Overcoming Barriers to Oral Oncolytic Access in CLL


In the setting of tighter restrictions to access of oral oncolytics, expert panelists discuss how patients with chronic lymphocytic leukemia can utilize assistance programs to attain medication.


Troy Trygstad, PharmD, MBA, PhD: I come in now, and I’m on Medicare Part D or dually eligible, and I say, “Wow, I’m in the doughnut hole.” What do you say? Do I go to a financial counselor and say the same thing, “Hey, I need a patient assistance program?”

Christina Patterson, PA-C: Typically our staff is already looking ahead. We work ahead because we do not want our patients without drugs.

Troy Trygstad, PharmD, MBA, PhD: And you don’t want to have the conversation go down 1 path and then have to back up from that conversation. So you know ahead of time, you’re prepared for this. You know that I’m a Part D recipient and the conversation is a little bit different. Why?

Christina Patterson, PA-C: Because with Part D there are a lot more restrictions with government programs.

Troy Trygstad, PharmD, MBA, PhD: So there are a lot more regulatory requirements.

Christina Patterson, PA-C: There are limited resources they’re eligible for.

Troy Trygstad, PharmD, MBA, PhD: So there are limited resources and regulatory considerations, where you can’t do this, can’t do that. Basically, it sounds to me like what you have for patient assistance is, “Here’s what can’t be done with the public payer programs, and here’s some flexibility that you have out here in the nonpublic-payer program space.” Is that accurate?

Christina Patterson, PA-C: Yes.

Troy Trygstad, PharmD, MBA, PhD: How do I take the handcuffs off in the public-payer spot if I’m that person, and how are you helping me?

Kirollos Hanna, PharmD, BCPS, BCOP: Actually, Medicare itself offers what’s called LIS, or the low-income subsidy.

Troy Trygstad, PharmD, MBA, PhD: So if I’m dually eligible, I’m eligible for the low-income subsidy. That dramatically reduces my co-pay anyway.

Kirollos Hanna, PharmD, BCPS, BCOP: Absolutely. So it helps with co-pay. It helps if you fall within that doughnut hole and you’re obviously paying a lot more, so it helps minimize all of that.

Troy Trygstad, PharmD, MBA, PhD: So in the thinking ahead part for both of your practices, at some point along the line somebody is flagged as, “Hey, we need to see if this person is LIS eligible, because why are we even having the conversation if really it’s about making sure that they are categorically eligible, such that they actually get that LIS?” OK, so I’m not LIS. Now what? Do I have any options? Take out a personal loan? Bye-bye, Phoenix second home?

Kirollos Hanna, PharmD, BCPS, BCOP: Unfortunately, at this point you really need to talk to the drug manufacturers and potentially apply for free drug. Because you also have to think about how these drug manufacturers are making tons of money off the medication. But outside of that, there’s mutual benefit if, for some reason, the insurance is saying no to covering a medication that is potentially not yet FDA approved or an off-label indication. But if the actual drug companies have X number of patients who they’re able to provide free drug for, and they’re seeing benefit in this specific indication, they can go and run clinical trials and potentially try to get that drug approved or receive expanded approval for that specific indication. So oftentimes the government-funded plans are limited to foundation money and co-pay assistance. But sometimes institutions themselves are able to provide financial assistance for patients. There are several organizations, such that even if the co-pay for patients is too high, and unfortunately the patient has to pay it, there are other types of foundation money that can help offset the cost of food, the cost of living, and the cost of travel expenses.

Troy Trygstad, PharmD, MBA, PhD: So you’re saying the US health care system has gone from cost shifting within health care delivery to cost shifting beyond health care delivery.

Kirollos Hanna, PharmD, BCPS, BCOP: Sometimes we have to when our hands are tied.

Troy Trygstad, PharmD, MBA, PhD: You’re patient advocates. You’ve got practices. So from your perspective, Mike, at the association, if you could wave a magic wand and say, “Here are some policy considerations that would be really good for the patient, the whole system,” what would they be?

Michael Reff, RPh, MBA: If there weren’t a restriction that Medicare patients cannot be eligible for the manufacturer’s co-pay cards, that would solve all this. About 2 years ago, there was a lot of heightened scrutiny with the foundations and the whole model behind foundation support. And because of that, in the last couple of years, there’s been a tremendous amount of reduced funding from the manufacturers to the foundations to help our patients receive their oral therapies. And because of that, manufacturers have seen a precipitous, huge increase in the amount of free drug that we talked about earlier that patients are now eligible for. And that’s the route that we have to go as providers to get that patient the medication that they need. It’s through the manufacturers’ free drug.

Troy Trygstad, PharmD, MBA, PhD: It sounds to me like the free drug program is subsidizing the plan, though.

Michael Reff, RPh, MBA: Well, this is a path that we have had to take because the foundation supports have dwindled or waned quite a bit.

Troy Trygstad, PharmD, MBA, PhD: So it’s not optimal. It’s just what’s available.

Michael Reff, RPh, MBA: It’s what’s available.

Troy Trygstad, PharmD, MBA, PhD: But you have a magic policy wand. You have an elder wand.

Michael Reff, RPh, MBA: What would I do?

Troy Trygstad, PharmD, MBA, PhD: What would you do?

Michael Reff, RPh, MBA: I would allow Medicare patients to be able to use the manufacturer’s co-pay card. That would be ideal.

Troy Trygstad, PharmD, MBA, PhD: So those are good, elegant solutions from your perspective.

Michael Reff, RPh, MBA: Yes, of course.

Troy Trygstad, PharmD, MBA, PhD: OK. Anything else? You have a magic elder wand for the next 30 seconds.

Michael Reff, RPh, MBA: I think that would cure just about all the co-pay concerns that I could think of for the oral oncolytics.

Kirollos Hanna, PharmD, BCPS, BCOP: Just to speak to Mike’s point about the amount of free drug that’s being utilized, our institution at the University of Minnesota Medical School, in 2017, was actually able to procure over $6 million of free drug for patients.

Troy Trygstad, PharmD, MBA, PhD: From manufacturers.

Kirollos Hanna, PharmD, BCPS, BCOP: From manufacturers.

Troy Trygstad, PharmD, MBA, PhD: Because you said pretty please?

Kirollos Hanna, PharmD, BCPS, BCOP: It’s being adamant. It’s advocating for that patient, wanting to do the right thing for that patient because we know that there’s a need. This is the right treatment, but we are limited by the payers. There is a gap there. And yes, if co-pay cards can be used, the problem is solved.

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