Concern Regarding Legislation Allowing Substitution of Biosimilars for Branded Drugs

This article originally appeared here.
Despite the ACA in 2010 that created a pathway for pharmaceutical companies to develop biosimilars, only 4 have earned FDA approval in the last 18 months.
Despite the ACA in 2010 that created a pathway for pharmaceutical companies to develop biosimilars, only 4 have earned FDA approval in the last 18 months.

There are dynamic changes afoot that promise to have an impact on the care of patients with inflammatory polyarthritis. Much concern has been voiced regarding legislation allowing the substitution of biosimilars for branded drugs, and physicians and patients are just becoming aware of the implications of such legislation for patient care.

Despite the Affordable Care Act in 2010 that created a pathway for pharmaceutical companies to develop biosimilars, only 4 have earned US Food and Drug Administration (FDA) approval in the last 18 months. In particular, 3 are approved for a number of indications, which has an impact on the management of autoimmune forms of arthritis, Crohn disease, multiple sclerosis, and psoriasis, among others.

It is vital that rheumatologists effectively communicate the potential drawbacks of biosimilars so that patients become aware of the safety concerns — and theoretical cost benefits — these medications confer. Patient-centered care means that rheumatologists prioritize and understand the management goals of their patients when planning both short and long-term treatment strategies.

Confidence in a New Class of Agents

Biosimilars are not exact replicas of their originator medications, as is the case with generic drugs. Although the FDA has determined that biosimilars will not have "clinically meaningful" differences in terms of safety, purity, and potency from their reference products, there are small, allowable variations in structure, owing to their derivation from living organisms, such as yeast and bacteria. These variations between biologic progenitors and biosimilars allow consideration of biosimilars as therapeutic options for some patients, with appropriate caution needed to protect potential drug recipients.

What is vital in the prescribing of biosimilars is that patients and physicians are directly engaged in the decision to use these medications. Biosimilars may cost less, making them an attractive option, assuming that patients are the beneficiaries of these discounts. To date, however, the existence of a cost-saving benefit is not clear.

If a patient wants to switch medications in the hope of reducing healthcare costs, then rheumatologists can outline a treatment plan that safely and effectively moves a patient from one treatment to another. The importance of a clear and uniform procedure allowing for substitution remains an area of acute concern for prescribing physicians.

Regarding the cost issue, it remains unknown whether savings will accrue to the patient. As things currently stand, it is not unreasonable to expect that an insurance company (or pharmacy benefit manager) might impose a "switch" without notification. For example, Humira (adalimumab) might be switched to biosimilar Amievita (adalimumab-atto).

Should this become standard operating procedure, there could be dangerous implications for patients regarding unforeseen toxicities, including drug reactions and allergies to components of the biosimilar that have not been studied. There are numerous potential unseen costs related to biosimilar substitution in the form of hospitalizations, surgeries, follow-up visits, absenteeism, lost wages, and unemployment. These have yet to be calculated, as models have not been proposed to account for potential unseen costs.

The key issue is consent — whether pharmacists should be required to notify providers and patients when indemnity plans and pharmacy benefit managers request automatic substitution of a biosimilar agent for a branded biologic. A patient-centric policy requires notification of physicians and patients to maintain open lines of communication. Luckily, nearly 30 states have enacted laws that outline the circumstances allowing for the substitution of a biosimilar molecule for a branded biologic. Patient safety should never be compromised for theoretical cost savings.

Cases in Point

Signed into law in December of 2016, new legislation in Ohio requires that pharmacists notify providers about a switch within 5 business days. The Global Healthy Living Foundation, an advocacy organization for people with chronic illnesses, worked with a volunteer patient advocate who testified before her legislators about why biosimilars are a welcome option for patients, but only when the decision to use them is made by the patient and their healthcare provider. Her testimony, and that of other stakeholders, led to passage of the Ohio law.

Pressuring Patients

As biosimilars enter the US market, physicians and patients must protect their independence in the decision-making process, carefully monitoring the landscape for “bargains” that payers may institute in an effort to reduce costs. For example, one such barrier to effective prescribing is the “fail first” policy, in which insurance companies encourage a preferred (read: less expensive) first-line medication for patients with a specific diagnosis. These strategies lead to higher co-pays should patients — and their physicians — prefer to remain on a previously effective medication.

Insurance companies may attempt to enforce biosimilar uptake by pressuring patients to switch medications for reasons other than medical necessity. A 2016 Global Healthy Living Foundation survey in Tennessee found that 58% of chronic disease respondents had their insurance companies make changes to their health plan's formulary in the middle of a plan year.

The effect was to reduce coverage for prescribed medications. This practice is called “non-medicated switching,” and creates a bait-and-switch situation in which consumers purchase a plan but do not receive their desired medications because the insurance company has changed the formulary or added new access restrictions (eg, prior authorization, step therapy, etc).

In the same survey, two-thirds of patients were unable to afford the increase in out-of-pocket prices and were forced to switch to an entirely different medication. When faced with loss of coverage for a currently prescribed medication, nearly half of respondents (49%) reported that their ability to access or obtain the prescribed medication was subsequently delayed.

People with chronic, lifelong diseases like rheumatoid arthritis are at risk for complications — not to mention rising healthcare utilization costs – when insurance companies block access to effective therapies and mandate substitution of ineffective, or potentially dangerous, biosimilar medications.

Patients First

It has been forecasted that the safe and regulated introduction of biosimilars into the market will increase access while reducing costs, potentially paralleling the substitution of generic drugs for branded progenitors (which have been thoroughly studied in the diseases for which they are prescribed). It is easy to understand the motivation of certain payers who are only too eager to switch patients to biosimilar medications. The evolving landscape of biologics and their biosimilars warrants our close attention. Even the slightest difference between a biosimilar and the progenitor biologic it mimics — whether in manufacturing or during the handling process — could have a significant health impact for patients.

From a safety perspective, substitution rules must account for tracking the prescription and its associated biosimilar agent, especially when adverse events are known to occur with these medications. The room for ambiguity is problematic. It may also confound our understanding of drug toxicity.

At the end of the day, cost considerations can never be used to endanger patient welfare. This is the substance of the Hippocratic Oath, requiring physicians to both protect and serve their patients. We should all be vigilant about upholding the highest standard of care, and this cannot be forgotten as the dialogue regarding the role of biosimilar medications becomes louder and closer to home.

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Reference

Tennessee Patient Sentiment toward Non-Medical Drug Switching. Global Healthy Living Foundation. Published online November 28, 2016. Accessed April 14, 2017.

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