Evaluation of Specialty Drug Price Trends Using Data from Retrospective Pharmacy Sales Transactions.

BACKGROUND: The past 25 years have seen a substantial increase in the effect of specialty drugs on patient care. These agents were initially not considered financially viable because they often served a comparatively small market of patients. However, the extended monopoly afforded to manufacturers of these drugs by the Orphan Drug Act of 1983 has made treatment of rare diseases, which specialty drugs often target, a more viable option. As a result, pharmaceutical companies began to increase research and development expenditures in this area, and the pipeline of specialty drugs began to grow in the late 1980s. OBJECTIVE: To analyze the annual change in wholesale acquisition cost (WAC) pricing of specialty drugs sold over a period of 11 years. METHODS: Pharmacy claims data, including date and WAC, were collected for each specialty drug transaction that occurred from 2002 through 2013 at the University of Illinois at Chicago Ambulatory Care Pharmacy Department. The data were organized to create a chronological sequence of WAC values from the initial to final sales of each available drug. Those values were then used to calculate annual percentage of change in WAC. These results were grouped into subsets and graphed in order to illustrate the effects that various factors had on the annual changes in price. RESULTS: The price of the specialty drugs studied has generally shown a greater rate of increase since experiencing a trough rate increase in 2009 of 4.08%. The economic crisis of 2008 created a short pause in this overall trend, but increases in the rate of price growth have since rebounded. WACs increased at a rate of 7.03% or greater from 2010 through the end of the study period. There was a clear increase over the last few years of the study in the number of drugs with more than 10% annual increases in WAC, which has also shown a rebound after the economic crisis at the end of the last decade. CONCLUSIONS: Specialty drugs are getting more expensive at a faster rate over time. The period from 2010 to 2013, the final year of this study, has also seen biologic agents take a more prominent role in driving these annual increases in WAC. DISCLOSURES: No funding was provided for the commission of this study. The source data was provided by the University of Illinois at Chicago Ambulatory Care Pharmacy Department and described de-identified data from customer transactions from 2002 through 2013. The authors report no conflicts of interest. Study concept and design and data interpretation were contributed by Stubbings and Penington. The manuscript was written primarily by Penington with assistance from Stubbings.

Pilot assessment of patient satisfaction and clinical impact of Medicare Part D in diabetic geriatric patients

Objectives: To assess patients’ 1) satisfaction with their decision to enroll or not enroll in the Medicare Part D program, and 2) clinical status of diabetes before and after decision to enroll in Medicare Part D. Methods: Patients 65 years or older were enrolled in the study from November 2006 through February 2007. Patients were screened by a clinical pharmacist at their clinician visit and administered a Medicare Part D satisfaction survey. Upon completion of the survey, a retrospective chart review was completed in diabetic patients who were enrolled in Medicare Part D to assess goal attainment of glycosylated hemoglobin (HbA1c), low-density lipoprotein (LDL) and blood pressure. Pre-enrollment values were obtained in the 6 months prior to the start of Medicare Part D enrollment (July 1- December 31, 2005). Post-enrollment values were obtained after enrollment was complete for the 2006 year (May 1- October 31, 2006). Results: Results show that 74% (60/81) of patients surveyed were enrolled into the Medicare Part D program, including patients who have dual eligibility. Of the 60 patients who were enrolled in Medicare Part D, 48 patients (80.0%) responded that they were satisfied with their decision to enroll. Clinical outcomes were unchanged from the pre-enrollment to the post-enrollment periods. Mean HbA1c was 7.47% in the pre-enrollment period and 7.25% post-enrollment (difference pre-post = 0.23; 95%CI = -0.28 to 0.73). There was no change in LDL in the two time periods (pre = 79.4 mg/dL; post = 79.7; difference pre-post = -0.25; 95%CI = -13.6 to 13.1). Similarly, there were no significant differences observed for blood pressure. Mean systolic blood pressure was 129.5 in the pre-enrollment period and 131.6 in the post-enrollment period (difference pre-post = -2.1; 95%CI = -7.0 to 2.7). Mean diastolic blood pressure was 70.3 for the pre-enrollment period and 70.7 for the post-enrollment period (difference pre-post = -0.4; 95%CI = -4.2 to 3.4). Conclusion: Patients were generally satisfied with their decision to enroll in Medicare Part D. Clinical outcomes were not affected by participation in a Medicare Part D plan. More longitudinal studies are necessary to determine long term impact of Medicare Part D on diabetes management (AU)

Objetivos: Evaluar 1) la satisfacción de los pacientes con la decisión de incluirlos o no en el programa de Medicare Part D, y 2) el estado clínico de la diabetes antes y después de incluirlos en el Medicare Part D. Métodos: Se incluyeron en el estudio pacientes de 65 o más años desde noviembre 2006 a febrero 2007. Los pacientes fueron cribados por un farmacéutico clínico en su visita clínica y se les administró una encuesta de satisfacción sobre Medicare Part D. Después de completar la encuesta, se realizó una revisión del historial en los pacientes diabéticos incluidos en Medicare Part D, para evaluar la consecución de objetivos de hemoglobina glicosilada (HbA1c), lipoproteínas de baja densidad (LDL) y presión sanguínea. Los valores pre-inclusión se obtuvieron en los 6 meses anteriores a comenzar la inclusión en Medicare Part D (1-jul a 31-dic). Los valores post-inclusión se obtuvieron en el año 2006 (1-may a 31-oct). Resultados: El 74% de los pacientes se incluyeron en el programa Medicare Part D, incluyendo los pacientes que tenían doble elegibilidad. De los 60 pacientes incluidos en Medicare Part D, 48 (80,0%) respondieron que estaban satisfechos con la decisión de incluirse. Los resultados clínicos no variaron del periodo pre- al periodo post-inclusión. La HbA1c media fue de 7,47% en el periodo pre- y de 7,25% en el post-inclusión (diferencia pre-post=0,23; IC95%=-0,28 a 0,73). No hubo cambios en las LDL en los dos periodos (pre=79,4 mg/dL; post=79,7; diferencia pre-post= -0,25; IC95%=-13,6 a 13,1). Igualmente, no hubo diferencias en la presión arterial. La media de la presión sistólica fue de 129,5 en el periodo pre- y 131,6 en el periodo post-inclusión (diferencia pre-post=-2,1; IC95%= -7,0 a 2,7). La media de la presión diastólica fue de 70,3 para el periodo pre- y de 70,7 para el periodo post-inclusión (diferencia pre-post= -0,4; IC95%= -4,2 a 3,4). Conclusión: Los pacientes estaban generalmente satisfechos con la decisión de incluirse en el Madicare Part D. Los resultados clínicos no se afectaron por su participación en el plan Medicare Part D. Son necesarios más estudios para determinar el impacto a largo plazo de Medicare Part D en la diabetes (AU)