Consumers, Employers, and Prescription Drugs During COVID-19: A Q&A With Arxcel's Chris Robbins

AJMC®: During the recent AMCP Virtual Meeting, we heard that many consumers ordered a 90-day supply of key prescriptions in March to be sure they would have their key medicines throughout a lockdown. A key item to watch to will be how many of those prescriptions get renewed in June. Which renewals will you be looking at most closely in June?

Robbins: We are monitoring prescription utilization trends on behalf of our clients, and likewise report that there has been a significant upward trend in utilization of maintenance supplies (both at retail, and mail order channels). In general, this increase is a positive for several reasons:

• Generally, less expensive for the plan sponsor and member
• Higher likelihood of medication adherence for chronic conditions
• Less frequent COVID exposure to the general public

Categories that we are particularly focusing on are around chronic conditions, and treatment that may require more intense care, where members do not have access to health care professionals as readily as “pre-COVID”. Particularly, we are seeing an upswing in utilization of the mental health category (anti-anxiety and antidepressant medications). Particularly with this class, it is important that individuals utilize the medication long enough to experience a benefit (most do not have a noticeable onset until 3-4 weeks into treatment), and many can have significant adverse events if discontinued abruptly.

In the chronic condition space, we are particularly focused on monitoring adherence of treatment for hypertension, hypercholesterolemia, and diabetes. We have found that many employers are offering new or expanded tele-medicine access, particularly for these conditions. We are optimistically tracking adherence rates, and hope the positive trends continue through the second and third quarters of this year.

AJMC®: Did employers see a rush of people stocking up on prescription drugs due to fears of being laid off or furloughed?

Robbins: Not necessarily. At the onset of the COVID shut-down across the country, we were originally concerned that there were be a flood of new prescriptions, and refills for those looking to stockpile antibiotics, antivirals, and certain respiratory products. But so far, medication access and/or shortages has not been an area of concern to date throughout the pandemic. Most plans have proactively implemented coverage precautions, such as “refill too soon” restrictions, to ensure that members do not have access to an inappropriate amount of medication on hand at any one time.

With regard to layoffs and furloughs, we have identified that across the county, many employers are extending coverage, federal and state regulations have extended eligibility periods for benefits, and many have offered supplemental benefits during this difficult time.

AJMC®: As people lose jobs, some will migrate over to Medicaid, but some may stay on employer plans for a time. How will these dynamics play out in prescription fills and renewals in the next few months?

Robbins: Nationally, there has been a shift of commercial participants into Medicaid (for those eligible); however, many do remain covered under an employer-sponsored health plan. We have seen an increase in utilization in maintenance supply fills (90-day) at retail or mail order pharmacy, and an increase in certain therapeutic areas (such as anti-anxiety, antidepressants, sleep disorder medications).

As a whole, there has not been a significant additional expense related to COVID-19 treatment under the pharmacy benefit, as those who require most intensive care are billed under an inpatient claim stay.

For those individuals where income has become diminished, and/or employee benefits are now a financial hardship, many may be more reliant upon manufacturer assistance programs, especially for high-cost specialty therapies.

AJMC®: Oncologists are telling us they expect to see more use of oral oncolytics, but adherence and prescription abandonment has been issues with these drugs. What do you expect to see in the oncology area?

Oral oncology continues to be a booming area of pharmacy research and development. As individuals are able to shift site of care from infusion centers to their own homes via oral alternatives, this poses new challenges and benefits. As a benefit, there is a general quality of life improvement, potential for less adverse effects (dependent upon the specific therapy), and convenience. As a potential challenge, prescribers may have less ability to control adherence when a member receives their medication.

That being said, there is an abundance of prescriber and patient resources designed to improve adherence to oral oncology medications. Primarily, most specialty pharmacies have expertise in oncology regimens, and can advise the patient on optimum dosing regimens, and counsel them on the importance of strict adherence. Additionally, there are several technology resources available to improve patient adherence, such as trackers, daily medication reminders, adherence apps and clinical resource teams supported by pharmaceutical manufactures. I would expect to see an uptick in the adoption of technology (ie, telehealth, patient interaction) for clinical interaction, and utilization of adherence technology.

AJMC®: What are the health issues that employers expect to confront as people return to work from being in lockdown? How will these issues present themselves in the formulary area?

Robbins: Health issues that employers may expect as populations return to work:

• Concern over wait times for routine, preventive care, primary care visits, and vision/dental procedures, etc.
• Persistence/exacerbations of mental health related conditions (ie, anxiety, depression, sleep disturbances, etc.)
• Additional regulatory guidance on social distancing requirements, personal protective equipment (PPE), etc. (additional infrastructure and operational resources dedicated to logistics, access to PPE, commercial cleaning, etc.)
• Some employers are looking to implement screening protocols for return to work, such as temperature readings, questionnaire/survey, thermal monitors, etc.
• Additional expenses in areas such as workers compensation, disability, and Paid Family Leave related to COVID-19 treatment and/or isolation periods.

From a formulary perspective, I anticipate that there may be a surge in prior authorizations being processed as physician and specialists’ offices “return to work” and re-submit authorizations to pharmacy benefit managers (PBMs) and health plans.

AJMC®: What trends do you see with the use of hydroxychloroquine and the 2-drug cocktail with azithromycin? Do you expect to see protocols calling for use with some patients but not others? Do you foresee a preventive use for the combo?

Robbins: With the advent of FDA-approval of remdesivir, current clinical recommendations advise against the COVID cocktail of hydroxychloroquine and azithromycin. Current recommendations against the regimen due to the potential for serious adverse events including: heart rhythm irregularities (specifically known as QT-prolongation), renal and liver sufficiency issues, and hypoglycemia. Additionally, there is unsupported evidence at this time for the use of COVID-19 treatment. In the first quarter of the year, we had anticipated that there would be a spike in utilization; however, that has been limited and anticipated to be nominal since the new FDA recommendations which advise against the regimen for COVID treatment at this time.

AJMC®: As we speak, the FDA is expected to approve emergency use of remdesivir (it was approved May 1, 2020); other experimental therapies are moving through the pipeline. By fall, when employers will approve formularies for 2021 health plans, how will employers and health plans deal with the pressure to pay for drugs that may be approved and offer some help, but may not have robust evidence behind them?

Robbins: With the approval of remdesivir and pending market access, I anticipate that payers and PBMs will have the challenge of balancing appropriate access, while limiting unnecessary cost and inappropriate utilization. This will be managed primarily through utilization management, and strict prior authorization criteria. I imagine that most policies will require criteria for coverage to include the following:

• Submission of positive diagnosis of COVID-19 testing within a reasonable clinical period (ie, requesting treatment within 24 hours of testing)
• Submission of request must come from a specialized healthcare professional, ie, Infectious disease
• Limit treatment to those individuals who meet criteria for severe disease, as defined as: oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO).
• Submission of patient weight, for the purposes of dosage verification
• Ensure appropriate monitoring of renal (GFR, creatinine), and hepatic panels have been assessed at baseline and during treatment to monitor for adverse effects
• Limit treatment to 5-10 days (depending on specific dosing and indication)

AJMC®: There has been some speculation that the cost pressures of COVID-19 will be helpful to the biosimilars market. Do you agree or disagree?

Robbins: In general, COVID-19 has forced health plans, PBMs, and businesses across the country to evaluate the financial stability of employee benefits coverage. That being said, I am optimistic that many will be more receptive to creative payment mechanisms for biosimilars, and will open doors for clinical access and acceptance to these cost-effective alternatives to their originator products.

There is still much work to be done in the areas of advocacy, education, and both clinical and general public acceptance of biosimilars as a market class. As with many aspects of the “world as we know it”, there may be aspects to health care payment and delivery models that are vastly different pre- and post-COVID.

AJMC®: What other formulary issues will employers face in light of COVID-19?

Robbins: Formulary issues that may continue to surface as a result of COVID-19 include:

• Dependent upon the length of COVID-19 shutdown, large demand and wait times for direct clinical care upon reopen
• Extensions of clinically appropriate prior authorizations while COVID shut down limits provider access
• Focus on expanded telehealth solutions, specifically around chronic conditions and medication adherence
• Continue to monitor new starts, and appropriate access to mental health related medications