Managing Discrepancies in NCCN and Payer Guidelines in Multiple Myeloma

Ola Landgren, MD, PhD: I would like to shift the discussion a little bit from these different options to specifically talk about some of these drugs that can be given in twice weekly dosing versus once weekly dosing. The NCCN [National Comprehensive Cancer Network] guidelines don’t have dosing included, they just say that this regimen is supported by the guideline. But then there are references in the guideline, and some of the insurance companies like to read all those details. If physicians use these combinations but, for example, use weekly dosing because there are studies that show that they could be similar to the twice-weekly dosing, some insurance companies would say that’s not what the guideline uses as a reference. So therefore it is denied.

John Fox, MD, MHA: Yes.

Ola Landgren, MD, PhD: So what’s the answer to this?

John Fox, MD, MHA: You’d like to use once-weekly dosing at a lower cost compared to twice-weekly dosing at a higher cost. Or even if cost is the same, you’d like to use….

Ola Landgren, MD, PhD: The reason is that it’s more feasible for the patient.

John Fox, MD, MHA: Sure. For most health plans you’re going to follow the NCCN guidelines, but most health plans also, and some by state statute, say that if you can produce 2 peer reviewed articles supporting the treatment regimen that you’re recommending, that we have to follow that. And we’ll do that. In this circumstance, especially if the cost is lower and the evidence shows that the outcomes are comparable, we get better patient compliance with the regimen and better convenience, we’d be foolhardy not to follow the recommendation. But you’re saying that some health plans won’t allow you to do that because it’s not in the NCCN guidelines, and I think that’s why no 2 health plans are created equally. But I think over time, most people migrate to the more patient friendly, lower cost regimens.

Ola Landgren, MD, PhD: We told you about transparency here for the purpose of cost. Couldn’t you think of transparency also to apply, let’s say that there is a drug that is a few percentage points better as far as PFS [progression-free survival] when given twice a week compared to once a week. But for the patient if it’s twice a week, maybe it’s not feasible. So, this isn’t an option for the patient. If the patient chose the once-a-week dosing, because that’s really the only option for this individual patient, why shouldn’t the patient be the one who makes that decision?

John Fox, MD, MHA: Well let me tell you a secret. If you ask for twice-a-week dosing but only give once a week, I’ll never know it. If you ask for, I can’t remember the dosing for the twice-a-week carfilzomib, but if you give less than the prescribed dose, I’ll never know it. I think even if health plans aren’t willing to cover those things, I think there’s still some latitude for discretion in how you manage the patient. Now on the other hand, if you ask for once-a-week dosing and you give it twice a week, well we’ll figure that out really quick.

Sundar Jagannath, MD: But this brings an important point, the flip side of it, that they don’t have a dose recommendation. Because sometimes we want to use Kyprolis in a patient, in an older patient. If you go to the website of carfilzomib, it’ll say, “Use carfilzomib with precaution in patients over the age of 75. Be extra cautious if the patient already has atrial fibrillation.” So clinical trials were done in patients who did not have that, or if the blood pressure is not well controlled.

The clinical trials were all done in a patient in a completely strict environment who met the criteria, and you still had the toxicity, including cardiotoxicity. The treating physician may choose to still use 27 mg per meter squared twice weekly rather than 36 mg per meter squared, which is the KRd [carfilzomib, lenalidomide, dexamethasone] regimen that was approved.

Another side is, I may start with the recommended dose. And the toxicity; clinical trials all give you dose reduction. So you can’t have dose as the criteria that would be policed by a third-party payer or NCCN guidelines. You can’t put a dose in the NCCN guidelines.

Ola Landgren, MD, PhD: The NCCN guideline does not have any dose....

Sundar Jagannath, MD: Exactly, they should not.

Ola Landgren, MD, PhD: And they don’t. For these same reasons.

Sundar Jagannath, MD: Exactly.

Ola Landgren, MD, PhD: Does the weekly dosing beyond milligrams…the drug is charged by milligrams. One component is that. But then you have the once versus twice visits per week. Is that an important aspect for the payer also?

John Fox, MD, MHA: We don’t have any limits on the number of visits that a patient can have with the provider.

Ola Landgren, MD, PhD: But the patient has to come to the chemotherapy suite 2 times a week…

John Fox, MD, MHA: Right. We don’t have any limits on the number of infusions you can get, so we’re focusing our attention on the high cost elements of care, and you’re not one of them; it’s the drugs.