Generic Specialty Medications: The Paradigm Shift

** Phone rings **
Patient: “Hello?”
Pharmacist: “Hello, this is your specialty pharmacy and I’m wondering if you’d be interested in switching to the generic form of your specialty medication?”
** Click. Patient hangs up **
 
** Phone rings **
Patient: “Hello?”
Pharmacist: “Hello, this is your pharmacy and I’m wondering if you’d be interested in switching to the generic form of your non-specialty medication?”
Patient: “I didn’t even know that they make brand-name medications anymore. Give me whatever is cheaper. Thank you so much for calling.”
** Click. Patient hangs up **
 
Can you spot the difference?

If you are familiar with traditional pharmacy practice and retail dispensing, then you already know the narrative here. To put it simply, almost all non-specialty medications at the retail pharmacy level—and even that of mail order—are dispensed as generics.

If you walk into a retail pharmacy with a Z-Pak prescription, you are likely to walk out with the more cost-effective generic, known as azithromycin, instead. Generally, patients are very accepting of this practice, in part due to the fact it saves them money on their prescription medications. In fact, most states have laws that mandate substitution for a more cost-effective generic equivalent drug of the brand name, unless the patient or prescriber indicate otherwise.

In specialty pharmacy, however, we are still trying to write this narrative. Specialty medications are still mostly branded products, but even when a generic alternative is available, it’s often not an acceptable practice from a patient’s perspective.

Drug manufacturers are continually improving their marketing skillset to increase or create brand awareness and superiority. But, considering this, it’s important to take a step back and get a basic understanding of the drug development process and how generic medications are developed.



New FDA Policies to Help Generic, Biosimilar Drug Competition and Access



Per the FDA, there are 5 steps in the drug development process:
 
1. Discovery and development
2. Preclinical research
3. Clinical research
4. FDA drug review
5. FDA post-market drug safety monitoring

When a new innovator drug is identified, the drug manufacturer will file for a patent. This patent is valid for 20 years, effective the day in which the application is filed for it.

Alright, so, what does this have to do with generic specialty medications again? Specialty medications treat complicated, complex, often rare disease states, that are potentially life-threatening. Examples of these disease states are cancer, autoimmune disorders, blood disorders, etc.

For example, consider the perspective of a patient with cancer or their caregiver. During the patient journey, many events are likely to happen. First, is hearing the life-changing diagnosis and the words “you have cancer.”


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