Featuring a conversation with Dr. Mark David Vincent, MB, ChB, MRCP(UK), FRCPC, Medical Oncologist, London Regional Cancer Program.
Our Simplify Prior Authorization communications are gearing up. This third podcast in our dedicated prior authorization series will provide you with first hand insights into the challenges of efficient and timely access to therapies for oncology patients and how healthcare practitioners (HCPs), drug access navigators (DANs), and patient support programs (PSPs) are struggling to cope with private payer prior authorization requirements and reimbursement assistance.
If you are not sure why private payer prior authorization processes need to become more efficient, then we recommend that you listen to this podcast and look out for our communications over the coming weeks and months.
Questions? Just send us an email at [email protected] or review our microsite at www.simplifypriorauth.ca.
Recorded May 14, 2021.
Welcome to the benefits, connection podcast, number 18, and the third in our simplified prior authorization podcast series. My name is Denise Bosch. I'm the president of connects health and your host for today. And I have the pleasure to welcome , um, Mark David Vincent, who is a medical oncologist at the London regional cancer program. Uh, Dr . Vincent received his medical degree from the university of Cape town in 1976 and trained in oncology at the Mount Royal Marsden hospital in London, England coming to Canada in 1987, he completed his post-graduate training in the department of medicine at the university of Ottawa. His activities at the London regional cancer care program include the management of lung and gastrointestinal cancer and laboratory research into the reversal of cytotoxic drug resistance by means of gene therapy is also an associate professor at the university of Western Ontario in the department of medicine in the division of medical oncology, where he received the award of excellence and teaching in 2004, his interests include the translation of basic research into the clinical and the design and conduct of clinical trials in lung and colorectal cancer. So Dr. Vincent, welcome. Glad to have you with us today. Thank you. AndSpeaker 2:
I've , um , I've been promoted since then as a , as a full professor, so I'm sorry . You're the real deal now, right? To believe everything I say.Speaker 1:
Okay, excellent. Excellent. Uh , so today, as the introduction indicates, we want it to talk about prior authorizations specifically as it relates to the field of oncology and your work. Um, obviously you're working with patients that have been diagnosed , uh, with oncology , uh, with cancer and , uh, wanted to talk to you a little bit about their journey today and , and your journey with them. So maybe we can start with asking you what some of the treatments are that you prescribed that are subject to prior authorization,Speaker 2:
Treat patients with , um , a variety of cancers , um, lung cancer , um, and GI cancers , uh, predominantly , uh, some mesotheliomas and some less common cancers, but basically thoracic cancers and gastrointestinal cancers. And , uh , these are both fields, especially lung cancer, which has undergone substantial , uh, sophistication of the last five to 10 years , uh, with the advent of multiple new drugs. Uh, some of which have been funded , uh , through the Ontario government for which we are very grateful and others , uh, of which of , um, our funding is pending , uh, and may or may not be successful , uh, but where the needs are immediate for the individual patients. So , um, these novel legends could be categorized briefly as either immunological based, which is , um, usually , uh , immune checkpoint inhibitors , um, but also small molecule targeted agents for , um, particular , um, particular types of patients who have certain specific mutations that these novel targeted molecules address very specifically, but which may themselves constitute small segments of the market. So , uh, you know, people with, for example , uh, RAF mutations in lung cancer and colorectal cancer or RET mutations and so on where these constitute less than 5% of the overall population, maybe one to 2% ROS, one for example, and so on relatively small segments of the market. So w we've changed now from just regarding , uh , say something is a lung cancer or colorectal cancer. Uh , in other words, just an anatomical classification to a much more sophisticated molecular classification based on the specific , um, targetable , uh , molecular determinants within each cancer , uh, which , um, opened up different kinds of doors for therapy. Uh, and so this has created problems because evidence-based medicine, which is the system that the government is using and kind of relies on to make funding decisions really thrives on having large numbers of patients that can enter large randomized clinical trials. But if you're only one or 2% of the lung cancer market, or, you know , 5% of the colorectal market, it's very difficult and even perhaps impossible to do large randomized trials. And so we are struck with data that's quite compelling, but isn't, so-called level one data , uh, and this might , uh , impede funding. Um,Speaker 1:
Yeah , sorry, go ahead. Does that apply to the private site as well? That there's someSpeaker 2:
Militia side is , is more open to , um, you know, evidence that's perhaps published and, and , um, uh, validating , um, approval by the FDA and maybe the European union or Japan , uh , based on data that they found that those regulatory agencies found compelling. Um, and I think you just need some kind of validation it's . In other words, it's not something that I've just had a , had a good idea about over lunch half an hour ago, right ? Maybe this is going to work, let's kind of suck it and see kind of thing and just give it a fling. I don't think it's not that it's stuff that's published approved in the United States or elsewhere, but maybe even health Canada approved, but not yet funded and where you have an obligation ethically , uh, in fact, ethically and legally to inform the patient about this data, because some people have money and some people don't and , and , uh , you know, they can go and buy it. It's a drugs available in Canada where they can take themselves to the United States or elsewhere and pay for it elsewhere if they so choose , um, if it's the right thing to do. Um, so I don't think you can make value late in judgments about what patients ought to ought not to get based on your political orientation. I think you have to do the best for the individual in front of you, and you don't know whether somebody's got money or not, or got insurance or not, and you can ask them, have they got the means to do this, or have they got an insurance plan and usually they'll be quite forthcoming. And then you have to tell them about what the data is and then they can either get it or not. And it's, it's a difficult situation.Speaker 1:
Yeah. And we've seen some headlines where , um, uh, perhaps patients were in a situation where they weren't fully informed. And , uh, I think we've seen some headlines in the media about that. So I can certainly understand both that ethical and legal, legal obligation you have. So if , uh, if not all drugs are funded , um, for cancer patients , uh, through public means because of , uh , the situation you described , um, how is it going on the private side with respect to funding for , uh, for patients who need , uh, the drugs that you prescribed ? It strikesSpeaker 2:
Me is see , you know, the variation and some insurance companies are , um , I think do the right thing. And some of them don't, and maybe a function of the premiums and , and, and, and, you know, their business model, which I'm not privy to. And , and, you know, don't have a particular interest in investigating, but some do some don't. So you had this kind of variability across the private insurance market. Um, you know, which seems to us curious , um, but maybe there's good reasons for it, but it's , um, some people get it, some people don't , uh, and of course there's some people who are not insured or very have very low, you know , uh, thresholds where their funding would cut off , um, which are probably archaic , uh, you know, given the price of drugs today, which can easily go to $10,000 a month retail. Um, and they can burn through a, you know, a low threshold very, very quickly because many of these drugs work and they work for a long time, you know, that they can prolong people's lives for years. Um, you're not a $10,000 a month for two years. That's a quarter of a million dollars. Um, you know, I mean, I'm not yet to , to say the drug prices are good or not good, or should be changed or whatever, but they are what they are and we have to deal with it. And that's a much bigger issue, but, you know , we are confronted with this reality. Um , and what is the point of getting insurance if you can't use it when you're desperately ill? Yeah.Speaker 1:
And that's, and that's, I think what I wanted to really focus on as we , um , you know , uh, speak today is, is access and reimbursement, because we know that , um, there are situations where , uh, treatment , uh, for cancer and other diseases as well. It's not just cancer , um, are available , uh, but on a limited basis because of probably our prior authorization requirements. So for those listeners that aren't aware of what prior authorization is, it's basically a process by which the insurer , uh , decides on a case by case basis based on their own unique criteria, whether they are going to reimburse a product or a drug for a patient that a physician has prescribed. So what's your experience , um, with the ability of patients who have private coverage to actually access those medications and the process for doing so.Speaker 2:
So we , we have, in terms of the process, we've used the drug navigator process. We've had a couple of drug navigators , um, through our cancer center. And , um, it's a little bit of a learning curve, but they , they get up there pretty quickly and they realize , uh, because they're there , they have an office in the cancer center and often sit down face-to-face with the patient. They , they realize , um , you know, the, the, the need , um, and they're committed. Um, uh, but frankly in my experience, they've been overworked and that we don't have enough of these people. We need more of them and they need to be reimbursed properly because it's a stressful job. Um, you know, when you're confronted with , uh , people who are dying or could die, if they don't get a particular drug , um, and sometimes the approval process goes through pretty smoothly and quickly, sometimes did the mile, comes through pretty quickly. And, you know, if it's denied, it's denied and that's, you know, that's efficient, at least, you know, where you are. Sometimes there's a kind of a back and forth that , um , may take a couple of weeks that the patient doesn't have, because these are often people who , um, who've got metastatic disease , uh , that is progressing , um, because , um, previous treatments have failed or because they haven't yet started treatment, but they've been on a waiting list where they've been symptomatically, deteriorating and desperate. So there's often a kind of aura of desperation in the doctor and the patient. And then you're faced with a complicated, bureaucratic process that seems to be obstacles , um, and not as efficient as it might be. And so I think there's a need to streamline to get to a decision, even if the decision is no we'd want to know sooner rather than later. And so the worst situation is, well, maybe, but may not yet. And we've got to argue backwards and forwards. And in the meantime, the patient is declining and sometimes to the point where they become untreatable, because you want to get what you know is a better treatment and it's sort of dangling in front of you, but you constantly grasping for it. And it seems to move away six inches each time your hand gets near, and you're telling the patient to hang on, to hang on, to hang on. Um, and this, this kind of thing is dangerous. Um, because patients deteriorate sometimes rapidly to the point where they may not be able to have the treatment because they need to have a reasonable level of what we call a performance status of maybe at most two , for many of these drugs, especially if they're combined with chemotherapy , uh , where people need to be reasonably fit. Um, and if the , if you wait too long, they just go over the edge and become untreated.Speaker 1:
So, and in your opinion, like, I mean, I guess , um, in your opinion, are you involved in offer aware enough of that, that claim process with private insurers to comment on what some of the , the challenges are, or exactly what maybe needs to be improvedSpeaker 2:
On the project ? Yeah. So if the, if the post office works efficiently, you know, the drug navigator gets to meet or call the patient to within 24 hours , um, then need to find out the details of the insurance coverage or the spouse's insurance coverage. And that seems to work fine. You know, most people know what they're covered or not of this spouses and whether the coverage extends to them and their family members. And then , um, we put it in and usually the form work requires some kind of justification , um , and the justification could vary. Um, you know, they want to know, is it approved in the United States? Uh, is it approved by health Canada, but just not funded? Um, is it going to be oral or is it going to be Ivy? And if it's Ivy, then they say, well, maybe the , uh, the, you know, the institution should cover it. Um, but you know, the institution doesn't, so we have to send people to Bayshore in a more one of these infusion clinics, but they also want to know, you know, is there, what is the published information or evidence? Um, and so that's fine. And I think that's the doctor's responsibility. Know if I want to give somebody a particular treatment that , um , is relatively novel. I think it's up to me to provide the evidence. And I think that's fine. I think it's a good and appropriate use of my time , uh , to provide the publication, even if it's a presentation at ASCO or ESMO or one of these international meetings, high quality international presentations. And it's , I think they should rely on people like myself, our judgment as to whether this is the right thing or the wrong thing. Um , but not just word of mouth. You know, I think it's very reasonable to say, what is the publication? What is the best data that you can provide? Uh , but then I think, you know, for me to say, is it approved by the FDA? I don't think it's up to me. I think the system should be the drug navigator should be able to know if this is approved by the FDA and make and provide a link to it efficiently and quickly. He has the FDA approval. He has the indication in the United States. And then we also need to know, is this in front of health, Canada for the same indication , um, or is it a drug already approved for another indication that is available in Canada? It's got a drug identification number. It's got a din number, but there's new data. Hey, you know, it works in the slightly different setting now and he has the evidence. So I think that all of the details kind of differ, but you know, all of them are either. Yes, no, yes, no, yes, no. So this is a project that I think could be that lends itself to automation to a certain extent better than is currently the case.Speaker 1:
So I think that's a really good point. And we were discussing before the, we went into this podcast recording and I was updating you a little bit about the simplified prior authorization initiative that I know we've discussed before. And just kind of bringing you up to speed on some of the additional things that , uh, this certainly I've learned as a project manager, since the original white paper was published in November of 2020. Um, and you've given me some additional information today , uh, for us to take back , uh, to provide input into this process. But , um, we did speak to a Dan , um, a few months ago , uh, about some of the challenges in his work , um, and , uh, as he's working with patients and with the prior authorization process. So , um, what were just so that listeners are aware, the , what the simplify prior authorization program is looking to do is to , uh, provide really one system , uh, that's agnostic that , uh, whether it be an NMR or a Bayshore or a drug access navigator, they can all use and physicians , um, to complete , uh , the necessary information that is required by insurance companies. Uh, and then have that information related to insurance companies in , um, a fashion that's a more efficient electronically as well as , uh, B takes less time because you're not, there's not paper flying back between different stakeholders in order to get the claim prepared. And as you've said yourself , uh, in addition to , uh , an actual prescription, often the physician particularly in oncology will need to provide additional information to the insurance company before they can consider approval. So I'd like to ask , um, in our, in our conversation about , uh, the potential to implement , um , an agnostic , uh, system or software, if you'd like , um, that can be used by patient support programs and Dan's , and quite honestly a physician start the claim that way. Um, do you think that would be beneficial to patients and healthcare practitioners and patient support programs? Yeah . Anything,Speaker 2:
Anything that makes the process more efficient , um, less , uh , consumptive of the time of the doctor , um, and perhaps more, you know, it gets rid of redundancies and basically cones down on what you really need to know. Uh , and that should be common information to all pharmaceutical companies or all insurance companies will need to know certain core amount of information. I think anything that makes this process more efficient , uh , I would really support anything that makes the lives of drug access navigators or pharmacists who sometimes fill that role. Anything that makes lives easier, quicker, more efficient. Uh, we, I would completely support as , as something that we desperately need.Speaker 1:
Yeah, absolutely. Okay. Well, I'm glad to hear that because , uh, you know, when you're working on some of these projects and you're in sort of it's in your head every day , um, it's important to sort of have a , um, a point where you get some impartial, you know, advice and input on not only sort of what an ideal solution would look like, but what some of the , um, some of the nuances , um , that would need to be addressed in any system that was developed for, as you said, Dan's or healthcare practitioners. Um, so do you actually get involved in , uh , starting a claim ever, or does it, you just literally write a script and hand it over to the drug access navigator or in your case right now, because you're short of them , uh, the hospital pharmacy.Speaker 2:
Yeah. So we may not even write the script until, until the approval has been made. So we , we would say initiate a request , uh, often a verbal request to the pharmacist or the drug access navigator , uh, to say, you know, to , to, to sort of look into this and I'd say, well, I would like to use drug X in this particular patient , um, for this particular indication. Um, can you investigate the possibility around it? And so not even, not even Institute a script until I know that this is feasible one way or the other, so , uh , they then kind of work on it and it may take a week or two, and they will come to me saying, you know, yes, he has the script , uh , just sign here and fill in the details , uh , or no it's denied. Or as I said to you before, we're still trying to work through the process , um, you know, provide me some more information or, you know, et cetera. Um, so, so that's how it sort of works. We, it's almost impossible in my busy day to initiate and carry out this process myself. And I would say that that's equally true for all of my colleagues. They do not want to be doing this. They don't feel competent to do it. They don't feel it's their job. Um, the doctors should not be doing a lot of this paperwork and the legwork . It should be other automatic or delegated down to a dedicated individual. Let me just say one other thing. The, the dollar value of the , um, the , uh, new drugs that we can put through in an institution like this in a cancer center like this every month , uh, probably exceeds a million dollars probably. Um, it seems to be absurd that if funding to make this process work is a small fraction of that. Uh, you know, it seems to me that you could fix this problem with a small investment in both, you know, the quality of life and the remuneration of the drug , um, to have , um , a software program that can facilitate this, because I think we'll never have enough drug navigate. Is there always going to be overworked ? And whenever people are overworked, you, they need to work smarter, right ? Um , cause we can't make them work overnight, so they need to work smarter. They need to be quite so they need productivity tools. They need a tool that is going to enhance their productivity , uh, and make their lives more pleasant, easier, and to get answers more quickly. So whatever tool you can put in front of them that enhances their productivity , uh, this is something that is really, really needed right now. And I think for small investment, the returns , uh , to the patients, to the doctors, to the pharmaceutical industry, you know , and even actually to the insurance companies, because they can, they can then use this as a, as a, as a kind of an advertising tool to say, you know, we have access to this kind of machinery. Um, and , uh, you know, if you, this is what you're going to get, you know, what you're going to get for your money because , uh , they need to attract clients. Right?Speaker 1:
Absolutely. And as you said , uh, whether it's , uh, even if it's a no, at least you and the patient knows, and then you can look for others, you know, either alternative sources of funding,Speaker 2:
Well , maybe there's a clinical trial. Maybe I've got to send them up to Toronto to have to go on a clinical trial, or maybe there's a clinical trial, but at least we know, and we're not in this kind of limbo where patients deteriorating in front of your eyes without a proper decision being made quickly. Yeah.Speaker 1:
And nowhere more important than, than in cancer. I'm sure. Yeah . So yeah, no, I definitely get that. And, and certainly in terms of the discussions that we've had with drug access navigators, as I said in our last podcast , but also , um , we have a drug access navigator, luckily , um, who's volunteered to assist us on the tech working group , uh, to , uh, initiate a solution. Um, but of course the other part of the solution is that while we're working kind of on the front end of what happens from the time you decide a patient should go on therapy or there's a recommended therapy to the time that claim is submitted to the insurance company in a format that they'll accept usually on their own claim form and every claim forms different, of course. Um, there's also the backend and that's what happens once that information gets to the insurance company and, and how , um, automated or how streamlined and efficient their own processes. So I think we're really talking about, you know, we've talked so far in our discussion about that kind of front-end , um, that patient facing end. Uh, but then of course there's also work to be done by insurance companies to say, okay , uh , that's great. We'd like to take advantage of efficiencies in getting us the information in the first place. So we can make deficient , uh , decisions more quickly , uh , better informed decisions, but also , uh, from their perspective at the backend , uh, you know, internally , uh, if they can connect into the system through an API, which we've discussed in some people will be familiar with that term, basically it's the, it's the tech vehicle that allows the exchange of information between two systems. Um, then they also will be able to download that information because right now what's happening is that , um, insurance companies are keying in all of the information they get on that claim form. They're keying that into their systems . So , um, or they're putting it on an Excel spreadsheet from her understanding. It there's a lot of different ways that insurance companies are uniquely looking after these prior authorization claims, as opposed to, you know, your standard claim that goes through a pharmacy adjudication , uh , system , um, uh, run by either Telus or express script or one of the other , uh , pharmacy benefit managers. So I think, you know, you've given us some good insights and some of the frustrations that not only you face, but drug access, navigators face , um, and the importance , um, in real terms at the patient level, but also from a health care practitioners. And of course, people that work with them, how important it is to actually create efficiencies in a system that right now is at best , um, arduous and at worst , uh, can be costly in terms of lives and patient health. Um, is there anything else that you'd like to share with , uh , those folks that are , uh , working on the private sector and listening to this podcast today? Is there anything else you'd like to say about the whole patient access from a private perspective? Yeah, I mean,Speaker 2:
Anything I would say, you know, is that , um, we know we all know that new drugs cost a lot of money to develop, you know, billion dollars is what's the number that's been bandied around. And we know that the pharmaceutical industry needs to get, it needs to have a business model that functions. And so it , it needs to have , uh, this whole thing paid for. So as a result, you know, new drugs are costly. Um, and , uh, you know, nobody's shocked or surprised by this with any insights. But what I would say is this sometimes, you know, the dollar amount per month, maybe more than what the insurance company or what that person's plan , uh , is able to provide. However, it could provide a part of it . The patient may be prepared to kick in one or $2,000 a month themselves. Um, but not more. The government is in the meantime, negotiating with the pharmaceutical company, trying to get them to bring the price down. But in the meantime, the government could say, you know what, we could kick in three or $4,000 a month. In the meantime, without committing to, you know, this doesn't say anything, it doesn't tie our hands legally going forward in our negotiations. But in the meantime we understand there's a human need. So I think there's a possibility here for the patient, the government, the insurance company, and even the pharmaceutical industries , you know, which had these access programs with our cover part of the costs to chip it in, to chip in, if everybody chipped in a quarter of the costs, I think in the meantime, you could treat patients while the whole negotiation thing was going on. Um , so I would appeal to people to think about that model, which not just the insurance company that's been told to pay, you know, X dollars a month, that might be an excessive, a particular patient's threshold to , to see. Is there a way, is there a mechanism that you could even put on a computer to, you know, solicit contributions from the government, the patient insurance company, the pharmaceutical company , uh, you know, some relative , uh, that that could put together a package for people as opposed to just it's all loaded on the insurance company? Yes or no? Yeah. I mean, you know, I was involved with the Olympia, you know, where Eli Lilly tried to get unlimited negotiation, took a couple of years to get it funded. Um, but , um, you know, we understand the government has to, the government's responsible for our tax money. They're not going to write a check, a blank check. We understand the governance to be responsible. We understand that part of those tactics involve pushing back and pushing back and pushing back. We understand that, you know, we're all adults in the room, we know how it works and how it's got to work, but in the meantime, there are people dying and they need help, you know, and this isn't the humane way to let people thresh out in there in the wind. Um, so there could be a few say an interim solution whereby you know, we cobbled together a mechanism to get people, you know, sometimes the pharmaceutical companies will do this and provide a generous program for a year or two, but then their perspective is if we carry on doing this forever, the government's not going to pay for it. But I think there's a, if an intelligent group of people got round in a humane way , um, they could provide solutions for people in the meantime, in, in a manner that doesn't jeopardize the negotiating positions, you actually have to be sympathetic to that. Yeah,Speaker 1:
No, I think it's a great suggestion. And, you know, while at the simplified prior-auth initiative is really talking about is sort of addressing the process to make, to bring efficiencies to the process of, you know , decision-making and , uh , and , uh, submissions. Um, I think, you know, funding is a huge issue and I speak to, you know, pharmaceutical companies, advisors, employers , uh, um, uh, brokers consultants all the time. And it's challenging. And particularly in that interim funding in oncology where you, your time is, is time is literally , um, it can be life-saving and the decisions need to be made quickly. And because some of these drugs are very new, this decisions are sorry that the information may not fully be available to insurance companies. So it's, it's , um , it's very challenging.Speaker 2:
So, I mean, there's a lot of details we could discuss, you know , but , but one of the obvious things in oncology is that drugs sometimes work and sometimes they don't. So, you know, sometimes we were interested in this idea of a trial of therapy for a month or two, and we can usually, and I think there is technology now available to assess benefit and responsiveness very, very quickly, even within two weeks, you know, you know, something's working or not. And so it may be an idea to have something free, upfront to see if it works. And if it, then if it works, you know, then some kind of mechanism kicks in with the insurance company says, okay, we'll pay 60% patients, 25% going to government pay the, you know, et cetera. But if , if something doesn't work, you want to know if something's going to work or not. The only way to do it is to try because we have all these biomarkers that predict and so on and so forth at the end of the day, you may have to try. But what I'm saying is that we now have technology that can work out if something's going to work within probably two weeks circulating tumor DNA, tumor markers, biomarkers, sophisticated imaging, how you feeling that kind of stuff, rapid re you know, we can know rapidly whether something's working or not, but in order to do that, you may have to try it. And is there a way to say, make that free? And then, you know, this is worth it, or it's not rather than pay for three months for something and wait for a cat scan in three months time. And, you know, it's not working in that is money down the drain. So there's efficiencies with respect to finding out rapidly if something's working or not, not spending the money, if it's not working, but then deciding it's worthwhile, how are we going to put it together to fund it for this person? And ,Speaker 1:
And those types of agreements, which are loose loosely , um, those types of arrangements or something like that , uh, are, would be categorized under the value-based agreements that are becoming , um, certainly there's a lot of , uh , discussion about value based agreements. Um, how many there are in the marketplace, I think is anybody's guess right now. But I think that we are definitely heading towards , um, more opportunities and more situations where value-based agreements are going to be appropriate and will be negotiated in the future. Um, well, Dr. Vincent, I know you've got a really busy schedules, and I know that your beepers got off and your phone's gone off a couple of times, but I'd like to thank you very much for spending your valuable time with us today, which happens to be at least where I am a very sunny Friday afternoon. Um, and appreciate the time that you spent with us at your insights as well. And I look forward to keeping you up to date on a Simpli fi simplified prior authorization initiative. And I look forward to , um , you know , keeping you informed as to what's going on and getting your , uh, your input as well.Speaker 2:
Well, thanks, thanks for the opportunity Denise, and you know, anything that I can do to help this process move along in the interests of what I see in front of me every day is worthwhile. That's great. Thanks so much.