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.”

The diagnosis creates an uncertain, murky future for these patients and their families. The next step is to treat their specific cancer with some sort of oncology regimen. Of note, according to the National Cancer Institutes at the National Institutes of Health, there are more than 100 types of cancer, with each type carrying its own regimen.

What follows is potentially the most nerve-wracking part, the waiting game. It can take anywhere from a few days to a few weeks from the time of diagnosis to the time a patient gets their medication. Factors that influence this include the regimen that is prescribed, the patient’s insurance, and whether the medication will be an oral therapy or infusion.

For these patients, their oncology prescription can never arrive quick enough. Fast forward to the patient having already received several months to a year of therapy, which has been successful. The patient’s cancer is regressing, they are tolerating the medication, and their disease is under control. Their life is somewhat normal again and they are no longer living in fear.

The intention of this scenario is to present an accurate representation of what the patient journey could look like to gain an understanding of their perspective. This allows health care professionals to better communicate with patients to help them overcome fears or hesitations they may experience when presented with the decision of whether to stay on their brand name medication or switch to its generic alternative.

Consider a patient diagnosed with chronic myeloid leukemia (CML), a slow progressing form of cancer that affects myelogenous blood cells. One of the most common medications to treat CML is Gleevec, which is widely considered a revolutionary product due to the mechanism in which it works.

Gleevec is a targeted therapy, meaning that it attacks cancerous cells without attacking healthy cells as do traditional chemotherapy agents; however, this revolutionary treatment comes with a cost. When the FDA approved Gleevec in 2001, it carried a price tag of $26,400 per year.

At the time, this was an extraordinary price for such a therapy. Fifteen years later, the price of Gleevec skyrocketed to more than $120,000 per year. In 2015, Gleevec provided $4.65 billion in revenue to its respective manufacturer.

The drug manufacturer has done everything it could to extend Gleevec’s brand name patent protection for as long as possible to thwart off cannibalization from a generic form entering the market. Gleevec’s original patent was scheduled to expire in May 2013.

However, after multiple patent extensions filed by the brand manufacturer, Gleevec’s patent protection was extended until February 2016. Around this time, the generic alternative imatinib mesylate was launched.

A patient’s perspective

Imagine the outlook of a patient who is gaining momentum and winning the fight against their cancer diagnosis. Just as life has reset back to normal, they get a call asking them if they are willing to switch to the generic alternative of the brand name medication that got them into remission.

In my experiences as a pharmacist, I’ve had quite a few occurrences to discuss generic substitution with patients regarding their specialty medications. I gained an appreciation for the patient journey, but more specifically, their thought process.

Patients simply do not want to change their therapy if it is working. They may wonder why they should fix something that isn’t broken, question where the generic was made and why it is so much cheaper. They may simply just say, “I don’t want the knockoff product.”

Up until a certain point, I was a little taken aback by these comments from patients. But then it dawned on me, they are a victim of the marketing. These folks did not always dislike generics, they had just been influenced to think otherwise.

In fact, their entire non-specialty medication profile is often comprised of generics. It is this very point that brings us back to the original question: can you spot the difference? Why is it that patients rarely ever opt for brand name medications at the retail counter, but seemingly only want brand name drugs for their specialty medications?

Which raises the question of whether health care providers are to blame.

As of December 2017, pharmacists, nurses, and medical doctors earned 3 of the top 5 spots for America’s most trusted and ethical professionals. A patient will surely interface with all 3 of these health care professionals during their journey.

I believe the negative misconceptions that patients have about generics is widely due to a lack of education around generic products.

It’s frequently far too easy for us to abide by a patient’s request and take the path of least resistance. For example, a patient hears from his neighbor that a friend’s cousin’s aunt tried a generic medication once and sneezed, therefore, generics simply aren’t as good as the brand. There is clearly an opportunity for patient education here. This is where pharmacists come into play.

A few considerations

In the FDA’s words:

· Generic medications contain the same activate ingredients as the brand name.

· FDA-approved generics contain the same high quality.

· Generics work the same way in the body, therefore, carry the same safety and efficacy profile.

· Generics have the same strength, indication, dosage form, and route of administration as their brand counterparts.

· The FDA mandates that generic medications undergo the same rigorous standards that brand name medications do.

· Generic medications cost less than brand name medications.

When the opportunity for patients to use a generic substitution presents itself, pharmacists need to have an open conversation with them to gain a better understanding of why they prefer the brand name. It’s important to listen and understand their challenges and hesitations so that we can provide appropriate education around these concerns.

We’re in the midst of a paradigm shift. With more brand name medications due to come off patent, we can expect to see more specialty generics, and even biosimilars (but that’s a whole separate topic) come to market. Generic drugs have saved the American health care system more than $1.5 trillion in the last decade and $253 billion in 2016 alone.

Although generics account for only 26% of total drug costs in the United States, we need to continue building momentum for creating sustainable and affordable health care in the years to come.

About the Author

Mark Thomas, PharmD, earned his Doctor of Pharmacy degree from Lake Erie College of Osteopathic Medicine and is currently enrolled in the Master of Science in Pharmacy Business Administration program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. He spent the past 4 years as a clinical pharmacist in a specialty pharmacy working on high profile initiatives to expand his organization’s national footprint, as well as directly coordinating with patients, prescribers and other health care providers to educate and promote the utilization and uptick of generic specialty medication. In his current role as a clinical advisor in the managed care setting, he works directly with clients to help manage and develop strategies that promote optimal health outcomes in the most cost-effective manner.