A new study suggests secukinumab (Cosenytx) has a high retention rate among biologic-experienced patients with psoriatic arthritis (PsA) in real-world settings, and also produces minimal serious side effects.

The research is important because previous data on the real-world usage of the recombinant human monoclonal antibody has been scarce. The drug, which targets interleukin-17A, has been approved for the treatment of PsA since 2015 in Europe and 2016 in the United States.

A team of Greek investigators wanted to know specifically how patients with PsA fared on secukinumab if they had already taken a biologic. The investigators enrolled 75 biologic-experienced patients who were treated with secukinumab at 2 university rheumatology clinics between 2016 and 2018. Their findings were 

Most of the patients (76%) were female. The patients had a mean age of 53.9 years, a median disease duration of 6.7 years, and a median treatment duration of 11.1 months with secukinumab.

Forty-eight (64%) patients had previously been exposed to anti-tumor necrosis factor (TNF) agents only. Five patients (7%) had been exposed only to ustekinumab, an IL-12/23 inhibitor. The remaining 22 patients had been exposed to both therapies.

Fifty-three percent of patients in the study received secukinumab in combination with non-biologics; 35% received the biologic along with glucocorticoids.

At baseline, 97% of patients had peripheral arthritis; 42% had axial involvement; 22% had enthesitis; and 12% had dactylitis, the authors reported.

At the end of the study’s follow-up period, peripheral arthritis scores improved, as did patients’ function scores, which were assessed by questionnaire. All patients with dactylitis at baseline saw the symptom resolve, as did 56% of patients with enthesitis at baseline.

Overall, the secukinumab survival rate was 64%, a rate that was not significantly affected by whether the patients were previously exposed to anti-TNFs only, or anti-TNFs and ustekinumab. The serious adverse event rate during follow-up was 4.8/100 patient-years, and the serious infection rate was 1.2/100 patient years.

Corresponding author Dimitrios Vassilopoulos, MD, of Hippokration General Hospital, in Athens, and colleagues said while the drug had performed well in randomized controlled trials (RCTs), a number of important factors made it important to attempt to gather real-world data.

“Our real life patient population had some unique characteristics compared to the RCTs,” Vassilopoulos and colleagues wrote. “This was a biologic-experienced, treatment-resistant population since almost all patients had been previously exposed to anti-TNFs (93%) and ~29% both to anti-TNF and anti-IL12/23 agents. Furthermore, these patients had long-standing, established disease (median: 6.7 years) and were recruited from university referral hospitals.”

One limitation of the study was that it was retrospective, and the authors said it is possible that their data are missing unreported adverse events. The follow-up period was also relatively short, they said.

Still, the overall findings lend evidence to support the idea that secukinumab can be a meaningful solution for this patient population.

“Our findings suggest that SEC [secukinumab] is an efficacious and well-tolerated biologic agent in this multi-resistant, difficult to treat patient group,” they said.

Klavdianou K, Lazarini A, Grivas A, et al. Real Life Efficacy and Safety of Secukinumab in Biologic-Experienced Patients With Psoriatic Arthritis. 

(Lausanne). Published online June 19, 2020. doi:10.3389/fmed.2020.00288

Articles

New real-world data shows 64% of patients with psoriatic arthritis who had previously been on a biologic stayed on secukinumab for the duration of the study.

Secukinumab Has High Retention Rate in Real-World Psoriatic Arthritis Study

A recent literature review about the use of noninvasive vagus nerve stimulation (nVNS) for 

 relief from headaches adds more information about this 

 the effectiveness and safety of peripheral nerve stimulation of the cervical branch of the vagal nerve in primary headache disorders.

The authors note that primary headache disorders (migraines, cluster headaches, and tension‐type headaches) are a 

. Globally, the prevalence of tension‐type headaches is about 20.1%, migraine is approximately 14.7%, and cluster headaches about 0.1%-0.4%.

The major parasympathetic branch of the autonomic nervous system, the vagus nerve transmits or mediates sensory information to the brain.

“The mechanism of action of nVNS in the treatment of headache is largely elusive and likely multifactorial,” said the authors, writing in 

To their knowledge, this is the first meta‐analysis to probe the effectiveness of nVNS in these types of headaches, they said.

The authors searched the Medline, Embase, and CENTRAL databases and used a random‐effects model to report all outcomes where nVNS was used to treat headaches in randomized controlled trials (RCTs).

Studies were included if the population included patients diagnosed with primary headache disorders, according to the 

International Classification of Headache Disorders

 (ICHD)‐II or ICHD‐III beta version); if the intervention compared cervical nVNS with sham‐device treatment or standard care; and if outcomes were measured by a reduction in headache days or attacks, pain‐free status, pain‐relief status, abortive medication use, ≥50% responder rates, adverse events, or satisfaction.

Researchers determined study quality with the Revised Cochrane tool for assessing the risk of bias.

The literature search yielded 746 articles, and of those the authors reviewed 51. Ultimately, 7 articles in 6 clinical trials were included in the review. The 6 trials included 983 randomized patients (486 to nVNS and 497 to a control).

= 634) and 3 other trials recruited patients with cluster headache (

= 349). Females made up the majority of the migraine population, and males made up most of the cluster headache participants. The percentage of preventive medication use ranged from 28.5% to 90%.

In 5 trials, the control was sham treatment with an identical device and standard care while 1 trial used only standard care. Therapy lasted from 2 to 12 weeks.

Compared with sham‐device treatment, results showed that overall, nVNS was effective at providing acute pain relief. Specifically, the outcomes were:

Pain‐free status within 30 minutes (odds ratio [OR], 2.27; 95% CI, 1.16-4.44; 

Pain‐relief status within 30 minutes (OR, 1.8; 95% CI, 1.17-2.78; 

Pain‐relief status at 60 minutes (OR, 1.93; 95% CI, 1.2-3.1; 

Reduced abortive medication use (OR, 0.61; 95% CI, 0.41-0.92; 

Pain‐free status in ≥50% of treated attacks (OR, 2.15; 95% CI, 1.27-3.66;

There were no significant differences in decreased headache days, adverse events), or satisfaction between nVNS and sham‐device treatment. Additionally, the ≥50% responder rate could not be determined.

However, some unanswered questions remain due to limited data, and larger RCTs are needed, they said.

Lai YH, Huang Y, Huang LT, Chen RM, Chen C. Cervical noninvasive vagus nerve stimulation for migraine and cluster headache: A systematic review and meta-analysis. 

. Published online March 12, 2020. doi: 10.1111/ner.13122

A recent meta-analysis looked at noninvasive vagus nerve stimulation (nVNS), a nonpharmacologic method of acute pain relief for headaches.

Vagus Nerve Stimulation Effective for Acute Headache Pain, Review Finds

 for patients with inflammatory arthritis, such as rheumatoid arthritis (RA), and a 

 can have on patients with RA, psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA).

Danish researchers used a questionnaire-based cross-sectional survey to collect patient characteristics from patients in Denmark with RA, PsA, and axSpA.

“Fatigue is considered a multidimensional and complex phenomenon and is found to be associated with pain, sleep problems and low physical activity,” the authors explained. “Also, severe fatigue has been found to predict depression, low physical activity and quality of life, and more healthcare utilization. On the other hand, depression, reduced illness beliefs, psychological distress and low self-efficacy have been found to contribute to fatigue.”

Data was collected on 487 patients over a 6-month period from January 2017 to June 2017. The majority (60%) of patients had RA (n = 292), 23% had axSpA (n = 110), and 17% had PsA (n = 85).

Patients completed a questionnaire that asked about their disease history, type of household, education, employment, and household income. The researchers also used respondents’ medical journals to gather information about type of diagnosis, age, gender, treatment, treatment changes, and disease activity score. For the disease activity score, Disease Activity Score 28 (DAS28) was used for RA and PsA, Bath Ankylosing Spondylitis Disease Activity Index for axSpA, and Bath Ankylosing Spondylitis Functional Index for PsA and axSpA.

Fatigue did not differ significantly between the disease groups. The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale has a range of 0 to 52, with higher scores indicating lower levels of fatigue. The FACIT-Fatigue score was 34.9 for RA, 31.8 for PsA, and 34.8 for axSpA. In comparison, the general population has a mean fatigue score of 44.0. While levels of fatigue were similar across the diseases, women, experienced patients, and patients who changed medication in the past 12 months all reported higher mean fatigue rate.

The socioeconomic characteristics that were correlated significantly with fatigue were education, employment, and income, with patients who had less education, were unemployed/retired, and had lower income showing a higher mean fatigue rate.

There was also a correlation between fatigue and work impairment, quality of life, pain, sleep problems, depression, and physical functioning.

The authors noted the limitations of their study included the fact that the cohort was slightly older and consisted of more women and the geographical scope was limited since the cohort was drawn from 2 clinics in the Capital Region of Denmark. They added that they cannot make conclusions concerning causality because they used a cross-sectional study.

“Fatigue cannot be seen as a single problem, but rather as a symptom that broadly affects the lives of people with [inflammatory arthritis],” the authors concluded.

Appel Esbensen B, Elkjær Stallknecht S, Elmegaard Madsen M, Hagelund L, Pilgaard T. Correlations of fatigue in Danish patients with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis. 

. Published online August 3, 2020. doi:10.1371/journal.pone.0237117

A new study in PLOS ONE has highlighted the broad impact fatigue can have on patients with rheumatoid arthritis (RA), psoriatic arthritis, and axial spondyloarthritis.

Fatigue Broadly Impacts Patients With RA, Psoriatic Arthritis, Axial Spondyloarthritis

Beyond telework, some notable strategies that 

 should consider when managing back-to-school and other leave related concerns among employees include child care benefits and flexible work options. Moreover, accessibility to mental health services and changing the physical layout of the workplace to promote social distancing are also key to address during the coronavirus disease 2019 (COVID-19) pandemic, said David Weisenfeld, JD, Legal Editor and host of a 

, on post-reopening challenges for employers and employees.

: Hello, I'm Matthew Gavidia. Today on the MJH Life Sciences™’s Medical World News, 

® is pleased to welcome David Weisenfeld, a legal editor and host of a new 

XpertHR podcast on post reopening challenges for employers. Can you just introduce yourself and tell us a little bit about your work?

: Sure, Matthew. So, as you noted, I host a podcast series at XpertHR, and we've been doing quite a number of programs on COVID-19–related issues affecting the workplace—not only affecting employers, but affecting employees as well. So, certainly a lot of things to discuss there and glad to be here with you.

: Recently, XpertHR conducted a poll examining COVID-19 related challenges for employers. In their findings, some of the most significant issues listed were back-to-school and other leave related issues. How are some employers managing these concerns from employees who may now be tasked with a more caregiving role?

: Well, certainly offering telework as an option is 1 key way that they can respond because what we're seeing, or what we're about to see as the kids go back to school in late August or early September, is something that's going to be quite different even from what we experienced in March through June because now some parents are back to work physically, but the kids in many cases are still going to be home either part or all of the time. So, an employer really has to navigate that and kind of be flexible in dealing with their employees and how they handle that. Having child care benefits, flexible work options, really, those are key elements.

: Additionally found in the report were increases in adverse mental health outcomes, such as anxiety and workplace safety issues. As we alluded to before, the workplace is going to be different to promote safety. Can you discuss how employers are easing employees back into the workplace?

: Sure. So, as we noted, in that broadcast you mentioned, the mental health numbers really were off the charts in May and June compared to what we were seeing pre-COVID-19 in terms of the number of employees who are experiencing not only anxiety but depression. So, employers really need to make sure that employees know where to go, that they not just have an employee assistance plan, but that it actually has some concrete steps for employees to know who they can turn to, who they can call if they need help.

Managers should be communicating regularly with employees, because it's very easy during this time to be distant and removed and assume everything's fine when it might not be. So, those are really steps that employers need to take and need to be on top of, and again, flexible work certainly is an option in keeping employees, hopefully reducing their anxiety.

: A rising political issue is the use of masks, which may be further intensified when in the workplace. How are employers dealing with these concerns, especially those who refuse to wear a mask?

: That's a tricky issue because there have been some stories of customers assaulting employees who confront them about not wearing masks and employers really need to make sure that their policies have teeth here. It's all well and good to have a policy, but—just like we saw with sexual harassment in the pre-Harvey Weinstein years—if you don't actually have enforcement, it doesn't really mean anything.

The same is true with the masks. So, if you're requiring low-wage employees to just be the frontline of defense and enforce those policies, that's really putting them in harm's way and could open the employer up to trouble later on, not to mention the safety of their employees. So, it's important to have managers out front enforcing the policies. It's also important to be consistent and make sure that it's applying across the board.

: I know we alluded to some before, but what are some steps employers can undertake to address notable back-to-work challenges precipitated by the pandemic?

: Well, certainly, as we noted, telework would be 1 way to address challenges, but there are others. So, obviously, certain employers, that's not going to be effective. As a practical matter if you're on the assembly line, it's not as easy to work remotely as with what you and I do; but certainly there are steps in even for an assembly line or construction that can be taken.

For instance, an employer could have staggered shifts. So, maybe only 50% of the workers are at the worksite at a given time, which can help in terms of not only the social distancing, but in terms of keeping the workers safe, and having A and B days could be 1 option, just like we've heard with the schools, employers can do that, as well, and some are already doing that.

Also, I would just add, kind of rethinking the physical layout of the worksite, and by that, I mean there's been such an emphasis in recent years on open floor plans and having us be close to our neighbors and that seemed great in terms of collaboration before, but that just doesn't work now, with the pandemic going on. So, thinking about things like a one-way corridor, so that your employees aren't bumping into each other going to the restroom or to break rooms. Limiting the number of people in the break room at a given time and having plexiglass, which we've already seen in grocery stores and other retail establishments, but even in an office building, either having that or higher cubicles are all things that employers can and should be considering.

: Lastly, do you have any other concluding thoughts?

: I would just say, Matthew, certainly we're seeing this trend already, but it's probably worth noting that we've seen some employers like Google say they're not going to go back to work until July 1 of 2021 and others have closed at least through the end of 2020 physically.

So, if you have a company where the work can be done remotely, it's certainly worth considering whether that can continue to be the case, at least for the near future especially as we're seeing a spike in COVID-19 cases in many different regions of the countries. That's certainly something to consider and of course, the flexible work options would be another thing as well.

: To learn more, visit our website at ajmc.com. I’m Matthew Gavidia, thanks for joining us!

Videos

Beyond telework, some notable strategies that employers should consider when managing back-to-school and other leave related concerns among employees include child care benefits and flexible work options, said David Weisenfeld, JD, legal editor and host of a XpertHR podcast.

How Are Employers Addressing Back-to-School, Leave-Related Concerns Amid the Pandemic?

Patient choice has always been the cornerstone of my beliefs. In 2016, Congress decided that people who are eligible for Medicare due to a diagnosis of End Stage Renal Disease (ESRD) would become eligible to enroll in 

 (MA) plans beginning January 1, 2021. MA is an option under Medicare to receive coverage through a private company that contracts with Medicare to provide plans offering Part A and Part B benefits. Most MA plans also offer prescription drug coverage under Part D, and they can offer services not covered by Medicare, plus improved care coordination.

When MA plans were first signed into law in 1997 (first called “Medicare+Choice” and renamed “Medicare Advantage” in 2003), Congress decided it was best to prevent people on Medicare due to ESRD from enrolling in these plans, due to concerns that inadequate networks could lead to serious health issues, or even death, for this population. For example, if a person with ESRD needed a vascular access repair to receive dialysis but no doctor in the network was available, the person would have to get very sick and be admitted to a hospital to have a chance at lifesaving treatment.

MA plans don’t require secondary payers; therefore, these plans can offer additional benefits (such as access to a dentist) at reduced costs. Enrollees are often required to pay a co-pay for the service. Insurance companies contract with providers and negotiate fees. The downside is that people enrolled in MA plans are in a network of providers that may require authorization to see a specialist or get a test. Before signing up for a managed care plan, it is recommended that the beneficiary ensure that the doctors they need to see, and the medications they are currently taking, will be offered in the plan.

Much to my dismay, and to many kidney care advocates, the policy that was intended to help—opening up ESRD enrollees to MA plans on a broader basis—can actually be harmful.

Specifically, CMS has decided to eliminate a longstanding policy that required MA plans to include a minimum number of dialysis facilities and establish time/distance standards (known as network adequacy standards) that are designed to give people access to life-sustaining dialysis treatments. The network adequacy safeguard was put in place to protect patients from joining plans that would restrict their access to adequate care for a serious illness. With no network adequacy, nor the ability to see beforehand which facilities participate in the MA plan, I don’t know how someone who needs access to dialysis could make a choice without potentially dire consequences. It will equally be important for plans to be transparent and list transplant centers, as well. A patient can be listed and ready to receive the gift of life and then enroll in a managed care program and learn their transplant center isn’t an option. This would require the person to go through the entire screening process again.

Most people with kidney disease need dialysis 3 times a week, and in the MA plan they may have to drive across town for treatment, or further, even if one is closer to their home. People in rural areas will have even more issues with distance. Even those who do home dialysis require in-center treatments from time to time, and they rely on either public transportation, healthcare transport companies or friends or family members for help.

This new policy does not expand patient choice; it hinders it and puts a blindfold on it.

Not knowing if you will be able to continue your care with the same trusted doctors and clinicians you have counted on for years seems cruel. Other Medicare beneficiaries are not being asked to make such choices.

Congress has mandated expansion of a choice to enroll in MA plans to everyone with ESRD. Continuity of care is central to the long-term treatment of someone with a chronic illness that requires serious maintenance. Unfortunately, the intent of Congress to expand choices to those with kidney failure is being foiled by this unfortunate regulatory blunder that needs to be rectified immediately.

Patients who are drawn to the additional offerings that an MA plan might afford them will see what and where they can get care only after they sign on the dotted line. What will they do if, after they enroll in an MA plan, they find no in-center facilities in their network, or that the only facilities available to them are too far away to be practical? After all, they may need treatments 3 times a week!

In this scenario, I believe people who require life-saving dialysis will fall through the cracks. They will either have the unnecessary burden of becoming entangled in red tape trying to undo their MA plan enrollment—or worse—they will give up because of the burden.

This new regulatory approach needs to be reconsidered so that people who need dialysis know upfront whether an MA plan will allow them to continue to see their own doctors and receive treatments at their preferred facilities. People dialyze to live. They should not have to travel great distances or get caught up in the fear of not having access to lifesaving care because an MA plan did not provide them the choice.

A pioneer in kidney care, Lori Hartwell is founder and president of the 

. After requiring dialysis at age 2 in 1968, she is now doing well with her 4th kidney transplant, having spent thirteen years on dialysis. Hartwell works to help her peers navigate care and remain hopeful. She lives in Glendale, California.



A rule change to let those with end-stage renal disease enroll in Medicare Advantage has a twist that could stop patients from learning if their dialysis center iis in the network.

Contributor: Under New Rule, MA Plans Can Keep a Blindfold on Dialysis Facility Choice for Individuals With Kidney Failure 

CMS releases updates on evaluation and management services, telehealth, and accountable care organizations; experts highlight COVID-19 vaccine developments and remaining challenges; and a study examines how state policies may impact life expectancy.

Welcome to This Week in Managed Care, I’m Matthew Gavidia.

CMS Releases E&M Updates, Expands Telehealth, Makes ACO Changes

Among a swath of proposed policy and payment changes announced this week by the Trump administration, CMS continued its effort to simplify coding requirements, quality measurements, and focus on 340B drug costs.

Tuesday, CMS released the proposed calendar year 2021 Physician Fee Schedule, which includes Quality Payment Program changes affecting accountable care organizations and how evaluation and management, or E&M, services are billed, such as examinations, disease diagnosis, risk assessment, and care coordination.

Explaining some of the raft of changes Tuesday, CMS Administrator Seema Verma said E&M codes have not been updated in 2 decades and do not reflect the growing number of chronic conditions and medically complex patients or social determinants of health.

“The value of E&M has decreased as complexity has increased,” said Verma.

In the 340B drug program, CMS would, in 2021, cut the payment rate for drugs to the average sales price minus 28.7%.

CMS said the change would save Medicare beneficiaries an additional $85 million in out-of-pocket payments for these drugs and that the savings would be reallocated among all hospitals on an equal percentage basis, while exempting certain cancer hospitals, rural sole community hospitals, and children’s hospitals.

Experts Highlight COVID-19 Vaccine Developments and Remaining Challenges

Of the more than 160 COVID-19 vaccine candidates being examined in clinical trials, those that are leading the pack are utilizing a new vaccine technology that has never been approved for human use by the FDA, which has contributed to significant unknowns.

In a free, 1-hour webinar from MJH Life Sciences™, the parent company of 

®, 3 top experts discussed vaccine development, the latest clinical trial evidence, and the future of COVID-19 vaccines.

Missed the webinar? You can still register for free and watch the video on demand!

For more coverage of the webinar and to register, 

How Do State Policies Impact Life Expectancy?

, a study found that since 1970, changes in US state policies have played an important role in the stagnation and recent decline in life expectancy, while some policies appear to be key levers for improving life expectancy.

In 2016, life expectancy of American women was 3 years below the female average of high-income countries and 5.8 years below the leading country for life expectancy, with US men also having

shorter life expectancies at 3.4 years below the average and 5.2 years below the leader.

When it comes to root causes of these disparities, one major contributor is a rise in so-called “deaths of despair,” or deaths due to suicide or drug and alcohol abuse. Different regional policies on firearm use and availability of substance abuse rehabilitation programs can alter expectancy gains or declines across state lines.

Local policies were found to affect nearly every aspect of an individual’s life including economic well-being, social relationships, education, housing, lifestyles, and access to medical care, authors point out.

If the status quo is maintained, thereby allowing the current policy direction of states to continue, researchers found the results would yield minimal improvements in longevity. However, authors caution the analyses do not prove state policies have a causal effect on life expectancies.

“Taking these findings together, the slow gains in US longevity may partly reflect the national shift toward some conservative policies that are negatively associated with longevity, such as abortion restrictions, reductions in gun control,” researchers conclude.

Tafasitamab Combination Approved for Adults With R/R DLBCL

Last Friday, the FDA approved tafasitamab to be used in combination with lenalidomide for second-line treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, meeting the needs of patients who are not eligible for an autologous stem cell transplant.

Approval was based on phase 2 results for 80 patients in the L-MIND trial, which reported an update May 2019 at the American Society of Clinical Oncology,

 with final results published last month in 

FDA showed an overall response rate of 55%, including a compete response rate of 37% and a partial response rate of 18%.

Among non-Hodgkin lymphomas, DLBCL is the most common subtype, accounting for 22% of cases in the United States and 40% worldwide, with about 18,000 US cases per year. Tafasitamab, to be sold as Monjuvi by MorphoSys and Incyte, is a humanized Fc-modified cytolytic CD19 monoclonal antibody being studied in several B-cell malignancies.

“The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States,” said Hervé Hoppenot, CEO of Incyte, in a statement.

And, now our Paper of the Week, which looks back at some of the most important papers over the past 25 years of 

News about updates in E&M codes brings us back to an important 2014 paper from Dr. Richard Young and Tiffany Overton, whose review of data showed that billing codes did not fully reflect the scope of work done by family physicians, and contributed significantly to income disparities between these critical clinicians and specialists.

The disconnect between billing codes and actual work performed revealed a gap not only in income but in the way the physicians’ work is valued.

®, I’m Matthew Gavidia. Thanks for joining us!

This week, the top managed care news included CMS updates on telehealth and more; COVID-19 vaccine developments and remaining challenges; a study examines the impact of state policies on life expectancy.

This Week in Managed Care: August 7, 2020

Pathophysiology of Different Types of Heart Failure

Progressive Nature and Associated Risks of Diabetes on HF

Cost and Utilization Profile for a Patient With HF

Economic Burden of Heart Failure and Goals of Treatment

Standard of Care in Patients With Heart Failure

Reducing Readmissions Due to Heart Failure

CV Outcomes Studies With Medications Indicated for Diabetes

Recent Studies of SGLT-2s in Patients with HFrEF

 Quantifying the Potential Impact of SGLT-2 Inhibitors in Heart Failure

 The Veterans Health Administration implemented a pilot program for primary care intensive management (PIM) for patients at high risk for hospitalization. We examined the impact of the program on medication adherence and adjustments for patients with chronic conditions.

 A randomized quality improvement trial was conducted in 5 sites in which high-risk patients were randomized into PIM or usual primary care; outcomes were measured in the 12 months before and after randomization. Interdisciplinary PIM teams assessed patients for unmet needs and offered services including pharmaceutical care and care coordination.

 Outcomes included adherence, measured by proportion of days covered, and several measures of medication adjustments for diabetes, depression, hyperlipidemia, and hypertension medications. Differences-in-differences methods were used to estimate changes in outcomes between PIM and usual care groups.

 There were 1527 patients in the medication adherence cohort and 1719 in the medication adjustments cohort. Mean adherence was mostly similar between groups but 16% higher among PIM patients for dipeptidyl-peptidase-4 (DPP-4) inhibitors (for diabetes) after randomization (0.12 vs –0.04; 

 = .02). The mean number of hyperlipidemia drugs filled was higher among PIM patients (1.1 vs 1.0; 

 = .006). The mean number of discontinued depression medications was higher and the mean number of dose changes for hypertension medications was lower for PIM patients, although these comparisons did not reach statistical significance.

Medication adherence improved for DPP-4 inhibitors, and more hyperlipidemia drugs were prescribed for PIM patients. Overall impacts of PIM were modest.

A pilot program for primary care intensive management enrolled patients at high risk for hospitalization in 5 Veterans Health Administration sites. These programs all included pharmaceutical care.

Twelve months after patients were randomly assigned to the program or usual primary care, most medication adherence and adjustments outcomes were similar.

For patients randomized to the program, medication adherence improved for dipeptidyl-peptidase-4 inhibitors, and more hyperlipidemia drugs were prescribed.

Although impacts were modest, intensive management teams appear to have contributed to medication management for diabetes and hyperlipidemia.

Many health care systems are developing new models of care to target patients at high risk for poor outcomes and high health care costs.

 These patients often have multiple chronic conditions, behavioral health conditions, and social issues,

 so traditional care models may not be sufficient to address all their needs. Intensive management in primary care through interdisciplinary teams and case management is a new type of model that targets high-risk patients.

 Evidence from these types of programs has shown increased utilization of primary care and other outpatient care but little change in inpatient care or total health care costs.

 Little is known about the effect of these programs on medication adherence or adjustments.

Primary care intensive management (PIM) was piloted in the Veterans Health Administration (VHA) beginning in 2014 to improve management of patients at high risk for hospitalization. These patients often had multimorbid conditions and were prescribed multiple medications for chronic conditions.

 In the PIM program, interdisciplinary care teams assisted with medication management and provided services such as medication reconciliation, assistance with refills, education about medications, and coaching to improve medication adherence.

 These services addressed common issues among older adults with multimorbid conditions, including polypharmacy and low adherence.

 Furthermore, these services may fill a gap in care because physicians do not typically have time to conduct thorough medication reviews and adherence assessments to identify medication management problems.

 Also, patients may not receive optimal doses or quantities of drugs

 or may have difficulty managing multiple medications and may benefit from simplified regimens.

Although PIM programs were primarily intended to improve management of high-risk patients and reduce unnecessary acute care utilization, they may also have affected medication adherence and medication adjustments. Medication adjustments for patients managing multiple prescriptions can be considered markers of patient-centered prescribing and are considered modifiable provider behavior, similar to adherence.

 We examined the impact of PIM on adherence to medications and medication adjustments, including changes in number of drugs filled, switches between drug classes, added or discontinued prescriptions, and dose changes. We compared these outcomes for diabetes, depression, hypertension, and hyperlipidemia drugs among patients randomly assigned to PIM and usual primary care after 12 months of program enrollment.

The VHA piloted the PIM program at 5 sites to develop and test intensive outpatient management programs. The evaluation was designed as a randomized quality improvement trial in which patients in the top 10% of risk for 90-day hospitalizations20 and with at least 1 hospitalization or emergency department (ED) visit in the prior 6 months were randomized into PIM or usual primary care.

 Details on the overall study design and intervention were described previously.

Briefly, an interdisciplinary team composed of primary care providers, registered nurses, social workers, licensed vocational nurses or peers, and mental health specialists at each site performed chart reviews and in-person visits to assess patients randomized to PIM. PIM was designed so that patients who were thought to benefit immediately from PIM services received these services in addition to usual primary care whereas patients not thought to benefit from immediate services were monitored through their electronic health record. Patients assigned to usual primary care did not receive any additional care. Usual primary care was delivered through the VHA patient-centered medical home model, called Patient Aligned Care Teams (PACT), in which pharmacists were integrated into primary care teams; we refer to patients assigned to usual primary care as the PACT group.

To analyze our 2 sets of outcomes for medication adherence outcomes and medication adjustments outcomes, we used 2 study cohorts. Patients randomized to PIM or PACT from July 21, 2014, to August 28, 2015, who had at least 1 diagnosis for diabetes, depression, hypertension, or hyperlipidemia and VHA prescription records for medications to treat these conditions (

]) were included in our analysis for medication adjustments. For the medication adherence analysis, we imposed an additional restriction to include only patients who filled drugs in both the pre- and postrandomization periods, to avoid counting patients who discontinued prescriptions appropriately as nonadherent.

Data were from the VHA Corporate Data Warehouse (CDW) and included prescription drug records from the Managerial Cost Accounting Prescription Drug Files for fiscal years 2013-2016. Other CDW data included inpatient and outpatient utilization, diagnosis, and patient characteristics.

Our dependent variables included outcomes for medication adherence and medication adjustments and were measured for 2 separate cohorts. For both sets of outcomes, we measured medication outcomes in the 12-month periods before and after randomization to PIM or PACT and limited drugs to those that were noninjectable.

Our first set of outcomes involved medication adherence. Adherence has been previously conceptualized as having 3 components: initiation of treatment, when the first dose of a medication is taken; implementation of dosing regimen, for the period where a patient’s dosing may or may not correspond to the prescribed dosing; and discontinuation, when a treatment ends.

 We focused on measuring adherence in the implementation phase, and it was measured by proportion of days covered (PDC) for each unique drug filled, based on prescription drug refill records.

 The numerator for the PDC was the number of days covered by the patients’ prescription fills, and the denominator was the number of days between the first fill and last day of the observation period, within each pre- and postrandomization period. If patients filled drugs for more than 1 drug in a class, the PDCs for the drugs were averaged to obtain a mean PDC for the drug class. The PDC excluded the hospitalization period for patients with any hospitalization. We obtained the mean PDC for each patient for all drugs filled for each study condition (diabetes, depression, hypertension, and hyperlipidemia).

Our second set of outcomes involved adjustments made to patients’ medication regimens. We created several measures of medication adjustments that occurred between the pre- and postrandomization periods: (1) change in total number of unique drugs filled, (2) switches between drug classes, (3) added prescriptions, (4) discontinued prescriptions, and (5) dose changes.

 To measure the change in total number of medications, we took the difference between the number of unique drugs that each patient filled in the 12-month pre- and postrandomization periods for any prescription for the study conditions. To count switches between drug classes, we compared unique drug classes filled for each patient in the pre- and postrandomization periods to see if any switches occurred. For added prescriptions, we counted the number of drugs filled in the postrandomization period but not in the prerandomization period. For discontinued prescriptions, we counted the number of drugs filled in the prerandomization period but not in the postrandomization period. For dose changes, we established an index fill for the last fill for a unique drug that occurred in the 12-month prerandomization period, and we compared all subsequent prescription records during the postrandomization period to see if any of these fills had a different dose than the index fill. We then calculated the number of medication adjustments per patient per condition.

For descriptive purposes and regression adjustment, we measured several patient characteristics: age, gender, race/ethnicity, marital status, VHA enrollment priority, common chronic conditions (cancer, heart failure, diabetes, hypertension, ischemic heart disease, renal failure, hyperlipidemia, lower back pain, arthritis, chronic obstructive pulmonary disorder, vision impairment, dementia, alcohol use disorders, depression, drug use disorders, posttraumatic stress disorder, manic depression, and schizophrenia), Charlson Comorbidity Index (CCI) score, and site. Categories used for VHA enrollment priority, which takes into account service-connected disability and household income, included 1 to 3 for high priority, 4 to 6 for medium priority, and 7 or 8 for low priority. We also obtained the mean number of primary care visits in the 12-month period after randomization, including PIM visits.

After excluding patients who died during the 12-month follow-up period (n = 65), all other patients were analyzed based on treatment group assignment. We compared unadjusted outcomes by time period (pre- or post randomization) and study group (PIM or usual PACT care) for each condition. SAS (SAS Institute) was used to conduct unadjusted analyses.

In adjusted analysis, we used differences-in-differences (DID) methods to estimate the change in adherence for the PIM group relative to the PACT group from the pre- to the postrandomization period. We used fractional logit models

 with covariates for group assignment, time period, interaction between group and time period, age, gender, CCI score, presence of mental health or substance use conditions, and site. Standard errors were adjusted for clustering within patients. We estimated separate models by drug class and by condition.

Numbers of total medications were compared in adjusted analysis in separate models for each condition using DID methods and generalized linear models. These models included the same covariates as adherence models. The other medication adjustment measures (switches between drug class, added medications, discontinued medications, and changes in dose) were analyzed using generalized linear models with the appropriate family and link function based on the modified Park test.

 We used a statistical significance level of 0.05 that was adjusted for comparing 5 different measures of medication adjustments simultaneously (Bonferroni-adjusted significance level of 0.01). Stata (StataCorp) was used to conduct all regression analyses.

There were 1527 patients in the medication adherence cohort and 1719 in the medication adjustments cohort. Patient characteristics were similar across the PIM and PACT groups (

). The mean age ranged from 62 to 64 years, about half of patients were white, and the vast majority were male. A minority of patients were currently married, many had high priority for VHA care, and the mean CCI score was 1.4 in both groups. The most common study condition was hypertension (75%-82%), followed by hyperlipidemia (43%-47%). After randomization, patients assigned to PIM had a mean of 6.1 to 6.2 primary care visits compared with 4.4 to 4.6 among PACT patients.

Unadjusted mean medication adherence for the study conditions (

) was similar between care groups, ranging from 77% to 93% across drug classes. In adjusted analysis, there was a 12% increase (79% to 91%) in predicted mean adherence to dipeptidyl-peptidase-4 (DPP-4) inhibitors for diabetes in PIM patients between pre- and post randomization. PACT patients had a 4% decrease (71% to 67%) in predicted mean adherence to DPP-4 inhibitors over the same time period. The DID estimate was 16% (

). There were no significant differences in adherence for all other drug classes between the care groups.

The total mean number of drugs filled for PIM and PACT patients was similar at baseline for most conditions (

). However, the PIM group had a significantly higher mean number of hyperlipidemia drugs at study end (1.1 and 1.0, respectively; 

 = .006) due to a greater mean number of prescriptions added in the postrandomization period (0.19 and 0.13 for PIM and PACT, respectively; 

The Veterans Health Administration implemented primary care intensive management for high-risk patients. Impacts of this program on patients’ medication adherence and adjustments were modest.

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