When filling a niche pays off
Provider assists drug manufacturer with protocol
Building Blocks of Newport Beach, CA, does one thing and one thing only - pediatric home care. Thanks to that focus, Building Blocks recently was called on to help a drug manufacturer develop home infusion protocols for a new drug, leading to a win-win situation for both companies.
Mark McConnell MD, CEO and medical director of Building Blocks, is always on the lookout for new services.
"I saw in the literature that RespiGam was going to become available to the public and receive FDA approval, so we put together a program to deliver RespiGam in the home," says McConnell, referring to Bethesda, MD-based MedImmune's drug for infants with respiratory syncytial virus (RSV). "After we marketed that, MedImmune representatives contacted us and asked if we would help put together home infusion protocols."
Jorge Valdivieso clinical marketing manager in MedImmune's San Diego office, says because RespiGam was new, there was no existing information on home infusion protocols for the drug.
"There were very few people to fall back on who had done something like this before, so the hospitals and physicians were scrambling to figure out how to provide this therapy in the home," he says.
The choice to work with Building Blocks in developing those protocols was a natural choice.
"RespiGam fit right into what their business is about, so we talked about how we could provide RespiGam and how they could provide the services and try to provide a solution to hospitals and doctors on how to do this," says Valdivieso. "Building Blocks has pediatric nurses on staff, ready to provide this to high-risk infants. Other providers talked about it, but if you asked them, 'Do you have pediatric nurses on staff?' they said, 'Well, we have access to them.' It's not their specialty."
The process was fairly straightforward, according to McConnell.
"We provided our protocols for them to review, and then discussed their suggested revisions and why we thought they were important or weren't important," he says. "Based on their recommendations, we developed the final protocol, which we submitted back to MedImmune."
Valdivieso stresses the relationship was informal.
"We weren't contracted together," he says. "They set up their own protocol, based on their expertise in home infusion therapy, that they can take to a hospital and say, 'We can do this right now, and here's our protocol.'"
The benefit for MedImmune was clear. Because infants with RSV are typically fragile, high-risk patients, many physicians were reluctant to move such patients from the hospital to home to receive the drug. But thanks to Building Blocks, MedImmune was able to show that providing RespiGam in the home was not only possible, but safe as well.
"Most physicians said, 'No way in home care,'" says Valdivieso. "But we were able to tell physicians, 'There's a company called Building Blocks that specializes in pediatrics, and they even have a protocol set up, so why don't you call them and see if that might be a solution?'"
Everyone wins
With their protocol already in place, why would Building Blocks agree to help MedImmune finalize the home infusion protocol for the drugs, a move that could potentially assist competitors? McConnell says Building Blocks reaped two specific benefits thanks to assisting MedImmune:
· "We were then viewed as the leader of infusion of RespiGam in the home," he says. "That had a positive marketing aspect for us."
McConnell notes that it was able to land business it never would have attracted if not for its involvement with MedImmune.
"We were able to get business from people who normally would not have given us business or who were capitated with other providers," he says. "They saw our leadership in providing RespiGam in the home, and they were willing to give us patients we otherwise would not have had access to."
· When there were supply problems late in the season last year, Building Blocks was able to get access to drugs for patients because it had a working relationship with MedImmune.
Other benefits resulted from Building Blocks being first out of the gate with RespiGam.
"In the first year we had very little competition," says McConnell. "This past season, there was more competition, because everyone tells their payer they can infuse RespiGam in the home."
But once a physician gains confidence in a provider, it can be difficult to get him or her to switch care providers, a benefit for Building Blocks in the RespiGam arena.
"Many of the doctors we worked with the first year were comfortable with us, so in the second year, when payers were asking for other provi ders, the physicians would push the payer to give us the business, even though we may not have been that payer's preferred provider," says McConnell.
This was particularly true for RespiGam due to the nature of the patients receiving the drug.
"You're talking about very sick children; neonates who have been in the neonatal intensive care unit for some period of time and who have chronic lung disease, and children who are very fragile," notes McConnell. "To shift that trust to another provider that may not have the experience we had may have been a big leap for some physicians."
How much work?
McConnell notes that setting up a protocol for a new drug takes plenty of work, but first and foremost you've got to be on your toes.
"The key is to be aware of what is on the horizon and what type of drugs are coming out," he says.
Once he became aware of RespiGam, the next step was to see if it could be offered in the home by reviewing literature on the drug's side effects.
"If the incidence of side effects was as high
as 10% to 20%, then RespiGam would not have been a good drug for use in the home," says McConnell. "It turns out that RespiGam had a fairly low side-effect profile." (See chart, above right, on Building Blocks' experiences with RespiGam.)
Next, McConnell compared RespiGam to services Building Blocks already offered.
"It turns out that RespiGam is somewhat related to IVIG [intravenous immune globulin]," he says. "Since we've done IVIG in the home and this shouldn't be much different, that at least provided a framework for us."
McConnell then went to work with Building Blocks' director of nursing, pediatric pharmacist, and members of the nursing team to adapt the IVIG protocol to RespiGam, a process that took nearly two months.
"It was fairly time-consuming because we knew there was going to be resistance to doing this in the home, so we needed to make sure we did it safely so those prescribing it would trust the program," says McConnell.
Pediatric monitoring proved crucial
Because RespiGam already was being administered in hospitals, creating the protocol did not require reinventing the wheel.
"The literature already had information on how the drug had to be infused, how it had to be ramped up, and things like that," McConnell says. "What was more important was the physiological monitoring of the child during the protocol, so we had to consider monitoring standards such as how often we were going to check vital signs, what was going to happen if a patient had complications, and what kind of equipment should be in the home."
McConnell points out that the protocol for infusing RespiGam is included in the package insert of the drug. Building Blocks attaches a patient to physiologic monitors including heart rate, blood pressure, and pulse oximeter (if indicated). Nurses check vital signs every 15 minutes during the infusion, and remain with the child until thirty minutes after the infusion is completed. An anaphylaxis kit is placed in the home as well as an intravenous diuretic should the child develop evidence of fluid overload. If indicated, a bag-valve-mouth device and oxygen are also placed in the home.
Staffing is also somewhat unique.
"In most cases, we have sent two nurses into the home to start the IV, since most of these children have poor IV access after spending much of their early life in the neonatal intensive care unit," notes McConnell. "Once the IV is established, then the second nurse leaves."
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