Patient Access to Biosimilars

Kashyap Patel, MD: Mylan has started providing the aggressive support program, an advocate program that really helps practice assimilation in a better way. Pretty much most of the manufacturers have started doing a similar program. Again, this was more like a response to the demand from the market that multiple manufacturers started developing the support programs.

It does actually cover the patients who are not really insured and patients who are commercially insured but their out-of-pocket cost is too high. Within the guidelines of the payer world as well as in the restrictions of the CMS-CMMI as to what they can do and what they cannot do, they have developed a program that helps patients access drugs better.

Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: Looking at patient support for biosimilars is a key discussion. The majority of the patients who come in throughout the country, especially for cancer, have to be looked at for patient assistance, manufacturer drug support, and foundation support, to name just a few. That usually occurs in the outpatient setting, but can occur for inpatient utilization as well. Many of these processes that occur, including database registration, patient registration, etcetera, are sort of looking at all these different pieces through a 1- to 2- to 3- to 4- to 5-piece basis.

When we’re looking at that, what makes this a little different is that when we’re looking at biosimilars, you have to address it from the biosimilar standpoint. Making sure first you don’t switch between the brand name and the biosimilar, which can be an easy error to occur. But also when looking at the patient assistance programs, one of the key pieces will be how easy is its use, how user-friendly is it, and in many cases how it applies to the patient.

We always have to discern some of those from the patient assistance program, or PAP, or medication assistance program, depending on what word you use to help with those patient populations. In many cases, some of these are more friendly, more easy to use. They have a database; everything is online. All of these hopefully apply for the patient and, therefore, require less work on patient member teams to start that patient on therapy, to decrease the interval from the time that drug comes in to the time the patient can get the drug, and to address any free drugs—in which that patient has that drug therapy in hand for application for their disease treatment.

Kashyap Patel, MD: For biosimilars access, we ensure, first of all, that they are available in a constant supply chain. The second thing we look into is the payer co-pay, because we do not want the patient to be stuck with a huge amount of out-of-pocket costs if a payer does not cover it. If needed, we reach out to the manufacturer and ask them for their help to ensure that as we look at the eligibility verification. We look at the coverage policy. We also have safety net programs of different manufacturers.

Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: Are there differences or easier administration with the biosimilars and biologic? That’s a great question. There are new drug therapies, biologics, which have differences in administration. We’ve seen the subQ [subcutaneous] formulations come up recently with 2 of the biologics. There may be even more as the future develops with new biologics coming into the US system and utilizing some of these new technologies, which allow for subQ administration.

If you look at the ease of use of maybe a biologic versus a biosimilar, there will be a lot of discussion on that: which is actually less expensive, which is less expensive to the health system, which is less expensive to the patient? I think there will be a lot of discussion. Because if you go to a very busy healthcare system, they may prefer 1 type of therapeutic agent versus another. They go, “It will decrease my chair time, the patient comes in, they’re in and out in less than 30 minutes.”

In other cases you may find out that the utilization of biosimilars will be directed to lower cost. If that’s the actual piece as well, you may have different institutions define themselves based on what the ease of use is and also, in many cases, why they’re switching. Switching is going to be based on the lower cost of the biosimilar to the patient health system as well as the payer definition for it for their approval process. We’ll see those switches actually occur in concert.

Ease of switching is not so easy. When we’re taking a look at this, there’s a lot of work that’s done. We always talk about the number of people involved in healthcare. In many cases it’s almost like the military, where for every person on the frontline, you have several people backing and supporting them. It’s a very similar case when you have a physician and many different lines of service that we have to develop. You have your pharmacy team, your nursing team, potentially your nurse practitioner, your PA [patient advocate] team, your financial advocates. A number of different people are involved, including your IT [information technology] team, which is working on this. For those changes you have to go through all those lines. Therefore, switching is not as easy as you would think, because you have to have all those different pieces being addressed.

Specifically, it will be the patient and the prior authorization process for the actual insurance company getting that approval done. If there are variations based on what they approve versus others, or certain specific biosimilar preference, they’ll make it a little tougher to actually switch.

Kashyap Patel, MD: Assimilation of biosimilars does create some initial hiccups. Simply because it’s a different compound, we have to educate our employees. We have to spend more time with the patients. We help them understand what they are and that they are equally effective.

Coverage also becomes an issue. Most of the state Medicaid agencies don’t cover biosimilars even now. And that creates a problem because 20% of the patients are clearly excluded simply because state Medicaid agencies have not kept updated with the peer coverage policy. These are some practical challenges we face. Also the patient assistance program, access to the drug, incorporating them into the EHR [electronic health records]—all these factors are variables that we have to look into when we use biosimilars.