Adult Heplisav Uptake is Key to Product Success
By Mia Burns (firstname.lastname@example.org)
Optimism may circulate around Dynavax Technologies Corporation’s plans for a large Phase III trial of the long awaited hepatitis B virus vaccine Heplisav, but the company’s marketing efforts will fail unless executives have a plan for increasing vaccine uptake. According to research and consulting firm GlobalData, Dynavax has seized upon the untapped market opportunity presented by “non-responders” – hepatitis B virus patients who fail to achieve high levels of seroconversion when administered the currently marketed hepatitis B virus vaccines.
“I believe that adult hepatitis B virus vaccine coverage rates will largely dictate the commercial fate of Heplisav, not only in the United States, but also in the 5EU,” says Christopher J. Pace, Ph.D., GlobalData’s analyst covering infectious diseases. “While a clear patient population with high unmet need exists, Dynavax must succeed in improving adult hepatitis B virus vaccine uptake if it wishes to be more than a niche player in the prophylactic hepatitis B virus vaccine marketplace.”
GlobalData also says that to meet the needs of this patient population, Dynavax focused Heplisav’s initial Phase III clinical trials on specific groups of non-responders, such as those with chronic kidney disease (CKD). With the recently announced Phase III Study, HBV-23, Dynavax hopes to generate safety data required by the FDA, as well as to investigate the vaccine’s immunogenicity in adults with diabetes mellitus. The population represents an enormous, yet largely untapped, segment of the hepatitis B virus vaccine market when combined with other non-responders.
One approach to overcome obstacles, according to GlobalData, would be to advocate the universal immunization of adults against hepatitis B virus. This would provide a stable funding mechanism for vaccine administration while simultaneously easing the pressure on physicians and patients alike. “In order for universal adult HBV immunization to be a realistic possibility, the cost-effectiveness of such a program must be proven,” Dr. Pace told Med Ad News Daily. “In addition to increasing awareness and education, healthcare providers advocating for this vaccination strategy must stress the ability of adult immunization to mitigate the horizontal transmission of hepatitis B virus, reduce the incidence of HBV-associated diseases such as hepatocellular carcinoma (HCC), and decrease healthcare costs associated with the management of chronic hepatitis B virus.”
In addition, Dr. Pace says that the only way for Heplisav to achieve commercial success is if Dynavax executives work with regulators and healthcare providers towards finding a solution to improve hepatitis B virus vaccine uptake in the adult population. “As I mentioned in the expert insight, key opinion leaders have indicated that one approach to overcoming low hepatitis B virus vaccine uptake in adults would be to push for the universal immunization of adults against hepatitis B virus, as this strategy would provide a stable funding mechanism for vaccine administration and eliminate obstacles associated with compliance in high-risk groups,” he told Med Ad News Daily.
“The current strategy of targeting at-risk adults has not been successful for a few reasons,” Dr. Pace says. “First, because the currently available vaccines often do not induce a protective immune response in high-risk patients, such as those with chronic kidney disease (CKD), human immunodeficiency virus (HIV), or diabetes mellitus, there is little medical incentive to seek out these individuals for immunization. Second, those with behavioral risk factors, such as injection drug users (IDUs), are often unable or unwilling to admit a risk factor to physicians, which is a requirement for reimbursement. A universal adult hepatitis B virus immunization program would mitigate both of these obstacles and likely stimulate increased vaccine uptake, but cost-effectiveness concerns will pose a formidable barrier to a future hepatitis B virus vaccine recommendation expansion in the United States. Other strategies Dynavax may use to improve vaccine uptake in adults include increasing physician and patient awareness of the benefits of hepatitis B virus immunization in the adult population, as well as emphasizing the safety and immunogenicity of Heplisav in these targeted groups.”
Posted: October 2013