Biosimilar utilization initiation increased from a baseline of 1% in June 2019 to 96% by February 2021 among eligible patients; 20% of all patients (n-98) had insurance which preferred originator product
Estimated cost savings over the project duration were nearly $381,000 (average sales price) over the 20 month study
My take: The introduction of biosimilars have resulted in huge cost savings. In addition, for infliximab, the originator product price has also dropped substantially (more than 60% in some locations)
Methods: This was a prospective multicenter cohort study of adult IBD patients (n=176) who underwent 2 switches from the originator IFX to CT-P13 to SB2 (group 1), 1 switch from CT-P13 to SB2 (group 2), and 1 switch from the originator IFX to CT-P13 (group 3).
At 12 months after the most recent switch 76.9% (40 of 52, group 1), 65.7% (46 of 70, group 2) and 76.9% (20 of 26, group 3) of patients were in clinical remission. Treatment persistence at 12 months was 85.0%, 87.0%, and 70.1%, respectively.
There were no significant differences in the rate of clinical, CRP, FC remission, or treatment persistence at 12 months between the 3 groups.
My take: This study did not identify detrimental effects from multiple successive switching and switching between biosimilars of IFX. Longer followup and more clinical experience will be needed to confirm these findings.
A recent single-center study (AW Fondell et al. Inflamm Bowel Dis 2020; 26: 635-40, editorial by Joel Rosh, 641-2) examined the first-year costs of children with inflammatory bowel disease (IBD) in 2016. There were 67 patients (43 with Crohn’s disease (CD), and 24 with ulcerative colitis (UC)).
Mean cost was $45,753; $43,095 for CD, $50,516 for UC
Severe CD (n=11) was $71,176 and severe UC (n=5) was $134,178; it is notable that only one patient with CD had surgery and only one patient with UC had surgery.
69% of CD patients and 33% of UC patients received biologics
21% (n=9) of CD patients and 45% (n=11) of UC patients were hospitalized
Private payer reimbursement was a mean of $51,269 compared to $24,610 mean for Medicaid.
In any cost analysis, many assumptions are needed. For medications, for example, the author used pharmaceutical retail prices. The actual costs are near-impossible to calculate as every insurance policy and every hospital system has a multitude of charges based on proprietary negotiations.
While this data comes from a referral center, all of the patients in the study were from Connecticut.
Due to the expense of care, Dr. Rosh points out that many insurers have often mandated the use of “standard dosing” of biologic therapy, “ignoring that robust data” indicate that this dosing is “the exception rather than the rule in pediatric IBD patients.” These type of short-sighted interventions could affect long-term medical outcomes.
My take: There clearly are areas where costs can be reduced (eg. lower infusion costs, lower endoscopy costs, biosimilars). However, no amount of cost cutting will change the conclusion that good care for IBD is expensive.
Briefly noted: TS Kafil et al. Inflamm Bowel Dis 2020; 26: 502-9. This study examined evidence for cannabis effectiveness in IBD. After performing a literature search, the authors could only identify five randomized controlled trials (n=185). Each study used different doses, formulations and routes of administration. No studies evaluated maintenance treatment and relapse in CD or UC. Findings: “no firm conclusions can be made regarding the safety and effectiveness of cannabis and cannabionoids in adults with CD and UC.”
A recent study (LE Targownik, EI Benchimol, J Witt et al. Inflamm Bowel Dis 2019; 25: 1718-28) shows that direct health care costs are increased with anti-TNF therapy.
In this retrospective study using the Manitoba IBD Database, the authors examined the direct costs associated with anti-TNF therapy initiation in 928 patients (676 CD, 252 UC). Only 84 subjects were <18 years.
The median costs for health care in the year of anti-TNF initiation increased compared to prior year. In year prior to initiation, median costs were $4698 for CD and $6364 for UC; in the first year of anti-TNF treatment, costs rose to $39,749 and $49,327 respectively.
Costs remained elevated through 5 years of anti-TNF therapy for continuous users with total median of $210,956 and $245,260 respectively
There were reductions in non-drug costs. Inpatient and outpatient costs decreased in the year after anti-TNF initiation by 12% and 7% respectively, when excluding the costs of anti-TNFs. These observed savings are considerably less than the medication expenditures.
Costs for medications are likely to improve with the introduction of biosimilars. Currently these are being used mainly in persons with a new diagnosis due to reticence to switch from originator product in established patients.
The authors note that costs were overall higher with infliximab (IFX) than adalimumab (ADA) though “it is possible that patients with higher-severity disease are channeled toward IFX over ADA.”
Indirect costs like ability to go to work and achieve educational potential could offset some of the direct costs. In a prior study in the U.S., ADA treatment was estimated to reduce indirect costs of “nearly $11,000 per person treated.”
Some costs were not measured in the study including emergency room visits, over the counter medications and alternative health care use.
This was not a randomized study; thus, it is impossible to know what costs of persons with similar disease who were untreated would have been.
My take: This study shows that saving money is not the main reason to use anti-TNF therapies; rather, their effects on improved health and fewer complications.
A recent study (DY Graham, A Tansel. Clin Gastroenterol Hepatol 2018; 16: 800-808) analyzed 56 randomized trials to determine relative potency of proton pump inhibitors (PPIs) based on time in which intragastric pH was 4 or less (pH4time).
Pantoprazole 20 mg was equivalent to 4.5 mg of omeprazole
Lansoprazole 15 mg was equivalent to 13.5 mg of omeprazole
Esomeprazole 20 mg was equivalent to 32 mg of omeprazole
Rabeprazole 20 mg was equivalent to 36 mg of omeprazole
The authors note that peak effectiveness for PPIs was at ‘approximately 70 mg of omeprazole equivalents’. In addition, they state that twice a day dosing was more effective than increasing once a day dosing; however, three times a day dosing was not more effective than twice a day. “Dexlansoprazole, a quasi-twice-a-day formulation produced similar acid suppression to the lowest twice-daily PPI regimen and 20 mg vonoprazan once daily provided similar efficacy aas high-dose twice-daily PPI.” The authors also compare costs; generics of pantoprazole, omeprazole, and esomeprazole cost as little as $0.02-0.04 per omeprazole equivalent. Thus, 20 mg of omeprazole would be as little as 40 cents.
My take: Using the lowest effective dose of a PPI is recommended. In patients needing higher dosing or with suboptimal response to acid suppression, this data can be very helpful.
The average biologic-taking patient accounted for $25 275 PMPY in 2007 and $36 051 PMPY in 2015. The average paediatric biologic-taking patient accounted for $23 616 PMPY in 2007 and $41 109 PMPY in 2015. In all patients, the share of costs for biologics increased from 72.9% in 2007 to 85.7% in 2015 (81.7% in 2007 to 94.9% in 2015 in paediatrics).
The vast majority of costs allocated to out-patient IBD medications in the USA is attributed to increasing use of biologic therapies despite the relative minority of biologic-taking patients.
My take: Biologic therapies are costly but also very effective.
Two articles highlight the upside and downside of retail clinics.
Iglehart JK. NEJM 2015; 301-3
Chang JE et al. NEJM 2015; 382-8
Currently, there are ~1900 retail clinics with four main ‘players:’ CVS, Walgreens, Kroger, and Target. However, Target has recently made a deal with CVS and Walmart is expanding into retail clinics as well. Almost all of these clinics accept private insurance and medicare; growing numbers accept medicaid too.
Retail clinics offer a limited scope of care and typically are staffed by midlevel providers (nurse practitioners or physician assistants). In contrast, urgent cares offer more complex services and typically are staffed by physicians.
For consumers, the key advantages of retail clinics: lower costs with transparent pricing, convenience due to extended hours and locations, and often short wait times.
Potential disruption in longitudinal care (“medical home”)
What about quality?
“Research has not found that retail clinics deliver poor quality care, overprescribe antibiotics, or adversely impact delivery of preventive care.”
Do Retail Clinics Enhance Access?
Yes but these clinics are disproportionately located in areas with relatively high income. Nevertheless, “approximately 61% of retail-clinic visits and 37% of urgent care visits involve patients without a primary care provider.”
“One study …showed that patients did properly self-triage, with more than 88% of retail-clinic episodes resolved in one visit. Another study showed that 2.3% of retail-clinic patients were triaged to an emergency department or physician’s office.”
Why Would Physicians Oppose These Retail Clinics?
While primary care organizations have raised concerns about quality and continuity of care, a basic economic issue is likely at work as well. “The current reimbursement system renders simple acute health problems high-margin work that can offset losses from treating more complex problems.“
Bottomline: Retail clinics are filling a need for many patients in terms of cost and convenience for simple acute problems.
With the arrival of newer expensive hepatitis C virus (HCV) therapies, there has been an effort to prove that the costs are within reason. One study (Hepatology 2014; 60: 1187-95) looking at this issue examines the cost of a sustained virological response (SVR) with the previous best therapy: Telaprevir-Based Triple Therapy.
Design: Records from 147 patients who received telaprevir-based triple therapy in 2011 were reviewed.
According to the authors (supported by Gilead Sciences), median cost of care was $83,721 per patient and the median cost per SVR was $189,338. The costs of two of the drugs, telaprevir and pegylated interferon, accounted for 85% of the total costs. Other costs included adverse management (8%), ribavirin (4%), professional fees (2%), and laboratory fees (1%).
The main reason besides pharmaceutical prices for the high costs were the SVR rate of 44%.
Bottomline: If a patient requires HCV therapy, the newer, more effective, expensive agents are likely to compare favorably with the less new, less effective, expensive medications.
Also noted: Hepatology 2014; 60: 1211-21. “WELCOME” Study tested whether 15-18 months of docosahexaenoic acid (DHA) plus eicosapentaenoic acid (EPA) decreased liver fat and histology in nonalcoholic fatty liver disease (NAFLD). n=101, with 51 in treatment group. Findings the DHA+EPA had a “trend toward improvement in liver fat” percentage but no improvement in fibrosis.