Specialty Products: BriovaRx's Holistic Approach

In an exclusive interview with Specialty Pharmacy Times, Albert Thigpen, Senior Vice President of Pharmacy Operations & Industry Relations at Catamaran Corporation, spoke about his distinct responsibilities surrounding the management of pharmaceutical manufacturers, Catamaran’s 3 mail order pharmacies, and BriovaRx’s 11 specialty pharmacies.

In a bid to coordinate their specialty pharmacy assets, Catamaran recently rebranded their specialty pharmacy offering to BriovaRx in October 2012.

Specialty Pharmacy Times spoke to Albert Thigpen, senior vice president of pharmacy operations & industry relations at Catamaran Corporation, who explained that BriovaRx is a distinct offering within the Catamaran organization. “We wanted to create a separate, independent identity around Briova outside of Catamaran so that it can compete and win both in the open market and as a specialty offering within other PBMs, coupled with a stronger focus on the consumer,” Thigpen said.. “This way, Briova can capitalize on its own PBM business inside of Catamaran but not be totally dependent on it for its future growth.”

“We feel the current dilution of specialty within other PBMs—coupled with a stronger focus on the consumer that health care reform is championing—creates opportunity for Briova as a stand-alone offering,” Thigpen continued. “This is unique to the industry since the 2 largest specialty providers are housed within the ‘Big 2’ PBMs so the specialty pharmacy offering is diluted and tied too closely to other elements of the business.”

In an exclusive interview with Specialty Pharmacy Times, Thigpen also spoke about his distinct responsibilities surrounding the management of pharmaceutical manufacturers, Catamaran’s 3 mail order pharmacies, and BriovaRx’s 11 specialty pharmacies. Read on for more insight about measuring the value of diagnostic tests, educating manufacturers about access issues, and the challenges with ensuring that specialty pharmaceuticals are both affordable and accessible to patients.

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Q: What services does BriovaRx offer that sets it apart from other specialty pharmacies?

A: I think if you look traditionally at what specialty pharmacy has been focused on, it’s been very drug delivery-focused. Certain specialty companies will say, “We dispense medications for multiple sclerosis or hemophilia or HIV or fertility or rheumatoid arthritis.” But, in general, they’re very focused on the distribution side of the house and their drug dispensing defines their specialty pharmacy. Briova is very different in the respect that we are holistically looking at the patient and making sure that we are doing what is in the patient’s best interest.

Q: Does Briova also manage some of the medical benefit or just the pharmacy benefit?

A: Most specialty pharmacies—just as a core competency—are very skilled at clearing medical benefits. Retail pharmacy or mail order pharmacy, particularly those affiliated with large PBMs, are not necessarily focused too much on the medical benefit. Retail in and of itself cannot clear a medical claim but a specialty pharmacy can. And if you think about the evolution of the pipeline and where certain specialty pharmacy products are going to evolve out of, more are going to continue to be covered under the medical benefit. In order for any specialty pharmacy to be successful, including BriovaRx,the specialty pharmacy has to master pharmacy benefit claims communication,a nd more importantly, has to be able to bring the 2 [pharmacy benefit and medical benefit] together to build a respectable picture of what’s going on to the payer and to the patient with respect to specialty care. Briova is extremely competent on both sides of the house.

Q: When it comes to working with manufacturers, what would you say is one of your major challenges?

A: Some challenges really arise when educating the manufacturers on how can they get the most access for a product that they’re trying to launch in the market. Probably the biggest challenge for the industry, not so much for the specialty pharmacies, but probably more so for the manufacturers, is understanding which specialty pharmacies are in network with which payers. Does understanding that network model provide them enough access to where they can launch a particular product or continue to seek reimbursement? The business of specialty pharmacy network management and patient management services is under continuous evolution, and continuing to educate the manufacturers is very important.

Q: How important is utilization management (UM)?

A: First off, the utilization management footprint and the governance of how drugs are reimbursed and clinically managed are very client specific. And if you think about the ultimate payer, whether you are a managed care plan or a labor group or a union or a TPA [third-party adminsistrator] or self-funded employer or a Medicare part D plan, they’re going to handle utilization management very, very differently. So the successful specialty pharmacy has to be able to have enough flexibility and capability in their arsenal to handle a multitude of players. Managed care organizations tend to be very aggressive on the UM front and tend to curtail a lot of inappropriate utilization much more aggressively than a labor or a GPA group would. But each one of them has a need for a specialty pharmacy and that specialty pharmacy needs to be flexible and creative and have the system architecture and the skill set to manage those varied abilities.

The second piece is when we start talking about clinical appropriateness and the management of pharmaceuticals, particularly the super high-cost specialty drugs, you have to be very, very confident and skilled in managing additional PBM-like tactics for drugs covered under the pharmacy benefit. Some UM tactics are things that have historically been cultivated and perfected in the PBM space, and those specialty pharmacies operating under the PBM benefit and that are affiliated with a PBM are usually probably the best at mastering it.

The third layer here is the coverage of drugs under the medical benefit. If we’re talking about hemophilia or CML or non-Hodgkin’s lymphoma, we know third party organizations like NCCN have published their own guidelines on how to treat certain cancers, and these are great references. Several organizations, including Briova, will look at established guidelines at these levels in lieu of nationally established guidelines. What we want to be careful of is not being so Machiavellian in nature or aggressive that we are curtailing a physician’s right to prescribe and treat certain diseases in lieu of any guidelines being present. So that’s the aspect that we also bring into our clinical product offerings—understanding what national guidelines are there. If the payer wants to adopt and use those guidelines, we have an option for the payer to do that. If the payer doesn’t want to adopt a nationally-recognized guideline or standard, then we also want to make sure that we are managing the physician population in a way that is also deemed “medically acceptable practice.” Ultimately, coverage decisions reside with how aggressive the payer wants to be.

Q: Would you say that clinical pathways are a medically accepted practice?

A: It depends. For example, clinical pathways, if they are evidence based in nature, could be appropriate guidelines. Let’s talk about Synagis (palivizumab) for a second. Synagis, the drug to treat respiratory syncytial virus (RSV), is for premature babies. We’re in the middle of the season right now, during the cold and flu season months anyway, and the American Academy of Pediatrics (AAP) puts out recommended guidelines for the use of Synagis every year. And more times than not, MedImmune the manufacturer of Synagis, may not in every single case agree with the guidelines created by the AAP around the use of Synagis. There are entities that are out there—whether they be a PBM, a specialty pharmacy, a managed health care plan, or a physician practice group—that will develop their own clinical pathways that may or may not be as aggressive. Catamaran and Briova’s entire premise is based on evidence-based medicine.

Q: In terms of looking at the whole distribution chain for getting medication to the patient, which pathway presents the most challenges?

A: Tough question. Each one of them has their own individual roadblocks. If you think about why we have so many channels now of distribution: through a specialty pharmacy; direct physician dispensing like they do with oncology; pharmacy benefit management through a retail pharmacy like CVS or Walgreens, or Rite Aid, or a mass merchandiser like Target, Walmart, or Costco; mail order pharmacy through traditional mail order; buy and bill from the physician perspective; or these funky little models that are hybrids of the 2 where we can get specialty pharmacy shipped directly to the physician in order to dispense that product; or some avenue of home care. All of those models have evolved in general because of the individual plan designs of the payers and the associated economics of how that drug needs to be billed, whether physician services are required or not, whether it is covered under the pharmacy benefit and/or medical benefit, whether it has to be administered in a physician’s office or through an infusion at an infusion site. The complexity in the channels is primarily due to how the payer has set up their billing practices and reimbursement practices relevant to the specialty supply chain.

There are always challenges surrounding the accessibility and affordability of a product regardless of which channel we’re talking about. When a patient gets a prescription, their insurance company should cover a big chunk of it and he or she should be able to afford it with minimal roadblocks. That’s affordability. The other piece is accessibility. Is the drug accessible? Can the patient go to any channel and get it or do they have to jump through ten thousand obstacles to get it? We can talk until we’re blue in the face about different supply chain dynamics and the models of distribution, but affordability and accessibility are always the key concerns.

Q: What’s your view on companion diagnostics? Do you think that they’ll eventually be a given part of all treatments that are specialty moving forward?

A: The theory behind companion diagnostic is very noble and it’s one that I support. Companion diagnostics is, in theory, designed to render a test back that says this drug will or will not be successful in a particular type of patient. But there have been several tests out there that have been known to render false positives, so the current companion diagnostics aren’t 100% foolproof. So although it's still in its infancy, there’s still the evolution of companion diagnostics rendering a very true and accurate test, number one. Number two, the labs that are governing companion diagnostics today render different responses. So, there’s not necessarily clear quality standards put in place for the labs that are rendering the tests back for companion diagnostics and there needs to be a leveling of the playing field of reputable labs and companies that can manage the tests appropriately with a high degree of sophistication and quality.

The third piece is, right now, the tests that are commercially available are also pretty expensive. I think the vast majority of payers would support the payment of an expensive companion diagnostic if they had a high degree of confidence or certainty that the test was going to prove or disprove the use of that particular pharmaceutical. Companion diagnostic tests are great in theory—as a pharmacist, I support them—but I think the science and technology behind them still needs to evolve. I think the pharmaceutical industry needs to probably step in a little bit more and support companion diagnostics whether they prove or disprove the value of one pharmaceutical over the other. But it’s in its infancy and I only hope for greater things to come in the future.

Q: What is your take on restricted channels in specialty?

A: Well, I think the use of restricted channels depends on the product in and of itself. I put myself in the shoes of the pharmaceutical manufacturer. In some cases, a preferred or limited network would make a whole heck of a lot of sense because of the availability of the product, their resources required to manufacture, the ability to control the product ingredients, returns, and the administration of the product. There’s a lot of merit to that by limiting who can buy it and how it can be delivered. Particularly if we’re talking about a product that has very detailed REMS associated with it. You just can’t supply a product to everybody and expect them to be held accountable to the management of a REMS program if you don’t have the infrastructure to manage it. In most cases, that is one of the criteria for inclusion or exclusion of the network itself. It all really depends on the particular product—in some cases, a limited network makes sense, whereas in others, it makes zero sense.