Discoveries/Innovations: Potential Breakthrough Drug for Leukemia?
According to research published in the New England Journal of Medicine (NEJM), Pharmacyclic’s Ibutinib is showing signs of efficacy for the treatment of chronic lymphocytic leukemia (CLL) without devastating side effects. Researchers came to this conclusion when they tested the experimental drug on 85 CLL patients who were unsuccessful with at least two anti-cancer drugs. Patients were randomized into two dosage treatment groups of Ibutinib. Results showed that after two years of treatment, 71% of the group had slower tumor growth, and 75% showed no additional cancer progression at 26 months.
By the end of the study, 83% of the participants survived, and most patients did not experience severe side effects. Ibrutinib also exhibited positive results with Mantle Cell Lymphoma (MCL) patients, an aggressive form of lymphoma that is hard to treat. In a separate study published in NEJM involving 11 MCL patients, 68% of patients responded to Ibrutinib and almost 60% of participants survived after 18 months of treatment. The studies suggest that patients may benefit and survive longer from slower growing or growth-free cancer, even from very aggressive forms of the leukemia, if treated early. It also suggests that the drug is better tolerated and less harmful to the body than traditional chemotherapy.
TeleMed Texts: Health Company Launches Personalized Health Plan Service
Are online employee wellness services undergoing a revolution? Well, a new mobile app called RevUp brings a new concept to the space. MDRevolution, a healthcare company, teamed up with mobile tech company Qualcomm, and genetics testing companies 23andMe and Pathway Genomics to launch the service. RevUp is a HIPAA compliant, cloud-based system that integrates fitness, genetic and metabolic assessments, nutrition and other medical data to provide customized health plans to patients. Corporate employers, as well as healthcare organizations and physician groups can deploy this system to their patients. Not only does RevUp present customized health plans, it allows patients to log and monitor their individual progress, and receive personalized coaching and feedback. Employers and physicians can track their patient’s progress as well. Among its current clients are Sharp Healthcare and Pharmatek.
MDRevolution’s founder and CEO, Samir Damini, credited its facility’s physician office and research lab model and mobile device program that helps improve patient health using genetic and metabolic data to develop insights. These are used to inform RevUp’s algorithms to generate customized plans. Unlike programs meant to lower healthcare costs, and boost productivity, Damini believes that RevUp’s data-driven model gives it an edge over its competitors.
Sales Sector: Pharma Industry Forecasted to Grow by 2018
“The worst is behind us,” according to market intelligence firm, Evaluate Ltd. Worldwide prescription drug sales for the pharma industry took a 1.6% decline in 2012 due to increasing drug patent losses. However, forecasts show that sales will begin to grow this year and increase steadily almost $900 billion by 2018 according to Evaluate’s report, World Preview 2013, Outlook to 2018: Returning to Growth. The report revealed that the industry will see an increase in investor confidence and R&D.
But while many drugs are slated for patent expirations, which will account for $227 billion in global drug sales, only half of that is forecasted to be lost over the next five years, due to the rise in biological product sales. By 2018, biological products are forecasted to account for 50% of global sales. The report also revealed that 1) Pfizer is the number one pharma company in 2012 in terms of global sales. While Novartis is number two, the company is forecasted to take over as number one in global sales by 2018. 2) Worldwide R&D spend is forecasted to reach $149 billion by 2018, growing at a rate of 1.4% annually. 3) Teva Pharmaceuticals remained the leading generic company in 2012.
Patient Pages: Report Reveals Consumer Attitudes Toward ACA
A new report analyzing consumer awareness, motivations and attitudes toward the Affordable Care Act (ACA) provides interesting insights for healthcare marketers and providers who need to better understand and engage this market segment. The 2013 Consumer Healthcare Market Report released by customer engagement agency Harte-Hanks, surveyed over 600 consumers throughout the U.S. who were between the ages of 18 and 64, uninsured, and subsidy eligible. The survey looked at factors such as motivation, affordability and likelihood to purchase.
The report revealed that consumers who are in good health, but uninsured, and young adults between the ages of 18 and 39 are significant and most attractive to insurers. The study found that these groups need more education on the ACA, are motivated, and will require different marketing approaches. The results also showed that consumers believed that the average price they would pay for healthcare insurance was $161. Scott Overholt, Vice President, Healthcare Markets at The Agency Inside, believes that healthcare providers must invest in education in order to persuade consumers that this expense is necessary and worthwhile.
Therapeutic Talk: Sequester Puts Oncology Practices on Edge
The survival of community oncology practices throughout the country are now in jeopardy because of budget cuts brought on by the sequester that took effect this past March. The sequester reduced Medicare reimbursement for oncology drugs from 6% to 4%, which costs an individual community practice an average of $250,000 each year, according to global sales and marketing company ZS Associates.
According to a 2012 report from the American Society of Clinical Oncology, 34% of oncology practices are unsure of their ability to survive as an independent entity in the short- and even long-term. Another survey of community oncologists revealed that 49% of oncologists reported sending their Medicare patients somewhere else for treatment and 14% of respondents said they were discussing either an acquisition deal or entering into a professional service agreement deal with hospitals. Others have reported that they will seek these options more urgently if the budget cuts last through July 2013.
FDA Update
Label Updates Proposal
Unlike branded drug manufacturers, generic drugmakers are not allowed to update their drug labels even to include a safety warning. However, the FDA proposed a requirement for all manufacturers of a drug to be able to revise labels after the FDA approves a revision by one company. This proposal comes after the Supreme Court’s ruling that generic drugmakers cannot be sued under state law for adverse reactions.
FDA’s Action to Protect Consumers
In response to the online sale and distribution of counterfeit and illegal drugs, the FDA in partnership with international regulatory and law enforcement agencies, took action against almost 10,000 fraudulent sites selling unapproved drugs to consumers. The agencies issued regulatory warnings, seized illegal websites and over $41 million worth of illegal medicines. So far the FDA and partnering agencies seized and shut down operations of 1,677 illegal pharmacy websites from June 18 to June 25, 2013.
New Approvals
Boehringer Ingelheim’s Gilotrif (afatinib) was approved for patients with late stage (metastatic) non-small cell lung cancer. Gilotrif is a tyrosine kinase inhibitor that blocks the protein that promotes the development of cancer cells. Noven Therapeutics’ Brisdelle (paroxetine) received approval to treat moderate to severe hot flashes associated with menopause. Verify Cronos Self-Contained Biological Indicator (SCBI) manufactured by Steris Corp. received marketing approval of a new test that can help speed the determination of whether steam sterilization of reusable medical devices is effective.
