What is the estimated out-of-pocket expense for a patient with no underlying medical conditions seeking Pre-Exposure Prophylaxis (PrEP) with emtricitabine (Emtriva)/tenofovir disoproxil fumarate (Truvada)?

Out-of-Pocket Costs for PrEP

Most patients with commercial insurance can access PrEP with zero or minimal out-of-pocket costs when utilizing manufacturer copay assistance programs, though uninsured patients face substantial barriers with list prices around $2,000 per month. 1, 2

Cost Landscape for Insured Patients

The majority of commercially insured patients (86%) successfully use manufacturer copay cards to reduce their out-of-pocket medication costs to $0. 2 In a cohort of 63 patients initiating PrEP through a specialty pharmacy model, the median total out-of-pocket medication cost was $0 (interquartile range $0-$0). 2

However, the underlying reality is more complex:

• The list price for emtricitabine/tenofovir disoproxil fumarate is approximately $2,000 per month, creating a significant financial barrier before assistance programs are applied. 1
• High levels of cost-sharing can leave insured users with more than $1,000 in annual out-of-pocket costs when manufacturer assistance is not utilized or unavailable. 1
• Patient deductibles, monthly premiums, copayments, and coinsurance vary widely across insurance plans and may substantially increase the financial burden. 1

Insurance Coverage and Prior Authorization

Insurance prior authorization was required in only 27% of patients in one specialty pharmacy cohort, and all requests were approved. 2 This suggests that when PrEP is prescribed appropriately with proper documentation, insurance approval is generally obtainable. 2

The CDC explicitly acknowledges that ARV medications are expensive and persons in need may be unable to cover out-of-pocket costs, emphasizing the need for thorough assessment of patients' ability to obtain a full course of medication. 3

Assistance Programs for Uninsured or Underinsured Patients

When public, privately purchased, or employer-based insurance coverage is unavailable, healthcare professionals can assist patients with obtaining ARV medications through pharmaceutical company medication assistance programs. 3 These programs have online applications or established phone lines, though requests often need urgent handling to avoid medication delays. 3

Drug payment-assistance programs have made PrEP more affordable to uninsured and underinsured users, though lack of insurance remains a barrier to PrEP accessibility. 1

Generic Availability Considerations

The FDA approved a generic version of emtricitabine/tenofovir disoproxil fumarate in 2017; however, that version has not been widely distributed to US consumers and may not be substantially more affordable. 1 Healthcare professionals should be aware that generic ARV options are available among recommended PrEP regimens, which may reduce costs. 3

Common Pitfalls to Avoid

• Do not assume all patients can afford PrEP without explicitly discussing cost and assistance programs. 3 Ensuring PrEP access requires thorough assessment of costs and patients' ability to obtain medication. 3
• Pharmacy dispensing practices can create barriers, as some pharmacies require calling prescribers for 28-day ARV scripts due to 30-day supply bottle packaging. 3 Consider prescribing a 30-day supply with instructions that the course is complete after 28 days. 3
• Do not delay PrEP initiation while arranging financial assistance. 3 Work urgently to connect patients with manufacturer assistance programs or specialty pharmacy services that can navigate these issues efficiently. 2

Practical Approach for Your Patient

For a patient with no underlying medical conditions seeking PrEP:

1. If commercially insured: Expect $0-$100 out-of-pocket costs with manufacturer copay assistance programs. 2
2. If uninsured: Direct the patient to pharmaceutical company patient assistance programs immediately, as list prices approach $2,000 monthly. 3, 1
3. Connect with specialty pharmacy services that have expertise in navigating insurance approval and manufacturer assistance programs. 2
4. Median time from initial appointment to treatment initiation should be 7 days when financial barriers are appropriately addressed. 2