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Ninlaro should be a great drug, but storm clouds on the horizon

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Ninlaro should be a great drug, but storm clouds on the horizon

By most accounts, ixazomib (trade name, Ninlaro) should work as well or even better than Velcade. Preliminary reports are hopeful that adverse side effects may be fewer and more tolerable, too. “But storm clouds on the horizon?”

The good news is Ninlaro is an oral capsule, taken once weekly. How convenient! For most patients this shouldn’t be too big a financial burden. But for others it could be a real challenge in states without oral parity legislation, making use of the drug very expensive. I’ll explain after I run some basic information about Ninlaro’s approval.

It’s still early. Online news will be flooded with details over the weekend if you’re interested. I’m dexed up and my anti-diarrhea meds cut out at a most inopportune time, so I’m up and writing before the sun comes up. Here’s what ASCO had to say in an announcement to their members:

FDA Approves Ixazomib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma

By The ASCO Post
Posted: 11/20/2015 12:24:22 PM

The U.S. Food and Drug Administration (FDA) granted approval for ixazomib (Ninlaro) in combination with two other agents to treat patients with multiple myeloma who have received at least one prior therapy.

“As we learn more about the underlying biology of multiple myeloma, we are encouraged to see the development of new ways to treat this disease,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Today’s approval is the third drug for multiple myeloma approved this year and provides patients with a new oral treatment that slows disease progression when other therapy has failed.” The FDA approved panobinostat (Farydak) in February and daratumumab (Darzalex) earlier in November.

Takeda logoIxazomib is a proteasome inhibitor that works by blocking enzymes from multiple myeloma cells, hindering their ability to grow and survive. Ixazomib is the first oral proteasome inhibitor and is approved in combination with another FDA-approved treatment for multiple myeloma, lenalidomide (Revlimid), plus the corticosteroid dexamethasone.

Clinical Study Details
The safety and efficacy of ixazomib were demonstrated in an international, randomized, double-blind clinical trial of 722 patients whose multiple myeloma did not respond to one to three previous treatments. Study participants received either ixazomib in combination with lenalidomide and dexamethasone, or placebo plus lenalidomide and dexamethasone. Those taking ixazomib showed a significant improvement in progression-free survival (average, 20.6 months) compared to participants taking the other regimen (14.7 months).

The most common side effects of ixazomib are diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain.

Let’s take a look at the financial side of things that could be a problem. First, my understanding is that Takeda plans to have the best patient assistance program in the business; even better than Celgene’s–and theirs is darn good. Even so, I’d like to paraphrase some information from a phone call I received yesterday.

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.

Here was my advice. First, I believe there are supplemental policies that cover more of these costs, they’re just more expensive than she was probably willing to accept. A $300-400 a month supplemental policy sounds outrageous when compared to the 0-$100 policies we see gleeful advertised on TV. But do the math. If she could find a $400 policy that could get her co-pay down to $100 she could come out way ahead. It would hurt, but she could save thousands of dollars a year.

But I had a better short term solution. Since Revlimid isn’t a good idea for patients that may be harvesting within the next few months, which should apply to her. I get the feeling she’s only seeing a medical oncologist, so maybe harvesting her stem cells is an afterthought at best.

Regardless, Mayo Clinic has started skipping Rev upfront and has gone to CyBorD; that’s Cytoxan, bortezomib (Velcade or soon Ninlaro) and dexamethazone. It works just as well for most patients, and saves everyone a lot of money. Oral Cytoxan and Dex are cheap. Or they can be given IV, and then they’re free. So fire up the old IV, infuse Cytoxan and Decadron, and get a sub-q Velcade shot in the belly and it’s all good.

Efficacy? Within a percentage point or two of RVD: Revlimid, Velcade and dex.

But how could she gain access to Ninlaro? Well, her friend told me she’s stage three, so its likely one or more lesions will be radiated. If that’s the case, or she ends up using Rev/dex for a few months until she switches over to CyBorD; either way she’s used one prior therapy. Simple once you know the rules.

Which brings us back to Ninlaro. Hopefully Takeda’s new patient assistance program (to be named and available real soon) will have some answers when similar situations come up. I filled out a questionnaire recently, giving input into what I felt should be an important part of their program. I believe I made this a top priority. That and providing patients with emotional support.

I’m ecstatic Ninlaro has been approved. Word is it works for one out of three or four patients that have become refractory to Velcade. That’s hopeful. Darzalex (daratumumab) does, too. These odds start to stack up in our favor. What a week!

Feel good and keep smiling! Pat