Health Advisory Council Member Updates | Winter 2017

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Alliance for Aging Research
The Alliance for Aging Research has released a number of new educational resources including: 

  • A Spanish version of Taking a Closer Look at AMD was released this Fall. The film gives an overview of this leading cause of vision loss in the U.S., including risk factors, symptoms, diagnosis, treatment options, and the role of nutrition and lifestyle in protecting eyesight. It also addresses some of the challenges of living with AMD and encourages those diagnosed with the disease to take control of their sight. The film can be viewed on YouTube and downloaded from Vimeo for use off-line.
  • Last February, the Alliance and 29 other partner organizations helped establish the first-ever National Heart Valve Disease Awareness Day. The campaign reached millions of Americans through social media, a Hill briefing, a Twitter Chat, and more. This year’s campaign will continue to reach out through traditional and social media, and will provide resources for hospitals and heart centers hosting Valve Disease Day events. To learn more and become a partner visit www.ValveDiseaseDay.org.
  • Additional Alliance initiatives include a pocket film on the importance of volunteering for a clinical trial; information on the safe use, storage, and disposal of OTC pain medications; and an upcoming White Paper on mental health in older adults.    

AMAG Pharmaceuticals
In recent months, AMAG Pharmaceuticals launched Intrarosa™ (prasterone), the first and only FDA-approved, local non-estrogen product for the treatment of moderate to severe dyspareunia (pain during intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Nearly 32 million women (approximately half of all post-menopausal women in the United States) suffer from symptoms of VVA and, of those women, between 10-13 million are suffering from moderate to severe dyspareunia. AMAG has also continued to work closely with leading organizations in the women’s health space – including NCL – to consider the most effective ways to bring down barriers to better outcomes in women’s sexual health and with organizations in other key health areas — such as maternal and child health, stem cell preservation, anemia, and oncology – to help educate patients and providers on unmet needs and solutions in areas specific to our products. 

America’s Health Insurance Plans
The Modern Medicaid Alliance continues to work with its partners like NCL to educate policymakers and the public about the value of Medicaid across the country. This summer, the Alliance unveiled the Medicaid Solutions series, highlighting innovative approaches organizations are taking to increase quality, efficiency, and affordability for people covered by Medicaid. The series focuses on how distinct populations are benefiting from Medicaid, including school children, newborns, and those with disabilities. 

The Alliance also launched the MMA Medicaid Dashboard – an interactive online tool and database that tracks national and state level data, local program details, statistics, and public polling on Medicaid. The Dashboard is a valuable resource that creates a “one stop shop” for Medicaid data.

This fall, MMA has been busy promoting and advocating on the value of the Children’s Health Insurance Program (CHIP).The Alliance released a fact sheet to help bring individuals up to speed on the program, and continues to advocate for reauthorization through all social media channels. 

In addition to CHIP, AHIP has been actively promoting Open Enrollment, and educating consumers on the value of private health insurance. 

American Society of Health-System Pharmacists 
The American Society of Health-System Pharmacists (ASHP) has been working to address the opioid crisis and drug shortages that could adversely affect patients, including the current acute shortage of small-volume parenteral solutions.    

Association for Accessible Medicines 
The Association for Accessible Medicines (AAM) and its Biosimilars Council applauded CMS’s recent decision to revise its current biosimilars reimbursement policy in Medicare Part B, as part of the Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018 final rule. Led by the Council, a variety of stakeholders have been urging the agency to provide each non-interchangeable biosimilar with a unique billing code and payment rate. A recent report by The Moran Company finds providing separate codes would save the federal government $11.4 billion over the next 10 years.

AAM and the Biosimilars Council are also working with stakeholders to urge Congress to include biosimilars in the Medicare Part D Coverage Gap Discount Program. Biosimilars present a significant opportunity for patient and program savings in the Medicare Part D program. However, under current law, patients in the Part D coverage gap face significant barriers to access for biosimilar options, and may actually be forced into using higher priced biologics. The result: patients paying higher out-of-pocket costs for lower-cost medicines, and physicians having fewer alternatives to prescribing higher priced medicines. Congress should amend the Part D program so that it treats biosimilars and brand biologics equally, so that patients will not be forced into paying for higher-cost treatments. This change would also lower Part D program spending and provide the federal government with at least $1 billion in savings over ten years. 

Astellas
Astellas has been focused on implementation of the 21st Century Cures Act and promoting regenerative medicine and the appropriate use of real world evidence.      

Consumer Healthcare Products Association (CHPA) Educational Foundation
Reminding Parents and Caregivers about Candy Confusion during Halloween 

Working with the Centers for Disease Control and Prevention (CDC) and Dr. Dan Budnitz, the Up and Away campaign leveraged Halloween to promote the importance of safe medicine storage and reminding parents about how easily children can confuse medicine for candy. Working with healthcare provider spokespersons, as well as state poison control center representatives, the campaign conducted an earned media pitch to national and local media markets, resulting in 23 hits in Seattle, Atlanta, Tallahassee, Eastern Washington State, and Miami. The efforts secured solid broadcast, online, and radio coverage to 645,000 TV viewers, 24,000 readers, and 2,500 radio listeners.

Council for Affordable Health Coverage
The Council for Affordable Health Coverage (CAHC) hosted a national summit on healthcare costs entitled, “The Price of Good Health” on November 1, 2017 at the Newseum in Washington, D.C with speakers including Senator Bill Cassidy (R-LA), Congressman John Larson (D-CT), Acting HHS Secretary Eric Hargan, Aetna CEO Mark Bertolini, and others. A repository of videos, pictures, and other materials from the event is available on CAHC’s website here, and CAHC President Joel White’s blog on the takeaways from the conference and next steps for CAHC can be read here. 

More recently, CAHC sent a “holiday wish list” to Members of Congress and staff, urging action on a bold set of legislative priorities before the end of the year. The agenda includes a reauthorization of the Children’s Health Insurance Program (CHIP), market stabilization measures like the Alexander-Murray compromise bill, and reforms to improve prescription drug access and medication adherence like those championed in CAHC’s Prescriptions for Affordability initiative and CAHC’s medication adherence campaign, Prescriptions for a Healthy America (P4HA) (click here to read our white paper on the need for an adherence-specific safe harbor to the anti-kickback statute). 

P4HA has also been advocating to improve data sharing in order to promote medication adherence. Language included in the Senate-passed CHRONIC Care Act could help, by breaking down silos in a patient’s continuum of care that allow medication mismanagement to fester unseen. Specifically, the provision of the bill — mirrored in a standalone House bill authored by Rep. Lynn Jenkins (R-KS) — would improve care coordination by establishing a process for Medicare to share information about hospitalizations or physician office visits with Part D prescription drug plans. This gives providers a better opportunity to recognize those most at risk of medication nonadherence and intervene before it is too late.

Duke University

Duke-Margolis Center for Health Policy 
The Duke-Margolis Center for Health Policy works to improve health and the value of health care by developing and implementing evidence-based policy solutions locally, nationally, and globally. On December 12, 2017, the Duke-Margolis Center hosted a briefing entitled ”FDA’s New Regulatory Framework for Tobacco and Nicotine: the Role of Medicinal Nicotine,” which featured a keynote address by FDA Commissioner Scott Gottlieb, followed by a panel discussion. The event brought together regulators, public health and addiction experts, and advocacy groups to discuss the FDA’s regulatory approach to medicinal nicotine in more depth, and highlight the key outstanding scientific and policy questions that will need to be addressed to support the development and appropriate use of innovative nicotine replacement therapies.

Medication Adherence Alliance
Duke’s Medication Adherence Alliance works closely with NCL’s Script Your Future campaign, supporting patient engagement and enhancing patient-provider communication to improve medication adherence. 

FDA Office of Women’s Health
FDA’s Office of Women’s Health is working on a number of initiatives, including its Diverse Women in Clinical Trials Initiative; College Women’s Campaign; Medicine & Pregnancy education campaign; and women and dependence, focusing on opioids and tobacco use.      

Healthcare Distribution Alliance
The Healthcare Distribution Alliance has been focused on implementation of the Drug Quality and Security Act (DQSA) as well as efforts to address the opioid crisis and prescription drug abuse and misuse. 

Johnson & Johnson
On November 30, 2017, Johnson & Johnson announced that its Janssen Pharmaceutical Companies together with a consortium of global partners have initiated the first efficacy study for an investigational mosaic HIV-1 preventive vaccine. The Bill & Melinda Gates Foundation and National Institutes of Health are joining forces with Johnson & Johnson to advance the potential prevention option, which is designed to be a “global vaccine” that could prevent a wide range of viral strains responsible for the HIV pandemic. 

Momenta Pharmaceuticals
Momenta applauds the recent CMS decision to revise reimbursement policy under Medicare Part B for non-interchangeable biosimilars. CMS recognized in its new policy that non-interchangeable biosimilars are not substitutable at the pharmacy for one another or the reference product. As such they should have separate reimbursement codes to allow for more predictable reimbursement to providers. This facilitates the use of biosimilars, and more importantly, access to affordable medicines by patients.

Mylan
On December 1, 2017, Mylan announced FDA’s approval of Mylan’s Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon. Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Mylan CEO Heather Bresch commented: “The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system.”  

National Alliance for Caregiving
Join the National Alliance for Caregiving for the 12th Annual National Conference of Caregiver Advocates — The Aging Network’s Largest Non-Elder Stakeholder. The meeting will be hosted in partnership with the American Society on Aging at the Aging in America Conference, on Monday, March 26, 2018 in San Francisco. Presentation topics include: Building Capacity to Support Caregivers Across the Lifespan; Caregiver Friendly Communities; The 21st Century Workforce in a 21st Century Workplace; Mapping the Caregiver Journey; and Workshop: Next Steps for Caregiver Advocacy. For more information, go to http://www.caregiving.org/coalitions/annual-conference/.  

National Community Pharmacists Association
The National Community Pharmacists Association (NCPA) is committed to high-quality pharmacist care and to restoring, maintaining, and promoting the health and well-being of the public. NCPA has a particular interest in the Medicare Part D rule proposal, which includes a RFI about providing manufacturer rebates and pharmacy price concessions to the price of a drug at the point of sale. Comments are due to CMS by Jan. 16, 2018.       

National Council on Patient Information and Education
An estimated 15% of high school seniors have misused some type of prescription drug, and about one in four young adults aged 18 to 20 report using these medications non-medically at least once in their lives. This means many students are coming to college campuses with exposure to the misuse of prescription drugs or they may experiment at some point during their college career. The FDA’s Office of Women’s Health and NCPIE have teamed up to share educational resources to help college students incorporate safe medicine use into their busy campus life – especially during times of high stress like midterms and final exams. The packet of free medication safety resources includes materials on making healthy medication choices, using medication safely, avoiding the dangers of medication misuse, and a link to NCPIE’s “toolkit” for America’s college campuses, Taking Action to Prevent and Address Prescription Drug Abuse. A new blog, “3 Tips for Safe Medication Use on Campus,” provides tips students can use to make healthy decisions about medication use. Campuses are encouraged to share the blog in their newsletters, on their web page, and on social media. Find the blog and other resources at www.fda.gov/collegewomen. 

During NCPIE’s “Talk About Your Medicines” Month (TAYMM) in October, NCPIE partnered with NCPIE Board Member Healthline on a bold social media campaign, #DontMix. The campaign seeks to educate millennials about the potential risks of mixing alcohol and medications. The social media campaign, its companion #DontMix website and news articles – Most Consumers Unaware of Dangers in Mixing Alcohol and Common Drugs and Don’t Mix: Parenting, Pills, and Pinot helped drive awareness of NCPIE’s “Think Before You Drink” TAYMM messages. The #DontMix campaign combines witty, funny, and poignant posts with often hilarious graphics to make its point. For example, socks and sandals don’t mix, cliffs and selfies don’t mix, and neither do alcohol and medications. NCPIE members were notified each week during October with a particular #DontMix graphic and theme that they could share with their members and stakeholders on social media. The graphics which have garnered over 1.3 million views thus far – can also be viewed on the GIPHY DONTMIX Channel.

Network for Excellence in Health Innovation
The Network for Excellent in Health Innovation (NEHI) is dedicated to identifying innovations that improve the quality and lower the costs of health care. Priority issues include medication adherence and evidence-based decision-making, among others.  

Pharmaceutical Research and Manufacturers of America (PhRMA)     
On November 9, 2017 PhRMA partnered with The Atlantic on Vaccines and Immunity: Examining Modern Medicine, an event that brought together a number of stakeholders to examine the tremendous public health impact of vaccines, dissect challenges facing researchers in driving vaccine innovation, and explore ways to communicate the safety and benefits of vaccines to the public.

PhRMA also released a new report on the impact and value of vaccines, the unique challenges of developing these medicines, and the long-term promise they hold in both preventing and treating disease. The report was released alongside an update to PhRMA’s Medicines in Development series, illustrating the industry’s commitment to vaccines research with over 260 medicines in clinical development across a variety of therapeutic areas, including infectious diseases, cancer, and Alzheimer’s. The new resources can be found here. 

USP
On October 23, 2017, USP convened a roundtable of experts from healthcare provider groups, research organizations, patient advocacy groups, government agencies, industry representatives, and others to explore strategies to curb the opioid crisis using public standards. The four approaches being considered are: 

  • Recommendations for effectively and safely storing and disposing of opioid prescriptions in order to help prevent misuse, including how this information should be communicated;
  • Clear prescription label information to ensure patients understand that a prescribed drug is an opioid and can be addictive;
  • Easy-to-follow instructions for using naloxone, so that first responders and others (including family, friends, and others who may not be trained healthcare providers) can quickly understand when and how to administer this life-saving antidote; and
  • New standards for healthcare providers to counsel patients about appropriate use of prescription opioids and how to avoid misuse.

In follow-up to the roundtable, USP will release a report to help inform the USP Healthcare Quality and Safety Expert Committee to develop new, or revise existing, standards related to the opioid crisis. All proposed new or revised standards will be open to public comment for 90 days and USP welcomes additional discussions with a broad base of interested parties.