The FDA has approved Kinrix and Pentacel, two new combination products for the prevention of diphtheria, tetanus, pertussis and polio. Although the new combinations will reduce the number of shots and increase the convenience for vaccinees, their introduction may cause financial challenges for physicians, potentially limiting their uptake.
Sanofi Pasteur’s Pentacel is a 5-valent combination vaccine, protecting against diphtheria, tetanus, pertussis (DTP), polio and infections with Haemophilus influenzae b in one single shot. The vaccine has been approved for use as a four-dose series at two, four, six and 15-18 months of age for infants and children between six weeks and four years old. However, it will face some tough competition in this segment: GSK is marketing its 5-valent combination vaccine Pediarix, which provides protection against DTP, polio and hepatitis B, in the same age group.
GSK’s Kinrix, the other vaccine which has been approved by the FDA this week, combines antigens against DTP and polio in one shot. Unlike Pentacel, this vaccine is not targeted at the infant population, but is aimed instead at the pre-school booster market. In the US, a DTP/polio booster is recommended for all children aged four to six years of age, and, prior to this approval, no combined vaccine was available. As a result, Kinrix, which has been approved precisely for this segment, has good prospects for capturing a large share of sales in this segment. Since Kinrix’s approved indication is limited to use in those children who have previously received GSK’s DTP vaccines Pediarix or Infanrix, it would seem that the company is attempting to protect its leading position in DTP infant vaccination, providing tailored options for each age group. However, following the approval of Pentacel, the tables could turn if physicians prefer Sanofi’s new vaccine over Pediarix.
A common challenge for both of these vaccines, however, is the reluctant attitude of many US pediatricians towards combination products. Although they increase the convenience for the vaccinee by reducing the number of shots they must endure, US physicians claim that, under current reimbursement rules, using combination vaccines instead of single-antigen products results in financial losses for them. This is because most payers reimburse combination and single antigen products at the same rate, although the administrative effort for combination vaccines is significantly higher. In other words, less pain for the children translates into less gain for the physician. These concerns need to be addressed in order to maximize the uptake of combination vaccines such as Pentacel and Kinrix across the US.
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