Letter on MassHealth coverage of long-acting injectable PrEP

Mike Levine
Acting Director of MassHealth
Acting Assistant Secretary
Massachusetts Executive Office of Health and Human Services
One Ashburton Place
Boston MA 02108

Dear Acting Assistant Secretary Levine,

A number of Massachusetts-based providers, community-based organizations and clinical sites joined us in writing to you in August 2022 to express our concern that MassHealth had not yet added cabotegravir, a new long-acting injectable form of pre-exposure prophylaxis (PrEP) to prevent HIV, to its formulary, and to urge MassHealth to make sure it is available without any barriers to access, such as utilization management or prior authorization requirements.  (A copy of the August letter is attached.)

We are pleased to note that MassHealth added long-acting cabotegravir as PrEP to formulary in September.  We were disappointed, however, that MassHealth (alone among northeastern state Medicaid programs) has imposed prior authorization requirements for beneficiaries prescribed long-acting PrEP.  We have also been disturbed to hear reports from Massachusetts clinicians that they are experiencing continued difficulty with approvals for prior authorization for MassHealth beneficiaries who might benefit from this new HIV prevention modality.   Some of these reports concern patients with a history of difficulty adhering to daily oral PrEP, a compelling reason to prefer a long-acting formulation.  Here are two examples:

• A patient covered by MassHealth CarePlus was prescribed oral emtricitabine/tenofovir disoproxil fumarate as PrEP but has proved unable to take the medication despite leaving the pill bottle in sight. After diagnosis with gonorrhea and chlamydia the patient requested long-acting PrEP, indicating this would “help me take care of myself.”  A prior authorization for injectable PrEP was submitted and denied by MassHealth on the grounds that the patient had not demonstrated “poor response, allergy, negative reaction, or contraindication to a trial of at least 4 medications (if available) in same therapeutic category.”
• A patient with MassHealth Limited coverage with chronic kidney disease had elevated creatinine levels alongside a history of acute kidney injury on oral emtricitabine/tenofovir disoproxil fumarate. Creatinine increased as well when prescribed emtricitabine/tenofovir alafenamide fumarate (Descovy).  A prior authorization for injectable PrEP was submitted, but denied because the creatinine clearance was not yet under 30.  The provider had to resubmit a prior authorization emphasizing the concerning creatinine trajectory on Descovy before MassHealth finally approved coverage.

We are concerned that prior authorization requirements imposed by MassHealth for long-acting PrEP and implemented as described in these two cases will prevent access to new HIV prevention innovations by low-income and disabled Massachusetts residents.  Obstacles to accessing novel PrEP medications also risks worsening widening disparities in access to PrEP between populations.  A recent study[i] has shown that northeastern states have extreme racial/ethnic disparities in PrEP uptake, as measured by the PrEP-to-need ratio, which compares the number of PrEP users with the number of HIV diagnoses in a population:

• Among northeastern White individuals, there are 54.5 people on PrEP for each HIV diagnosis
• Among northeastern Black individuals, there are 5.7 people on PrEP for each HIV diagnosis
• Among Hispanic/Latinx individuals, there are 8.6 people on PrEP for each HIV diagnosis

No other region of the country has such a wide disparity in PrEP uptake between racial/ethnic groups.  With the importance of Medicaid coverage for underserved racial/ethnic groups, MassHealth coverage is key to improving PrEP uptake among Black and Latinx individuals at risk for HIV. 

The United States Preventive Services Task Force has recently released a draft update[1] to its 2019 “A”-rating for PrEP to include long-acting cabotegravir.  The draft update notes that cabotegravir provides a greater reduction in new HIV and improves adherence.   State Medicaid plans covering all USPSTF “A”- and “B”-rated preventive services without cost-sharing receive a 1% increase in the federal medical assistance percentage (FMAP).  CMS guidance has underlined that “states’ utilization review and approval procedures should conform to USPSTF […] periodicity or indications as specified.”[ii]

All state Medicaid programs are obliged to cover all FDA-approved medications manufactured by companies that participate in Medicaid rebate program.  Though states are allowed to institute reasonable prior authorization requirements, we believe the current prior authorization is not reasonable and MassHealth is in effect denying access to injectable PrEP to patients whose providers have determined they would benefit from it.  We note that almost all state Medicaid programs cover PrEP without prior authorization requirements. 

For these reasons, we call on MassHealth to cover long-acting PrEP without prior authorization requirements. 

If you have any questions or comments, please contact Carl Schmid, HIV+Hepatitis Policy Institute at cschmid@hivhep.org or (202) 462-3042; Kevin Herwig, HIV+Hepatitis Policy Institute at kherwig@hivhep.org or (617) 666-6634; or Elizabeth Kaplan, Center for Health Law and Policy Innovation of Harvard Law School at ekaplan@law.harvard.edu.

Sincerely,

Carl E. Schmid, II
Executive Director
HIV+Hepatitis Policy Institute

Elizabeth Kaplan
Health Care Access Director and Clinical Instructor
Center for Health Law and Policy Innovation of Harvard Law School

cc:         Daniel Tsai, Deputy Administrator and Director of Center for Medicaid and CHIP Services, Center for Medicare and Medicaid Services (CMSJohn Coster, Division of Pharmacy, Center for Medicaid and CHIP Services, CMS 
Mary Beckman, Massachusetts Acting Secretary of Health and Human Services
Dr. Jatin Dave, Chief Medical Officer, MassHealth
Kimberly Lenz, Senior Pharmacy Director, Office of Clinical Affairs, MassHealth
Kevin Cranston, Assistant Commissioner and Director, Bureau of Infectious Disease and Laboratory Sciences (BIDLS), Massachusetts Department of Public Health (MDPH)
Dawn Fukuda, Director, Office of HIV/AIDS (OHA), BIDLS, MDPH
Dr. Bisola Ojikutu, Executive Director, Boston Public Health Commission (BPHC)
Dr. Sarimer Sanchez, Director, Infectious Diseases Bureau, BPHC

[1] https://www.uspreventiveservicestaskforce.org/uspstf/draft-recommendation/prevention-human-immunodeficiency-virus-hiv-infection-prep

[i] https://aidsvu.org/local-data/united-states/northeast/

[ii] https://www.medicaid.gov/federal-policy-guidance/downloads/smd-13-002.pdf