The decision about how to procure radiopharmaceuticals is a personal decision for each facility and it’s based on their location, capital, space, resources and demand. Here’s DOTmed Health- Care Business News’ guide to the options available today as well as some new developments that are making their way into the space.

Option one — nuclear pharmacies
Nuclear pharmacies such as PETNET Solutions Inc., Cardinal Health and IBA Molecular are one of the ways to get PET radiopharmaceuticals in the U.S.

PETNET was formed by CTI Molecular Imaging 1996 around the same time that PET/CT was introduced to the general marketplace. “The mission of PETNET Solutions at that time was to help grow PET/ CT as a modality,” says Edgar Alvarez, senior marketing manager for PETNET.

At the start, the company’s main customers were non-academic centers, free standing imaging centers and community hospitals.

In 2005, Siemens Healthcare acquired CTI which became Siemens Molecular Imaging. That branch of the company now has 50 sites in the U.S. as well as sites in Europe and Asia.

“The large academic centers had their cyclotrons, but the non-academic hospitals really didn’t have access to any PET radiopharmaceuticals until the commercial supply was made available,” says Alvarez.

The main reason why ordering from nuclear pharmacies is so popular is because the facilities get the right amount of dose they need at the right time—in other words, it’s efficient and cost-effective.

They can place the order online with PETNET Direct or they can fax it. They enter the patient- specific information, the referring physician information, what tracer they need, the amount they need, the time the patient will be there and the type of procedure that will be done.

“If you look at the business model for it, if you buy from the nuclear pharmacy, you have no inventory, you have no special building or room, you have no special, highly trained people and you only buy what you need and you get reimbursed for it,” says Wayne Webster, owner of ProActics Consulting (Webster also sits on the editorial advisory board of HCBN).

Cardinal Health operates roughly 160 sites that compound and dispense radiopharmaceuticals. The company says that it reaches more than 85 percent of all U.S. hospitals within three hours.

IBA Molecular, which runs a manufacturing facility in France, has a total of 57 nuclear medicine sites in Europe, the United States and Asia. Two other players in the U.S., Triad and UPPI, have four and twelve cyclotrons respectively.

Triad started as an alliance of three to five radiopharmacies and through acquisitions, has grown to be the second largest radiopharmaceutical supply company in the U.S. However, Triad’s main focus is on low energy, or SPECT radiopharmaceuticals. According to Dave Wilson, vice president of PET operations for the company, Triad does have some production capabilities for PET isotopes via the four cyclotrons Triad currently runs that were owned by radiopharmacies the company acquired. The cyclotrons are seeing some extra use due in part to a partnership with IBA. “We’ve expanded our relationship and we’re working with them as a subcontractor to provide FDG for some of their customers,” says Wilson.

Wilson says the four cyclotrons serve the Southeast U.S. market.

Meanwhile, UPPI is a GPO, basically an association of independent commercial radiopharmacies and university radiopharmacies that provides uniform doses of SPECT and PET labeled products.

According to company president, John Wintowski, the GPO consists of 83 radiopharmacies, which serve several hundred accounts. The organization does delve into radiopharmaceutical research and development and Wintowski says they’re particularly excited about PET cardiac applications, but they still are working on developing them.

As for supply of PET, Winkowski says the 12 cyclotrons act as “hubs” with another 20 UPPI members with hot boxes acting as “spokes” to cover much of the country with the exception being the far West.

Option two — purchasing your own cyclotron
Although the majority of facilities in the U.S order from a nuclear pharmacy, it’s not the best option for every facility. For many large academic centers the best option might be to purchase a cyclotron.

Webster says there are four reasons why a large academic center might want to have their own cyclotron. They may want it for particle accelerator research, they lack access to a nuclear pharmacy within a reasonable delivery distance for standard PET radiopharmaceuticals, or to provide their own source of approved PET radiopharmaceuticals.

However, the most likely reason for having an onsite cyclotron is that researchers want to develop new and interesting PET-based radiopharmaceuticals, also called short-lived PET isotopes or solid target isotopes.

Through a partnership with Cardinal Health, Washington University School of Medicine in St. Louis., for example, made the decision to buy their own cyclotron to advance research in the molecular imaging field.

One example of what’s possible when researchers in an academic setting are able to experiment with the creation of PET radiopharmaceuticals is the story of Amyvid. In the early aughts, Dr. Daniel Skovronsky led a team of researchers from the University of Pennsylvania’s Center for Neurodegenerative Disease Research in developing Amyvid. The PET tracer was the first to be approved by the U.S. Food and Drug Administration to help physicians measure beta-amyloid plaque load in the brain, which is associated with Alzheimer’s disease. Skovronsky’s company, Avid Radiopharmaceuticals Inc., is now a subsidiary of Eli Lilly and Company.

Since December 2011, the FDA has put new good manufacturing practice guidelines in place. The agency declared they now require new drug or abbreviated new drug applications for any PET radiopharmaceutical that will be used in a clinical setting.

When the deadline for submission rolled around in June 2012, many of the facilities realized that putting together their own drug applications was a difficult task.

“There are a lot of regulatory burdens and paperwork and costs associated with these filings with the FDA,” says PETNET’s Alvarez. “The FDA does audit these sites quite frequently to ensure that they’re compliant with the cGMP regulation.”

Once the facilities filed with the FDA and understood the cost and additional regulatory constraints on manufacturing, many looked to outside suppliers to run their operations.

Besides the collaboration with the University of Washington, Cardinal Health also entered into a partnership with Ohio State University in 2009 to research and ultimately create short-lived radiopharmaceuticals. According to written material from Ohio State, the investment from the pharmaceutical industry can help not only with the research being done in the academic setting, but also in the commercialization of new radiopharmaceutical development projects.

Option three — buying a mini cyclotron
A mini cyclotron is a third option. ABT Molecular Imaging developed one of these units, called the Biomarker Generator. It’s commercially available in most countries, but still pending FDA approval in the U.S. for clinical use.

In the case of the Biomarker Generator, there is no need for a radiopharmaceutical laboratory or hot lab because the unit produces a single dose of FDG on demand. For now, the Biomarker Generator only produces FDG since it’s the primary PET agent in the world.

The Biomarker Generator was created for sites which are off the beaten path and where a radiopharmacy is not available or a cyclotron is not close enough.

Hospitals in countries with emerging medical practices may be able to afford a PET scanner, but may not have the capital and resources that are needed for a cyclotron. “The adoption of PET has been very strong in Western Europe and in the United States, but not as much in the emerging countries,” says Rick Rippin, sales director at ABT Molecular Imaging. “The primary reason is the availability of FDG.”