FDA Expands Approval of Imbruvica for Rare Blood Cancer

gYik8JVToday, the US Food and Drug Administration (FDA) announced that it has expanded approval of Johnson & Johnson and Pharmacyclics’ Imbruvica (ibrutinib) for a rare form of blood cancer.

The agency approved Imbruvica for patients with Waldenstrom’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system. WM is a type of non-Hodgkin lymphoma (NHL), which usually gets worse slowly over time and causes abnormal blood cells, called B lymphocytes (B-cells), to grow within the bone marrow, lymph nodes, liver and spleen. Additionally, in WM abnormal B-cells overproduce a protein known as immunoglobulin M or IgM (macroglobulin) that can lead to excess bleeding, problems with vision and with the nervous system.

Imbruvica was granted Breakthrough Therapy Designation for WM from US health regulators. In addition to WM, Imbruvica is approved for three other indications in the US, including patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, chronic lymphocytic leukemia (CLL) patients who have received at least one prior therapy and CLL patients with 17p deletion.

The FDA’s decision to approve Imbruvica for treatment of WM is based on results from a 63-patient study, which showed that 62 percent of participants had their cancer shrink after treatment, with the duration of response ranging from 2.8 months to approximately 18.8 months.

“Since the first description of Waldenstrom’s macroglobulinemia more than 70 years ago, there has been no approved treatment for this cancer. Rather, doctors relied on therapies borrowed from similar cancers to treat these patients. I am truly grateful to the FDA for their work and dedication of scientists and clinicians at various leading medical centers who diligently worked on the clinical trial that supports Imbruvica as a safe and effective therapy for patients with Waldenstrom’s macroglobulinemia,” said Steven P. Treon, MD, PhD, Director of the Bing Center for Waldenstrom’s Macroglobulinemia at the Dana-Farber Cancer Institute and Associate Professor at Harvard Medical School, and, who led the trial.

In addition to Breakthrough Therapy, the FDA granted Imbruvica priority review and orphan drug designation for treatment of WM. The agency’s approval comes more than two months ahead of its prescription drug user fee goal date.

“Waldenstrom’s macroglobulinemia patients and physicians have been waiting for a treatment specifically studied and approved to treat this rare disease,” said Carol Harrington, President of the International Waldenstrom’s Macroglobulinemia Foundation. “The approval of Imbruvica is an important milestone for the entire global WM community and has the potential to positively impact our patients, their physicians and caregivers.”

Source: US Food and Drug Administration; Janssen Biotech, Inc.

H7N9 bird flu case confirmed in 2nd B.C. patient

2KlMpSzOTTAWA – Canada’s Chief Public Health Officer, Dr. Gregory Taylor and Dr. Bonnie Henry, British Columbia’sDeputy Provincial Health Officer today confirmed that the second individual in B.C. has now tested positive for the H7N9 avian influenza strain. As noted by health officials on January 26th, the husband and wife recently returned to Canada from China.

The risk to Canadians of getting sick with H7N9 is very low as evidence suggests that it does not transmit easily from person-to-person. Since both cases became symptomatic one day apart, it is likely they were exposed to a common source, rather than one having been infected by the other.

These individuals are residents of British Columbia and were not symptomatic during travel and began showing symptoms after arrival in Canada. The individuals did not require hospitalization and are currently recovering from their illness.

All close contacts of the individuals have been identified and their health is being monitored by provincial public health authorities. The Canadian healthcare system has strong procedures and controls in place to respond to and control the spread of infectious diseases and protect healthcare workers.

The first individual’s diagnosis of H7N9 was confirmed by both the B.C. provincial laboratory and the Agency’s National Microbiology Laboratory (NML) in Winnipeg on Monday, January 26th.  The second individual diagnosis of H7N9 was confirmed by both the B.C. provincial laboratory and the NML late on January 29th.

The Agency works closely with its national and international partners, including the WHO, to track all types of flu activity in Canada and around the world.

FDA Approves New Glucose Monitoring App for Data-Sharing Among Diabetic Patients and Caregivers

The US Food and Drug Administration (FDA) allowed marketing of the first set of mobile medical apps that allow diabetics to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time.

The Dexcom Share Direct Secondary Displays system’s data-sharing capability allows diabetes patient caregivers to monitor an individual’s blood sugar levels remotely. Other CGMs are also available on the market, however Dexcom Share is the first to receive the FDA’s approval.

The app allows caregivers and families to keep an eye on a diabetes patient’s glucose levels remotely, in order to avoid complications, such as hyperglycemia. The Dexcom Share involves two apps, one which would be downloaded by the patient, who will be able to set up “followers” that can view their information and the second would be downloaded by the caregiver to view the CGM data in real time. The patient can share data with up to five followers.

The system includes a small, wire-like sensor which a patient would insert just under the skin. The device continuously transmits data to a monitor that is worn externally. When used along with a blood glucose meter, CGM information can help diabetes patients detect when blood glucose values are approaching dangerously high and dangerously low levels.

“This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”

Dexcom said that it anticipates to ship the Share receiver to new patients in March. This is the first Dexcom system that is mobile compatible without the use of a docking system.

The app was approved under the FDA’s de novo process, which was created for low- to moderate-risk devices, which doesn’t require the same review process as more complicated products. It is the first to receive regulatory approval for US sales since the FDA began regulating mobile medical apps as devices in 2013.

“The Dexcom Share receiver represents a significant step forward for our company and our mobile strategy, but more importantly, it will provide a huge improvement for people managing their diabetes and for those parents and caregivers who help them each and every day,” said Kevin Sayer, President and Chief Executive Officer of Dexcom. “The FDA understands the importance of this type of innovation and the need to regulate it appropriately, and we could not be more pleased with the speed at which they reviewed and approved this important innovation.”

Sources: US Food and Drug Administration; DexCom, Inc.; Specialty Pharma Journal

Obama Announces Precision Medicine Initiative at State of the Union

During the State of the Union address, President Barack Obama announced his new “Precision Medicine” initiative to deliver new and more effective treatments for diseases, such as cancer and diabetes.

In his address, Obama urged Congress to increase research funding to support investments in precision medicine, a growing field of care in which treatments are tailored to an individual patient.

Precision medicine, also known as personalized medicine, gets rid of the “one-size-fits-all” approach to medicine. Precision medicine targets individuals who will benefit most from certain treatments by identifying the genetic cause for a disease in a specific group of people. He said that he wants the country to lead a new era of medicine that provides the right treatment at the right time.

Precision medicine includes sequencing the genes of patients to help doctors choose the appropriate drug to fight it, as well as sequencing genes to discover the root causes of other diseases. This strategy has helped reverse cystic fibrosis (CF) in some patients, including Bill Elder, who attended the address seated next to First Lady Michelle Obama. Elder was diagnosed with CF when he was eight, when patients with the disease commonly only lived to early adulthood. Elder, who is now 27 and is in his third-year of medical school, is among patients who have been successfully treated with Kalydeco (ivacaftor), which is approved in the US for patients with specific gene mutations.

Obama said that he is launching a new Precision Medicine Initiative in order to bring us closer to curing diseases like cancer and diabetes.

According to the National Institutes of Health (NIH), more than 1,800 genetic links to disease have been identified since the Human Genome Project, and there are more than 2,000 genetic tests for disease conditions. Researchers have been developing and looking into large databases of detailed patient records to understand the association between genetic variation and disease.

The President did not provide details of the initiative and how much it would cost, but expects these to be outlined in his fiscal 2016 budget, which will be released February 2.

Source: Specialty Pharma Journal

PBM Sees New Cancer and Cholesterol Drugs as Cost Savings Opportunity

Express Scripts, the nation’s largest pharmacy benefit manager (PBM), is looking for savings from new treatments for cancer and high cholesterol.

Now that Express Scripts and CVS Health, the nation’s second largest PBM, have negotiated discounts for new hepatitis C drugs, Express Scripts’ CEO said that new cholesterol and cancer drugs may be its next focus for negotiating discounts.

In December, Express Scripts announced that it would stop covering Gilead Sciences’ hepatitis C treatment Harvoni. The PBM struck a deal making AbbVie’s newly-approved Viekira Pak the exclusive option for its members with genotype 1 hepatitis C, in exchange for a discounted price. According to the company’s Chief Executive Officer George Paz, Express Scripts’ next cost-cutting targets include expensive new treatments for cancer and high cholesterol.

At the J.P. Morgan Healthcare Conference, Paz noted that the new cholesterol-lowering drugs, known as PCSK9 inhibitors, which significantly reduce bad cholesterol to low levels but are expensive, is an area of opportunity for cost savings. Like the new hepatitis C drugs, the PCSK9 medications are likely to enter the market around the same time, with Amgen and Regeneron in the lead and Pfizer not far behind. With high competition between these companies, PBMs will be in a position to impose pricing pressure to reduce costs.

However, Paz said that the big opportunity for cutting treatment costs is in cancer. He said that cost savings on cancer treatments could be achieved if the PBM were involved earlier in the decision making process. Currently, physicians run a patient’s cancer treatment regimen through a major medical benefits instead of through the PBM. However, according to Paz, if they did go through the PBM first, Express Scripts would get its doctors and pharmacists involved to ensure the prescribed regimens are appropriate. Although the physician makes the final decision, the PBM would advise on the most cost-effective, best regimen for the individual.

“The big opportunity out there is really in cancer,” said Paz. “If we can get out in front of that, that is a huge opportunity.”

Source: Specialty Pharma Journal

Survey Reveals One in Five Insured Americans Avoid Seeing a Doctor Due to Fear of Cost

XiMEB2cWEST HARTFORD, Conn – A recent online survey conducted by Harris Poll on behalf of SCIO Health Analytics® revealed that approximately two in five insured Americans (38 percent) do not have a good understanding of which healthcare services are covered under their current plan. One in five insured Americans, or approximately 44 million1 people, have avoided visiting a doctor for a general health concern within the past 12 months because of cost concerns.

The online poll surveyed more than 2,000 U.S. adults aged 18-plus about their general sentiments around the Affordable Care Act (ACA) or Obamacare, healthcare costs and their overall understanding of the healthcare system, as well as services covered under their health plan.

Ambiguity and cost fears prevent millions with a chronic condition from visiting their doctor.

Approximately half of U.S. adults (117 million) have at least one chronic condition2, of which 14 percent of (or 16.4 million) have avoided a doctor’s visit in the past 12 months because of cost concerns. While chronic conditions such as heart disease, asthma, and diabetes are generally incurable, they can be managed through early detection, improved lifestyle and treatment.

“These findings are particularly relevant at this time as millions of Americans are once again deciding their annual healthcare benefit options through Open Enrollment,” said Siva Namasivayam, CEO, SCIO Health Analytics. “While Americans are spending more time researching health plans, the survey reveals a significant knowledge gap in the specifics of their health care options that may eventually lead to unnecessary risks and costs.”

Namasivayam warned that the implications of these findings are even more staggering when you consider treatment costs for Americans with chronic conditions are already around $277 billion annually.3 Avoiding medical treatment for these conditions can lead to an increased risk of complications, emergency room visits, hospitalizations, readmissions, work absenteeism and disability that could potentially drive healthcare costs even higher and cripple an already over-burdened system.

When asked how their healthcare situation has changed since the introduction of the Affordable Care Act:

  • 41 percent of Americans say they have spent more time researching what is covered by insurance plans (either in their own plan or other plans)
  • 60 percent of Americans say they do not have a better understanding of the healthcare system despite the media coverage and public/political discourse around Obamacare
  • Among those insured, 44 percent did not know the out of pocket costs/co-pay for prescription drugs, and 61 percent did not know the costs for urgent care/walk-in clinic visits

The survey also found that age and gender play a role in understanding healthcare costs and services. Among insured adults, 48 percent of those aged 18-34 say they do not have a good understanding of what healthcare services are covered under their plan, compared to 27 percent of those aged 65 and older. Younger insurance holders, especially men, are also much more likely to be cost-conscious when visiting the doctor. When asked if they avoided visiting the doctor for a general health concern in the past 12 months because of cost concerns, 40 percent of insured men aged 18-34 said yes, whereas 27 percent of insured women in the same age group responded the same (compared to an overall average of 20 percent for all adults age 18+).

While the ACA has encouraged the U.S. healthcare system to become more consumer-focused, this study suggests that health plan managers need to be more aware of the needs of the millions of Americans who are new to health insurance and better communicate with more targeted messages and education around plan coverage and cost.

“It’s like buying a car without a manual or taking a test drive. You are left somewhat disoriented in the driver’s seat,” said Dave Hom, Chief Solutions and Business Development Officer at SCIO Health Analytics. “Health insurance companies need to adopt customized solutions based on big data to understand and reach these new members. Through the use of segmentation and consumer data such as medical literacy, communication preferences and geographic access to care, companies can find the most effective channels and messages to educate members on coverage, costs, and how to get the care they need.”

How do Americans want to receive health plan information?  According to the survey:

  • 62 percent (the majority) say they would be likely to better understand their health plan information using the websites offered by their healthcare plan provider
  • 41 percent would be likely to better understand their health plan information using member phone support offered by their healthcare plan provider
  • 37 percent of U.S. adults say they get information about healthcare costs and services from their insurance company
  • 31 percent get information about healthcare costs and services from their doctor

For more information, visit www.sciohealthanalytics.com/harrispoll

About SCIO Health Analytics  

Based in West Hartford, Connecticut, SCIO Health Analytics is a leading health analytics services company, serving more than 50 health care organizations including 15 of the top 25 insurers that represent more than 80 million members and 4 of the top 5 PBMs. SCIO’s consumer analytics provide actionable insights on consumers, helping healthcare organizations gain insight into consumer preferences and drivers affecting their behavior to streamline their experience and improve engagement. Through the use of integrated healthcare data, proprietary algorithms and technologies, SCIO focuses on predictive analytics, business services and insights in the areas of payment integrity, risk and care management, opportunity analysis and incentive design, consumer segmentation and engagement, marketing analytics, ACO and network analytics. For more visit www.sciohealthanalytics.com

About The Harris Poll
Over the last five decades, Harris Polls have become media staples.  With comprehensive experience and precise technique in public opinion polling, along with a proven track record of uncovering consumers’ motivations and behaviors, The Harris Poll has gained strong brand recognition around the world. The Harris Poll offers a diverse portfolio of proprietary client solutions to transform relevant insights into actionable foresight for a wide range of industries including health care, technology, public affairs, energy, telecommunications, financial services, insurance, media, retail, restaurant, and consumer packaged goods. Contact us for more information.

1 2013 U.S. Census data showed a U.S. population of 316,128,839 – 76.7% of whom were adults 18 and over. 91% of the U.S. adult population has health insurance, which is equal to 220,648,446. 20% of the 220,648,446 with insurance =  roughly 44M.
2 Ward BW, Schiller JS, Goodman RA. Multiple Chronic Conditions Among US Adults: A 2012 Update. Prev Chronic Dis 2014;11:130389. DOI:http://dx.doi.org/10.5888/pcd11.130389.
3 An Unhealthy America: The Economic Burden of Chronic Disease. Milke

Source SCIO Health Analytics


Physician-Patient Alliance Recommends Continuous Respiratory Monitoring of All Patients Receiving Opioids

HDeIS0jCHICAGO – The Physician-Patient Alliance for Health & Safety today issued the following statement encouraging the continuous electronic monitoring of all patients receiving opioids:

To improve patient safety and save patients’ lives, we recommend adopting continuous respiratory monitoring of all patients receiving opioids to improve timely recognition of respiratory depression, decompensation or clinical deterioration.

The Centers for Medicare & Medicaid Services (CMS) issued on March 14, 2014 revised guidance, “Requirements for Hospital Medication Administration, Particularly Intravenous (IV) Medications and Post-Operative Care of Patients Receiving IV Opioids“.

The CMS guidance recommends “at a minimum” that hospitals “have adequate provisions for immediate post-operative care, to emphasize the need for post-operative monitoring of patients receiving IV opioid medications, regardless of where they are in the hospital.”

In addition and more importantly, the CMS guidance necessitates monitoring for all patients receiving opioids when in hospital:

Narcotic medications, such as opioids, are often used to control pain but also have a sedating effect. Patients can become overly sedated and suffer respiratory depression or arrest, which can be fatal. Timely assessment and appropriate monitoring is essential in all hospital settings in which opioids are administered, to permit intervention to counteract respiratory depression should it occur.

The CMS guidance provides increased vigilance to patients receiving opioids, particularly those patients receiving opioids postoperatively. CMS explains the reason behind the issue for this guidance:

Each year, serious adverse events, including fatalities, associated with the use of IV opioid medications occur in hospitals. Opioid-induced respiratory depression has resulted in patient deaths that might have been prevented with appropriate risk assessment for adverse events as well as frequent monitoring of the patient’s respiration rate, oxygen and sedation levels. Hospital patients on IV opioids may be placed in units where vital signs and other monitoring typically is not performed as frequently as in post-anesthesia recovery or intensive care units, increasing the risk that patients may develop respiratory compromise that is not immediately recognized and treated.

About Physician-Patient Alliance for Health & Safety

Physician-Patient Alliance for Health & Safety is a non-profit 501(c)(3) whose mission is to promote safer clinical practices and standards for patients through collaboration among healthcare experts, professionals, scientific researchers, and others, in order to improve health care delivery. For more information, please go to www.ppahs.org


Source: Physician-Patient Alliance for Health & Safety

Costly, Complex Headache Treatment on the Rise

(Reuters Health) – Contrary to most treatment guidelines for uncomplicated headaches, doctors are ordering expensive scans and referring patients to specialists more often, racking up unnecessary healthcare costs, a new study finds.

“In U.S. healthcare we have a general over-treatment problem and headache is no different except that with headaches a lot of the over-treatment is potentially low value and high cost,” said lead author Dr. John Mafi, an internal medicine fellow at Beth Israel Deaconess Medical Center in Boston.

The great majority of people will experience a headache at some point in life, and about one in four Americans have recurrent severe headaches such as migraines. About 12 million Americans visit their doctors complaining of headaches each year at an annual cost of about $31 billion, Mafi and his colleagues write in the Journal of General Internal Medicine.

Most evidence-based guidelines for headaches advise conservative treatments such as counseling about stress reduction or avoiding dietary triggers for headaches, and reserve imaging or specialty referrals for “red flag” headaches that stem from neurological problems, cancer, trauma or human immunodeficiency virus (HIV), the authors note.

“Oftentimes less can be more, particularly for things like uncomplicated headache where the vast majority of times they’ll go away on their own with very conservative treatment and by listening to your body and really paying attention to the triggers,” Mafi told Reuters Health.

Mafi thinks many people have a misconception that more referrals and tests equal better care than simple, but often effective, lifestyle counseling.

To analyze trends in headache treatment from 1999 to 2010, Mafi and colleagues looked at national healthcare databases. They examined more than 9,000 physician visits that were representative of the 144 million total visits for headache during that time period. The study team omitted visits for headaches associated with red flag conditions.

The researchers discovered that use of advanced imaging procedures such as CT scans and MRIs rose from less than 7 percent of visits in 1999-2000 to almost 14 percent in 2009-2010. Referrals to other physicians increased from about 7 percent to 13 percent.

The use of over-the-counter medications remained stable at approximately 16 percent, but use of anti-migraine medications such as triptans and ergot alkaloids rose from about 10 percent to more than 15 percent. Opioid and barbiturate use remained unchanged.

They study team also found that clinician counseling for lifestyle changes dropped from almost 24 percent of visits to less than 19 percent.

Mafi doesn’t blame primary care providers, saying they’re overworked, and there are financial and medico-legal pressures to order excessive testing procedures.

He thinks the current “20-minute model” of healthcare is broken and suggests moving toward one that reimburses electronic communications and secure messaging, along with patients’ ability to enter their information online.

“There’s less time than ever in the primary care visits because the doctors are increasingly hurried, it’s just that much easier to click a button, order the test and move on because it takes so much more effort and time to actually counsel the patient and to explain to the patient why a test is unnecessary,” he said.

In their report, Mafi’s team notes that the increase in the use of scans such as CT and MRI is “of particular concern” because of the added costs and potential harms of the scans themselves. In addition to the anxiety provoked in patients, scans may lead to unnecessary follow-up tests and incidental findings.

Moreover, contrast dyes used for some kinds of scans can provoke allergies or kidney problems, they note. Finally, they write, the unnecessary exposure to radiation is also a hazard, pointing to an estimate that 4,000 additional cancers were created by the 18 million head CT scans performed in the U.S. in 2007.

For busy clinicians, Mafi said, “One of the most important things that primary care can do is to stress non-pharmacological therapies, so just going over common dietary triggers like caffeine, chocolate and alcohol.”

He added that counseling patients on good sleep hygiene and stress reduction are also important. “And most important (counseling on) just leading an overall healthy lifestyle with a balanced diet rich in fruits and vegetables, and getting plenty of exercise.”

Mafi said that having patients keep a daily diary of the events leading up to a headache is critical in helping to identify the patient’s personal triggers.

“And when they can identify all the different triggers in their life, they can make active changes that actually prevent headaches from starting, which could actually lessen the need for more tests, medications and even doctor visits,” he said.

Source: Reuters, Journal of General Internal Medicine

Hawaii Faces Physician ‘Crisis’

HONOLULU (AP) — Hawaii’s doctor shortage is getting worse, and it’s getting especially difficult to find a physician on its neighboring islands.

The state is nearly 900 doctors short of the amount it should have based on population, according to the University of Hawaii John A Burns School of Medicine’s Area Health Education Center. The shortage is expected to jump as high as 1,500 by 2020, school researchers said.

The center is trying to find ways to deal with the issues that make practicing medicine in Hawaii difficult, including government regulations and the state’s high cost of living.

The shortage is up nearly 20 percent from 742 in 2013, and 43 percent from 622 in 2012, the Honolulu Star-Advertiser reported Tuesday (http://ow.ly/HE4eW).

“I would already call it a crisis,” said Kelly Withy, primary researcher for the center’s Physician Workforce Assessment. “You don’t realize how desperate it is until you can’t find the care you need.”

Many patients wait months to get an appointment. In many cases — especially on the neighboring islands — people aren’t getting prompt treatment for serious diseases such as cancer, she said. On the Big Island, it can be two to three times more difficult to find a primary care physician, the type of doctor the state needs the most.

One-third of Hawaii’s doctors will reach retirement age in the next five years.

Despite the shortage, there are fewer than 40 positions for doctors in the community, Withy said.

“Traditionally, physicians chose to open their own practices, and nowadays they don’t want to,” she said. “They want a job. So even if we had 800 doctors who wanted to move to Hawaii, unless they wanted to open their own practice, we could not accommodate them.”

 Source: Huffington Post