Top Performing Drug of 2021 – Biktarvy (October Edition)

Active Ingredient: bictegravir, emtricitabine, and tenofovir alafenamide

Strength: 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF/ 30 mg of BIC, 120 mg of FTC, and 15 mg of TAF

Dosage Form: Tablet

Mechanism of Action: HIV reverse transcriptase inhibitors

First Approval: US (07 Feb 2018), EU (25 Jun 2018)

Revenue¹

Gilead’s HIV drug, Biktarvy has contributed to its revenue growth in all geographies. The annual sales reached $8.62B vs. $7.25B in 2020 showing an increase of 19%. Gilead commercializes Biktarvy in the US, Europe, and other international markets. Biktarvy was one of the key drivers of Gilead’s annual revenue growth of $27.3B in 2021. PharmaShots has done the revenue analysis for Biktarvy of its revenue growth in the last four years with a 23.69% CAGR. 

Approved Indications of Biktarvy² 

Biktarvy is indicated for the treatment of infected with human immunodeficiency virus-1 (HIV-1) in adults and paediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA >50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. 

Clinical Trials Analysis³

Biktarvy has a total of 73 trials, including 47 industry trials of which 43 are interventional, 4 observational & 1 expanded access trial. The analysis of clinical trials through a representation is shown below (trials are taken as of 6 Oct 2022)

*Active trials include Recruiting; Active, Not Recruiting; Enrolling by Invitation, and suspended

*Inactive trials include Terminated; Withdrawn; Unknown Status

Gilead Advancing Access program⁴

Gilead’s patient support programs help make Gilead therapies accessible for individuals who need information regarding insurance and financial support.

Gilead’s Advancing Access program helps patients understand their coverage and identify financial support options to access their Gilead HIV treatment, HIV prevention medication, and COVID-19 medication Veklury, remdesivir. The program offerings include

• Access to program specialists who can help answer insurance-related questions and provide information regarding coverage options.
• Advancing Access co-pay coupon program, which provides co-pay support for eligible people on HIV treatment and HIV prevention medication with commercial insurance who need help paying for their out-of-pocket medicine costs. Eligible patients could pay as little as $0 per month. The co-pay coupon program is not available for people enrolled in government healthcare  prescription drug programs, such as Medicare Part D and Medicaid. Additional restrictions are also applied.

Financial Support for Government Insurance

Gilead’s Advancing Access program helps patients to pay for their medicines whether they have insurance or not. These programs help patients to better understand which options are available to them.

Alternative Funding Sources

There are many different types of government insurance and programs, that can help patients to understand precisely what their coverage. Several types of government healthcare programs, such as Medicare Part D, Medicaid, TRICARE, and VA, may cause the patients to be ineligible for Gilead’s Advancing Access program. However, they can be eligible for additional sources of alternative funding through independent co-pay foundations. Advancing Access can help provide additional information about those additional sources.

How to get started with Gilead Advancing Access Program

Advancing Access can provide you with information to help you find financial and insurance support every step of the way.

1. Support by Phone

 The patients can Call 1-800-226-2056 to speak to an Advancing Access agent directly. They can also leave a confidential message any time and day of the week. This facility is available from Monday to Friday from 9 am to 8 pm EST

2. Enrolment

The patients can enrol through a form that requires some information from the healthcare provider. The patients can download this form from www.gileadadvancingaccess.com or enrol online

Biktarvy Patents⁵

A patent is a property right issued by the United States Patent and Trademark Office (USPTO) to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States” for a limited time.

Biktarvy has 341 International patents and 12 US patents. The estimated expiration date for Biktarvy which includes patent term extensions, supplementary protection certificates/paediatric exclusivity in the US and the EU for the primary patents is 2033.

Biktarvy Alternatives⁶

References:

1. Gilead Sciences 10-K
2. Biktarvy Prescribing Information
3. ClinicalTrials.gov
4. Gilead Advancing Access Program
5. Biktarvy Patents
6. Bikartvy Alternatives

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