Marketing Role Play (4)

[Virtual Presenter] Name: Samar Mohamed Mousa and Hussein Majed Abu Yousef Student ID: 201810067 and 201910732 Course: Marketing and Pharmacoeconomics Course ID: 0204420 Topic: Pharmaceutical Selling Skills Supervised by: Doctor Asim El Nour 1.

[Audio] Overview: Sotrovimab, also known as Xevudy, is an investigational single-dose monoclonal antibody for the treatment of mild-to-moderate COVID19 in adults and pediatric patients, 12 years of age and older weighing at least 40 KG. The drug has been developed by GlaxoSmithKline, also known as GSK, and Vir Biotechnology. Clinical trials have proved that the drug shows positive results of direct Sars-CoV-2 viral testing and is an effective treatment for those who are at high risk for progression to severe Covid and can prevent hospitalization or death. The UAE's health ministry, on Saturday 29th of May 2021, approved the emergency use of Sotrovimab (Vir7831) as a highly effective new treatment for COVID-19. UAE became the first country in the world to license and enable immediate patient use. The drug was endorsed by the US FDA. Hussein: Good morning, I am Hussein Majed, a medical representative for GSK. I was wondering if I could meet up with the Head of The Emergency Department. Receptionist: Good morning, actually Dr. Samar Mousa is on a break right now. She is The Head of The Emergency Department and one of our ER specialists here, but I am not sure if she will accept meeting you during her break without a previously scheduled appointment. Hussein: Please, this meeting must occur as soon as possible. Ask her if I could meet her now if it won't be any trouble. Receptionist: Alright, let me try to reach out. *calls Dr. Samar* Hello Dr. Samar this is the receptionist, I have here Mr. Hussein Majed, a medical representative who is insisting on meeting you now Samar: Is there any chance he can take an appointment and this meeting can be held on another day? Receptionist: He is saying it's urgent. 2.

[Audio] Samar: *sighs* Alright, send him to my office and inform him beforehand that I only have 15 minutes. Receptionist: Sure, have a good day *ends the call and turns to Hussein*. Dr. Samar will see you now, but please keep in mind she only has 15 minutes left from her break. Hussein: Thank you so much, this is more than enough. Receptionist: Very well then, her office is just around the corner. Hussein: Thank you again, I appreciate it. *Hussein walk around the corner heading towards Samar's office* *Hussein knocks on the door* Samar: Come in *eats food* Hussein: Good morning Dr. Samar, I am really sorry for cutting your break short but this meeting couldn't be postponed. Samar: It's okay, I was told that this meeting is urgent. You had me really curious though, please have a seat Mr . . . . Hussein: Hussein Majed, a medical representative for GSK short for GlaxoSmithKline . . . Samar: Oh, isn't that the company that manufactured Panadol? Hussein: Yes, that's right. Samar: Impressive . . . So what is so urgent it couldn't wait? Hussein: Alright, so allow me to briefly introduce the company I am representing; GSK began in 1715 with the opening of an apothecary shop in London, our story has always focused on innovation. From a selection of individual entrepreneurs to a global company of around 100,000 employees, we've developed a variety of medicines and healthcare products that form the foundations of today's GSK. Through 1715 – 1891: The early history of GSK shows how a range of entrepreneurs built the foundations of the GSK we know today. Throughout 1892 – 1918 In this period, our legacy companies expanded globally, developing and selling new products worldwide. Past 1892 – 1918 in this period, our legacy companies expanded globally, 3.

[Audio] developing and selling new products worldwide. Moving forward to 1950 – 1999 which was An exciting period of discovery: we developed the first treatment for HIV, enhanced our consumer brands and developed new treatments for asthma. Fast forward 2000 – present with our three global businesses of Pharmaceuticals, Vaccines and Consumer Healthcare, we aim to bring differentiated, high-quality and needed healthcare products to as many people as possible. Samar: GSK is known to be one of the world's most leading healthcare companies, it is admirable honestly. You must be proud of being part of their team. Hussein: I am, please allow me to ask this, given now that we are living in a pandemic, can you please inform me of the health protocol that occurs when a patient that tested positive for COVID rushes to the ER. Samar: We usually start off with measuring the vital signs, this includes temperature, pulse rate, blood pressure, respiratory rate, along with oxygen saturation. We gather the history of the patient to take note of any diseases that might put the patient at any risks and we mostly worry about chronic diseases like asthma and high blood pressure, we then perform a chest X-ray to ensure that the lungs are not yet infected or affected by the virus. If the patient has no chronic diseases we ask them to isolate themselves in their home and we ask the pharmacy to dispense Vitamin C, Vitamin D, Zinc, Magnesium, panadol. Similarly this also occurs for patients who have chronic disease but are only mild, but we just add an additional antiviral drug called Favipiravir. In cases where a patient has a chronic disease that is not under control we isolate and hospitalize the patient. Hussein: And how has this health protocol helped out so far in terms of mortality? Samar: Honestly, people with mild Covid infections when taking the dispensed medications seem to heal nicely but of course not all of them can escape the Post Covid Syndrome, we worry more about people who are hospitalized since some of them their lungs cannot handle the strain of the virus, which causes their oxygen levels to drop and unfortunately this leads to their death. Hussein: I am really sorry to hear this, I know it is not easy to witness the death of patients under your care. Samar: It is not, but we need to move forward and focus on the health of who we can save. Hussein: That is why I am here . . . Samar: What do you mean? 4.

[Audio] Hussein: GSK has come up with a drug called Sotrovimab, also known as Xevudy Samar: Go on . . . Hussein: GSK along with Vir Biotechnology have developed an investigational monoclonal antibodies drug called sotrovimab that is capable of neutralizing the Sars-Cov-2 spikes by surrounding them before it can interact with the ACE-2 receptor on the cell membrane and enter the cell. These monoclonal antibodies are designed in a specific way so it is capable of conforming to the very specific conformation of the viral spike protein. Samar: That is nice and all, but the US Food and Drug Administration has approved Bamlanivimab on the 9th of november 2020, Casirivimab + imdevimab on 21st of november 2021, and it has also approved Bamlanivimab + Etesivimab in Early 2021. What makes Sotrovimab any different? Hussein: The US FDA issued an emergency use authorization on 26th of May for sotrovimab which was 2 days ago. As what makes sotrovimab different, according to the clinical trials that took place with the monoclonal antibodies you mentioned and Sotrovimab: - Bamlanivimab + Etesivimab, which was manufactured by Eli Lilly, had an Absolute Risk Reduction of 5% and a Relative Risk Reduction of 87%, so the Number Needed To Treat is 20, which means that if I would treat 20 patients with this drug I would prevent only one death, and according to the clinical trial were I got this information from there were 1035 patients in the trial. - Casirivimab + Imdevimab, which was manufactured by Regeneron, had an Absolute Risk Reduction of 3.3% and a Relative Risk Reduction of 71%, so the Number Needed To Treat is 30, which indicates that if I would treat 30 patients with this drug I would prevent one death which is not ideal, and there were 2696 patients in the trial. - Sotrovimab had an Absolute Risk Reduction of 6% and a Relative Risk Reduction of 85%, so the Number Needed To Treat is 17, which imply that if I would treat 17 patients with Xevudy I would prevent one death, and there were 583 patients in the trial. Sotrovimab also binds to a highly conserved epitope of the receptor binding domain of viral spike protein, Samar: There is an antiviral medication that also works wonders called Molnupiravir which was manufactured by Merck. Hussein: You are right, but Molnupiravir is a 5-day treatment course, while sotrovimab is a 30 to 60 minutes single dose IV drug. Samar: It must be expensive. 5.

[Audio] Hussein: Additionally, Molnupiravir should be given within 5 days of symptoms onset while Sotrovimab can be given within 7 days of symptoms onset. Samar: How much does it cost? Hussein: I am coming to that Doctor, I am sure the price is not your only consideration. Furthermore, Molnupiravir is contraindicated in pregnant women while Sotrovimab is category B2 and considered safe for pregnant women. Samar: And who is eligible to take sotrovimab? Hussein: Sotrovimab can be given to most adults, and children aged 12 years or older who weigh at least 40kg. You may be eligible for sotrovimab if: you've had a positive PCR test within the last 5 days you have had coronavirus (COVID-19) symptoms within the last 5 days Mild- to- moderate symptoms The high risk group includes some people who have: Down's syndrome a rare condition affecting the brain or nerves (including multiple sclerosis, motor neurone disease, Huntington's disease or myasthenia gravis) sickle cell disease certain types of cancer HIV or AIDS a severe liver condition (such as cirrhosis) chronic kidney disease (CKD) stage 4 or 5 had an organ transplant certain autoimmune or inflammatory conditions (such as rheumatoid arthritis or inflammatory bowel disease) a condition or treatment that makes you more likely to get infections had certain types of chemotherapy in the last 12 months 6.

[Audio] had radiotherapy in the last 6 months Obesity (BMI > 25) Samar: Are there any side effects that we should worry about? Hussein: After infusion, the patient must be monitored for an hour to ensure they don't have any allergic reaction towards Sotrovimab, other than that severe side effects are extremely rare. Samar: What about the pricing? Hussein: A single vial costs 2,100 dollars which is equivalent to 7,707 Dirhams. Samar: But that is very costly. Hussein: I am sure with the mentioned advantages and the decrease in morality you will witness when this drug is administered you will believe it is worth it. Samar: We will see, but the usage of this drug cannot occur without the approval of The Ministry of Health. Hussein: An approval from the Ministry of Health has already been granted, and that drug has already been registered, and this is the code of registry you can look it up. Samar: Excellent, thank you Mr. Hussein Hussein: It was a pleasure to meet you Dr. Samar, here is my card if you would like to contact me for further information about the drug or if you are having any inquiries you can reach out to me. Samar: Likewise. *shakes hands* Conclusion: Sotrovimab is being hailed as a game-changer in the treatment of the coronavirus. The drug proved 100 percent successful in preventing deaths and 99 percent effective in stopping admissions to intensive care in more than 6,000 patients, over a two-week period in early July in the UAE, according to the Ministry of Health and Prevention. Almost 97 per cent of recipients fully recovered within 14 days, in line with previous findings. 7.

[Audio] Dr Anwar Salam, chief medical officer at Seha, the Abu Dhabi health services company, said thanks to the Department of Health Abu Dhabi, public hospitals were quick to adopt the emergency use of sotrovimab. "It has proven successful, with a number of those who used this treatment after contracting Covid-19 showing positive response in a short timeframe," he said. And unlike Bamlanivimab + Etesivimab and Casirivimab + Imdevimab, Sotrovimab was shown effective in fighting off the Omicron Variant of Covid-19 and thus the FDA stopped the usage of the other monoclonal antibodies in fighting the Omicron variant. Furthermore, Sotrovimab had the highest cost per hospitalization at $91,000, and its cost per quality-adjusted life year was $69,000. ICER considers anything below $100,000 per quality-adjusted life year to be cost-effective. Resources: https://www.idsociety.org/covid-19-real-time-learning-network/therapeutics-andinterventions/monoclonal-antibodies/ https://www.gsk.com/en-gb/media/press-releases/gsk-and-vir-biotechnology-announcesotrovimab-vir-7831-receives-emergency-use-authorization-from-the-us-fda/ https://www.vizientinc.com//media/documents/sitecorepublishingdocuments/public/cv19mabsbscomparison_final.pdf?la=en &hash=050182387828FC22BEDCAB7C7B6E191484082E64 https://investor.lilly.com/news-releases/news-release-details/lillys-bamlanivimab-etesevimabauthorized-first-and-only https://www.fda.gov/media/149534/download https://www.sotrovimab.com/ https://www.nhs.uk/medicines/sotrovimab/who-can-and-cannot-have-sotrovimab/ https://www.seha.ae/sotrovimab-recipients-share-stories-of-covid-19-recovery-after-taking-antiviral-drug/ https://www.nps.org.au/coronavirus/summary-table-molnupiravir-nirmatrelvir-ritonavir-andsotrovimab https://www.youtube.com/watch?v=HnFjVXmiglk https://www.covid19treatmentguidelines.nih.gov/tables/mab-data/ http://infusioncenter.org/wp-content/uploads/2021/11/SOTROVIMAB-EUA.pdf 8.

[Audio] https://www.beckershospitalreview.com/pharmacy/covid-19-treatments-prove-cost-effectiveicer-says.html 9.