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Specialty Pharmacy Continuum • March/April 2021
CLINICAL
Medication selection, patient education among skills driving better outcomes
SPs Help Make HCV+ Organ Transplantation Safer Organ transplants from hepatitis C virus (HCV)-positive donors to HCV-negative recipients will continue to increase in frequency as more transplant centers develop protocols for their management, said experts from major transplant programs in a session at the ASHP 2020 Midyear Clinical Meeting and Exposition. Integrated specialty pharmacies have responded to this trend by playing a key role in assisting with the selection of medication, management of drug interactions, procuring medication (including insurance approval and financial assistance) and patient education. These are timely efforts, given that the number of transplant centers using HCV-infected kidneys jumped from 11 in 2015 to 39 through the first three months of 2019 (J Am Soc Nephrol 2019;30[10]:1939-1951). Although direct-acting antiviral (DAA) drugs have had virtually universal success in clearing the virus from these patients in multiple clinical trials over the past several years (Rev Recent Clin Trials 2019;14[3]:173-182), management of these cases can be complex. “Integrated
specialty pharmacy programs can provide the resources necessary to allow these patients to gain access to and remain adherent to DAA therapy,” said Alicia Carver, PharmD, BCPS, a specialty pharmacist in the Digestive Disease Center at Vanderbilt University, in Nashville, Tenn. More than 110,000 patients were on the waitlist for solid-organ transplants as of late 2020, and more than 5,000 people died while on the waitlist in 2019. Meanwhile, the opioid epidemic has led to an increase in overdoses as well as an increased number of potential organ donors who are HCV-positive. Beginning with a pioneering clinical trial launched by researchers at Penn Medicine in 2016, a series of trials have demonstrated the safety and efficacy of positive-to-negative transplants for
‘In our program, the inpatient transplant pharmacist provides medication administration teaching upon discharge, with a detailed medication action plan [MAP].’ —Alicia Carver, PharmD
solid organs—including kidney, liver, heart, lung and pancreas—with high rates of sustained virologic response (SVR), low rates of adverse effects and decreased costs, while reducing waitlist time and increasing life expectancy (N Engl J Med 2017;376[24]:2394-2395; Ann Intern Med 2017;166[2]:109-117; [2]:109-117; Am J Kidney Dis 2020;75[6]:857-867; 57-867; N Engl J Med 2019;380[17]:1606-1617; 6-1617; Lancet 2019;4[10]:771-780).
Preemptive Versus Reactive DAA Treatment ment There are two primary ary approaches to treatment nt initiation for patients receiving an HCV-positive organ: preemptive (beginning prior to the transplant) and reactive (after the transplant), each with its own advantages and disadvantages. “The preemptive strategyy allows for a shorter DAA A course, which patients and providers both may find attracttractive,” said Kristin Beeker, PharmD, MBA, a clinical pharmacyy specialist in the specialty pharmacy at the Medical University of South Carolina (MUSC), ( ) in Charleston, which began transplanting HCV-positive kidneys to HCV-negative recipients in 2018 and expanded the program m to heart, liver, pancreas and lung recipients pients in 2019.
Insurance and Financial Advocacy y
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etting insurance coverage for direct-acting antiviral (DAA) therapy in transplant patients, particularly in a preemptive situation, can be complex. The involvement of a skilled specialty pharmacy team is essential. In a report presented at the American Transplant Congress in May 2020, Vanderbilt University specialty pharmacists reported on a series of 91 transplant patients who received DAA therapy. “All of them were able to access coverage,” said Alicia Carver, PharmD, BCPS, a specialty pharmacist in the Digestive Disease Center at Vanderbilt University, in Nashville, Tenn. “Of the 91 patients, 97% were insured; the 3% who were uninsured or underinsured went on to get medications through the manufacturer. For those with insurance, 65% were approved through the prior authorization process, and 35% were approved on appeal. We did not have to move forward with a second level of appeal for any patient.” The most common reasons for denial were lack of chronicity of the hepatitis C virus diagnosis and a request for more than eight weeks of therapy. The median time to approval was six days, and to first dose, eight days. “To improve your chances for success, be sure to provide all the requested information, including genotype, if it is at all possible to get it,” Carver said. “Most of the insurance providers do require it at this point.” Other tips to improve the chances of getting a course of DAA therapy approved: • Use a formulary agent if possible. • Ensure appropriate duration of therapy. Ledipasvir +
“We also can potentially prevent HCV infection from occurring, decrease HCVrelated complications and eliminate the need for genotyping. However, there is an increased risk of clinical instability since the patient is receiving a new
sofosbuvir (Harvoni, Gilead) and glecaprevir + pibrentasvir (Mavyret, AbbVie) may be only approved for eight weeks; if that is insufficient, consider appeal prior to treatment start. • If denied, cite appropriate studies and clinical documentation. • Consider a peer-to-peer option if necessary. Financial assistance options for DAA therapy also can be pursued, including manufacturer copay cards for those patients with commercial insurance. All of the recommended regimens have cards available that reduce patient out-ofpocket costs to $5 and reduce the overall cost of care. Foundations including the Patient Assistance Network Foundation, the Patient Advocate Foundation, Healthwell Foundation, The Assistance Fund and the Good Days Foundation have income-based assistance that can range from $6,000 per year to maximums of $15,000-$30,000, but funds open and close throughout the year depending on available resources. For patients who are underinsured or uninsured, manufacturers have their own support programs: Gilead’s SupportPath and AbbVie’s MyAbbVie Assist are income-based, and may also assist patients after multiple insurance denials or if insurance coverage is lost while on treatment, Carver said. —G.S.
organ and we aren’t sure how they will respond to that transplant. That adds another potentially complicating factor iin the early post-transplant recovery period when the patient may not yet be fully stable. There is also an increased risk of drug interactions. “You also have to have a backup plan if the patient’s insurance doesn’t approve the therapy, since preemptive appr treatment is not FDA approved,” she treat said. “That involves either partnering with the manufacturer to obtain medication through a study, or moving to i reactive therapy post-transplant.” Reactive therapy has the advantages of clinical stability in the patient as well as a known decrease in drug–drug interactions, treatment failures and resistance. “Every patient responds differently to transplantation, so it is nice to understand how the patient responds before introducing a new medication with known drug interactions and side effects to potentially complicate the patient’s clinical course,” Beeker said. “But reactive treatment can mean an increased time to DAA initiation, an increased risk for hepatitis C–related complications, and genotyping may or may not be required.” Studies have demonstrated successful outcomes with both strategies (N Engl J Med 2019;380[17]:1606-1617; Lancet 2019;4[10]:771-780; Am J Transplant
