NACDS RxImpact calls on Senate to support action on DIR fees
NACDS RxImpact pharmacy advocates are urging Senators to sign a letter to Health and Human Services Sec. Alex Azar that is being led by Sen. Shelley Moore Capito, R-W. Va., and Sen. Jon Tester, D-Mont. The letter describes the negative effects on Medicare patients and on pharmacies of the rapid expansion of the use of direct and indirect remuneration, or DIR, fees in recent years.
The NACDS RxImpact program has consistently linked pharmacies’ real-world experiences with their legislators to urge action on DIR fees.
In March, pharmacy advocates from all 50 states reached all members of Congress through in-person meetings in Washington, D.C., during NACDS RxImpact Day on Capitol Hill, with DIR fees among the priority issues discussed. This topic also is a focus of NACDS RxImpact Congressional Pharmacy Tours and other events in states and Congressional Districts.
“NACDS thanks Sen. Shelley Moore Capito and Sen. Jon Tester — as well as all of the senators who are signing the letter — for their leadership in explaining the consequences of the current state of DIR fees, and for urging Sec. Azar to not allow the current focus on drug prices to pass without taking meaningful action on this extremely critical issue,” said NACDS president and CEO Steve Anderson.
“The senators are making clear the consequences of DIR fees on patients, who are facing higher cost-sharing for drugs and who are hitting the ‘donut hole’ coverage gap more quickly. The Senators also are sharing the real-world jeopardy to patient care when pharmacies learn well after a transaction occurs that some of the payment that they received must be returned to a health plan.”
DIR fees were originally intended to capture and report rebate amounts paid by manufacturers at the end of the plan year during the reconciliation process in Part D. In recent years, however, NACDS said the fees have become a catch-all category used increasingly by payers to include various pharmacy price concessions, such as fees related to performance-based programs or fees for participation in a preferred network. As a result, pharmacies find themselves in the untenable position of being paid by plan sponsors for prescription services, only to find out later that some of the payment must be returned, NACDS said.
In April, the Centers for Medicare and Medicaid Services stated in the Final Part D Rule that it has the authority to take action to remedy this issue and that no legislative action would be needed before it could begin a rulemaking process.
Avella highlights adherence, refill boosts from AdhereTech’s smart pill bottles
Avella Specialty Pharmacy is highlighting how its use of AdhereTech smart pill bottles for multiple specialty medications from various manufacturers has resulted in improvements in duration, refills, and the patient experience.
Avella uses the AdhereTech program for five specialty medications, in programs with four different pharmaceutical manufacturers.
Averaged across all patients and programs from 2015 through this year, Avella said AdhereTech has improved duration on therapy by 26%, fill rates by 9% and dose-level adherence by 15%. On average, the AdhereTech program generates 1-to-2 additional fills of specialty medications per patient per year, according to the company, which also touted the impact of AdhereTech’s additional support on the caregiver and patient experience.
The system sends intelligent reminders for missed doses and it is also able to determine if a patient may need additional care via proprietary data analysis that occurs on the backend.
In such an event, the system sends a real-time alert directly to an Avella nurse, who can review the information from AdhereTech. The nurse can decide to contact the patient to provide additional care, at the exact moment it’s needed. Patients receive this full service at no additional cost, and patient feedback is overwhelmingly positive, with the average patient satisfaction rating at 4.7 out of 5.
“The use of AdhereTech has been a strategic part of Avella’s overall efforts to increase medication adherence rates and improve health outcomes for our patients,” said Avella executive vice president of clinical affairs and quality Assurance Eric Sredzinski. “By improving our ability to provide targeted support right when each individual needs it, this technology has truly optimized our patient care practices.”
HIV-prevention vaccine candidate shows promise in human trials
A series of HIV-prevention vaccine regimens have been evaluated in a study of uninfected human volunteers in five countries and the results appear promising.
The study, published in The Lancet, was conducted by a team of researchers led by Beth Israel Deaconess Medical Center’s Dr. Dan H. Barouch, director of the Center for Virology and Vaccine Research in collaboration with Janssen Vaccines & Prevention and other partners.
Barouch and his colleagues tested the same vaccine for its ability to protect rhesus monkeys challenged with an HIV-like virus from infection. The vaccines induced robust and comparable immune responses in humans and monkeys and protected monkeys against the acquisition of infection.
“This study demonstrates that the mosaic Ad26/Ad26 plus gp140 vaccine candidate induced robust and comparable immune responses in human and monkeys,” said Barouch, who also is a professor of medicine at Harvard Medical School. “Moreover, the vaccine provided 67 percent protection against viral challenge in monkeys.”
Intended to provide broad protection from the many strains of HIV that are prevalent worldwide, the “mosaic” vaccine contains a patchwork of genetic sequences found among various HIV strains. Known as APPROACH, the phase 1/2a trial tested seven different Ad26/Env HIV vaccine regimens for their safety, tolerability and the ability to elicit immune responses in 393 healthy adult volunteers in Rwanda, South Africa, Thailand, Uganda and the United States. All vaccine regimens were well-tolerated and induced robust immune responses in the participants.
“Based on these data, the mosaic Ad26/Env HIV-1 vaccine has been advanced into a phase 2b clinical efficacy study to determine whether this vaccine will prevent HIV infection in humans in southern Africa,” said Barouch. “We expect results in 2021. This is only the 5th HIV vaccine concept that will be tested for efficacy in humans in the 35-plus year history of the global HIV epidemic.”