By Nicolas Arkells, CEO, Manticore Consulting Group
In my previous article, I argued that biosimilar companies must engage states as partners for successful U.S. market access. This article accepts that premise and also assumes interchangeability will occur at the federal level. My goal is to provide insights, along with several solutions for biosimilar companies to engage local politicians and patients in a manner that is mutually beneficial. This analysis is based on reading and assessing all 38 of the local statutes addressing biosimilars and my prior experience proposing statutes for local legislatures.
Variability Among State Statutes Indicates A Wide Information Gap
Often, states pass statutes in a uniform matter with minor variations, especially when they involve federal statutes. Even among the states themselves, there tends to be a level of coordination, such as the uniform commercial code or reciprocity of drivers’ licenses. At the very least, there are usually regional commonalities among neighboring states. However, based on analysis of the different state statutes affecting biosimilars, there is considerable variability.
In addition, there are also significant differences in terminology. For example, many states do not use the term “interchangeability”; instead they use the less precise word “substitution.” This is a serious issue because the actual definition of substitution is closer to the term “complimentary” than to “interchangeable.” The use of substitution by most local statutes seems to convey an assumption of interchangeability, as it is usually about a pharmacist switching to a biosimilar without direct approval from a prescriber (interchangeability). Substitution’s plain meaning, on the other hand, would generally imply any intervention with a similar goal, regardless of relative safety or efficacy. This also indicates an information gap within the legislature and its citizens as to biosimilars. These drafting oversights cause considerable uncertainty regarding enforceability, as courts will ultimately be the ones left to guess the legislature’s intent.
These information gaps present opportunities to educate representatives about biosimilars. Beyond just education, representatives need to be provided with a framework to explain the policy underpinning biosimilars. If biosimilars are explained as a simple means to increase patient access by reducing healthcare costs, the message will resonate with constituents and fellow representatives. This is because constituents and local politicians are ultimately patients, and for patients, affordable healthcare is still one of the most important policy concerns for Americans.1
A cross-sectional survey among patients demonstrates such opportunities. The survey found those unaware of biosimilars were 17 percent less likely to feel comfortable switching to a biosimilar, 18 percent less likely to feel it effectively would treat their condition, and 18 percent less likely to believe biosimilars are affordable. 2 None of these misperceptions are supported by actual evidence; they are simply caused by unfamiliarity with biosimilars.
In the U.S. system of representative democracy, it makes perfect sense for confused citizens to elect confused politicians. If patients are given the information needed to understand biosimilars, even if it is just initial exposure, there is an opportunity to align biosimilars with concerns about affordable healthcare. This will, in turn, encourage politicians to support other leaders favorable to biosimilars. For citizens, they may even elect more representatives favorable to biosimilars. Ultimately, direct local patient engagement will afford biosimilar companies opportunities to help patients while also helping themselves.
Local Statutes Should Include These Provisions
Engaging states as partners includes making sure the most effective solution is implemented. To avoid uncertainty and legal chaos, it is best not to leave the federal statute’s interpretation to local courts. Instead of engaging in skirmishes in the court system, biosimilar companies should proactively engage state governments to pass statutes more supportive of biosimilars. Model statutes should be proposed that address each of the following provisions:
1. Include default rules mandating that if a less expensive biosimilar is available, it will be prescribed, in the absence of a serious medical reason.
New York’s requirement for a pharmacist to substitute a less expensive biosimilar product if one is available provides the most important measure for biosimilar success. State statutes should mandate biosimilar prescription and substitution as a default rule, absent a serious and compelling medical reason. A default rule requiring switching a biologic for a biosimilar also eliminates the reimbursement debacle. For these reasons, patient access rates would exponentially increase in a manner similar to generic small molecule drugs.
2. Include liability protections for the physician and pharmacist.
Delaware’s statute provides a model for protecting the pharmacist from legal liability for switching to a biosimilar. States should further expand this measure to include physicians, in the event there are patient incidents related to prescribing biosimilars over biologics. States are likely to be amenable to this measure as it comports with existing ideas about limiting medical malpractice liability as a measure to reduce healthcare cost. It also mitigates concerns over “defensive medicine,” which reduces patient treatment options. There should be no increased risk to patients, since biosimilars undergo rigorous safety and efficacy testing under FDA requirements for clinical trials.
3. Prevent state agencies, along with medical and pharmacy boards, from approving or blocking biosimilar compounds.
Hawaii sets forth a model biosimilar provision repealing authority for its drug product selection board. State statutes should take this further to prohibit approval or intervention limiting biosimilars from state pharmacy or medical boards. A survey conducted by the Biosimilars Forum determined that 75 percent of doctors would agree a biosimilar was safe if it was approved by the FDA.3 There is no reason to invite the statute to be vulnerable to special interests. Further, state regulatory bodies must have clear parameters for regulating and enforcing biosimilar statutes. If an agency is given too much authority and unclear guidelines, it could cripple biosimilar success, as state agencies are mostly run by appointees rather than elected officials.
4. Include provisions permitting patients to directly engage their pharmacist to switch to a biosimilar.
Michigan provides a model for allowing a patient to directly ask a pharmacist if a less expensive biosimilar is available for the prescribed biologic. Allowing patients to make such directly requests is critical. Patients may be intimidated or at a general disadvantage if they try to directly confront their prescriber, since the prescriber could have other interests for encouraging biologics over biosimilars, such as reimbursement rates.4
5. Require patients to be informed by the pharmacist of the list of interchangeable products and prices for a prescribed biologic.
Hawaii includes a statutory provision requiring pharmacists to inform consumers of interchangeable biosimilar products for a prescribed biologic. This should be further expanded to require a pharmacist to show a list of the names and prices of all approved biosimilars for the biologic. Pricing transparency is proven to drive down costs in any industry. Further, the list should contain the name of manufacturer, since survey data has shown that patients trust biosimilars more when given this information.2
6. Ensure precise language that is harmonized with federal terminology is used.
If the state’s statute uses terminology that is harmonized with federal legislative and regulatory definitions, it will be easier for stakeholders and other states to clearly understand and follow. Further, when statutes use precise language, it avoids many enforceability issues, as there is less opportunity for lawyers to second guess legislative intent.
A carefully coordinated strategy is needed to engage local political leadership and patients as legislative advocates, who in turn can put pressure on the local governments to adopt statutes supportive of biosimilars. This can only be achieved by closing the current information gap. By demonstrating to patients an alignment of goals through open communication, biosimilar companies can empower patients to act as critical allies in the struggle for biosimilar success.
About The Author:
Nicolas Arkells, JD, MBA, is the CEO at Manticore Consulting Group, a global health economics and outcomes consulting firm. He has over 15 years of leadership experience focusing on ensuring organizational commitment to statistical analysis and implementation. His law and science juris doctorate concentration in intellectual property allowed him to focus his research on biotechnology, market access, policy, regulatory strategy, and patent law. He is certified in medical devices and pharmaceuticals by the Regulatory Affairs Professionals Society, Lean Six Sigma Black Belt trained in the healthcare industry, agile certified as a PSM and PSPO, and advanced certified in global human capital through Columbia University. He has been recognized for excellence in legal research, alternative dispute resolution, and leadership. You can reach him via email or connect with him on LinkedIn.