J&J, Pharmacyclics slap $130,000 price on Imbruvica for rare lymphoma - FiercePharma
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`Topics: Sales and Marketing
`J&J, Pharmacyclics slap $130,000 price on
`Imbruvica for rare lymphoma
`November 14, 2013 | By Tracy Staton
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`Another cancer drug approval, another
`nosebleed-level price. Johnson & Johnson ($JNJ)
`and Pharmacyclics' ($PCYC) breakthrough drug
`Imbruvica (ibrutinib) won FDA approval yesterday
`for a rare form of lymphoma. Soon after, the
`companies said Imbruvica would be priced at
`more than $90 per pill. At four pills per day, that's
`about $130,000 per year.
`
`That's the sticker price, subject to rebates and other discounts for payers. But
`even so, $130,000 is among the highest prices on a new cancer drug in recent
`memory--and cancer is a price-elastic field (at least for now). Dendreon
`($DNDN) got itself into trouble with a $90,000 price on its prostate cancer
`therapy Provenge, and Bristol-Myers Squibb ($BMY) raised eyebrows with its
`$120,000 tag for the melanoma drug Yervoy. The latter proved to be little object
`for Yervoy, which hit the ground running, sales-wise. Roche's ($RHHBY) newly
`minted breast cancer treatments Perjeta and Kadcyla are priced somewhat
`lower--about $71,000 and $94,000 per year, respectively--but they're designed
`to be used together. That's $165,000 for the combo.
`
`Patients won't bear the brunt of Imbruvica's cost. As TheStreet reports,
`Pharmacyclics will offer two months' worth of the drug for free to patients who
`have trouble on the insurance-reimbursement side. Plus, the company is setting
`up copay assistance plans for patients who can't afford their share of the cost.
`
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`clinical and research background as a backdrop for the discussion. Register Now!
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`Payers, on the other hand, have to add Imbruvica to the list of high-priced
`therapies patients want. The most skeptical are likely to focus on the supporting
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`J&J, Pharmacyclics slap $130,000 price on Imbruvica for rare lymphoma - FiercePharma
`
`Page 2 of 3
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`research; approved under the FDA's new "breakthrough" therapy program,
`Imbruvica has so far delivered Phase II data showing an impressive overall
`response rate. More than 65% of patients responded to the drug, for a median
`duration of 17.5 months. Whether Imbruvica extends patients' lives hasn't yet
`been proven. Nor has its ability to tamp down cancer progression. The
`companies will go on to conduct Phase III trials, aiming to strengthen the case.
`
`Still, for patients eligible for Imbruvica--those who've seen their cancers progress
`after at least one prior treatment--the promise of a response is a big deal. As
`J&J notes in its press release, mantle cell lymphoma (MCL) is a "challenging
`disease associated with poor prognoses." Just the fact that the FDA chose to
`grant Imbruvica breakthrough status shows there's a clear need for new drugs in
`the area.
`
`MCL affects only 2,900 patients in the U.S. per year, J&J says. With so few
`patients affected, insurers are better able to absorb the high cost. At least that's
`how it's worked for rare-disease drugs in the past. In the orphan drug world,
`Imbruvica isn't all that expensive. Just think of Alexion ($ALXN) and its Soliris
`treatment for paroxysmal nocturnal hemoglobinuria and other rare disorders,
`which bears a $400,000-plus annual price tag. Or Sanofi's ($SNY) rare-disease
`meds acquired with Genzyme; Fabrazyme and Cerezyme run about $200,000
`per year. And Vertex Pharmaceuticals' ($VRTX) cystic fibrosis drug costs some
`$290,000.
`
`Soon enough, Imbruvica will expand into other, related diseases. It will become
`more of a cancer drug, less of a rare-disease med. J&J and Pharmacyclics have
`their eyes on chronic lymphocytic leukemia (CLL) and small lymphocytic
`lymphoma, a broader market. Imbruvica won the FDA's coveted "breakthrough"
`status for those two uses as well. For CLL, fewer Imbruvica pills are required,
`and that will bring the cost down to about $8,200 per month, Pharmacyclics CEO
`Robert Duggan said, as quoted by The New York Times. That works out to
`about $98,400 per year.
`
`As TheStreet notes, analysts were expecting an Imbruvica price of about
`$110,000. Investors are likely to cheer at the higher price, expecting higher sales
`as a result. Already, analysts are looking for $1.3 billion in 2018 sales, according
`to EvaluatePharma.
`
`The real pricing test will come in other countries with government cost-
`effectiveness agencies. The U.K.'s National Institute for Health and Care
`Excellence (NICE) initially balked at Yervoy's sticker, pressuring Bristol-Myers to
`offer a discount.
`
`- get the release from J&J
`- read TheStreet's story
`- check out the NYT piece (sub. req.)
`
`Special Reports: Top 20 Orphan Drugs by 2018 - ibrutinib | Top 10
`Experimental Cancer Drugs 2013
`
`Related Articles:
`J&J, Pharmacyclics win early approval for 'breakthrough' cancer drug ibrutinib
`Australia to track Yervoy patients to see if it's worth the $110K price
`With nod, Roche's Kadcyla should quickly become a blockbuster
`FDA approves Roche's pricey new Herceptin partner, Perjeta
`NICE on Bristol-Myers' melanoma drug Yervoy: The cost is too darn high
`
`EMAIL ADDRESS
`
`| WEDNESDAY, SEPTEMBER 2ND |
`11:30AM ET / 8:30AM PT | PRESENTED
`BY: MEDPACE
`
`In this webinar, Dr. Frank Smith will explore
`advances in precision medicine and how it is
`affecting clinical research. As a pediatric
`hematologist/oncologist, he will use his
`extensive clinical and research background as
`a backdrop for the discussion. Register Now!
`
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`Filed Under ibrutinib, Imbruvica, Johnson & Johnson, Pharmacyclics
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`http://www.fiercepharma.com/story/jj-pharmacyclics-slap-130000-price-imbruvica-rare-l...
`
`08/11/2015
`
`Coalition for Affordable Drugs IV LLC - Exhibit 1030
`
`

`

`J&J, Pharmacyclics slap $130,000 price on Imbruvica for rare lymphoma - FiercePharma
`
`Page 3 of 3
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`http://www.fiercepharma.com/story/jj-pharmacyclics-slap-130000-price-imbruvica-rare-l...
`
`08/11/2015
`
`Coalition for Affordable Drugs IV LLC - Exhibit 1030
`
`