Louis Ledan, PharmD

Insurance companies are currently investigating the option of modifying which medications they will cover for HIV pre-exposure prophylaxis (PrEP) therapy, with broad implications for patient access considering the limitations of the patient populations who will be able to use one of the drugs.

PrEP is a medication used to prevent HIV infection in patients most at risk of infection.

In October 2019, the FDA approved tenofovir alafenamide/emtricitabine (TAF/FTC, Descovy, Gilead Sciences) for PrEP;

 however, recent research has challenged whether the medication is worth the price.

The 2 FDA-approved medications for PrEP are tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, Truvada, Gilead Sciences) and TAF/FTC.

 TDF/FTC is approved for all adults and adolescents at risk of contracting HIV, whereas TAF/FTC has a more selective approval status.

Currently, TAF/FTC is approved for use by adults and adolescents, but not for adults and adolescents who are at risk of contracting HIV through vaginal sex.

 This is due to its still pending approval by the FDA for protection against HIV transmission through vaginal sex. An additional difference between the 2 drugs is that TAF/FTC showed more positive effects on bone mineral density and kidney safety than TDF/FTC.

The debate over drug insurance companies covering 1 of these drugs but not both has potentially far reaching implications. Since the 2 drugs have not been tested and approved for use among the same populations, making comparisons between the 2 becomes challenging.

 the authors explained, “It would be a clinical leap of faith to use TAF/FTC instead of TDF/FTC in other populations.”

The authors also noted that in the future, in order to avoid this issue, no HIV prevention drug should be allowed to undergo FDA review without first testing the drug among all key populations at risk for HIV.

Another factor to consider in the debate regarding which drug should be covered is there are already hundreds of thousands of people taking TDF/FTC.

 Switching these patients to another medication might disrupt adherence and have other unforeseen consequences, including cost considerations.

Currently, PrEP therapy with TDF/FTC is approximately $24,000 a year. TDF/FTC is scheduled to have a generic released later this year, which should be more cost-effective, but this has not yet occurred while the debate regarding coverage continues.

In order to address this debate, 1 insurance company has already made their decision. UnitedHealthcare announced starting September 1, 2020, that TDF/FTC will be the only covered medication for PrEP until a generic hits the market.

 In light of this decision, it may be possible that the pressure to save money will force other insurance companies to follow suit in the coming months. 

U.S. Department of Health & Human Services. Using HIV Medication to Reduce Risk: Pre-Exposure Prophylaxis. HIV.gov. Published 2020. 

hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis#:~:text=Approved%20for%20PrEP%3F,Currently%2C%20there%20are%20only%20two%20FDA%2Dapproved%20medications%20for%20PrEP,the%20brand%20name%20Descovy%C2%AE

Haefner M. United Healthcare changes coverage for Gilead’s new HIV prevention drug. 

beckershospitalreview.com/payer-issues/unitedhealthcare-changes-coverage-for-gilead-s-new-hiv-prevention-drug.html

Mayer K H, Molina JM, Thompson MA, et al. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. 

thelancet.com/journals/lancet/article/PIIS0140-6736(20)31065-5/fulltext

Shaw M. In Debate Over PrEP, Researchers Raise Question About Benefit vs Value. 

ajmc.com/view/in-debate-over-prep-researchers-raise-questions-about-benefit-vs-value-

Articles

Insurance companies are currently investigating the option of modifying which medications they will cover for HIV pre-exposure prophylaxis (PrEP) therapy, with broad implications for patient access.

Addressing the Debate Regarding Coverage for PrEP

Adding a few practices to one’s daily routine can help to mitigate the effects from some of the challenges in daily life that can impair mental cognition.

Mental cognition encompasses attention, knowledge acquisition, memory formation, memory storage, and the ability to reason.

 There are numerous factors that impair our mental cognition, such as drugs, alcohol, and diet. Some common elements of modern life that can exacerbate these problems include the innumerable distractions of daily life, lack of exercise, and insufficient sleep that plagues many people today.

However, there are some activities that can help to boost mental cognition and overall brain health.

Meditation has been shown to improve mental cognition and the effects can be felt in less than 1 week.

 In a study, 22 college-aged students with no meditation experience underwent 4 separate 20-minute meditation sessions.

In the study, the participants were asked to close their eyes, relax, and focus on the flow of their breath occurring at the tip of their nose. When thoughts arose, they were told to notice, acknowledge, and let go of those thoughts by bringing focus back to the breath.

After just 4 days, the participants showed a significant benefit in several cognitive activities that involve sustained attention and executive processing efficiency.

In terms of overall health, few things are as beneficial as physical activity. Physical activity helps to lower the risk of cardiovascular disease, cerebrovascular disease, hypertension, diabetes, cancer, and obesity.

In addition, years of research point to an inverse relationship between physical activity and cognitive decline.

 The mechanism by which physical activity improves mental cognition seems to involve an increase in neural plasticity along with the upregulation of neuronal proliferation and anti-inflammatory processes.

Specifically, recent research indicates a neurotrophin called brain-derived neurotrophic factor (BDNF) increases during physical activity.

 Elevated BDNF levels have been shown to be positively correlated with better mental cognition.

Sleep is a key component of proper cognitive functioning.

 Several cognitive functions, such as attention, reasoning, and memory, can be impaired with just a few hours of sleep loss.

 Proper sleep can even boost mental cognition above normal conditions, especially when it comes to memories.

During sleep, memories acquired before sleep are consolidated, facilitating the acquisition of new memories during the next waking day.

 This is done with the help of sleep-specific brain oscillations that cause the neuronal reactivation of memories that boost mental cognition.

 Research into ways of manipulating these sleep-specific brain oscillations is being done to help in the treatment of people with memory dysfunctions.

Meditation, sleep, and physical activity are just a few of the ways possible to boost mental cognition. Unfortunately, more obstacles are being introduced into our lives that hinder our ability to calm our minds, exercise, and sleep a sufficient amount. For this reason, finding the time to incorporate cognition-boosting strategies into our daily routine is becoming ever more important.   

Psychology Today. Cognition. 2020. Accessed August 15, 2020. psychologytoday.com/us/basics/cognition

Zeidan, Fadel, et al. "Mindfulness meditation improves cognition: Evidence of brief mental training." Consciousness and cognition 19.2 (2010): 597-605.

Phillips, Cristy. "Lifestyle modulators of neuroplasticity: how physical activity, mental engagement, and diet promote cognitive health during aging." Neural plasticity (2017).

Sofi, Francesco, et al. "Physical activity and risk of cognitive decline: a meta‐analysis of prospective studies." Journal of internal medicine 269.1 (2011): 107-117.

Belviranli, Muaz, et al. "The relationship between brain-derived neurotrophic factor, irisin and cognitive skills of endurance athletes." The Physician and sportsmedicine 44.3 (2016): 290-296

Diekelmann, Susanne. “Sleep for cognitive enhancement.” Frontiers in systems neuroscience vol. 8 46. 2 Apr. 2014, doi:10.3389/fnsys.2014.00046.