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Evaluating Gilead's Pricing Strategy of Sovaldi

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Evaluating Gilead's Pricing Strategy of Sovaldi The specific hepatitis C treatment depends on a few Evaluating Gilead’s Pricing Strategy of factors, including the genotype of the virus, previous 1 Sovaldi (A): Launch Price, 2013-2014 treatment experience and patient’s tolerance for the drug(s) (Hepatitis C: The Basics, 2014). Prior to 2011, the standard of care was a combination therapy of ribavirin and pegylated interferon taken for a minimum of 12 weeks (Treatments for Hepatitis C, 2014; U.S. FDA, 2011). However, the combination therapy produces an 80% cure rate at best after administering full treatment (Sadeghi-Nejad, 2014). Interferon is a naturally occurring protein secreted to trigger an immune response in the event of an infection. Pegylated interferon, a laboratory version, is injected in combination with oral antiviral drugs to artificially boost the immune system (Treatments for Hepatitis C, 2014). This component of the therapy causes severe side effects, including reduced red and white blood cell counts, depression, and flu-like symptoms (Hepatitis C: The Basics, 2014). Further, interferon is also poorly tolerated by some patients who then are ineligible for treatment (Treatments for Hepatitis C, 2014). Currently there are only two brands of pegylated interferon available, Pegsys (from Roche) and Pegintron (from Schering-Plough/Merck), with Pegintron offering the most cost effective version at a price of $8,688-10,932 for the minimum of 12 weeks, dependent on patient weight (Evaluating the Pegylated Interferons Used to Treat: Hepatitis C Comparing Gilead Science’s decision in 2013 to price its Effectiveness, Safety, Side Effects, and Price, 2010). breakthrough hepatitis C treatment Sovaldi at $84,000 Ribavirin is a nucleoside analog that mimics the a treatment in the U.S. is one of the most controversial structure of a vital viral genetic component and drug prices in the history of the pharma industry. prevents the hepatitis C virus from replicating. Although its exact method of action is unknown, ribavirin is proven to be effective when administered Hepatitis C: Disease and Treatments in a combination therapy with pegylated interferon. Ribavirin also causes harsh side effects including Hepatitis C is a blood-borne disease that damages the hemolytic anemia and birth defects when taken by liver. It is propagated by various strains of the pregnant women (Hepatitis C: The Basics, 2014). hepatitis C virus that manifests either as an acute or Although branded ribavirin such as Copegus (from chronic illness. An estimated 130-150 million people Genentech/Roche) and Rebetol (from Schering- are infected by the virus globally, predominantly Plough/Merck) are available, the generic Ribosphere within Central/East Asia and North Africa. brand offers ribavirin at a lower cost of $3,240-5,130 Consequently, approximately 350,000 – 500,000 per 12 weeks, in which dosing is also weight persons living with hepatitis C die every year as a dependent (Evaluating the Pegylated Interferons Used result of the disease. Currently, there are no vaccines to Treat: Hepatitis C Comparing Effectiveness, Safety, available, but antiviral treatment can successfully cure Side Effects, and Price, 2010). 50-95% of the patients treated based on the form of therapy administered (Hepatitis C, 2014). In 2011, the Food and Drug Administration (FDA) approved protease inhibitor antiviral drugs for administration with ribavirin and pegylated interferon in a combination therapy (U.S. Food and Drug Administration, 2011). These drugs, the first direct- 1 Based on a report by Piraveina Gnanasuntharam, Rotman School acting antivirals, function by inhibiting the processing of Management, with incremental additions by Will Mitchell (September 2014). and assembling of viral proteins (Treatments for 1 Hepatitis C, 2014). A few of the reported side-effects possible. Additionally, the most commonly reported include anemia, reduced red and white blood cell side effects are fatigue and headache for therapies with count, vomiting, and diarrhea. just ribavirin, and fatigue, headache, nausea, insomnia, and anemia for the combination regimens that include The sustained virological response experienced by interferon (Product Monograph: Sovaldi, 2013). treated patients is significantly higher when these antiviral drugs are included in the combination therapy (Hepatitis C: The Basics, 2014). Protease inhibitors Discovery and Development are used for patients with the genotype 1 strain who are deemed to be the most common and difficult to Sofosbuvir was engineered by Michael Sofia in 2007 treat. The most commonly used and preferred brand of at Pharmasset, a small biotech company in New Jersey protease inhibitors, Incivek (from Vertex), has a price known for their research in HIV antiviral drugs. tag of approximately $49,200 per 12 weeks of dosage Following the discovery, human clinical trials began (Telaprevir (Incivek), 2014). in 2010 to prove sofosbuvir’s robust capabilities in treating hepatitis C infections with minimal side As a result of the numerous side effects caused by the effects (Gounder, 2013). aforementioned regimens, treatment uptake has been low. Additionally, if a patient is eligible for interferon In 2011, Gilead Sciences, Inc. acquired Pharmasset for administration, the most effective treatment costs $11 billion. At the time of the acquisition, sofosbuvir approximately $61,128-$65,262 for patients with the was still in its phase II of clinical trials and its genotype 1 strain and $11,928-$16,062 for patients efficacy, safety and potential side effects were still to harboring the other types for a 12-week course. be determined (Gilead Sciences to Acquire Pharmasset, Inc. for $11 Billion, 2011). Moreover, However, a 12-week course is usually not enough. other companies were exploring alternative Patients are often expected to continue treatment of approaches, such as Bristol-Myers Squibb’s interferon and ribavirin for longer periods of time, compound, BMS-790052, which sought to hinder a often up to 48 weeks. Hence, the long-term treatment protein called NS5A that creates a scaffolding around cost can exceed $100,000 for most patients with the virus, thereby stopping the virus from replicating. chronic hepatitis C (Telaprevir (Incivek), 2014). Following the submission of results from six clinical trials testing nearly 2000 participants who were Sovaldi previously deemed incurable, in Dec. 6, 2013 the FDA not only approved sofosbuvir, but designated it as a Breakthrough Drug breakthrough therapy for showing substantial In 2013, FDA approved yet another treatment option improvements over existing alternatives (FDA for patients with chronic hepatitis C infections. approves Sovaldi for chronic hepatitis C, 2013). Sofosbuvir is also a direct-acting antiviral that inhibits Specifically, sofosbuvir, branded Sovaldi, the viral protein involved in the replication of the viral demonstrated a staggering >90% cure rate in test genetic code. Sofosbuvir’s high antiviral potency results (Beasley, 2014). stems from its unique ability to remain in the inactive Consequently Incivek, the previous standard of care form until it reaches the liver, where the liver enzymes treatment developed by Vertex, experienced a 96% activate the drug for optimal activity (Zoe Mariño, drop in sales after the introduction of Sovaldi. As a 2014; Product Monograph: Sovaldi, 2013). result, Vertex has decided to discontinue Incivek This breakthrough drug is administered orally and (Helfand, Sovaldi forces Incivek off the hep C market used in combination with only ribavirin for the first as Vertex calls it quits, 2014). ever all-oral regimens for all types of the virus except Although Sovaldi, would forever shift the chronic for genotype 1, which still requires interferon (Zoe hepatitis C treatment paradigm and present a faster Mariño, 2014). A recent clinical study has further and more effective cure for those suffering from the shown that sofosbuvir also shows promise in curing deadly disease, the drug comes at a high price. Once hepatitis C infections in patients who are co-infected Gilead was permitted to market Sovaldi, it announced with HIV. Until now, interferon and protein inhibitor a price of $1,000 per pill, adding to a total of treatment components interacted with HIV $84,000/12 week treatment of Sovaldi alone. medication, prohibiting co-infected patients from receiving hepatitis C treatment (Lee, 2014). For patients, this meant that to obtain the minimum dosage of combination treatment required, it will cost Sofosbuvir is proving to be an excellent candidate for well over $100,000, depending on the virus genotype treating many more infected patients than previously and patient status. At the time of launch, Gilead’s 2 hefty premium on Sovaldi will make it only available of $2 million; Menlo's partner Dubose Montgomery to a small patient population (Somashekhar, 2014). served as Board Chair until 1993, when Riordan became Chair. Riordan also recruited two Nobel Prize winners as scientific advisers – Harold Varmus, who Treatments on the Horizon later became Director of the National Institutes of Health, and Jack Szostak, who received the Nobel Many pharmaceutical companies are still investing in Prize for Physiology/Medicine in 2009. novel protease inhibitors that will increase efficacy in treating hepatitis C infections in patients with the type Riordan served as CEO until 1996 when he was 1 strain, who still require the use of interferon even succeeded by the current CEO, John Martin, who had with Sovaldi. For example, Merck’s vaniprevir
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