Division of Medicaid

Office of the Governor

State of Mississippi
Drug Utilization Review (DUR) Board Meeting

March 4, 2021 at 1:00pm

ZOOM Meeting

Prepared by:
 2021 DUR Board Meeting Dates
March 4, 2021 September 16, 2021
June 10, 2021 December 9, 2021

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 1
As with any analysis, great efforts are made to ensure that the information
reported in this document is accurate. The most recent administrative claims
data available are being used at the time the reports are generated, which
includes the most recent adjudication history. As a result, values may vary
between reporting periods and between DUR Board meetings, reflecting
updated reversals and claims adjustments.
Unless otherwise indicated, all MS-DUR analyses are conducted for the entire
Mississippi Medicaid program including beneficiaries receiving services
through the Medicaid fee-for-service (FFS) and the two Mississippi Medicaid
Coordinated Care Organizations (CCOs). When dollar figures are reported,
the reported dollar figures represent reimbursement amounts paid to
providers and are not representative of final Medicaid costs after rebates.
Any reported enrollment data presented are unofficial and are only for
general information purposes for the DUR Board.
Please refer to the Mississippi Division of Medicaid website for the current
official Universal Preferred Drug List (PDL).
http://www.medicaid.ms.gov/providers/pharmacy/preferred-drug-list/

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 2
 MISSISSIPPI DIVISION OF MEDICAID
OFFICE OF THE GOVERNOR
DRUG UTILIZATION REVIEW BOARD
AGENDA
March 4, 2021
Welcome

Old Business
Approval of December 2020 Meeting Minutes page 5
Resource Utilization Review
Enrollment Statistics page 11
Pharmacy Utilization Statistics page 11
Top 10 Drug Categories by Number of Claims page 12
Top 10 Drug Categories by Amount Paid page 13
Top 25 Drug Molecules by Number of Claims page 14
Top 25 Drug Molecules by Dollars Paid page 15
Top 25 Drug Molecules by Change in Number of Claims page 16
Top 25 Drug Molecules by Change in Dollars Paid page 17
Top 15 Solid Dosage Form High Volume Products By Percent Change In
Amount Paid Per Unit page 18
Follow-up and Discussion from the Board
New Business

MS-DUR Educational Interventions page 21

Special Analysis Projects

HIV Pre-Exposure Prophylaxis page 22
Guest speaker: Dr. James Brock
Epidiolex page 33
Growth Hormones page 45

FDA Drug Safety Updates page 51

Pharmacy Program Update Terri Kirby, RPh

Next Meeting Information

Remaining 2021 Meeting Dates: June 10, September 16, and December 9

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 3
 HIV Pre-Exposure Prophylaxis

BACKGROUND

At its peak in the mid-1990s, Acquired Immunodeficiency Syndrome (AIDS) was the leading cause
of death for individuals aged 25 to 44 years in the United States.1 Despite tremendous advances
in care, data indicate Human Immunodeficiency Virus (HIV) infections continue to be a major
public health problem in the United States and around the world. According to the Centers for
Disease Control and Prevention (CDC), in 2018 over 1 million individuals in the United States and
dependent areas had an HIV diagnosis with an estimated 38,000 new infections occurring that
year.2 While overall trends in new HIV infection rates have decreased in the US, progress has
stalled in recent years.

The disease burden of HIV is disproportionately distributed across the US. The overall rate of HIV
diagnosis in the US in 2018 was 11.5 per 100,000 population. Individuals age 20 to 24 years and
25 to 29 years had the highest rates of HIV diagnoses per 100,000 population at 27.9 and 32.6,
respectively. Incidence among Black/African Americans was more than twice the rate when
compared to other racial/ethnic groups at 39.2.2 Although Southern states make up 38% of the
population, they accounted for 52% of new diagnoses in the US in 2018.2 Drilling down even
further, Mississippi was included among those states with high rates of HIV infections. According
to the 2018 HIV Surveillance Report, there were over 9,000 people living with HIV in Mississippi.3
In 2018, Mississippi was tied with Maryland as having the 6th highest incidence of HIV infection
among adolescents and adults in the US with a diagnosis rate of approximately 19.3 per 100,000
population, while the US average diagnosis rate was 13.6 per 100,000 population.4 (Figure 1)
More specifically, Jackson, Mississippi had the 8th highest diagnosis rate of HIV infections (28.4) for
all metropolitan statistical areas measured in the US.5

FIGURE 1: HIV Diagnosis Rates per 100,000 population for the US in 2018.4

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 22
In 2019, the US Department of Health and Human Services (HHS) launched an initiative, Ending the
HIV Epidemic: A Plan for America.6 This multi-year initiative’s goal was to drastically reduce
incident HIV infections in the US by 90% within 10 years. (Figure 2) The initiative was designed to
rapidly increase utilization of these key components in 48 counties, plus Washington, D.C., and
San Juan, Puerto Rico with the highest number of new HIV diagnoses in 2016 and 2017.
Additionally seven states with a high proportion of HIV diagnoses in rural areas (Mississippi was
included) were added to the focus areas.7

FIGURE 2: Ending the HIV Epidemic: A Plan for America Key Components.6

One of the primary components of this initiative is prevention, which many consider the key to
eliminating HIV.8 Pre-exposure prophylaxis (PrEP) is one aspect of prevention that involves the
use of antiretroviral medications on a routine basis by individuals that are HIV negative who are at
high-risk of being exposed to HIV. Currently, there are two FDA products approved for use as PrEP.
Both products are combination antiretroviral drug formulations consisting of emtricitabine and
tenofovir. The first product approved by the FDA in 2012 to be used for PrEP was Truvada®.9 A
second product, Descovy®, was approved in October 2019.10 Both products are approved for use
in PrEP for adults and adolescents > 35kg to reduce the risk of HIV infection.9,10 A key factor in the
effectiveness of HIV PrEP therapy is adherence. Studies have shown that PrEP can reduce the risk
of acquiring HIV from sex by up to 99% and from injection drug use by 74%, but effectiveness was
highly associated with the degree of adherence.11

In 2019 the US Preventive Services Task Force (USPSTF) issued updated recommendations on PrEP
for the prevention of HIV infection. After a systematic review of evidence, PrEP was found to be of
substantial benefit in decreasing the risk of HIV infection among high-risk persons. Adherence to
PrEP was highly associated with efficacy at preventing HIV infection, and PrEP use was associated

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 23
with minimal harms.12 Categories of individuals identified by USPSTF as high-risk for acquiring HIV
infection include:

o Men who have sex with men, are sexually active, and have 1 of the following
characteristics:
• A serodiscordant sex partner (i.e., in a sexual relationship with a partner living with HIV)
• Inconsistent use of condoms during receptive or insertive anal sex
• A sexually transmitted infection (STI) with syphilis, gonorrhea, or chlamydia within the
past 6 months
o Heterosexually active women and men who have 1 of the following characteristics:
• A serodiscordant sex partner (i.e., in a sexual relationship with a partner living with HIV)
• Inconsistent use of condoms during sex with a partner whose HIV status is unknown
and who is at high risk (e.g., a person who injects drugs or a man who has sex with
men and women)
• An STI with syphilis or gonorrhea within the past 6 months
o Persons who inject drugs and have 1 of the following characteristics
• Shared use of drug injection equipment
• Risk of sexual acquisition (see above)

For Mississippi Division of Medicaid beneficiaries, PrEP medications are covered under the
Universal Preferred Drug List (UPDL). Both branded Truvada® and Descovy® are preferred agents
available without prior authorization requirements. To further increase access to PrEP products,
DOM’s Family Planning Waiver is available to women and men to receive family planning related
services, including many medications for the treatment of sexually transmitted infections/ sexually
transmitted diseases (STIs/STDs). The two medications currently approved for PrEP use are
included on the list of medications covered under the Waiver.

MS-DUR conducted an analysis assessing the utilization of PrEP products in Mississippi Medicaid
between 2014 and 2020. A summary of those findings follows.

METHODS

A retrospective analysis was conducted using Mississippi Medicaid fee-for-service (FFS) and
coordinated care organization [CCOs: United Healthcare (UHC), Magnolia (MAG), and Molina
(MOL)] claims for the period of January 1, 2014 to November 30, 2020. The identification period
for beneficiaries on HIV Pre-Exposure Prophylaxis (PrEP) was January 1, 2014 to October 31, 2020,
which allowed for a 12 month look back period and a 30-day follow-up period for every
beneficiary in the sample. MS-DUR has complete medical claims in its database beginning CY
2013. Beneficiaries on (PrEP) were identified according to the algorithm developed by Wu et.al.
which is used by CDC.13,14 Beneficiaries aged ≥ 16 years who were prescribed tenofovir and
emtricitabine (TDF+FTC or TAF+FTC) for PrEP were included in the sample. The first claim was
assigned as the index date. Dual eligible beneficiaries and those age > 64 years were excluded
from the study sample. Additionally, beneficiaries with a diagnosis code for Hepatitis B (HBV) or an

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 24
HIV infection (assessed from medical claims) at any time before or within 30 days after the index
date were excluded from analysis.13 All 25 ICD 10 diagnosis codes as well as the principal diagnosis
code of each claim were checked from inpatient, outpatient and medical claim files to identify
beneficiaries with HIV or HBV. Beneficiaries having a prescription intended to treat HIV or HBV
(assessed from pharmacy claims), at any time before or within 30 days after the index date, were
excluded from analysis.13 Finally, beneficiaries prescribed TDF+FTC or TAF+FTC for Post-Exposure
Prophylaxis (PEP), identified as those with a prescription for ≤ 28 continuous days, were excluded
from the analysis.14 Figure 3 provides a description of the attrition associated with the algorithm
used.

FIGURE 3: Sample Attrition for Beneficiaries on PrEP Therapy

Plan was determined as of index date (earliest prescription fill date for PrEP). Information on
beneficiaries’ race, gender, age, and plan (FFS/UHC/MAG/MOL) were summarized in the analysis
(Table 1). Age and plan were assessed as of index date. Trends in number of people utilizing PrEP
was reported according to the plan as of index date, for each year from 2014-2020 (Figure 4 &
Figure 5). PrEP utilization patterns for beneficiaries on PrEP were reported according to plan at
index date in terms of mean duration of continuous use and length of continuous use in the
following categories 29-60 days, 61-90 days and 91 days or more (Table 2). Continuous use was
defined as continuous PrEP use with a maximum allowable gap of up to 14 days between
consecutive prescription fills after adjusting for early refills. Code of eligibility (COE) for each index
PrEP fill was reported by plan in Table 3. County level distribution of number of unique providers
that prescribed PrEP during the study period was reported in Figure 6.

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 25
RESULTS

In Table 1 demographic characteristics of beneficiaries initiated on pre-exposure prophylaxis

(PrEP) between January 1, 2014 and October 31, 2020 are displayed.
• A total of 159 beneficiaries were initiated on PrEP therapy.
• 71.7% were between the ages of 18-35 years.
• 55.3% were male.
• 75.5% were African American.

Figure 4 displays yearly trends in beneficiaries initiating PrEP Therapy.

• The maximum number of annual initiates of PrEP therapy occurred in 2019 with 40
beneficiaries.
• 2020 saw a 30% drop compared to 2019.

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 26
FIGURE 5 also shows a decrease in 2020 in the total number of beneficiaries having a PrEP
prescription claim. These declines follow national trends associating the coronavirus disease 2019
(COVID-19) pandemic with changes in PrEP utilization. 15

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 27
Length of therapy patterns for Medicaid beneficiaries prescribed PrEP products is detailed in Table
2.
• Mean length of therapy across all programs was 72.46 days.
• The majority of beneficiaries (104/159) appear to have taken PrEP < 60 days.

As mentioned earlier in the report, PrEP therapy is covered under Medicaid’s Family Planning
Waiver. Of the 159 beneficiaries started on PrEP therapy, 53 were covered under the Family
Planning Waiver as of the index fill date. (Table 3)

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 28
One of the key components to initiating PrEP therapy is beneficiary access to providers that will
identify high-risk individuals and prescribe PrEP. Providers were identified across the state that
had prescribed PrEP to Medicaid beneficiaries during the study period. (Figure 6)

FIGURE 6: Distribution of Unique Providers Prescribing PrEP by County

A total of 76 Providers across 20 counties prescribed PrEP therapies to Medicaid beneficiaries

between 2014–2020.
• Hinds county accounted for 48.7% (37) of the providers prescribing PrEP therapies.
• Only 24.4% (20) of the 82 counties in MS had a provider prescribe PrEP to a
Medicaid beneficiary.
• 55% (11/20) of the counties where PrEP was prescribed only had 1 provider.

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 29
CONCLUSIONS

HIV infections continue to be a major public health issue in the United States, with Mississippi
among the highest states in the nation in HIV incidence rates. One of the keys to ending the HIV
epidemic is prevention through PrEP. PrEP therapy is covered under Medicaid’s UPDL with no
prior authorization criteria needed and is also included under the Family Planning Waiver. Even
with no restrictions to access, there have been only 159 beneficiaries initiated on PrEP therapy
since January 2014. In order for PrEP therapy to be effective in reducing incident HIV infections in
Mississippi, more high-risk individuals need to be identified and initiated on PrEP therapy.

RECOMMENDATION

1. The Division of Medicaid should conduct provider education on PrEP therapy to include:
• Incidence rates for HIV infections in Mississippi;
• Categories of individuals identified as being high-risk for acquiring HIV infection;
• Preferred status of PrEP products on UPDL;
• Inclusion of PrEP products as covered medications under the Family Planning
Waiver for both males and females;
• Need for more providers around the state to identify high-risk beneficiaries and
prescribe PrEP.

2. MS-DUR to conduct future research related to PrEP utilization in the Medicaid population
to include:
• Compare sociodemographic, clinical, and social determinant of health
characteristics between PrEP utilizers and those newly diagnosed with HIV
infections;
• Assess PrEP persistence patterns and predictors of PrEP persistence;
• Assess geographical disparities in PrEP uptake and persistence;
• Assess potential barriers to PrEP therapy (social stigma, provider stigma,
adherence, lab monitoring, etc.).

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 30
REFERENCES:

1. Hariri S, McKenna MT. Epidemiology of Human Immunodeficiency Virus in the United

States. Clin Microbiol Rev. 2007;20(3):478-488. doi:10.1128/CMR.00006-07

2. HIV Surveillance Report 2018 (updated). 31:119.

3. AIDSVu - Mississippi|2018. AIDSVu. Accessed September 9, 2020. http://aidsvu.org/local-

data/united-states/south/mississippi/

4. HIV Diagnoses, Adults and Adolescents. The Henry J. Kaiser Family Foundation. Published
February 10, 2020. Accessed February 26, 2020. https://www.kff.org/hivaids/state-indicator/hiv-
diagnoses-adults-and-adolescents/

5. HIV Surveillance Data Tables | Reports | Resource Library | HIV/AIDS | CDC. Published
September 3, 2020. Accessed September 9, 2020.
https://www.cdc.gov/hiv/library/reports/surveillance-data-tables/vol-1-no-3/index.html

6. Fauci AS, Redfield RR, Sigounas G, Weahkee MD, Giroir BP. Ending the HIV Epidemic: A Plan
for the United States. JAMA. 2019;321(9):844. doi:10.1001/jama.2019.1343

7. Federal Response, Policy H, July 02 Hhsd last updated:, 2020. Federal-Response|Ending-

the-HIV-Epidemic|Overview. HIV.gov. Published July 2, 2020. Accessed September 9, 2020.
https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview

8. Poku NK. HIV Prevention: The Key to Ending AIDS by 2030. Open AIDS J. 2016;10:65-77.
doi:10.2174/1874613601610010065

9. Truvada - MICROMEDEX. Accessed February 23, 2020.

https://www.micromedexsolutions.com/micromedex2/librarian/CS/51F374/ND_PR/evidencexper
t/ND_P/evidencexpert/DUPLICATIONSHIELDSYNC/C72358/ND_PG/evidencexpert/ND_B/evidence
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oard?docId=928216&contentSetId=100&title=Emtricitabine%2FTenofovir+Disoproxil+Fumarate&s
ervicesTitle=Emtricitabine%2FTenofovir+Disoproxil+Fumarate&brandName=Truvada#

10. Descovy- MICROMEDEX. Accessed February 23, 2020.

https://www.micromedexsolutions.com/micromedex2/librarian/CS/116FB3/ND_PR/evidencexper
t/ND_P/evidencexpert/DUPLICATIONSHIELDSYNC/5C75F6/ND_PG/evidencexpert/ND_B/evidence
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oard?docId=931813&contentSetId=100&title=Emtricitabine%2FTenofovir+Alafenamide&servicesT
itle=Emtricitabine%2FTenofovir+Alafenamide&brandName=Descovy#

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 31
11. Riddell J, Amico KR, Mayer KH. HIV Preexposure Prophylaxis: A Review. JAMA.
2018;319(12):1261-1268. doi:10.1001/jama.2018.1917

12. US Preventive Services Task Force, Owens DK, Davidson KW, et al. Preexposure Prophylaxis
for the Prevention of HIV Infection: US Preventive Services Task Force Recommendation
Statement. JAMA. 2019;321(22):2203-2213. doi:10.1001/jama.2019.6390

13. Wu H, Mendoza MCB, Huang Y-LA, Hayes T, Smith DK, Hoover KW. Uptake of HIV
Preexposure Prophylaxis Among Commercially Insured Persons-United States, 2010-2014. Clin
Infect Dis Off Publ Infect Dis Soc Am. 2017;64(2):144-149. doi:10.1093/cid/ciw701

14. Furukawa NW, Smith DK, Gonzalez CJ, et al. Evaluation of Algorithms Used for PrEP
Surveillance Using a Reference Population From New York City, July 2016-June 2018. Public Health
Rep Wash DC 1974. 2020;135(2):202-210. doi:10.1177/0033354920904085

15. Pampati S, Emrick K, Siegler AJ, Jones J. Changes in sexual behavior, PrEP adherence, and
access to sexual health services due to the COVID-19 pandemic among a cohort of PrEP-using
MSM in the South. JAIDS J Acquir Immune Defic Syndr. 2021;Publish Ahead of Print.
doi:10.1097/QAI.0000000000002640

Mississippi Division of Medicaid DUR Board Packet (Ver 1) – March 2021 - Page 32