The staggering price tag of some oncology drugs points to a health care system that is out of control, the president of the Hematology/Oncology Pharmacists Association said at the group’s Inaugural Fall Practice Management Meeting.
Coupled with the added costs associated with chronic medication shortages, off-label medication use and unfunded regulatory mandates, hematology/oncology pharmacists have their hands full, Niesha Griffith, MS, RPh, FASHP, said. Ms. Griffith offered several strategies to help hematology/oncology pharmacists rein in these costs based on her experience as director of pharmacy and infusion services at the James Cancer Hospital (JCH) and Solove Research Institute at The Ohio State University, in Columbus.
Develop a high-dollar chemotherapy process. “Don’t just assume that because a medication is FDA-approved that the insurance company is going to pay for it,” Ms. Griffith said. JCH created a process to review patient benefits and determine coverage, which in some cases is assisted by the pharmaceutical company’s support program for the specific medication. “We also determine the patient’s financial obligation so we can let them know what to expect. This process not only helps us ensure payment, but, just as important, prevents any ‘expensive surprises’ for our patients.”
The addition of sipuleucel-T (Provenge, Dendreon) to the JCH formulary triggered the development of the hospital’s high-dollar chemotherapy process, according to Ms. Griffith. The hospital’s Hematology/Oncology Pharmacy & Therapeutics Subcommittee determines which agents will be managed under the program. This generally includes all medications costing more than $50,000 for a typical course of treatment. In addition to sipuleucel-T, the list currently includes ado-trastuzumab emtansine (Kadcyla, Genentech), omacetaxine mepesuccinate (Synribo, Cephalon), ipilimumab (Yervoy, Bristol-Myers Squibb), brentuximab (Adcetris, SeattleGenetics), eculizumab (Soliris, Alexion Pharmaceuticals) and pertuzumab (Perjeta, Genentech).
“The process enhances patient satisfaction,” Ms. Griffith noted. “Patients feel like they have some control over their treatment because they are involved in the decision making.” With the development of specific workflows for each medication at JCH, she added, “To date, there have been no write-offs for the medications when this process is used. Because of our investment in front-end resources, we are improving our chances of getting paid for these very expensive medications.”
Be proactive to head off medication shortages. Ideally, such efforts should include a dedicated staff person who can stay on top of a “bread, butter and milk” list of agents with a history of shortages by keeping sufficient quantities on hand and stocking up before holidays, when some pharmaceutical manufacturers are known to stop production. “It’s been a different world for us having someone with responsibility for managing this,” she said.
Develop clear policies and processes for off-label medication use. A multidisciplinary group of clinicians can best develop and oversee this process, Ms. Griffith noted. The goal here is to ensure that when off-label medications are used, it is done in a manner that is supported by clinical evidence and compendia, Ms. Griffith noted. The system should also seek payor approval when possible and peer review as necessary. “Without the appropriate buy-in and institutional support, addressing off-label use can be a difficult task and lead to uncomfortable situations for pharmacists,” she said. “It’s important to communicate that safety and effectiveness are as much a consideration as cost and reimbursement.”
This type of program takes time to effectively implement and requires a significant amount of education and communication with the medical staff, Ms. Griffith added. As a result of those efforts at JCH, “our physicians are familiar with the policy and process and let us know in advance, as soon as they are considering prescribing an off-label use,” she said.
In terms of specific steps involved, one of the first is for a physician to send a request for an off-label use to a clinical specialist pharmacist, who enters the request, the evidence-based literature and compendia support and the associated costs into a database. “The physician’s main responsibility is to let us know they’re thinking of off label. We walk through the process, even if they’re only considering it, because sometimes it takes us up to two weeks to get approval from the payor,” Ms. Griffith said.
Entry of a request into the database triggers an email to the pharmacy director, the chair of the Hematology/Oncology Pharmacy & Therapeutics committee and dedicated nurses in the finance department. A nurse then contacts the payor to request predetermination (approval for off-label use) and reports the result back to the patient care team. If the request is not approved, the clinical specialist pharmacist contacts one of the medication assistance staff to determine availability of support programs for off-label use. If the payor does not approve the request (and a support program is not an option), the off-label use is then peer-reviewed by the disease-specific lead physician. “If the lead says yes, then the head of the [hematology or oncology] division must also approve,” Ms. Griffith said. “I get involved in almost all of the high-dollar requests. Some also involve our chief financial officer.”
According to Ms. Griffith, the requests that involve peer review are few and far between. Because this system for vetting high-cost off-label medication use has been in place for several years “our physicians usually have a good understanding of the data and whether an off-label use is going to be covered,” she noted.
“Regardless, we go to the ends of the earth to get these medications paid for if we think it’s the right thing to do, even if it means writing it off, Ms. Griffith said, adding that “because we have such robust infrastructure in place, we actually have few denials and don’t write off very much [off-label therapy].”
Treatment plans at JCH containing off-label indications are clearly labeled as such to ensure adherence to the off-label approval process, she added.
Standardize the ordering of medications. Standardizing the ordering of chemotherapy and supportive care can have a significant effect on the ability to control medication costs (including the use of off-label medications noted above), Ms. Griffith said. “As you move to electronic ordering, premedications and supportive care drugs that are specific to a regimen and reflective of your institutional guidelines can be built into comprehensive treatment plans.”
Make full use of medication assistance programs. Ms. Griffith recommends having dedicated staff that can navigate the complexities of the different assistance programs and effectively communicate the details of those prograns to patients and clinical staff. The individuals supporting these activities don’t have to be pharmacists, she noted. At JCH, the medication assistance coordinators who handle these responsibilities have backgrounds as pharmacy technicians, social workers and financial counselors. However, because these staff members are likely to receive and transport medications, it is important to know whether your state regulations allow a medication assistance program to operate that is not supported by the pharmacy department.
In addition to programs that provide free medications for qualified patients, copay assistance foundations are available to help the underinsured. “With changes in health care, this patient population is likely to grow, further supporting the need for dedicated personnel to assist patients with accessing these programs,” she said.
Limit waste associated with compounding of high-cost chemotherapy products. Strategies that can be used include dose-rounding, standardizing administration times and use of closed-system transfer devices to extend the expiration dating for chemotherapy single-dose vials up to seven days.
Educate your pharmacists about payor rules. “Most pharmacists never expected to become experts in accessing CMS [Centers for Medicare & Medicaid Services] coverage determinations, navigating various compendia or learning payor requirements, but if you work in oncology today, it’s becoming unavoidable,” Ms. Griffith said.
Make judicious use of personnel resources. Pharmacists don’t have to do everything in the pharmacy department. “All of our budgets are being scrutinized because of our expensive medications and expensive staff,” she said. “Think about the activities being performed, qualifications needed to perform them and whether those activities really require a pharmacist.”
Significant Savings With Dedicated Clinical Staff
Like JCH, the USC Norris Cancer Hospital (NCH), part of the University of Southern California’s Keck Medical Center (KMC), in Los Angeles, clearly knows the value of a multipronged approach to cost management. One of the facility’s most successful efforts has been the creation of a clinically staffed department that focuses solely on obtaining third-party payor authorizations and interfacing with patient assistance programs—a strategy that yielded savings of $500,000 in its first year and $1.4 million within 2.5 years. The process, created by a pharmacist at the USC School of Pharmacy, also has reduced disputed claims from third-party payors (Am J Health-Syst Pharm 2011;68:828-834). The program has since been expanded to the entire medical center, said Caroline Chellamy, PharmD, KMC’s director of ambulatory pharmacy services. According to Dr. Chellamy, the allocation of dedicated nursing staff to handle these complex and time-consuming tasks has freed pharmacists to focus more on patient care and to spend more of their time working at their level of training. “We don’t expect our pharmacists to become insurance experts. We prefer that they stay focused on the patients,” she said.
The pharmacy works proactively to identify medication shortages as quickly as possible, keeps all clinical staff abreast of developments with a monthly newsletter, “Pharmacy Capsule,” and sends department heads frequent updates via email, Dr. Chellamy added.
“We’ve built in our own process improvements and checks to help reduce costs, but everything we do is centered on the patients,” Dr. Chellamy stressed. “We collaborate with the physicians and nurses so we get the right drug, regardless of payment structure.”
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.