Supplements Improving Patient Access to Critical Therapies in the Age of Cost Sharing
In-Office Dispensing of Oral Oncolytics: A Continuity of Care and Cost Mitigation Model for Cancer Patients
The high cost of cancer therapies continues to lead to questions of affordability for the healthcare system and to patients. Ensuring patient access to oral cancer drugs presents a unique set of challenges due to the significant cost of these novel agents, healthcare/payer policies, and established distribution practices. The National Community Oncology Dispensing Association, Inc (NCODA) is a grassroots, nonprofit organization established by pharmacists who are directly involved at the community practice level in assisting patients with the acquisition of their oral cancer drugs. Community oncology practices that embrace the NCODA Quality Standards are able to provide exceptional patient care by providing direct access to oral cancer drugs through the in-practice dispensary. Patient continuity of care is ensured by allowing practice staff to manage all aspects of drug therapy—from initial dispense to completion of therapy—and in-practice dispensing allows for improved patient convenience, safety, and compliance. Practice staff in the dispensary area work directly with patients to address the insurance coverage limitations and financial toxicity of procuring these drugs.
Medicare patients are not eligible to take advantage of patient assistance and/or co-pay programs that have been established by pharmaceutical companies. Foundations such as the Patient Access Network Foundation have been established to provide assistance to Medicare patients. This case report focuses on a new dispensary in a moderately sized oncology community practice that prescribes to the NCODA Quality Standards and outlines the processes developed to assist Medicare patients in accessing their oral cancer medications.
Am J Manag Care. 2016;22(4 Suppl):S99-S103Newly approved oncology therapies in the United States continue to expand cancer treatment options for patients. In 2015, 18 cancer drugs were approved by the FDA, 9 of which were oral drugs.1 The oncology pipeline currently has an estimated 836 drugs in clinical development, with 25% being oral agents.2
The emergence of targeted therapies for treating cancer has allowed for more precise treatment based on tumor mutations and patient genotypes. This past year, we also witnessed the emergence of immuno-oncology drugs being utilized for an increasing number of tumor types, such as melanoma, lung, and renal cell cancers. However, these breakthrough therapies come with escalating costs.
The “financial toxicity of cancer” is a term being used to describe the increased financial burden faced by patients with cancer due to multiple factors, including increased out-of-pocket (OOP) expenses for co-pays and deductibles for prescription drugs and medical care, lost income for patients while undergoing treatment, and indirect costs experienced by caregivers. Insurance companies, struggling to cover the rising expenses of cancer drugs, are shifting more of the cost burden to patients.
Over the past decade, oral cancer drugs have become more prevalent in the treatment armamentarium. Many patients now receive combination chemotherapy consisting of intravenous and oral drugs within the same regimen or as single therapies administered sequentially through multiple lines of therapy.
Cost and Coverage
Traditional infusion chemotherapy is covered under a patient’s medical coverage, and for Medicare patients, under Part B benefits; however, there are a few oral cancer drugs that are also covered under Medicare Part B. Oral cancer drugs are billed through a patient’s prescription benefits, and for Medicare patients, under Part D. Under the Affordable Care Act, the Medicare Part D benefit now includes coverage in the coverage gap (“donut hole”). Before 2011, there was no coverage between the initial coverage limit to the OOP threshold and commencement of catastrophic coverage (Table 14). The “donut hole” will be completely phased out by 2020 using a combination of Part D benefits and discounts for generic and brand-name drugs. However, despite the emergence of Part D benefits and the shrinking donut hole, due to the extremely high cost of oral cancer drugs, patients continue to have challenges with medication access because of OOP expenses. The cost for new oral cancer drugs is in the range of $10,000 per month (Table 25).
The federal anti-kickback statute precludes pharmaceutical companies from allowing Medicare beneficiaries to use co-pay coupons to help cover the cost of Part D drugs. The law specifies that coupons cannot be used for the purchase and/or payment of drugs paid for by any federal healthcare program, including Medicare Part D.6 It is acknowledged that allowing patients to use coupons would save OOP expenses for patients significantly; however, coupons could potentially induce patients to use more expensive brand-name drugs, subsequently increasing costs to the Medicare system and taxpayers.
Payers are managing oral cancer drugs by shifting management to their pharmacy benefit managers (PBMs), and PBMs then further control costs by limiting dispensing through specific specialty/mail order pharmacies. PBMs also place oral cancer drugs into cost-sharing tiers with variable co-pay expectations for patients. Overall, more of the cost burden of cancer care is being shifted to patients. Simply coping with the physical and emotional burden of a cancer diagnosis can be overwhelming for patients, even before the financial ramifications are taken into consideration. There are numerous reports of patients and families going into debt or declaring bankruptcy in order to cover the costs of their cancer medications, as well as examples of patients cutting back on drug doses and groceries, and utilizing less heat in their homes.7 All of the aforementioned are desperate measures patients may take to maintain medication access. The quality of cancer care suffers as a result, in addition to poor compliance and adherence to life-saving treatment plans.
As cancer therapeutics becomes more complex and costly, with more options for patients, healthcare providers are being challenged to take on a larger role in assisting patients to maintain access to treatments. Discussion about the cost of chemotherapy is now a standard part of pretreatment planning and has to be communicated from the physician when treatment alternatives are discussed with patients. Some community oncology practices employ staff specifically trained as financial counselors to meet with patients prior to the start of their treatment. Patients meet with financial counselors and are apprised of their insurance benefits and limitations, allowing for a better understanding of their insurance coverage for their treatment plans and out-of-pocket expenses before their therapy begins.
Oral cancer therapies present a unique set of clinical management challenges for healthcare providers. Patients take these medications at home unsupervised, and therefore, patient education becomes more critical to ensure patients are taking their medications appropriately; timely follow-up contact with patients also needs to occur on a regular basis to monitor compliance and to mitigate potential toxicities. Clinical staff need to regularly assess if affordability is negatively impacting access to appropriate care.
In-Office Dispensing vs Specialty/Mail Order Pharmacies
As more oral drugs have become part of standard therapy for many cancers, there has been a recent trend within community oncology practices to establish in-office dispensing (IOD) services or retail pharmacies. Individual state regulations determine whether full retail pharmacies may be offered from within an oncologist’s practice; many states allow physician dispensing as an alternative to retail pharmacies.8 Both models allow for oncologists to dispense medications directly to their patients, which allows for close management of a patient’s cancer therapy.
Prior to this trend of IOD in community practices, the majority of oral cancer drugs, considered specialty drugs by PBMs, were obtained strictly through specialty/mail order pharmacies. These pharmacies manage many classes of specialty drugs, including those for hepatitis C, multiple sclerosis, rheumatoid arthritis, Crohn’s disease, and oncology. Additionally, specialty/mail order pharmacies strive to provide certain services for cancer patients and overall disease management, offering services such as dose accuracy assurance, education/telephonic outreach, waste management, adherence oversight, cost savings, and outcomes measures. However, oral cancer drugs being dispensed to patients from a remote specialty/mail order pharmacy has the potential to cause many problems from both the provider and patient perspective. Significant delays in time to therapy start often occur. It is fairly typical for a patient to wait at least 1 to 2 weeks to receive their oral cancer prescription from a specialty/mail order pharmacy.
Also, prescriptions generated at the practice are typically e-prescribed or faxed to specialty/mail order pharmacies, so once that prescription leaves the practice, the provider loses control over the entire prescription event, including the processing and dispensing of the drug to the patient. Unfortunate instances of prescriptions getting lost in this transition occur with some degree of frequency. Clinical staff members at the practice spend a significant amount of time on the phone trying to follow-up with specialty/mail order pharmacies on the status of the prescription, where it stands in the queue for dispensing, and when the medication is actually being dispensed to the patient. There is a significant amount of time, as well as resources, dedicated to this administrative burden, and the overall management of the patient’s cancer therapy becomes quite fragmented.
Having dispensing services available at the practice setting offers a better care model for patients. However, challenges remain when deciding to start IOD services within a community practice. There is a paucity of information on how to go about establishing IOD services, which creates a strong need for establishing quality standards and guidelines to ensure best practices for this unique model of patient care.
The National Community Oncology Dispensing Association (NCODA) was established in 2014 by a group of community-based oncology pharmacists to promote the practice of dispensing cancer medications directly to patients at the site of care: the oncologist’s office. NCODA practices adhere to quality standards that establish best practices related to the dispensing and management of oral cancer therapies. NCODA also works directly with other practices to implement and improve practice IOD operations which ultimately result in improved quality of patient care. The NCODA Quality Standards9 include:
1. Patient-Centered Quality Standard: standard that ensures dispensing services are centered on patient safety and education to maximize patient outcomes.
2. Positive Quality Interventions Quality Standard: positive quality interventions are performed by clinical staff to coordinate patient care and safety.
3. Foundational Elements Quality Standard: fundamental standards and systems are identified for achieving the highest level of quality patient care.
4. Health Information Technology Quality Standard: extrapolation of quality data from health information technology provides improved quality of care.
It is NCODA’s belief that IOD is uniquely positioned to provide improved and more cost-effective care compared with traditional specialty/mail order pharmacies. NCODA promotes the concept of the oncologist and the clinical and administrative staff at the clinic working together with the patient as a team, to offer a unique, high-touch, patient-centered model for managing oral chemotherapy.
Practices with IOD are able to coordinate all aspects of patient medication management using the electronic medical record, pharmacy dispensing program, and inventory and practice management systems. There is direct coordination and communication about patient care at all times with those managing the IOD and the physician. Further benefits of IOD include face-to-face patient education for all patients initiating an oral cancer medication, with personalized chemotherapy classes scheduled prior to the patient picking up their prescription from the dispensary. In addition to the oncologist, practice clinical staff, including both oncology-certified pharmacists and nurses, are directly involved with dispensing medications, patient education, and monitoring for side effects.