2010
April 29, 2010.
Brand name: Provenge
Generic name: Sipuleucel-T
Marketed by: Dendreon
Indication: therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.
FDA press release here.
US Price: $31,000 per infusion. A full course of treatment is three infusions over a one-month period, or $93k.
Courtney Hutchison, Provenge Cancer Vaccine: Can You Put a Price on Delaying Death? ABC News. Jul. 29, 2010
Can you put a price tag on the life of a prostate cancer patient?
With the advent of Provenge, the first-ever vaccine cancer treatment, that tag has been set at about $23,000 per month of life gained — $93,000 in total for a treatment that extends life, on average, by four months.
Gold says that the cost of Provenge was based on the “overall landscape” of treatment prices for cancer. More specifically, the comparable chemotherapy for advanced stage prostate cancer patients, Taxotere, ends up costing about $23,000 per month of life extended by the treatment.
This was used, in part, to set the price of Provenge — four months, on average, of extended survival comes out to about the $93,000 price tag.
Luke Timmerman, Dendreon Sets Provenge Price at $93,000, Xconomy, April 29, 2010
The product, sipuleucel-T (Provenge) will cost $31,000 per infusion, and patients will get three infusions over a one-month period, chief operating officer Hans Bishop said today on a conference call with analysts. That price is far higher than the $62,000 average estimate that Wall Street analysts had been expecting. Dendreon stock surged more than 25 percent to over $50 after the company disclosed the price today.
June 17, 2010
Brand name: Jevtana
Generic name: cabazitaxel
Marketed by: Sanofi
Indication: A chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.
FDA press release is here.
US Price: $48k for a course of treatment.
Joel T Nowak, Can Our Society Find Its Way To An Honest Dialogue About The Price Of A Human Life? AdvancedProstateCancer.Net Jul 23, 2010
In June, the FDA approved a new drug, Cabazitaxel (Jevtana) as a second line treatment for men with metastatic prostate cancer who have failed chemotherapy. Jevtana demonstrated an increased survival of 2.5 months. The projected cost for the Jevtana protocol is $48,000, or $19,200 per additional month of survival. This number does not include any allowance for additional medical or hospital costs that I am sure will be required for many men who take Jevtana. These additional costs can become significant since Jevtana comes with many very significant side effects and the men who do qualify for the drug are already very sick and weakened.
November 15, 2010
Brandname: Halaven
Generic name: Eribulin Mesylate
Marketed by: Eisai
Indication: treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.
FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm233863.htm
NDA 201532
US Price:
UK Price: Put on the UK market at £313 per 2ml vial. Reimbursement rejected by NICE.
Shinya Sato, Why Eisai’s Novel Anticancer Agent Halaven Received the Highest Ever Operating Profit Rate, Pharma Japan, August 2008.
Halaven’s NHI price was set using the cost calculation method. In 2008, a rule was introduced by which drugs receive a standard operating profit rate of 19.2% plus a premium ranging from +50% to -50% based on degree of innovativeness, efficacy, and safety. Halaven’s premium of 40% was the highest ever received. . . . Awarding high NHI prices to innovative new drugs will encourage innovation, but it will also hinder patients’ access to these drugs. Whether Halaven’s record-high premium and resulting higher price discourage patients from using it will need to be watched closely in the future.
Nov. 19, 2010 (for this indication)
Brand name: Xgeva
Generic name: Denosumab
Marketed by: Amgen
BLA 125320
Indication: To help prevent skeletal-related events (SREs) in patients with cancer that has spread (metastasized) and damaged the bone. Skeletal-related events include bone fractures from cancer and bone pain requiring radiation.
FDA press release here.
US Price: The initial wholesale price of Xgeva was $1,650 for an injection given every four weeks.
2011
March 25, 2011
Brand name: Yervoy
Generic Name: ipilimunab
Marketed by: Bristol-Myers Squibb
Indication: patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.
FDA Press Release here
US Price: $30k per infusion. Four infusion course of treatment is $120k.
Makiko Kitamura, Bristol-Myers Skin-Cancer Drug Yervoy Rejected by U.K. Health Cost Agency, Bloomberg, Oct 14, 2011
Bristol-Myers Squibb Co. (BMY)’s Yervoy drug was rejected by the U.K.’s health-cost agency, which suggested the company consider lowering the price of the skin- cancer treatment.
About 30 percent of patients treated with the drug would have improved survival, with 10 percent potentially experiencing long-term benefits, the National Institute for Health and Clinical Excellence said in a statement today, citing clinical specialists.
The drug costs about 80,000 pounds ($125,600) per patient, said the agency, known as NICE, which advises the National Health Service on whether drugs provide value for money. Yervoy is the first medicine proven to extend the lives of patients with advanced melanoma, the most deadly form of skin cancer.
“On the basis of evidence provided so far, ipilimumab could not be considered a cost-effective use of NHS resources,” NICE Chief Executive Officer Andrew Dillon said in the statement. There’s no way to identify which patients will benefit from the drug, he said.
April 6, 2011
Brandname: Caprelsa
Generic name: Vandetanib
Marketed by: AstraZeneca
NDA 022405
Indication: treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms.
FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250168.htm
US Price: $10,454.00 for 30 day supply.
Ben Comer, Biologics specialty pharmacy.AstraZeneca Signs Exclusive Distribution Deal for Vandetanib, Pharm Exec, April 27, 2011
Biologics is tasked with managing vandetanib’s REMS requirements (only REMS-certified pharmacists are allowed to dispense the drug) in addition to working with payers and consolidating referral sources. Ten nurse liaisons are “going out to educate the physician and clinical staff about program specifics, how to make it efficient for them, and to ease the administrative burden for the physician,” said Duffy. For patients, the company expedites available copay assistance, with a focus on rapid turn-around times. Without insurance, a 30-day supply of 300 mg vandetanib, taken once daily, costs $10,454.00, according to an employee in Biologics specialty pharmacy.
April 28, 2011
Brand name: Zytiga
Generic name: abiraterone acetate
Marketed by: Centocor Ortho Biotech, Inc.
Indication: In combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).
FDA press release here.
US Price: $5k for 120 pills, taken 4 per day. Median treatment is eight months, or $40k.
August 17, 2011
Brand name: Zelboraf
Marketed by: Roche/Genetech
Generic name: vemurafenib
Indication: patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
FDA Press Release here
US Price: $9,400 per month. An average course of treatment is 6 months, or $56,400. Sold with a diagnostic test that is priced at $120 to $150.
Jonathan D. Rockoff, Guided By Genes, Shrinking Cancer, A Big Step for ‘Personalized Medicine’ With Approval of Roche Drug; Results ‘Take Your Breath Away’ WSJ, AUGUST 18, 2011.
The rival treatments are expensive, with a course of Yervoy costing $120,000. Most patients will take Zelboraf for about six months at an estimated cost of $56,400, Roche said. The genetic test identifying skin-cancer patients with the BRAF mutation will cost $120-$150, the company said.
Despite the high price, the impact might be temporary without the addition of complementary treatments. The molecular mechanisms that have made for such promising drug targets can also lead the tumors to develop resistance to the new treatments. As a result, companies are researching the combination of therapies, including vemurafenib and Yervoy.
August 19, 2011
Brand name: Adcetris
Generic name: brentuximab vedotin
Marketed by: Seattle Genetics
Indication: Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).
FDA Press Release here
US Price: $13,500 per dose $94,500 to $121,500 (8 cycles “average”)
Seattle Genetics Will Test Oncology Pricing Acceptance With Adcetris, The Pink Sheet, August 29, 2011
Adcetris is priced at the high end of the oncology drug spectrum, roughly $94,500 to $121,500 per patient based on clinical trial experience. But the price could run even higher in the real-world setting if more doses are used.
August 26, 2011.
Brand name: Xalkori
Generic name: crizotinib
Marketed by: Pfizer
Indication: certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.
FDA Press Release here.
US Price: $6,600 per month for the drug, $115k for a year of treat. Plus cost of screening for NSCLC patietns ALK gene.
Matthew Herper, Pfizer Wins Approval For Xalkori, Lung Cancer Drug That Heralds Age Of Expensive, Personalized Medicines, Forbes, 8/26/2011
Pfizer announced that the Food and Drug Administration has approved Xalkori, generically known as crizotinib, a new medicine that can have a dramatic impact in a small minority of lung cancer patients.
The drug will come with a high financial cost to society. Pfizer says it will cost $9,600 a month, or $115,000 for patients who take it for a year. In clinical trials, the average duration of treatment was between 22 and 32 weeks, but because the drug appears to extend patients lives, many may be on it for far longer than that. One study, presented at this year’s American Society of Clinical Oncology meeting, said that 60% of patients on Xalkori were alive after two years, compared to 9% in historical controls.
Matthew Herper, Gene Test For Pfizer Cancer Drug To Cost $1,500 Per Patient, Forbes, August 31, 2011.
On Friday, Pfizer announced that its new gene-targeted lung cancer drug, Xalkori, will cost $9,600 per patient per month, meaning it could cost $80,000 or more for the average patient. But Xalkori is only effective in about 5% of patients whose tumors have a mutation in a gene called ALK. As biotech executive Gautam Kollu noted on Twitter, the real cost of the drug is $9,600 plus 25 ALK tests, because that’s how many patients will need to be screened for one to actually get Xalkori (which up until now was known by the generic name crizotinib.)
Abbott Laboratories makes the ALK test through its Vysis unit, and I asked a spokesman how much it would cost. Like the test for Roche’s Herceptin, a type of test called a FISH test is used. The spokesman said: “An ALK test, including the pathology service, will be approximately $1,500 (a one time cost). The price we charge for the test kit itself is less than $250, which is similar to other FISH tests.”
Appendix:
From Don Sharp’s Ten Trends Transforming The Business of Oncology, Oncology Business Review, September 19, 2011,
Entering 2010, oncology blockbusters had become much more valuable than they were in 2000. In 2000, only two oncology drugs had more than $1 billion in revenue. In 2010, all of the top 10 oncology drugs exceeded $1 billion in sales. This revenue growth has come in the face of decreasing incidence for most cancers in the US. Instead, the revenue growth has come largely through the increasing price of new oncology drugs.
..In the past decade, the growth in oncology sales representatives was 6.9% annually, far outstripping the 3.3% growth in oncologists. This growth has outpaced the growth of oncologists in the US to the point where there are three reps for every 10 oncologists. This increase in sales reps per oncologist limits access by competition. In addition, the survey respondents confirmed that access is increasingly limited, such that about half the time, sales reps are unable to see the oncologist. This limited access suggests that the industry may be over-invested in sales representatives targeting high prescribing oncologists.
..
Payers are also controlling access to oncology therapeutics explicitly. Typically, payers seek to control costs by requiring an FDA indication, prior therapy failure, appropriate dosage, appropriate therapy intervals, or compendia listing. Prior authorizations are required for up to 65% of covered lives for the most expensive oncology monoclonal antibodies.
Misc news stories
- 2005, July 12, Alex Bernson, Cancer Drugs Offer Hope, but at a Huge Expense, New York Times.
- 2006, July 11. Liz Szabo, Prices soar for cancer drugs, USA Today.
- 2009, May 30, Matthew Herper and Robert Langreth, Are Cancer Drugs Worth The Money? Drug companies are making big profits from very small increases in cancer drug effectiveness., Forbes.
- 2010, August 19, Sarah Boseley, Doctors question high price of cancer drug Herceptin, Concern raised that commercial interests of pharmaceuticals such as Herceptin producer Roche is steering path of research, the Guardian.
- 2010, August 30. A High Price for Rare Cancer Drugs, GoozNews.
- 2010, September 26. Marilynn Marchione, Provenge, Cancer Drug, Costs $93,000: Sky High Drug Prices Impact Life-Or-Death Decisions, Huffington Post.
- 2011, February 15. Jo Cavallo, Containing the High Cost of Cancer Care: Four experts examine the issue and offer solutions. ASCO Post Volume 2, Issue 3
- 2011, July 8, Paul Howard, High-Priced Cancer Drugs: Are They Worth It?, Critical Condition, NRO’s health-care blog, National Review.