FDA APPROVES HAND-HELD NALOXONE AUTOINJECTOR TO REVERSE OPIOID OVERDOSES

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NEW HOSPICE MODEL WOULD ALLOW CURATIVE THERAPY TO CONTINUE

The Centers for Medicare and Medicaid Services (CMS) may remove a barrier to hospice care near the end-of-life. To receive hospice care patients have been obliged to agree to forego further curative treatment. The new Medicare Care Choices Model will soon offer an option for Medicare beneficiaries to receive palliative care services from certain hospices while still receiving treatment from curative care providers. Dr. Eytan Szmuilowicz, a palliative care physician at Northwestern University's Feinberg School of Medicine in Chicago, told Reuters Health that the new program may ease the burden families face in choosing treatment options.

“Now, we have a problem with patients having to make a choice,” Szmuilowicz said. “It may be based on hope that a treatment will continue to work, even if chances are low. This way, they are not forced to make this choice.”

“There is so much stigma around hospice, and it's so negative in people's minds, many can't bring themselves to try it,” Szmuilowicz added. “If we open the door to help people realize the benefits hospice can bring, it may allow them more time to realize these therapies aren't helping that much. Maybe that's a good thing.”

CMS plans to evaluate whether providing hospice services earlier can improve quality of life among patients and reduce Medicare spending. The agency plans to limit participation to beneficiaries with advanced cancers, chronic obstructive pulmonary disease, congestive heart failure, and human immunodeficiency virus/immunodeficiency syndrome (HIV/AIDS).

“It's the right thing to do,” said Shelly Ebbert, director of foundation and external relations at Rainbow Hospice and Palliative Care in Park Ridge, Illinois. Rainbow, serving more than 300 patients daily, is among the Medicare-certified hospice programs applying to participate. Following a June 19th application deadline, CMS will select at least 30 rural and urban hospices to pilot the 3-year trial; those selected will receive $400 per beneficiary monthly from CMS.

The current daily Medicare reimbursement for home hospice care is roughly $150 per patient. The benefit includes physician services, nursing care, physical and occupational therapy, social services, home health aides, medical supplies, and symptom-relieving pharmaceuticals.

“It's no financial boon to us,” said Ebbert, emphasizing the advantage Rainbow sees in the model is the opportunity to introduce services earlier in a patient's illness.

Don Schumacher, president of the National Hospice and Palliative Care Organization (NHPCO), said this model may change the future of end-of-life care. “One of the biggest sadnesses and regrets in hospice is that patients are admitted and die within a very short time,” he said, underscoring that too many are not enrolled long enough to realize benefits.

According to the NHPCO, the median length of hospice service in 2011 was 19 days. One benefit of receiving hospice care sooner might be that symptoms could be addressed before they become difficult to control, said Szmuilowicz. “It's a lot easier to stay on top of somebody's pain than catch up to it.”

In the current model, patients no longer see the doctors who've been caring for them, as curative therapies are no longer pursued. But as patients pursue curative therapy and hospice support simultaneously, physicians may need to rethink their presentation of this end-of-life option.

“It should be designed as an extension of care patients are getting, rather than an abrupt change to something totally different,” Szmuilowicz said, as shifting care modalities often proves challenging when presented to patients suddenly. An earlier hospice introduction, he said, will allow patients more time to transition to the idea of facing death.

“It's a lot of work,” Szmuilowicz said of the end of life. “The ideal would be that everybody finds peace with their dying, and that takes time. If we don't give people that time, we are really robbing them of the potential to find some peace.”

OPIOID PRICE WATCH

Morphine and other opioid medicines provide effective pain relief for patients with cancer or other chronic pain. However, in many countries of the world oral morphine is not available, whereas in others, even if available, patients may not be able to afford it. Therefore, the International Association for Hospice and Palliative Care (IAHPC) has launched Opioid Price Watch (OPW), a project to monitor and report the dispensing price of opioids around the world. This project is as a component of the agreement of work as an nongovernmental organization (NGO) in formal relations with the World Health Organization (WHO). This project was funded with a seed grant from the US Cancer Pain Relief Committee.

IAHPC developed and implemented a pilot to test OPW and report the information collected on the availability, prices, and affordability of five opioids (fentanyl, hydromorphone, methadone, morphine, and oxycodone) in 13 formulations. The pilot project has been completed and a report published in the Journal of Pain and Symptom Management, abstract accessible at: http://www.jpsmjournal. com/article/S0885-3924(14)00146-8/abstract. The report is available free to all (Open Access). The published report presents data on availability, dispensing prices and affordability submitted by 30 participants from 26 countries.

Using the data on availability and dispensing prices, IAHPC calculated the affordability of a one 30-day treatment of morphine and developed a flash map housed in the IAHP Web site (http://hospice care.com/abohttp://hospicecare.com/about-iahpc/pr ojects/opioid-price-watch/ut-iahpc/projects/opioid-price-watch/C).

IAHPC plans to continue nurturing the OPW map as a living project that the palliative care community can nurture and participate in. The report findings were consistent with findings published in other studies on the limited availability of opioids around the globe where the vast majority of the population lives. But it also presents findings that were unexpected:

In regards to its international reference price the median price of a morphine immediate release tablet (10 mg) is almost 6 times higher in low- and middle-income countries (LMICs) than in high-income countries (HICs). Hydromorphone and oxycodone were the highest-priced medications. However, in three countries some oxycodone formulations were priced lower than morphine and/or methadone. Results also show an unexpected favorable price difference for fentanyl transdermal patch: it is free in five countries and the cheapest one in seven, indicating that there are heavy subsidies in place at all gross national income (GNI) levels.

It would be useful to find out the reasons why morphine, which is cheaper in the international prices than other medications, is not included in subsidy programs, even in LMICs. Artificially lowering the dispensing price of the most expensive medications and formulations results in less efficient use of limited resources, an economic disadvantage for morphine intermediate release (IR), and probably also in less demand for this medication.

The palliative care resolution, which will be presented to the next World Health Assembly in Geneva, urges governments to take the necessary steps to ensure access to essential medicines, especially opioid medications. Morphine is included in the WHO Model List of Essential Medicines. Patient advocates and the civil society also play an important role. The Morphine Manifesto (see: http://palliumindia.org/manifesto/) launched by Pallium India in collaboration with other NGOs brings attention to this issue.

Dr. Roberto Wenk, Director of the OPW project and Past IAHPC Chair remarked:

This is the first international study that presents and compares data on opioid prices at the dispensing level and the affordability of morphine treatment for patients around the world. With the collaboration of our members, OPW will serve as monitoring tool for the global palliative care community.

Dr. Lukas Radbruch, Chair of IAHPC and coauthor of the report, commented:

OPW is in consonance with the call for action to recognize access to medicines as human rights in the Prague Charter. We hope that the published report will increase awareness on the difficulties that patients face trying to access medicines for pain treatment.

Dr. Tania Pastrana, one of the coauthors, stated:

The results of OPW support existing data on the limited availability and access to medicines for pain treatment. It also shows that many countries more expensive formulations are subsidized while cheaper ones have to be paid by the patients. We hope that the report will bring attention to this issue so that corrective measures are taken.

Ms. Liliana De Lima, executive director of IAHPC commented:

We are very grateful with the US Cancer Pain Relief for the seed grant, the IAHPC members who participated and reported the prices of the opioid medications, with Dr. Willem Scholten for his guidance, the WHO Department of Essential Medicines for their support, and all the board members and advisers which made OPW possible. This is an ongoing project and IAHPC members are invited to participate in this exciting opportunity.

IAHPC members interested in participating in the OPW will have some benefits. To inquire more and learn how you can be part of this project, contact Ms. Ana Restrepo, Operations Officer via the Association Web site at: http://hospicecare.com/about-iahpc/contact-us/members-issues.

NEW APP BRINGS PALLIATIVE CARE FAST FACTS FREE TO iPhone AND iPad

A new free app for the iPhone and iPad provides a mobile version of the Fast Facts database from the Medical College of Wisconsin's End of Life/Palliative Education Resource Center. The database includes a wide range of information from delivering bad news to diagnosing and treating terminal delirium. More than 500 users worldwide have downloaded the app since its introduction in May. The app was developed by Haipeng (Mark) Zhang, DO, a 2014–15 Harvard Palliative Care Fellow, Mike Caterino, and students in the Fall 2013 System Analysis and Software Design class taught by Jeff Jackson, PhD, at Duquesne University in Pittsburgh, Pennsylvania. To access the application source, see, https://itunes.apple.com/us/app/palliative-care-fast- facts/id868472172?mt = 8.

PHYSICIANS RELUCTANT TO DISCUSS END-OF-LIFE CARE WITH HEART FAILURE PATIENTS

A presentation at the American Heart Association Meeting on June 4, 2014, documented that few health care providers report talking to their heart failure patients about end-of-life care preferences, Doctors, nurse practitioners, and physician assistants cited patient uneasiness, their own discomfort, and lack of time as main reasons for not discussing the subject, and nearly a third of clinicians surveyed said they lacked the confidence to bring up the subject of end-of-life care.

The health care providers were reluctant to discuss end-of-life care with heart failure patients and their families because they feel uncomfortable broaching the topic or lack time, according to a new study presented at the Quality of Care and Outcomes Research 2014 Scientific Sessions.

Researchers surveyed 50 physicians and 45 nurse practitioners or physician assistants at three practices at the Mayo Clinic in Rochester, Minnesota, and the Mayo Clinic Health System. Ninety-five clinicians completed the survey.

Among the findings:

• Only 12% of the health care providers reported having routine yearly discussions about end-of-life care as advocated by the American Heart Association.

• Thirty percent of the group reported having little confidence in discussing or providing end-of-life care.

• Among the 52% who said they felt hesitant mentioning end-of-life-care, 21% cited their perceptions that patients weren't ready to talk about the issue; 11% said they felt uncomfortable bringing it up; 9% said they worried about destroying a sense of hope; and 8% said they lacked time.

Health care providers were often unsure about who should bring up end-of-life care: 63% of heart failure specialists and 58% of community cardiology clinicians thought end-of-life care discussions were the responsibility of heart failure cardiologists, whereas 66% of primary care providers felt it was their responsibility. Despite these perceptions, heart failure specialists and community cardiology clinicians were far more likely to have referred heart failure patients to palliative care within the past year than primary care physicians (89% versus 21%).

“Providers did express an interest in receiving additional training to develop the skills and confidence to talk about end-of-life care with their patients with heart failure,” said Shannon Dunlay, MD, MS, the study's lead researcher and a cardiologist at the Mayo Clinic in Rochester, Minnesota. There is no evidence that bringing up end-of-life care ruins hope, and it may ease anxiety for some patients and families, Dunlay said. About 5.1 million Americans have heart failure and about half of those die within 5 years of their diagnosis, according to American Heart Association statistics.

“Communication is key but in many hospitals and health systems this can be difficult as patients often have multiple health care providers,” Dunlay said. “Sometimes it's helpful to pick up the phone and have a provider-to-provider conversation so that everybody is on the same page. Incorporating end-of-life conversations into the ongoing, routine care of the patient is important as goals and preferences can change over time and patients and their families can feel more comfortable and confident in relaying their wishes to multiple providers.”

Coauthors are Jilian L. Foxen, MEd; Terese Cole, RN, CNP; Molly A. Feely, MD; Ann R. Loth, RN, CNS; Jacob J. Strand, MD; Keith M. Swetz, MD, MA; Jean A. Wagner, MS, CNP; and Margaret M. Redfield, MD.

JONAS CENTER, MAYDAY FUND, AND MILBANK FOUNDATION TO SUPPORT VETERANS’ PAIN AND PALLIATIVE CARE

The Jonas Center for Nursing and Veterans Healthcare (Jonas Center) announced on June 9, 2014, a partnership with The Mayday Fund and The Milbank Foundation to support doctoral nursing students focusing their studies on pain and palliative care for veterans, an expanding group with special challenges related to care. Of the roughly 21 million veterans in the United States, nearly half—9.6 million—are 65 and older.¹ More than 54,000 veterans, mostly from World War II and Korea, die each month, and the number of Vietnam-era veterans over 65 will continue to grow through 2034.² Soldiers who served in Iraq and Afghanistan have suffered grave physical wounds: since 2000, nearly 6000 service members have experienced traumatic amputation. The need for chronic pain, hospice and palliative care are great—and growing.

“Caring for our nation's heroes as they age and especially reach the end stage of their lives is central to our mission at the Jonas Center,” said Darlene Curley, executive director of the Jonas Center. “The Veterans Administration and other veterans service organizations are working overtime to meet the growing needs of this population, but more help is needed. The Jonas Center is proud to partner with The Mayday Fund and The Milbank Foundation to support a new generation of nurses dedicated to serving gaps in veteran care.”

The partnership expands the Jonas Nurse Leaders Scholar Program and Jonas Veterans Healthcare Program (JVHP), established in 2008 and 2012, respectively. These programs address the shortage of nursing faculty and veterans’ pressing, often life-altering, health issues. Currently supporting nearly 600 doctoral scholars nationwide, the Jonas Center's goal is to support 1000 Scholars by 2020.

Six PhD candidates have been selected to receive support from this partnership beginning in fall 2014; two are focused on pain and four are concentrating on palliative care for veterans.

• Michael Baumgardner/University of San Diego is an assistant nurse manager of the organ transplant unit at the University of California at San Diego Medical Center, which serves a significant veteran population. He is investigating spiritual well-being and quality of life outcomes among patients who receive palliative care as part of their overall treatment.

• Valerie Hoffhines/University of Maryland has spent the last 8 years providing care at the Greater Baltimore Medical Center and is currently studying chronic pain—specifically urogenital pain and its physiological and psychological effects on active military and women veterans.

• Cassandra Krumpelmann/University of Alabama at Birmingham, a full-time Veterans Affairs nurse for the last 14 years, is focusing her research on improving quality of life for breast cancer survivors during and after treatment and at the end of life.

• Natalie Meyers/University of San Diego is examining the relationship between posttraumatic stress disorder, chronic pain, and the acute pain of surgery and medications to help manage symptoms experienced by veterans with these conditions upon awaking from general anesthesia. Meyers has served in the Air National Guard since 2005 and currently works as a nurse anesthetist at the West Los Angeles VA Hospital.

• Tanna Thomason/University of San Diego, a clinical nurse specialist (CNS) at Sharp Memorial Hospital in San Diego, is focused on clinical effects and perceptions of telemedicine and home monitoring among congestive heart failure patients.

• Denise Kelsey Wishner/University of California San Francisco is interested in a critical component of quality palliative care: how well clinicians honor patients’ pre-stated wishes for end-of-life care. Her work will contribute to understanding how to assist patients in communicating these wishes. A health care ethicist, Wishner serves as the ethics consultation coordinator and the IntegratedEthics® Program Officer at the VA Long Beach in California.

“The work of the Nurse Leader Scholars will address the enormous burdens of pain and suffering that veterans have sustained and which are the responsibility of us all. That so many focus on palliative care illustrates how far this model has progressed as a strategy for quality medical care,” said Christina Spellman, executive director of The Mayday Fund, which is dedicated to alleviating the incidence, degree, and consequence of human physical pain. “For the Trustees of The Mayday Fund, this partnership with the Jonas Center for Nursing and Veterans Healthcare and The Milbank Foundation holds great promise, for the veterans, for the researchers, and for the better care of pain more generally.”

According to Carl Helstrom, executive director of The Milbank Foundation, which counts improving palliative care as a key priority in its mission to help people with chronic illnesses and disabilities, “Each organization brings to this collaboration specific strengths and resources that, together, can result in a new level of understanding and care for America's service members.”

FDA APPROVES BUPRENORPHINE/NALOXONE BUCCAL FILM FOR THE MAINTENANCE TREATMENT OF OPIOID DEPENDENCE

BioDelivery Sciences International, Inc. (BDSI), announced on June 9, 2014, approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA). BUNAVAIL is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. BDSI expects to launch BUNAVAIL late in the third quarter of 2014. BUNAVAIL was designed using BDSI's advanced drug delivery technology, BioErodible MucoAdhesive (BEMA®), allowing for the efficient and convenient delivery of buprenorphine while potentially overcoming some of the administration challenges presented by the sublingual (under the tongue) dosage forms currently available. BUNAVAIL has twice the bioavailability (drug absorbed into the body) of buprenorphine compared with Suboxone, the market leader in this category. As a result of the improved absorption of buprenorphine with BUNAVAIL, which is the direct result of the BEMA technology, plasma concentrations of buprenorphine comparable to Suboxone can be achieved with half the dose, which may help to reduce the potential for misuse and diversion and potentially lessen the incidence of certain side effects.

BUNAVAIL is the first and only formulation of buprenorphine and naloxone for buccal (inside of the cheek) administration. The ability of BUNAVAIL to stick on the inside of the cheek, unlike sublingual products that need to be kept in place under the tongue until they dissolve, allows patients to talk, swallow, and go about normal daily activities while the medication is being consistently absorbed.

“BUNAVAIL is a novel treatment approach for the more than two million people in the U.S. afflicted with opioid dependence,” said Gregory Sullivan, MD, principal investigator of the Phase 3 BUNAVAIL safety study and an addiction specialist and Medical Director of Parkway Medical Center in Birmingham, Alabama. “BUNAVAIL utilizes advanced drug delivery technology to fulfill an important need for treatment options with improved drug absorption and patient convenience, and as such, may help to address some of the challenges associated with sublingual administration and possibly help improve treatment compliance.”

Dr. Sullivan continued, “BUNAVAIL was assessed in a Phase 3 clinical study in 249 patients who were converted from Suboxone sublingual tablet or film to BUNAVAIL. In this study, BUNAVAIL demonstrated favorable safety and efficacy in the maintenance treatment of opioid dependence as demonstrated by the high study retention rate and the low frequency of patients with positive urine tests for non-prescribed opioids over the 12-week period. The majority of patients who participated found BUNAVAIL easy to use and pleasant in taste. Additionally, prior to conversion to BUNAVAIL, about 40 percent of patients were experiencing constipation while receiving Suboxone tablet or film, a common problem with chronic opioid use, and more than two-thirds of these patients reported resolution of symptoms when they switched from Suboxone to BUNAVAIL.”

BUNAVAIL is the first mucoadhesive buccal film formulation of buprenorphine to compete directly with Suboxone sublingual film. In 2013, sales of Suboxone sublingual film increased to more than $1.3 billion in the United States (U.S.), while the total market grew to more than $1.7 billion, driven by a 14% increase in prescriptions according to data from Symphony Health Solutions. BDSI plans to launch BUNAVAIL in late third quarter 2014 and anticipates peak sales potential of BUNAVAIL of up to $250 million in the U.S. BDSI will also begin entertaining commercial partnerships for BUNAVAIL outside of the U.S. In March 2014, BDSI announced it had entered into an agreement with Quintiles to support the launch of BUNAVAIL. Under terms of the agreement, Quintiles will provide a range of services to support the launch and subsequent commercialization of BUNAVAIL in the U.S., including recruiting and training a field sales force. In the U.S., nearly 5000 physicians are responsible for approximately 90% of prescriptions for buprenorphine products for the treatment of opioid dependence, according to recent data from Symphony Health Solutions.

BUNAVAIL is not recommended in patients with severe hepatic impairment. BUNAVAIL may be used with caution for maintenance treatment in patients with moderate hepatic impairment.

BEMA Buprenorphine is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Pharmaceuticals.Clonidine Topical Gel for the treatment of painful diabetic neuropathy is currently in Phase 3 development.

BDSI's approved product for the maintenance treatment of opioid dependence is BUNAVAIL, which was approved by the FDA in June 2014 and is expected to be commercially launched during late third quarter 2014. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit: www.bdsi.com.

NEW HOSPICE DRUG POLICY PAYMENT RULE PROBLEMATIC

The federal Centers for Medicare and Medicaid Services (CMS) met on June 25 with 30 hospice and health care organizations after outcry over a new rule that was intended to minimize duplicate payments for hospice medications, but may be having unintended negative consequences. More than 40 organizations called for the rule's suspension in a letter to CMS. These include the American Medical Association, the American Society of Clinical Oncology and the American Geriatrics Society. These organizations posit that the policy places “undue burden” on beneficiaries—requiring “dying patients to navigate payer disputes.”

Until now, hospices paid only for the drugs patients needed for symptom management, and Medicare Part D drug policies covered drugs for hospice patients’ unrelated conditions.

Under the new rule, CMS requires prior authorization for hospices and Part D providers to determine responsibility of drug coverage, and hospices must cover medications not related to the hospice diagnosis. The policy was recommended by the Office of the Inspector General to minimize mistakes in which Part D plans covered hospice drugs, but many hospice providers say they now face financial burdens that are not theirs to bear. Hospice advocates say they are pleased CMS heard concerns but received no indication the rule may be amended—to the detriment of providers and patients.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.