PHARMACY

Study: High-dose influenza vaccine optimal for seniors living in long-term care facilities

BY Michael Johnsen

ARLINGTON, Va. — For frail older adults living in long-term care facilities, the high-dose influenza vaccine appears to be a better option than the regular shot, producing a stronger immune response than the standard vaccine, according to a study published in The Journal of Infectious Diseases on Thursday and now available online. High-dose vaccine may play a key role, along with improving vaccination rates among healthcare workers and other strategies, in preventing flu in this vulnerable and growing population.
 
About 90% of the deaths associated with influenza in the United States annually are among adults aged 65 years of age and older, according to estimates from the Centers for Disease Control and Prevention. Those 85 years of age and older who live in long-term care facilities are particularly at risk: They are more likely to be exposed to influenza, their immune systems are not as responsive to vaccines, and other medications or medical conditions may impair their immunity.
 
 
In the first study of its kind in this population, David Nace of the University of Pittsburgh, along with colleagues, compared the immune response generated by the high-dose vaccine with that of the standard dose. (Designed for adults 65 years of age and older, the high-dose vaccine was approved in the United States in 2009.) Conducted during the 2011-2012 and 2012-2013 flu seasons, the randomized controlled trial included 187 frail older adults from 15 long-term care facilities in western Pennsylvania. The participants' average age was 86.7 years old.
 
The high-dose vaccine produced a stronger immune response to all but one of the influenza vaccine strains, according to antibody titers from blood samples collected just prior to vaccination and 30 and 180 days after. Although the trial did not evaluate clinical disease, a study published in August comparing the two vaccines in older adults living in the community showed a correlation between stronger immune response and lower rates of influenza illness and hospitalizations.
 
"For frail older adults, the high-dose vaccine appears to be a better option to protect against flu than the standard dose," Nace said. "Even in the frail, long-term care population, the high-dose flu vaccine looks like it produces a greater antibody response than the standard dose vaccine."
 
Even so, the stronger immune response prompted by the high-dose vaccine was still modest, Nace said, highlighting the need for continued work to develop better influenza vaccines for this at-risk population. The findings, he noted, also underscore the need for "a bundled approach" to flu prevention in this setting that also includes boosting vaccination rates among healthcare workers and other steps.
 
In a related editorial, Megan Lindley and Carolyn Bridges of CDC outlined several related strategies, including ensuring that facilities are prepared to detect influenza outbreaks and intervene rapidly to limit their spread. Vaccination of both residents and caregivers will continue to be key elements, as well.
 
"Although far from perfect," they wrote, "annual influenza vaccination of both residents and healthcare personnel remains one of the most important measures available to reduce the risk of influenza and its complications in long-term care settings."
 
The study was supported by an investigator initiated grant from Sanofi Pasteur and from the University of Pittsburgh Claude D. Pepper Older Americans Independence Center. 
 

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PhRMA outlines progress in battling hepatitis C in new report

BY Michael Johnsen

WASHINGTON — The Pharmaceutical Research and Manufacturers of America on Thursday released a new report, “Twenty-Five Years of Progress Against Hepatitis C: Setbacks and Stepping Stones,” that examines the scientific challenges and setbacks researchers have faced on the path to developing new medicines with the potential to transform treatment for hepatitis C patients, and how “failures” are an integral part of the drug discovery process.
 
The new report found that between 1998 and 2014, 77 investigational medicines failed in clinical trials, laying the groundwork for 12 approved medicines over the same period.
 
“New and forthcoming hepatitis C treatments represent a remarkable advance against a very serious disease,” stated PhRMA president and CEO John Castellani. “These treatments are often curing more than 90% of patients — transforming lives and helping to avert billions of dollars in unnecessary hospitalizations and other costly medical services. Forthcoming treatments are projected to provide even greater cure rates and shorter duration of treatment, vastly improving patients’ health and quality of life.” 
 
The learnings from development setbacks inform the continuous innovation in treatment, leading to new advances in treating the hepatitis C virus. The evolution of treatment from interferon-based therapy to direct-acting antiviral agents has helped transform hepatitis C from a chronic and often fatal illness to an infection that, with new and forthcoming treatments, may one day be considered a rare disease.  
 
While the trajectory of hepatitis C is changing, substantial unmet medical need for patients remains, which is why the industry continues to research further treatment advances for patients. According to the report, there are 75 new hepatitis C medicines either in clinical trials or awaiting review by the U.S. Food and Drug Administration.
 
Hepatitis C is the leading cause of liver transplants and the primary driver of increases in liver cancer. The costs of treating hepatitis C is estimated at $112,000 per year, and the cost of a liver transplant can range as high as $500,000 per patient. These costs underscore the importance of new therapies in treating and potentially curing the disease for both patients and the healthcare system.
 

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U.S. Senate Special Committee on Aging advocates increased generic utilization

BY Michael Johnsen

WASHINGTON –  The U.S. Senate Special Committee on Aging unveiled a new bipartisan report earlier this week that focuses on ways to increase the use of generic drugs within the Medicare Part D program. 
 
In addition to the report, the committee is calling on the Government Accountability Office to examine what is behind recent price increases for certain generic drugs like heart medication digoxin, which has been on the market for years. The issue of generic drug price spikes has recently attracted attention from the Justice Department and the Senate Committee on Health, Education, Labor & Pensions Subcommittee on Primary Health and Aging. 
 
Specifically, the Special Committee on Aging’s report outlines a series of policy recommendations that include:
 
  • Providing incentives to prescription drug plan sponsors who increase generics use;
  • Finding innovative ways to expand generic drug usage among low-income subsidy beneficiaries;
  • Increasing education of beneficiaries and health professionals on the safety, effectiveness and cost benefits of generic medications; and
  • Improving investigations of questionable pharmacy billing practices that thwart efforts to incentivize generics.
“We need to do everything we can to boost drug saving for beneficiaries and taxpayers,” stated committee Chairman Bill Nelson, D-Fla. 
 
“Although the use of generic drugs has increased over time, more can be done to encourage appropriate use of generics in order to keep rising drug costs in check,” added Sen. Susan Collins, R-Maine, the panel’s ranking member. “For example, greater attention should be given to educating Medicare beneficiaries and healthcare professionals about the efficacy of generic drugs, and encouraging them to select generic drugs instead of brand-name drugs, when appropriate.”
 
“GPhA applauds the new findings of the Senate Special Committee on Aging and welcomes further conversation on increasing generic drug utilization in government programs, particularly Medicare Part D," commented Ralph Neas, president and CEO of the Generic Pharmaceutical Association. "One additional area that GPhA is hopeful that Congress will address in 2015 is the misuse of programs designed to protect patient safety, such as Risk Evaluation and Mitigation Strategies. These tactics cost the U.S. health system $5.4 billion, according to Matrix Global Advisors," Neas noted. "That is why the association supports the bipartisan Fair Access for Safe and Timely (FAST) Generics Act, introduced by Congressman Steve Stivers, R-Ohio and Congressman Peter Welch, D-Vt., which would limit brand drug company maneuvers that misuse REMS and thwart competition from more affordable generics."
 
The committee’s findings were part of a comprehensive two-year review that analyzed drug plan formularies, pharmacy billing, physician prescribing practices and plan sponsor programs to incentivize generics use. 
 
 

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