PharmExec Blog

Ibrutinib's Breakthrough to Market

FDA’s new Breakthrough Therapies designation sped Pharmacyclics/J&J’s ibrutinib (brand name: Imbruvica) through regulatory review in four months, based on Phase 2 studies. Pricing and access issues, though, may not get resolved so quickly.

On a conference call with investors on the day FDA approved Imbruvica (ibrutinib), a Breakthrough Therapy-designated treatment for Mantle Cell Lymphoma (MCL), Robert Duggan, CEO at Pharmacyclics, praised the FDA for its “vision, leadership and execution.” That praise is understandable, considering that Imbruvica went from first-in-man trials to commercial availability in just four and a half years.Imbruv_resize

Imbruvica was approved on the basis of phase 2 studies, and biotech analysts were pleased to note that FDA greenlighted the drug just four months after the NDA submission was filed – a two-month improvement over the standard six-month accelerated approval period – ostensibly thanks to Imbruvica’s Breakthrough status.

Roughly 150 sales reps (half Janssen, half Pharmacyclics) will market Imbruvica, targeting around 7,000 of the 8,000 hematologist/oncologists practicing in the US. The drug was made available on the day it was approved, company executives said on the call.

Currently indicated in the refractory setting, Imbruvica costs $91.11 per pill, or just under $11,000 a month ($132,000 annually) for MCL patients taking four pills a day. If approved for CLL, that cost will drop to roughly $8,200 a month, since CLL patients would take only three pills a day. This is a premium price per pill, to be sure, but it’s more or less in line with its competitors in these small (CLL) and smaller (MCL) Non-Hodgkins lymphoma cancer subtypes. According to Kantar Health data, the 2013 total drug-treated MCL population in the US is 4,747 patients; in CLL, that number is 15,415.

Imbruvica’s average duration of response extends to 18 months; that’s a lot of pills, and a lot of coverage changes for Medicare Part D patients. Responding to a question about the anticipated payer mix for Imbruvica during the Pharmacyclics conference call, Matt Outten, senior director of market access, said the company anticipates a “higher percentage” of Medicare Part D patients, meaning more than half of US sales will depend on whether or not patients can afford the leftover costs of what the government, and pharma, won’t pay.

Debbie Warner, VP, commercial planning at Kantar Health (and formerly a managed markets oncology brand director at AstraZeneca), says patients just starting out with a Medicare benefit and hoping to access Imbruvica could pay roughly $2,657 out of pocket from treatment initiation through the end of the donut hole, followed by a monthly payment of around $650 (or five percent of the drug cost under Medicare Part D’s catastrophic coverage) after that: until the end of the calendar year, when the whole process resets.

Imbruvica isn’t listed yet on the website, but the $2,656 figure Warner cites is based on an examination of Celgene’s Revlimid, which picked up an indication for MCL patients in June and is priced at almost $13,000 for a month supply, according to Kantar. Revlimid has an average 16.6 month duration of response in MCL, according to the PI. Below is Kantar’s breakdown for Revlimid coverage under Medicare Part D, with an AARP Medicare Rx Saver plus plan. ICL stands for Initial Coverage Limit, and OOP stands for Out of Pocket:


The true out of pocket cost for a Medicare patient taking Imbruvica could be $2,656, plus a $650 monthly payment during the catastrophic coverage period, according to Medicare rules and Kantar’s analysis, but Warner cautions that the amount could vary. “I can’t say definitively what Imbruvica will cost Medicare patients before it is actually loaded into Medicare’s formulary finder,” says Warner. “Each plan may have slightly different pharmacy reimbursement rates, which would cause the co-pay during catastrophic coverage to vary somewhat.”

Given the small patient population for MCL, it’s likely that many will receive financial help from foundations and other third party organizations. On the Pharmacyclics call, Outten said “a majority of MCL patients will qualify for at least one of our [financial assistance] programs.”

Pharmacyclics “You&i” program offers eligible patients up to 60 days of free Imbruvica therapy, in an effort to overcome insurance coverage and reimbursement delays and other hang-ups. Pharmacyclics executives said they would not seek retroactive reimbursement from payers for patients receiving free Imbruvica during this period.

A second You&i program, called Access Instant Savings,  helps commercially insured patients who “find it difficult” to pay the copay or coinsurance out-of-pocket expense afford the drug, said Outten. “These patients will receive support so that they have a maximum monthly out of pocket expense of $25,” said Outten. That $25 copay cap for commercially insured patients will continue throughout the course of treatment, or up to 19% of the drug’s full wholesale acquisition cost, per patient, he said.

Janssen/J&J will help uninsured low-income patients (those who make less than 600% of the federal poverty limit) get access to Imbruvica.

Will foundations and non-profits pick up the tab for Medicare patients with co-pays likely to exceed – significantly – the $25 monthly cap for commercially insured patients? The answer to that question is an important one for elderly, fixed-income MCL patients, and Pharmacyclics/J&J alike.

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  1. Dave
    Posted November 26, 2013 at 5:16 pm | Permalink

    I’m a retired vet using TRICARE standard. I am not elligible for Medicare. Will this drug be available to TRICARE patients, or maybe through the VA? I was diagnosed with CLL in 2006 and went through six months of chemo in 2012. The symptoms are returning (enlarged lymph nodes) and my doctor thinks I am a good candidate for this treatment.

  2. Jeremy
    Posted December 2, 2013 at 11:54 am | Permalink

    If Janssen / Pharmacyclics want to make Imbruvica available under Medicare and Medicaid, they must also make it available to the VA / TRICARE. Keep pressing.

  3. Becky Hugg
    Posted December 5, 2013 at 6:08 pm | Permalink

    My 44 yr. old son is a candidate (B-cell CLL) and is not on Medicare or poverty stricken–just regular hard working middle class young man. How likely is it that his Blue Choice insurance will consider covering this expense?

  4. Posted December 6, 2013 at 5:11 pm | Permalink

    Hi Becky and Dave: Imbruvica (ibrutinib) hasn’t received FDA approval for CLL yet, even though it was filed for approval in both MCL and CLL indications. The people I’ve spoken with about ibrutinib expect that it will be approved for CLL one day soon, but until that happens, it may be difficult to get insurance coverage for what is, at the moment, an off-label indication. During our conversation, Kantar Health’s Debbie Warner told me that payers are trending toward stricter management of off-label drug coverage (based on recent Kantar payer research), so if a doctor prescribes Imbruvica for a CLL patient, you may be able to get it covered to some degree, but my guess is you’d have to make a lot of phone calls and jump through a lot of hoops to make that possible.

  5. Mike Kavanagh
    Posted December 17, 2013 at 12:51 pm | Permalink

    Have just got the news about a third mantle cell relapse. I have medicare. What is or can be done so that I might beable to afford this treatment. There is no way That I could afford this kind of cost

  6. al
    Posted December 20, 2013 at 10:01 am | Permalink

    i was diagnosed with CLL more then 10 years ago. did not have any treatment asyet ( please help me which kind of first time treatment should I take) when HB dropped to 47 Symptoms like, not able to walk even with walking stick and frequent chest and abdomam pains with a little exertion. had to take blood transfusion. I can not afford Ibrutinib or ABT199. can any body tell me about charities and how to apply for drug assistance. I am afraid to FCR for trigring secend aggresive cancer .

  7. Posted April 15, 2014 at 8:35 am | Permalink

    I have been diagnosed with CLL. I see that Ibrutinib has received FDA approval for CLL in February 2014. I would like to find doctors who will prescribe Ibrutinib vs. chemo. However, I have Cigna POS who just told me they don’t have that drug on their listing. Does that mean I may qualify for assistance in paying for the medication? Also, where can I get a list of doctors who will treat CLL with Ibrutinib?

  8. Preeti
    Posted November 16, 2014 at 10:12 pm | Permalink


    What are the options for patients in India to get Ibrutinib? What are the costs? My father has been diagnosed with MCL last year and has since relapsed after 1 round of Chemo. Thanks

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