Seventy-three percent of insured patients receiving assistance from Patient Access Network (PAN) Foundation reported that health care costs are influencing their medication and treatment decisions more this year than last. Nearly half of these said that cost is having a “very big” or “big” impact on whether they seek treatment or fill prescriptions.

The results were part of a 2009 patient survey to determine the effects of the economy, the impact of PAN assistance on patients’ lives and their satisfaction with PAN services. PAN helps insured individuals make copayments for medications for 21 specific diseases, including certain cancers and a number of chronic illnesses.

“Our patients do have health insurance; many have Medicare, and yet they still can’t meet all the out-of-pocket costs required for life-sustaining medications,” said Lyn Boocock-Taylor, chair of the PAN Board of Directors. “The needs of our patients and of the estimated 25 million underinsured people nationwide simply must be considered in the current health care reform debate.”

For a number of patients struggling to meet medical costs, timely PAN help sometimes means the difference between life and death, as a cutaneous T-cell lymphoma patient from Colorado wrote: “I was dying because I did not have the means to fight my cancer…thanks, thanks, thanks.”

For others, like a rheumatoid arthritis patient from Texas, PAN’s assistance eliminated their need to make tough financial choices, saying that: “[With PAN help] I do not have to choose my treatment over other bills that need to be paid.”

Patients receiving PAN assistance also reported a striking 28 percent increase (from 71 to 99 percent) in their ability to comply with physicians’ medication orders, because of their copayment assistance for vital medications and infusions. Failure to take prescriptions as prescribed often disrupts the medication’s helpful effects and can lead to negative consequences such as hospitalization.

Patients said that the copayment assistance reduced family financial and emotional strain, improved their overall health and ability to take medications as prescribed and sometimes sufficiently improved their health allowing their return to work or education.

“We know patients are struggling, but these survey results confirm that we are truly reaching those who need help and making a difference in their lives,” said Julie Reynes, President of PAN.

Additionally, PAN enjoys a patient satisfaction rate of 97%. Patients say that PAN’s professional case managers staffing the call center are compassionate and helpful.

PAN is a nonprofit foundation dedicated to providing copayment assistance to insured patients who otherwise lack the means to meet out-of-pocket medication costs for specific diseases. Since 2004, PAN has helped more than 60,000 patients across the United States and U.S. territories.

Source: Patient Access Network Foundation

People with chronic health conditions who receive coaching tailored to their level of health activation showed significant improvements in clinical outcomes, and experienced fewer hospitalizations and visits to the emergency room than those coached using traditional methods, according to a study published in the June issue of The American Journal of Managed Care.

The study, led by Judith Hibbard, Ph.D. and colleagues at the University of Oregon, compared the behaviors of patients receiving standard telephone disease management (DM) coaching with those who received more tailored coaching based on their “activation level” as part of a DM program offered by the health improvement company LifeMasters Supported SelfCare, Inc. Activation levels are determined by the Patient Activation Measure(TM) (PAM(TM)), a survey tool developed by Hibbard and colleagues to assess an individual’s knowledge, skills and confidence in playing a role in one’s own health and healthcare.

“LifeMasters is continually implementing new methodologies and tools to improve outcomes,” said Mary Jane Osmick, M.D., Vice President and Medical Director. “We have learned that deploying targeted interventions rather than using a ‘one size fits all’ approach is a critical success factor. Our nurses and coaches are the first in the DM industry to provide individual patient support by applying a fully integrated coaching model that includes the PAM. The findings reinforce our understanding that improved activation is an overarching measure of success that leads to significant clinical improvement and financial savings. “

The quasi-experimental research, which was conducted in a real-life DM setting, included an intervention group and a control group of nurse coaches and their patients in geographically separate call centers, which were selected based on the similarity of their nurse coaches’ tenure and years of experience.

The findings show those who received coaching with the PAM experienced a 33% decline in hospital admissions compared to the control group, which remained flat, and a 22% decline in emergency room visits compared with an increase of 20% in the control group. The PAM group also experienced statistically significant improvements in diastolic blood pressure and in LDL cholesterol levels relative to the control group, and increased their adherence to recommended immunization and drug regimens, including the influenza vaccine.

The PAM score intervention group showed fewer hospital stays, which translated into a savings of $145 per person per month for the intervention population. A similar decline was seen in visits to the emergency room among this group, which equates to an $11 per person per month savings.

“The PAM is unique among social science-based assessments in that it measures an individual’s underlying health belief structure. This structure reflects the degree to which the person feels in charge of his or her own health and healthcare, and is the basis for a whole spectrum of health behaviors. This creates a more holistic view of the individual, one which is essential to providing effective support,” said Dr. Hibbard.

The Patient Activation Measure, which is licensed and marketed by Insignia Health, consists of a 10 or 13-question survey that asks people about their beliefs, knowledge, skills and confidence for engaging in a wide range of health behaviors. Based on responses to the survey, each person is assigned an activation score and level. The PAM segments participants into one of four progressively higher activation levels.

At the low end of the spectrum, individuals tend to be passive in managing their health, and may fail to see the connection between their own behaviors and health outcomes. At the high end, individuals understand that relationship and have become good self-managers across a constellation of behaviors. However, even high activation level individuals show opportunities to improve and can benefit from coaching to help them stay on course in times of stress or change to their routine.

More than 85 studies have documented the PAM’s ability to effectively measure patient activation and to predict a range of behaviors in wide demographic and socioeconomic variability. Research has shown that higher levels of activation rates correlate with improved self-care behaviors. In fact, the Hibbard study demonstrated that PAM scores increased 4.6 pts for the intervention group compared to just 1.4 points for the control group, demonstrating that the tool improved the patients’ ability to manage their conditions.

“Tailoring support to an individual’s level of activation and self-management ability allows coaches to address the competencies that drive the behaviors critical to better health and the more efficient use of healthcare resources,” said Chris Delaney, Insignia’s Chief Executive Officer. “This study clearly demonstrates the benefits of this patient-centric model.”

Funded by the Health Industry Forum at Brandeis University, the study and its practical applications will be discussed on September 21-22 at DMAA: The Care Continuum Alliance’s Forum 09 conference in San Diego. The American Journal of Managed Care is an independent, peer-reviewed publication dedicated to disseminating clinical information to managed care physicians, clinical decision makers and other healthcare professionals.

About LifeMasters Supported SelfCare, Inc.

LifeMasters Supported SelfCare, Inc. is a leading provider of health improvement and condition management programs and services that create health partnerships among individuals and their physicians. The programs improve the quality of care for populations with risk factors and chronic conditions and reduce healthcare cost trends for the nation’s leading health plans, employers, retirement systems, labor unions/trusts and governmental organizations. LifeMasters offers programs for individuals with asthma, cancer, depression and musculo-skeletal pain. LifeMasters’ programs are holistically focused, support co-morbidities like depression, and facilitate lifestyle changes such as smoking cessation and weight loss. LifeMasters is accredited by the National Committee for Quality Assurance (NCQA) and URAC.

About Insignia Health

Insigna Health supports organizations and their efforts to help individuals develop the behaviors that are crucial to becoming more active and successful managers of their health and healthcare. This support is anchored by the Patient Activation Measure(TM) assessment. Insignia’s tailored products leverage a wealth of self-management insight to help individuals master new positive behaviors that are realistic given a level of activation. Research has shown consistently that with increased activation comes better health and the more effective and efficient use of healthcare resources.

Source: LifeMasters Supported SelfCare, Inc

Cephalon, Inc. (Nasdaq: CEPH) presented results from a pivotal trial that showed NUVIGIL(R) (armodafinil) Tablets [C-IV] significantly improved wakefulness in people with excessive sleepiness associated with jet lag disorder. These phase three data were presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies meeting in Seattle, Washington. NUVIGIL is currently indicated to improve wakefulness throughout the day for the millions of patients who struggle with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder and narcolepsy.

“We know that jet lag disorder affects approximately two-thirds of international travelers and that eastbound flight across multiple time zones can be particularly troublesome. We are excited to present our data at a major scientific meeting about the use of NUVIGIL in acute excessive sleepiness associated with jet lag disorder,” said Dr. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon. “Based on the findings of this study, Cephalon will submit a supplemental New Drug Application to the U.S. Food and Drug Administration during the third quarter of this year.”

This novel phase three, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy men and women aged 18 to 65 over the course of three days. Study participants all had experienced jet lag symptoms at least once during the previous five years. Participants in the study traveled eastbound from the United States to France, where they were then evaluated at a sleep facility. Clinical efficacy in the study was demonstrated using two measures: an objective assessment (Multiple Sleep Latency Test, MSLT), and a subjective assessment (Patient Global Impression of Severity, PGI-S).

The data showed NUVIGIL significantly improved wakefulness in the participants, as assessed by the MSLT averaged across days one and two. Participants taking NUVIGIL 150mg/day had an average time to fall asleep of 11.7 minutes, compared to 4.8 minutes for subjects taking placebo and 7.7 minutes for subjects taking NUVIGIL 50mg/day (p<0.0001 for both doses compared with placebo). An average time to fall asleep of less than 5 minutes on the MSLT is considered pathological sleepiness and an average time to fall asleep of greater than 10 minutes is considered within the normal range.

Researchers also found that NUVIGIL 150mg/day significantly improved patient-reported clinical condition, as assessed by the mean PGI-S [rating 1=normal to 7=extremely ill], averaged across days one and two, compared with placebo (1.6 armodafinil 150mg/day versus 1.9 placebo; p=0.04). NUVIGIL was generally well-tolerated in the study. The adverse events reported in this study are consistent with the current NUVIGIL label. The most common adverse events observed more frequently with NUVIGIL use compared to placebo (greater than or equal to five percent), included headache, nausea, diarrhea and palpitations.

“Following travel across multiple time zones, many travelers can schedule their meetings or activities to take place after their bodies have adjusted to the local time zone. Others may not have these options and must conduct their daily activities while functionally impaired and excessively sleepy due to the time zone change,” said Dr. Richard Bogan, Primary Investigator for the study, Chief Medical Officer of Sleep Med Inc., and Clinical Associate Professor of Medicine, University of South Carolina School of Medicine. “We now have data that show NUVIGIL can play a role in addressing the primary symptom of excessive sleepiness associated with jet lag disorder due to eastbound travel.”

Jet lag disorder is an acute circadian rhythm sleep disorder that results from rapid travel across several time zones. This disorder affects approximately 70 million American travelers annually and gradually resolves once a person adjusts to the new local time.

Circadian rhythm sleep disorders are disruptions in a person’s internal body clock, which controls sleep patterns. When the internal body clock is disrupted, certain symptoms may develop affecting a person’s ability to sleep, stay awake and function normally. Circadian rhythm sleep disorders can be caused by many factors, including shift work, time zone changes and medical conditions.

About NUVIGIL

NUVIGIL, the longer-lasting formulation of modafinil, was launched in the United States in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD) and narcolepsy. NUVIGIL is not currently indicated for the treatment of jet lag disorder or its associated symptoms. The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication.

The most common adverse events in controlled clinical trials (greater than 5 percent) were headache, nausea, dizziness, and insomnia

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.

Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.

The company’s proprietary products in the United States include: NUVIGIL, TREANDA(R) (bendamustine hydrochloride) for Injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) Tablets [C-IV], and ACTIQ(R) (oral transmucosal fentanyl citrate) (C-II).

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, clinical development of NUVIGIL, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Cephalon’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.

Source: Cephalon, Inc

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