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Global Access To Xtandi

Ms. Merith Basey is the Executive Director of Universities Allied For Essential Medicines (UAEM) North America, a global network of university students who believe that their universities have an opportunity and a responsibility to improve access to publicly funded medicine developed on their campuses.

Prostatepedia spoke to her about UAEM’s Xtandi (enzalutamide) campaign and how prostate cancer patients can help.

Can you tell us about UAEM’s Xtandi (enzalutamide) campaign?

Ms. Basey: We launched this campaign at the University of California in Los Angeles (UCLA) to urge the university to drop its pursuit of a patent claim in India for the drug Xtandi, which people may know by its generic name, enzalutamide. The drug was developed at UCLA with the support of public grants or funds from the National Institutes of Health (NIH) and the Department of Defense (DoD). Xtandi (enzalutamide) is currently sold in the United States at an eye-watering $130,000 per patient per year and around $30,000 in Canada while at the same time we know it is estimated to cost just a few dollars to produce. Obviously, these prices are out of reach for most.

In India, prostate cancer is among the top ten most commonly diagnosed forms of cancer. And yet UCLA filed a patent claim with the High Court of Delhi on behalf of two massive pharmaceutical giants, Pfizer and Astellas that acquired the rights for the medicine from the university. Our concern is that, if this patent is granted, it will further obstruct the introduction of a more affordable, lower priced generic drug onto the Indian market and it will set a very dangerous precedent for the role of universities in determining patient access. We know the potentially devastating impact that this could have for people living with cancer in India and other countries that import their generics from India as well. In our view, the impact of this case goes far beyond this one drug, one community, one country. This is about standing up for health equity and justice and putting people’s lives over profits.

To give you some further background to this story, while UCLA still currently holds three patents on Xtandi. they initially licensed the drug to Medivation, a biotech based in San Francisco. In 2016, Medivation was acquired by Pfizer and they ended up in an agreement with Astellas, a large Japanese pharmaceutical corporation. In the same year, UCLA then sold its royalty interests on the patents for the drug to Royalty Pharma for a massive $1.14 billion dollars. The Xtandi site application in India was initially rejected by the Indian Patent Office on the grounds that it wasn’t patentable. This was when UCLA filed the patent appeal suit with the High Court of Delhi. At UAEM, we believe universities must be part of the solution not part of the problem to the global challenge of high drug prices. They need to live up to their social missions rather than protecting corporate interests. We know the impact it will have on people who need access to this drug as well as others in many countries around the world.

In response, we’ve been organizing students, and they have been leading a campaign at their university to urge the UC President, Janet Napolitano, to drop the patent claim. Students have spoken up at multiple Board of Regents meetings in San Diego, Los Angeles, and San Francisco. They’ve met with some of the deans, and collected over 3,500 signatures that were delivered to Janet Napolitano. At the most recent campus rally the university even appeared to silence the student voices reducing the opportunities to speak and even putting up barriers outside the building. Disappointingly,

The UC offices have acknowledged that they know the campaign is happening but the overall silence from Janet Napolitano and the Regents has been deafening. The university is publicly funded, and the drug was developed with public research dollars, they should not be fighting a court battle on behalf of private pharmaceutical corporations. This is not the role of the university. We believe that they’re on the forefront to provide access to medication for people regardless of income which is not what they’re doing.

How can someone reading this participate? What can we do?

Ms. Basey: There are several ways to help.

1) If you can, any financial donation to UAEM makes a difference. We’re grassroots, a small and lean organization so any donation goes a long way for our campaigning . Learn more here.

2) We’d love to hear from you at: info@uaem.org You can follow us on most social media!

3) Email President Janet Napolitano–she is the woman with the power within the University of California system to drop the claim–at janet@ucop.edu. Tell her why this drug is so important and why the UC should drop the patent claim and make efforts to ensure publicly funded drugs developed on university campuses should be made affordable and accessible to the public who paid for the research in the first place.

4) We’d also like to hear from people who are affected by prostate cancer who might be interested in writing or being part of the campaign. We’d particularly like to hear from people in California as we’re scaling up our efforts there as well as in India.. Your voices matter. Email us at info@uaem.org

We want to make sure that winning this fight sends a message not only to universities about the importance of living up to their social missions but also to pharmaceutical corporations. They’re making billions of dollars off this drug at the expense of patient lives, and we can urge them to do better.

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Dr. Maha Hussain On Biochemical Recurrence

Dr. Maha Hussain is the Genevieve Teuton Professor of Medicine in the Division of Hematology, Department of Medicine, and the Deputy Director of the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine.

Prostatepedia spoke with her recently about biochemically recurrent prostate cancer.

What is biochemical recurrence?

Dr. Hussain: A biochemical recurrence implies that an individual with prostate cancer who has received therapy now has evidence of disease activity as reflected by their PSA blood test. In the context of negative imaging, the PSA is a flag. It generally indicates a relapse. Generally speaking, when the patient has a rising PSA, they get imaged. If the scans are negative, then this becomes purely biochemical recurrence.

Why is this a disease state that we’re particularly focused on? What are some of the key issues in how we approach treating these men?

Dr. Hussain: There are two settings of biochemical recurrence. One is the non-metastatic hormone sensitive setting. This means a patient has had local therapy with surgery and their prostate was taken out, or they’ve had radiation therapy with or without hormonal treatment, and now they have a PSA that’s going up. This implies there is cancer activity. Generally, imaging is done, and most of the time, conventional imaging such as bone and CAT scan are negative.

While not imminently harmful, non-metastatic hormone sensitive biochemical recurrence has significant psychological implications for the patient because it reminds them that there is cancer activity in their body that’s growing.

With regard to management, salvage radiation plus hormone therapy is the standard of care for patients who developed PSA-only relapse post radical prostatectomy as it reduces risk of mets and improves longevity. While there are options for patients who had radiation therapy plus hormonal therapy, they are not optimal.

For example, while hormone therapy is an option for patients whose PSA started to increase after salvage radiation and hormonal therapy, the totality of the data to date does not suggest significant benefit for early hormone therapy versus waiting until there’s a reason to treat.

This population; non-metastatic hormone sensitive PSA relapse, tends to live quite long, and some may not develop visible mets. The speed by which the PSA starts to go up and how fast it increases—what we call doubling time—can imply earlier versus later development of metastatic disease. Detailed discussion is needed to address options, pros and cons of treatment, and potential options for clinical trials.

The other setting of biochemical recurrence is the non-metastatic but castrate-resistant setting, which differs from the previous setting in that patients were treated with hormone therapy and now their PSA is rising while on therapy; that is the rising PSA is occurring despite the fact that hormone therapy has lowered their testosterone levels to the castration range. This is a different clinical phase of disease where the cancer has shown that it is no longer responsive biologically to the hormonal therapy that they are receiving. We know that, given enough time, cancer will show up. We know also that the speed by which the cancer is growing, as reflected by the PSA rate of increase, has an implication as to how soon the cancer will show up on the scans.

This is an area of an unmet need for decades, until last year when two drugs were FDA-approved for this particular patient population, specifically Erleada (apalutamide) and Xtandi (enzalutamide) based on significantly delaying time to development of metastasis. At this year’s American Society of Clinical Oncology GU (ASCO GU) conference, there was also positive data from another trial with Darolutamide in this disease setting. I believe the drug is in front of the FDA at this moment for review.

These three trials were done in a population of patients who had a worse prognosis as reflected by their fast PSA doubling time—a doubling time of 10 months or less. This is because these patients are likely to show metastases within an average of about two to two and a half years.

The issue is whether there is benefit for people who don’t have that kind of PSA doubling time. What if the doubling time is one or two years? It certainly is an area where we need to think about value to that patient.

For both Erleada (apalutamide) and Xtandi (enzalutamide), the FDA approval did not specify the doubling time requirement. The FDA approved it in all patients who have non-metastatic castrate-resistant disease. Clearly one size does not fit all. It’s critical to make shared decisions between the patient and the treating physician with regard to the value of the treatment, the risks from the cancer, the risks from the treatment, the treatment objectives, and when to initiate therapy.

Some good news about this disease phase is, because it’s invisible cancer, and while this means there’s micrometastatic disease, the patient has some time to think about things and also monitor carefully.

In my experience, probably about 8 to 9 out of 10 patients elect to be on treatment because of the concern over worsening disease and the value based on the clinical trials. There are some patients who feel great, and if they’re not going to have an issue tomorrow, then they want to wait a few months before deciding on treatment. That’s perfectly reasonable.

Isn’t that true for a variety of situations in prostate cancer, that you have time to gather a variety of opinions?

Dr. Hussain: Correct in general, but specially for this disease space because no one is going to die overnight from a PSA that’s not controlled. That’s to put it bluntly. There is that room. Patients should talk with their physician about that and discuss risk-benefit ratios as all therapies have side effects.

For certain patients, those side effects might be more important, especially for those who have significant cardiovascular disease. It becomes important to incorporate risk-benefit and close monitoring, but it doesn’t mean that no treatment should ever be done.

Do you have any other advice for men in this situation?

Dr. Hussain: One thing to remember for men with hormone-sensitive biochemical recurrence who have had salvage therapy or post radiation and hormonal therapy is that if therapy is to be done, it ought to have a good reason. Lowering the PSA alone is not the objective; clinical benefit should be the objective.

There is potential harm from treatment in the absence of proof that giving hormone therapy for a PSA of let’s say 0.5 or 0.6 will have a benefit. One has to balance the risks from the treatment and both physical and monetary risks to the patient and ultimately implement a shared decision.

These conversations with patients can be long and potentially stressful to the patient. Yes, hormone therapy can be given. The issue is not whether it can be given but whether it should be given, and if so, when.

There’s a fair amount of population-based data that suggests there’s no clear advantage, but there’s limited prospective clinical trial data. I would encourage patients to discuss these issues with their physicians, understand the upsides and downsides, and also discuss opportunities for clinical trials. Clinical trials are one space in which we need informative data and partnerships with patients to come up with better answers.

For patients who had radical prostatectomy (surgical removal of the prostate), and then their PSA is going up, their best treatment option is salvage therapy, which involves radiation with hormonal treatment.

Based on the more recent data from Radiation Therapy Oncology Group (RTOG), the radiation involves the prostate bed and the pelvis to include the pelvic lymph nodes with four to six months of hormone treatment. This is something that should be discussed with the care team. Radiation alone is not enough, and certainly the data indicate the combination is better with regard to outcomes. If the patient doesn’t want to do the hormones, that’s fine, but the hormones can reduce risk of progression and potentially add to overall survival.

The other side would be situations where patients have had radiation therapy and have received hormonal treatment as part of their primary treatment. Then they stopped the therapy, and now months or years later, the PSA is rising. That’s a different scenario. The issue is whether to resume hormone therapy or not. That’s when a careful conversation is necessary between patients and their physician because there is no compelling data that say it’s necessary to do the hormone therapy.

So, there are a variety of situations.

Dr. Hussain: Yes and/or access to clinical trials. We know the phases of prostate cancer now. The same disease state now has multiple phases, and it’s becoming complicated. That’s important because this speaks to the importance of personalizing care for the patient at all levels.

We’re becoming more and more personalized about how we categorize the different disease states.

Dr. Hussain: Yes, absolutely, and we do individualize the care. A 50-year-old who comes in with non-metastatic castrate-resistant prostate cancer and no comorbidities has a very different disease than someone who is 85, had a stroke, and is in a wheelchair.

Patients should ask their physicians specifically about the type of biochemical recurrence they have, their expected prognosis based on their PSA doubling time, their risk-benefits ratio, and which scientific information from prospective clinical trials can help guide their decisions. Patients should ask for educational material, and doctors should help patients make a decision that’s not based on being afraid but being informed about the choices, pros, and cons.

Would you give similar recommendations to anyone along any stage of the disease progression?

Dr. Hussain: Absolutely. Informed decisions are critical in every disease setting. But biochemical recurrence is a complicated phase of disease. In the setting of metastatic disease, it’s relatively easy in that there is no question regarding the disease risks. Earlier therapy, before symptoms or before the disease worsens, is better generally. This a disease setting that is likely to cause harm if therapy is delayed significantly.

But with non-metastatic hormone sensitive biochemical relapse, a patient can go for years without having any visible metastasis. It’s more complicated when there’s no imminent danger. At the end of the day, I tell patients with non-metastatic hormone sensitive disease in whom there is no clear data to support benefit from systemic therapy, that this is a gray area where we don’t have compelling data to say that giving hormone treatment is going to give a meaningful benefit. Therefore, one option is we monitor closely with interval PSA checks and periodic imaging. Based on doubling times and trends, what new evidence that comes up, and patient comfort we can watch. Once the patient is informed about the specifics, it is fascinating that the majority tends to be comfortable with watching and about a third are not comfortable with not getting therapy. There is not a one-size-fits-all approach. Personalized shared decision is critical.

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Cancer + Finances

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The Patient Access Network (PAN) Foundation offers cancer patients help with copay assistance, out-of-pocket costs, insurance premiums, and travel expenses.

Prostatepedia spoke with two members of their team, Mr. Dan Klein and Ms. Amy Niles, about their services for prostate cancer patients.

What does PAN do?

Mr. Klein: PAN’s mission is to help people with life-threatening, chronic, and rare diseases get access to their critical medications and also to advocate on their behalf.

Primarily we provide copay assistance to patients and help them cover the out-of-pocket costs of their prescription medications. We also help with insurance premiums and travel expenses.

We have about 60 different disease areas where we provide assistance to patients. In most of those, we only provide copay assistance, but in a small number of those areas—including prostate cancer—we also provide travel assistance. In some instances, we provide assistance with premiums.

We are a fairly large-scale organization. We help several hundred thousand people a year, and we provide many hundreds of millions of dollars in financial assistance a year. There are many people who need help, the need is growing, and we expect it to continue to grow. By that, I mean more and more people struggle with covering the out-of-pocket costs of their care.

We focus on people with income between 200% and 400% of the federal poverty level. That’s sort of our sweet spot if you will. We focus largely on people on Medicare because, under the regulatory rules, people on Medicare can only get assistance of this kind from independent charities like the PAN Foundation. They’re not able to get help directly from drug manufacturers.

You’re making a distinction between the uninsured versus the underinsured. Does “underinsured” refer to patients who have health insurance that does not cover all of their expenses?

Mr. Klein: Right. We really are organized around helping the underinsured. Within Medicare programs, and Medicare Part D particularly, many people are underinsured because of the high out-of-pocket costs. In Medicare, there’s an infamous donut hole, or coverage gap, that people have to get through. Once they’re through, they still have to pay 5% of the cost of their medication with no out-of-pocket limit. If they take an expensive specialty medication—and many people with prostate cancer take expensive medications—it can easily cost $10,000 a year out-of-pocket just for a single drug.

And you also help with travel?

Mr. Klein: We do. We have a travel fund for people with metastatic prostate cancer. In particular, people who may live far from a treatment center sometimes struggle to afford to get to the specialized care that they need. The travel fund will pick up those expenses related to travel. It could be livery services. It could be the hotel expenses, and we’ll help with those.

What other kinds of out-of-pocket expenses do prostate cancer patients face?

Mr. Klein: There are all sorts of out-of-pocket expenses, and people tend to forget about the fact that it’s not just the copays and deductibles related to the medications. There can also be out-of-pocket expenses related to their medical care or to hospitalization.

How can patients apply to benefit from your programs? What’s the process like?

Mr. Klein: It’s a very streamlined process. Patients can enroll in multiple ways. They can come to our website and enroll through the patient portal, or they can call our 800 number and enroll. Many patients are enrolled by their physicians or by their pharmacists. A pharmacist or physician can enroll a patient through the portal or the call center.

It takes around 10 minutes to complete the enrollment. Within that 10 minutes, they’ll learn whether or not they’ve been approved, and if so, they can use the grant immediately to fill a prescription.

Are they one-time grants or recurring?

Mr. Klein: The grants are for a maximum amount. In the case of prostate cancer, that amount would be $7,500 a year. That’s meant to cover out-of-pocket costs for one year. We use a lot of data to help us try to set that number. Patients who need more than that can ask for a second grant in that same 12-month period. Then at the end of the 12 months, they can renew the grant, provided funding is available.

The eligibility criteria for prostate cancer are that the patient has to be at or below 500% of the federal poverty level, and they need to live in the US. It’s a Medicare-only fund, so they need to have Medicare coverage, not commercial coverage. Patients who have commercial insurance coverage can get help directly from drug manufacturers.

Are there any nonprofits who do something similar for private health insurance companies?

Mr. Klein: Charities like PAN generally provide a similar kind of assistance to patients on Medicare. The reason is that under the Anti-Kickback Statute, drug manufacturers are able to serve people who have commercial insurance, but they’re not able to serve people who have coverage through Medicare.

As an independent charity, we’re highly regulated in what we can do, and we have to keep an arm’s-length relationship from the drug manufacturers. For example, we’re required to cover all of the different medications that might be needed by a patient with prostate cancer. We cover about 35 different medications for prostate cancer.

What about people who are completely uninsured? Is anyone offering help to them?

Mr. Klein: Yes. There are several ways that those patients can get assistance. Drug manufacturers operate Patient Assistance Programs (PAPs), or free drug programs. These are designed to help people who do not have insurance and who are below a certain income threshold. It varies from manufacturer to manufacturer.

The other option is to talk to one of the patient advocacy groups that help navigate the system to find insurance coverage available through the Affordable Care Act (ACA) health exchanges or possibly through Medicaid.

Are financial issues more prevalent in patients who are newly diagnosed and starting on medications, in patients who have been through a couple rounds, or is it all over the map?

Mr. Klein: All of the above. Our particular prostate cancer funds are for people with metastatic prostate cancer. That could either be newly diagnosed patients who were diagnosed at a later stage, or it could be patients who had been diagnosed with local disease that has progressed.

With the types of treatments available today, many patients live longer and manage their disease almost like a chronic disease, and so they may need assistance with out-of-pocket costs for a number of years.

Anything else patients should know?

Ms. Niles: We are very pleased to be working with Us TOO so that patients who contact PAN for assistance can benefit from the range of services that the organization provides. Financial assistance is obviously very important, and it removes barriers to care. But patients, especially when first diagnosed, have many questions about their illness. Addressing those concerns is beyond PAN’s mission, but it’s not beyond what we want to do for patients.

We have aligned with Us TOO which helps patients have a conversation about their illness, medication adherence, and provides a range of support services.

We have close to 20 alliances with various leading patient advocacy organizations to provide this level of support for patients.

Does Medicare refer patients to you?

Mr. Klein: Medicare does. If you go to http://www.cms.gov, they have a whole page that refers people to PAN and programs like PAN.

Do you have any advice for patients who face these issues?

Mr. Klein: There is help available. Patients should not get frustrated or despondent. If a patient calls PAN and we can’t help them, we’ll try to refer them to someone who can.

Ms. Niles: I think it’s really important for patients to have conversations around cost. It’s a difficult conversation to have with their physician or the staff in his or her office. We don’t want patients to refuse treatment because of costs or do things like cut pills in half, delay treatment, or go into medical debt and bankruptcy because of the cost. They should have these conversations and know that resources exist to help them.

Why are patients hesitant to have these conversations?

Mr. Klein: Someone who’s provided for himself for most of his adult life who then gets diagnosed may feel isolated and stigmatized in terms of asking for help. For people who are older, it can feel uncomfortable. Patient advocacy groups like Us TOO and charities like PAN can help them navigate these issues as well.

I imagine there must be a lot of fear involved. Not only are you struggling to pay for your medication, but what is it going to mean for your financial future?

Mr. Klein: Healthcare cost is still one of the leading causes of personal bankruptcy in the US.

Is that more problematic among, for example, older patients who are perhaps on a fixed income?

Mr. Klein: Yes. It’s more problematic for older patients who have serious illnesses because they aren’t able to recover financially. They may not have the ability to go back to work. They may not have a lot of assets. It’s a challenge across the board.

From a public policy perspective, we’re concerned that an increasing number of people have difficulty meeting the deductibles, copays, and coinsurance. And yet, the direction that the insurance industry and the government have taken is not going to make that problem go away anytime soon. We’re worried about the current situation and even more worried about what may come in the next year or two.

What about people who would like to donate?

Mr. Klein: Like any not-for-profit, we are happy to get donations from all sources. Because of the amount of money that’s needed to support the large number of patients who need help, the drug manufacturers are our main source of support. Without their help, we wouldn’t be able to provide the number of grants that we do.

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