22 GlaxoSmithKline Zika Virus Vaccine: Coverage and Aid through Patient Assistance Programs

GlaxoSmithKline Zika Virus Vaccine: Coverage and Aid through Patient Assistance Programs

By: MAHAM HAFEEZ

Emma Walmsley sat in her office chair, preparing for the start of the meeting with the stakeholders about the much awaited Zika Virus Vaccine. She was the newly appointed Chief Executive Officer (CEO) of GlaxoSmithKline (GSK), and her job left little room for error. With several people inflicted with Zika Virus and its ever-progressing spread to the United States of America, the access of the vaccine to patients of all socio-economic status was important. Therefore, the establishment of the coverage of the drug despite its price and any actions required to ensure those unable to afford the vaccine have access was crucial. To decide on the coverage of the new vaccine and who gets which type of coverage from the organization, the Patient Assistance Program at GSK played a critical role.

GlaxoSmithKline

GlaxoSmithKline (GSK) was a research-based pharmaceutical company that provided products within their product segments that included Pharmaceuticals, Consumer Healthcare, and Vaccines (Bloomberg, n.d.). Pharmaceuticals, Consumer Healthcare, and Vaccines generated a total revenue of $17.28 billion, $7.75 billion, and $5.16 billion respectively (Bloomberg, n.d.). Even though vaccines accounted for the least revenue compared to other products (17%), $5.16 billion remained to be a substantial amount. Therefore, the success of the vaccine segment of the company was important as the healthcare system’s ideology shifted from disease treatment to disease prevention (Rheinberger, Herrera-Araujo, & Hammitt, 2016). GSK had several locations across the globe and were one of the largest pharmaceutical companies.

Zika Virus Infection

Zika virus was a mosquito-borne flavivirus that had impacted the United States of America (USA), Australia, and several countries in South America and Africa (“Infographic,” n.d.). The mosquito capable of carrying Zika virus was called Aedes mosquito, which was found in abundance across USA (“WHO | Zika virus,” n.d.). Zika virus had been around for 60 years, however, the outbreak in 2016, resulted in the World Health Organization (WHO) labeling it as a disease with “explosive pandemic potential” (“Infographic,” n.d.). The virus was transmitted through mosquito bites, mother-to-fetus, sexual contact, and potentially blood transfusion (“WHO | Zika virus,” n.d.). The disease symptoms were similar to those of dengue and chikungunya virus, which included fever, skin rash, conjunctivitis (eye inflammation), muscle and joint pain, malaise (general feeling of discomfort) and headache (“WHO | Zika virus,” n.d.). The incubation period (exposure time) of the virus was unknown, however, upon the appearance of symptoms, the symptoms lasted only 2-7 days (“WHO | Zika virus,” n.d.). No specific treatment was required to treat those infected due to the mildness of the viral symptoms (“WHO | Zika virus,” n.d.). Therefore, the infected individuals were prescribed with plenty of rest, higher levels of fluid intake, and common medicines to treat the fever and pain (“WHO | Zika virus,” n.d.).

The main issue with Zika virus was not the fact that it infected many individuals because of the mild nature of the symptoms. Instead, the growing link between Zika virus infection in pregnant women and its negative impact on the fetus was very concerning. There had been a growing consensus within the scientific community that upon mother’s infection, the virus caused neurological symptoms in developing fetuses (“WHO | Zika virus,” n.d.). The virus was believed to cause microcephaly and Guillain-Barré syndrome in newborns, and associations with other neurological conditions in newborn were being tested (“WHO | Zika virus,” n.d.). In fact in South America, after the 2013-2014 circulation period of Zika virus, the number of infants with neuronal birth defects increased from 2.86 infants per 1000 births to 58.8 infants per 1000 births in 2016 (“Risk of Zika Virus-Related Birth Defects in Pregnant Women,” 2017). Most of the observed neurological conditions were the ones observed physically after birth, and other long-term neurological complications remained unclear, highlighting the potential impact of the virus on infants (“Risk of Zika Virus-Related Birth Defects in Pregnant Women,” 2017). Therefore, governments across the globe were scrambling to produce a vaccine for Zika virus infection.

Zika Virus Vaccine Development, Vaccine Affordability, and Disease Spread

The increasing prevalence of Zika virus and its association with neurological symptoms in infants had promoted the need for the Zika virus vaccine development. However, pharmaceutical companies have been hesitant to invest in the Zika virus vaccine Research and Development (R&D) on the assumption that individuals will naturally build a resistance to the virus (“GSK jumps into Zika vax hunt on heels of Sanofi’s deal | FiercePharma,” n.d.). Nonetheless, political pressure had warranted the development of a vaccine (“GSK jumps into Zika vax hunt on heels of Sanofi’s deal | FiercePharma,” n.d.). Therefore, GSK had formed partnerships with National Institutes of Health (NIH), Sanofi, and Walter Reed Army Institute of Research (WRAIR) to fast-track the development of a Zika virus vaccine (“GSK jumps into Zika vax hunt on heels of Sanofi’s deal | FiercePharma,” n.d.).

The development of a vaccine was costly and time-consuming. On average vaccine development can cost around $US205-878 million and can take up to 16 years, with 7.5 years being the average duration (Waye, Jacobs, & Schryvers, 2013). This leads into high prices for vaccines and with further rigorous regulation, the prices have only soared. Vaccines can range from as little as $US30 up to over $US145 (“The Price of Prevention: Vaccine Costs Are Soaring – The New York Times,” n.d.). In fact over the decades, the federal costs incurred by US government alone has increased 15-fold over time regardless of the discounted prices (“The Price of Prevention: Vaccine Costs Are Soaring – The New York Times,” n.d.). Sanofi’s rejection to the US Army’s negotiations to set an affordable price for Zika virus vaccine, even after being given a $43 million grant from the US Biomedical Advanced Research and Development Authority (BARDA), only raised further affordability issues (“The Battle Over a Fair Price for Zika Vaccines – Scientific American,” n.d.). The current price set for Zika virus vaccine made it unaffordable for many US citizens (“The Battle Over a Fair Price for Zika Vaccines – Scientific American,” n.d.). As a result, Sanofi’s ability to secure further funding and an exclusive license to sell the vaccine was jeopardized (“The Battle Over a Fair Price for Zika Vaccines – Scientific American,” n.d.).

The issue with high prices was that it made it unfeasible for many individuals to afford the Zika virus vaccines. The concern was further highlighted as the majority of the individuals affected by the virus were in South America and Africa, where poverty was more prominent. Several countries in Latin America faced various levels of poverty. Certain countries faced poverty rates of around 10% (Uruguay, Argentina, and Chile) while other countries such as Nicaragua and Guatemala faced higher poverty rates of 37% and 50% respectively (“10 Shocking Facts About Poverty in Latin America,” 2016). Poverty rates were further made tricky as they not only varied from country-to-country, they also varied drastically from city-to-city within a country. Brazil, the country to first report the association between Zika virus and neurological abnormalities, was a prime example of the city-to-city poverty variation. In Brazil, Santa Catarina had a chronic poverty rate of 5%, while Ceará had a rate of 40% (“10 Shocking Facts About Poverty in Latin America,” 2016; “Risk of Zika Virus-Related Birth Defects in Pregnant Women,” 2017). The importance of poverty consideration was further highlighted when contrary to general belief, the urban regions in these countries had higher poverty than the rural areas (“10 Shocking Facts About Poverty in Latin America,” 2016; “Four Facts About Poverty in Latin America you Probably Didn’t Know | HuffPost,” n.d.). Even though the rate of poverty in rural locations may be higher, there was a higher number of individuals in poverty in the urban areas compared to rural (“10 Shocking Facts About Poverty in Latin America,” 2016; “Four Facts About Poverty in Latin America you Probably Didn’t Know | HuffPost,” n.d.). This trend was clear in countries like Chile, Brazil, Mexico, Colombia and the Dominican Republic (“10 Shocking Facts About Poverty in Latin America,” 2016). With an average individual earning only $4 a day in Latin America, the affordability of the vaccines was concerning (“10 Shocking Facts About Poverty in Latin America,” 2016).

Access to Zika virus vaccines was also important for the poverty-stricken countries because the majority of the individuals with lower income lived in urban areas where population densities were higher, making disease transmission easier (“10 Shocking Facts About Poverty in Latin America,” 2016; “Four Facts About Poverty in Latin America you Probably Didn’t Know | HuffPost,” n.d.). The incidence of disease was only increased as those living in poverty had poor living conditions. According to World Water Council, in Latin America, 77 million people lacked access to safe water or a water source altogether in their homes (“10 Shocking Facts About Poverty in Latin America,” 2016). Moreover, it was estimated that 256 million people relied on latrines and septic tanks in place of basic sanitation (“10 Shocking Facts About Poverty in Latin America,” 2016). The poor living conditions further added to the facilitation of environments suitable for disease spread, which led to higher risks of incidences of disease contraction and spread.

Therefore, the scope of the market for the Zika virus vaccine, and the considerations necessary pertaining to the price and the affordability of the therapeutic was a multi-facetted concern.

GlaxoSmithKline (GSK) Patient Support Program: GSK for you

GSK for you program was a patient support program at GSK that provided assistance to those who were unable to afford GSK products. The type of aid that was provided was divided into three categories that included uninsured patients, patients with Medicare Part D, and vaccines (“GSKForYou | Patient Assistance Program,” n.d.). They also had additional offers such as coupons and free trials to help patients in need gain access to quality medications (“GSKForYou | Patient Assistance Program,” n.d.).

The free trails were applicable to only certain prescription medications that individuals with commercial insurance or without any insurance were eligible for (“Coupons & Free Trial Offers for Medications | GSKForYou,” n.d.). Those enrolled in any of the government-based insurance programs such as Medicare Part D in the USA were not eligible (“Coupons & Free Trial Offers for Medications | GSKForYou,” n.d.). The trial was also a one time offer for the prescriptions and the acceptance of the trial offer varied based on the pharmacy (“Coupons & Free Trial Offers for Medications | GSKForYou,” n.d.). Similar to free trials, the Dollars-Off coupons by GSK were offered to individuals with commercial insurance or without insurance at all (“Coupons & Free Trial Offers for Medications | GSKForYou,” n.d.). Those enrolled in any federal program like Medicare Part D were excluded from this offer (“Coupons & Free Trial Offers for Medications | GSKForYou,” n.d.). Those with insurance were covered only up to the amount that was not covered by their insurers, provided the value was less than that listed on the coupon (“Coupons & Free Trial Offers for Medications | GSKForYou,” n.d.). Those without insurance were covered up to the value listed on the coupon (“Coupons & Free Trial Offers for Medications | GSKForYou,” n.d.). The main goal of the coupons was to reduce any out-of-pocket costs associated with certain medications (“Coupons & Free Trial Offers for Medications | GSKForYou,” n.d.).

The most relevant aid provided by GSK to their new Zika virus vaccine was the assistance provided under the vaccine segment for GSK for you program (“Patient Assistance for Vaccines | GSKForYou,” n.d.). The program provided assistance to patients in gaining access to certain GSK vaccines (“Patient Assistance for Vaccines | GSKForYou,” n.d.). Like all other patient support programs, there were specific eligibility criteria that were set for the patients (“Patient Assistance for Vaccines | GSKForYou,” n.d.). To qualify for the assistance program, patients had to reside within the 50 states of USA, Columbia or Puerto Rico; could not have any third party insurance coverage; could only be enrolled in other federal programs like Medicare Part D; have had spent at least $600 on prescription medication through their Medicare Part D program; be of age 19 and over; could not be eligible for Puerto Rico’s Government Health Plan Mi Salud or been denied from the program after application; and be within a specific house income that varied depending on family size and location (“Patient Assistance for Vaccines | GSKForYou,” n.d.). The income criteria outlined by GSK can be found in Appendix I.

The eligibility criteria set forth by GSK posed several concerns. One major concern was that it was limited to only USA, Columbia, and Puerto Rico, while it was evident that those in South America also had a great need for such a program. In fact, about 20% of the individuals residing in Latin America and the Caribbean lacked access to health care due to poverty conditions (“10 Shocking Facts About Poverty in Latin America,” 2016). Even if the program was to be deployed in these regions, certain considerations were required. The program in its current format faced several gaps and barriers; it was still inefficient (took long processing times; around 3-4 weeks), and did not work with any third-party insurers. To effectively launch any patient support programs in a new location, GSK had to take the patient eligibility criteria, program cost, and program success indicators under consideration.

Patient Eligibility Criteria

The current eligibility criteria of the patient support program at GSK was heavily dependent on the socio-economic status of a patient and the impact the disease would have on the patient’s ability to work. The patients also had to be over the age of 19 years (“Patient Assistance for Vaccines | GSKForYou,” n.d.). These criteria proved concerning for individuals who did not meet these requirements but were still in need of the vaccine such as retired elderly or young children. The elderly did not have access to any income and were dependent on their children who themselves could not afford any vaccines or medications. The same applied to young children. The question was then how would these individuals who were dependents and could not access the vaccines be covered? Even though Zika virus caused only mild symptoms and affected pregnant women and their fetuses more severely, elderly and children had weaker immune systems. That meant that the severity of the symptoms was increased, and the virus could further compromise the immune system, leading to an increased risk of infection by other opportunistic viruses (“Are Seniors at Risk for Zika Virus?,” 2016). Therefore, young children and elderly required vaccination as well, not only for their own health but also to avoid its spread to those around them. Moreover, the major risk associated with Zika virus infection was related to pregnant women; thus, the access priority of the vaccine to those already pregnant or planning on having children, and those around them was important. These considerations played an important role in identifying the right assistance eligibility and application priority criteria for the Zika virus vaccine.

The ineligibility of individuals carrying third-party insurers for the patient programs was also concerning as the likelihood existed that the vaccine would not be covered enough by the insurers as the prices set by the pharmaceutical company were high. Therefore, despite having insurance coverage, a large subset of the population would not be able to afford the vaccine, rendering the concept of vaccination pointless.

Even after the determination of a better eligibility criteria, it was important to understand the level to which funding or coverage by GSK that would be provided. It was also important to determine that once individuals met the eligibility criteria, regardless of the income variations within the sub-set, would everyone receive the same amount of coverage or would it change based on income?

Cost Estimation

The feasibility of the program was also important for GSK to ensure the overall profit margins of the company did not suffer and to ensure sufficient allocation of funds. To estimate the costs associated with the program, the company needed to estimate the number of patients expected to buy the vaccine and the number unable to afford it without aid. In order to determine the costs associated with the program, many different forecasting models could be taken into consideration.

Some of the potential forecasting models included Dartboard methods, Workstation methods, Simple Spreadsheet methods, Analytic Spreadsheet methods, and Systems Dynamics methods (Cook, 2006). Each model had its own advantages and disadvantages. Dartboard method and Workstation method were two extreme type of forecasting styles within the pharmaceutical industry (Cook, 2006). Dartboard method heavily relied on the gut feeling that came with experience, while Workstation method relied heavily on huge amounts of data, which led to misinterpretations and confounded analysis (Cook, 2006). Simple Spreadsheet method, on the other hand, was a middle-ground approach that utilized spreadsheet software like Excel and combined it with forecast formulae to generate cost estimates. Therefore, Simple Spreadsheets was the most popular forecasting method for the pharmaceutical industry (Cook, 2006). Analytic Spreadsheet method added a layer of complexity as it took the country-to-country variation under consideration (Cook, 2006). Systems Dynamics method incorporated the potential occurrences of relapse and repeated doses for medications under consideration (Cook, 2006).

Proper forecasting was important as previous pharmaceutical sales forecasts have either over-projected or under-projected sales (Cook, 2006). Any incorrect projections were likely to either stop the deployment of the support program or cut drastically into company’s profits. Therefore, the costs analysis played a critical part in patients’ ability to gain access to an important vaccine within poverty-stricken countries.

Program Success: Key Performing Indicators (KPIs)

Like any project deployed, it was important to judge the effectiveness and success of the project. To determine the success of the program, several key performing indicators (KPIs) could be considered. These KPIs included the number of patients that were served, the rate of applications reviewed, length of time spent on approval per application, and the accuracy of the forecasting model used.

Determination of the number of patients served and comparing it to the number of individuals living under the poverty line (expected patients who were eligible for the program) indicated the access of the program and how well individuals were informed by their healthcare professional about the vaccination options available to them and their affordability. This was indicative of the communication between the company and the healthcare professional in getting their jobs done effectively.

The rate of applications reviewed was indicative of the efficiency of the work done by the patient program employees. It was also indicative of the ease of the navigation of the program by company employees, patients, any insurance companies, and healthcare professionals. Any lapse in the rate would indicate areas of inefficiencies in the newly deployed program. Gaining insights on the duration of the application process also provided insights into the inefficiencies of the program. Moreover, the understanding of processes that took longer than expected narrowed the specific problem areas for proper resource allocation in problem resolution. As a result, the overall efficiency and effectiveness of the program were expected to improve by setting the KPIs.

Forecasting accuracy was important in determining the actual costs of the program compared to expected. Ensuring accuracy in projections also ensured that the company funds were properly utilized to avoid any loss of revenue for the company.

The final overarching KPI that was set for the success of patient programs was the reduction in the global incidence of Zika virus infection and neurological abnormalities due to virus contraction by pregnant women.

With understanding all the considerations needed for setting the price of the Zika virus vaccine and any coverage plans for those in need, Emma Walmsley walked towards the door of the conference room. She knew the discussion would be long and many points would be raised. Going into the meeting, she knew that tackling the concerns of the advocacy groups like Doctors Without Borders and World Health Organization was going to play a key role in securing an exclusive license to the vaccine and commercializing the product.

References

10 Shocking Facts About Poverty in Latin America. (2016, October 24). Retrieved April 7, 2018, from https://borgenproject.org/10-facts-about-poverty-in-latin-america/

Are Seniors at Risk for Zika Virus? (2016, April 22). Retrieved April 7, 2018, from http://www.metrohealthinc.com/seniors-risk-zika-virus/

Bloomberg [HL] GlaxoSmithKline PLC (Large Pharma). [FA].

Cook, A. G. Forecasting for the Pharmaceutical Industry. Gower e-BOOK. 2006.

Coupons & Free Trial Offers for Medications | GSKForYou. (n.d.). Retrieved April 7, 2018, from https://www.gskforyou.com/coupons-free-trials-prescription-drugs/

Four Facts About Poverty in Latin America you Probably Didn’t Know | HuffPost. (n.d.). Retrieved April 7, 2018, from https://www.huffingtonpost.com/jamele-rigolini/four-facts-about-poverty-_b_6820048.html

GSK jumps into Zika vax hunt on heels of Sanofi’s deal | FiercePharma. (n.d.). Retrieved April 7, 2018, from https://www.fiercepharma.com/pharma/gsk-enters-zika-vaccine-scene-nih-collaboration

GSKForYou | Patient Assistance Program. (n.d.). Retrieved April 7, 2018, from https://www.gskforyou.com/

Infographic: The Spread Of The Zika Virus. (n.d.). Retrieved April 7, 2018, from https://www.statista.com/chart/4322/the-spread-of-the-zika-virus/

Patient Assistance for Vaccines | GSKForYou. (n.d.). Retrieved April 7, 2018, from https://www.gskforyou.com/vaccines-patient-assistance/

Rheinberger, C. M., Herrera-Araujo, D., & Hammitt, J. K. (2016). The value of disease prevention vs treatment. Journal of Health Economics, 50, 247–255. https://doi.org/10.1016/j.jhealeco.2016.08.005

Risk of Zika Virus-Related Birth Defects in Pregnant Women. (2017, March 9). Retrieved April 7, 2018, from https://www.neurologyadvisor.com/pediatric-neurology/zika-virus-related-birth-defects-increased-in-pregnant-women/article/641964/

The Battle Over a Fair Price for Zika Vaccines – Scientific American. (n.d.). Retrieved April 7, 2018, from https://www.scientificamerican.com/article/the-battle-over-a-fair-price-for-zika-vaccines/

The Price of Prevention: Vaccine Costs Are Soaring – The New York Times. (n.d.). Retrieved April 7, 2018, from https://www.nytimes.com/2014/07/03/health/Vaccine-Costs-Soaring-Paying-Till-It-Hurts.html

Waye, A., Jacobs, P., & Schryvers, A. B. (2013). Vaccine development costs: a review. Expert Review of Vaccines, 12(12), 1495–1501. https://doi.org/10.1586/14760584.2013.850035

WHO | Zika virus. (n.d.). Retrieved April 7, 2018, from http://www.who.int/mediacentre/factsheets/zika/en/

Appendix I

*The table was taken from GSK for you program website (“Patient Assistance for Vaccines | GSKForYou,” n.d.)