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The Impact of Formulary Controlson Commercially Insured Patientsin Five Chronic Therapeutic Areas RAHEL EHRENBERG, Principal, U.S. Market Access Strategy Consulting, IQVIAKRISTEN COPLEY, Consultant, U.S. Market Access Strategy Consulting, IQVIASIDDHANT GUPTE, Assoc. Consultant, U.S. Market Access Strategy Consulting, IQVIA Table of contents Introduction1Key takeaways1Formulary controls2Time and effort to overcome formulary controls4Impact of formulary control on patient treatment5Discussion6Disclaimer8Acknowledgements8Key terminology8About the data8About the authors9 Introduction Commercial payers leverage formularies to manageprescription utilization and costs by employing controlmeasures such as prior authorizations, step therapy,and formulary exclusions. These payer restrictionshave increased over the past decade and can result inpatients’ prescriptions being rejected at the pharmacycounter. Experiencing a rejection at the pharmacy canadd layers of complexity to a patient’s treatment journeyand can also lead to delayed or forgone care. unable to overcome a rejection — meaning the patientdid not ultimately receive their prescribed medicine —we tracked the proportion of patients who started analternative therapy and the proportion who failed toinitiate a new treatment in that therapeutic area. To demonstrate how commercial payer controls mayimpact patients attempting to initiate treatment, weconducted in-depth, longitudinal analyses of payerrejections occurring from January 2020 through July 2024across five chronic Therapeutic Areas (TAs) — pulmonaryarterial hypertension (PAH), osteoporosis, multiplesclerosis (MS), immunology, and migraine. Top brands,as determined by market share, across the selected TAswere selected for analysis. This report sheds light on the time and effort requiredfor commercially insured patients to begin a newlyprescribed therapy after being denied coverage dueto a payer rejection. Overcoming payer rejectionsrequires patients with chronic illnesses, especiallythose beginning treatment after a recent diagnosis,to work with their healthcare providers to navigate acomplex appeals process. This research aims to quantifythe impact of these challenges on patient access toprescription medicines. Patients were tracked for one year following an initialattempt to fill a prescription. For those who faceda payer rejection and successfully overcame it, thetime to coverage and number of attempts needed toovercome the rejection were quantified. For those KEY TAKEAWAYS •Over 75% of commercially insured patients were initially denied coverage when attempting to fill a newprescription across the five therapeutic areas analyzed. More than 90% of patients were initially denied in fourof the five therapeutic areas. •Patients who were initially denied but successfully appealed a payer rejection experienced average coveragedelays exceeding three to five weeks, depending on therapeutic area. Between 17% and 31% of patientsexperienced a delay of more than five weeks. •Patients had to overcome an average of two to four rejections before obtaining approval, although some had tonavigate through 11 or more rejections. •Between 64% and 82% of patients who did not overcome their initial payer rejection within a year failed toinitiate any new treatment in the same therapeutic area. therapy had the lowest initial rejection rate, but threeout of every four migraine patients still experienced arejection at the pharmacy. For osteoporosis, immunology,MS, and PAH, more than 90% of patients were initiallydenied coverage due to payer controls. Formulary controls Initial pharmacy rejection rates were assessed tounderstand the pervasiveness of payer formularycontrols. Rejection rates reflect the proportion of newpatient attempts denied coverage by commercialpayers. Longitudinally tracking patients after their firstattempt and throughout the following year enables theassessment of whether and how quickly a rejection wasovercome and payer approval obtained. After one year, 20% to 67% of commercially insuredpatients attempting to initiate a new therapy had stillnot received payer approval. The proportion of patientsunable to obtain approval for their originally prescribedmedicine within a year varied across TAs and washighest for osteoporosis and PAH patients at 54% and67%, respectively. Across the therapeutic areas analyzed, 75% to 92% ofcommercially insured patients were initially rejected whenattempting to begin therapy. Patients initiating migraine Reasons for initial payer rejections varied across the TAsstudied. Prior authorization and step therapy were themost frequently observed reasons for rejection across fourof the five TAs, affecting 31% to 64% of patients. Fewerthan one in three patients faced an initial rejection due toa formulary exclusion, except for osteoporosis patients,who were rejected 41% of the time because their medicinewas not covered on formulary. Rejections for other reasonsaccount