Biomedical Engineering Reference
In-Depth Information
13.4.4.2
Launching a New Vaccine
Key goals when launching a new vaccine in a country are: (1) recommendations by
the country's NITAG and the medical societies, which are most important to the
vaccine core prescribers; (2) WHO recommendation and prequalifi cation; (2) favor-
able pricing and reimbursement conditions by public and private third-party payers;
(3) strong recommendations by physicians to eligible patients, and (4) consumer
willingness to be vaccinated with the vaccine.
NITAGs start working on future vaccines several years before the expected
licensing date. For example, ACIP formed an HPV Vaccine Workgroup in 2004, 2 years
before the fi rst HPV vaccine Gardasil was licensed in June 2006 (Shefer et al. 2008 ).
Most NITAGs and WHO collect and review data on the epidemiology, burden of
disease, vaccine effi cacy, safety, and cost-effectiveness (see sections “National
Technical Advisory Groups (NITAGs)” and “The World Health Organization
(WHO)” ). A vaccine manufacturer can infl uence this process by providing appro-
priate data, build epidemiological, health-economic, and other economic models,
and generating evidence of vaccine effi cacy, safety, and other relevant aspects.
Obtaining favorable recommendations from medical societies similarly requires
that the manufacturer interacts with these societies prior to the launch and provide
them with relevant information.
The goal is to obtain recommendations as quickly as possible following the
licensing, because this facilitates price and reimbursement discussions with payers.
For example, Merck succeeded in obtaining a favorable ACIP recommendation for
Gardasil in the same month as the FDA approval. For vaccines destined mainly for
countries procuring via UNICEF and PAHO, obtaining a WHO recommendation
and prequalifi cation rapidly is essential. It is not relevant for vaccines destined for
the United States, EU, and other high-income countries.
Obtaining a high price and favorable reimbursement conditions from public and
private third-party payers is the next challenge. This requires a good understanding
of the decision process, who the key infl uencers are (e.g., through social network
analysis as illustrated by Conway et al. 2008 ), their decision criteria and perceptions
of the burden of disease, the vaccine and the manufacturer. Like for NITAG recom-
mendations, the goal is to arrive at satisfactory price and reimbursement agreements
as rapidly as possible after licensing.
A new vaccine which has obtained recommendation by the NITAG and key med-
ical societies, favorable reimbursement conditions, namely no consumer cost shar-
ing, and physician reimbursement that promises profi ts from dispensing and
administering the vaccine, is in a good position to trigger strong physician recom-
mendations to eligible consumers. Including the vaccine in the metrics used by
payers to measure physician performance can generate additional physician sup-
port. According to Freed et al. ( 2011b ), one of the reasons why the vast majority of
primary care physicians stocked the pneumococcal polysaccharide (PPSV23) vac-
cine compared with the much lower stocking rate of most other adult vaccines was
that it was one of two vaccines included as part of the Healthcare Effectiveness Data
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