Before beginning my story, let’s review a little
bit about influenza vaccines. For a long time we’ve known that older patients
and those with certain underlying diseases such as kidney failure, diabetes and
others had a lower response to many vaccines than young, healthy subjects. One
way to deal with this problem might be to give the vaccine in higher
dosage. This has been done with
hepatitis B vaccine in patients with kidney failure as one example – and it
does work. Very recently, the same strategy was applied to flu vaccine. A high
dose vaccine was developed by Sanofi-Pasteur (Fluzone). In a clinical trial published in the New England Journal of
Medicine, researchers demonstrated that the high dose vaccine was 22-45%more
effective at preventing flu than regular vaccine in patients 65 years of age or
older. Another study examined all respiratory illness
occurring during flu season among older vaccine recipients. This study
demonstrated a 13% advantage for the high dose vaccine. There are two other new
flu vaccines that may also work better in older patients but the data to
support that conclusion for those vaccines is much less strong than the data
behind Fluzone (see below). So there is at least one flu vaccine available that
works better than other vaccines.
This story starts two years ago at an assisted
living facility here in Connecticut where my mother was living at the time.
During the winter my mother was telling us about several friends who had
contracted “pneumonia” and ended up hospitalized. Some never came back. I asked the administration at the facility
which flu vaccine was offered to the residents the previous fall and discovered
to my surprise that they did not offer the high dose vaccine to their elderly
residents. The average age there was
probably around 80. I then sent them information on the high dose flu vaccine
and asked that they offer it to their residents the next year (last year) – and
they did. This past spring my mother moved to another assisted living facility
in Connecticut. Thinking ahead, I sent them information from the CDC website on
the high dose vaccine and asked them both in writing and in person to make it
available for their residents this past fall.
In spite of my request, they decided not to offer the high dose vaccine
even though I think the average age of their residents is probably close to 75.
That led me to search for pharmacies that would
offer the high dose vaccine. I called
three CVS pharmacies in our area. One had the vaccine early on but had already
run out by the beginning of November. A second had never ordered the high dose
vaccine. The third had it available. My
personal physician also offered high dose vaccine for all his patients age 65
years and older and that’s where we finally went to get our vaccinations.
Further inquiries showed that the high dose vaccine was 2-3 times more
expensive than the regular vaccines. But
the vaccine is reimbursed by Medicare at a higher rate as well. My physician’s office staff confirmed that
they did not lose money nor make less money giving the high dose compared to
regular flu vaccine. But the higher procurement cost may have deterred some
providers from ordering the high dose vaccine.
In discussing this situation with friends and with
other residents at my mother’s facility, I was surprised to find that no one
knew that there was a high dose vaccine and no one knew that there might be an
advantage in taking the high dose vaccine compared to any other vaccine. I also
called the Connecticut Department of Health and learned that they and no
specific policy on which vaccine long term care facilities in the state should
offer. They said that they just go by
what the CDC recommends.
And that
brings me to the CDC and Advisory Committee for Immunization Practices (APIC).
APIC provides recommendations as to which vaccine should be given to which
population in what dosage, when and how often. In many cases, these
recommendations serve as guidance for insurers for reimbursement policies
especially for childhood vaccinations. In considering flu vaccines, the APIC
has decided NOT to make a specific “preference” for the high dose flu vaccine
for subjects 65 years of age or older.
As such, state health departments and providers have no incentive to
offer this vaccine. Since procurement
costs for the vaccine are higher, they may be reluctant to order the vaccine
even though it may be better for their patients and their reimbursement will
make up the difference in cost.
I spoke with Dr. Lisa A. Grohskopf who is the CDC’s
liaison with the APIC. She explained that there are 13 different influenza
vaccines available this season of which two are licensed for use in persons
aged 65 years of age and older. They are Fluzone, a high dose killed vaccine,
and Flublock, a recombinant flu vaccine also using a higher dose of antigen.
Data from various clinical trials are shown in table 3 from this CDC webpage. The best data including a study
carried over two seasons and enrolling about 32,000 subjects are those for
Fluzone*. The improved efficacy ranges from 22-45% improvement as compared to
standard dose vaccines depending on which population you are looking at. The
APIC will not provide a specific “preference” for this vaccine because (1)
there might be differences across different flu seasons (only two were
studied); (2) it was not compared to other high dose or newer adjuvanted
vaccines; and (3) it is not clear that the manufacturer would have been able to
provide it to a larger popultion. (I did
not speak to Sanofi-Pasteur about this). But to me – this reasoning is specious
since there was a large randomized trial showing consistent improvements in
efficacy across several different analysis populations in two different flu
seasons for Fluzone. If the objection is
that it should have been compared to other high dose or adjuvanted vaccines –
that seems unreasonable. Those other
manufacturers should be encouraged to come up with the same kind of data that
Sanofi-Pasteur provided in order to get a preference for use in older
individuals.
The end result of APIC’s dithering is that no one
understands that there is a better vaccine available for older individuals and
therefore, that those who need it don’t get it.
*I did not count the study shown in the table from 2009-10 where the
virus circulating was not present in the vaccine and therefore no conclusions
about the relative efficacy of the vaccine could be drawn.
No comments:
Post a Comment