Specialty Pharmacies Have Many Roles to Play During Outbreak

As the COVID-19 pandemic continues its assault on the globe and the U.S. passes 12,000 deaths from it, all eyes are on the health care industry. While the public looks to pharma manufacturers for potential treatments and vaccines, labs for testing to detect the virus, and providers and others in their realm for being on the front line of the defense against it, specialty pharmacies still have a vital role to play.

“During this unprecedented time, specialty pharmacies need to be nimble and possess the flexibility necessary to continue serving patients while keeping team members safe,” says John Stephens, vice president, transformation and growth at AllianceRx Walgreens Prime. At that specialty pharmacy, 75% of employees are working from home, with the rest “still working on site to dispense and ship lifesaving medications. Ship-to-home is the basic skill or capability keeping people out of pharmacies and hospitals, especially since specialty patients are more at risk due to the pandemic.”

“Specialty pharmacies have been involved in a number of emergency situations such as hurricanes or earthquakes or other weather-related events and have established emergency protocols and procedures in place [in order to] execute their plan,” says Richard Gourash, R.Ph., vice president of oncology at BioPlus Specialty Pharmacy. At that company, “the management team meets regularly to receive feedback from local, state and national governmental agencies and provides updates from manufacturers, providers and patients and adjusts the plan as necessary.”

Specialty pharmacies can offer “enhanced patient-centric care protocols” and provide “risk stratification” of high-risk patients, such as those who are respiratory- and immune-compromised, says Bill Sullivan, principal consultant for Specialty Pharmacy Solutions LLC. Patients “should be targeted for clinical baseline validation, changes in status (temperature, etc.),” which can be relayed to their physicians.

“Clinicians at specialty pharmacies are experienced in managing patients with weakened immune systems and in providing patient education on taking precautions to prevent from contracting viral infections, such as COVID-19,” states Lily P. Duong, Pharm.D., R.Ph., chief clinical officer at Therigy, LLC.

Pharmacists Can Help Educate Patients

“Specialty pharmacies in hospitals are working and supporting infectious disease and ambulatory care clinics, and they can assist physicians and clinic staff in providing education to patients in terms of taking [precautionary] measures and/or filling prescriptions for symptom control,” she continues. “Pharmacists need to emphasize the severity of this disease to specialty patients because they are at high risk due to weakened immune systems and make sure these specialty patients are being counseled during this time.”

At BioPlus, says Gourash, “our clinical pharmacists and nurses outline our current processes and make updates to provide clinical counseling for complex REMs [i.e., Risk Evaluation and Mitigation Strategies] program support for patients” who are in greater danger than others. The specialty pharmacy reaches out to patients with proactive wellness calls in which team members can assess patients’ status, answer medication questions and questions about COVID-19, “provide assurance and reduce stress.”

“Specialty pharmacies must be proactive when supporting patients during this pandemic,” asserts Tracey James, senior vice president, pharmacy services at AllianceRx Walgreens Prime. “We have expanded our hours of operation to accommodate team member availability, tapped into nonoperations teams to support operations functions and are currently hiring additional support staff including pharmacy technicians, patient care advocates and insurance verification specialists.”

Firms Can Work With Patient Advocates

In addition, specialty pharmacies can work with patient advocacy groups “to educate patients about how to protect themselves from COVID-19, especially for patients coping with a chronic or rare disease,” she says.

When it comes to supporting providers, says James, the best way for specialty pharmacies to do this is “by making it easy to transfer and refill prescriptions. We can also educate our providers on refill-too-soon overrides, prior authorization accelerations and drugs at risk of shortage.” AllianceRx Walgreens Prime also sent 5,000

infection control kits to hundreds of provider offices. “But our main response to support our providers has been to minimize contact with them to what is truly necessary. We are helping them by helping their patients get their medicines as expeditiously as possible and allowing them to focus on their patients.”

BioPlus’ regional clinical liaisons and local sales teams support physicians via video and videoconferencing about COVID-19 updates on BioPlus’ emergency plan, explains Gourash. “Many physicians do not have the staff or resources to keep up with all the manufacturer product updates and patient insurance updates and to manage patients that need radiation therapy and surgery as part of their oncology treatment plan. This opportunity is where the BioPlus team becomes an extension of the physician office.”

Companies Can Provide Insurance Status

Specialty pharmacies can assist with determining whether any changes have occurred with respect to patients’ “insurance status and ability to pay” and knowing “what to expect if they are admitted to the hospital, especially as relates to their current specialty therapies,” Sullivan notes.

With all the consolidation in the health care industry, many specialty pharmacies “are part of companies with complementary capabilities,” points out Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates. For example, on CVS Health’s website, the company explains that it is undergoing “company-wide COVID-19 preparation” that includes its CVS Health Enterprise Response & Resiliency Team and Infectious Disease Response Team, Aetna and MinuteClinic.

“Specialty pharmacies should maintain regular contact with manufacturers to determine availability of medications,” maintains James. During past drug shortages, AllianceRx Walgreens Prime worked with pharma companies to create customized patient communications. If there is a shortage during the pandemic, “we will support manufacturers in the same way, by acting as a communications channel to our patients and providers.”

“Manufacturers would want to know why compliance may fall precipitously in coming months,” says Sullivan, and specialty pharmacies can provide that data. “Did the patient terminate their specialty therapy because they were admitted to the hospital? Did they die? Did they cease refills on their specialty therapy because of loss of health coverage? Inability to pay co-share, ran out of financial assistance?”

According to James, a big challenge posed by the pandemic is with drugs shipped to provider offices, many of which are closed now. For these drugs, “we are working with manufacturers on ways to enable these treatments to occur in a patient’s home via our subcontracted nursing network, where clinically appropriate/available.”

Firms Can Help With Treatment Delays

With the potential for some patients’ treatments being delayed due to the pandemic, can specialty pharmacies do anything about that?

Sullivan tells AIS Health that “diagnoses may be delayed, especially if lab work competes with virus-testing capacity. However, therapy starts for medically managed patients should not be otherwise impacted except for access to the physician.” As long as carriers continue to work, medications will be shipped, he says.

But, says Rubinstein, if “diagnostic workups and physician visits to determine next steps based on diagnostic evidence are delayed, new prescriptions will not be issued. The pharmaceutical sector — manufacturers, distributors, pharmacies — cannot do their parts absent orders.”

Also likely impacting drug supply is President Trump’s “repeated inexcusable promotion of unproven drug therapies,” he says, resulting in “hoarding of supplies, causing shortages for patients with legitimate medical needs for these drugs.”

Specialty pharmacies, though, can benefit from the fact that “state boards of pharmacy have suspended rules, some of which are intended to alleviate shortages in drugs and personnel and to relax rules that may impair the emergency response,” so these entities do have some processes that could help them prevent against any potential supply disruptions, he adds.

And payers can allow specialty pharmacies to institute dynamic prior authorizations and relax their refill-too-soon controls, says Stephens. “We’ve seen many patients taking advantage of this to help ensure they have medication at their home.” In addition to earlier refills, payers could offer 90-day refills, says Duong.

“We proactively collaborated with state boards of pharmacy across our seven pharmacy locations,” Stephens says about AllianceRx Walgreens Prime. “This enabled our pharmacists and pharmacy techs to support our patients from home, in compliance with our work-from-home policies to protect patient privacy.”

“In some states, licensed pharmacists have prescribing privileges, and they can assist physicians in authorizing script renewals via a collaborative practice agreement in the clinic,” Duong explains.

Staff May Help Find Financial Resources

In addition, she points out, “the stay-at-home and social distancing policies might cause patients to be at risk for unemployment and loss of insurance coverage for their therapy. Specialty pharmacy staff may potentially connect them to financial assistance resources for alternative funding to continue to access their therapy.”

Beyond drug shortages, “in major metro areas around the country, patients’ nonurgent physician visits and surgeries have been canceled, to be rescheduled at a future time,” points out Rubinstein.

In mid-May, the American College of Surgeons called on surgeons, hospitals and health systems to “minimize, postpone or cancel” scheduled elective procedures. The society has since issued additional guidance on this, including guidelines to help decision-making on various procedures such as multiple cancer surgeries, emergency general surgery, metabolic-bariatric surgery, pediatric surgery and vascular surgery. Even organ transplants are being delayed, with the American Society of Transplantation weighing in with an FAQ in response to queries.

Will Patients Delay Needed Testing?

Rubinstein tells AIS Health that he wonders “if ill patients also delay necessary diagnostic testing, both to adhere to stay-at-home orders and to avoid exposure to COVID-19. Medical testing and visits postponed mean therapeutic decisions and prescribing delayed — not a trivial matter for cancer and other patients with severe disease. Given that many parts of the country are still on the steep upward slope of the curve vis-a-vis COVID-19 cases, it will be months until nonurgent care availability improves. There is nothing that a specialty pharmacy can do about this, although I wonder if organizations such as United/Optum, CVS/Aetna and Cigna/Express Scripts will develop special testing, care and prescription-access programs for these uniquely at-risk health plan members.”

AIS Health reached out to two of those organizations but did not receive a response.

According to Gourash, while many oncology patients already started on therapy are able to continue it, “new patient starts may be on hold due to the COVID-19 pandemic as the hospital that provides the surgery, PET scan or radiation therapy may be overwhelmed with COVID-19 flu patients. If a patient is delayed or if the treating physician feels that the risk of immunosuppression is extremely high and puts the patient at a greater risk of contracting the COVID-19 virus, the specialty pharmacy clinical team can assist the patient with answering any questions or working with the physician’s office.”

He adds that some oncologists have transitioned patients who need to have chemotherapy administered in a health care setting to an oral oncolytic, and specialty pharmacies can assist with supplying these medications.

But often people on specialty therapies may change “drugs, dosage and secondary medication to manage their conditions,” says Stephens. “With many doctors’ offices limiting nonemergency appointments, patients may delay checkups and lab tests, which means they may delay switching therapy, if needed. Specialty pharmacies help through clinical programs and counseling to specialty patients. These programs allow specialty patients to monitor any changes in their health, especially when they cannot get into the doctor.”

Newer Technology Can Help With Support

At a time when social distancing and working from home are required, “new modern technology would provide an alternative means to keep communications with patients as usual,” says Duong. “System connectivity and IT [assistance are] very helpful to support clinicians and patients. Text messaging functionality can provide outreach to patients instead of trying to get ahold of them via phone, which saves time and resources.”

Stephens notes that his company’s pharmacists are available 24/7 by phone and online, and email and text notifications can provide status updates, while online self-serve capabilities allow patients to perform a variety of functions. “Specialty pharmacies must also be innovative when creating solutions for meeting patient demands. Many companies are experiencing elevated demand for delivery services and high call volumes.”

For more information, contact Duong through Lindsey Harris at Lindsey.Harris@therigy.com, Gourash at rgourash@bioplusrx.com, James and Stephens through Adrienne Foley at adrienne.foley@primetherapeutics.com, Rubinstein at elan.b.rubinstein@gmail.com and Sullivan at wsullivan@specialtyrxsolutions.com.