Human Immunodeficiency Virus (HIV) remains a notable public health issue in the US, with an estimated 1.2 million individuals living with the virus in 2021. Fortunately, advancements in medication have led to substantial progress in both preventing and treating HIV.

Among the leading medications for HIV is Biktarvy. Since its approval by the FDA in 2018, Biktarvy has quickly emerged as one of the most successful HIV treatments worldwide. By 2021, it was the leading choice for HIV treatment among both newly diagnosed and transitioning patients in the US, and it ranked first for treatment-naïve patients in five significant European markets.

Biktarvy, a complete once-a-day prescription medication, contains bictegravir, emtricitabine, and tenofovir alafenamide. It’s used to treat HIV-1 in adults and children weighing at least 55 pounds, either for those who have never taken HIV-1 medications before or for those replacing their current regimen.

Despite its effectiveness in HIV treatment, Biktarvy’s price has raised concerns. In this article, we explore the intricacies of Biktarvy’s cost, revealing the reasons behind its high price and the factors influencing it.

Key Findings

  • Biktarvy is a leading HIV medication approved by the FDA in 2018, offering a once-a-day regimen and significant efficacy in treating HIV-1 in adults and children.
  • Despite its effectiveness, Biktarvy’s cost is a concern, with prices ranging from $3800 to $4500 for a 30-day supply in the US.
  • Factors contributing to Biktarvy’s high cost include extensive research and development expenses, patent protection, market dynamics, manufacturing costs, and the complexities of the US healthcare system.
  • Manufacturing costs, influenced by raw materials, synthesis methods, and quality control standards, contribute to the overall expense of Biktarvy.
  • Strategies for mitigating Biktarvy’s cost include purchasing from Canadian pharmacies, using commercial insurance coverage, accessing federal assistance programs like Medicaid, Medicare, and the Ryan White HIV/AIDS Program, or seeking support from initiatives like Gilead’s Advancing Access Program and the Patient Access Network Foundation.

How Much Does Biktarvy Cost?

The average retail price of Biktarvy can vary based on factors such as pharmacy location, insurance coverage, and discounts offered. However, as of 2024, the average retail price for a 30-day supply of Biktarvy ranges from approximately $3800 to $4500 in the US. This price may fluctuate over time due to market dynamics and other factors.

Factors Affecting Biktarvy Cost

At first glance, the price tag on Biktarvy may appear excessively high, reaching thousands of dollars per month. So, why is Biktarvy so expensive? Several factors contribute to its high cost:

Research and Development (R&D) Expenses

Researchers developing a concept in a modern laboratory.

Biktarvy has been extensively studied in a diverse adult population for over five years to assess its safety and effectiveness. However, these studies require substantial expenses.

In 2023, Gilead Sciences ranked 12th among the top 25 investors in pharmaceutical R&D, spending $5.7 billion, up from $5 billion in 2022. A significant portion of those funds is being directed towards Gilead’s two established divisions – cell therapy and HIV.

A 2021 study identified several factors influencing R&D costs, including:

  • Discovery and Pre-clinical Development Costs: These include the expenses associated with identifying potential drug candidates and conducting initial testing in laboratory settings before conducting clinical trials in humans.
  • Clinical Development Costs: These are the expenses incurred during the various phases of clinical trials, which involve testing the drug’s safety and effectiveness in human subjects. The study revealed that these expenses account for 50-58% of R&D costs.
  • Capitalization Needs: Companies often need significant financial resources to sustain R&D activities over extended periods. These funds may come from sources like investors or loans. R&D expenses are modified using a rate reflecting the expected return on investment. According to the study, the cost of capital accounted for 33-51% of total expenses per new drug.
  • Industrial, Regulatory, and Policy Environment: Factors like industry regulations, government policies, and the competitive landscape can influence R&D costs. Compliance with regulations and navigating the complexities of the regulatory environment can incur additional expenses.
  • Process Development and Manufacturing Costs: These are the costs associated with scaling up production processes and manufacturing the drug on a larger scale once it has been approved for market release. Estimates revealed that these costs amount to approximately 13-17% of the total R&D budget.

Patent Protection

Pharmaceutical patents are crucial for incentivizing innovation and investment in developing new drugs and treatments. This patent grants them the exclusive right to produce and sell the medication for a certain period, usually around 20 years from the filing date.

In the case of Biktarvy, there are 12 US patents and 363 international patents protecting the drug. These patents grant Gilead Sciences exclusive rights to produce and sell Biktarvy, preventing others from manufacturing generic versions without permission.

Did you know…

In 2022, Gilead Sciences resolved a patent dispute with ViiV Healthcare by paying $1.25 billion. Additionally, Gilead agreed to pay 3% royalties until 2027 on future sales of Biktarvy and any future bictegravir-containing products sold in the US.

This settlement was related to Gilead’s bictegravir, marketed as “Biktarvy,” which was found to have copied the formulation of ViiV Healthcare’s dolutegravir under US Patent 8,129,385 (“patent 385”).

Market Dynamics

Various market factors, including demand and competition, significantly influence Biktarvy’s cost. With limited alternatives and a pressing need for effective HIV treatment, drug companies have the discretion to establish prices based on their assessment of market demand.

Additionally, drug industry leaders often justify high prices by emphasizing the value their drugs provide. For instance, while a $3 million cure may seem steep, it can be viewed as a wise investment if it prevents $10 million in healthcare expenses and lost wages.

Research shows that preventing HIV infections can save a lot of money. Each prevented infection is estimated to save $229,800. Moreover, if all HIV-infected individuals were to present early and remain in care, the total cost savings could reach $338,400 per person.

Manufacturing Costs

Arranging pills by hand in a pharmaceutical production setting.

Several key factors influence the cost of manufacturing Biktarvy. Firstly, the raw materials and ingredients, especially the active pharmaceutical ingredients (APIs), vary in availability and complexity, impacting their prices.

The synthesis of its active substances involves various methods, each affecting costs differently. For instance, emtricitabine undergoes stereoselective synthesis. This means that during its production, certain chemical reactions are manipulated to favor the formation of a particular stereoisomer or enantiomer of emtricitabine.

This ensures that the final product primarily consists of the desired version of emtricitabine with the correct spatial arrangement of atoms, which is important for its effectiveness and safety as a pharmaceutical compound.

Additionally, compliance with quality control standards and regulations further adds to expenses, necessitating specialized resources.

Location

In 2021, a study revealed that drug prices in the US were 2.56 times higher than in 32 other similar countries. This can be attributed to various factors:

  • Lack of Price Regulation: Unlike many other countries where governments negotiate drug prices with pharmaceutical companies, the US has a relatively free-market approach to drug pricing.

Fortunately, the Inflation Reduction Act, passed in 2022, will change this scenario, granting the US government to negotiate drug prices for Medicare recipients. Biktarvy is one of the drugs identified as the most probable candidates for inclusion in the initial rounds of price negotiations, set to occur in 2026 for Part D and in 2028 for Part B. 

  • Direct-to-Consumer Advertising: The US is one of the few countries allowing direct-to-consumer prescription medication advertising. Pharmaceutical companies pour billions of dollars into these advertising campaigns each year, with estimates reaching nearly $8.1 billion in 2022 alone. However, this practice has been linked to higher drug prices.

One such example is the Biktarvy TV advertisement, which aired in mid-March 2019. Despite its relatively short duration, the commercial, ‘Keep Being You,’ amassed nearly $18 million in spending, as reported by the real-time TV ad tracker iSpot.tv.

  • Complex Supply Chain: The US healthcare system has a complex supply chain involving multiple intermediaries, such as pharmacy benefit managers (PBMs) and health insurance companies. Each layer adds administrative costs and markup to the final price of medications.
  • Fragmented Market: The US healthcare system is fragmented, with various insurers, employers, and government programs negotiating drug prices separately. This fragmentation can lead to pricing disparities and reduce purchasers’ bargaining power, resulting in higher prices overall.

Ways to Save on Biktarvy

Living with HIV may result in significant medication costs. However, utilizing available resources can lead to substantial savings. Here are some tips for saving money on Biktarvy:

Buying Biktarvy from a Canadian Mail-Order Pharmacy

Patients seeking to save on Biktarvy and other prescription medications may consider purchasing them through a Canadian mail-order pharmacy. By doing so, customers can potentially save up to 90% on their medication costs compared to prices in the US.

For example, on Pharma Giant, a Canadian mail-order pharmacy partner, Biktarvy is priced at $1684.95 for a 30-tablet supply, significantly lower than prices at US mail-order pharmacies, which can reach up to $4000 for the same quantity. Similarly, Truvada, another HIV medication, costs around $2000 in the US but only $1030 through Pharma Giant.

In addition to lower prices, customers can enjoy further discounts and offers when ordering larger quantities. For new customers, Pharma Giant offers 10% off on their first order using the coupon code FIRST10.

Furthermore, Pharma Giant promises expedited delivery, with medications typically arriving within 3-5 business days, ensuring timely access to essential treatments.

Did you know…

On January 5, 2024, the FDA granted authorization to Florida to import specific prescription drugs from Canada. This landmark decision follows over three years of efforts by Governor Ron DeSantis and his administration to implement an importation plan.

The FDA’s approval, valid for two years, affirms that the program meets safety standards while offering significant cost savings. Florida estimates potential savings of up to $183 million in the first year, primarily benefiting the state’s Medicaid program.

Commercial Insurance Coverage for Biktarvy

Biktarvy, like many medications, is usually covered by different health insurance plans such as employer-sponsored and individual plans. However, coverage can vary based on the plan and formulary.

Patients with insurance covering Biktarvy may have to make a copayment, a fixed amount paid directly at the pharmacy (e.g., $20 per prescription). Alternatively, some plans may require coinsurance, a percentage of the medication cost paid by the patient. For instance, if the coinsurance rate is 20% and the drug costs $1000, the patient pays $200.

Certain insurance plans may need prior authorization before covering Biktarvy. This involves the healthcare provider providing additional information to demonstrate the medication’s medical necessity.

Tips for Navigating Insurance Coverage

  • Review your insurance plan’s formulary to ensure Biktarvy is covered and understand any coverage restrictions or requirements.
  • Check for prior authorization requirements and work with your healthcare provider to complete any necessary paperwork.
  • Stay informed about changes to your insurance plan’s coverage and be proactive in addressing any issues or questions with your insurer.

Federal Assistance Programs for Biktarvy

For those who don’t have a private health insurance or if their insurance doesn’t cover the treatment they require, there are federal initiatives available.

Medicaid

Medicaid is the largest insurer for HIV patients in the US, covering about 40% of nonelderly adults with the virus. It includes services like prescription drugs, inpatient and outpatient care, and preventive measures.

Medicaid eligibility criteria vary by state, and applications or enrollment are open year-round. Typically, coverage is available for adults with children at certain income levels. Moreover, under the Affordable Care Act (ACA), states can expand eligibility to include low-income childless adults who were previously ineligible for Medicaid.

Medicare

Medicare provides comprehensive coverage for many essential healthcare services for individuals either living with HIV or at risk of contracting it. Medicare benefits are categorized into four parts (Part A, B, C, D), each covering different aspects of healthcare.

So, does Medicare cover Biktarvy? Yes, Medicare Part D plans are obligated to cover all approved antiretroviral drugs (ARVs), as outlined by the Centers for Medicare & Medicaid Services (CMS) guidelines and mandated by the Affordable Care Act (ACA).

Additionally, certain ARVs used for treating and preventing HIV are administered by physicians through injections. These injectable medications are covered under Medicare Part B. However, beneficiaries are typically required to pay a 20% coinsurance.

Other services important for people with HIV include:

  • Facial Wasting (Lipoatrophy) Treatments
  • HIV Testing
  • Pre-exposure Prophylaxis (PrEP)

There are three primary criteria through which individuals with HIV become eligible for Medicare. These are:

  • Individuals age 65 and older: For individuals at least age 65, they or their spouse must have accumulated a sufficient number of work credits (equivalent to 40 quarters) to qualify for Medicare.
  • Individuals below the age of 65 who have a long-term disability: Individuals under 65 may qualify for Medicare via Social Security Disability Insurance (SSDI) after receiving SSDI payments for at least 24 months. SSDI is the main route to Medicare for those with HIV.

To qualify for SSDI, an individual must have a disability that prevents them from working for one year or more or is anticipated to result in death. Additionally, they must have accumulated an adequate number of work credits, which varies based on their age.

  • Individuals with End-Stage Renal Disease (ESRD) or Amyotrophic Lateral Sclerosis (ALS)/Lou Gehrig’s disease: Those under 65 could be eligible for Medicare if diagnosed with ESRD or ALS without undergoing a 24-month waiting period. Certain HIV treatments may lead to renal complications, such as ESRD, qualifying some HIV patients for Medicare due to this condition.

As of 2020, 77% of HIV-positive Medicare beneficiaries gained eligibility through disability pathways, primarily via SSDI, though some may have qualified due to conditions like ESRD or ALS.

Ryan White HIV/AIDS Program (RWHAP)

The RWHAP is a federal initiative established in 1990 to provide support and outpatient care services for people affected by HIV/AIDS in the US. It serves as a safety net for those without other sources of coverage or facing coverage limits, acting as the “payer of last resort.”

To be eligible for the drug assistance program, individuals must meet the following criteria:

  • Must be diagnosed with HIV or AIDS.
  • Must be at least 18 years old.
  • Prior to accessing Ryan White-funded services, the patient must utilize their own private insurance, their spouse’s or partner’s insurance, or public benefits like Medicare or Medicaid to cover applicable services. This is because the program serves as a “payer of last resort.” 
  • The patient’s modified federal gross income should not surpass 500% of the federal poverty level, determined by family size and household income.
  • A valid prescription

Other State And Local Assistance Program

In addition to established federal programs like Medicare and Medicaid, there are other federal initiatives providing support and resources for individuals managing HIV. These include:

  • Programs for Veterans: One of the providers of medical care for individuals with HIV in the US, assisting over 31,000 Veterans with HIV, is the Department of Veterans Affairs (VA).
  • Medi-Cal: California’s Medicaid health care program, Medi-Cal, provides various medical services for children and adults with low income and limited resources, supported by federal and state taxes.
  • Ready, Set, PrEP Program: This initiative offers free PrEP HIV-prevention medications to eligible individuals across the US, including tribal lands and territories.
  • Specific Programs for American Indian and Alaska Native Communities: The Indian Health Service (IHS) offers health care services, including HIV care, to members or descendants of federally recognized tribes.
  • Federal Programs for Women and Children: Programs like the Children’s Health Insurance Program (CHIP) provide coverage for children up to age 19 at no cost or at a reduced rate. Additionally, Title V programs, supported by the Maternal and Child Health Services Block Grant, cater to women with low income, children, and youth with limited access to health care.
  • Health Center Program: Community health centers offer services that focus on prevention and primary healthcare, including HIV testing, PrEP, and medical treatment, regardless of ability to pay. These centers have expanded opportunities for HIV care delivery through major investments in recent years.

Gilead Advancing Access Program

The Advancing Access program extends financial assistance to commercially insured patients who meet the eligibility criteria and have a valid prescription, providing cost-sharing assistance of up to $7,200 per calendar year with no monthly limit. These products include:

  • Biktarvy
  • Descovy
  • Genvoya
  • Truvada

Note that the program is solely valid for prescriptions reimbursed by commercial insurance. Moreover, it cannot be applied to prescriptions covered by commercial health insurance or other health benefit programs that either fully reimburse for prescription drug costs or prohibit the use of coupons.

Patient Access Network Foundation

This foundation is a non-profit organization that helps underinsured individuals with chronic, critical, or life-threatening illnesses get the medications and treatments they need. They provide financial assistance to cover out-of-pocket costs, such as deductibles, co-payments, and coinsurance, for prescription medications and treatments.

PAN Foundation covers HIV medications like Biktarvy among its assistance programs. To qualify for assistance, individuals must meet certain criteria:

  • Must have a household income between 400-500% of the Federal Poverty Level (FPL).
  • Must have a diagnosis of HIV.
  • Must reside in the US and receive treatment within the country.
  • Must have insurance that covers the medication they need assistance with.

Bottom Line

Biktarvy, a groundbreaking HIV treatment approved by the FDA in 2018, offers a convenient once-a-day regimen that has significantly improved patient care. However, its effectiveness comes with a high price tag, ranging from $3800 to $4500 for a 30-day supply in the US.

The price of Biktarvy reflects various factors, including extensive research and development expenses, patent protection, market dynamics, manufacturing costs, and the complex US healthcare system.

Despite these challenges, there are strategies to reduce costs. Patients can explore options like purchasing from Canadian pharmacies, using commercial insurance coverage, accessing federal assistance programs such as Medicaid, Medicare, and the Ryan White HIV/AIDS Program, or seeking support from initiatives like Gilead’s Advancing Access Program and the Patient Access Network Foundation.

Addressing the affordability of HIV medications like Biktarvy necessitates a collaborative effort among stakeholders from the pharmaceutical industry, government, healthcare providers, insurers, and advocacy groups to ensure equitable access to life-saving treatments for all individuals living with HIV.

Frequently Asked Questions

How much does Biktarvy cost with insurance?

The cost of Biktarvy with insurance differs depending on factors like insurance plan, deductible, copay, and whether Biktarvy is included in your plan’s formulary. Typically, with insurance coverage, patients may have copays ranging from $0 to $5 per month for Biktarvy. It’s best to check with your insurance provider to get an accurate estimate of the cost of your specific insurance plan.

How much does Biktarvy cost per month?

The average retail price for a 30-day supply of Biktarvy ranges from approximately $3800 to $4500 in the US. This price may fluctuate over time due to market dynamics and other factors.

How long does Biktarvy stay in your system?

The active components of Biktarvy generally exit the body within a few days following the final dose, though this timeframe may differ from person to person. Bictegravir has a plasma half-life of around 17.3 hours, enabling once-daily dosing when combined with other medications. Meanwhile, emtricitabine has a half-life of approximately 10 hours, and tenofovir alafenamide’s half-life is just approximately 25 minutes. Half-life refers to the time it takes for the concentration or amount of a substance to decrease by half.

Can Biktarvy be crushed?

The manufacturer of Biktarvy advises against crushing, dissolving, or splitting tablets. Only proceed with such actions if directed to do so by your physician.

Can Biktarvy be used for Pre-exposure Prophylaxis (PrEP)?

Regulatory authorities have not granted approval for Biktarvy’s use as Pre-exposure Prophylaxis (PrEP). Nonetheless, the US FDA has approved two HIV oral medications, Truvada and Descovy, for PrEP purposes.

Is Biktarvy used for Post-exposure Prophylaxis (PEP)?

Biktarvy lacks FDA approval to be used as an HIV-1 preventive measure for post-exposure prophylaxis (PEP) treatment. However, in a study conducted in Boston, researchers investigated 52 adults with very recent HIV exposure who sought PEP. HIV-negative participants were provided with Biktarvy for 28 consecutive days. Nearly all participants completed the study, and findings suggested that Biktarvy was better tolerated compared to older PEP regimens.

How effective is Biktarvy?

Recent real-world data from the ongoing multinational observational BICSTaR (BICtegravir Single Tablet Regimen) study were gathered from individuals with HIV enrolled in Canada, France, and Germany.

The findings indicated high effectiveness of Biktarvy for trial participants over a three-year follow-up period, with 97% (58 out of 60) of treatment-naïve participants and 97% (356 out of 367) of treatment-experienced participants achieving virological suppression (HIV-1 RNA <50 copies/mL; analysis excluded missing data). Notably, no instances of treatment-emergent resistance were reported.

How fast does Biktarvy work?

Biktarvy typically takes effect within the initial four weeks of treatment, often resulting in a noticeable reduction in the HIV viral load, representing the amount of virus in the bloodstream. Within three to six months of consistent use, many individuals experience a decrease in their viral load to an undetectable level.

This measurement, indicating the amount of HIV genetic material in the blood, is typically assessed upon initial diagnosis of HIV and just before commencing Biktarvy treatment. Additionally, follow-up tests are conducted at one month, three months, and six months to monitor the medication’s efficacy and track the ongoing viral load reduction.

How long can you go without Biktarvy?

If you accidentally missed a dose of Biktarvy and it has been less than 18 hours since your usual dosing time, it’s recommended to take the missed dose promptly. However, if it has been more than 18 hours since your regular dosing time, it’s advised to avoid taking the missed dose and instead wait until your next scheduled dose.

What happens if you stop taking Biktarvy?

It’s important not to discontinue Biktarvy unless your healthcare provider permits it. When you discontinue your HIV treatment, dormant HIV cells can reactivate, leading to the virus replicating because there are no medications to suppress it. To maintain an undetectable status and prevent this, adhere to your prescribed HIV treatments daily as directed by your healthcare provider.

Can Biktarvy cause weight gain?

Weight gain has been reported as a side effect associated with Biktarvy, although these reports emerged after the drug’s approval, and it remains uncertain whether the drug directly causes this effect. Studies have indicated an increase in weight ranging from 2.2 to 8.8 pounds over a two-year period with the use of integrase inhibitors.

Can Biktarvy cause hair loss?

Hair loss was not identified as a side effect of Biktarvy in clinical trials. However, Biktarvy comprises active drugs from two classes of medications – nucleoside reverse transcriptase inhibitors and integrase inhibitors. Drugs within these classes have been associated with reports of hair loss.

Is Biktarvy a controlled substance?

No, Biktarvy is not classified as a controlled substance.

Is Biktarvy an immunosuppressant?

Biktarvy is not classified as an immunosuppressant. It is an antiretroviral medication used in the treatment of HIV-1 infection. While it works to reduce the viral load and inhibit the replication of HIV in the body, it does not suppress the immune system like immunosuppressant drugs do.

Are there alternatives to Biktarvy?

Yes, there are several alternatives to Biktarvy for the treatment of HIV-1 infection. Some of these alternatives include:

  • Truvada (emtricitabine/tenofovir disoproxil fumarate)
  • Descovy (emtricitabine/tenofovir alafenamide)
  • Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide)
  • Triumeq (abacavir/dolutegravir/lamivudine)
  • Tivicay (dolutegravir)
  • Isentress (raltegravir)
  • Prezcobix (darunavir/cobicistat)

These alternatives may be prescribed based on individual patient characteristics, tolerability, drug resistance profiles, and treatment guidelines.

Are there drug interactions with Biktarvy?

There are 423 known drug interactions with Biktarvy. Among these interactions, 186 are categorized as major, 235 as moderate, and two as minor. Notably, Biktarvy is contraindicated with two medications, dofetilide and rifampin, due to the risk of serious and life-threatening events.

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https://www.health.harvard.edu/blog/why-do-your-prescription-drugs-cost-so-much-202401183007

Mulcahy, A.W. (2021, Jan). Prescription Drug Prices in the United States Are 2.56 Times Those in Other Countries. RAND. https://www.rand.org/news/press/2021/01/28.html 

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