The Risk Evaluation and Mitigation Strategies (REMS) Program


The panel defines the REMS program and the criteria for obtaining authorization.


Peter Salgo, MD: Before you go any further, what is a REMS [Risk Evaluation and Mitigation Strategies] program? We’re going to be hearing more about this.

Noa Biran, MD: The REMS program was intended because of the teratogenic effect of thalidomide to ensure a safety over lenalidomide, when lenalidomide was approved. So patients have to answer on a survey, through Celgene, that they will use 2 methods of contraception, and women of childbearing age have to take several pregnancy tests before lenalidomide will be dispensed. That’s the purpose of the REMS program. But Celgene has ownership over this program, so it would be very difficult for another company to make a similar type of drug, an IMiD [immunomodulatory drug], because the IMiDs have to go through the REMS program.

Peter Salgo, MD: Yes, but they have to create a similar program of their own.

Cheryl Allen, BPharm, MBA: Yes.

Noa Biran, MD: Right, which is a very difficult program to create.

Cheryl Allen, BPharm, MBA: These are risk evaluation and mitigation strategies.

Peter Salgo, MD: That’s REMS—R-E-M-S.

Cheryl Allen, BPharm, MBA: That’s REMS, yes.

Peter Salgo, MD: Thank you.

Cheryl Allen, BPharm, MBA: They’re mandates by the FDA. Thalidomide actually was the STEPS [System for Thalidomide Education and Prescribing Safety] program originally, remember back when. The FDA put these in place, and today in the immunomodulator class it is the Celgene products. However, if others came to market, or should there be a generic in the space, they would follow if it were a generic lenalidomide, or something. It would go by the same REMS program.

Peter Salgo, MD: But someone would have to administer the REMS, so they’d have to create a standalone silo for that somewhere.

Cheryl Allen, BPharm, MBA: Yes, and there are proxies for that in the space. We have now generics coming to market and the branded company created the REMS, and then the generic manufacturers now have to fund the administration of that REMS program.

Peter Salgo, MD: All right. Let’s walk through a path for a patient to get an oral oncolytic. How do you go about getting a prescription for it? Do you need prior authorization? You’ve already talked about REMS, but how do you get integrated into that? Why don’t you start us off?

Noa Biran, MD: You start by filling out we’ll go with lenalidomide because I think it’s the most widely used oral oncolytic. The provider will write a prescription, the patient will have to fill out a form, sign a form, to allow us to put their name and prescription through the REMS program. Simultaneously, we have to put in a prior authorization for the lenalidomide.

Peter Salgo, MD: A prior authorization is, you’ve got to get approval from the insurance company for that patient.

Noa Biran, MD: You have to get approval.

Cheryl Allen, BPharm, MBA: But that’s separate from the REMS; that’s not a mandate on the REMS.

Peter Salgo, MD: Right.

Cheryl Allen, BPharm, MBA: But the mandate on the REMS was that the prescribers and the patients and the pharmacies had to understand the risk of the embryo-fetal toxicities. And that they understood the risk/benefit ratio. So the prescriber has to be certified by the REMS, not just any prescriber can write these drugs, so they have to certify with the REMS program. And then once the patient has been counseled by a certified prescriber on the risks and the benefits, if the decision is made to move forward to the drug therapy, then the prescriber and the patient sign off on an agreement form and send that in to the REMS’ administrator.

Peter Salgo, MD: All right, that’s the REMS piece. Now what about the prior authorization piece?

Cheryl Allen, BPharm, MBA: That’s only the start of the REMS piece.

Peter Salgo, MD: I was afraid you were going to say that.

Cheryl Allen, BPharm, MBA: Tat’s at just the beginning, that just gets it started. For male patients, that’s all they do to get enrolled. For female patients, there’s a separate patient questionnaire that has to be filled out. Then the prescriber has a questionnaire that needs to be filled out. At the end of the prescriber’s questionnaire they’ll be given an authorization number. So they are authorized for that patient to prescribe that product.

Peter Salgo, MD: Now that’s not a prior authorization

Cheryl Allen, BPharm, MBA: No.

Noa Biran, MD: There’s 2 simultaneous.

Peter Salgo, MD: That’s simply you’re allowed to do this, so now you can go ahead and get an authorization to prescribe.

Cheryl Allen, BPharm, MBA: Yes.

Peter Salgo, MD: That’s the prior authorization that we’re coming up to, right?

Noa Biran, MD: You do both at the same time.

Cheryl Allen, BPharm, MBA: Yes.

Noa Biran, MD: You do the prior authorization and you do the REMS form.

Peter Salgo, MD: So there’s a REMS authorization and then there’s this prior authorization, which is through the insurance industry.

Cheryl Allen, BPharm, MBA: Yes. Maybe it’s helpful to segment those. So the REMS program is administered by the pharmaceutical manufacturer as a mandate from the FDA and it has all of these requirements. And there’s a reporting requirement from the manufacturer back to the FDA. Outside of that, there is a prior authorization by the patient’s insurance. These are actually separate.

Peter Salgo, MD: Right, that’s what I’m trying to get at. The REMS authorization is not prior authorization.

Noa Biran, MD: No, but with the REMS portion, once the patient is enrolled, they receive a phone call from the manufacturer, and they have to do a verbal survey. Once they do that…and if the prior authorization has been obtained, then the patient will receive the drug. And that survey has to be done every single month.

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