Does the 340B Program Reach Communities in Need, and How Do Prescription Dispensing Patterns Compare to General Outpatient Dispensing? 2013 Walgreen Co. All rights reserved.
Communities in Need
Does the 340B Program Reach Communities in Need? Chia-Hung (Ed) Chou, PhD 1 ; Bobby Clark, PhD, MSPharm, MHA, MS, MA 2 ; John Hou, PhD 2 ; Elbert S. Huang, MD, MPH 1 ; Rena M. Conti, PhD 1 1 University of Chicago 2 Walgreen Co.; 2013 Walgreen Co. All rights reserved.
Background Since 1992, the 340B program has provided deep acquisition cost discounts for outpatient prescription drugs for qualified healthcare organizations (i.e., covered entities) in the U.S. A 2010 regulatory change expanded the program s reach to include dispensing through qualified contract pharmacies. It is of significant national policy debate whether and how current covered entities serve the original mission of the program to serve the nation s most vulnerable populations.
Objective This study is the first contemporaneous, nationwide examination of whether 340B qualified covered entities and contract pharmacies serve poor, uninsured and medically needy populations. 5
Methods We used the publicly available 340B database maintained by the Health Resources and Service Administration (HRSA) to identify 340B covered entities and contract pharmacies active through December 2012. All 340B covered entities and contract pharmacies were identified by name, city, state, zip code, and year using HRSA s database. Demographic, economic, and health insurance population characteristics were obtained from the Census Bureau (2012 American Community Survey) for each primary care service area (PCSA). 6
Methods (cont.) 340B covered entities and contract pharmacies at each zip code were aggregated to the PCSA level (n=6,527) and then matched to Census Bureau population data (>99% match, all measures). A PCSA, defined by Dartmouth Atlas of Health Care, is considered the smallest discrete service area for primary care. 7
Table 1: 340B Poverty and Uninsured Coverage Indices Census Division CE Poverty Coverage Index CP Poverty Coverage Index CE Uninsured Coverage Index CP Uninsured Coverage Index New England 26.7 58.3 31.7 69.2 Middle Atlantic 13.3 37.3 11.2 31.4 East North Central 12.8 46.3 11.0 39.9 West North Central 22.8 60.7 17.8 47.5 South Atlantic 8.8 27.7 6.2 19.4 East South Central 11.4 44.8 12.4 48.7 West South 9.5 27.7 6.1 17.7 Mountain 11.2 39.7 7.6 26.8 Pacific 16.6 31.3 11.1 21.0 8
Table 2: Demographic Coverage under varying 340B Coverage Scenarios Measured Category PCSAs with covered entities and contract pharmacies Mean (95% CI) (n= 1,949) PCSAs with covered entities only Mean (95% CI) (n= 264) PCSAs with contract pharmacies only Mean (95% CI) (n= 1,373) 340B Non- Covered PCSA Mean (95% CI) (n= 2,941) Total Mean (95% CI) (n= 6,527) Population per PCSA 91,397 97,572) 17,186 20,588) 53,565 56,687) 14,524 15,378) 45,799 (85,221- (13,783- (50,444- (13,671- (43,644-47,954) Percent in 12.6 12.9 9.9 10.6 11.2 poverty (12.3-12.9) (12.0-13.8) (9.6-10.2) (10.4-10.9) (11.0-11.3) Percent 17.2 16.8 15.7 16.6 16.6 uninsured (17.0-17.5) (16.1-17.4) (15.4-16.0) (16.4-16.9) (16.5-16.8) Percent 22.7 19.9 17.3 14.0 17.5 minority (21.8-23.6) (17.3-22.5) (16.4-18.1) (13.4-14.6) (17.1-18.0)
Key Findings Sixty-six percent of PCSAs do not have covered entities. The percent in poverty, percent uninsured, and percent minority were higher in PCSAs with both covered entities and contract pharmacies than PCSAs without either. Contract pharmacies have coverage indexes approximately 2 to 4 times larger than covered entities. 10
Conclusion Our findings strongly suggest currently 340B qualified covered entities and contract pharmacies serve vulnerable populations. Our results also suggest 340B qualified contract pharmacies may have broader geographical reach to serve vulnerable populations than covered entities do. The majority of primary service areas have significant vulnerable populations without 340B coverage by qualified healthcare organizations. 11
Implications for Policy or Practice This study supports the contention that the current 340B program, including recent expansions to include contract pharmacies, likely serves its intended patient population. Whether and how the 340B program ensures access to needed comprehensive medical services is critical for policy makers to evaluate whether and how the 340B program could be expanded to serve vulnerable populations without current 340B coverage. 12
Prescription Dispensing Patterns
National outpatient prescription dispensing patterns through contract pharmacies serving the 340B drug discount program in 2012 Bobby Clark, PhD, MSPharm, MHA, MS, MA 1 ; John Hou, PhD 1 ; Chia-Hung (Ed) Chou, PhD 2 ; Elbert S. Huang, MD, MPH 2 ; Rena M. Conti, PhD 2 1 Walgreen Co.; 2 University of Chicago 2013 Walgreen Co. All rights reserved.
Study Design We provide the first national description of 340B-qualified prescriptions compared to all prescriptions dispensed in contract pharmacies. The data were derived from 2012 prescriptions dispensed at Walgreens, the market leader in 340B contract pharmacies.
Objective Little is known regarding which drugs are dispensed under the expansion. To describe national, contemporaneous 340B qualified prescriptions compared to all prescriptions dispensed in the contract pharmacy setting.
Table 1. Medication Dispensing by Therapeutic Class (2012): Ranked by Top 10 340B Classes Therapeutic Class Rank Order Script Proportion Generic Dispensing Rate 340B All Rx s Fills as % of all 340B Rx s Fills as % of all Rx s P-Value 340B All Rx s a P-Value Antivirals 1 31 10.6% 0.9% <.0001 10.6% 74.6% <.0001 Antiasthmatic & bronchodilator agents 2 6 9.7% 3.2% <.0001 5.9% 18.5% <.0001 Antidiabetics 3 5 6.9% 3.6% <.0001 24.9% 58.8% <.0001 Antihyperlipidemics 4 4 6.1% 5.3% <.0001 48.4% 70.2% <.0001 Antihypertensives 5 3 6.0% 6.3% <.0001 67.9% 82.5% <.0001 Antidepressants 6 2 5.1% 6.3% <.0001 75.4% 87.3% <.0001 Analgesics - opioid 7 1 5.0% 8.7% <.0001 88.4% 94.3% <.0001 Ulcer drugs 8 7 3.9% 3.2% <.0001 63.0% 79.6% <.0001 Dermatologicals 9 10 3.3% 2.9% <.0001 75.7% 77.2% <.0001 Anticonvulsants 10 11 3.0% 2.9% <.0001 81.2% 88.9% <.0001 All classes total 53.8% 82.3%
Table 2. Specialty Medication Dispensing by Therapeutic Class: Ranked by Top 10 340B Specialty Classes Therapeutic Class Rank Order Script Proportion Generic Dispensing Rate 340B Specialty Rx s % of 340B Specialty Rx s % of All Specialty Rx s P-Value 340B All Specialty Rx s a P- Value Antivirals 1 2 89.8% 24.9% <.0001 2.3% 7.4% <.0001 Assorted classes 2 1 4.5% 25.5% <.0001 74.5% 84.3% <.0001 Anticoagulants 3 4 1.5% 13.0% <.0001 87.6% 93.6% <.0001 Analgesics - anti-inflammatory 4 5 0.9% 6.7% <.0001 0.0% 0.0% 1.000 Digestive aids 5 6 0.8% 4.0% <.0001 3.4% 0.0% <.0001 Endocrine and metabolic agents - misc. Antineoplastics and adjunctive therapies Psychotherapeutic and neurological agents - misc. 6 3 0.8% 14.8% <.0001 24.9% 60.0% <.0001 7 7 0.6% 2.3% <.0001 2.7% 6.4% <.0001 8 10 0.2% 1.4% <.0001 0.0% 0.0% 1.000 Hematopoietic agents 9 11 0.2% 0.9% <.0001 0.0% 0.0% 1.000 Antipsychotics/antimanic agents 10 9 0.1% 1.4% <.0001 10.6% 35.6% <.0001 All specialty classes total 7.1% 33.3% <.0001
Table 3. Specialty Medication Dispensing by Drug Name and Indication: Ranked by 340B Specialty Drugs Drug Name Therapeutic Class Subclass/ indications Truvada Antivirals Antiretroviral/HIV Atripla Antivirals Antiretroviral/HIV Norvir Antivirals Antiretroviral/HIV Reyataz Antivirals Antiretroviral/HIV Prezista Antivirals Antiretroviral/HIV Isentress Antivirals Antiretroviral/HIV Epzicom Antivirals Antiretroviral/HIV Kaletra Antivirals Antiretroviral/HIV Complera Antivirals Antiretroviral/HIV Viread Antivirals Antiretroviral/HIV Rank on Script Count Percent of total by drug 340B All Specialty 340B All Specialty P-Value 1 6 16.39% 3.40% <.0001 2 5 14.85% 3.67% <.0001 3 10 14.75% 2.82% <.0001 4 18 8.04% 1.37% <.0001 5 15 6.63% 1.57% <.0001 6 17 6.44% 1.46% <.0001 7 23 3.31% 0.85% <.0001 8 22 2.56% 0.91% <.0001 9 47 2.20% 0.39% <.0001 10 16 2.09% 1.50% <.0001
Key Findings Approximately 500 million prescriptions were identified for this analysis; 340B prescriptions amounted to less than one-half percent of the total. By volume, the same six therapeutic classes were ranked among the top ten for 340B and all prescriptions: Antivirals, antiasthmatics, antidabetics, antihyperlipidemics, antihypertensives, and antidepressants. Antivirals accounted for 10.6% of 340B prescriptions compared to 0.9% of all prescriptions, antiasthmatics accounted for 9.7% versus 3.2%, and antidiabetics accounted for 6.9% versus 3.6%.
Key Findings (cont.) Specialty medications accounted for 9% of 340B prescriptions and 0.4% of all prescriptions. Generic drugs accounted for 54% of 340B prescriptions and 82% of all prescriptions. Antivirals were the most dispensed therapeutic class among 340B specialty medications and accouned for 89.8% of all dispensing. The top ten 340B specialty drugs by dispensing volume were all antiretrovirals indicated for HIV. 21
Conclusion Drugs used to treat chronic diseases, including hypertension, cholesterol disorders, diabetes, and asthma dominated all and 340B prescriptions. However, antiviral drugs used to treat HIV/AIDs and hepatitis-b, antiasthmatic drugs, and antidiabetic drugs were much more commonly dispensed among 340B prescriptions. 340B prescriptions also exhibited a much higher specialty drug percentage and a much lower generic percentage compared to all prescriptions.
Implications for Policy or Practice Our results strongly suggest contract pharmacies dispense drugs that serve the general chronic disease burden of the US population. Among 340B prescriptions, contract pharmacies also appear to disproportionately serve one vulnerable population targeted by the 340B program, individuals suffering from HIV/AIDS. Research is needed to better understand the rationales underlying the low generic percentage and high specialty percentage of 340B prescriptions.
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