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Delays and difficulties in making appointments with neurologists are key barriers interfering with optimal care people for with multiple sclerosis (MS), Canadian researchers wrote in a recent 

In fact, a recent online survey of Canadians living with MS found that 70% experienced challenges in obtaining appointments with their neurologists. Even when meeting with healthcare providers, multiple studies reported that MS patients do not receive enough education or support from their providers in order to meet their needs.

., associate professor in the Division of Neurology at the University of Alberta College of Health Sciences and colleagues evaluated the effect of add-on nurse practitioner-led care for depression and anxiety.

The study and program were paid for through the University Hospital Foundation via a donor who “had visions of improving the care delivery to people with MS followed by general neurologists,” Smyth told 

Studies Find MS Patients Need Early Help for Pain and Anxiety

Here is how the program worked: 228 people with MS at community neurologists were randomized to add-on nurse practitioner-led or usual care (community neurologist, family physician) for six months.

Study subjects were highly educated (71%), working full-time (41%), living independently (68.86%). Their mean duration since MS diagnosis was 12.18 years and 85% had relapsing remitting MS.

Patients in the intervention group received a comprehensive consultation with a nurse practitioner. The consultation included patient history, a physical examination, individualized symptomatic strategies (lifestyle strategies, mobility issues, fatigue, spasticity, bladder and bowel concerns, depression or anxiety, and medications), exploration of the MS patient’s local community, discussion of resources to optimize mood and quality of life, and regular follow up visits at three and six months, either in-person, via telehealth\ or via phone call.

The mean change in the nurse practitioner-care group’s Hospital Anxiety and Depression Scale at3 months was -0.41 compared to 1.11 in the usual care group, a difference that was present at six months. For anxiety, the mean change was − 0.32 in nurse practitioners group versus 0.42 in the usual care group.

"Care led by a nurse practitioner can improve depression and anxiety levels of people with MS over the short term. These are important comorbidities for people with MS that are known to be associated with lower quality of life,” Smyth told 

The study provides an alternate and possibly cost-saving management strategy for complex management of symptoms and quality of life measures for MS patients, Smyth wrote.

“It has been suggested that NPs (nurse practitioners) might be easier to access and less costly to see than physician health providers for people with multiple sclerosis. The use of specialized MS NPs in general neurology outpatient settings could potentially address some of these unmet needs that various researchers have identified including healthcare access, education, counseling and support, and support to informal caregivers of people with MS,” Smyth wrote.

While nurse practitioner-led care improved depression and anxiety scores, other secondary outcomes were not significantly different. In addition, the researchers did not see a difference in satisfaction of care

The research team had wanted to determine overall healthcare savings of the nurse practitioner program, but could not, Smyth told 

. "The patients really did not keep up their healthcare visit diaries reliably to look at outpatient in addition to inpatient costs.”

Articles

Research conducted in Canada suggests that people with multiple sclerosis would benefit from being seen by nurse practitioners. However, secondary outcomes in the study did not improve among patients with access to nurse practitioner-led care.

  Nurse Practitioner-led Care Improved Depression, Anxiety in People with MS

Adherence to oral anti-cancer medications  is “suboptimal” — particulary for blood cancer patients — most commonly due to high out-of-pocket (OOP) costs, according to new research.

“Policies addressing cost and access to OAMS (oral anti-cancer medications) and health-system strategies to address barriers to the effective use of OAMs are needed to improve patient access to these vital medications,” wrote 

, Ph.D., assistant professor of pharmacy practice at the University of Rhode Island, Kingston, in the 

Journal of Managed Care Specialty Pharmacy

Vyas and her colleagues conducted a retrospective cohort study using data from Optum Clinformatics Data Mart commercial claims database for 2010-2018. They followed patients with a new pharmacy claim for an oral anti-cancer medication  between July 2010 and December 2017 for six months.

They found that out just over half (51.9%) of 37,938 patients with cancer were adherent to oral anti-cancer medications. Patients with blood cancer had some of the lowest adherence rates at 49.6%, although the rates were lower still for patients with several other types of cancers, including ovarian cancer patients (44.6%), colorectal cancer (37.3%) and liver cancer (32.8%).

The highest rates of adherence by cancer type were: brain tumor (70.4%), stomach (68.8%), lung (64.7%), and breast (55.7%).

The researchers attributed low adherence to oral anti-cancer medications for blood cancer and certain other cancers to high monthly OOP expenses, race and ethnicity disparities, higher hospitalization rates, receiving Medicare low-income subsidy (LIS), and other issues.

The average monthly out-of-pocket costs among patients with blood cancer were $749 versus $106 monthly for those with prostate cancer.

“Higher OOP costs may lead to prescription abandonment,delayed initiation,or other forms of nonadherence,which may lead to poorer outcomes and avoidable health care utilization,” Vyas wrote.

In additon, due to the high cost of oral anticancer medications, hospitals may not have them on their formularies, according to Vyas.

Patients with inpatient hospitalizations during the six months following oral anticancer medications initiation — which is common among blood cancer patients — had significantly higher odds of nonadherence for all cancer types except stomach cancer.

“We are unable to determine the specific reasons why OAM (oral anti-cancer medication)  nonadherence was higher among patients who were hospitalized. Lengthy inpatient stays may have delayed the time between refills; however, patients may have continued using their own medication while in the hospital,” Vyas wrote.

Among patients with lung, blood, renal, breast, liver, and ovarian cancers, those who received injection chemotherapy along with oral medications and those who had hospitalization had higher odds ofnonadherence.

Patients who received concurrent injection chemotherapy may have experienced treatment-related adverse events that disrupted adherence, according to another systematic review. “These patients may also experience disease-specific toxicities and events, age-related factors including polypharmacy, and adverse drug-drug interactions, resulting in hospitalizations,” Vyas wrote.

Among patients with blood cancers, Black and Hispanic patients had higher odds of OAM nonadherence compared with White patients (AOR=1.48; 95% CI=1.25-1.75 and AOR=1.38; 95% CI=1.13-1.68, respectively).

“Race and ethnicity were significantly associated with nonadherence in patients with blood cancer or lung cancer,” Vyas wrote.

The researchers attributed low adherence to oral anti-cancer medications for blood cancer and certain other cancers to high monthly out-of-pocket among several other reasons.  

Adherence to Oral Anticancer Meds Low

The high cost of chemotherapy drugs is leading some leukemia patients to buy medications online from rogue web sites, a new study found.

Gleevec (imatinib), the first-line treatment option for chronic myeloid leukemia (CML), is cost-prohibitive for many patients because it needs to be taken indefinitely, wrote co-author

 Ph.D., M.H.S., an associate professor at the University of North Carolina Eshelman School of Pharmacy in the 

Journal of the National Comprehensive Cancer Network

While generic imatinib was approved in the US in 2016 and lowered average retail prices by 30%, patient assistance programs from pharmaceutical manufacturers have declined in response to the availability of generics, according to Ozawa and colleagues. That increased out-of-pocket payments for some U.S. patients taking generic imatinib; many pay as much as $700 monthly at brick-and-mortar pharmacies.

As a result, more CML patients are turning to online pharmacies. The authors of this study say that the vast majority (96%) of online pharmacies failed to adhere to US legal standards, the author.

“Online access to treatment for CML is a significant concern if medicines are dispensed without a prescription or proper clinical oversight,” Ozawa wrote. “With imatinib, contact with a medical team is critical because patients must be frequently monitored for treatment response and must receive medication adjustments as necessary.”

Gleevec requires an adherence rate greater than 85% to 90% to achieve optimal clinical outcomes, but patients with higher copayments have been found to be more likely to discontinue or be nonadherent to drugs in the tyrosine kinase inhibitor class.

In their survey of online pharmacies that sell imatinib, only 3 of the 44 identified English-language sites that shipped within the U.S. were certified through the LegitScript online pharmacy monitoring service, according to a 

 about this study. Half (52%)were classified as “rogue” pharmacies that might operate without a license, sell counterfeit or expired products, stealpayment information, or reject important safety precautions, such as requiring a prescription for potentially hazardous medications, the researchers found. 

Notably, 13 of the online pharmacies sold Gleevec without a prescription, and more than three-quarters did not offer a way for patients to speak with a pharmacist, according to Ozawa.

“This is a significant concern for patient safety,” Ozawa said. “We were struck by just how easy it is to buy an oral chemotherapy medication online, as imatinib is not a benign drug.”

“Taking imatinib requires monitoring and frequent dosage adjustments. Even if an online pharmacy provides the medication as ordered, “patients bypassing provider interactions are likely to face much greater risks of nonadherence, discontinuation, treatment failures, and adverse events,” Ozawa added.

In addition, rogue or unclassified pharmacies may not be providing patients with the real medication, and could be stealing patients’ medical or payment information, according to the authors.

Unfortunately, the rogue sites are difficult to regulate, as they often originate abroad. “We also found it deceiving how well some illegitimate websites mimic legitimate sites,” Ozawa said.

“The exorbitant price of oncology drugs is a major barrier to optimal therapy of many malignancies, including CML,” said 

, Pharm.D., B.C.O.P., a clinical pharmacist specialist at Michigan Medicine who treats patients with leukemias and other hematologic malignancies but was not involved in the research. “…The problem has become so bad that there is a major illegitimate online marketplace for generic oral oncology drugs. Healthcare providers need to be aware that many of these rogue and unapproved pharmacies do not even require a prescription or have access to pharmacist consultations, putting patients at high risk for adverse drug events.”

The study reminds healthcare professionals about “the need to fully recognize the dangers of illegitimate online pharmacies and ensure our patients have appropriate financial support when prescribing high-cost medications,” Marini added.

Patients should be encouraged to speak with their pharmacist, financial counselor, or other members of their healthcare team if they can’t afford their medications, added study co-author Benyam Muluneh, Pharm.D., B.C.O.P., assistant professor at the University of North Carolina Eshelman School of Pharmacy.

“Cancer drugs are very expensive; however, there are some resources such as third party foundation grants that may be able to help. If a medication is not affordable through regular channels, patients could also discuss alternative medication options with their providers rather than look for discounts online,” Muluneh said.



Researchers report that half of the online pharmacies are rogue operations that may operate without a license or have other serious shortcomings.

High Chemo Drug Prices Leading Leukemia Patients to Online Pharmacies

Stem cell treatments may result in substantial improvement in muscle strength in patients with multiple sclerosis (MS), according to new research.

In a preliminary analysis of the data, researchers at the Tisch MS Research Center of New York found that stem cells are the first treatments that improve neurological outcomes in secondary progressive MS (SPMS) and primary progressive MS (PPMS) patients, Tisch MS Research Center of New York, said in a 

Following the stem cell treatments, upper limb dexterity and walking speed improved for 36% of patients, while 30% realized improved muscle strength.

 Ph.D., a senior research scientist with Tisch MS Research Center of New York who is also closely involved with the stem cell treatment study. Harris not only discussed the stem cell treatment research, but also other promising MS discoveries.

MHE: Please discuss the significance of the Center’s interim stem cell treatment trials, and the next steps in this research.

 We are conducting a phase 2 double-blind, placebo-controlled clinical trial testing the efficacy of autologous mesenchymal stem cell neural progenitors (MSC-NPs) administered into the spinal fluid (intrathecally) of patients with SPMS and PPMS. While we did observe encouraging trends of improvement in patients treated with stem cells, it must be emphasized that a full data analysis with comparison with the placebo arm remains to be completed to determine whether trends in efficacy are statistically significant. We are currently completing the final stages of the trial and anticipate a full data analysis completed by the end of this year.

Based on the preliminary analysis, we are starting discussions with the FDA to explore whether a dose escalation trial is warranted for the more disabled patients who did not respond to stem cell treatment. Our goal is to optimize cell therapy for progressive MS patients, which may require higher doses in some patients in order to achieve clinical benefit. In line with the goal of treatment optimization, we are particularly excited about our biomarker research, which would allow us to predict which patients are most likely to respond to cell therapy based on their biomarker profile.

MHE: Describe the progress in stem cell research globally and the implications for treating MS. Are there already commercial applications?

 Translation of stem cell technology to patients with MS has been frustratingly slow. Regarding mesenchymal stem cell-based therapies, multiple early-stage clinical studies have been performed with encouraging data but small sample sizes. Very few phase 2 studies have been conducted, so we really need more data from larger trials to show efficacy. Good phase 2 data is complicated by the fact that MS is a heterogenous disease, and we lack good clinical outcomes or surrogate markers for progressive MS.

I am less familiar with the commercial space for cell therapy in MS, but it is most likely hindered by the high cost of treatment, lack of standardization, and regulatory hurdles associated with biological licensing. Altogether, this slows the pace of translation, despite the very exciting stem cell research that continues to be conducted around the world. Given the rapidly-advancing stem cell research and associated technology, I assume more and more companies will start to enter this field to address this unmet need in MS.

MHE: Which other MS treatments and research are you excited about?

 Recent clinical success with anti-CD20 monoclonal antibody therapy (ocrelizumab, rituximab) as a highly effective treatment for MS has shifted the focus of MS research to CD20-expressing cells. CD20 is mostly present in B-cells; however, a population of CD20-containing T-cells has been acknowledged for some time, and these are present in higher numbers in MS patients.

New research seems to suggest that the interaction between B-cells and T-cells is required for the origin of CD20+ T-cells, which along with the antigen-presenting activity of B-cells, play an important role in MS disease. Understanding what population of CD20-containing cells are being targeted by anti-CD20 therapy and how they contribute to MS is essential to better characterize disease onset and progression.

MHE: Please explain the connection between Epstein-Barr virus and MS.

 Understanding the cause of MS has been a central and unanswered question in MS research. We have long suspected that Epstein-Barr virus (EBV) plays a critical role in the development of MS, and a 

 from Harvard adds substantial data to support the EBV hypothesis.

What we still don’t know is the mechanism that connects EBV infection, which happens in most people, to the development of MS, which only happens in some people. People with MS may have a genetic predisposition along with other environmental triggers — including low vitamin D — but we have yet to connect the dots between EBV and MS.

There is renewed interest in developing a vaccine against EBV, which would block EBV infection and hypothetically prevent MS. This line of research is challenging, but critically important to finding a cure for this disease.

Violaine Harris, Ph.D., a senior research scientist with Tisch MS Research Center of New York, discusses new research that shows stem cell treatments can improve disability in patients with MS.


Stem Cells Treatments Show Promise in MS

Cognitive impairments are common in patients with multiple sclerosis (MS) but addressing this can be challenging. Few effective interventions are available to restore or preserve cognitive function for individuals with MS, according to the authors of a new study.

To address the cognitive issues associated with MS, Feng Yang, Ph.D., associate professor in the Department of Kinesiology and Health at Georgia State University in Atlanta, and colleagues looked to whole-body vibration training, or vibration training, which has been “increasingly used as a novel clinical prevention and rehabilitation tool in individuals with movement disorders,” the wrote in the 

During vibration training, trainees stand or sit on a platform vibrating at specific frequencies and amplitudes. “The intense mechanical oscillation from the platform stimulates various sensorimotor units of the human body and leads to improvements in sensorimotor functions,” Yang wrote.

Mounting evidence supports that a short-term (6-week to 10-week) vibration training course improves physical functions, such as balance, mobility, strength, and power, in older adults, they wrote. Additionally, previous studies found positive effects of vibration training on cognitive functions in healthy adults and children and in people with pathologic conditions, such as attention-deficit/hyperactivity disorder and dementia.

This is the first study to examine the possible effects of vibration training on changing cognition and quality of life (QOL) in people with MS.

Yang and his team randomized 18 adults with MS into 2 groups: vibration training and control. The control group maintained their normal lifestyle throughout the study.

In both groups, before and after the training course, the disability status was evaluated by the Patient Determined Disease Steps scale and the Multiple Sclerosis Functional Composite (MSFC). Cognitive function was assessed by the Behavior Rating Inventory of Executive Function-Adults (BRIEF-A) and the Buschke Selective Reminding Test (SRT), and QOL was gauged by the 36-item Short Form Health Survey (SF-36).

All participants finished the entire protocol with no adverse events. The training group showed greater improvements in MSFC score, Metacognition Index score of the BRIEF, SRT score, and physical domain score of the SF-36.

For the quality-of-life endpoint, the training group, but not the control group, experienced a significant improvement in the Physical Component Summary (PCS). Additionally, the between-group difference in the PCS value further increased at the post-training session. The training group displayed higher Mental Component Summary values than the control group.

“The results indicate that the 6-week progressive vibration program is safe, feasible, and tolerable to individuals with MS,” Yang wrote. "This training program could be effective in improving cognitive function, QOL, and disability status in individuals with MS.”

The results provide an encouraging base to conduct a large-scale clinical trial, Yang wrote.

This is the first study to examine the effects of vibration training on changing cognition and quality of life in people with multiple sclerosis.

Vibration Training Enhances Cognition, Quality of Life in MS Patients

There is a huge unmet need for new treatments for patients with the progressive form of multiple sclerosis, which is characterized by a slow progression of the disease. But promising developments in research are under way, MS leaders said during the International Progressive MS Alliance’s 

One of the primary obstacles in developing treatments for MS is a lack of clinical understanding of the progressing form of the disease, said Robert Fox, M.D., staff neurologist at the Mellen Center for Multiple Sclerosis and professor of neurology at Cleveland Clinic Lerner College of Medicine.

“At the level of the biology, we don’t know what’s really driving that little-by-little progression. If we don’t know what’s causing it, it makes it really difficult to find a solution.”

About 85% of MS patients have the relapsing-remitting form of the disease, which is characterized by acute flares of symptoms followed by periods of stability. With relapsing MS, investigators conducting clinical trials can examine new lesions on an MRI and are able to conduct a six-month clinical observation to see if a potential therapy reduces lesions, Fox said. “If it does, we can move to a large phase 3 trial. The short MRI study helps us pick the drugs that are likely to be winners.”

But with progressive MS, “we don’t have a way to identify the most promising therapies for MS,” Fox noted. “We don’t know what biomarkers to use in that short proof-of-concept trial. That has made the development of new treatments much more difficult.”

Fox said the International Progressive MS Alliance has three main priorities to overcome some of the barriers. (He is chair of the Scientific Steering Committee.)

“The first is to understand, prevent, and reverse progression. These priorities are driving the research that seeks to answer the question of what is causing the progression, what biologic mechanisms are leading to it and what, therefore, might be leveraged to stop the progression,” Fox said.

Additionally, the Alliance aims to speed and improve clinical trials. “How can clinical trial methodologies be modified to make testing potential therapies more sensitive, more specific and more efficient so we can find therapies faster?” Fox said.

The Alliance also aims to improve well-being through proven therapeutic approaches, according to Fox. “Working to strategize ways to improve the quality of life of people living with progressive MS, the Alliance is bringing together the best and brightest minds in MS research,” he noted.

Some exciting new research trials should lead to better medicines and therapies for progressive MS, said Ruth Ann Marrie, Ph.D., professor of Medicine and Community Health Sciences at the University of Manitoba and director of the Multiple Sclerosis Clinic at Health Sciences Centre in Winnipeg.

 in the United Kingdom is important because it is focused on people with more advanced progressive MS than the usual trial, Marrie told 

. “One of the big frustrations for people…is that those who are older or who have more significant impairments get excluded from clinical trials,” she said.

mproving Cognition in People With Progressive Multiple Sclerosis Using Aerobic Exercise and Cognitive Rehabilitation clinical trial

, which is the first multinational rehabilitation trial in MS. In this trial, cognitive rehabilitation and aerobic exercise will be evaluated individually and in combinations to address cognitive dysfunction as the primary outcome variable.

Marrie said another notable trial is the 

. This trial will assess Genentech’s Ocrevus (ocrelizumab) in 1,000 patients with primary progressive multiple sclerosis including those later in their disease course and will assess improvement in hand function.

The lack of biomarkers for progressive multiple sclerosis has made the development of new treatments much more difficult for this form of the disease.