Peter Salgo, MD: Let’s talk about prior authorization from the insurance industry. What is that all about? Why do we need it? What does it involve?
Cheryl Allen, BPharm, MBA: It’s appropriate utilization of drug therapy. We’ve talked about this for years now.
Peter Salgo, MD: As long as I’ve been talking about this.
Cheryl Allen, BPharm, MBA: Right. And it is within a specialty class of drugs, and all of these oral oncolytics are considered specialty; 99.9% of the time they’re going to require a prior authorization.
Peter Salgo, MD: So that means that somebody, somewhere in the insurance industry has to say, “OK, you made a case for Jane Doe or John Jones to get this drug, and so we’re going to approve it.” Now, I don’t prescribe these drugs. All that I hear is screaming and crying and bellyaching about it because it takes a while. And then you’ve got to appeal it if they don’t like what you’re trying to do.
So from a pragmatic clinician’s perspective, how do you avoid the delay at least in getting this insurance-related prior authorization?
Noa Biran, MD: There are programs in place by the manufacturer for some of the oral oncolytics where they in an emergency setting can provide you with a drug within 3 to 5 days. I personally have never used any of those programs. In theory they exist. You have to have a very good system in place. You have to have a staff.
Peter Salgo, MD: What’s your system? Do you have somebody on staff who does nothing but that?
Noa Biran, MD: I have many people on staff who do not only that. There’s one person who does, there’s several people who only do the prior authorization. There are several people who only look for grants and to help with funding.
Peter Salgo, MD: The grants are to help with the out-of-pocket.
Noa Biran, MD: With the out-of-pocket expenses. There are nurses who help fill out the forms. We have a whole team of people who work to get patients their treatment.
Peter Salgo, MD: Can this be done in the pharmacy or does it have to be done in the provider’s office?
Noa Biran, MD: I think both.
Peter Salgo, MD: I’m so sorry you said that.
Noa Biran, MD: We have a lot of pharmacies that we work with very closely because we have contacts over there who we know are going to fight to rapidly get our patients their drugs.
Peter Salgo, MD: How can the pharmacy help the provider to get this process streamlined? Is there anything that the pharmacy can do specifically?
Cheryl Allen, BPharm, MBA: Well, I think if we go back and we say what’s the payer looking for.
Peter Salgo, MD: Other than lots of drug for free? What?
Cheryl Allen, BPharm, MBA: Well, if oncology is and specialty is approaching half the spend of a payer, then they have to look at the utilization and they have to keep their finger on the pulse of that utilization. So the way they do it.
Peter Salgo, MD: Nobody wants to bankrupt America, let’s be very clear, right?
Cheryl Allen, BPharm, MBA: It’s appropriate utilization. The way that we can look at appropriate utilization is by the guidelines and understanding that if the prescriber is going by the guidelines, you know first therapy, second therapy, and writing according to that, and we supply that information to the payer, generally in the oncolytic space, these prior authorizations are approved.
Peter Salgo, MD: You’ll forgive me, but what I heard from that person sitting to your left, is that there is a small army of people who are not providing patient care, who are not dispensing drugs, who are not taking care of this disease but are taking care of paper, that are taking care of bureaucrats, that are taking care of massaging the papers so that everyone gets approved. Is this the best use of the resources in the health care area?
Cheryl Allen, BPharm, MBA: I think in some areas you’ve seen some movement in space. So Regeneron Pharmaceuticals with ESI [Express Scripts] and the PCSK9 inhibitors space. They’ve come to an agreement in that space that it’s a prescriber attestation that the patient needs the drug and qualifies to the requirements, and then there’s no prior authorization. I don’t think we’re there.
Peter Salgo, MD: She doesn’t believe you. Look at her face.
Noa Biran, MD: For what disease? It must be a disease for which life expectancy is less than a year.
Cheryl Allen, BPharm, MBA: It’s cardiology.
Noa Biran, MD: Oh, it’s cardiology.
Cheryl Allen, BPharm, MBA: So hypercholesterolemia.
Peter Salgo, MD: But those are cheap drugs.
Noa Biran, MD: Right.
Peter Salgo, MD: Most of the statins are now in the generic space.
Cheryl Allen, BPharm, MBA: Yes. These are PCSK9s and they have priced in the specialty space. Not as high as oncology but they’re there. So what we’re hoping is that we use ICER [Institute for Clinical and Economic Review] guidelines, NCCN [National Comprehensive Cancer Network]. Will we ever get to the point where we don’t have prior authorization in the oncology space? I don’t see that in the short term. Remember the time where we had 60% of oncology was off-label use, right? So now we have to go to the guidelines, validate the patient who qualifies for the therapy, send that information in.
Noa Biran, MD: It’s getting harder and harder to approve. I mean look, compared with your other countries, yes, we have a lot of leeway. We get to use 2 novel therapies at the same time whereas in Europe you have to pick 1. You have to pick an IMiD [immunomodulatory drug] or a proteasome inhibitor, you cannot combine the 2. So in that sense we are lucky in this country. We do spend a lot of money on drugs. But on the other hand, it’s getting harder and harder to obtain authorization for regimens that help patients. And a lot of insurance companies now require, they don’t want to see a phase 2 study, they want to see a randomized phase 3 study that supports the use of a regimen, which when somebody’s in their ninth, 10th, 11th line of therapy, you will never find a phase 3 randomized study to support specific combinations.
Cheryl Allen, BPharm, MBA: There’s a process in place and it’s very time-consuming and costly. It’s prior authorization, it’s appeal.
Noa Biran, MD: Peer-to-peer.
Cheryl Allen, BPharm, MBA: Peer-to-peer. Ultimately, I believe that patients for the most part in oncology, they do get the therapy. It can take a long time.
Peter Salgo, MD: But time, time is cell division.
Cheryl Allen, BPharm, MBA: I understand that.
Noa Biran, MD: There’s an abstract that shows that a particular drug that’s used for lymphoma works in myeloma patients 95% of the time, in refractory myeloma patients. We have such a difficult time getting this drug for patients, even though it’s an approved drug for lymphoma, and we want to use it. It’s incredibly difficult because the data that’s published on this is in less than 100 patients. It’s not a phase 3, it’s not a phase 2 yet. The results are astonishing, but we can’t.
Cheryl Allen, BPharm, MBA: Yes. And I think, too, a trend is we’re seeing the FDA look at phase 1, phase 1/2 and this is incredible technology, and we’re going to continue to have that problem.
It’s cost utilization and in multiple myeloma we do have patients who are living years and decades. In other areas within oncology, we have patients who are living months longer for tens of thousands of dollars of therapy. So within the payer space, I think that we have to take a broader view and kind of balance the individual patient to the overall, taking care of all patients perspective.
Peter Salgo, MD: OK, but in all fairness.
Cheryl Allen, BPharm, MBA: Population, we’ve got a population to take care of.
Peter Salgo, MD: But it’s not fair, is it?
Cheryl Allen, BPharm, MBA: It is fair.
Peter Salgo, MD: It is not fair to lump into 1 big group cancers that kill in 7 months and cancers that don’t kill for 30 years and say, it costs a lot for these short-term cancer deaths, so we’re not going to give it to you. Is that fair?
Cheryl Allen, BPharm, MBA: Is it fair that in Europe they can only use 1 targeted therapy and here we use 2 and 3? We have a lot of advantages of living here in this country. We have some quirks in the system, and it is heartbreaking when we come across patients where we can’t get them therapy. Either the payer doesn’t pay for it or we finally get it paid for, or we work it through the system, and the patient can’t afford the out-of-pocket.
Peter Salgo, MD: I hear you.
Cheryl Allen, BPharm, MBA: So it is a challenging time.