Category Archives: Uncategorized

Increasing Cost/Use of Biologic Therapies for Inflammatory Bowel Disease

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As noted in a previous blog post (Changes in the Use of IBD Biologic Therapy), there has been an increased use of biologic therapy early in the course of patient’s with inflammatory bowel disease (IBD). Another retrospective study (H Yu et al AP&T 2018; 47: 364-70 -thanks to Ben Gold for this reference) examines the market share and costs of biologic therapy for IBD using the Truven Marketscan Commercial Claims and Encounters database (2007-2015).  This database consists of out-patient and in-patient pharmaceutical claims of approximately 40-50 million privately insured patients each year from patients from all 50 states (U.S.).

Key findings:

  • Among 415,405 patients with IBD (188,842 with Crohn’s, 195,183 with ulcerative colitis, 31,380 with indeterminate IBD), the proportion using biologics increased over the 9-year period (2007-2015); overall, the market share increase was from 7.1% (2007) to 20.5% (2015).
  • There were 28,797 pediatric patients with IBD (17,296 with Crohn’s, 9368 with ulcerative colitis, and 2133 with indeterminate colitis). The overall market share in pediatric patients was the highest, increasing from 19.1% to 45.9%.
  • For all patients with Crohn’s disease (CD) the proportion receiving biologic therapy increased from 21.8% to 43.8%.  For patients with ulcerative colitis (UC), the proportion increased from 5.1% to 16.2%.
  • Per-member per-year (PMPY) costs increased. “The average biologic-taking patient accounted for $25,275 PMPY in 2007 and $36,051 PMPY in 2015.”  This was similar in the pediatric population, going from $23,616 PMPY in 2007 to $41,109 PMPY in 2015.
  • The share of costs of medicines: the costs of biologics as a share of the total increased from 72.9% in 2007 to 85.7% in 2015. 95% of the pharmacy costs in children with IBD are attributed to biologics.

My take: This trend of increasing use of biologics and their associated costs is going to continue due to their effectiveness. While there are direct costs related to these medications, the net cost is unclear as they can prevent hospitalizations and surgeries. In addition, by helping to spare corticosteroids and increasing response rates, biologic therapies improve quality of life, minimize opportunity loss, and optimize long-term health outcomes.

Bright Angel Trail, Grand Canyon

 

Ketchup Packet Ingestion–Crohn’s Disease Mimic

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In the category of –“I have not seen that before”…

Link: NY Daily News Women diagnosed with Crohn’s disease actually had ketchup packet in her intestines for six years (Thanks to my son for pointing out this story)

An excerpt:

A woman believed she was suffering from Crohn’s disease for six years until doctors performed surgery and discovered a ketchup packet in the lining of her intestine.

The 41-year-old patient had symptoms consistent with the serious bowel disease — including acute abdominal pain and bloating lasting up to three days — but she did not respond to the standard treatments.

Case study reference: Visagan R, et al. BMJ Case Rep 2013. doi:10.1136/bcr-2013-009603

Related blog post: Add it to the list

 

CALM Study: Tight Control Improves Outcomes in Crohn’s Disease

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A recent study (JF Colombel et al. Lancet 2017; http://dx.doi.org/10.1016/S0140-6736(17)32641-7 ) shows that “tight control” improves outcomes in Crohn’s disease.  This study was alluded to in a previous post: CCFA 2017 Updates (part 2)

Background: The CALM study was an open-label, randomized study.  122 adult patients were randomized to typical clinical management and 122 patients received “tight control” in which treatment was modified by fecal calprotectin (≥250 mcg/g) and CRP (≥ 0.5 mg/dL) values in addition to clinical symptoms.

Treatment was escalated in both groups in a stepwise manner.  Initial treatment was with adalimumab induction and then every other week. If patient did not meet treatment objectives, which differed in the groups, then adalimumab would be given every week, and then, if still needed, azathioprine would be added. Interestingly, both groups had ~25% of participants who were smokers which is known to worsen outcomes.

Key Findings:

  • Mucosal healing (CDEIS <4) was significantly improved in tight control group at week 48: 46% vs. 30%.
  • Similarly, steroid-free remission based on CDAI <150 was better in tight control group compared with standard treatment at week 48: 59.8% vs. 39.3%.  Endoscopic response was 50.8% compared with 40.2% respectively.

My take (1st part borrowed from authors): “Tight control of inflammation in patients with Crohn’s disease, with objective markers of disease activity  and clinical symptoms to drive treatment decisions, achieved better endoscopic and clinical outcomes than conventional care based on symptoms alone.” Yet, there are a large number who do not respond adequately and better treatments in these patients are needed.

As an aside, these response rates based on objective markers are far lower than the remission rates claimed by ImproveCareNow; thus, while ImproveCareNow is forward-thinking and helping improve outcomes with inflammatory bowel disease, we need to be careful about citing remission rate trends that are not directly linked to objective markers.

NY Times: Humira’s Best-Selling Drug Formula: Start at a High Price. Go Higher.

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NY Times: Humira’s Best-Selling Drug Formula: Start at a High Price. Go Higher.

An excerpt:

Humira is the best-selling prescription drug in the world…The price of Humira, an anti-inflammatory drug dispensed in an injectable pen, has risen from about $19,000 a year in 2012, to more than $38,000 today, per patient, after rebates, according to SSR Health, a research firm. That’s an increase of 100 percent…

How much you actually pay out of pocket, and whether you can afford Humira at all, depend on your insurance and eligibility for discounts…

Humira, which accounted for nearly two-thirds of AbbVie’s $25.6 billion in revenue in 2016, was not simple to develop. It is among a new class of drugs known as biologics, which are made from living cells rather than synthetic chemicals…

Looking at the international picture tells its own story about drug costs. A prefilled carton with two syringes costs $2,669 in the United States, compared with $1,362 in Britain, $822 in Switzerland and $552 in South Africa…

An analysis by the Institute for Clinical and Economic Review found that Humira’s list price would need to be discounted by at least 55 percent to be cost effective for rheumatoid arthritis, its originally approved use.

Dr. Steven D. Pearson, the founder of the institute, which provides cost benefit data to health plans, said competing drugs were overpriced as well.

“Even in a space like this, where there is a lot of competition, we don’t see the prices coming down,” he said. “That speaks to the fact that it doesn’t often function like a free market usually would.”..

AbbVie joined a few of its rivals in saying it would limit price increases to single digits this year, and so only raised Humira by another 9.7 percent this month, roughly four and a half times the inflation rate. For the drug industry, that counts as generosity.

My take: Humira is a very important and effective medication, particularly for inflammatory bowel disease and rheumatoid arthritis. I infer from this article which compares the Humira pricing strategy to that used by Martin Shkreli that if U.S. consumers are to have more affordable pharmaceuticals, government intervention will be needed. AbbVie, like many other pharmaceutical companies, will continue to aggressively price Humira; after all, 8 billion in profits is not as good as 10 billion.

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Why Stomach Pain Improves in the Summer

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A recent small study (published online: KL Pollard et al. JPGN  doi: 10.1097/MPG.0000000000001886) indicates that the well-recognized phenomenon of improvement in functional abdominal pain during the summer months is associated with lower anxiety.  Here is a link to abstract: Seasonal Association of Pediatric Functional Abdominal Pain Disorders and Anxiety

Excerpt:

Results:

In a sample of 34 participants who completed both questionnaires, 22 reported improvements during the summer months. These participants reported a significantly higher seasonal decrease in anxiety than participants whose children’s symptoms did not improve from spring to summer (mean decrease 2.21 vs 0.08, P = 0.017). Both groups reported equal improvements in sleep and decreased stress from spring to summer. Neither group experienced statistically significant seasonal change in physical activity or fruit, vegetables, dairy, or caffeine consumption.

Conclusions:

This study suggests that amelioration of gastrointestinal symptoms in pediatric patients with AP-FGID during summer months is associated with amelioration of anxiety in the same time period. It is not yet clear whether decreased anxiety is the cause or effect of decreased AP-FGID symptom

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Last Year’s Most Popular Posts

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I want to thank the many people who have helped me with this blog –now with 2180 posts over more than 6 years.  This includes my wife, my colleagues at GICareforKids, and colleagues from across the country who have provided critical feedback as well as useful publications to review.  I hope this blog continues to be a useful resource.

Here are the top dozen most popular blog posts from 2017:

 

Expert Guidance on Pediatric Postoperative Crohn’s Disease

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A recent NASPGHAN clinical report (JB Splawski et al JPGN 2017; 65: 475-86) updates recommendations to lower the rate of postoperative recurrence in pediatric Crohn Disease (CD).  In this report, after review of a number of studies, the authors provide a management algorithm (Figure 1).  In addition, they review risk factors for surgery/postoperative recurrence in CD.

Key points:

  • “Endoscopic recurrence precedes clinical recurrence, and is a better predictor of the risk for future surgery.”
  • “Anti-TNF agents appear to be the most effective treatment in preventing postoperative recurrence.”  These agents “can be started as early as 4 weeks after surgery.”
  • “Prophylactic treatment to prevent recurrence rather than treating after the disease recurs, appears to be more effective in preventing further surgery.”
  • “Early postoperative surveillance for disease recurrence allows for a change in management to prevent complications that may lead to further surgery.” The authors note that fecal calprotectin (and lactoferrin) return to baseline around 2 months after surgery, and “monitoring disease activity postsurgery with these tests may help determine appropriate selection for more invasive testing such as endoscopy.”

My take: The authors emphasize that “whatever treatment is chosen, early surveillance for disease recurrence is clearly needed.”  In addition, anti-TNF agents are most likely to lower risk of further surgery.

Related blog posts:

Silver Bridge, Colorado River, Bright Angel Trail. Grand Canyon

 

Does It Matter How Hard Your Poop Is?

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A recent study (MH Vriesman et al. J Pediatr 2017; 190: 69-73) with 1835 children examined the issue of stool consistency, comparing the Bristol Stool Scale (BSS) and the Questionnaire on Pediatric Gastrontestinal Symptoms-Rome III (QPGS-RIII). Most of the patients in this study were older children, with 803 (43.7%) age 8-12 years and 1032 (56.3%) ≥13 years.

Key findings:

  • Surprisingly (to me) there only slight agreement between BSS and QPGS-RIII for assessing stool consistency (κ = .046; P=.022).
  • With the BSS, hard stools (types 1 & 2) were reported more frequently than QPGS-RIII: 18.0% vs. 7.1%.
  • Both scales reported similar levels of functional constipation, 9.3% for BSS and 8.6% for QPGS-RIII. The presence of hard stools or painful defecation is only 1 of 6 Rome criteria for the diagnosis of functional constipation.

These results indicate significant variability in how often pediatric patients considered their stools hard based on the instrument (BSS vs QPGS-RIII).  The reason why there is fairly close agreement on functional constipation is due to the fact that Rome III criteria combine the presence of hard stools and painful defecation into a single criteria and the fact that there are multiple criteria needed.  “Not all children with hard stools have painful defecation and vice versa, with only 21% of children with painful defecation reporting hard stools.”

My take: This study suggests that painful defecation is more important to ascertain than if the stools are hard. In addition, this may explain why softening the stools as a stand alone strategy is not effective in many children.

Related study: S Muddasani et al. J Pediatr 2017; 190: 74-8.  This retrospective study showed that pelvic floor physical therapy was effective in the majority of children (n=64,mean age 8.7 yrs) with fecal incontinence due to pelvic floor dyssynergia. It is notable that there were only two physical therapists involved; thus, in order to replicate these results, one would need quite capable PTs.

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