By Paul Hudson, President, AstraZeneca US and Executive Vice President, North America
As parents, we do everything we can to protect our children from harm. We fasten seat belts, insist on bike helmets, and visit the pediatrician for a seasonal flu vaccination. But what if a decision about helping to protect your high-risk child from an infectious disease was made for you – not by your child’s doctor, but by a committee of doctors whose ruling would replace what is already an accepted standard of care?
That’s the reality for many parents when it comes to protecting their children at high risk of severe respiratory syncytial virus (RSV) disease. RSV is a seasonal virus that affects nearly all babies by age 2. In most cases, it causes only mild-to-moderate cold-like symptoms. But for some babies – particularly those born prematurely and those with certain types of heart or lung disease – RSV can lead to serious lung disease. In fact, severe RSV disease causes approximately 125,000 infant hospitalizations each year in the United States.
A high-risk infant’s risk of hospitalization due to severe RSV disease can be significantly reduced with monthly injections of an FDA-approved therapy that my company has been making since 1998. Pediatricians, neonatologists, pediatric cardiologists, and pediatric pulmonologists around the country count on this medicine to help protect their tiny patients.
Paul Hudson, President, AstraZeneca US and Executive Vice President, North America
But every few years, a committee within the American Academy of Pediatrics (AAP) issues recommendations that progressively narrow the population of babies they believe should qualify for this medicine, despite the fact that the clinical benefit of this therapy has not changed. On July 28, they did it again – this time endorsing drastic reductions in babies who will be eligible.
This is ironic, given that the AAP is the same organization that issues recommendations – on topics from hand washing to toy safety – that are designed to protect children.
While the AAP will say that its recommendations have no binding or legal authority, many insurance companies and public payers have used them each time they are updated to deny coverage to families whose children fall outside of the AAP committee’s suggested eligibility parameters.
I have heard many stories from physicians who are trying to help protect their young patients from severe RSV disease, only to spend hours on the phone fighting with insurers to try to overturn their denial of coverage. And I have heard similar stories of parents, who feel helpless after spending months on the phone fighting to reverse denials, knowing that when they finally give up, their babies will be left without the protection their doctors prescribed.
Do these restrictive recommendations have a financial impact on my company? Of course. But this is about much more than the bottom line. It’s an issue of access to care for vulnerable children – and an issue of making critical medical decisions for the right reasons, based on the right information. More importantly, it’s about giving vulnerable babies the best possible chance at a healthy start to life.
There are real-life consequences from the AAP’s continued restrictions. For example, Vanessa Moore’s daughter, Sydney, was born at 34 weeks gestational age during the peak of RSV season. Despite being born 6 weeks before term, Sydney’s doctors deemed her healthy and didn’t discuss the option of preventive treatment for RSV. Vanessa took every precaution to keep her daughter safe during the same RSV season – constantly sanitizing hands and toys, avoiding crowds and even skipping family gatherings – but Sydney still contracted the highly contagious virus and was hospitalized for nearly a week.
After it became clear that Sydney would benefit from added protection, her doctors prescribed the preventive therapy but she was quickly denied coverage. Over the course of several months, Vanessa and Sydney’s doctors pleaded with their insurance company to obtain coverage, but they were denied time and time again. Meanwhile, Sydney had three more RSV-related hospitalizations that year.
So much for saving money – not to mention the emotional and physical toll it took on the family.
I wonder how many more preemies like Sydney will suffer a similar impact when the new, more restrictive recommendations take effect?
While the AAP asserts that its recommendations are based on research, it has chosen only certain studies on which to base its guidance. A more balanced approach would be to systematically review all of the existing data before reaching a conclusion. This is what has been outlined in the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines.
I’m not the only one who disagrees with the AAP’s recommended approach. Several professional organizations and individual clinicians have expressed concerns that the new recommendations are inconsistent with current evidence.
As a father of three, I know there is no greater fear than your child becoming gravely ill. And there is no excuse that makes it OK to deny a proven method of prevention to a baby for whom it was prescribed.
Visit www.RSVfacts.com to take action to help protect our most vulnerable babies.