The Prior Authorization Process and its Effect on Patient Care

By: Zachary Reale, PharmD Candidate c/o 2018

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Today there are over fifty oral anticancer agents on the market and the Food and Drug Administration (FDA) have approved much of these agents within the last ten years.  The number of oral anticancer agents will likely continue to grow in the near future, as more than 25% of developing anticancer agents are oral formulations.¹ Although there is a major shift from IV to oral therapy, the price of therapy remains high.  A recent study by the American Society of Clinical Oncology found the median monthly patented anticancer drug price to be $8694 in the United States.² Third-party payers utilize prior authorizations (PA) to contain costs and ensure that these costly medications are used appropriately.  However, the PA process is time consuming and requires a coordinated effort between the patient, provider, and pharmacy. The various parties that are involved in obtaining approval of medications often delay the initiation of a patient’s therapy for critical conditions such as cancer.³

Studies have explored the correlation between delays and interruption in therapies and the detrimental effects that suboptimal therapy can have on patient outcomes.  Ganesan et al. studied imatinib compliance and its relationship to clinical outcomes. Nonadherence is shown to adversely affect event free survivals in chronic phase myeloid leukemia (CML).  In the study, nonadherence is considered as any dose interruption of more than one week, excluding dose interruptions caused by pregnancy or for toxicity as per physician’s recommendation.  Of the 516 evaluable patients, 150 patients (29.6% of the cohort) had imatinib dose interruptions of more than one week due to non-adherence.  The endpoint measured was the estimated 5-year event free survival (EFS), which was 70.8% for the entire study cohort (95%, CI = 63.3-78.3). The estimated 5-year EFS in patients with nonadherence was 59.8% compared to 76.7% in those with no dose interruptions (P = 0.011).⁴

A delay in the initiation of therapy, specifically due to PA approval, is shown to negatively affect outcomes in other disease states.  A study from the Canadian Journal of Cardiology examined the effects of the PA process on the timeliness of clopidogrel prescription filling and clinical consequences, following stent insertion for the prevention of sub-acute stent thrombosis. The study sample comprised 112 patients who received an intracoronary stent and a prescription for clopidogrel upon discharge. Forty-five of these patients had to go through the PA process and suffer a significant delay in filling their clopidogrel prescription putting them at risk of future cardiovascular events. Fewer patients in the PA group than in the non-PA group had their prescription for clopidogrel filled on the day of discharge (31% versus 54%; P=0.02). The median time to fill was 4 days versus 0 days in the PA group and non-PA group, respectively (P=0.04).⁵ It is clear that the PA process greatly reduces the likelihood of a patient beginning a drug regimen in a timely manner. This in effect, allows a disease state to remain uncontrolled and perhaps even progress further.

Another study recently published in the Journal of Managed Care & Specialty Pharmacy specifically showed the benefits of having a dedicated PA team to shorten the time of authorization and dispensing. The prospective observational study took place over the course of one year and compared PA requests at two clinics, one utilizing the usual care group to conduct the PA and the intervention group utilizing a collaborative practice agreement to streamline the PA process. The time necessary to complete the PA was significantly lower in the intervention clinic than in the usual care clinics (0.53 days vs. 7.02 days, respectively, P < 0.001). Additionally, the average PA approval rate was 93% for the intervention clinic and 68% for the usual care clinics (P=0.0018).³

Having a special task force to expedite the PA process could have numerous benefits for the patient and the healthcare system.  A study in the Journal of Managed Care Pharmacy analyzed the impact of the PA process for type 2 diabetes medications on overall health care costs.  Of the 4,101 members who were retrospectively analyzed, all-cause health care costs (medical and pharmacy) were lowest for the 1,728 individuals in the received authorization cohort. Plan-paid medical costs were $8,192 for the received authorization cohort and $10,127 for the non-qualifying non-filling cohort; this difference in plan-paid medical costs were significant in both the unadjusted and adjusted models (P=0.005 and P<0.001, respectively).⁶ While it may seem that the PA process is time consuming and costly, this analysis shows that the PA process, in terms of cost, is beneficial for the entire healthcare system. When the PA process is utilized and a medication is approved, the overall cost to care for the patient is significantly reduced.

Preliminary studies have already shown that a centralized pharmacist-led PA process can improve both the approval rates and greatly reduce the time to dispense.² The PA process in healthcare has become a common step in treating patients. Unfortunately, there is a lack of substantial outcome evaluation of these processes.⁷ The few completed studies about the PA process support the need for more controlled studies on the effects of medication coverage on healthcare outcomes.⁵

 

SOURCES:

1. Stein J, Mann J. Specialty pharmacy services for patients receiving oral medications for solid tumors. American Journal of Health-System Pharmacy. 2016;73(11):775-796.
2. Goldstein DA, Clark J, et al. Global differences in cancer drug prices: A comparative analysis. Journal of Clinical Oncology. 34, 2016 (suppl; abstr LBA6500).
3. Cutler T, She Y, Barca J, et al. Impact of Pharmacy Intervention on Prior Authorization Success and Efficiency at a University Medical Center. Journal of Managed Care & Specialty Pharmacy. 2016;22(10):1167-1171.
4. Ganesan P, Sagar TG, et al. Nonadherence to Imatinib adversely affects event free survival in chronic phase chronic myeloid leukemia. American Journal of Hematology. February 2011:471-474.
5. Ackamn ML, Graham MM, et al. Effect of a prior authorization process on antiplatelet therapy and outcomes in patients prescribed clopidogrel following coronary stenting. Canadian journal of Cardiology. 2006;22(14):1205-1208.
6. Bergeson JG, Worley K, et al. Retrospective Database Analysis of the Impact of Prior Authorization for Type 2 Diabetes Medications on Health Care Costs in a Medicare Advantage Prescription Drug Plan Population. Journal of Managed Care Pharmacy. 2013;19(5):374-384c.
7. Rajagopalan K, Hassan M, et al. Review of Outcomes Associated With Restricted Access to Atypical Antipsychotics. The American Journal of Managed Care. 2016;22(6):e208-e214.