Consider generic or brand name therapy for glaucoma


Neil Minkoff, MD: The question I’m asking is when do you determine that a patient has failed a generic and should switch to a branded agent, and then how do you choose the branded agent given that there are these new classes drugs?

Terri-Diann Pickering, MD: If we start with a generic, I will usually have the patient come back in 2-3 weeks and recheck their intraocular pressure and look for some percentage decrease in pressure, at least between 20% and 30%. If they respond, so much the better, we continue the treatment. If they don’t respond then we can try a generic in a different class or we can then go to a brand agent and appeal.

Neil Minkoff, MD: I will continue to insist, but do you think a call is necessary? Many payers, usually for most classes, have an electronic system where if the patient has used the generic brand before, it doesn’t necessarily require a call or extra work. Is this your experience? It doesn’t look like that.

Terri-Diann Pickering, MD: No. I did not find that to be my experience.

Neil Minkoff, MD: OK. Doctor Radcliffe?

Nathan Radcliffe, MD: My experience there is that after a drug has been on the market for 3-5 years you start to have this type of process where you may experience a traffic accident or just a PA [prior authorization] must be done. But almost like a box must be clicked type of PA that does not require much time. At first, however, with a new therapy, it can be very difficult. The 1 thing I wanted to do is if we have an algorithm in my practice and I can never follow it because my patients keep derailing me from my algorithm. One drop will sting 1 patient, it will make another patient’s eyes orange, red, another patient will have no adverse effects.

It’s a masterclass in human variability for treating glaucoma because everyone will have something different. And that’s why we end up on all these different diets, even though we’re just treating one disease with one goal, which is to bring the pressure down. It’s really driven by patience that we end up coming back to prescribe a dark agent. I use pilocarpine [Salagen]which essentially eluded the FDA [Food and Drug Administration] approval is such an old drug. We need all the tools we have, and we find ourselves looking for them because patients, their side effects, and their reactions to these drugs are pushing us in all these different directions.

Neil Minkoff, MD: Let me bring Dr. Lopes back and ask a question because one of the things we’ve talked about before is that the prevalence of disease increases with age, Medicare plans, Medicare Advantage plans, Part D, are probably the most important part of this. What are your thoughts on the prioritization and cost of outpatient care in a health insurance plan for an aging population that may face blindness?

Maria Lopes, MD, MS: Yes, and also where you have generics available. We are lucky that in some action mechanics we have a plethora of generic options, and with some of the new action modes [mechanism of action] we don’t have generic options. Where we have generic options they are usually available at very little cost to the patient. In my experience, where you have generic options is where newer brands struggle to hit the preferred tier. And, if they’re covered, they’re usually in a non-preferred tier, which means they’re covered. It’s just when patients try to access it at the pharmacy that they realize it can cost $100 and maybe coinsurance, 30% coinsurance on a non-preferred product, which patients just can’t afford it, especially if it’s not the only medication they’re on. And for many of these patients, this may be their 12th medication, especially if they have multiple comorbidities. This is the challenge.

Then there’s the medical exception, and that’s where the appeal comes in, as Dr. Radcliffe mentioned. And the medical exception process is to justify what else [has] been judged and you are trying, essentially through an appeal process, to help us understand that the drug that otherwise would not be preferred should be preferred because there is no other alternative. This is an obstacle and it takes time for suppliers. But we also react to the difference in costs. There is very little stage management. It’s a difference in level, and if patients can’t afford it, then this medical exception kicks in.

The other reason something may not be covered is if it just hasn’t been reviewed yet. And we have what’s called a moratorium on new drugs, new classes where initially for a period of sometimes 6 months, or in Medicare until the start of the new year, and now there’s a new form in which products may not be readily available because they haven’t been reviewed, they are not on the form. And despite feeling it’s appropriate, again, you’ll have to go through a medical exception process to help us understand the need to cover something that costs more.

Neil Minkoff, MD: I would like Dr. Stephens to comment on the same question, and then I would have any other thoughts or questions about how medications are used or replaced. But I want to make sure we get Dr. Stephens’ input on formulary considerations, especially in Medicare.

Kevin Stephens, Sr., MD: Again, let me go to the end of the question first and then back up. The Medicaid population is totally different and it’s determined by the state, and usually the formulary is based on the state in that budget. The second is that you have commercial insurance, and commercial insurance is attractive in that quite often the cost of the plan is passed on to the employer. And when we have an employer, they have to watch and they determine, we do some type of analytical and predictive model until we can tell what their disease burden is, and we assess their bonuses based on the pool of employees. And that’s a much harder population to manage because, again, the employer looks at what we pay and how much can we afford to pay. It’s a second problem in this whole picture, that we have different plans. We have Medicaid, commercial, and we have Medicare and we have different utilization management strategies and so on.

The other comment I wanted to make is that 1 underutilized thing we have is a peer-to-peer process. And often we can get an informal consideration, you can ask to speak to a medical examiner. And when you talk to the medical examiner, the medical director, you can say, “Look, here’s our problem. We tried the generic. They are allergic to sulfonamides. They are asthmatic. They have this, that and the other, and that’s the only option I have left.

And, many times, you can avoid having to go through the appeal process and go through the appeal by simply doing a peer review and the medical director based on the clinical diagnosis. Because often our view of what is happening with the patient is limited in many ways to what you fill in the form, and you fax it or email it or however you send it. And often even the medical record is not that complete, and that’s why it’s important that we have those unusual and extraordinary cases where you should take advantage of this peer-to-peer process.

Transcript edited for clarity.

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