On April 20, 2010, Arthritis Today published an article that unfortunately contained some inaccuracies. We have reprinted that article below with our corrections to the inaccurate statements placed where appropriate to give the reader accurate information.
The Price of Gout Drug, Colchicine, Goes Up
Why sticker shock may soon be a side effect of taking this centuries-old medication
By Andy Miller
Arthritis Today: “For the past few years, Peggy Lewis has paid $10 or less for a 90-day supply of her gout drug, colchicine. But Lewis, 71, fears she will soon be forced to pay hundreds of dollars more for that medication.
Lewis, of Fairfield, Ohio, has taken colchicine for about 20 years to prevent attacks of gout, a form of arthritis that causes flares of sudden pain, stiffness and swelling in joints.
But sometime this year, Lewis will have to replace her current version with a brand-name colchicine medication, Colcrys, which, she was told, could cost up to $550 for a 3-month supply.
‘I think it’s a shame,’ she says of the price increase. ‘It would take my whole Social Security check.'”
URL Pharma Response: Ms. Lewis will not have to pay anywhere near that amount for Colcrys. The author of this article was provided with the details of our Patient Assistance Program (PAP) and briefly mentions it later in this article. A patient like Ms. Lewis, living on Social Security, will not have to pay anything for Colcrys. At the time that this article was published, our PAP provided Colcrys for $5 per month for uninsured and Medicare Part D patients with incomes of up to $88,000 per year for a family of four. Patients with incomes up to $132,000 per year can obtain Colcrys for $25 per month. In late April, 2010, we added another improvement to our PAP, making it even more generous. Uninsured and Medicare Part D patients with incomes up to $66,000 per year for a family of four can now obtain Colcrys free of charge.
Arthritis Today: “The jump in price follows a push by the U.S. Food and Drug Administration (FDA) to stop the sale of hundreds of medications that had been grandfathered onto the drug market because they were dispensed before the agency began reviewing and approving new drugs.
Colchicine, for example, which is made from a flowering plant called the Autumn Crocus, was first used for gout treatment in the 1800s.
It’s estimated that thousands of drugs fall into this ‘marketed, unapproved’ category, and they include many other medical mainstays, including forms of the painkiller morphine and the heart drug nitroglycerine.
The agency says it is concerned that many of these medications could have safety issues that have never been brought to light. In 2008, for example, the FDA banned injected forms of colchicine after 23 deaths were linked to its use.
The FDA has called on drug manufacturers to conduct clinical trials on these unapproved medications. In return, the Agency offers them some patent protections so they can recoup their investments in the drugs.
In 2009, Philadelphia-based company, URL Pharma, which is thus far the only company that has tested colchicine and submitted an application for FDA approval, was granted the exclusive rights, for three years, to market colchicine as a treatment for gout attacks. The company was also granted the right to be the sole supplier of colchicine as a treatment for familial Mediterranean fever, a rare disease, for seven years.
Colchicine currently accounts for about 3.5 million prescriptions in the U.S. annually, according to IMS Health.
Pharmacies still carry the unapproved, generic versions of colchicine, but as these versions are forced off the market, at some point, those supplies will dry up.”
URL Pharma Response: This is a factually incorrect statement. There is no “generic version” of colchicine. The author is incorrectly characterizing illegal, unapproved, colchicine products as generics, despite the fact that we provided him with information demonstrating that unapproved colchicine products are not generic. Generic drugs have been reviewed and approved by the FDA. Unapproved drugs are illegal. Unapproved colchicine products lack FDA controls on potentially toxic impurities, sources of raw material, labeling to warn about drug-drug interactions, dosage adjustments to implement in the face of drug-drug interactions, and manufacturing and chemistry controls.
A March 3, 2010 letter from the FDA’s Center for Drug Evaluation and Research (CDER) states, “Of important note, the colchicine products you are referring to in your communication to FDA are not “generic” drugs. By definition, generic drugs are those evaluated and approved by FDA to demonstrate bioequivalence to a brand name reference product. Healthcare professionals and consumers can be assured that FDA-approved generic drug products have met the same quality, strength, purity and stability as brand-name drugs. Additionally, the generic manufacturing, packaging, and testing sites must meet the same quality standards as those of brand-name drugs. These colchicine products have not been evaluated and approved by FDA. They are unapproved drugs, not generic medications, and neither their safety nor their efficacy can be assured.”
Arthritis Today: “When that happens, the price of colchicine is expected to soar from about $.10 to $5 per tablet.
The steep increase of Colcrys has alarmed both patients with these diseases and the rheumatologists who treat them.”
URL Pharma Response: The price of Colcrys has remained the same since it became available last year. Additionally, the price of a safe, legal, FDA-approved drug such as Colcrys, backed by research, discovery, and the financial risks and intellectual commitment to achieve such advancements, cannot be compared to that of an illegal, unapproved product. We have made numerous significant discoveries that greatly enhance the safe and appropriate use of colchicine. And our Co-Pay Assistance and Patient Assistance Programs make Colcrys easily affordable to all patients. The only patients who are not covered are individuals with income above 600% of the Federal Poverty Level who have chosen to not purchase health insurance. Additionally, the neediest patients can receive Colcrys free of charge.
Arthritis Today: “’Rheumatologists are incensed – there’s anger out there,’ says Edward Herzig, MD, an Ohio rheumatologist who treats Lewis.
In response to the price uproar, URL Pharma points out that their testing of colchicine revealed that lower doses were equally effective as the dose commonly prescribed by doctors.
The company also points to newly-identified drug interactions between colchicine and some kinds of antibiotics and antifungal drugs, which might not have been identified without its research.
The company also promised to expand its patient assistance and co-pay programs, which, the company says, should make Colcrys affordable to all.
Nevertheless, the American College of Rheumatology in January said it asked the FDA to prolong the typical ‘grace period’ of one year before forcing other colchicine makers to halt production. Read the ACRs letter to the FDA here.”
URL Pharma Response: There has been a lack of transparency around this issue. If you would like to get the full story behind the ACR’s efforts, then please click here to read the series of letters among ACR, FDA, and URL Pharma.
Arthritis Today: “’The fact [URL Pharma] did safety studies is to be applauded,’ says Dr. Herzig, adding that some return on investment is appropriate. But he says that at $5 a pill, ‘my personal belief is that it’s gouging.'”
URL Pharma Response: This doctor has no basis for his judgment about the price of Colcrys. He has no knowledge of the resources that were committed to these new discoveries for Colcrys that will benefit patients for years to come, nor has he any knowledge of the risks or costs of our studies for other research and development programs that were not successful but nonetheless required significant investment. Furthermore, URL Pharma is spending tens of millions of dollars to educate physicians about these discoveries so that physicians can change their usage of colchicine for the benefit of patients.
Arthritis Today: “Currently, some patients have been forced to go to several pharmacies to get the cheaper drug, says Chris Morris, MD, a Kingsport, Tenn., rheumatologist.
Stanley Cohen, MD, president of the American College of Rheumatology, says the company appears willing to listen to physician concerns about the cost of Colcrys. Yet Dr. Cohen adds that he believes the FDA “was not prepared for the unintended consequences” of having just one company control the colchicine market.
FDA spokeswoman Karen Riley said the agency does not address pricing issues. ‘We took action on colchicine to ensure that what was on the market had been reviewed for safety and effectiveness,’ she said recently. Read the FDA’s response to the price increase here.
But other experts say the FDA should be concerned about the price impact.
In ‘The Curious Case of Colchicine,’ a Perspective published online on April 14, 2010 in the New England Journal of Medicine, Aaron S. Kesselheim, MD, and Daniel Solomon, MD, both of Brigham and Women’s Hospital, in Boston, said that reward to drug companies for testing older drugs appears to be out of proportion to their level of investment with ‘no evidence of any meaningful improvement to the public health.'”
URL Pharma Response: The NEJM Perspective cited in this article was filled with inaccuracies and false statements. Please click here to learn the truth about that Perspective.
Arthritis Today: “‘An alternative solution,’ they wrote, ‘probably much less expensive, would be for the FDA or the National Institutes of Health to fund trials that address outstanding questions related to widely available drugs such as colchcine.’ Read the full editorial.
URL Pharma Response: The authors of the NEJM Perspective made an interesting and bizarre contradiction to the major theme of their entire Perspective when they suggested that the government should have done these studies instead of URL Pharma. Throughout the Perspective, the authors claimed that nothing new was discovered by us for colchicine. But then the authors stated that the government should “fund trials that address outstanding questions related to…drugs such as colchicine.” If we did not make new discoveries then how could there have been “outstanding questions”?
The FDA highlighted our discoveries and their positive impact on public health in their March 3, 2010 letter, stating that “…as part of the approval process, the sponsor of Colcrys submitted data from a clinical trial to evaluate the safety and efficacy of a low-dose regimen of oral colchicine for treatment of acute gout flares compared to the traditional high-dose regimen… the rate of gastrointestinal adverse events (diarrhea, nausea, vomiting, abdominal pain) was considerably lower in low-dose patients (26%) compared to high-dose patients (77%). Further, there were no severe adverse events reported in low-dose patients compared to 10 reported in high-dose patients. These findings suggest that prior use of high-dose colchicine may have exposed patients to increased toxicity with no greater efficacy than the low-dose regimen.
FDA is highlighting these important safety considerations in the approved prescribing information to help ensure safe use of Colcrys. Without this review by FDA, outdated assumptions of what is safe and effective for treatment with oral colchicine would have remained unchecked, and patients would have continued to suffer from adverse reactions such as severe gastro-intestinal complications — and even death — needlessly.”
Arthritis Today: “Meanwhile, Kindle Horton of Jonesborough, Tenn., says the higher price is likely to lessen access to colchicine for many people with familial Mediterranean fever.”
URL Pharma Response: The Colcrys PAP assures that everyone who needs Colcrys will have access to it.
Arthritis Today: “Horton, 29, was diagnosed with the disease after years of misdiagnosis and devastating pain and weakness. The disease is a rare, inherited disorder that produces recurrent fevers and painful inflammation of the abdomen, lungs and joints.”
“The colchicine gave me my life back,” she says.
Horton is now taking an older version. The eventual switch to Colcrys will increase her health insurance costs, she says. “This is horrible that you take away something that can help people,” she says. “This is a huge, huge issue, especially since we are supposed to be reforming health care.”
URL Pharma Response: Our PAP is well-aligned with the goals of healthcare reform. The program ensures that people who need Colcrys are able to obtain it and eliminates financial barriers to access. Additionally, patients who are in greatest financial need can obtain Colcrys free of charge.
Arthritis Today: “URL Pharma, which as a privately held firm does not publicly disclose its financial information, says that improving its patient assistance program should make Colcrys affordable to everyone without insurance.
A patient in a family of four making up to $132,000 a year will now qualify to pay, on a sliding scale, from $5 to $25 for a month’s supply of Colcrys, the company said. In addition, people with health insurance can qualify for a $25 co-pay plan.”
URL Pharma Response: As of April 27, 2010, we have further expanded our PAP so that patients with incomes of less than $66,000 per year for a family of four can get Colcrys for free. Please click here if you would like to learn more about our PAP.
Arthritis Today: “’We want to make sure people get access to Colcrys,’ says Matthew Davis, MD, the chief medical officer for URL Pharma.”
Still, Nancy Sparks Morrison, who has familial Mediterranean fever, wants to see how the new pricing plays out with her Medicare Part D plan. Morrison, 71, of Cross Lanes, W.Va., who blogs on familial Mediterranean fever and monitors a support group on the condition, now orders colchicine from Canada, paying $100 for 200 pills. She says she may run into the Medicare Part D doughnut hole after a few months – and pay a lot more for her drugs – if she starts taking brand-name Colcrys.
URL Pharma Response: This will not happen if Ms. Morrison enrolls in our PAP. Under our PAP, the cost of FDA-approved Colcrys is less than what Ms. Morrison is paying for her drug from Canada and it will not affect her Medicare Part D “doughnut hole” at all.
Arthritis Today: “Before this year, Morrison says, most patients were paying 10 cents a pill for colchicine. ‘People are worried,’ she says. ‘A lot of folks are ordering it from Canada or Israel.'”
URL Pharma Response: There is no need for patients to worry or to risk the uncertainties of getting their medication overseas. URL Pharma is committed to ensuring that patients who can benefit from Colcrys are able to obtain it without barriers to access.