FDA Approves Vaccine for 2009-2010 Seasonal Influenza

The U.S. Food and Drug Administration today announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States.

The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009. The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus.

Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine. No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths.

“The approval of this year’s seasonal influenza vaccine is an example of the FDA’s important responsibility to assure timely availability of vaccine to help protect the health of the American public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

The six vaccine brand names and manufacturers are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur Inc.; and FluMist, MedImmune Vaccines Inc.

Each year, experts from the FDA, WHO, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of the FDA’s Vaccine and Related Products Advisory Committee, the FDA determines the three strains that manufacturers should include in their vaccines for the U.S. population. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against the disease.

The vaccine for the 2009-2010 seasonal influenza contains:

* an A/Brisbane/59/2007 (H1N1)-like virus
* an A/Brisbane/10/2007 (H3N2)-like virus
* a B/Brisbane/60/2008-like virus

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year. More than 200,000 are hospitalized from its complications and about 36,000 people die. Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications. Vaccination of these groups is critical.

Additionally, influenza immunization of health care personnel is important in protecting them and others from influenza.

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Oncology Care Quality Improvement Program Introduced by Bipartisan Coalition Dedicated to Better Cancer Care Nationwide

/PRNewswire/ -- A bipartisan group of members from the U.S. House of Representatives introduced a bill late yesterday aimed at improving oncology care in the United States by refocusing efforts towards patient-centered cancer care delivery and studying the best methods to coordinate care and extend quality of life. The "Oncology Care Quality Improvement Program of 2009" will establish a voluntary pilot program to identify major areas of potential improvement to oncology care, including error reduction, increased patient education and care coordination, and expansion of end-of-life planning and counseling services.

This groundbreaking oncology legislation, led by U.S. Representative Joseph Crowley (NY-7), has 18 original cosponsors, including lead sponsors Reps. Mike Rogers (MI-08), Lois Capps (CA-23), Anna Eshoo (CA-14) and Paul Ryan (WI-01). The bill has been endorsed by National Patient Advocate Foundation (NPAF), US Oncology, Society of Gynecologic Oncologists (SGO), Association of Community Cancer Centers (ACCC) and UPMC Cancer Centers.

"Fighting cancer is a fight we must win," said Rep. Joseph Crowley (NY-7). "This innovative demonstration project will ensure that patients and doctors have the best tools and information at their disposal. By providing our health care providers with most-up-to date information on best practices, we will ensure cancer patients are given the best and most cost-effective care. I thank Rep. Rogers, Capps, Eshoo and Ryan and colleagues from both sides of the aisle for joining me in leading this fight for oncology patients, doctors and families. We are proud to have the endorsement of the National Patient Advocate Foundation and US Oncology, our partners in working to get this program enacted swiftly."

"Cancer is one of the great health care challenges of our time," said Rep. Mike Rogers (MI-08). "Half of all men and one third of women will be diagnosed with cancer at some point in their lives and these figures are expected to skyrocket as the Baby Boom generation ages. That's why I'm proud to join Rep. Crowley to introduce this legislation, which will improve the quality of care for seniors with cancer while also creating a more efficient Medicare system."

"As researchers and clinicians work to improve cancer care in innovative ways, I'm proud to be part of this effort by Congress and CMS to evaluate the innovative use of health information technology in order to improve cancer care overall," said Rep. Lois Capps (CA-23). "The standard for oncology care in the 21st Century is about comprehensive care planning and coordination. By providing incentives to use the newest health information technology tools available, we can assist providers and patients in achieving optimal information sharing on best practices and better coordination among clinicians."

"As we begin to work on health care reform in the House, it's more important than ever that we look at every option available to help increase the quality of care while decreasing the overall cost of health care," said Rep. Anna Eshoo (CA-14). "This pilot program gives participating oncology groups the flexibility and incentives necessary to explore cost-saving measures without sacrificing the quality care their patients receive."

"Like most Americans, my family has been personally touched by cancer and personally motivated in our fight against cancer," said Rep. Paul Ryan (WI-01). "I remain committed to doing all that I can to find a cure for this disease, while working to promote innovate and compassionate improvements to oncology care. I am a proud to help introduce the Oncology Care Quality Improvement Program, and thank Rep. Crowley and my colleagues on both sides of the aisle for working on this important piece of legislation and for their leadership in the fight against cancer."

"Finally, we have a thoughtful, progressive, quality-driven program that achieves patient-centric cancer care delivery, while reducing costs at the same time. It is a win for the patient, the taxpayer and the physician," said Dr. Roy Beveridge, Chief Medical Officer, US Oncology.

National Patient Advocate Foundation (NPAF) continued, "NPAF is pleased to offer its strong support for the Oncology Care Quality Improvement Program of 2009. This legislation calls for adherence to evidence-based guidelines which will reduce variation in care for patients and help physicians make clinical decisions with evidence of proven treatment regimens. In addition, NPAF commends Rep. Crowley for addressing the importance of an adequate medical workforce as well as appropriate reimbursement which are critical in order for education and care coordination to have a meaningful impact on patients and our health care system."

Background on the Oncology Care Quality Improvement Program of 2009:

The oncology care quality improvement (OCQI) program is a cost-saving, voluntary pilot program, to be led by the Centers for Medicare and Medicaid Services (CMS) in consultation with an advisory committee of expert oncology community physician, nurse, patient organizations and industry leaders. The OCQI will evaluate the impact of provider-led approaches to improve care quality and outcomes for Medicare beneficiaries with cancer while creating greater care efficiencies to reduce costs. The OCQI aims to foster evidence-based guideline adherence to minimize variation and reduce errors in care, offers patient education and care coordination services to help patients avoid and/or address common effects of their cancers and treatments, and provides end-of-life planning and counseling services that aims to improve quality of life.

The OCQI will provide payments to participating oncology groups - based on their meeting of defined performance goals as well as per capita expenditure targets created by CMS - to be allocated from half of the program savings generated by the participating group. The other half of the program savings will be retained by the Medicare program.

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Prescription Drug Benefits for Medicare Patients with Cancer to Cost More in 2009

/PRNewswire-USNewswire/ -- People with cancer enrolled in Medicare Part D plans will spend more out-of-pocket for their Part D drugs and face increased restrictions on access to them in 2009, according to new research released today by Avalere Health and the American Cancer Society Cancer Action Network (ACS CAN).

The Avalere-ACS CAN research found that Medicare stand-alone prescription drug plans (PDPs) have been increasingly shifting name-brand oral cancer drugs to higher formulary tiers over the last four years, meaning that with each year, the products have cost more for consumers.

In 2009, the large majority of PDPs placed name-brand oral oncology products -- including Gleevec, Sutent, Tarceva, Thalomid, and Tykerb -- on specialty tiers that require cost sharing of 26 percent to 35 percent for each prescription. For example, 84 percent of PDP enrollees are in plans that put Gleevec -- a name-brand drug used to treat leukemia and other forms of cancer -- on their most expensive tiers (fourth or higher) in 2009, up from 39 percent in 2006.

"This pattern of shifting the costs of branded medications to patients needs to be scrutinized, especially in light of the economic difficulty being experienced by so many seniors," said Valerie Barton, a vice president at Avalere Health.

"Shifts in drug coverage can limit access to treatment for people with cancer, significantly reducing their treatment options or even requiring a stoppage of treatment," said Daniel E. Smith, president of ACS CAN. "We urge policymakers to pay close attention to how these changes impact people with cancer. At the same time, it is critical that people with cancer understand their health coverage and the potential hurdles that may impact their treatment."

In addition to changing tier placement, PDPs in 2009 are increasing their use of prior authorization to control access to branded cancer drugs. The Avalere-ACS CAN research found that Gleevec had the largest increase in the number of PDPs requiring prior authorization, with 70 percent of plans requiring it, up from 35 percent in 2006. Tarceva had the next highest increase, with 62 percent of plans requiring prior authorization in 2009, up from 35 percent in 2006. Thalomid was next, with 68 percent of plans requiring prior authorization in 2009, up from 43 percent in 2006.

Geography and plan choice influence how much a person with cancer will spend out-of-pocket in Medicare Part D. Avalere and ACS CAN modeled hypothetical drug regimens for women with breast cancer and found that total out-of-pocket costs for a woman enrolled in AARP MedicareRx Saver in Florida will be about $1,985, while total out-of-pocket costs for beneficiaries enrolled in Humana PDP Standard in California will average about $2,551.

ACS CAN and the American Cancer Society are closely monitoring these issues as part of their nationwide efforts to ensure access to quality, affordable health care for all Americans. The organizations believe that the health care system needs to be retooled with an emphasis on prevention and early detection; meaningful health insurance that is adequate, affordable, available and administratively simple; and reducing pain and suffering with an emphasis on quality of life.

Avalere continues to analyze Medicare drug benefit data. Since the inception of the Medicare drug program, Avalere has used its proprietary DataFrame(R) database to track trends in drug pricing, plan strategy and structure, and the beneficiary experience.

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