Tamiflu Set to Switch to OTC Status
The popular prescription influenza antiviral will become more accessible in the United States thanks to Sanofi deal.
In July 2019, manufacturer Sanofi said it had signed a deal with Roche Pharmaceuticals to obtain exclusive OTC rights for the antiviral agent Tamiflu (oseltamivir phosphate), a neuraminidase inhibitor indicated for the treatment and prophylaxis of the influenza virus.1
“The US market is the largest OTC market in the world, and a successful switch of Tamiflu to OTC would support our global cough and cold strategy by expanding into flu with a sustainable point of difference in the market,” Sanofi said in a statement.1
The company has not announced an exact date of availability of OTC Tamiflu. Under the agreement, in addition to leading the FDA negotiations, Sanofi will head the clinical program and fund all studies needed to support the OTC switch in the United States in consultation with leading experts in the field.1 Tamiflu is currently sold in the United States by Genentech, a member of the Roche Group, for prescription use. Roche will continue to market Tamiflu in the rest of the world. Sanofi will retain the rights to first negotiations for switch rights in other select markets.1
The Role of Pharmacists
The pending switch of Tamiflu from prescription to OTC status will augment accessibility of this effective antiviral, allowing patients to initiate therapy to prevent or treat the influenza virus early on. Pharmacists are in a pivotal position to increase awareness and educate patients about the influenza virus, including prevention and treatment options. Once Tamiflu becomes available as an OTC medication, pharmacists will likely encounter many questions from patients about this agent, and they should be prepared to counsel them about its proper use, dosing, and adverse effects. During counseling, pharmacists should seize every opportunity to encourage and remind patients, especially those in high-risk populations, to get the yearly influenza vaccine. They can also dispel common misconceptions and myths about the influenza vaccine. Finally, they can inform patients that the vaccine is the most effective way to prevent the influenza virus and has been shown to be beneficial in diminishing the risk of influenza virus illness, hospitalization, and even the risk of death due to influenza-related complications, such as pneumonia, especially among elderly and pediatric patients.
Currently, OTC medications marketed for influenza are limited to and intended to provide only symptomatic relief from the common symptoms associated with the influenza virus, such as body or muscle aches, chills, fever, headache, nasal congestion, and sore throat. Examples of these medications include analgesics, antipyretics, cough medications, and decongestants. Additionally, OTC homeopathic medications for management of the influenza virus are available. Although most people recover from the influenza virus after a week or so, certain patient populations, such as geriatric and pediatric patients and those with certain medical conditions, are at greater risk for complications. The annual influenza vaccination rates in the United States are still considered suboptimal, and many people are not aware of the availability of prescription antivirals to prevent and treat the virus.
The CDC has designated the 2018-2019 influenza season as the longest in a decade.2 A total of 130 pediatric deaths occurred during that influenza season, according to the most recent report from the CDC.3 The highest rate of hospitalization occurred among adults 65 years and older.3 In preliminary approximations for October 1, 2018, through May 4, 2019, the CDC reported that an estimated 42.9 million people had the flu during the 2018-2019 flu season, 647,000 people were hospitalized, and 61,200 deaths occurred.3
On average, more than 31 million individuals annually in the United States are afflicted with the influenza virus during its peak season in the fall and winter months, according to a CDC report.3
The CDC also indicated that just 7 million individuals actually receive the appropriate antivirals to treat the influenza virus.4 The CDC has conducted limited qualitative research into clinician knowledge, attitudes, and practices related to these antiviral medications. The findings suggest that many possible factors are involved in the underprescribing of antivirals. These include an extensive range in perception about how well these medications work and minimal clinician awareness of the CDC’s antiviral recommendations.4 In addition, some clinicians may not prescribe antivirals after the 2-day window when benefit is optimal, and some may require a positive flu test before prescribing antivirals, even though the results of rapid influenza diagnostic tests, if ordered, may not be accurate.4
Yvette C. Terrie, BSPharm, RPh, is a consulting pharmacist and a medical writer in Haymarket, Virginia.
- Sanofi signs strategic deal for exclusive US over-the-counter rights to Tamiflu in flu care. Paris, France: Sanofi; July 23, 2019. sanofi.com/en/media-room/press-releases/2019/2019-07-23-07-00-00. Accessed October 6, 2019.
- Brown T. Influenza season now longest in a decade, CDC reports. Medscape website. medscape.com/viewarticle/912079. Published April 22, 2019. Accessed October 1, 2019.
- 2018-2019 U.S. flu season: preliminary burden estimates. CDC website. cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm. Updated October 22, 2019. Accessed November 15, 2019.
- Influenza antiviral medications: summary for clinicians. CDC website. cdc.gov/flu/professionals/antivirals/summary-clinicians.htm. Updated November 15, 2019. Accessed November 15, 2019.