Vaccines are critical to global health security, being the most effective form of prevention and control of the spread of communicable diseases, some of which are particularly serious and potentially life-threatening. Vaccines’ crucial role and high-priority nature become even more evident in cases of pandemic, endemic or epidemic events.

Despite the major role of vaccines in healthcare systems on a global level, few countries explicitly indicate which pricing mechanisms they are subject to as part of the traditional pricing and reimbursement (P&R) process. Germany is one of the most striking cases, reportedly using international reference pricing (IRP) for vaccines to calculate discounts paid by pharmacies to the statutory health insurance funds. Otherwise, their characterisation within P&R frameworks is generally shrouded in ambiguity, with no specific mention of vaccines with respect to core pricing legislation. This produces substantial uncertainty on whether the same rules are applied, or rather if they benefit from any plausible exception.

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Vaccine manufacturers are, therefore, required to make additional efforts in understanding the various national regulatory landscapes, the consequence of which leads to important challenges in optimising their market access and pricing strategy across multiple markets worldwide.

The 2022 edition of GlobalData’s International Reference Pricing (IRP) Strategic Guidebook responds to this need to provide greater clarity in the field, integrating the results of extensive screening and interpretation of legislation and broader regulatory frameworks complemented by primary research insights. The newly added section on ‘IRP and Vaccines’ provides an immediate repository investigating how vaccines are considered within the P&R setting, with a specific focus on IRP application, taking concrete action to navigate the prevailing opaqueness of the subject.

The deep-dive investigation covers a total of 30 markets worldwide, across all regions: Albania, Algeria, Austria, Azerbaijan, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Croatia, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Moldova, North Macedonia, Norway, Romania, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, and Turkey.

The analysis reveals that vaccines are not exempted from IRP considerations, and should represent an integral part of a vaccine manufacturer’s comprehensive launch and pricing strategy. While IRP applies without any exception in only six cases, ten countries allow IRP application if specific conditions are met. For an additional 12 geographies, there is concrete potential IRP could apply the same way as for any other drug, even if final decisions might be case-dependent. Just two markets do not make use of IRP while evaluating vaccines as part of the traditional P&R process.

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Among countries applying IRP to vaccines, it is worth noting that only a few of them have introduced a different pricing mechanism more favourable to vaccines provided their role is deemed critical to public health or essential by the World Health Organisation (WHO). As an additional reflection, combination vaccines are surrounded by an even more heightened degree of uncertainty, with pricing mechanisms potentially adjusted to mirror the ones applied to combination drugs more generally.

The 2022 edition of the GlobalData International Reference Pricing (IRP) Strategic Guidebook also includes one more new section on ‘IRP and Combination Drugs’ with a deep-dive investigation across 23 countries into IRP applied to fixed-dose combination drugs (FDCs), in the attempt to provide more clarity on this topic as well. Only nine markets present separate pricing mechanisms for FDCs from that of single-INN drugs.

Learn more about the GlobalData International Reference Pricing (IRP) Strategic Guidebook, 2022 edition.