January 11, 2021
By Russell Spjut, PharmD, owner of Formulary Intel Consulting
Recent updates to preventive measures recommended by the US Preventive Services Task Force (USPSTF) seek to open access to HIV preventive treatment; though the rollout may be confusing for some patients, providers, pharmacies, and even health plans. Under the Public Health Services Act section 2713 non-grandfathered health plans are required to cover items and services covered by USPSTF recommendations with an A or B rating with zero member cost-share.
When the USPSTF creates a new recommendation, covered plans must begin coverage supporting that recommendation no later than the next plan year date, following 12 months from the recommendation’s approval date. This allows plans to prepare for the coverage update including accounting for increased financial impacts and system updates.
On June 11, 2019, the USPSTF published a final recommendation that clinicians should offer preexposure prophylaxis (PrEP) medication treatment to patients who are at a high risk of acquiring and HIV infection. Several factors are included in the recommendation to assess if a patient is at high risk and include items like sexual activity, shared use of needles, and recent history of sexually transmitted infection. If a patient is determined to be high risk, the recommendation is to offer oral medication therapy. The recommendation notes that combination tenofovir disoproxil fumarate and emtricitabine (currently Descovy, Truvada, or generic Truvada) is the only FDA approved medication regimen for PrEP but that tenofovir disoproxil fumarate alone may be considered for certain patients.
The timing of the recommendation, availability of generic preparations of Truvada, and eager anticipation of coverage for PrEP treatment have created some confusion. Covered plans with plan years that began after June 11, 2020 needed to include PrEP coverage with no member cost share. This meant that a handful of plans went live on July 1, 2020, and the months that followed.
Many plans though start of the calendar year, so we did not see a large implementation of coverage until just a couple of weeks ago on January 1, 2021. I heard from patients who were confused why they had to wait for 1/1 while some of their friends had already received coverage. Once I explained the timing they completely understood, but it is not information most would know. Adding to the confusion generic preparations of Truvada became available in September 2020. The generics offered price savings vs the brand alternatives, so choice of medication availability has differed plan to plan. Some cover only the generic at zero cost, some will cover Descovy if the generic is not a viable option for a specific patient, and other plans cover brands and generic options leaving the choice solely to the provider and patient.
The operational considerations of covering the PrEP medication therapies on the pharmacy benefit have also led to some confusion at the pharmacy level as they bill these medications for their patients. As Descovy, Truvada, and generic preparations are approved for both prophylaxis of HIV and the treatment of HIV, many plans have implemented measures to determine which indication the medication has been prescribed for to adjudicate the appropriate copay. As the USPSTF recommendation only covers prophylactic use, plans will likely continue applying the plan’s normal copay if the medication is used for HIV treatment. Common measures being used to determine indication for use include requiring a prior authorization, requiring the pharmacy to submit additional information on the claim such as a submission clarification code, or using historical member claims to infer the member’s likely HIV status. The claims processors I have worked with have tried to provide information about these processes to their network pharmacies and often provide point of sale messaging on the claim response to help guide the pharmacy through the process. A lack of industry standard though will still cause confusion as the pharmacies get used to each of the options.
As with any new procedure, there will be some operational quirks to work out and a learning curve by all parties involved about what these changes mean. At the end of the day though, providing greater access to preventive medications may help decrease the transmission of HIV in the United States. We have made great strides in slowing transmission and increasing life expectancy since HIV first caught our attention in the 1980s.
To me, this recommendation, with increased coverage, feels like a good next step to a goal of making HIV a thing of the past. The confusion surrounding the recent changes should subside as all the parties get used to the new procedures, and I am hopeful we will see a positive impact on the lives of patients we work to care for every day.