COVID-19 has enhanced interest in infectious diseases, such that vaccine rollout is seen as the light at the end of the pandemic tunnel. For decades, the vaccine segment of the pharmaceutical industry had been regarded as a market with limited revenue opportunities. However, these myths have been dispelled by novel, high-price products such as Prevnar and Gardasil, illustrating that vaccines have commercial potential with the right strategies in place.
Gardasil, an exceptionally successful example, achieved blockbuster status soon after its market debut. In 2019 alone, Gardasil generated $3.7 billion in revenue (1).
Developed by Merck, Gardasil was the first human papillomavirus (HPV) vaccine to be granted regulatory approval by EMA and the FDA in 2006 (2,3). This approval represented a significant breakthrough in women’s health considering the association with cervical cancer secondary to HPV infection. Gardasil is a quadrivalent recombinant vaccine that spurs production of antibodies against HPV subtypes 16 and 18, which cause approximately 70% of HPV-related cervical cancer cases, and subtypes 6 and 11, which cause about 90% of genital wart cases (4).
In 2015, Merck received regulatory approval for its 9-valent Gardasil vaccine, which includes 5 additional HPV strains (5). The vaccine is widely known as Gardasil 9.
The Gardasil case could potentially offer several lessons for future vaccine launches.
Merck primed the market prior to launch by establishing the link between HPV and cervical cancer through several campaigns such as “Tell Someone”, “One Less”, or “Make the Connection”. By creating awareness amongst healthcare professionals, governments, and the public and simultaneously steering clear of cultural taboos, Merck positioned Gardasil as a cancer vaccine rather than an STD vaccine. This strategy was effective in the early generation of disease burden data, clearly demonstrating the substantial burden of cervical cancer on women and healthcare systems. With such momentum built prior to its regulatory approval in Europe, it received a positive recommendation by all EU5 National Immunization Technical Advisory Groups (NITAGs) within one year of regulatory approval – a considerably shorter time compared with other vaccines launched within the last two decades. (Bexsero was recommended after 3 years, while Zostavax was recommended after 5 years)
Gardasil is one of the most expensive vaccines on the market. Its relatively high price was driven by the vaccine characteristics and value it offers, alongside a robust pricing strategy that encompassed capturing and anticipating health impacts and economic saving. Moreover, Gardasil has a remarkable efficacy of 100% for prevention of HPV vaccine type-related persistent infection. However, it was the protection against genital warts which represented a key differentiating factor against its competitor Cervarix, making Gardasil the preferred product to be reimbursed by payers, so much that in the US, Cervarix was discontinued from the market in 2016.
Merck collaborated with universities and research centres to publish cost-effectiveness analyses up to 3 years prior to regulatory approval in order to demonstrate the reduction of burden of disease and the estimation of the monetary savings. Complex modelling was required due to both the long and uncertain time to cancer development (20‒30 years) and the inability to quantify healthcare expenditure reductions in the near future.
Another reason for the enhancement of the cost-effectiveness of Gardasil was the inclusion of genital warts prevention. Since prior to Gardasil’s launch the economic impact of genital warts was scarce, Merck commissioned health economic consultancies to generate the required evidence.
Finally, Merck engaged with key stakeholders in order to secure public acceptance and widespread vaccine uptake. In the UK for example, the Department of Health commissioned work on knowledge and public attitudes about cervical cancer, HPV and vaccination. The study looked at the parental responses to the introduction of a vaccine against HPV. The work demonstrated that parents were generally very positive about a vaccine to prevent cervical cancer. A crucial factor of these attitudinal studies is that they were not company led, which helped build public confidence on the vaccine safety and efficacy.
Conclusively, by generating the appropriate evidence prior to NITAG evaluation and employing the right stakeholder engagement and pricing strategy, higher priced vaccines such as Gardasil have reshaped a market with historically low margins. The strategies employed by Merck could potentially be leveraged by other vaccines in the pipeline to spur another wave of double-digit growth in the future.
Braaten KP, Laufer MR. Human Papillomavirus (HPV), HPV-Related Disease, and the HPV Vaccine. Rev Obstet Gynecol. 2008;1(1):2-10.
About the author
Jona is a UK qualified pharmacist, registered with the General Pharmaceutical Council (GPhC). She holds an MPhil in Management from the University of Cambridge. Jona has extensive experience in the healthcare sector gained through several UK NHS Trusts and rotations within pharmaceutical companies. Jona has transferred her expertise to Consulting with Access Infinity.