Coalition Recommends for Mississippi Division of Medicaid to Eliminate Prior Authorization Requirements
April 4, 2016
David J. Dzielak, Ph.D. Executive
Director Mississippi Division of Medicaid
550 High Street, Suite 1000
Jackson, Mississippi 39202
RE: Recommendation to Eliminate Prior Authorization Requirements
Dear Dr. Dzielak:
We, the undersigned community organizations and clinics, are writing to strongly urge the Mississippi Division of Medicaid to eliminate prior authorization requirements for two antiretroviral medications (Stribild® and Triumeq®) by adding both to the universal preferred drug list. This recommendation is based upon sound scientific evidence as well as our experience serving the more than 10,000 Mississippians living with diagnosed HIV infection.
The HIV epidemic in Mississippi is among the worst in the nation. According to the most recent CDC surveillance data (from 2014), Mississippi ranks 8th among states in rate of new HIV diagnosesi, and Jackson ranks 4th among metropolitan areas.ii The state ranks 5th in rate of new stage three (AIDS) diagnoses.iii Nearly one-third (32%) of those diagnosed with AIDS in Mississippi die within five years.iv Clearly, too few people living with HIV are benefiting from treatment in Mississippi. The state estimates that only 35% of Mississippians with diagnosed HIV infection achieve viral suppression, far below the goal of 80% established by the updated National HIV/AIDS Strategy (NHAS).v,vi For Mississippi to achieve the goals of the NHAS by 2020, the Mississippi Division of Medicaid (DOM) must ensure that all low-income people living with HIV have unfettered access to lifesaving antiretroviral therapy, including the newest and most effective single tablet regimens.
Restricting access to newer single tablet regimens is dangerous for Mississippians living with HIV. The choice of HIV treatment regimen should always depend on a person’s individual needs, as determined by his or her provider, with consideration of possible side effects and potential drug interactions. The current prior authorization requirements and step therapy protocols restrict access to the optimal HIV treatment regimen for some Medicaid beneficiaries with HIV and may permanently limit their future treatment options. Unlike some other conditions, step therapy is never appropriate for persons living with HIV. HIV treatment failure results in drug resistance and viral mutations that limit future therapeutic options and can cause irreversible damage to the immune system. Providers and their patients must be able to select the HIV treatment regimen that will most effectively suppress the virus.
Restricting access to newer single tablet regimens threatens the health of all Mississippians. For a number of years, there has been growing evidence of the benefits of HIV treatment as a prevention method. In 2011, a landmark study, HPTN 052, showed early initiation of antiretroviral treatment for the HIV-positive partner in a serodiscordant couple reduced HIV transmission to the HIV-negative partner by 96 percent.vii A number of follow-up studies since have also reported significant reductions in HIV transmission and numbers of new infections averted.viii, ix, x Consequently, HHS guidelines now recommend that all persons with HIV be offered treatment not only for their own health, but also to significantly reduce the risk of HIV transmission to others. To realize the public health benefits of treatment as prevention (TasP), DOM should consider the efficacy of single tablet regimens in ensuring that Mississippians living with HIV remain virally suppressed. Single tablet regimens simplify pill burden, which has been shown to significantly improve treatment adherence and health outcomes.xi, xii
Restricting access to newer single tablet regimens ignores current research and treatment guidelines. The Pharmacy and Therapeutics Committee has committed to “take into account the best practice guidelines, such as those published by AIDSinfo, a service of the U.S. Department of Health and Human Services or HHS” when conducting clinical reviews.xiii HHS maintains Guidelines for the Use of Antiretroviral Agents that are widely recognized as setting the standard for HIV treatment in the United States. By requiring prior authorization for Stribild® and Triumeq®, DOM is restricting access to two medications that are recommended as first line options for treatment naïve patients. Moreover, the only two single tablet regimens currently on DOM’s universal preferred drug list, Atripla® and Complera®, are no longer recommended for treatment naïve patients. One regimen, Atripla®, was recently downgraded to the alternative regimens category due to concerns about the tolerability of efavirenz in clinical trials and practice, especially the high rate of central nervous system toxicities and a possible association with suicidality.xiv
Requiring prior authorization for newer single tablet regimens is an inefficient use of Mississippi’s limited HIV provider network. HIV requires a highly trained, skilled, and culturally competent workforce to achieve treatment and prevention goals. The Mississippi State Department of Health (MSDH) identified lack of medical providers capable of providing HIV care as a “significant barrier to access to and participating in care for [people living with HIV/AIDS], particularly in rural areas.”xv Notably, there are currently no health care providers who can serve people living with HIV/AIDS in Districts IV and VI.xvi Prior authorization requirements weaken an already fragile HIV care infrastructure in Mississippi by imposing substantial administrative burdens on providers that detract from their ability to care for patients. Indeed, a 2010 American Medical Association survey found that providers spend an average on 20 hours per week (a number that some providers say is too low) on prior authorization activities.xvii
Lastly, the short-term savings from restricting access to newer single tablet regimens will ultimately cost Mississippi more in the long term. While we appreciate the challenges of managing prescription drug costs, any short-term sacrifice in cost will be more than repaid by decreases in other areas of healthcare utilization. Single tablet regimens have been linked to lower hospitalization rates and reduced health care costs.xviii Further, as noted earlier, suppression of viral load achieved through adherence to treatment greatly reduces the likelihood of further transmissions. Each new HIV infection averted saves countless life years and $379,668 in lifetime treatment costs.xix
We share your concern for the health of all Mississippians, especially those living with HIV. For the abovementioned reasons, we strongly urge DOM to promote high quality HIV care for the state’s Medicaid beneficiaries by eliminating prior authorization requirements for Stribild® and Triumeq®. We welcome the opportunity to meet with you to discuss this matter. Please contact Nic Carlisle, executive director of the Southern AIDS Coalition, at (888) 745-2975 or [email protected] for more information.
Thank you for considering our recommendation.
Southern AIDS Coalition
Southern HIV/AIDS Strategy Initiative
Grace House, Inc.
Mississippi Center for Justice
Mississippi GLBT Activism Society
Mississippi in Action Mississippi PLHIV Caucus
Mississippi Rainbow Center
My Brother’s Keeper, Inc.
Cc: Billy R. Brown, Pharm. D. Clinical Assistant Professor of Pharmacy Practice University of Mississippi Nicholas G. Mosca, DDS STD/HIV Director Mississippi State Department of Health
i Centers for Disease Control and Prevention. HIV Surveillance Report: Diagnoses of HIV Infection in the
United States and Dependent Areas, 2014, Table 22; http://www.cdc.gov/hiv/pdf/library/reports/
ii Centers for Disease Control and Prevention. HIV Surveillance Report: Diagnoses of HIV Infection in the
United States and Dependent Areas, 2014, Table 26; http://www.cdc.gov/hiv/pdf/library/reports/
iii Centers for Disease Control and Prevention. HIV Surveillance Report: Diagnoses of HIV Infection in the
United States and Dependent Areas, 2014, Table 23; http://www.cdc.gov/hiv/pdf/library/reports/
iv Reif, S. et al (2014), HIV Diagnoses, Prevalence and Outcomes in Nine Southern States, J Community
Health, DOI 10.1007/s10900-014-9979-7; https://southernaids.files.wordpress.com/2015/01/hivdiagnoses-prevalence-and-outcomes-in-nine-southern-states-final.pdf.
v Mississippi Department of Health, Annual Summary (pending publication).
vi White House Office of National AIDS Policy. National HIV/AIDS Strategy for the United States: Update to
vii Cohen, M.S. et al (2011), Prevention of HIV-1 Infection with Early Antiretroviral Therapy, The New
England Journal of Medicine 365:493-505; http://www.nejm.org/doi/full/10.1056/
viii Baeten, J.M. et al (2012), Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and
Women, The New England Journal of Medicine 367:399-410; http://www.nejm.org/doi/full/10.1056/
ix Thigpen, M.C. et al (2012), Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in
Botswana, The New England Journal of Medicine 367:423-434; http://www.nejm.org/doi/full/10.1056/
x Das, M. et al (2010), Decreases in Community Viral Load Are Accompanied by Reductions in New HIV
Infections in San Francisco, PLOS One 5:e11068; http://journals.plos.org/plosone/article?id=10.1371/
xi Nachega, J.B. et al (2014), Lower Pill Burden and Once-Daily Dosing Antiretroviral Treatment Regimens
for HIV Infection: A Meta-Analysis of Randomized Controlled Trials, Clin Infect Dis. 2014 May:58(9);
xii Sweet D. et al (2014), Real World Medication Persistence with Single Versus Multiple Tablet Regimens
for HIV-1 Treatment, J Int AIDS Soc. 2014 November 2:17; http://www.jiasociety.org/index.php/jias/
xiii Mississippi Division of Medicaid, Pharmacy and Therapeutics Committee Meeting Minutes, August
xiv U.S. Department of Health and Human Services, Guidelines for the Use of Antiretroviral Agents in HIV-1
Infected Adults and Adolescents, April 2015; https://aidsinfo.nih.gov/contentfiles/lvguidelines/
xv Mississippi Department of Public Health, CAPUS Executive Summary, http://www.cdc.gov/hiv/pdf/
xvi See footnote xv.
xvii American Medical Association, Standardization of Prior Authorization Process for Medical Services, June
xviii Cohen, C.J. et al (2013), Association Between Daily Antiretroviral Pill Burden and Treatment Adherence,
Hospitalization Risk, and Other Healthcare Utilization and Costs in a US Medicaid Population with HIV,
BMJ Open 2013;3; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3733306/.
xix Centers for Disease Control and Prevention, HIV Cost-effectiveness, 2014;