the legitimacy of opioids prescriptions while warning against penalizing pharmacists who deny inappropriate prescriptions. The commission also focuses on PDMP enhancements, including a push for Justice Dept. funding to establish and maintain a hub for PDMP reporting required from states who would receive federal funding. It also wants PDMPs to be integrated with electronic health records, overdose episodes and tools for substance use disorder-related decisions, among other initiatives.
The report has drawn praise from industry organizations, who noted that the report includes several proposals they suggested.
“We appreciate that many concepts urged by NACDS and by others have been incorporated into the report released today," National Association of Chain Drug Stores president and CEO Steve Anderson said Wednesday. “In addition, many of the concepts in the report are consistent with new public policy recommendations that NACDS issued last week, based on first-hand experiences of pharmacists on the front lines of patient care and intended to build on pharmacy’s ongoing engagement on this issue.”
Also commending the report was the Healthcare Distribution Alliance.
“We commend the commission for its work over the past several months to identify comprehensive solutions to address the opioid epidemic,” HDA president and CEO John Gray said. “Our industry is strongly committed to working with the public and private sectors to advance meaningful reforms at both the state and federal levels to reduce the prevalence of overprescribing; increase awareness of proper use and disposal of opioids among patients and families; and ensure individuals with legitimate pain needs have access to safe and effective treatments. In our letter to the Commission, we outlined the proactive solutions that would strengthen our country’s response to this epidemic. We were encouraged to see the Commission call for urgent action on a number of these policies.”
Other suggested efforts include the Centers for Medicare and Medicaid Services changing set rates that might discourage use of non-opioid pain treatments. It also calls for a federal review of and funding for National Institute on Drug Abuse research that would take place alongside pharmaceutical industry research. The research should focus on new treatments for substances use disorders, more potent overdose-reversal drugs and opioid vaccines, the report said.
The final report comes less than a week after President Donald Trump declared a Public Health Emergency, a move that drew criticism for its lack of a call for funding. Commission chairman and New Jersey Gov. Chris Christie noted that this was done in accordance with the commission’s recommendations.
“The president did exactly what I asked him to. I wanted this to be a public health emergency because I wanted HHS to take the lead in administering funds, not FEMA,” Christie said. “Now it’s incumbent upon Congress to step up and put money in the Public Health Emergency Fund so the President can utilize that, and that should happen without delay, in the view of the commission.”