Even before COVID-19, half of families with employer-sponsored insurance delayed care or avoided filling a prescription due to cost concerns. Now, with record levels of unemployment and the nation 

, recent data shows consumers need help overcoming financial barriers to medically necessary care.

 conducted in early April shows 58% of consumers would consider delaying a non-emergency but medically necessary surgery this year due to cost, while 56% said they would delay a diagnostic procedure due to the expense.

Perhaps most striking: high-income earners were more likely to say they would delay surgeries and diagnostic procedures than those with lower incomes. That’s because 75% of consumers in the $100K+ income bracket are concerned they will lose their jobs due to the pandemic.

These are sobering statistics. It is clear that assisting members in overcoming financial barriers to care is vital to ensuring they will pursue recommended treatment. Such an approach improves members’ ability to maintain their health while reducing healthcare complications. It also helps contain costs—for members and health plans—over the long term.

How can health plans help members navigate healthcare cost concerns? Here are four strategies to consider:

Educate members on a new IRS rule that covers lifesaving healthcare products and services

 that expands the definition of “preventive services” to include products, services, and prescription medications used to treat chronic disease. The rule enables members to pay for these expenses through their health savings accounts (HSAs). Formerly, HSAs could not be used to treat preexisting conditions.

However, because the rule is so new, members will need guidance around what the rule means and how they can apply it to their out-of-pocket costs for chronic conditions. Health plans should provide targeted marketing by age group and across multiple channels to ensure policyholders with chronic conditions are aware of the change and are able to receive the services they need. One generation health plans should be sure to target: Millennials, whose rate of chronic conditions is 

Run claims analyses to spot members who have not filled prescriptions for chronic disease

. One in three consumers has skipped refilling a prescription one or more times due to cost, a recent 

 have had to choose between filling a prescription or being able to afford food or housing. When members with chronic conditions put off filling their prescriptions because they cannot afford their copay, this results in hospitalizations, readmissions, and increased costs. Use claims data analysis to spot instances where at-risk members demonstrate challenges refilling their prescriptions. Then, assign care managers to contact these members to determine the root cause and find a solution. It’s an approach that helps policyholders with chronic conditions access the medications they need while lowering their costs of care.

Health plans also are testing risk contracts with pharmaceutical companies to ensure members with chronic conditions not only receive their medications, but also demonstrate improved outcomes from taking prescription drugs. These health plans use data to target vulnerable populations and put in place social supports to ensure members get the medications they need. When the medications don’t achieve the desired outcomes, the pharmaceutical companies pay rebates to the health plans.

Assist policyholders in finding lower-cost options for care

 found health plans could save billions by helping members navigate today’s highly complex healthcare system. This strategy significantly reduces calls to customer service and other administrative costs. Options to consider include the following:

Implement health literacy initiatives—especially among those with high-deductible plans

. Health illiteracy doesn’t just affect those who have limited schooling. The analysis found 48% of consumers with low health literacy are college-educated, reflecting the complexity of the nation’s healthcare system. Consider targeted education for policyholders with high deductibles, whether through the health plan app or a short online webinar—and offer incentives for completing the education, such as a $25 gift card for taking a half-hour session.

Use digital tools to help members identify lower-cost options for care

. Incorporate simple tools within your health insurance app that help members quickly determine their out-of-pocket costs for specific types of care and point them to high-value providers. Design the approach so that consumers can identify options quickly and make a decision within seconds.

Work with healthcare organizations to ensure members have multiple options for medical bill payment

 shows 64% of families with children are very or somewhat concerned about their ability to pay for medical care following COVID-19. When providers don’t adopt flexible payment options, consumers feel the burden in multiple ways. According to the survey results, 46% of high-income earners plan to delay non-emergency but medically necessary surgery by up to six months, and 43% would hold off on undergoing a diagnostic procedure. Among other income brackets, about one in three consumers plan to delay care for up to six months.

At a time when cost pressures and income uncertainty have intensified, it’s critical that health plans help members navigate their costs of care. Work with providers to increase price transparency, knowing that the most meaningful price transparency is an estimate of the out-of-pocket costs members will pay after insurance. Encourage providers to offer multiple options for members to settle their accounts, including zero-interest and low-interest payment plans. A 2019 

 found 54% of consumers would use a low-interest or zero-interest financing option for a medical balance of $1,000 or less, and 46% would rely on financing for higher balances.

Taking these steps ensures members who fear they will be unable to pay for medically necessary care following COVID-19 get the care they need when they need it—improving health outcomes while reducing costs of care.

Mark Spinner is CEO and president of AccessOne, a leading provider of flexible, co-branded patient financing solutions that help patients afford medical expenses for health systems nationwide.

Articles

Before COVID-19, half of families with employer-sponsored insurance delayed care or avoided filling a prescription. Recent data shows consumers face barriers to care.

Getting Members the Care They Need—Despite COVID Cost Concerns

We are living in an era that promises more personalized healthcare, yet value-based payment models don’t align with the systems of care to support person-centered, team-based care or to focus on safe, effective use of medications and gene therapies to optimize medication use and support high quality outcomes.

Today, 30% of adults in the United States take five or more prescription drugs and they should benefit from - or not be harmed by - the over 10,000 medications available on the market. Medications are common medical interventions; their potential to both help and harm is enormous. More than 275,000 deaths occur annually and over $528 billion - including your benefits dollars - are wasted because drugs are misused, overused, they lead to treatment failure, a new medical problem or both. We can save lives, reduce waste, curtail physician burnout and lower costs by getting the medications right the first time. An evidence-based process for optimizing medication use is 

comprehensive medication management (CMM)

Why does this matter for you as an employer? The reasons are plentiful, but firstly, achieving medication optimization through comprehensive medication management in practice will reduce waste in health care spending, ensure appropriate use of medications and decrease low-value care. It also supports employers’ fiduciary responsibilities as plan sponsors to manage plan assets and enhances the quality of life and care provided to benefit plan recipients. And, perhaps most simply, it facilitates employees being mentally and physically able to effectively work.

Employers are powerful influencers in driving system change, and they can assert that influence to address misaligned incentives within the medication use system. Here are five things you can do to get involved in medication management reform:

 Talk to your vendors and carriers about strategies used in provider networks to track and manage medication therapy problems. Have them outline their quality improvement process for safe, effective, appropriate use of medications. Consider how they link pharmacogenomic (PGx) testing with the process of care to target correct therapies. Determine if their network providers can consistently and positively answer, “Is this the right medication, or combinations of medications, for this person?” Confirm that between your medical carrier and PBM, collaborative and effective processes are being followed and outcomes are measured to ensure appropriate use of medications. Non-adherence is a small part of all medication therapy problems. To be effective, a comprehensive process of care to address problems is essential. 

2. Ask your Vendors for Data and Analytics.

 Ask your vendors and carriers how they evaluate, measure, track, report and resolve medication therapy problems — wrong dose, wrong drug, adverse events, inadequate therapy, failed therapy, non-adherence. What actions are taken to intervene when providers are consistently identified as being the sources of such problems? Do they reward providers that consistently deliver care absent of medication therapy problems (misuse, over/under use)? Ask for regular reports on how they measure, track and evaluate medication therapy problems (misuse, over/under use).

 If your organization uses brokers or consultants, what are they doing about medication management reform? Ask them to identify current carriers that monitor and evaluate network providers to ensure they have a comprehensive medication use process — not just adherence programs — that rewards providers for safe, effective and appropriate use of medications and gene therapies. Do they offer effective strategies to answer and ensure, “Is this the right medication, or combinations of medication, for your plan members?”

 Partner with primary care and specialist physician organizations and carriers to support and encourage team-based models that have a defined medication use process. Ensure they include and pay for team-based services using a clinical pharmacist as a medication expert, working in collaborative practice with physicians, to get the medications right for the patient populations they serve. What is the process to efficiently answer, “Is this the right medications for my patient?”

 Engage service providers and consumer groups focused on chronic care management. Encourage them to demand a team-based, comprehensive, patient-centered approach to medication management that includes a medication expert working in collaborative practice with the treating physician to assure the patient receives appropriate, safe and effective medications the first time. Team members should consider all medical conditions of the patient, all prescriptions and non-prescriptions, as well as the patient's mental, physical and financial abilities to use a medication as well as assessing cultural factors that may impact their medication use.

The current system for medication management is broken, and it won't be fixed by just one party. Reform must come from across the board. And taking a look at your own organization, and your solution providers, is the first step.



Katherine Capps, is co-founder & executive director, of 

, a catalyst for change that brings critical stakeholders together, bound by the urgent need to get the medications right.

Lives can be saved, physician burnout and waste can be reduced, and drug costs can decrease by achieving medication optimization through comprehensive medication management.

5 Tips for Employers on Reforming and Optimizing Medication Use

Strict social distancing, or “shielding,” of patients with rheumatic diseases to prevent COVID-19 infection doesn’t reduce the incidence of infection and is associated with worse mental health, researchers reported.

“Shielding” is a strict form of social distancing that requires people to remain in their homes and have minimal contact with others, even members of their own household. The European League Against Rheumatism and the British Society of Rheumatology recommended shielding for patients taking immunosuppressive medications.

British researchers looked at the effects of shielding among 1,693 patients who agreed to fill out questionnaires. Half (50%) had rheumatoid arthritis; 16%, psoriatic arthritis, and 5%, ankylosing spondylitis.

When they compared the 61 patients in the group that contracted COVID-19 with the 1,632 patients who didn’t, they found that roughly the same percentage of the COVID-19 patients had shielded as those non-COVID-19 patients (24 of 61, or 40% vs. 768 of 1,632, or 47%), although the comparison did not meet the usual standard for statistical significance.

“Our study suggests that overall strict social isolation had little impact on the incidence of COVID-19 infection,” wrote Natasha Cleaton and her co-authors in the report published in the 

Cleaton also looked at the mental and physical heath effects of shielding, comparing the 722 who shielded to the 823 who did not among the patients who didn’t contract COVID-19. They found the mental and physical health of shielding patients to be significantly lower than those who didn’t shield.

“Patients are likely to require increased mental and physical support as result of the COVID pandemic,” wrote Cleaton and her co-authors, adding that further study is needed on the efficacy and effects of shielding.

Shielding means staying at home and limiting contact with members of the household. Research also calls into question on how effective it is in reducing the incidence of COVID-19.

"Shielding," An Extreme Form of Social Distancing, Hard on Mental, Physical Health

Stimulant medications (eg, methylphenidate, amphetamine, and lisdexamfetamine) are frequently prescribed for attention-deficit/hyperactivity disorder (ADHD). (1) According to data from the US Drug Enforcement Administration’s Automation of Reports and Consolidated Orders Systems, amphetamine use increased 2.5 times between 2006 to 2016, from 7.9 to 20 tons. In that same time period, methylphenidate use increased from 16.5 tons to 18.6 tons, with peak consumption in 2012 (19.4 tons). (1)

While considered first-line treatments for ADHD, stimulant medications are frequently used for nonmedical purposes.(1) Because stimulant medications induce euphoria and improve alertness and concentration, their potential for abuse, misuse, and diversion is high. (2) Abuse is “the intentional, nontherapeutic use of a drug product or substance, even once, to achieve a desirable psychological or physiological effect,” whereas misuse is “the intentional therapeutic use of a drug product in an inappropriate way and specifically excludes the definition of abuse.” (3) Nonmedical use, which includes both abuse and misuse, is the use of a prescription medication without a prescription, or in a way other than prescribed. (4) Data from the 2016 National Survey on Drug Use and Health determined that an estimated 5.6 million individuals at least 12 years of age misused stimulant medications at some point during the past year. (5)

Stimulant misuse is common among high school and college students. (6-8) A national multicohort study found that 9.5% of high school seniors used stimulant medications for nonmedical uses.6 Data reported by Garnier-Dykstra et al indicated that over a 4-year period, 61% of the college students who participated in the study were offered prescription stimulant medications at least once, and 31% of study participants reported using them for nonmedical purposes. (7) This is particularly concerning because another peer reviewed study by Wilens et al demonstrated that compared with controls (subjects who were not being treated with stimulant medications and had never misused), stimulant medication misusers are at a higher risk for ADHD and/or multiple drug-and/or alcohol-use disorders. (9)

Because of their abuse potential, both the American Academy of Pediatrics (AAP) and the American Academy of Child and Adolescent Psychiatry recommend that clinicians assess for symptoms of substance abuse in adolescent patients receiving stimulant medications. (10,11) According to recently released guidelines from the AAP, “Clinicians should monitor the adolescent’s symptoms and prescription refill requests for signs of misuse or diversion of ADHD medication, including by parents, classmates, or other acquaintances of the adolescent.” (10) 

To better understand the nonmedical use of prescription stimulants across the lifespan, Faraone et al conducted a systematic review to explore risk factors and motivations for the use of stimulant medications for nonmedical uses. The goal for this review was to add to existing research to assist with identifying high-risk patients and developing more sophisticated approaches to management. (2) 

A literature review was conducted using Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines to examine the epidemiology, risk factors, motivations, and outcomes of the nonmedical use of stimulant medications, specifically methylphenidate and amphetamine.(2) PubMed, PsycINFO, and SCOPUS were searched using ADHD, nonmedical use, illicit use, abuse, misuse, enhancements, stimulants, and other similar terms.2 Studies relating to nonmedical use, diversion, shopping behavior, or malingering of ADHD were included in the analysis.(2) Two reviewers evaluated the studies to ensure inclusion and exclusion criteria were met before the necessary data were extracted. (2)

A total of 86 studies that examined the epidemiology of stimulant nonmedical use and diversion were identified.(2) Self-reported rates of nonmedical use varied considerably among the studies. The majority of studies used the term “nonmedical use,” but others used terms such as misuse and abuse or it was not clearly defined. Reported rates of nonmedical use ranged from 2.1% to 58.7%, depending on definition used, study design, and population studied.(2) In 50% to 90% of nonmedical cases, the stimulant medications were obtained from family or friends.(2) Between 4% to 35% of individuals reported using their own prescribed stimulant medications for nonmedical uses.(2) A total of 20% of adults who reported nonmedical use of stimulants in the past year revealed that they obtained prescriptions fraudulently.(2) College students reported that it was “easy” and rarely difficult to obtain stimulants.(2) The most frequent route of administration was oral (52%-95%), but snorting (nasal route: 7%-48%), smoking (1%-6%), or injecting intravenously (1%-11%) were also noted.(2)

Risk Factors for the Nonmedical Use of Prescription Stimulant Medications

The nonmedical use of prescription stimulant medications was most common in individuals aged 18 to 25 years.(2) Among middle and high school students, those in higher grades were more likely to use stimulant medications for nonmedical uses compared with those in lower grades. Although there were some exceptions, male students were at greater risk for nonmedical use than females, across all age groups.(2) Nonmedical use of stimulants was higher with white students than with Hispanic or African American students.(2) An inverse relationship was observed between grade point average (GPA) and nonmedical use of stimulant medications.(2) Among college students, those belonging to sororities and fraternities were more likely to use stimulants nonmedically than others.(2) Individuals who reported nonmedical use of stimulant medications generally had higher levels of ADHD symptoms versus those who did not report such use, though self-reporting of symptoms may be a confounding factor.(2) Certain conditions were also associated with higher levels of misuse. These included eating disorders and other substance-use disorders (eg, alcohol, marijuana, cocaine, tranquilizers/sedatives, hallucinogens, heroin, inhalants, and pain relievers).(2)

Motivations for the Nonmedical Use of Prescription Stimulant Medications

Academic motivations (cited by 50%-89%) were the primary reason for nonmedical use of stimulants in college students, and 40% of adults reported nonmedical use to improve productivity.(2) Other motivations included recreation, “getting high,” curious/wanting to experiment, boosting the effects of alcohol, augmenting social situations, socialization, enhanced wakefulness, and weight loss.(2)

The adverse effects of stimulant medications from nonmedical use were generally similar to those reported in clinical trials (eg, headache, stomachache, irritability, feeling sad, reduced appetite, sleep difficulties, and dizziness).(2) The outcomes observed in this systematic review were further divided into medical and academic outcomes.(2) 

Medical outcomes associated with prescription stimulant nonmedical use were determined to be burdensome for health care facilities. 

The authors noted an increased number of emergency department (ED) visits due to nonmedical use of stimulant medications in adults.(2) Amphetamine abuse was associated with high rates of ED visits and a high number of ED visits and admissions to critical care units.(2) Route of administration also played a role in the risk of adverse outcomes.(2) Nasal and intravenous amphetamine abusers had higher rates of death compared with nonabusers.(2) In one study, amphetamine nasal abusers had a mortality rate of 0.5% and intravenous abusers had a 1.2% mortality rate, compared with 0.03% for nonabusers. Compared with nonabusers, the mortality rate was 13x greater for nasal abusers and 22x greater for intravenous abusers.(2)

Academic outcomes were a common motivation for the nonmedical use of stimulant medications; however, data do not correlate with positive academic improvements. 

This review demonstrated that there were no improvements in academic performance when students without a diagnosis of ADHD used stimulants.(2) Conversely, students who were prescribed stimulant medications did not have lower educational achievement.(2)

Five Strategies for Addressing the Nonmedical Use of Stimulant Medications

Misuse of stimulant ADHD medications is associated with safety concerns such as overdose and drug-drug interactions.(8) An unmet need exists for better methods of identifying and mitigating the use of stimulant medications for nonmedical uses.(2,6,8) Five such strategies are discussed below.

Prescriber participation and education are essential components of any strategy.

Prescribers not only have the platform to explain the health risks associated with medication abuse, but also the legal consequences of such activity. Utilizing prescribers as allies in adolescent education provides the opportunity to inform students of pertinent judicial considerations in addition to standard clinical concepts.(2) Because of the potential for abuse and diversion, it is important that prescribers screen all patients for comorbid disorders prior to prescribing stimulant medications for ADHD.(6)

It is important to proactively identify individuals and households at risk for using stimulant medications for nonmedical purposes.(2) In addition to these risk factors, household diversion should also be considered. Data suggest that homes with children taking ADHD medications are likely to have family members who use stimulant medications for nonmedical purposes.(12)

Better identification methods are needed for patients who are malingering. 

Data suggest that it can be difficult for clinicians to detect malingering.(8) When assessing patients for symptoms of ADHD, clinicians need to consider malingering and fully understand the diagnostic criteria for ADHD.8 Improving validity testing could be useful in identifying patients who exaggerate their ADHD symptoms.(2,8) 

Increased support and deterrents can be established to minimize the nonmedical
use of stimulant medications.

Tutoring programs for students having difficulty keeping up in school and counseling for those who are struggling with body image are methods aimed to discourage misuse.(13) In addition, incorporating these choices into academic dishonesty policies in high schools and colleges holds individuals accountable for the decisions they make.(2,13) Because students frequently overestimate the nonmedical use of stimulant medications among their peers, correcting this misconception may help reduce such use and reiterate its illegality.(2)

Misconstrued beliefs about the benefits of using stimulant medications for nonmedical
uses should be addressed.

The most frequently reported reason for the nonmedical use of stimulant medications among college students was academic enhancement.(2) Although widely believed to improve productivity, attention, and cognitive performance in academic settings, prescription stimulant medications have not been proven to elevate scholastic achievements in individuals without a diagnosis of ADHD.2 Moreover, studies in student populations show an inverse relationship between nonmedical use of stimulant medications and GPA improvements.(2) It is important to highlight these data so that individuals, especially adolescents, understand that the use of stimulant medications to enhance academics is not beneficial in those who do not have ADHD. Challenging this misbelief may reduce the nonmedical use of stimulants.(2) 

When used as prescribed, ADHD stimulants are not associated with an increased risk of substance abuse.(14) However, the misuse and/or abuse of prescription stimulants may lead to a substance use disorder.(15) It is evident that various systemic improvements are needed to evoke necessary changes regarding the nonmedical use of stimulant medications. A combination of techniques is required to best combat this serious issue. Screening tools are needed to help detect patients at risk for nonmedical use, to allow clinicians to direct prevention and treatment efforts to the appropriate patients.(2)


Piper BJ, Ogden CL, Simoyan OM, et al. Trends in use of prescription stimulants in the United States and Territories, 2006 to 2016. 

. 2018;13(11):e0206100. doi:10.1371/journal.pone.0206100


Faraone SV, Rostain AL, Montano CB, Mason O, Antshel KM, Newcorn JH. Systematic review: nonmedical use of prescription stimulants: risk factors, outcomes, and risk reduction strategies. 

. 2020;59(1):100-112. doi:10.1016/j.jaac.2019.06.012


US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Abuse-deterrent opioids— evaluation and labeling guidance for industry. Published April 2015. Accessed June 29, 2020.https://www.fda.gov/media/84819/download


Holt LJ, Looby A. Factors that differentiate prescription stimulant misusers from those at-risk for misuse: expectancies, perceived safety, and diversion. 

. 2018;53(7):1068-1075. doi:10.1080/10826084.2017.1392984


Substance Abuse and Mental Health Services Administration. Center for Behavioral Health Statistics and Quality. Results from the 2016 National Survey on Drug Use and Health: detailed tables. September 7, 2017. Accessed June 15, 2020. https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.pdf

.
McCabe SE, West BT. Medical and nonmedical use of prescription stimulants: results from a national multicohort study. J

. 2013;52(12):1272-1280. doi:10.1016/j.jaac.2013.09.005


Garnier-Dykstra LM, Caldeira KM, Vincent KB, O’Grady KE, Arria AM. Nonmedical use of prescription stimulants during college: four-year trends in exposure opportunity, use, motives, and sources. 

. 2012;60(3):226-234. doi:10.1080/07448481.2011.589876


Clemow DB, Walker DJ. The potential for misuse and abuse of medications in ADHD: a review. 

. 2014;126(5):64-81. doi:10.3810/pgm.2014.09.2801


Wilens T, Zulauf C, Martelon M, et al. Nonmedical stimulant use in college students: association with attention-deficit/hyperactivity disorder and other disorders. 

. 2016;77(7):940-947. doi:10.4088/JCP.14m09559


Wolraich ML, Hagan JF Jr, Allan C, et al. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. 

. 2019;144(4):e20192528. doi:10.1542/peds.2019-2528


Pliszka S. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. 

 2007;46(7):894-921. doi:10.1097/chi.0b013e318054e724


Pham T, Milanaik R, Kaplan A, Papaioannou H, Adesman A. Household diversion of prescription stimulants: medication misuse by parents of children with attention-deficit/hyperactivity disorder. 

l. 2017;27(8):741-746. doi:10.1089/cap.2016.0058


Weyandt LL, Oster DR, Marraccini ME, et al. Prescription stimulant medication misuse: where are we and where do we go from here? 

 2016;24(5):400-414. doi:10.1037/pha0000093


Chang Z, Lichtenstein P, Halldner L, et al. Stimulant ADHD medication and risk for substance abuse. 

. 2014;55(8):878-885. doi:10.1111/jcpp.12164


National Institute on Drug Abuse. Drug facts: prescription stimulants. Published June 2018. Accessed June 29, 2020. https://www.drugabuse.gov/sites/default/files/drugfacts-prescriptionstimulants.pdf

Content of this article was sponsored by Arbor Pharmaceuticals, LLC. Copyright 2020. This Managed Healthcare Executive® publication provides key information regarding a review by Faraone, et al, which was originally published in the Journal of the American Academy of Child & Adolescent Psychiatry (doi: 10.1016/j.jaac.2019.06.012). The authors of the original review are Stephen V. Faraone, PhD; Anthony L. Rostain, MD; C. Brendan Montano, MD; Oren Mason, MD; Kevin M. Antshel, PhD; Jeffrey H. Newcorn, MD. Please consult the full published review for complete information.

Nonmedical Use of Prescription Stimulants: Risk Factors, Outcomes, and Risk-Reduction Strategies

The discovery of a key protein could change the way psoriasis and psoriatic arthritis is treated in the future.

Researchers at Case Western Reserve University School of Medicine in Cleveland, Ohio — along with several other U.S. universities — found that an overabundance of a protein known as kallikrein-related peptidase 6 (KLK6) can produce and worsen the skin inflammation characteristic of psoriasis.

 — it is important to note that this is early, preliminary research — play a key role in determining which patients will go on to develop psoriatic arthritis, according to the article published earlier this year in 

About a third of people diagnosed with psoriasis also develop psoriatic arthritis (PsA), but reasons are not understood, the authors wrote.

Future research on KLK6 could be “paradigm-shifting” and would lead to a more personalized method for identifying which psoriasis patients will go on to develop PsA,” so we can modify their treatment accordingly," said Nicole Ward, the study's principal investigator and a professor of nutrition and dermatology at Case Western, in a university 

Researchers into many different kinds of disease are researching KLK6, and it may also play a role in the development of cancer, multiple sclerosis, Parkinson’s, and Alzheimer’s disease.

Ward and team sought to understand how the cellular and molecular mechanisms of KLK6 and another protein, protease-activated receptors (PAR)1, promote skin inflammation.

PAR1 is a receptor protein that receives chemical signals from outside a cell, such as from KLK6. “When such signals activate the receptor, they cause cellular/tissue responses, including inflammation,” said the press release.

In their previous research, Ward and colleagues found the skin of psoriasis patients contained as much as six times more KLK6 than normal. They also found that the PAR1 receptor was overproduced in skin and immune cells. Based on that, they theorized that KLK6 might drive inflammation by signaling through PAR1.

When they “turned down” the levels of KLK6 in mouse models, arthritis-like symptoms improved. They also found that "knocking out” PAR1 led to a reduction in skin inflammation and a significant improvement in bone and joint problems.

"To discover that turning down KLK6 eliminated the skin inflammation and even improved the arthritis-like changes — that was unbelievable,” Ward said. ”This suggests that clinicians need to aggressively treat patients with psoriasis to prevent the arthritis changes, which generally occur after the skin disease presents itself. Since the joint and bone damage are largely irreversible in patients, prevention becomes critical.”

Next, the researchers aim to study how skin inflammation causes arthritis-like damage and translate those findings to benefit patients. They also plan to study and compare models that do and don't develop arthritis to identify biomarkers that can predict the development of PsA.

Preliminary findings by Case Western researchers point to kallikrein-related peptidase 6 as possible culprit in the development of psoriatic arthritis.

Researchers Believe KLK6 Protein May Play a Role in the Development of Psoriatic Arthritis

State-mandated caps on out-of-pocket costs for specialty drugs reduced spending by patients with the highest bills by 32% and did not result in increases spending by health plans, according to research results reported in tomorrow’s 

Using complex statistical method and modeled values, a research team led by Kai Yeung, Pharm.D., Ph.D., of Kaiser Permanente Washington Health Research Institute estimated that the caps in the three states that imposed them — Delaware, Louisiana and Maryland — reduced out-of-spending costs by $351 per person per month (from $1,109 down to $758).

That finding was limited to people with out-of-pocket costs in the 95th percentile. As expected, the caps had less of an effect on the lower percentiles; for example, the researchers calculated that they reduced out-of-pocket costs for those in the 90th percentile by $74 per person per month ($450 with the cap, $523 without).

Yeung and his team made the with-cap and without-cap comparison by pairing the three “intervention” states with laws that cap out-of-pocket expenses with three neighboring “control” states without cap laws New Jersey (with Delaware), Arkansas (with Louisiana) and Virginia (with Maryland). They modeled the without-cap costs based on the experience in the control states and then applied to the states with the caps. Their dollar figures are derived from models, not actual tallies.

Legislation to put ceilings on out-of-pocket costs for specialty drugs has been introduced in 11 states, but they have become law only in Delaware (in 2014), Louisiana (in 2015), and Maryland (in 2016). Critics of caps say they have the drawback of shifting costs to health plans that will eventually lead to premium increases, which, in turn, may affect access to healthcare. But Yeung and his colleagues found that the cap did not affect health plan spending; for example, average health plan spending on specialty drugs with the cap was $821 per person, per month and without it, $817.

“Since a primary function of insurance is to spread the financial risk of catastrophically high spending for a small population, we interpret the caps as strengthening this risk-spreading function without detectably increasing spending for the broader population,” wrote Yeung and his co-authors in the discussion section of the paper.

The raw material for their study was claims data from Aetna, Humana and UnitedHealthcare commercial plans, by way of the Health Care Cost Institute. They focused on drugs for “diseases of interest”: rheumatoid arthritis, multiple sclerosis, hepatitis C, psoriasis, psoriatic arthritis, Crohn’s disease, or ulcerative colitis. Just over a third (36%) of the study population had multiple sclerosis. And they used a CMS threshold that works out to $600 per 30-day period to identify specialty drug claims.

The drugs in the study with the greatest number of prescription claims were adalimumab (Humira), 18,158 claims; etanercept (Enbrel), 13,589 claims; glatiramer acetate, 6,670 claims; and interferon beta-1a (Rebif), 6,646.

Research model shows that caps on out-of-pocket costs don't result in higher health plan spending

NEJM study: Caps on out-of-pocket costs for specialty drugs reduce patient spend by 32%

Like many health plans, Fallon Health in Worcester, Massachusetts, saw a drop in utilization because of COVID-19 and therefore a decrease in medical expenditures during the second quarter.

But Carolyn Langer, M.D., senior vice president and the health plan’s chief medical officer, said in a video interview with Managed Healthcare Executive that the plan has had to make directed provider payments to provider in some of its state-funded program and has taken steps to support provider financially. 

“We had a big push on telehealth. We currently reimburse (a telehealth visit) at 100% of in-person visit. We also cover telephonic encounters. All of this has really helped sustain the practices during this pandemic,” said Langer, who has been in her current position since 2018.

Langer said that Medicaid ACOs are Fallon’s largest product line and that value-based arrangements such as ACOs have helped providers cope with the drop in utilization, which, of course in fee-for-service arrangements means less revenue. “I think value-based payment has provided a cushion (to providers),” she said.

Fallon is a not-for-profit health plan that covers about 253,000 people. It operates several Programs of All-inclusive Care for the Elderly (PACE) programs for people who are dually eligible for Medicare and Medicaid. Langer said the organization has plans and programs that include people from throughout Massachusetts, and it has a PACE program in western New York. Still, most of the people it covers live in the western part of the state. 

Fallon tends to get high quality ratings. One of its plans, Fallon Community Health Plan, received a 4.5 rating for 2019-2010 from the National Committee for Quality Assurance.

For the first quarter of this year, Fallon reported adjust net income of $2.3 million on revenues of $441 million.

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In this part one of two series, Carolyn Langer, M.D., the chief medical officer, says the Massachusetts health plan mounted a big push on telehealth that includes in-person visit payment levels.

How Fallon Health Has Coped With COVID-19 

For years, cardiologists who worried about preventing heart attacks and strokes and endocrinologists or primary care physicians who kept tabs on blood sugar were in separate camps. A decade ago, only 13% of patients treated for coronary artery disease by cardiologists were screened for type 2 diabetes (T2D), and the idea that a drug developed to lower blood sugar would be prescribed to treat heart failure was unthinkable.

But a revolution in care has changed things. Today, the American College of Cardiology issued an update to a 2018 guidance for its members, who treat heart and vascular conditions, on how to prescribe two classes of drugs first approved by FDA for diabetes: the sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists.

When these drugs were approved, FDA required large studies to demonstrate their safety. And starting nearly 5 years ago, those studies started showing that patients who take them have fewer heart attacks and strokes, have lower rates of cardiovascular death or renal failure, and are less likely to be hospitalized for heart failure.

Called the 2020 Expert Consensus Decision Pathway (ECDP) on Novel Therapies for Cardiovascular Risk Reduction With Type 2 Diabetes, the document covers all the studies that have come in just the past two years—which have added to the data about what these drugs can do. It 

Journal for the American College of Cardiology

“An important paradigm shift in the care of patients with diabetes and cardiovascular disease is underway,” Sandeep R. Das, MD, MPH, FACC, co-chair of writing committee for the ECDP, said in a statement. “Patients and physicians can now choose from a number of medications that have important proven benefits on cardiovascular and renal outcomes, in addition to their effects on blood glucose.”

While the studies that fueled the 2018 document were designed to show that the two drug classes wouldn’t cause harm when they lowered blood sugar, the more recent wave of trials—including one that shows benefits for the SGLT2 inhibitor Farxiga in heart failure and Invokana in preventing renal decline—were designed to show benefits. And the new ACC document doesn’t single out a “preferred” therapy in each class as it did two years ago.

Among the recommendations in this new guidance:

Cardiologists should consider screening patients with heart failure, diabetic kidney disease, or atherosclerotic cardiovascular disease (ASCVD) for T2D once a year if they meet the criteria for prediabetes.

Because patients leaving the hospital are more likely to stick with a medication prescribed at discharge, this “must be weighed” by hospitals in deciding whether to put SGLT2 inhibitors or GLP-1 RAs on formulary.

An SGLT2 inhibitor with demonstrated CV benefit is recommended for patients with T2D and heart failure, especially with reduced ejection fraction (HFrEF).

When a patient is diagnosed with T2D or ASCVD, and when the other condition or a risk factor such as kidney disease or HFrEF is present, this “offers the opportunity” to talk to patients about taking an SGLT2 inhibitor.

GLP-1 RAs are recommended for those patients with established or very high risk ASCVD.

If a cardiologist wants to prescribe an SGLT2 inhibitor or GLP-1 RA for CV or kidney risk reduction, this “should not be contingent” on a patient’s A1C level.

For several years, ACC leaders have tried to promote the value of prescribing SGLT2 inhibitors and GLP-1 RAs for T2D patients with heart failure or demonstrated ASCVD. However, some cardiologists have balked at using “diabetes” drugs, in part because they have not traditionally been tasked with managing a patient’s glycated hemoglobin, or A1C. But those who advocate using these drugs for CV conditions say that these benefits must be separated from their effects on glycemic control, and this latter responsibility should remain with the endocrinologist, or more typically, the primary care physician.

Collaboration between cardiologists and those who treat patients with T2D has increased in recent years, and the ACC has worked closely with the American Diabetes Association (ADA) to jointly adopt guidelines that affect patients with diabetes and cardiovascular conditions or risk.

“Cardiologists play an integral role in preventing and treating cardiovascular disease in patients with type 2 diabetes, said Brendan M. Everett, MD, MPH, FACC, co-chair of the writing committee. “We should consider thesenew medications important tools to reduce cardiovascular morbidity and mortality in patients with type 2 diabetes. We can work together with our patients and other members of the care team to decide whether the patient would benefit from these therapies, and to initiate therapy if appropriate.”

The American College of Cardiology issues its second set of recommendations for its members on prescribing two groups of drugs first developed for type 2 diabetes.

An Update for Cardiologists Who See Patients With Type 2 Diabetes

We recently some sent three questions about biosimilars to the American Society of Clinical Oncology (ASCO). 

, M.D., M.P.H., a professor at the Fred Hutchinson Cancer Research Center in Seattle and past chair of the ASCO Biosimilars Work Group, emailed back some answers. 

Here they are, edited lightly for clarity and length:

Biosimilars are supposed to bring the cost of healthcare down. Have they made much of a difference in oncology so far?

The short answer is that we have very little evidence related to the impact of biosimilars on healthcare costs in the US.

In Europe, which is about a decade ahead of the US in approving biosimilars, there has been a meaningful decrease in drug prices. However, most of the healthcare systems in the EU are quite different than in the U.S.

., about half of which are relevant to cancer care including the earliest approvals for supportive care and the most recent approvals for actual cancer treatment.

Having said that, FDA approval is just the first step. There are then often patent challenges and disputes (the patent dance) related to the multiple patents on many of these agents and this can delay marketing by years.

Most of the approved biosimilars in the US have only been approved in the last 1-2 years and made it to the market and clinical practice in the last year or so, a period far too short to fully understand the impact on drug pricing.

) suggests that it often requires multiple competitors in a drug class to start to move the price curve down.

In the U.S., the initially marketed biosimilars may be more motivated to share in the very lucrative market of exorbitantly priced biologic therapies rather than compete directly by lowering prices significantly.

Drug prices represent only a piece of the problem we have with steeply rising healthcare costs in the U.S., which also include rising costs of hospitalization, test such as scans, etc. Therefore, we cannot yet draw any firm conclusions about the impact of these agents (biosimilars) on healthcare costs. 

We do have some early evidence that the price associated with supportive care biosimilars has begun to decrease with multiple biosimilar competitors.

Many of us hope that the prices of costly biologic agents for cancer treatment will also begin to decrease as it has elsewhere — but perhaps at a slower pace because of the unique U.S. healthcare market.

Lower prices are likely to improve access to these important agents and meaningfully reduce the financial burden or toxicity that patients with cancer experience on a daily basis. Although we remain hopeful that this will be the case, many believe that it will take more fundamental or structural change in healthcare financing in the U.S. for a real reduction in the enormous financial burden that patients with cancer and other serious illnesses face in the U.S.

One issue with biosimilars is, of course, just how similar they are to the reference product and whether the differences are clinically significant. What is your opinion? Are you confident of the similarity? Do you have any reservations are substitution?

I am very confident that the development, review and approval process in place related to biosimilars provides agents that are highly similar and as effective and safe as the originator or reference biologic. In fact, the analytic sophistication now available to companies and the FDA for carefully evaluating these complicated molecules today is far superior to what was utilized a couple of decades ago when the original biologic was developed and approved.

While less clinical data is required to approved biosimilars than for originators, the detailed analytics and early clinical testing of the pharmacokinetic-pharmacodynamic (PKPD) attributes and immunogenicity of a biosimilars has consistently demonstrated that trials will demonstrate highly similar clinical efficacy and safety.

Continuous monitoring of manufacturing and pharmacologic vigilance after approval are essential for both biosimilars and the originators, which should be thought of as biosimilars of the product produced and approved 20 years ago because of changes in manufacturing processes and components.

Both biosimilars and originator biologics are subject to “

” due to manufacturing changes and need to be closely monitored to be certain that safety and efficacy have not been compromised.

This is not a hypothetical concern. Drift in functionality of biologics has been demonstrated in actual practice but it is applicable to all biologics. While careful monitoring of the multiple attributes considered critical to a biologic, I am perfectly comfortable with using biosimilars in cancer treatment.

Would you draw any distinction between agents for supportive care (for example, Neupogen and its biosimilars) and agents for treatment (Herceptin and its biosimilars)?

Clearly, clinicians are more anxious about cancer treatment biosimilars than supportive care agents due to the potential impact on cancer outcomes and survival. This is understandable. However, there is every indication that with careful monitoring , there should be no reason for greater concern around biosimilar cancer treatment than for the most recent version of their originator counterparts. 

In fact, the most concerning apparent example of drift was seen with an originator* and not with the biosimilar cancer treatment, which we only became aware of during the process of biosimilar development and regulatory development. I think this has been a wake-up call that will make all biologic cancer treatments, properly monitored moving forward, as safe and effective as possible for use in patients with cancer.

*In response to a follow-up question about this originator, Lyman sent a 

 last year that pointed to drift — unplanned changes — in trastuzumab (Herceptin) as an explanation for the finding that a trastuzumab biosimilar, Ontruzant, was safer than trastuzumab with respect to cardiotoxicity. Lyman, who is one of the co-authors of that study, was paid a consulting fee by Samsung Bioepis, the manufacturer of Ontruzant. 

Here is a list of the biosimilars for cancer treatment drugs:

And here is a list of the biosimilars for cancer supportive care biologics (i.e., agents that boost white and red blood cell counts):

It's early days yet because patent and other issues have kept FDA-approved biosimilars off the market, but Gary Lyman, M.D., M.P.H.. of the Fred Hutchinson Cancer Research Center says there's evidence of some effect on the price of cancer supportive drugs. 

When Will Biosimilars Start Making a Serious Difference in Oncology? 

 digital therapy users reveals some of the groups most affected by the Covid-19 pandemic. Data shares essential workers and older populations are faring better than others, while those 25 and younger report more sadness and anxiety than any age group. However, there is a flip side to the pandemic story: many respondents also say the situation has helped them identify personal strengths, increase their appreciation of life, and strengthen their interpersonal relationships or spiritual connections.

“In a world where we’re hit each day with such bad news about Covid-19—its transmission, its growing numbers, its mutations—it’s wonderful to see that we can admit pain, but also simultaneously find and even cultivate hope,” says Athena Robinson, Ph.D., Woebot Health's chief clinical officer and adjunct clinical associate professor at Stanford University. “I’m humbled by what we’re seeing in the lived experiences of our users: the human capacity to navigate tough experiences and find meaning in persistently difficult and uncertain times.”

Most respondents report high stress and anxiety levels. Specifically, almost three quarters (71%) have found that changes in their way of life given the pandemic are moderately, very, or extremely stressful while more than half (58%) said they are bothered by being nervous, anxious or “on edge” more than half of days or nearly every day. Moreover, 42% indicate their mental health has worsened “very much” or “extremely.”

But there are also positive personal outcomes for Woebot users, who are using chat-based digital therapy as the pandemic spreads worldwide. The majority of respondents (69%) say the pandemic has created new possibilities and strengthened their relationships with others or community (70%). Nearly 80% say it has helped them increase their appreciation of life. The pandemic has also helped nearly three quarters (73%) of respondents identify personal strengths, and for more than half (59%), it has created spiritual change.

Essential Workers Faring Better Than Most

One in five survey respondents classify themselves as essential workers and report similar levels of pandemic impact (i.e., stress due to lifestyle changes, feelings, and changes in mental health), as other respondents, though they appear to be faring better in several ways. Fewer essential workers report being bothered by feeling down, depressed, or hopeless nearly every day (essential workers: 19%; all other respondents: 27%). Essential workers also report a lower rate of extreme anxiety, with 22% saying they have been bothered by not being able to stop or control worrying nearly every day, compared to 27% for all other respondents. 

“The difference could be because these people are among the most engaged in work for their communities and helping others in need,” Robinson says.

Millennials and Gen-Z More Anxious Than Boomers

Many are anxious or down but finding silver linings amidst challenges; essential workers and boomers are faring better than most.



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