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In today’s drug development environment, there is no doubt that supply chain decisions are paramount in a product launch strategy, writes Lisa Henderson.
The definition of a specialty medication, according to Randy Maloziec, VP of BioPharma Relations for AmerisourceBergen’s US Bioservices, is a medication that meets at least five of the following criteria: biotech, injectable, has a mandated FDA REMS requirement, chronic condition, specialist initiated, special handling, a cost in excess of $6,000 a year, and a limited pharmacy or wholesale distribution network. Now, specialty
medications and specialty pharmacy are two different things. You don’t always need a specialty pharmacy to handle a specialty medication, and specialty medications don’t always go through a pharmacy. So what is a specialty pharmacy? Maloziec told a recent audience at CBI’s Reimbursement and Access conference that no one really understands it.
Further, Maloziec outlined the medical-pharmacy vertical integration. The large insurers, Cigna, Aetna, UnitedHealthcare, and Blue Cross Blue Shield, feature their own PBM-ExpressScripts, CVS Caremark, OptumRX, and Prime Therapeutics, respectively. Then the specialty pharmacy aspect is also listed respectively with Accredo, CVS Specialty, BriovaRx, and Alliance Rx.
This issue of Pharm Exec focuses on specialty pharmaceuticals, not pharmacy. But in today’s drug development environment, where orphan designations are on the rise, more complex cell and gene therapies continue through the pipeline, and specialty drug spend grew 9.3% while traditional drug spend fell 4.0% in 2017, the two are linked. How a company decides to distribute its drug through the supply chain requires a discussion that most likely includes a specialty pharmacy.
In an article from Charlie Bell, a senior director at Archbow Consulting, he states, “specialty pharmacy brings to mind high-touch therapies supported by hubs, financial assistance, free drug programs, home nursing, and dutifully developed clinical protocols.” But, conversely, the specialty pharmacy market is seeing more products on the low-end range of specialty drug prices. And, he continues, “that trend is driving the demand for specialty pharmacy program options that accommodate lower-cost therapies.”
There is no doubt that supply chain decisions are paramount in a product launch strategy. At Veeva Systems Commercial Summit earlier this year, CEOs from Otsuka and Spark Therapeutics discussed their launch decisions. Otsuka chose a limited launch for its digital medicine-Abilify MyCite, co-developed with Proteus-to learn as much as it can about data handling implications in a challenging disease state. Spark, with its one-
time gene therapy, Luxturna, is opting for a limited centers-of-excellence model, where patients travel to the drug, basically eliminating the need for a complex supply chain or high-touch ancillary services.
Outside of Spark and Otsuka’s limited distribution choices, other game-changing therapies require cold distribution in the supply chain, adding to additional complexities.
Game-changing therapies aside, there continues to be a rough road for what one speaker at the CBI conference termed the “prescription journey map.” That is the journey from the prescription to actual medication delivery to the patient. That process should be as seamless as possible, which leads to the many enhanced patient services pharma initiates-including hubs, stopgap plans, rebates, prior authorization service and more.
With the current positioning of HHS Secretary Alex Azar to eliminate rebates, and put more transparency into the drug pricing process, PBMs and health plans appear to be the most against this move. On one hand they want transparency from pharma, but they don’t want to provide that same level of transparency themselves.
Lisa Henderson is Editor-in-Chief of Pharm Exec. She can be reached at firstname.lastname@example.org. Follow Lisa on Twitter: @trialsonline
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