Cautionary tales: biosimilar facts, evidence, and verifiable data

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We all have pet peeves. My particular bete noire is fed constantly by LinkedIn. I work in health economics and policy within the context of medical decision making. As a journalist, I am pulled in by the title of a breaking story. I target Google Alerts for content I am developing, specific talks I am preparing, or just to keep the expertise in top order.

Herein lies the problem. The headline is not a credible source of information. Hitting "share" on a story you have not read or do not understand is problematic and reflects poorly on your judgement. If you are a medical writer, journalist, or pharmaceutical stakeholder--that is your brand. If you are a consumer of medical information--it could be your health.

To prove a point, let's look at an abstract presented June 10, 2016 at European League Against Rheumatism (EULAR) Congress 2016. Abstract OP0225. 

The article circulating on LinkedIn reporting on this very abstract had the headline "Inflammatory Arthritis Stable After Switch to Biosimilar".

• The measure of stability is not indicated and the specific biosimilar being investigated is omitted from the headline.
• When you read further, the disease activity (DAS28) is the reported measure, in addition to the health assessment questionnaire (HAQ)--not a measure known to change in the short-term, CRP--inflammatory measure of disease progress, and visual analogue scale (VAS) patient global.
• 45 patients (7%) stopped biosimilar treatment during follow up due to adverse event (16), lack of effect (20), remission (3), cancer (2), other (4). Prior to the switch these pateints had been on treatment 5.9 years (3.5-9.1).
• "This warrents further investigation before such a non-medical switch can be recommended"-- authors 

If we are indeed communicators with a single objective of improving outcomes in patients seeking care within an evolving healthcare ecosystem we need to do a better job.

Suggested news stories of relevance and immediate importance should include:

Is there a difference between a biosimilar and a biologic?

1. Section 351(i) defines biosimilarity to mean “that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”--Guidance document for biosimilar labeling (did you notice the ommission of efficacy?)

You will notice in news stories that the distinction between biosimilar and interchangeable is not made clearly. Interchangeable refers to a biosimilar that meets and additional standards as defined below.

1.  To meet the standard for interchangeability, an applicant must provide sufficient information to demonstrate biosimilarity and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch (see section 351(k)(4) of the PHS Act). Interchangeable products may be substituted for the reference product without the intervention of the prescribing health care provider (see section 351(i)(3) of the PHS Act). 

 I have also noticed sloppy reporting where biosimilars are compared to generics. This is not the case --even if we consider the policy changes that help drive the distinction.

So back to our vague and misleading headline--"Inflammatory Arthritis Stable After Switch to Biosimilar".

Mention the specific marker for stability (CRP is an inflammatory marker indicative of disease activity)--CRP has actually increased--what is the significance of this finding? Should HAQ be able to detect a difference in 3 months?

This is a non-medical switch meaning the patients were stable on Remicade. Do we really want physicians to switch their patients that are responding to their current therapies? The reason provided for switching was purely economical. Where is the cost data? Did it reflect the downstream implications and cost for the 42 patients that had to stop the treatment early? What were their outcomes?

DAS28 stable in patients with inflammatory arthritis after 3 month switch to inflixumab biosimilar would be small nudge but a big shift in the accuracy of what was actually investigated.

Thoughtful discussions about content development and outcomes analytics that apply the principles and frameworks of health policy and economics to persistent and perplexing health and health care problems...