According to a recent report, the number of oral oncolytics is increasing and has been estimated to account for a quarter to a third of all anticancer agents in the pipeline.

 Oral agents are poised to provide advantages for patients, such as convenient administration requiring fewer office visits. However, these drugs are expensive, are not stocked by many retail pharmacies, and because they can cause side effects as serious as those caused by parenteral agents, require patient education. Additionally, patient adherence and persistence, which are difficult for prescribing physicians to measure, have been shown to be suboptimal for oral agents even as part of uncomplicated regimens in clinical trials, and in presumably highly motivated patients.

Prescriptions for oral chemotherapy agents can be filled in retail pharmacies (if the agents are stocked), hospital pharmacies, specialty pharmacies, mail order pharmacies, or through the doctor’s office either via a competitive acquisition program or in an office-based pharmacy.

 In-office drug dispensing by doctors, particularly those treating injured workers covered by workers’ compensation, has recently been vilified in the press as immoral and corrupt for the marked-up fees being charged, which are said to be contributing to significant healthcare costs.

 Nevertheless, doctors are increasingly filling the prescriptions they write,

 and in-house dispensing has paradoxically been suggested by the American Academy of Urgent Care Medicine as a way to reduce healthcare costs by increasing the number of patients who fill their prescriptions and take their medications appropriately, and by providing the opportunity for patient education to reduce side effects that would require additional management.

 Therefore, in-house dispensing of oral agents in the community oncology setting may provide a safer and more reliable and convenient way for patients to receive their medications.

In-house dispensing by physicians is allowed in some form in nearly all states

 except New York, Massachusetts, and Texas.

 In Utah, legislation has recently been passed to allow in-house dispensing despite opposition from pharmacists at large hospital-based cancer centers who have been responsible for the dispensing of oral anticancer agents.

 Furthermore, some states may require a physician or practice to either be licensed or to pay fees to dispense, or, in a few instances, to register as a retail pharmacy with pharmacists doing the actual dispensing.

 About half of states have “any willing provider” laws that specify that if an in-house pharmacy meets the requirements for a specialty pharmacy in that state, payers cannot prevent the in-house pharmacy from filling prescriptions.8 Although in-house dispensing could reduce the costs to a practice associated with the time involved in dealing with outside pharmacies that fill their prescriptions,

 there are other potential costs and barriers to be considered. For instance, Barbara L. McAneny, MD, chief executive officer of New Mexico Oncology Hematology Consultants, thinks that oral medications may disrupt the traditional method of financing community practices.

The historic model of IV chemotherapy delivery in the office, McAneny points out, resulted from Medicare paying a markup on the drug margin and letting the practices figure out how to administer and manage therapy. Although practices, including hers, still depend on the IV drug margin, the increasing prominence of oral therapies instead of IV infusions has contributed to the instability of community oncology practices. As more oncologists have chosen to work in hospital-based centers to take advantage of the higher payments received by hospitals for their services, McAneny believes that payers will eventually come to realize that it makes more sense to pay community practices enough to manage cancer in the lower-cost community setting.

	Copays, Parity, and Reimbursement Affect Oral Oncolytics

According to Bruce J. Gould, MD, medical director of Northwest Georgia Oncology Centers, oncologists who have specialty pharmacies will derive more revenue from oral oncolytics; however, drug margins for both oral and IV drugs are disappearing. He is working with some national organizations to find ways of compensating oncologists for taking care of patients that are not dependent on drug margins.

High copays for oral oncolytics are partly to blame for patients not filling prescriptions and community pharmacies not stocking the drugs.

 Unlike parenteral drugs, which usually involve a fixed copay for a drug and its administration, the copay for an oral agent may involve a percentage of the drug’s costs with no outof- pocket limit. As of June, 20 states have enacted oral oncology parity laws giving patients equal access to oral as well as parenteral agents.

 Although these laws may be opposed by insurance companies, they don’t necessarily increase costs substantially.

Jeff Patton, MD, is chief executive officer of Tennessee Oncology and a founder of RainTree Oncology Services, a group purchasing organization that is providing standardized practices for all of their clients to help overcome some of the barriers to in-house dispensing of oral oncolytics. Patton says that Tennessee Oncology “definitely has patients where we choose an IV product over an oral product because financially that’s the best decision for the patient, which is really a shame.” Copay foundations and other programs that help patients with costs exist, but community practices may need to invest time to find these programs for patients.

Pre-authorization requirements by insurance companies can also take up a practice’s time. The problem can be particularly acute for individual physicians who write only a few prescriptions a year for particular agents. Having a specialist in a community practice that helps patients with financial assistance and pre-authorization full-time is likely to be more efficient and productive.

According to Ray Bailey, RPh, pharmacy director, Florida Cancer Specialists & Research Institute, the largest private group practice other than US Oncology, they have centralized nurses to do prior authorization for patients, and they take responsibility for patients getting their medication in a timely manner even if the patient goes to a specialty pharmacy. In addition to prior authorization, the practice offers a financial aid support group, copay assistance, and a foundation to fill the Medicare “donut hole.” Bailey says that his group is developing their own system to improve adherence. When medications are dispensed, it will be recorded in the patient’s electronic medical record, so prescribers will be able to see it. They are also looking at other adherence aids, such as alarmed pill containers, and having pharmacists call to remind patients about refills, and to ask them if they have any issues. The practice also has chemotherapy training classes for all patients. These issues are documented in a defined adherence care plan for each drug and data are updated in both the EMR and the pharmacy system.

Tennessee Oncology has an in-house pharmacy that is licensed, and as a full retail pharmacy carries “everything,” says Patton. He says that they don’t try to talk their patients into getting non-oncology medications, such as antihypertensives, in-house, but are happy to provide one-stop shopping for patients. Patton notes that the carrying cost is lower for practices with a limited formulary, “but we are willing to provide whatever service our patients feel meets their needs.”

The in-house pharmacy at New Mexico Oncology Hematology Consultants sells oral chemotherapies and support drugs, such as pain medications or antibiotics, but no anti-hypertensive agents or other retail pharmacy products.

Northwest Georgia Oncology Centers also limits their inventory to oral oncolytics and support medications that a cancer or hematology patient would need, such as anti-emetics, pain medicines, antibiotics, and some selected antihypertensive drugs. Gould notes that patients need to understand why they need to take their medications and what the side effects could be. He believes that patients are more likely to trust their doctor and the doctor’s office staff to guide them through their chemotherapy rather than some third party from an outside pharmacy. In his practice, all patients are informed by their oncologist about their disease, diagnosis, prognosis, the risks and benefits of treatment, specific drugs and their side effects, and their treatment plan.

Patients prescribed oral medications also meet with the practice’s specialty pharmacist who educates them about how to use the medication, the side effects, and what they need to report to the practice. The practice’s pharmacy services are provided by RainTree Oncology Services.

	Tennessee Oncology “definitely has patients where we choose an IV product over an oral product because financially that’s the best decision for the patient, which is really a shame.”

Gould says that his practice has experienced the immediate benefits of saving money on the cost of the drugs they provide and acquiring expertise in pharmacy management. Now the group is better managing their pharmacy inventory, increasing their prescription capture, and paying more attention to compliance and persistence, such as making sure that patients receive their medicines and take them, and that side effects are managed properly. The practice is testing software to measure compliance and persistence. Once this has been demonstrated, the group hopes, with RainTree’s assistance, to apply for in-network benefits for patients whose insurers require use of a specialty pharmacy.

The practice of oncology is changing and has to accommodate changes in the types of medications available, how they are prescribed and dispensed, and how they will be paid for. The use of oral anticancer medications should be driven by benefits to patients, such as efficacy in their particular disease state, which could be expected to lead to improved outcomes. In-house dispensing in community oncology practices seems to have benefits for both patients and practitioners. Patients may have better access provided they can pay for their medications. Whether this access leads to improved adherence and better outcomes for patients, and how this will affect the bottom line of the dispensing practices remains to be demonstrated.

			O’Rourke, K. After fiery debate, physician dispensing bill passes in Utah. 

http://www.pharmacypracticenews.com/ViewArticle.aspx?d=Clinical&d_id=50&i=April+2012&i_id=829&a_id=20485

			Mosely WG, Nystrom JS. Dispensing oral medications: why now and how? 

			Andrews, M. Some states mandate better coverage of oral cancer drugs. 

http://www.kaiserhealthnews.org/features/insuring-your-health/2012/cancerdrugs-by-pill-instead-of-iv-michelle-andrews-051512.aspx

			Weingart SN, Brown E, Bach PB, et al. NCCN Task Force Report: Oral chemotherapy. 

			Meier B, Thomas K. Insurers pay big markups as doctors dispense drugs. 

http://www.nytimes.com/2012/07/12/business/some-physicians-makingmillions-selling-drugs.html?_r=1&ref=health

			Sell D, and Inquirer Staff Writer. Study says doctors increasingly fill prescriptions. 

http://articles.philly.com/2012-07-20/business/32747935_1_doctorsprescriptions-compensation-patients

			American Academy of Urgent Care Medicine. Available at: 

http://aaucm.org/Professionals/MedicalClinicalNews/DispensingRegulations/default.aspx

			National Conference of State Legislatures. Available at: 

http://www.ncsl.org/issues-research/health/2012-health-insurance-reformstate-laws.aspx

			International Myeloma Foundation. Equal access under the law. Available at: 

http://myeloma.org/ArticlePage.action?articleId=3708

Articles

In-house dispensing of oral agents in the community oncology setting may provide a safer and more reliable and convenient way for patients to receive their medications.

Can Practices Successfully Dispense Oral Anticancer Agents In-House?

Pertuzumab, a new HER2-positive breast cancer drug, is being launched at a 31% premium to the price of trastuzumab. This is an aggressive strategy that will substantially increase the cost of treating patients with metastatic HER2-positive breast cancer, while also aiming to deliver the best outcomes for patients.

Pertuzumab will be used as an add-on to trastuzumab to treat patients. Progression-free survival was boosted by 6.1 months when the drugs were used in combination in the CLEOPATRA study.

With payers already anxious about the rising costs in oncology, an 18-month course of the combination treatment is estimated to reach more than $180,000. This cost sets the bar high for the future, as expensive targeted drugs are expected to be used increasingly in combination to deliver the best outcomes.

To examine these treatment benefits, cost concerns, and potential insurance coverage strategies, Michael E. Chernew, PhD, professor, Department of Healthcare Policy, Harvard Medical School, moderated a panel discussion with Lee Newcomer, MD, MHA, senior vice president, Oncology, UnitedHealthcare, and Sandra M. Swain, MD, medical director, Washington Cancer Institute, Medstar Washington Hospital Center.

Chernew: Dr Swain, I am interested in the current treatment landscape for patients with breast cancer. Can you discuss how physicians choose breast cancer treatments for their patients?

 There are a lot of different treatment paradigms for breast cancer and it really depends on if you are talking about early stage disease or metastatic disease. Let’s start with metastatic disease. Unfortunately, even with some of our very effective treatments, we really don’t affect survival in a lot of cases of metastatic breast cancer. However, breast cancer has really been categorized now into different kinds of breast cancer—ER-positive breast cancer, triple negative breast cancer [meaning there is no estrogen receptor or HER2], and HER2-positive breast cancer [in which patients have the HER2 oncogene that is overexpressed]. So, it’s very complex; you can’t just answer that with one answer. The way an oncologist would choose is to look at the biology of the tumor [to see] if it has the receptors or not. For example, if the tumor had the HER receptor with metastatic disease and it was first line you would choose trastuzumab. And, with the recent data in the CLEOPATRA study showing that the addition of pertuzumab to trastuzumab plus docetaxel actually has a large benefit, oncologists would consider this also at this point.

So, can you provide a brief overview of the CLEOPATRA trial?

 The CLEOPATRA trial was a prospective, phase III, randomized study in patients who had not received any chemotherapy for metastatic HER2-positive breast cancer. The study included 808 patients and they were randomized to either receive placebo plus trastuzumab plus docetaxel [control group] or pertuzumab plus trastuzumab plus docetaxel [pertuzumab group]. It was firstline treatment, and the endpoint of the study was to look at an independently assessed progression-free survival. It really had a spectacular result in my opinion. It was a progression-free survival advantage of 6 months. This was actually a placebo-controlled study, so even though progression-free survival can be a difficult endpoint, it was clear in this study that there really was a benefit to the addition of the drug pertuzumab. The interim analysis of survival showed a trend in favor of pertuzumab in the initial report that we released at the San Antonio Breast Cancer Symposium and published in 

 in December 2011, but most recently we’ve reanalyzed the survival and, actually, a press release came out this past June showing that there was a survival benefit also with the addition of pertuzumab.

As a first-line treatment, how many breast cancer patients would be eligible? Just the patients who would have the HER2 target?

 ï»¿The patients with HER2-positive overexpression are approximately 15% to 20% of breast cancer. The indication is only for patients who have not had previous chemotherapy. It wouldn’t be for someone who’s had trastuzumab or other drugs or second-, third-, or fourthline treatments. It’s only for first-line treatment.

That would be approximately 15% or less because of the exclusions?

 Maybe a little less than [the general population of patients with breast cancer]. Per year, it would be 15%, but of the patients now, it’s certainly going to be less because a lot of patients now would have had other treatments.

 The manufacturers are estimating that there would be approximately 8000 women who would have HER2-positive metastatic breast cancer, per year, in the country. That’s a fair estimate.

One of the biggest challenges—because it sounds, clinically, like there are a lot of optimistic results&mdash;is how we might finance access to this treatment. The cost of the pertuzumab and trastuzumab combination is approximately $187,000 for a course of treatment over the entire duration. So, Dr Newcomer, how do you think plans might respond, how do you think oncologists might respond, and what general strategies will be utilized to provide access to this drug?

 I am in complete agreement with Dr Swain in that pertuzumab is a good drug. The trial showed a clear benefit and the benefit was probably one of the larger ones we’ve seen in a long time. Therefore, I would be quite surprised if there wasn’t ready access to pertuzumab from any payer for the indication for which it’s approved. As first-line therapy in combination with trastuzumab and docetaxel, I can’t imagine that anyone wouldn’t cover that. That said, it’s expensive, there’s no question. From a total expense though, it’s a very small population compared with all of the women with breast cancer. The way that we deal with that, as does every payer in the country, is we simply build it into the premium, and the premium for the next quarter goes up. There isn’t a way to pay for this other than simply passing the costs on in the premium, which means everyone who buys health insurance will see a slight increase.

Do you do modeling—because the population is so small&mdash;to show how big that increase might be? Is the premium increase small because of the small number of women, despite the per treatment sticker price?

 Yes, we actually do model all new technologies. We generally model them approximately 6 to 12 months prior to their emergence into the market and start building that into the premium in anticipation of the new technology coming on board. I don’t know the exact amount for pertuzumab and wouldn’t be able to release it anyway, but that is a process that we do routinely, looking for the new drugs coming out or other new technologies, estimating their costs and how many people would be using it, and building that into the premium.

In certain cases, there’s utilization of drugs or, more broadly, new technologies beyond the populations that were originally studied or for whom it was originally approved. Do you think that’s a big issue in this particular case and, if so, how do you think your plan and other plans might deal with that issue?

 I think it clearly is an issue to consider. Every drug that comes to the market eventually finds new uses as further clinical trials are undertaken and they may be reflected on the FDA label. What we’ve done at UnitedHealthcare is turned to the National Comprehensive Cancer Network (NCCN) recommendations to decide when there is enough evidence for coverage. If the NCCN recommends it in their guidelines, then we provide coverage. Other insurers are examining the evidence, whether using their own staff or other sources, but we are going to see people testing this drug in other indications. They may use it as an adjuvant with trastuzumab. They may try using it in second- and third-line treatments. If the evidence shows there is still a benefit, then I do think you will see a use expand.

Do you think there will be that type of experimentation prior to rigorous studies in those other populations?

 There already are other people attempting to use it that way, and as I was discussing with Dr Swain prior to the call, almost 90% of our requests for this drug in the first week were for indications other than what the CLEOPATRA trial showed. We don’t cover in that circumstance until there is proper evidence.

When you say other indications than what the CLEOPATRA trial showed, do you mean indications that were studied and there wasn’t an effect or do you mean indications that simply weren’t studied in the CLEOPATRA trial?

 In clinical situations that simply weren’t examined in the CLEOPATRA trial; for example, patients on their fourth or fifth line of therapy.

More broadly, what drives the cost of drugs in cancer care?

 I think what the companies say is that it’s very expensive to develop these drugs, such as the clinical trials. The CLEOPATRA study was 808 patients—I don’t know how many millions of dollars it cost, but it cost a huge amount of money. Sometimes the number you see is a billion dollars to develop a drug. Many of the drugs that they start developing don’t go to market, so then they don’t recoup any of those costs for developing those drugs. However, I think that the pricing is as high as the market can bear. There’s really no link right now between the pricing and effectiveness of drugs. For example, many of these other drugs that are chemotherapy drugs used for second-, third-, fourth-line treatment in breast cancer don’t have survival benefit and are expensive, and yet that really isn’t taken into consideration. I think we need to do that, certainly in the future. I think what’s happened in the past is that a lot of drugs have been approved when it’s later-line treatment because there’s not a lot of treatment options for the patient&mdash;the bar is lower. In other words, the benefit is not as great. In addition, the patient may have a lot of toxicity and may not have the benefit, so there’s a high cost there, too.

In this case, it seems pertuzumab provides a lot of value at a very high cost and, if I understand Dr Newcomer’s earlier answer, the benefit seems great in this case and the overall population seems relatively small. So, the overall premium impact isn’t enormous and he [Dr Newcomer] would expect that there would not be restrictions on access to pertuzumab. Is that generally your sense, Dr Newcomer?

The restrictions that will be placed will involve ensuring that the HER2 gene is actually overexpressed, so that the drug isn’t used on HER2 underexpressed patients. This was a problem when trastuzumab initially came out. I would expect the same thing here. But, within the same criteria that the trial used, I do think there will be readily available coverage.

I think that breakthroughs such as this lead to a lot of excitement. However, it does lead to a general dilemma about financing access to expensive, although I think in this case considered valuable, care.

 First, I would love to hear Dr Swain’s opinion and others on whether the CLEOPATRA trial should have had a third arm. That arm would have compared the control regimen used until progression followed by the addition of pertuzumab until the second progression. The study would then compare overall survival between the groups. One way to reduce the total cost of therapy is to use the drugs sequentially rather than as an initial combination. This would reduce the time required to use the more expensive medication if the results were comparable. Yet manufacturers, for obvious reasons, don’t ever do that trial. If sequential therapy obtained the same type of responses, it would significantly reduce the amount of drug necessary to treat them.

 I think that’s a really good design and that’s my criticism of a lot of trials and a lot of combinations. However, with pertuzumab, for example, when it was used as monotherapy, it had a very low response rate. Therefore, in this situation it would be unlikely to have had a benefit. If you use the sequential design, you still end up having the cost, though, because you would end up having both drugs over the lifetime, so I’m not sure it would decrease the cost that much.

 Yes, unless you could treat the patient for just 6 months instead of 18 months. So, if the patient got 12 months out of trastuzumab plus docetaxel, then the oncologist was able to add the pertuzumab to those two drugs at the time of relapse and get another 6 or 7 months of progression-free survival—that’s the kind of scenario I was thinking about. That would mean patients would be treated for only 6 months with pertuzumab instead of 18 months.

Do you think some plans, or I think more relevantly some healthcare providers, would try such a strategy? Or, do you think because of the way the CLEOPATRA trial was designed that it’s unlikely?

 I think given the trial design they are almost required to use the three-drug combination. What I just described needs testing because we don’t know if it would work. However, if it did, it would be one way to get the total cost of therapy down.

 The problem is that there’s a survival benefit now with the three-drug combination. You don’t know if there will be a survival benefit if you’re dropping out the newer drug. You may not have the survival benefit. I think that providers will go with the indication that’s in the trial right now.

So it’s much more likely that the drug’s use will be expanded by testing other indications in clinical trial rather than trying to economize by attempting indications that might not be as good?

 I think that people do need to economize, but definitely expansion is already being tested in the adjuvant setting and in the neoadjuvant setting. The other issue that we touched on is the length of treatment in these targeted drugs, especially in the adjuvant setting. There are several trials ongoing in the world looking at the length of treatment for trastuzumab, for example, to see if you really need to give a 1-year adjuvant treatment; there are trials looking at 9 weeks. I think those trials are going to be extremely informative, certainly for the adjuvant setting, and may even also help us in the metastatic setting.

 I’m in complete agreement. I just want to make very clear, though, that the suggestion I had about the 6 months of therapy after failure could only be done in the context of a clinical trial. I’m not recommending that anyone would do that in the clinic today.

There have been many advances recently, as the CLEOPATRA trial illustrates, and we welcome those advances for a whole number of reasons, but it does place some burden on financing. It might be the case that any particular product, such as pertuzumab, doesn’t add a lot to the overall premium; however, in combination with technologies, illnesses, and so on, premiums have been rising to rates that people consider difficult to finance. Therefore, how can we support the innovation that we all desire in our healthcare system without having a price tag that we can’t afford?

 We really need to have a high bar for what we consider effective treatment. I think that’s where we’ve gone wrong in the past. We’ve had statistically significant benefits for some of these drugs that may be a month-to-month [or] a couple weeks’ benefit if you look at the randomized study, but what does it mean to the patient? It probably doesn’t mean a whole lot. I really feel strongly about this issue. We’re looking at some of these things in my role as president at the American Society of Clinical Oncology (ASCO) to ensure we set a higher bar and don’t have incremental benefits. I think that’s where you get into very high costs, is when you are using these drugs that are marginally effective. We also need to be looking at toxicity issues, which we are doing. For example, in the CLEOPATRA trial, pertuzumab really didn’t add a lot of toxicity per se. A few patients developed febrile neutropenia and diarrhea, but not significant toxicity in most cases. We really need to be looking at cost-effectiveness and we really haven’t done that well in most of our randomized studies in the past.

 I’m in complete agreement with Dr Swain. We have to do something to reduce the consumption of both drugs and other technologies that aren’t really making a big difference. That’s going to be a very painful thing to do, but there’s a reason we have to do it. There are three reports recently on the ASCO News website where economists took a look at current trends in medical costs and current trends in US salaries, and what they found is that in 15 years you will have to use your entire US average salary to pay your average US healthcare premium. That doesn’t leave anything for food, clothing, and shelter. Obviously, we can’t do that. The only way we are going to be able to bring our healthcare costs down is to eliminate those things of very marginal value. It means we have to say no. That’s a tough thing for us to do politically in the United States.

 It’s very tough and it’s also tough for patients in the United States—American patients expect to be treated. They expect to come into the physician’s office and get a drug, antibiotics, or whatever in all aspects of healthcare. We just have to change that culture and educate the population that just because we have a drug doesn’t mean it’s the right thing to do at that point. It is very hard, as I do it in my practice all the time. People don’t want to hear “This drug is going to cause you a lot of side effects and it’s not going to help you a whole lot.”

How will utilization responses to innovation be affected by changes in payment models (eg, pay-for-performance, new bundled payments systems)? In general, how will oncology respond as many of these new drugs coming out are applied to cancer?

 There’s no question that, as we move forward in the United States, we’ll see more financing approaches that use budgets. The accountable care organizations are an example and bundled payments may be another. In those systems, a budget would require physicians to separate out those things that are really important from those that either don’t have an effect or don’t have enough of an effect to be important. I really believe those decisions are best made at the professional level. I’m hoping that as we evolve new financing systems that it will be doctors involved in making the decisions. But, I can’t emphasize enough, as we both said before, that it’s going to be hard. Looking at a patient and saying we aren’t going to do some of these things because they just don’t have value, even if the patient might want them, is a difficult thing to do.

 I think we are also in an era in which we are looking at quality improvement. One of the things we are doing at ASCO also is the Quality Oncology Practice Initiative program in which we are observing approximately 700 practices, and we have done this at the Washington Cancer Institute, to study different measures and how these different measures can improve the quality. We need to link that now to outcomes, and I think that’s really one of the basic areas of research that’s being done. If you make these changes, will the outcomes actually be better?

 An important part to add to that is that drugs are only one-third of the cost of caring for a patient with cancer. If you can anticipate problems, deal with them early, and keep the patient out of a hospital, there will be significant savings in terms of caring for that patient. This isn’t all about drugs; it’s about how we can improve the whole care process.

Some of these other payment models might enable the decisions to reflect these other savings?

 Something we’ve done at ASCO is the Choosing Wisely campaign. I know several other organizations have done something similar. We chose five common, costly procedures in oncology that are not supported by evidence and that should be questioned; for example, performing surveillance with PET scans or CTs for early breast cancer and prostate cancer, using growth factors when the likelihood of febrile neutropenia is low, or giving drugs in the last days of life when it’s really not effective. We have really taken this issue on and we are trying to do something as an organization of physicians to try to decrease healthcare costs. I think it’s going to take all of us working on this issue—the payers’, physicians’, and patients’ understanding and education of it&mdash;to really solve the problem.

 I was on the committee that developed the five choices and I’m finding, in my current role, people coming back and saying “OK, is it time for us to stop paying for PET scans? We’re getting a lot of pushback.” Even though ASCO has done a beautiful job of laying out the reasons for why it shouldn’t be performed, as we try to put some of that in the field, a lot of providers are pushing back on us and saying it’s unfair. It just helps illustrate how difficult this is going to be.

Do you think there’s any role in patient incentives to get patients with cancer more engaged, or isn’t it realistic to expect these patients to be engaged in the process, at least in weighing any of the financial ramifications of the decisions?

 I think they are doing that now. They have to do that with some of the copays—they have to look at whether they can afford it. However, we as physicians have to be honest and clear with the patients as to what the benefits are with the treatment being recommended. And, that’s why I again get back to having a very high bar. If you administer a treatment, it needs to have really good efficacy for the patient, especially if they are going to be paying some money out of pocket, which happens many times now, especially for oral drugs.

 The actual amount of out-of-pocket money for these folks—typically the ceiling is around $5000&mdash;is fairly high. It’s enough that some patients are forgoing treatment. So, I agree; patients get involved in the economics of some of these decisions pretty early.

In a case where the evidence of effectiveness is as strong as it is for pertuzumab, you might think that some different copay structure would be reasonable to avoid placing financial access barriers to very good medications. Do you see that type of differentiation going on now?

 What you are describing is called a valuebased copayment or value-based coinsurance and the concept is wonderful; putting it into action is really hard, particularly for drugs that have more than one cancer where they’re active. So, you might give a drug a good rating for effectiveness in one cancer, but a very low rating in a second cancer. Trying to keep that simple enough for a patient or consumer to understand and a business office to bill correctly gets to be pretty complex. It’s a great idea, but we haven’t learned how to simplify it enough to make it work.

Drs Newcomer and Swain, do you have any other comments you would like to add?

 I think one thing that we didn’t really talk about today is the importance of approving companion diagnostics with the newer drugs in oncology. This sets a higher bar for the new drugs that are coming out, plus it decreases the population of patients in which the drug is being tested. Therefore, clinical trials in the future should cost less and, hopefully, the drugs will cost less. That’s something where research is really important to try to decrease some of these costs.

I assume UnitedHealthcare supports the relevant companion diagnostics to assess, for example, whether HER2 is over- or underexpressed in order to get access?

 Absolutely, for all the reasons that Dr Swain just mentioned. They make perfect sense. We also didn’t address that the pharmaceutical industry is going to have to find a way to lower the costs of drug development. They’re a very innovative group and they are finding great drugs. They’ve got to find a way, then, to make the cost of developing those drugs less as well. Some of that innovation needs to be turned inward to see if we can reduce the price of those medicines.

Pertuzumab, a new HER2-positive breast cancer drug, is being launched at a 31% premium to the price of trastuzumab.

Treatment and Cost Implications of Pertuzumab

In a future-focused venture, ION Solutions, a physician services organization, has teamed up with John Sprandio, MD, president of the pioneering Consultants in Medical Oncology & Hematology, to assist oncology practices that are interested in becoming patient-centered medical homes.

Medical homes are physician-led healthcare teams that coordinate care for patients among various providers. Team members, including nurses and nurse practitioners, among other staff, reach out to patients to schedule preventive services and to follow up on potential health concerns, and are often available after hours, whether in person or electronically. Medical homes typically rely on electronic methods for record-keeping, care coordination, and data collection, as do accountable care organizations.

A growing number of community oncologists are looking to the model as a means to streamline services, improve care, and retain their independence in the face of financial pressures that are driving many solo practitioners to join larger organizations, such as hospitals.

Two years ago, Sprandio’s Pennsylvania-based medical oncology practice was the first in the country to earn Level III recognition from the National Committee for Quality Assurance (NCQA) under its Physician Practice Connections— Patient-Centered Medical Home (PCMH) Program.

“One goal in 2012 is to expand and verify the model,” said Sprandio, whose consulting company, Oncology Management Services, recently submitted its oncology adaptation of the PCMH criteria to the NCQA for consideration.

His company developed, among other tools, new physician data presentation and clinical decision support software (IRIS), as well as patient services such as a telephone triage and symptom management system to facilitate patient access to care. In becoming a medical home, he said his practice not only re-engineered its care processes, but continuously critiqued its performance by reviewing the data and making further improvements to standardize delivery and ensure that the services physicians were providing were efficient and clinically relevant.

Sprandio noted that patients also played a critical role in the process by monitoring and reporting symptoms so the practice could respond, thus avoiding hospital admissions and treatment of complications down the road. To help them, practices interested in moving toward the medical home model will need to make same-day appointments available, as well as provide access to the team after hours. “We tell patients to call early and often. If they’re experiencing symptoms at 8:00, call at 8:15. Patient engagement is a big component of this model.”

By implementing these measures, Sprandio’s practice has seen a reduction of a nearly 70% in emergency room use and a decline of just over 50% in hospital admissions for patients on chemotherapy, among other improvements, he said, adding, “Instead of restricting care, or shifting more of the cost burden on patients, we should focus on guiding the process of reducing waste.”

The new team’s quality management program is based on Sprandio’s experience in implementing national evidence-based guidelines, advance care planning for end-of-life care, and nurse triage systems, among other measures, said Mark Johnson, ION Solution’s president. They will also work with practices looking to integrate practice management systems—including electronic medical records (EMRs), inventory management cabinets, and claims management tools&mdash;to achieve greater connectivity among their technologies, improve their finances, and generate what Johnson calls “more meaningful and actionable data.”

“It has taken John years to change the methodology and amend systems accordingly, and we’ve contracted with him to take the lessons learned and make them available to other practices,” Johnson said, adding that ION Solutions will assist in bringing “the necessary assessment tools” to community oncology practices that are interested in becoming medical homeâ€’certified or adopting medical home components.

The partnership with ION Solutions, which provides contract purchasing representation and operational support services to more than 1600 community oncology practices, gives Sprandio’s consulting firm the opportunity to extend the reach of its services throughout the country.

Sprandio said he hopes to begin working with six practices in Pennsylvania that are “committed to transforming to an [oncology PCMH] model of cancer care delivery.” The team will also work with practices to develop financial compensation models that reward them for eliminating wasteful services and providing better care, Johnson said.

“One of the goals is to provide a mechanism for practices to demonstrate improved results and to participate in the savings reaped from cost avoidance. Before the practice goes to the expense of implementing these processes, however, we want to make sure that payers will compensate them for the reductions,” Johnson explained. He said that ION Solutions can provide the infrastructure to implement clinical pathways and the analytics on performance to report back to payers.

According to Johnson, ION Solutions will help link practices in several ways to help them achieve benefits of scale, including developing clinically integrated networks in which providers maintain their independence, while collaborating on clinical initiatives and payer negotiations.

“The idea is that practices would align among themselves rather than to become part of some larger sort of organization. Our mission is to support care in the community and provide physicians with the resources they need to thrive,” he said, adding, “I see a renewed initiative by practices and payers to keep community- based practices viable.”

The Community Oncology Alliance has embraced the medical home model, calling it “the future for oncology.” The group has put together a steering committee, composed of patients, payers, and providers, to advance its implementation.

“These discussions are designed to help practices be a part of the solution with payers and patients, and to adopt change rather than have it dictated to them,” Johnson said. “We have a sense of urgency in working with physician support groups. Everyone plays an important role in this." 

Medical homes are physician-led healthcare teams that coordinate care for patients and typically rely on electronic methods for record-keeping, care coordination, and data collection.

November 2012 | Oncology Business News®

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