Integrating biosimilars into health systems pharmacies

Biosimilars are reshaping the treatment landscape for biologic-based therapies. In addition to producing clinically-equivalent outcomes to their reference products, studies show biosimilars will contribute to lowering the overall cost of healthcare1.

As 2019 approaches, many blockbuster biologics – often, treatments for cancer – will lose their patents and face biosimilar competition. This paradigm is creating new opportunities for health system pharmacy leaders to champion biosimilars, suggesting their inclusion on health system formularies and ultimately supporting patient outcomes while reducing overall costs.

To help Pharmacy & Therapeutics (P&T) committees determine whether biosimilars are appropriate for their health system’s formulary, pharmacy leaders will need to help address three current barriers to adoption: physician support, operational concerns and potential economic considerations.

Educating the Physician
Inclusion of biosimilars in a health system’s formulary begins by working with and educating physicians. While most physicians understand the potential cost savings of biosimilars, they will not consider prescribing a product if they are not wholly confident it is the best medication for their patient. Physicians must feel certain a new biosimilar will deliver the exact same results and patient benefit as the biologic reference product. Because biologics are not chemically synthesized, there is no way to create identical copies, as is the case with branded small molecule drugs and generics. Instead, a biosimilar must prove that it is clinically equivalent in terms of patient safety and outcomes.

To build confidence in the integrity of this new class of drugs, pharmacy leaders can work with physicians to ensure they understand the FDA’s evaluation and rigorous approval process for biosimilars. To approve a biosimilar, the FDA applies a “totality of evidence” approach, which considers the full body of evidence for the product. A manufacturer must present clinical and analytical data sets that prove the product is “highly similar” to the referenced biologic. If meaningful differences in safety and efficacy occurred during studies, the biosimilar would not be approved by the FDA. Health systems and their leaders should also review FDA label indications and comparative clinical data (U.S.-based or international studies) to reinforce biosimilar safety and efficacy for their physicians.

Ensuring Successful Integration
Once prescribing physicians feel comfortable with biosimilars, health system pharmacy leaders will need to operationalize these therapies by adding them to the formulary and workflow. This process requires an integrated collaboration between the health system and manufacturer. For example, adopting a biosimilar to a formulary may require line of sight into supply chain availability, any existing educational tools and any past manufacturing issues. Biosimilars and their reference products may have differences in storage and dosage that need to be accounted for; a challenge that a seasoned logistics partner can quickly address. Health systems should take advantage of the support manufacturers provide but also look to supply chain and logistics partners that can apply their expertise to introducing biosimilars to the hospital workflow to ensure success.

Conversely, biosimilar and reference product naming conventions are very similar. Naming convention guidelines dictate that both biosimilars and their reference biologic products should have a nonproprietary name followed by a specific four-letter suffix, a practice undertaken so far only by biosimilar manufacturers. With no widely-accepted naming convention, pharmacists and prescribers should be aware of the potential confusion that may be generated. Biosimilar products should be clearly marked in electronic medical records, e-prescribing, prescription dispensing practices, adverse event reporting and in discussions with patients.

Economic Impact
The promise of biosimilars lies in their cost savings for the healthcare market. Biosimilars are expected to be priced 15 to 20 percent less than reference products, but given that they are biologically-based, they will need to be priced to uphold the cost of research and development. As a result, some patients may continue to need financial assistance to access these therapies. Health system teams can help patients navigate access challenges between the biosimilar and reference product and, in the process, prepare for impact to the health system’s bottom line.

It is standard for biosimilar manufacturers to have a patient assistance program in place that either meets or exceeds the assistance offered by the reference product. Health systems can evaluate these programs to determine their utility for their patient population. For example, if the biosimilar is not covered under the patient’s medical benefit, prescribers – or contracted health system partners – will need to work with the patient’s payer to determine specific requirements needed for prior authorization. Addressing patient-level financial concerns will ensure the hospital bottom line is not impacted by reimbursement issues later.

There are many factors that impact pricing and reimbursement for products at the health system level. For example, there may be differences between the biosimilar and reference products with respect to the 340B Drug Pricing Program. Earlier this year, the Centers for Medicaid and Medicare Services (CMS) changed its billing methodology in the 340B program to promote generics and biosimilars. However, there are still some unanswered questions regarding biosimilar reimbursement under this policy. P&T committees will need to be prepared to navigate the budgetary impact of biosimilars to their specific health system and its patients, keeping in mind any unclear or incomplete information from regulators, or they will need to turn to consulting partners who can do so.

Ultimately, as a growing segment of the biologic pharmaceutical market, biosimilars represent an opportunity for health system pharmacists to improve clinical outcomes while simultaneously lowering costs. P&T committees can speed the adoption of biosimilars by working with the manufacturer and expert partners to create a thoughtful approach that considers the needs of all stakeholders – health system providers, manufacturers, payers and patients. While there are challenges, P&T committees who successfully implement biosimilars can be seen as champions of innovative, cost-effective therapies and become well-positioned for future influence.

1 Gotham D, Jarber MJ, Hill A. Production costs and potential prices for biosimilars of human insulin and insulin analogues. BMJ Glob Health. 2018;3(5):e000850. doi: 10.1136/bmjgh-2018-000850.

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