Arthritis News and Treatment
For the Treatment of Rheumatoid Arthritis, Surveyed European Rheumatologists Expect Well-Established TNF-Alpha Inhibitors to Lose Considerable Patient Share to Newer Agents in This Drug Class
Enbrel, Humira and Remicade Will Lose Patient Share Through 2013, According to a New Report from Decision Resources
BURLINGTON, Mass., Oct. 14 /PRNewswire/ — Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, between 2010 and 2013, surveyed European rheumatologists expect well-established TNF-alpha inhibitors to lose considerable patient share to newer agents in this drug class, most notably Centocor Ortho Biotech/Merck/Mitsubishi Tanabe/Janssen’s Simponi and UCB/Otsuka’s Cimzia. The increased use of newer agents such as Simponi and Cimzia will most likely occur in newly diagnosed patients and/or in patients who do not respond to initial treatment with a biologic agent.
The new European Physician & Payer Forum report entitled Rheumatoid Arthritis in Europe: How Are Physicians and Payers Responding to an Expanding Arsenal of Biologic Agents? finds that the well-entrenched TNF-alpha inhibitors that stand to lose patient share include Amgen/Pfizer/Takeda’s Enbrel, Abbott/Eisai’s Humira and Centocor Ortho Biotech/Merck/Mitsubishi Tanabe’s Remicade. Surveyed European rheumatologists expect a particularly substantial decline by 2013 in the in-class patient share of Remicade — the only currently marketed intravenous (IV) TNF-alpha inhibitor.
“However, Remicade’s lost patient share among TNF-alpha inhibitors will not be fully replaced by uptake of Simponi IV,” said Decision Resources Analyst Martin Quinn. “Additionally, considerably more physicians from France, Germany, Spain and the United Kingdom expect to prescribe subcutaneous Simponi than expect to prescribe Simponi IV. This trend will be least pronounced in Italy, where rheumatologists report high patient share for Remicade.”
The report findings also suggest that the opportunity to gain patient share is set to increase for recently launched and emerging biologics with alternative mechanisms of action. These agents include Bristol-Myers Squibb’s Orencia, Roche/Chugai’s RoActemra and Genmab/GlaxoSmithKline’s Arzerra. Most notably, surveyed rheumatologists from France, Italy, and Spain predict that at least 40 percent of their patients treated with TNF-alpha inhibitors will receive a subsequent biologic with an alternative mechanism of action by the end of 2013.
The report also finds that patient cost-sharing for rheumatoid arthritis drugs does not pose a significant barrier to treatment for patients in France, Germany, Italy, Spain and the United Kingdom. For example, because patients with severe progressive rheumatoid arthritis in France make no out-of-pocket payments for biologics, private insurers — most of whom cover only out-of-pocket costs — do not play a central role in determining access to rheumatoid arthritis drugs.
The report is based on a survey of 250 rheumatologists from Germany (50), France (50), Italy (51), Spain (50) and the United Kingdom (50) and interviews with 16 European payers from Germany (3), France (3), Italy (4), Spain (3) and the United Kingdom (3).
Doctors, patients eagerly await new rheumatoid arthritis medicines
At first, Maria Perez couldn’t identify the severe pain that gripped her in her mid-30s, but she knew it wasn’t routine. She wondered if she had a hand sprain, considered surgery, and then discovered she had rheumatoid arthritis, a debilitating autoimmune disease that attacks a patient’s joints and vital organs.
“There were days when I could not even lift my leg. Like if I were to get out of bed and I were to put my foot on the floor, it would be the most incredible sharp pain up my leg,” said the 40-year-old New Jersey resident. “There were some days when I was just bedridden. I couldn’t be active at all.”
Perez got her life back when she began injecting Humira into her leg once every two weeks. Humira, a drug produced by North Chicago-based Abbott Laboratories, completely eliminated her pain, allowing her to take up new activities like kickboxing and walking her dog. But Perez said she would eagerly drop the injectable drug if she could find a pill that accomplished the same thing.
In several years, a new generation of drugs might give her that option and challenge Humira’s blockbuster status. Humira is in a class of genetically engineered pharmaceuticals known as “biologics,” which have changed the face of treatment for rheumatoid arthritis. Since the Food and Drug Administration approved it in 2002, Humira has been helping patients like Perez manage the disease and increase quality of life. In turn, the drug has evolved into a prominent cash cow for Abbott. This year alone, the drug is expected to rack up $6 billion in sales.
Now, researchers are looking to new remedies that could revolutionize treatment again. Oral drugs called JAK-inhibitors, aimed at blocking the parts of the immune system that perpetuate rheumatoid arthritis, are in the third phase of testing by Pfizer Inc. and Eli Lilly and Co. Rebecca Bader, a researcher with Syracuse University, said an oral medication will likely become the preferred medication for patients.
“If you can find something that’s administered easier, that’s a good thing for the customer,” said Bader. “I think anything that’s taken orally is better.”
Abbott spokeswoman DeAnna DuBose said the company also has an oral drug in preliminary development, but downplays the negative effects these new drugs might have on Humira. She noted that Humira is used by more than 500,000 patients worldwide for rheumatoid arthritis and other diseases and conditions, including Crohn’s, psoriasis and ankylosing spondylitis. The company also points out that Humira has undergone years of trials and patient use, and is well-positioned to remain a front-runner in rheumatoid arthritis treatment.
One percent of the U.S. population is affected by rheumatoid arthritis. Most people are diagnosed when they are middle-aged, according to researchers, but it also affects juveniles and the elderly. Several treatments exist for rheumatoid arthritis including painkillers, anti-inflammatory drugs and immune suppressants in addition to injectable biologics.
Dr. Nathan Wei of the Arthritis Treatment Center in Maryland, has been part of the research trials of the JAK-inhibitor drugs. He said the new drugs are as effective as the injectable ones on the market today. Wei said his biggest concerns are side effects, including decreased white blood cell count, elevated lipids levels, possible effects on kidney function and possibly elevated blood pressure. A Pfizer representative said the company’s drug has not yet been approved by the Food and Drug Administration and is still several years away from the market. Still, Wei has high hopes for these drugs.
I think they will change the landscape [of rheumatoid arthritis treatment], I do strongly believe that,” said Wei. “But in what way, it’s hard to say right now.”
If the drugs hit the market, they won’t become widely used immediately. For this reason, Sara Michelmore, a financial analyst at Cowan Financial Group, thinks companies like Abbott will not be seriously affected by the new drugs for a prolonged period.
“That’s several years away before there’s any significant impact,” Michelmore said. “They [doctors] are very unlikely to substitute a drug like Humira.”
Perez said she’s more than happy to take the injections as long as she must, but she is eager to simplify her life by switching to a pill. She hopes one day she’ll be able to plan airline flights without worrying about missing her scheduled doses and be able to carry her medication in her purse rather than storing it in a refrigerator.