I had an opportunity to interview several Takeda Pharmaceutical team members about the company’s new oral, proteasome inhibitor, Ninlaro (ixazomib), yesterday afternoon.
I have heard from dozens of patients who find themselves stuck paying thousands of dollars out-of-pocket for two established oral chemotherapy drugs, Revlimid and Pomalyst. I’m concerned that the same obstacles might face patients that are prescribed Ninlaro. My interview focused on how the company’s newly launched patient assistance program might help people afford the new medication.
Most Medicare supplemental drug plans leave patients responsible for the notorious Medicare doughnut hole, along with co-pay’s of 5 or 10%. Normally percentages like that wouldn’t be a big deal. But when a drug costs upwards to $10,000 a month, even 5% ($500) is a lot of money.
Many patients can get assistance to help defer costs. But those making more than $80,000 or so a year are stuck paying what could equal 10% of their gross annual income. Ouch!
My understanding is by spending $300 or more a month on a high end supplemental plan, these numbers can be greatly reduced. Another, better option might be paying extra to have a former employer’s plan as a back up in secondary position. This strategy may help some, but not all.
I would love to hear from those of you that have found so called “Cadillac” plans that cover a greater percentage of the cost.
On yesterday’s call, I spent 30 minutes asking questions about Ninlaro and ways Takeda plans to help patients find creative ways to get the new drug. The company’s patient assistant program is named Ninlaro 1 Point. It features a dozen different ways to help patients–insured and uninsured, and of all income levels and co-pays–find ways to affordability access Ninlaro.
Go to www.Ninlaro.com and click on the Ninlaro 1 Point button in the center of the page for specifics.
There is still a large elephant in the living room. Medicare guidelines don’t allow the same aggressive co-pay intervention. The same applies for oral parity legislation; it only applies to the 5-10% of privately insured patients.
So what are Medicare patients to do? The Takeda group reassures me that they’re working on it, but for now their hands are tied. The company can–and is–contributing to private foundations that are supporting patients. That helps. But there are some large cracks that need attention, like this one I wrote about on Saturday:
The caller was a nurse, reaching out on behalf of a newly diagnosed friend. Their concern: paying for Revlimid.
As you all know, Revlimid is a capsule taken orally. A very expensive capsule that’s price continues to rise: it now costs over $10,000 for a monthly supply of 21 capsules. Apparently this patient, who lives on the Gulf Coast of Florida, wants to keep her job as a clinical administrator. Admirable. But there’s a problem. She’s on Medicare, and the out-of-pocket cost of her prescribed Revlimid is over $2,7000 for the first month (donut hole), then a whopping $800+ a month after that.
I know, I know. She should call Celgene and then apply for LLS Co-Pat Assistance. Problem is, she makes well over the $85,000 threshold to qualify. And she’s frustrated that other Medicare supplemental plans aren’t any better…
There must be a solution. Maybe one of the foundations can focus newly bolstered resources on Medicare related patient expenses. I’m confident that the Takeda team can help get things figured out. They are already doing more than any of us could reasonably expect.
Switching gears, the largest and best known patient support foundation, the Leukemia and Lymphoma Society (LLS), has chimed in, trumpeting support for last weeks FDA approvals. By the way, did you know that the group’s name was formerly the Leukemia, Lymphoma and Myeloma Society? Even though 50% of their support is myeloma related, they decided to drop “myeloma” from the tag line to make it easier to remember. That’s unfortunate.
The last LLS support group meeting I attended featured 17 myeloma patients and caregivers, along with 2 representing lymphoma and 3 leukemia. The regional Florida Chapter has since disbanded the group.
I don’t have a problem with the LLS jumping back on the myeloma bandwagon, do you? And tongue-and-cheek teasing aside, the LLS Co-Pay program is amazing. I’m approved for up to $10,000 in assistance. I only use $2,500 – $3,000 a year, but it’s sure great to know the backup is there if I need it.
Don’t forget that the LLS will reimburse you for insurance premiums? This includes premiums for Medicare and supplemental policies. That’s why it is so important to get reader suggestions for ways to get oral chemotherapy drug expenses like Revlimid, Pomalyst and Ninlaro covered.
I’ll close by passing along the official press release, issued by our friends at the LLS. It isn’t bogged down with details about affordability or even effectiveness. It stresses the good things now that two new myeloma drugs have been FDA approved. Make that three; panobinosat garnered FDA support earlier in the year, too.
Great news as we move into the holiday season. Hold on to the positives. The drug companies and supporting foundations will get things figured out. Most importantly, our myeloma specialists can start focusing on which therapy combinations will benefit individual patients best. We have a lot to be thankful for!
Feel good and keep smiling! Pat
Two New Multiple Myeloma Drugs Win Approval as Pipeline Builds Hope for Blood Cancer Patients
WHITE PLAINS, N.Y., Nov. 23, 2015 /PRNewswire-USNewswire/ — The Leukemia & Lymphoma Society (LLS) applauds the FDA’s recent approval of two new drugs — daratumumab and ixazomib — to treat patients with relapsed multiple myeloma. These therapies are the latest in a growing arsenal to fight this blood cancer that impacts nearly 100,000 patients in the U.S. Advances in treatments for many different types of blood cancers are happening with dizzying speed and these two approvals in just one week are the latest evidence of this phenomenon.
The FDA approved two additional multiple myeloma drugs earlier this year: panaobinostat (Farydak ®), in February and carfilzomib (Kyprolis ®) in July. Another promising myeloma therapy still in the pipeline is elotuzumab.
Blood cancer research has been the gateway to better therapies and even cures for all cancers. Over the past 15 years, approximately 40 percent of therapies approved by the FDA to treat cancers have been specifically for blood cancers, and many are now helping patients with other cancers and serious diseases.
The past 12 years have seen remarkable changes in the treatment for patients diagnosed with multiple myeloma (MM), a painful blood cancer that begins in the bone marrow and causes the bones to become brittle. While myeloma remains incurable, ixazomib and daratumumab are the latest in an array of new therapies that are extending survival rates for patients coping with this painful and difficult to treat cancer.
“We are seeing rapid progress in new therapies coming on line for patients with multiple myeloma, as well as for all types of blood cancers. LLS applauds the FDA’s accelerated approval of ixazomib and daratumumab this week,” said Louis J. DeGennaro, president and CEO of The Leukemia & Lymphoma Society (LLS). “LLS continues to support cutting-edge research to advance more effective treatments for multiple myeloma, and for all blood cancers.”
Ixazomib (Ninlaro ®) was approved today for relapsed and refractory multiple myeloma patients, in combination with another drug, lenalidomide. It works by cutting off the production of proteins the tumor cells need to grow. Daratumumab ( Darzalex ®) was approved Monday for patients who have failed on at least three prior lines of therapy. The FDA hastened its approval based on data showing the drug’s safety and effectiveness. It works by targeting a protein called D38 on the surface of myeloma cells.
The most current data on these two therapies, as well as other emerging therapies for multiple myeloma is anticipated to be a major topic of discussion during the upcoming American Society of Hematology Annual Meeting in Orlando next month, when more than 20,000 researchers from around the world will convene to share their latest findings.
LLS-Supported Research on Multiple Myeloma
LLS supports a large portfolio of research seeking to better understand the mechanisms of multiple myeloma, to help approved therapies work better, and to support novel approaches to treatment. For example:
• Through LLS’s Therapy Acceleration Program ® (TAP), LLS is supporting a company, OncoPep, in developing a vaccine designed to prevent pre-myeloma conditions from advancing to myeloma.
• Another TAP project at Johns Hopkins is developing an adoptive cellular therapy approach to treating myeloma.
• LLS is also supporting a T-cell immunotherapy project for myeloma at Baylor College of Medicine.
• LLS-supported researchers at Dana-Farber Cancer Institute are experimenting with different ways to prevent pre-myeloma conditions from progressing.
Overall, LLS is currently supporting more than 20 multiple myeloma projects. Approximately 10 percent of LLS’s research budget is focused on multiple myeloma therapies.
Background on Multiple Myeloma
Multiple myeloma is one of the three main types of blood cancers — diseases that affect the bone marrow, blood cells and lymph nodes. There are hundreds of subtypes of blood cancers, and currently more than 1.1 million people are living with a blood cancer in the U.S. While multiple myeloma is not as prevalent as some other blood cancers, such as lymphoma and leukemia, the urgency to find better treatment options for the disease is reflected in the surge of new therapies for multiple myeloma either recently approved or in the pipeline.
Prior to 2003, the prognosis for a patient diagnosed with multiple myeloma was very grim, as the standard therapies were largely ineffective. People diagnosed with multiple myeloma rarely lived beyond three years.
However, in 2003, the FDA approved bortezomib (Velcade®), a new therapy for myeloma, advanced with LLS support. This marked the first new effective treatment for myeloma patients and more than tripled survival rates for some patients. Other promising therapies followed, including lenalidomide (Revlimid), an oral therapy, and thalidomide (Thalomid ®), approved within a month of each other in 2006, giving myeloma patients even more options and more hope, extending lives and improving quality of life.