Patients Wrestle With Extreme Cost of Arthritis Medications

The first national investigation of Medicare coverage of biologic disease modifying drugs (DMARDs) found that in starting a single biologic DMARD, patients face more than $2,700 in copayments each year before receiving relief from catastrophic coverage. Results published in Arthritis & Rheumatology, a journal of the American College of Rheumatology (ACR), show that during the initial phase of coverage, most people are expected to pay a striking 29.6% of total biologic drugs costs (just under one-third) out-of-pocket, creating an enormous financial burden for patients with chronic, rheumatic diseases such as rheumatoid arthritis (RA).

American College of Rheumatology - Arthritis & Rheumatism - Arthritis Care & Research

RA is a chronic autoimmune disease affecting 1.3 million Americans. Medical evidence shows that until the late 1990s, one in three RA patients were permanently disabled within five years of disease onset. Over the last decade there has been significant improvement in treatment, with disease control now possible for many RA patients who receive early, aggressive DMARD therapy.

Treatment with DMARDs is now a standard component of guideline-based care with costs for some the newer drugs topping $20,000 annually. In fact, a recent report by GBI Research estimates that the U.S. market for RA treatment will increase from $6.4 billion in 2013 to $9.3 billion by 2020, driven in part by the increase in RA prevalence–forecasted to reach 1.68 million by 2020.

Regardless of the biologic DMARD, the study found that patients face high initial copayments, then fall into the coverage gap or “donut hole” by February or March. During the donut hole, patients’ cost-sharing increases to 45% of drug costs (for 2015) until they reach catastrophic coverage. Patients generally reach catastrophic coverage between January and July. After that taxpayers, insurers and pharmaceutical companies will pick up 95% of the cost of the biologic DMARD.

A previous study of 1,100 adults with RA found that 1 in 6 decreased their medication because of cost. “While specialty DMARDs have improved the lives of those with chronic diseases like RA, many patients face a growing and unacceptable financial burden for access to treatment,” said Dr. Jinoos Yazdany with the Division of Rheumatology at the University of California, San Francisco and lead author of the present study. “Rather than determining which drug is best for the patient, we find ourselves making treatment decisions based on whether patients can afford drugs,” adds Dr. Yazdany.

The study team analyzed the drug lists (formularies) of 2,737 Medicare Part D plans in 50 states and Washington, DC using the January 2013 Centers for Medicare and Medicaid Services Prescription Drug Plan Formulary and Pharmacy Network Files. Researchers included DMARDS based on the 2012 ACR RA guidelines and the National Committee for Quality Assurance’s DMARD quality measure. Nine biologic medications (abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab) and nine non-biologic DMARDs (azathioprine, cuprimine, cyclophosphamide, cyclosporine, hydroxychloroquine, leflunomide, methotrexate, minocycline, and sulfasalazine were analyzed.

Nationwide, although nearly all Part D plans covered at least 1 biologic DMARD, access was tightly controlled, with 95% of plans requiring prior authorization. Between 81% and 100% of plans required a coinsurance averaging 30% of the drug cost rather than a fixed copayment amount.

“Insurance payment reforms have been suggested by the US government, but are not widely implemented in the health care system,” notes Dr. Yazdany. “With the high cost of biologic DMARDS for RA, many patients are strapped with a substantial financial burden. Americans, especially those patients with chronic conditions such as RA, may be better served by payment and drug coverage reforms that look to decrease rising out-of-pocket costs for patients while keeping total costs in check.”

-MFP News Services
- 7/30/15

‘Good Bacteria’ v ‘Bad Bacteria’ :Dawn of Helpful Immune Cells

The body’s immune system may be the keeper of a healthy gut microbiota, report University of Chicago scientists recently in the journal Immunity. They found that a single binding protein on white blood cells could affect whether or not mice produced a balanced gut microbiota. Without the protein, harmful bacteria were more easily able to cause infection. Why this happens is unclear, but it may be that the immune system has a way to sense the presence of invading intestinal bacteria.

University of Chicago

“Our study reveals how our body’s immune system shapes the gut microbiota to naturally limit infections,” says senior author Yang-Xin Fu, a professor in the University of Chicago Department of Pathology. “Given the rapid rise of harmful bacteria that are resistant to antibiotics, it is paramount that scientists find methods of limiting harmful bacterial infections without the use of antibiotics. For future patients who are infected with harmful bacteria, it might be beneficial to promote the development of good gut microbiota to indirectly kill harmful bacteria, instead of using antibiotics.”

Fu and his collaborators found that intestinal immune cells–called type 3 innate lymphoid cells (ILC3s)–are less able to respond to harmful bacterial infections when they lack a protein called Id2. ILC3s that lacked Id2 were unable to produce a molecule called IL-22 that subsequently stimulates other intestinal cells to produce antimicrobial peptides (AMPs), which help protect the body against pathogenic infections. Notably, normal bacteria seem to be more resistant to AMPs.

When the team transferred microbiota from a mouse with such dysfunctional ILC3s into a completely germ-free mouse, the recipient animal was highly susceptible to infections when later exposed to harmful bacteria. Germ-free mice that received microbiota from animals with functional ILC3s could fight off the bacteria.

How immune cells distinguish between beneficial and harmful bacteria to maintain a healthy microbiota is unknown, although pathogens might produce some molecules that immune cells can sense. After invasion, it has been observed that ILC3s produce higher levels of antimicrobial peptides.

Fu notes that the human body and its microbiota have evolved to live in harmony over millions of years. “This mutually beneficial relationship provides us with the ability to properly receive all of the nutrients from our food, and as shown with this study, the ability to limit harmful bacterial infections,” he says.

-MFP News Services
- 7/29/15

Soccer used to promote Circumcision “Hits the Back of the Net” in Africa

By Ed Susman

Vancouver, BC – In the African nation of Zimbabwe where HIV infection is prevalent and where soccer is almost a religion, sports stars have successfully teamed up with a non-governmental agency to promote male circumcision among the nation’s youth, researchers reported here.

In the randomized, clinical trial, 12.2% of the young men and adolescents in a sport counselling group underwent circumcision compared with 4.6% of the group of young men assigned to usual care (P=0.02), reported Rebecca Hershow, of Grassroots Soccer, based in Cape Town, South Africa, and colleagues.

“Despite progress in supply scale-up, Zimbabwe is falling short of its target of 80% voluntary male medical circumcision,” Hershow’s group wrote in their poster presentation at the International AIDS Society meeting. Hershow is a doctoral candidate at the University of North Carolina at Chapel Hill.

North Carolina State University

North Carolina Chapel Hill

Hershow noted that trials have shown that voluntary male medical circumcision (VMMC) reduces female-to-male transmission of HIV by 50%-60%. Mathematical modelers from the various global health agencies estimate that, between 2011 and 2025, more than 3.3 million new HIV infections — including 570,000 in Zimbabwe alone — could be averted through increased scale-up and uptake of voluntary male medical circumcision.

The “Make the Cut” intervention has circumcised “coaches” promote voluntary male medical circumcision among male students, ages 14-19, in secondary schools in Bulawayo, Zimbabwe. It consists of a 60-minute soccer-themed educational session and logistical, behavioral reinforcement.

“This study provides strong evidence of ‘Make the Cut’ effectiveness and acceptability in Bulawayo schools. Findings highlight the coach-participant relationship as a key factor in increasing participants’ motivation to undergo voluntary male medical circumcision,” Hershow’s group concluded.

The intervention was performed on a soccer field with a goal keeper assigned to prevent the players from scoring. In the first round, the goal keeper represented an uncircumcised man who did not use condoms. The goal mouth was set at 6 m (about 20 ft) across. Most players were able to score a goal, demonstrating the high HIV risk associated with being uncircumcised and having unprotected sex.

In round two, the goalkeeper represented circumcised man who did not use condoms. The goal mouth was shrunk to 2 m (about 7 ft) across. Fewer players scored, demonstrating the reduced HIV risk once circumcised.

Finally, in round three the goalkeeper represented a circumcised man who used condoms consistently; the goalkeeper could bring in his teammates to help protect the goal, representing condom use. Almost no players scored a goal, demonstrating the dual protection of circumcision and consistent condom use.

The game was followed by discussions with coaches who describe their own circumcision story, including aspects of pain, recovery, and return to regular sexual activity.

After the session, participants received phone-based follow-up by coaches to arrange free transport to the circumcision clinic, coach accompaniment to the clinic, and soccer-based incentives valued at $5.

For the study, Hershow and colleagues enrolled 552 adolescent males to the intervention and recruited 640 adolescent males from 26 schools to act as controls.

Hershow said that most of the “Make the Cut” participants recalled the educational session in detail, citing increases in knowledge of dual benefits of voluntary male medical circumcision and condom use.

“I learned that by circumcising you reduce the chances of contracting HIV, sexually transmitted disease, but it doesn’t mean that you don’t have to use protection,” one circumcised participant reported.

The participants also expressed appreciation for their coaches, particularly their coaches’ openness and honesty when discussing circumcision. “To have someone who can actually tell you about circumcision was interesting, because all my life I have never had someone who can tell me about things, and for him to be open like that meant a lot,” reported another participant in the study who was later circumcised.

While the participants were pleased with the follow-up phone call from the coaches as well as being accompanied by coaches to appointments, their reactions were mixed to the incentives.

“Some participants felt incentives increased their motivation to go for VMMC, while others felt that the Coach’s Story was the most important motivating factor,” the authors explained.

Sharon Lewin, PhD, professor of medicine and director of the Peter Doherty Institute for Infection and Immunity, at the University of Melbourne in Australia, called “Make the Cut” a “very clever program.”

“This is a brilliant way of promoting male circumcision among the youth of a country such as Zimbabwe. Using these methods of visualization provides peer-to-peer education and that can be very effective,” she concluded.

- 7/24/15