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HHS funding development of groundbreaking influenza drug

The federal government is backing the development of new influenza drug, which early studies suggest may be a game changer in treating the viral infection that is responsible for over 36,000 deaths annually in the U.S. alone. HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) has announced that it will be funding the development of a new type of influenza drug that takes a novel approach to treating individuals suffering from influenza. The drug, VIS410, is a monoclonal antibody therapeutic drug, which binds to specific part of a virus with the aim of decreasing the amount of the virus present the body. No monoclonal antibody antiviral drug has ever been approved by the FDA to treat individuals with influenza.

Targeted Treatment

Visterra, Inc. is developing VIS410, which targets parts of the influenza virus that is commonly present in a wide range of flu strains. The targeted area has been found to evolve much more slowly than areas that are targeted by drugs that have been approved by the FDA. As a result, it is hoped that VIS410 could be effective against strains that are resistant to available antiviral drugs.

New Technology

Visterra, which is backed by various investors, including the Bill & Melinda Gates Foundation, is a biotechnology company that identifies unique disease targets through its “Atomic Interaction Network (AIN) analysis,” which is described as “computational tools and techniques.” Visterra has initially focused on infectious diseases that have complex and evolving properties with the potential to mutate. The company uses its Hierotope™ Platform to identify an area on a target protein, glycoprotein or glycan that is fundamental to its structure, which then becomes the target for which a therapeutic is developed.

Agreement

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will be overseeing the 40-month, $29.1 million agreement. As part of the agreement, Visterra will conduct clinical studies of VIS410’s safety and efficacy and will manufacture materials used in the clinical studies. The company will also optimize the manufacturing processes. Visterra’s work will provide data and support for the company when requesting FDA review and approval for the drug. The contract can be extended up to five years at a cost of $204.5 million. If the Visterra’s contract is extended, it will conduct larger clinical studies of the drug’s efficacy in treating severely ill individuals and hospitalized patients.

Treatment Timing

The clinical studies will also examine the drug’s efficacy when administered more than 48 hours after the beginning of influenza symptoms. This is notable because current treatments work best when administered within 48 hours of the onset of symptoms.

Users

Pre-clinical studies have suggested that the drug may be more effective than currently available FDA-approved drugs. The studies also suggest that the drug could be safe and effective for use in treating individuals for whom influenza may pose the highest risks, such as the elderly, children, or those with chronic conditions including heart disease. If the drug is successfully developed, it may provide a treatment for patients who are hospitalized as a result of seasonal or pandemic influenza infections. Each year, more than 200,000 individuals are hospitalized due to flu complications and 36,000 people die as a result of the seasonal flu.

Integrated Portfolio

The new antiviral monoclonal antibody development project is yet another part of BARDA’s integrated portfolio that seeks to advance the research, development, and manufacturing of vaccines, drugs, and diagnostic tools for public health emergencies.

Robin Robinson, Ph.D., Director of ASPR’s BARDA said, “Having multiple antiviral treatment options available for influenza is essential to saving lives in a pandemic and every day.” Robinson further stated, “Developing antiviral drugs that work against many strains of influenza provides a cost-efficient way to boost pandemic preparedness and at the same time potentially alleviate the suffering of hundreds of thousands of people who are hospitalized with influenza every year.”

Some hospitals dramatically inflating prices, mostly affecting uninsured

A study examining the Medicare cost reports of 50 hospitals across the country with the highest charge-to-cost ratios found that the hospitals charged patient fees that were 10 times more than the amount of their costs. Additionally, the study found that the uninsured individuals were most often charged the highest prices because public and private health insurers do not pay rates based on a hospital’s charges.

For-profit hospitals

The study found that, out of the 50 hospitals with the highest markups, 49 were for-profit hospitals. The study also revealed that 46 of the hospitals were owned by for-profit hospital systems, including one system owning 25 hospitals on the list. Additionally, 20 of the hospitals were located in Florida.

The Washington Post is reporting that the co-author of the study, Gerard Anderson, a professor at Johns Hopkins Bloomberg School of Public Health, explained that the lack of regulation may explain the inflated prices. “They are marking up the prices because no one is telling them they can’t,” he said. Additionally, he reportedly stated, “These are the hospitals that have the highest markup of all 5,000 hospitals in the United States. This means, when it costs the hospital $100, they are going to charge you, on average, $1,000.”

Uninsured most affected

The study pointed out that market forces are not likely to control the hospital prices because it is difficult for consumers to compare prices. Additionally, public and private health insurers do not set their payment rates based on hospital charges. As a result, uninsured individuals are often billed for full price and out-of-network patients and workers’ compensation insurers are also frequently required to pay a large portion of the charges.

Recommendations

The study recommended that the states and the federal government limit charge-to-cost ratios, set an all-payer rate, or require full disclosure by hospitals in order to control markups.

Highlight on Washington: Cash Influx & Mall Visits Help Exchange Toward Goals

Washington Healthplanfinder, the state’s Health Insurance Exchange, has enrolled 127,000 Washingtonians in qualified health plans during the 2014-2015 open enrollment period, around 40,000 of whom are new enrollees. In order for the state to meet its goals for open enrollment, which ends on February 15, 2015, an additional 88,000 individuals will need to enroll; according to the Associated Press, state health officials said they wanted to renew all 130,000 policies purchased during the first open enrollment period (October 1, 2013-March 31, 2014), and they hope to sign up 85,000 new enrollees.

Washington Healthplanfinder

Washington Healthplanfinder was established as an Exchange under the Patient Protection and Affordable Care Act (ACA), and allows individuals, families and small businesses in Washington to compare and enroll in health insurance coverage and gain access to tax credits, reduced cost sharing, and public programs such as Medicaid. Healthplanfinder is operated by the Washington Health Benefit Exchange, a public-private partnership that is separate from the state and governed by an independent 11-member board.

Enrollment Outreach

Since the beginning of the second open enrollment period on November 15, 2014, the Exchange has engaged in a statewide integrated advertising and outreach campaign to encourage Washington residents to sign up or renew their health insurance plans. The campaign includes TV, radio, digital, print, and out-of-home advertising, as well as grassroots activities, innovative partnerships, and social media outreach. Michael Marchand, Director of Communications for the Washington Health Benefit Exchange, explained that one of the Exchange’s goals is “to further drive awareness of the opportunity to enroll in low-cost and free health plans among our harder-to-reach populations across the state.”

More recently, the Exchange partnered with the Obama administration to create a public service announcement promoting Washington Healthplanfinder using two members of the Seattle Seahawks football team, quarterback Russell Wilson and cornerback Richard Sherman. HHS Secretary Sylvia Burwell said, “I want to thank Russell and Richard for volunteering their time to raise awareness around the importance of enrolling in health insurance coverage and join them in calling for new and existing customers to visit Washington Healthplanfinder to check out their options.”

Statewide Mall Enrollment Drive

On January 24, 2015, Washington Healthplanfinder’s It’s About Time: Enrollment Drive provided in-person help in eight locations, including six shopping malls, for residents who would like to enroll in a health plan for 2015 coverage. Richard Onizuka, CEO for the Washington Health Benefit Exchange, said, “Our customer support network can provide the assistance Washingtonians need to find the right plan to fit their needs and budget. Washingtonians should take advantage of the expert help available if they need assistance enrolling in a health plan.” Washington Health Benefit Exchange Director of Communications Michael Marchand added, “These events are a great way to connect with someone in your local community who can walk you through the process from start to finish.”

Customer Service Problems

The Washington Health Benefit Exchange board surveyed 8,116 people regarding their experiences using Washington Healthplanfinder. All individuals surveyed either enrolled in qualified health plans or Medicaid through the Exchange, or interacted with the Exchange website but either did not enroll or were later un-enrolled. The Puget Sound Business Journal reported that 64 percent of the surveyed individuals did not have problems applying or enrolling with Healthplanfinder, but 28 percent of respondents labeled the enrollment process difficult. Additionally, almost 30 percent reported technical problems with the website, while 23 percent said unanswered phone calls and emails to customer service were a problem due to staffing shortages. Onizuka said, “Customers should contact us as soon as possible if they need assistance with their application.”

The Exchange received a $27 million grant from the federal government to improve its website by making it easier to use, as well as adding some functions, including new ways to search for doctors and adult dental coverage. The Associated Press reported that the Washington Health Benefit Exchange board’s top priority for the funding is making the website stable and offering a good customer experience.

Low Enrollment

Despite its outreach and customer service improvement efforts, the Exchange is falling short of its goals. Exchange data shows that thousands of customers completed an application for 2015 coverage but did not submit payment in a timely manner. Onizuka explained that the Exchange has “seen communications from insurance companies that may have caused renewing customers to misunderstand what was required of them regarding the renewal process.” The Seattle Times reported that the carriers’ messages mistakenly indicated that previously-enrolled consumers did not need to take any action if they wanted to keep their current plan. However, the Times reported that this message is “not true,” and reminded consumers to contact the Exchange to renew or change plans.

State Insurance Commissioner Mike Kreidler said, “Any Qualified Health Plan customer who experienced confusion around the renewal process–especially those who were unaware that additional action was needed on their account–should take advantage of [additional notices the Exchange will send to enrollees.] We want to ensure that customers are receiving accurate information to avoid any impact to their coverage.”

Customers who are unsure of their current enrollment status should review their online account or contact the toll-free Customer Support Center at 1-855-923-4633. Local navigators and insurance brokers can be located via wahealthplanfinder.org and are available to answer questions.

Onizuka stated, “Washington residents who have not yet taken action to sign up for health coverage should remember that more than 85 percent of customers were able to receive financial help to pay for their coverage last year. The penalty is also increasing this year to $325 per individual or up to 2 percent of your income, so it’s worth taking another look at your health plan options on wahealthplanfinder.org.”

HHS Boosts Early Influenza Detection With $21M in Awards

With the arrival of the 2014 flu season comes news that the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) granted two awards in contracts for the development of improved, cost-effective influenza testing. The tests will advance diagnostic capabilities in doctors’ offices, clinics, and hospitals with quick and accurate flu diagnoses. The contracted companies received a combined award total of approximately $21 million. The tests use different technologies to detect influenza viruses and offer different levels of information about the viruses detected.

The first award is centered on a low-cost molecular test under a 3.5-year, $12.9 million contract with Alere Inc., located in Waltham, Massachusetts. The company plans to develop the Alere™ i Influenza A & B test, which could yield results within 15 minutes and detect which type of flu virus a patient has. The Influenza A & B Test is a rapid, instrument-based, molecular diagnostic test that uses isothermal nucleic acid amplification technology for detecting and differentiating influenza A and B through nasal swabs of symptomatic patients. Alere will conduct the required clinical studies and submit the results to the FDA for approval, including a Clinical Laboratory Improvement Amendments waiver, which would allow the rapid molecular test to be performed in doctors’ offices and hospitals.

The second award went to InDevR Inc., located in Boulder, Colorado. The funding allows the progression of a biochip test under a two-year, $7.9 million contract with options to extend the contract up to $14.7 million over four years. InDEvR’s FluChip-8G™ test will identify seasonal flu viruses and novel flu viruses within four hours by using a multiplexed analysis of eight genes. The test will be used in doctor’s offices and hospitals. Presently, this type of genetic testing is conducted only in state, federal, or specialty laboratories, and results take days rather than hours. InDevR maintains that if the test proves successful during the first two years, it will conduct required clinical studies for submission approval from the FDA and subsequently will develop a fully automated version of the test. This test will also use nasal swabbing.

The director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), Robin Robinson, Ph.D., said, “Administering fast and inexpensive tests at the point of care has tangible benefits to personal and public health, particularly in helping doctors prescribe the right therapy immediately.” Robinson’s office will be responsible for overseeing the test development programs.

BARDA supports development of other flu diagnostic platforms, including a test to identify drug resistance in influenza and other vaccine technologies. It also welcomes additional proposals for advanced development of new drugs and products to diagnose and treat other illnesses.