Medical Treatments Must Be Made by Providers and Patients

Medical professionals make it their life’s work to make sure patients have access to medicines that will improve their lives. Traditionally, this means diagnosing and treating a medical condition. But sometimes this means battling insurance company policies that run contrary to sound medical practice and have the potential to harm patients. An example of one such policy is a “fail first” requirement that makes it almost impossible for patients to gain access to new, lower cost medicines called biosimilars.

“Fail first” typically occurs when an insurer mandates that a patient should try and fail on a less costly medicine before having access to a more expensive treatment. Under this type of policy, insurance companies are ultimately deciding which treatments patients can or cannot use, rather than the provider who knows his or her patients’ medical profiles the best.

Many commentators have written how these “fail first” tactics are not in the best interests of patients. Think about the patient who must continue to suffer with a disease while being mandated to fail on a treatment deemed un-suitable not by their provider but by their insurance company. Recently, however, these “fail first” tactics have been flipped on their head. Several insurance companies, possibly due to nefarious contracting schemes, are now mandating that patients “fail” on higher priced medicines possibly due to nefarious contracting schemes before providing coverage for highly similar, less costly alternatives. Not only does such a fail first requirement potentially put patients at harm, it now does so in a way that results in higher – not lower – pharmaceutical costs.

Biosimilars are like generic drugs in a sense that they offer affordable options for comparable care. To be approved, a biosimilar must demonstrate that it is highly similar to its original drug with no clinically meaningful differences in terms of safety, purity, and potency. Several insurance companies are now requiring that a patient “fail” on the more expensive brand name TNF inhibitor, used for treatment of such diseases as rheumatoid arthritis, before they will provide coverage for the lower cost biosimilar. It defies logic, but according to one insurer, before a biosimilar will be reimbursed, the following criteria must be met: (i) the patient has tried the brand name TNF inhibitor for at least 14 weeks and the physician must attest that “the clinical response would be expected to be superior with biosimilar…, than experienced with the brand name TNF inhibitor,” or (ii) the patient has a history of intolerance or an adverse event to the brand name TNF inhibitor and the physician attests that “the same intolerance or adverse event would not be expected to occur with the biosimilar.”

The notion that a physician should ever attempt treatment with a biosimilar of its original drug that has already failed to treat the patient’s symptoms is nonsensical as by definition there are no significant differences between the biosimilar and the original drug. In case there was any doubt, recommendations from the European League Against Rheumatism for rheumatoid arthritis management reiterated this exact point: “if a TNF-inhibitor fails, another TNF-inhibitor—but not a biosimilar of the same molecule—can be as effective as changing the mode of action.”

This begs the question, why? Why would an insurance company invoke a medical policy that prefers the more expensive originator drug and provides reimbursement coverage for the lower cost biosimilar only if the biosimilar can show that the more expensive drug would fail? Shouldn’t the more expensive option have to prove it is better to justify its higher cost? Why drive all patients to the more expensive product and deny coverage to the less costly one that the FDA has approved as highly similar with no clinically meaningful differences?

Biosimilars have the potential to boost competitiveness across the pharmaceutical industry and lower costs for patients – but fail-first policies just won’t let them. For example, Inflectra costs about 20 percent less than its biologic counterpart. Yet, providers run into road blocks when trying to prescribe the more affordable option to patients. Ultimately, the only real beneficiary of these restrictive policies is the company selling the more expensive original biologic drug.

Patients deserve unobstructed access to the treatments they need – not to have their health outcomes determined by contractual restrictions that are designed to avoid competition. Lawmakers are trying to move the needle. In 2010, Congress passed the Biologics Price Competition and Innovation Act to bring down the cost of biologic drugs by encouraging competition and innovation. While this should have paved the way for “biosimilar” drugs to the consumer, anticompetitive barriers remain, making it difficult for patients to get the medicines they need.

Limiting the use of biosimilars discourages innovation, hurts patients, and increases health care costs. The BPCI Act was enacted to ensure those things don’t happen. Ten years of experience in Europe has demonstrated that un-hindered availability and adoption of biosimilars decreases costs and, most importantly, increases access to life-saving medicines.

Medical innovation is outpacing current health care protocols. Providers cannot offer the highest standard of care when there are systemic barriers to effective, affordable treatment. Such barriers must be lifted to serve the best interests of patients.


Robert Popovian is the vice president of Pfizer U.S. Government Relations. Dr. Sam Azoulay is a senior vice president and the chief medical officer of Pfizer’s Essential Health Business Unit. Inflectra is a Pfizer product.

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