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In this latest episode of MHE Talks: Improving Patient Access podcast, Dennis Bourdette, M.D., professor emeritus of neurology in the School of Medicine at the Oregon Health & Science University, spoke with Peter Wehrwein, senior editor of MHE. Bourdette, a nationally recognized expert on multiple sclerosis, discussed step therapy, tiers, insurance approvals and the need for greater communication between physicians and insurers.
Here are excerpts from a transcript of our "MHE Talks Improved Patient Access" podcast with Bourdette. They have been edited for length and clarity and include some answers to follow-up questions that were sent by email.
I started treating people with MS in 1983, so o a decade before the first disease-modifying therapy came on the market. And we really didn't have much in the way of access problems because we didn't have expensive drugs to prescribe. And actually, when I first started, MRI scans weren't available. So the first access issue we ran into was when the MRIs became available — justifying obtaining them, in people either with MS or suspected MS.
I think payers got used to having to cover that cost, and we gained more experience using them.
So I would say in general access was not an issue that we worried a whole lot about, aside from occasionally needing to get permission for coverage of an MRI scan. But did change dramatically. In 1993, when the first MS disease-modifying therapy, Betaseron, was approved.
People were shocked that the annual price which was $8,000 a year. Not only were payers shocked, but I think physicians were as well. There was a lot of discussion amongst neurologists whether this drug was really worth the cost.
Then there were two more drugs approved the next few years, Avonex and Copazone (glatiramer acetate). So for a number of years, we had three drugs to choose from and their prices were pretty stable, running between $8,000 and $10,000 wholesale a year. The payers required documentation but but it wasn't too onerous.
The documentation was really pretty simple. They wanted a copy of our office note in which we stated that the patient had relapsing, remitting MS, which is the indication for the drugs. And that's about it. We would we fax those in; it's surprising that some insurers still use fax. I didn't really think it was that onerous frankly. And nor did my staff.
Increases began in 2002 with release of third interferon, Rebif, which was brought on market 50% higher than first three drugs. Natalizumab (Tysabri) was re-released in 2006 and there was another upward inflection in prices. Prices increased again in 2010 with release of first oral drug, Gilenya (fingolimod).
The payers began to require more documentation, and then ultimately started coming up with tier systems that complicated our care of our patients and actually ended up taking more and more of our staff time with the documentation and appeals process
From my standpoint, as a physician, 10 years, I had nothing really, besides hope to offer patients I saw many people becoming disabled, having their from the disease, so I knew about the ravages of MS.
But we started having these drugs to use. And over time, it became quite apparent that we were having a positive effect on the disease course.
But it also became apparent that we needed better drugs and more choices because some people had trouble with self-injections or had problems with interferon side effects. So as a physician, treating people with a complex illness having more choices meant I had available to me to a palette of drugs, that had different mechanisms, different side effect profiles, and that we should be able to customize therapy for most, if not all, all patients. So that's the wonder of it, the excitement of it.
I think one of the tremendous advances in therapeutics in neurology has been the MS therapeutics, because we now have the data that indicates that we're decreasing the likelihood that people will become disabled long term if we get therapy started early. So we're really altering the natural history of
But there’s administrative burden for getting permission even for tier one drugs (on a formulary). we have to get preauthorization. And the tier one drugs for a given insurance company might not be appropriate for a given patient given the severity of their disease.
Also, it's very frustrating to have every insurance company having their own rules and regulations that are often quite opaque or difficult to understand. So we have now in our, our clinic, somebody who spends almost full time dealing with paperwork related to getting medication preauthorized and appealing decisions not to cover things.
There are issues now with regards to where people can get infusions, because some of the drugs are infusible. They want patients to use outpatient facilities or home infusion. where there's no physician available to deal with side effects. So it's become very frustrating.
On the administrative end, I think the brunt of it ends up on our administrative staff. So we had an RN that is doing most of this works. It's expensive and it is unreimbursed expense. So it so it is frustrating to have both the ability to alter people's lives favorably with these drugs, and at the same time, have to struggle to get them on the right medication, or coverage for the right medication.
Do patients have access to the medications they need?
I believe the patients that are seen by us at our MS center with varying degrees of difficulty get the right medication. But we'll see a lot of patients who are initially receiving the care in the community by community neurologists who just do not have the infrastructure or time to go to bat for the patients
Step therapy, there are financial reasons for that. It has to do with contracts that are made between either the PBM or the insurance company and the drug manufacturer. There are understandable reasons for cost control and that's one way to do it.
I think some of the frustrations could be dealt with. I think requiring, if you have a tier one, requiring us to go through the paperwork and preauthorization for one of those drugs is a big waste of time. And yet, we have to get preauthorization and reauthorization once a year for the tier one drugs. That's an administrative hassle that is not understandable because they're going to approve it.
There's a big controversy among MS specialists regarding how early you go with a higher efficacy drug.
There's a group of MS specialist that thinks everybody needs to go on higher efficacy drug because that's how we're going to control the disease. We take a more nuanced approach, because there are clearly people who will do well with safer lower efficacy drugs long term. So I'm often comfortable putting somebody on a tier one drug. I'm typically comfortable with that initially, as we follow the patient very carefully. But there are some patients, based upon the characteristics of their MS, how many lesions. We know that they're not going to do well, unless they get on a high efficacy drug upfront, and then we often have problems getting approval for that. So it would be good if there was a way to at least have some more easy flexibility for the subset of patients — it is about 25% of new patients — who meet certain criteria regarding disease activity, so that we don't have to step through two or three failures before we get access to the higher efficacy drugs, which include the monoclonal antibodies and cladibrine (Mavenclad).
One of the ironies is that the drug companies and biotech companies have all these representatives that meet with physicians — they're pretty restricted in what they can do at an academic center — but they build relationships for reasons that are obvious. The insurance companies don't do that. Physicians have terrible, terrible relationships with the insurance companies because of all the administrative hassles I've been alluding.
In fact, we should be having a partnership with insurers because I think most physicians believe in helping control costs. We understand that's a problem. We just would like to be more engaged by an insurance companies rather than having these decisions made that perhaps aren't nearly as logical as they (the insurers) think they are.