Bulletin Today

In a letter directed to congressional leaders on May 7, 2020, more than 240 patient advocacy and health care groups urged inclusion of DIR fee reform in the next coronavirus economic stimulus bill. The reforms would reduce patients’ prescription drug costs and help keep pharmacies—many of which serve as a health care hub in underserved communities—open and ready to provide patient care, the groups said. These issues are particularly vital as the nation battles the COVID-19 pandemic.
The letter is addressed to Senate Majority Leader Mitch McConnell (R-KY), Senate Minority Leader Charles Schumer (D-NY), Speaker of the House Nancy Pelosi (D-CA), and House Minority Leader Kevin McCarthy (R-CA).
“We ask that you remove barriers that threaten a pharmacy’s ability to support patients. This can be achieved by enacting much-needed pharmacy DIR reform, including clawback and pharmacy performance measure reform,” the letter reads.
Patient medication access protects patient health and well-being and leads to a reduction in avoidable emergency department visits. “Members of Congress should not overlook the clear and present opportunity to address these needed reforms this year,” the letter continues.
DIR fees refer to price concessions not reflected at the point of sale for pharmacies participating in Medicare Part D networks. Assessed weeks or months after Part D beneficiaries’ prescriptions are filled, the retroactive fees complicate decisions about staffing and whether to expand or even keep open a business. Pharmacies may not realize until long after a prescription is filled that they didn’t even recoup their costs. According to CMS, the fees have increased by 45,000% since 2010, correlating with a growing trend of pharmacy closures. Approximately 2,000 pharmacies have closed in the past 2 years.
Reform to DIR fees and other PBM practices that jeopardize patient access and increase out-of-pocket costs has bipartisan support. On April 27, 115 U.S. House of Representatives Members issued a letter urging Congress to include provisions that would permanently end retroactive DIR fees to ensure pharmacies remain viable during the public health emergency and beyond.
APhA signed onto the letter, along with the National Community Pharmacists Association, National Association of Chain Drug Stores, American Society of Consultant Pharmacists, National Association of Specialty Pharmacists, Food Industry Association (FMI), National Grocers Association, the National Alliance of State Pharmacy Associations, and many state pharmacy associations onto the letter.
Tobacco products evaporate from New York pharmacy shelves

New York pharmacies stopped selling tobacco products and flavored e-cigarettes on May 18 because of concern over the popularity of these products among adolescents.
New York State is now the second state in the country to stop selling tobacco in pharmacies and the fourth state to stop selling flavored e-cigarettes in pharmacies.
Perhaps New Yorkers saw this one coming. Last fall, the state intended to ban the sale of flavored e-cigarettes but was halted when the vaping industry sued the state. Less than a year ago, the smoking age in New York was increased to 21, and any pharmacy caught selling tobacco products will be fined up to $100 per product.
“Stores that sell products designed to heal people shouldn’t also be selling products that are a detriment to their health,” said Annalisa Rogers, director of the Smoking and Health Action Coalition, in an interview with RochesterFirst.com.
Pharmacists in New York will continue to offer smoking cessation counseling to patients when requested.
New NABP program accredits compounding pharmacies

In January, the National Association of Boards of Pharmacy (NABP) began offering accreditations for compounding pharmacies through its NABP Compounding Pharmacy Accreditation program.
The program evaluates and accredits compounding pharmacies that demonstrate a high level of patient care and dedication to reducing the risks associated with compounding practices and medication safety. The process involves a thorough review of business and quality assurance practices and compounding-specific requirements.
In addition to seeking compounding accreditation, a pharmacy may elect to bundle it with NABP’s other accreditations. This will create operational efficiencies and streamline the process for the pharmacy, as well as make it cost-effective for business, stated NABP in a news release.
NABP said this program complements the inspection services offered by the association and provides a full-service option for compounding pharmacies. Pharmacies that are currently accredited through FocusScript, LLC’s United Credentialing and Accreditation Program (UCAP), have been notified that NABP will grant them immediate accreditation through NABP’s new program for the remainder of their current accreditation cycle once they agree to NABP’s standards and terms and conditions. NABP said it has confirmed that certain pharmacy networks currently recognizing UCAP will accept the NABP Compounding Pharmacy Accreditation.
For more information, see the NABP website at nabp.pharmacy/programs/compounding. In addition to program information, a list of accredited sites will be posted soon.
New drug combo could improve survival for patients with common liver cancer

Since the drug sorafenib was approved in 2007, no new first-line therapy has been shown to improve survival in patients with advanced liver cancer. But that could be changing.
A new study published in the New England Journal of Medicine found that the combination of atezolizumab and bevacizumab improved survival by 42% for patients with hepatocellular carcinoma, the most common type of liver cancer.
“In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progression-free survival outcomes than sorafenib,” the study authors concluded.
The combination therapy is currently being reviewed for approval under FDA’s Real-Time Oncology Review pilot program.
“By using these two drugs with different mechanisms of action together, we have increased the number of patients who respond to this treatment and have increased the duration of these responses as compared to the standard treatment, sorafenib,” said the study’s lead author, Richard S. Finn, MD, professor of medicine at the David Geffen School of Medicine at UCLA, in a press release.
Atezolizumab is an immunotherapy drug that boosts the body’s natural defenses, and bevacizumab is an antiangiogenesis drug that inhibits the growth of a tumor’s blood vessels.
Finn called the new therapy a “game-changer” for people diagnosed with hepatocellular carcinoma. “We now have a new therapy that not only improves survival for people with the disease, which is very challenging to treat, but that helps them live longer while maintaining a high quality of life,” he added.
Finn and his research team analyzed results from roughly 500 adult patients worldwide with advanced metastatic or unresectable hepatocellular carcinoma who were randomly assigned different treatments: Two-thirds received the atezolizumab and bevacizumab combination, while one-third received sorafenib. Overall survival at 12 months was 67.2% with atezolizumab–bevacizumab and 54.6% with sorafenib.