By Andrew Pollack
The New York Times
December 4, 2009
A newly approved chemotherapy drug will cost about $30,000 a month, a sign that the prices of cancer medicines are continuing to rise despite growing concern about health care costs.
Critics, including many oncologists, say that patients and the health system cannot afford to pay huge prices for drugs that, on average, provide only a few extra months of life at best.
And Folotyn (made by Allos Therapeutics) has not even been shown to prolong lives ā only to shrink tumors. The drug was approved by the Food and Drug Administration in late September as a treatment for peripheral T-cell lymphoma, a rare and usually aggressive blood cancer that strikes an estimated 5,600 Americans each year.
(James V. Caruso, the chief commercial officer for Allos) said the price of Folotyn was not out of line with that of other drugs for rare cancers. Patients, moreover, are likely to use the drug for only a couple of months because the tumor worsens so quickly, he said.
In a note to clients in October, Joshua Schimmer, an analyst at Leerink Swann, estimated that a typical treatment would last 3.5 months and cost $126,000, or about $36,000 a month.
http://www.nytimes.com/2009/12/05/health/05drug.html?_r=1&hpw
And…
Prescribing Information for Folotyn (pralatrexate injection)
Allos Therapeutics, Inc.
Issued: September 2009
Indications and Usage:
Folotyn is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated.
Adverse reactions (list includes only those events occurring in 10 percent or more of patients treated):
Mucositis
Thrombocytopenia
Nausea
Fatigue
Anemia
Constipation
Pyrexia
Edema
Cough
Epistaxis
Vomiting
Neutopenia
Diarrhea
Dyspnea
Anorexia
Hypokalemia
Rash
Pruritis
Pharyngolaryngeal pain
Liver function test abnormal
Abdominal pain
Pain in extremity
Back pain
Leukopenia
Night sweats
Asthenia
Tachycardia
Upper respiratory tract infection
Percent of patients experiencing any adverse event: 100 percent
Forty-four percent of patients (n = 49) experienced a serious adverse event while on study or within 30 days after their last dose of Folotyn.
http://www.folotyn.com/pdf/package-insert.pdf
And…
Patient Protection and Affordable Care Act (Amendment in Senate)
The Library of Congress, THOMAS
H.R.3590
Title VII – Improving access to innovative medical therapies
Sec. 7002, (a), (2), (k)
(7) Exclusivity for reference product
(A) Effective date of biosimilar application approval – Approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a).
Comment:
By Don McCanne, MD
Fotolyn is a new miracle drug brought to us by our highly revered pharmaceutical industry. This new drug has no demonstrated clinical benefit, though all patients have adverse reactions, almost half of them serious – including death.
In an astonishing moment of candor, James Caruso, chief commercial officer for Allos, provided reassurance that the very high monthly cost of Fotolyn would not be protracted since the tumor worsens so quickly.
What makes this drug a miracle only the investment community can understand. Desperate patients will spend an average of $126,000 for this worthless drug. On Wall Street that’s a miracle, but within the health policy community, that’s a tragedy.
You can be assured that, in crafting health care reform, Congress has responded to the very high prices of newer patented therapeutic agents, but in a perverse way. Recognizing the great potential of genetically-engineered biologics, Congress has included in the legislation an unprecedented 12 year exclusivity, protecting the firms from competition of biosimilar products.
Maybe the biotech firms will be able to parley this into seven-figure treatment programs for the desperately ill. The soak-the-sick policies may not work for patients, but they certainly work well for Wall Street. And doesn’t that seem to be where Congress’s loyalties lie these days?
