Archives for September 2015

CMS announces Enhanced MTM model, hopes to bring efficiency to Part D

The CMS Center for Medicare and Medicaid Innovation (CMMI) announced a model designed to test strategies to improve the use of medication among Medicare Part D beneficiaries. The new CMMI program—The Part D Enhanced Medication Therapy Management (Enhanced MTM) model—will attempt to more effectively use MTM, to improve health care outcomes and quality. According to the CMS announcement, enhanced MTM also has the potential to lower overall health care costs.


Section 3021 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) established the CMMI to test innovative health care payment and service delivery models. A primary goal of the CMMI was to improve the quality of care and reduce Medicare, Medicaid, and CHIP expenditures. The ACA appropriated $10 billion to support Innovation Center activities initiated from FY 2011 to FY 2019.

Enhanced MTM model

The new model will evaluate whether Medicare Prescription Drug Plans (PDPs) that are given additional incentives and flexibilities to innovate will be better able to meet the goals of the MTM programs. CMS wants to test whether changes to PDPs will help meet the MTM goals of: “(1)improving compliance with medication protocols, including high-cost drugs, ensuring that beneficiaries get the medications they need, and they are used properly; (2) reducing medication-related problems, such as duplicative or harmful prescription drugs, or suboptimal treatments; (3) increasing patients’ knowledge of their medications to better achieve their or their prescribers’ goals of therapy; and (4) improving communication among prescribers, pharmacists, caregivers and patients.”


The Enhanced MTM model will consist of a five-year performance period beginning on January 1, 2017. CMS plans to test the model in five regions: Region 7 (Virginia), Region 11 (Florida), Region 21 (Louisiana), Region 25 (Iowa, Minnesota, Montana, Nebraska, North Dakota, South Dakota, Wyoming), and Region 28 (Arizona). Eligible PDPs in each of those regions can apply to vary the intensity and types of MTM interventions they offer. CMS will waive certain MTM program requirements for participating plans during the model’s performance period. Participating plans will be expected to work closely with their network pharmacy providers and local prescribers to identify enrollees with “medication usage that has caused, or is likely to cause, adverse outcomes and/or significant non-drug program costs.” Plans will be expected to offer targeted assistance to those beneficiaries in order to optimize medication use.

Food company Nestle building credibility in the health industry

Food company Nestle, through the Nestle Institute of Health Sciences (NIHS), is taking steps to enter the health business, most recently by signing a research collaboration agreement with AC Immune, a Swiss biotech company. The agreement will support the development of an Alzheimer’s disease diagnostic test. This is the second medical deal in one week for the world’s largest packaged food company, as sales in processed foods are slowing in many markets.

Alzheimer’s disease

Alzheimer’s disease develops as a result of a complex series of events taking place in the brain over a long period of time, according to AC Immune. Alzheimer’s disease results when tangles and other abnormal forms of Tau protein accumulate inside and spread between brain cells and beta-amyloid creates plaques and oligomers outside the brain cells. There are 9.9 million new cases of dementia each year, and the incidence and prevalence of Alzheimer’s increase with age. There are currently 46.8 million people living with Alzheimer’s globally, a number that is expected to rise to 131.5 million by 2050. Estimates show that the annual societal and economic costs of dementia rose from $604 billion in 2010 to $818 billion in 2015.

Research collaboration

AC Immune is a leading Swiss-based biopharmaceutical company focused on neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease, Down’s syndrome, and glaucoma. It designs, discovers, and develops both therapeutic and diagnostic products to prevent and modify diseases caused by misfolding proteins. It currently has three products in clinical trials.

The collaboration will develop a minimally invasive diagnostic assay for Tau. The test will have the potential to identify Alzheimer’s patients at a very early and potentially pre-symptomatic stage of the disease. The development of a test to identify patients in the early stages is one of the most pressing needs in Alzheimer’s disease, said Prof. Andrea Pfeifer, CEO of AC Immune. Early diagnosis is equally needed for the development of both pharmaceutical and nutritional approaches.

“We are very pleased about this research collaboration with NIHS, which marks our fourth partnership involving the Tau protein, endorsing our capability to develop both diagnostics and therapeutics for neurodegenerative diseases,” Pfeifer said. Nestle’s medical products are estimated to eventually make up 10 percent of sales or more.

Is FDA expedited review encouraging less-innovative drugs?

The increasing reliance on expedited development and review procedures by the FDA are being driven less by drugs that provide “noticeable clinical advances,” and more by drugs that are not first in class and are less innovative, according to a study published in the BMJ. This conclusion was drawn based on an analysis of FDA approval of drugs in the last two decades, which focused specifically on drugs that were subject to “special expedited development and review pathways” made available by the FDA.

Expedited reviews

The notion of expedited processes to obtain FDA approval of a certain drug product grew out of the desire to minimize delay of widespread access to drugs that treat rare and serious or life-threatening diseases. According to the BMJ, four programs for expedited review were created in response to this issue:

  1. the Orphan Drug Act (P.L. 97-414), which establishes tax breaks and market exclusivity periods for drugs that treat conditions that are considered too rare for large randomized clinical trials;
  2. fast track designation, which allows for approval of drugs after an abbreviated clinical trial phase for products that treat life-threatening or severely debilitating diseases;
  3. the accelerated approval pathway which allows drugs treating life-threatening or severely debilitating conditions “to be approved on the basis of surrogate endpoints reasonably likely to predict patient benefits;” and
  4. priority review designation, or guaranteed review for new drug applications within six months, for drugs that appeared to offer “a therapeutic advance over available therapy.”

In general, these pathways and designations were to be offered on a limited basis and were to be reserved for those products that seemed to offer “the greatest promise of therapeutic advance to patients with no other reasonable therapeutic choices.”


The study was focused on “approved novel therapeutics” between the years 1987 and 2014. In that time period, the BMJ found that 774 total drugs were approved. In terms of type of expedited review, priority review was the most popular path of expedited approval while accelerated approval was the least popular. The BMJ observed that there was a 2.6 percent increase in “the number of expedited review and approval programs granted to each newly approved agent… and a 2.4 [percent] in the proportion of drugs associated with at least one such program.”

Conclusion and policy implications

According to the BMJ, the results dictated that the increase in the use of expedited pathways was not simply the result of the increase in the number of innovative drugs over the studied period of time. Instead, the findings indicated that the expedited processes are increasing being driven by fewer first-in-class drugs, and other less-innovative drugs The BMJ noted that rather than recognize the danger associated with this trend, Congress is continuing to allow for additional expedited review and approval pathways. In fact, the 21st Century Cures Act, which was recently approved in the House, creates another pathway for expedited approval without the requisite conventional clinical trials for new antibiotics and antifungals.

SAMHSA awards $46.8M in grants for suicide prevention and crisis counseling

The Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it is awarding up to $46.8 million in grant funds to programs that help prevent suicide and provide assistance to those who have been affected by a natural or man-made disasters. The funds were awarded in September, which is National Suicide Prevention Month, and just days after President Obama proclaimed World Suicide Prevention Day 2015, which urges leaders, organizations, and health care providers to raise awareness about mental health and support services that are available in their communities and to encourage individuals in need of care to seek treatment.


SAMHSA awarded one $18.6 million grant that will provide funding for the next three years to Link2Health Solutions, Inc., which is based in New York City, and operates the National Suicide Prevention Lifeline (Lifeline) (1-800-273 TALK (8255)), and the National Disaster Distress Helpline (Helpline).

SAMHSA will be awarding $15.9 million of the funding to the Lifeline, which will be used for the continued administration and enhancement of the nationwide network of crisis centers that is available 24 hours a day, seven days a week, to provide counseling for individuals suffering from emotional distress or who are experiencing a suicidal crisis.

The Lifeline was launched on January 1, 2005, and was funded by SAMHSA. Since its launch, the Lifeline has embarked on various initiatives aimed at improving crisis services and suicide prevention. Last year, the Lifeline responded to more than 1.3 million calls, and received an average of 3,719 calls per day. Overall, the Lifeline has responded to over seven and a half million calls from people experiencing crises.

Anyone who is in crisis or is concerned about someone else can call the Lifeline and be connected to the nearest crisis center within the Lifeline network. Additionally, individuals can get help by going to the Lifeline website and clicking on the “Click to Chat” button. Individuals can contact the Lifeline via TTY for the deaf and hearing impaired at 1-800-799-4889 or in Spanish at 1-888-628-9454.


SAMHSA is also awarding $2.8 million over the next three years to increase the capacity of the Helpline (1-900-985-5990), which provides resources 24 hours a day, seven days a week, for people in need of crisis counseling after natural or man-made disasters or tragedies. The Helpline is toll-free and provides confidential services and connects individuals with trained professions from the nearest crisis counseling center. Additionally, people requiring emotional assistance after a disaster can also text TalkWithUs to 66746 or go to the SAMHSA disaster assistance website. Individuals can also contact the Helpline via TTY for the deaf and hearing impaired at 1-800-864-8517.

The Disaster Distress Helpline has provided assistance since its launch in 2012 to individuals after disasters such as Hurricane Sandy, the Boston Marathon bombing, and the Ebola outbreak.

Suicide Prevention Resource Center

In a separate grant, SAMHSA is awarding $28.2 million in funds over the next five years to the Education Development Center, Inc., in Waltham, Massachusetts, to help manage the Suicide Prevention Resource Center (SPRC). The SPRC provides technical assistance, training, and resources to various organizations such as states, tribes, and SAMHSA grantees, to assist in the development of suicide prevention strategies.

The SPRC is also the Executive Secretariat for the National Action Alliance for Suicide Prevention, which is a public-private partnership working to advance the National Strategy for Suicide Prevention.


The SAMHSA is an agency within HHS that implements efforts to advance behavioral health throughout the country. Its mission is to reduce the impact that substance abuse and mental illness takes on communities.

Acting SAMHSA Administrator, Kana Enomoto said, “Suicide and emotional turmoil can destroy lives and shatter families and communities.” Enomoto added, “Yet when people in crisis get help they can recover, and lead full productive lives. That is why these programs are so essential.”