Eric Sredzinski, PharmD, AAHIVE, vice president, clinical affairs, Avella Specialty Pharmacy, is involved in a National Institutes of Health trial evaluating adherence and persistence in renal transplant patients that was recently accepted for publication, and also recently contributed to Avella’s newest publication, “Dispensing Excellence
Specialty Pharmacy Times
sat down to talk with Dr. Sredzinski about the controversial topic of pricing for oncology medications, as well as common patient reimbursement hurdles and Avella’s technologically savvy efforts to break down patient adherence barriers.
SPT: Is the creation of accountable care organizations (ACOs) the main motivating force behind the recent acquisitions of community oncology practices by hospitals, or is specialty drug cost a more influential driver of this consolidation trend?
The cost of oncology products, whether in IV or oral form, is impacting the care landscape significantly. It will be interesting to see, because if a capitation cost to manage patients with an ACO is provided, treating an oncology patient with a drug that could cost over $100,000 per year could really bend or break that model of cost-containment. So, yes, we do see hospitals buying up some oncology groups, and I think that some oncology offices are looking to expand their degree of care or their range of offerings.
SPT: Do you think any of that has to do with 340B pricing?
340B is certainly a little bit of a different topic. I think when you talk about 340B and the intent of 340B, the issue is really to try to understand the definition of which patients qualify If you look at the Federally Qualified Health Center (FQHC) or hospitals that have a disproportionate share of patients, those hospitals are allowed to qualify for 340B drug pricing and then pass those cost savings to the patients. However, what we’re seeing is really a change in that model where you’re having third-party groups presenting claims data to FQHCs and showing them that they can save significant dollars and build a revenue stream with 340B. So I think the difficult piece today is that the Office of Pharmacy Affairs hasn’t yet really stepped forward and defined what a patient is. For instance, should a hospital be dispensing drugs for an employee and utilizing 340B inventory? It will be interesting to see this year, because I don’t think it’s a very sustainable model.
SPT: In your opinion, which oncology medications in the pipeline seem the most promising?
Since we manage self-administered oncology products (subcutaneous injectables and oral medications), there are a couple of products that we’re keeping our eyes on. One of them is a product for some B-cell malignancies. It’s called ibrutinib, and it’s likely to be approved for a few conditions, one being mantle cell lymphoma. We also may see it in chronic lymphocytic leukemia. So it’s a pretty exciting product. We sometimes talk about the “me-too” drugs--drugs that are practically copies of other drugs that have already come out--and we’re seeing some of that in the chronic myeloid leukemia space as well as in the renal cell carcinoma space. We’re seeing a number of drugs, and the space is getting a little crowded, so it’s nice to see drugs with unique mechanisms of action that offer patients an option where they may not have had one before. We also have another drug coming out for metastatic melanoma. We had one that was released a little over a year ago now, a BRAF inhibitor by Genentech. Now, we have another one coming out as well. And then we have something called a MEK inhibitor that’s coming out from GSK [GlaxoSmithKline]. Metastatic melanoma patients with an expression of the BRAF mutation have the option of using the brand drug Zelboraf (vemurafenib), but patients can develop mutations and become resistant to it. With this new MEK inhibitor, trametinib, we hope to reduce resistance and increase progression-free survival through combination therapy of a BRAF and MEK inhibitor. So that’s another exciting area for us. And there’s one other drug called afatinib in the pipeline for lung cancer patients. I attended ASCO this year in Chicago, and it was great to see some of the abstracts and hear some of the presentations about these agents and where they’ll be in the state where they’ll be utilized.
SPT: Should payers cover the routine costs of clinical trials in oncology care?
It would be difficult for some payers to fund some of these trials. The sheer cost of the trials and the complexity of patient recruitment makes them a significant undertaking and requires a tremendous financial commitment. It makes more sense for the manufacturers to cover them rather than the payers. I just don’t see how [the payers] could afford to manage that.
SPT: Novartis recently lost patent protection in India for its drug Gleevec. How will this ruling affect future innovation in the development of oncology treatments?
Gleevec was the first oral oncolytic targeted therapy. It was featured in Time
magazine, was approved in 2001, and has a patent expiration date in the United States of July of 2015. It’s one of those products that I believe will be an available “generic” agent in the United States in the future. From a cost perspective, these oncology drugs today run $5000 to $15,000 per month per therapy. Offering biosimilar products is going to present a significant opportunity for cost-containment. Gleevec today is roughly a $700-million-per-year product, so it still has high utilization in the States, even with 4 other competing agents available. I see that the trend for the use of biosimilars is going to continue. We’re seeing it in Europe already with biosimilars, for instance with a generic version of filgrastim (Neupogen). But questions remain: How do we regulate biosimilars, how do we run the approval process, and how do we guarantee that a biosimilar really is bioequivalent to the parent product? Sometimes these biosimilar products can produce hypersensitivity reactions in patients, and we need to ensure that we’re giving patients safe and effective medication.
SPT: Most specialty pharmacies are skilled at processing reimbursement claims for oncology medications. What is the most common hurdle you face when handling these types of claims?
Today, it’s the financial piece. The majority of Americans have some degree of health insurance--even Medicare patients have prescription drug coverage through Medicare Part D. So we see robust coverage. Most of the drugs in the oncology space require product authorization through the insurance company. So, it is up to the physician and the pharmacy to help provide documentation to the payer to let them make decisions based on the patient’s diagnosis and whether the care is appropriate. Once that’s approved, however, many patients find that with commercial insurance, they may have co-insurances or deductibles to hit, and today it’s not unheard of to have a deductible of $1000 or $2000. Out-of-pocket costs for a prescription can be a financial hurdle for many patients, especially Medicare D patients who are still facing out-of-pocket costs or donut-hole costs.
The main problem does not lie in getting the drug approved or getting access to the drug, it lies in finding the necessary financial assistance for patients. We have a dedicated team to manage that for patients and really help navigate the process to look for 501(c)(3) foundations that have funds available or are leveraging manufacturer copay cards for our commercial patients or free drug programs from the manufacturers. However, that process can take time in terms of gathering documents and it can be difficult for patients that are elderly. Asking them to gather their financial information and to sign forms when they don’t have access to fax machines can be difficult, especially when they’re mailing or sending it to the physician’s office. It can be a very traumatic experience for a patient when they hear they’re diagnosed with cancer and then they hear their copay is more than $2000 and then they need to start gathering the information. I think today that’s the most challenging piece.
I believe that we are uniquely positioned to offer patients opportunities to get access to these drugs by looking for the support dollars, but it’s still a bit of a process. It takes a lot of communication and it requires coordination from the physician’s office as well.
SPT: What are some of the most common questions your patients ask about oncology medications?
One thing we are finding is that with increased connectivity, many individuals are able to get on the Internet and look up information. Sometimes the goal is just to determine what the patient knows and what they don’t know. It can be striking at times when you ask the patient, “What did the physician tell you this medication is for?” and they state, “I’m not sure.” We really try to dive into that information. Patients certainly do bring interesting questions in after looking things up on the Internet. Perhaps they’ll mention a trial they read about on the Internet about the efficacy of a drug and will wonder how that drug is going to work for them. What should they expect at week 2 or week 4 of being on treatment? We’re finding that patients are increasingly more engaged with their therapy and are asking more questions, which is what we ultimately want. We want patients to be able to take charge of their care and to understand the complexities of these drugs.
SPT: What does Avella do to inspire better patient engagement?
It’s always a multimodal approach when you’re trying to increase patients’ engagement or trying to get them to take their medications. One thing we’ve been fortunate to do is to work with a few companies on a piece of technology called a GlowCap. It is actually based on a clinical trial piece of technology called a MEMS (a micro electronic monitoring system) that records when a patient opens and closes a bottle, providing an indicator that the patient took the dose. We can provide this technology to patients with certain oncology disease states, and it helps give them medication reminders. It also allows us to see what they’re doing. We get weekly reports on our patients who are using this technology, and if they fall below a threshold adherence rate, say, below 85% of their expected doses, then we get an alert. If they don’t open the cap 15% of the time or more, they’re considered to be non-adherent. Then we follow-up with a telephone call to these patients and engage them to determine what challenges they’re having. Was it a technology challenge? Were they traveling? Or is it a true adherence challenge, where they are not taking the medication because they are experiencing a side effect or their attitude towards their medication has changed? For a specialty pharmacy to successfully support patients, you really have to have multiple vehicles to support them, whether it’s direct live telephone calls, text messaging, technology like GlowCap, letter campaigns, or emails. It really is about trying to find ways to reach the patient and provide them with information.
SPT: Do the aforementioned methods ever make a patient defensive?
No, because ultimately, what we’re doing is providing this as an offering up front to a patient. A single solution can’t solve all problems. When we’re talking to the patient, if they meet the criteria for the drug and disease state, we’ll offer this program to them. It’s an opt-in situation, and the program is explained to the patient so they understand what they’re going to be getting.
Recently I was giving a presentation at the Leukemia and Lymphoma Society meeting, and a patient stood up during the question period and actually thanked our company for the technology that helped him stay on his medication. It’s nice to hear it’s having an impact. Patients understand we’re going to be involved with them, and they can cancel at any time if they feel it’s an intrusion or too much.