Biosimilars: Facts and Future Decisions ––>
With the first biosimilar approval in March and the FDA’s publishing of biosimilar industry guidance documents in April, it is essential to evaluate different stakeholder perspectives concerning what is already known about biosimilars and what still remains to be determined. In this article, we will review the knowns and unknowns for five key stakeholders: drug compendia, payers, wholesalers, pharmacies, and manufacturers.
The FDA has created the “Purple Book,” a listing of biological products, including any biosimilar or interchangeable drug products. While this reference will categorize biosimilars, drug compendia product categorization may have a larger impact on the functionality of dispensing software used by pharmacies. Wolters Kluwer projects that biosimilar products will be categorized in unique generic product identifier (GPI) numbers in their Medi-Span drug compendia. In anticipation of Zarxio’s launch, Medi-Span published a substitution file in March 2015, which states that the anticipated GPI for Zarxio 300mcg/0.5mL will be alphanumeric. Meanwhile, the equivalent strength of Neupogen is categorized under a purely numeric GPI. Along with the biosimilar rating in the FDA’s Purple Book, the creation of a new, alpha numeric GPI for the first biosimilar illustrates the fact that biosimilar products will not be substitutable with the reference product. Once the FDA finalizes guidance on interchangeability status, it will be interesting to see how Wolters Kluwer plans to incorporate these interchangeable products into the current GPI structure. While it is anticipated that First Databank will mirror Medi-Span’s approach and create unique generic code numbers (GCNs) for biosimilars, their exact methodology has not been published.
Pharmacy benefit managers (PBMs) and health plans will carefully review formulary placement for biosimilars. The potential cost savings will be one of the primary decision criteria. Payers will also have to evaluate the clinical factors, such as potential immune responses and neutralizing antibody development. We expect that each biosimilar will be its own unique case. Formulary placement and utilization management will be used, but the specific tactics for Zarxio and other biosimilars are unclear at this time. Will payers take an aggressive stance and force patients to switch to the biosimilar, or will they grandfather those who are responding to the originator and drive the use of the biosimilar in patients new to therapy? Payers may employ prior authorization tactics to help determine conversion criteria for biosimilars. Diligent pharmacists should review the payer’s formulary and utilization management strategies to prepare for prescription claim challenges and patient questions.
Pharmacy access to purchasing biosimilars shouldn’t vary much from the current procurement of drugs and biologics. But there are some key questions that pharmacies may ask current and prospective wholesalers. Will wholesalers conduct their own analysis and select a preferred biosimilar(s)? Will the selected biosimilar(s) be included on the wholesaler source program, just like generic drugs? Will all biosimilars be made available through the wholesaler, either through stocking or drop shipments, to account for payer-specific requirements? These are important questions, as a pharmacy would not want to lose a patient prescribed a specific biosimilar due to wholesaler lack of access to the specific biosimilar preferred by the payer.
As of Jan. 1, 2014, eight states had enacted statutes detailing pharmacy substitution of biosimilar drugs, while another 23 states have considered legislation. We know that pharmacies will be affected on a state-by-state basis, depending on legislation, but there are several features often included in the state legislation already passed. For example:
■ Biosimilars must be approved as “interchangeable” for substitution to take place at the pharmacy.
■ Pharmacies must notify both prescribers and patients of the substitution, and in some cases, state legislation also requires that individual patients give consent before substitution can occur.
■ Pharmacies will also be required to maintain records of substituted biologic medications. The length of record keeping will vary by state, but some states have mandated that records be maintained for a minimum of five years, longer than most other prescription record-keeping requirements.
■ In some states, pharmacists are required to complete the onerous task of explaining to patients the difference in price between a biologic and the interchangeable biosimilar.
Although we do not know what legislation will be passed in each specific state, we can assume that the above features will be included, at least on some level, in each state.
Due to the April 2015 publishing of several industry guidance documents, manufacturers now know a great deal about the biosimilar approval process. Among other things, the guidance discusses the following:
■ Factors to consider in assessing similarities.
■ Evidence needed to demonstrate biosimilarity.
■ Study data required.
For example, the guidance confirms that applicants may extrapolate clinical data from one indication to support the licensure of the product for additional indications for which the reference product is listed. Interestingly, unlike with traditional small molecules, the guidance notes that biosimilar manufacturers may use non-U.S.-licensed products to demonstrate that a proposed product is biosimilar to a reference product. Since biosimilars are already prevalent in Europe, this could expedite the approval process for many products in the United States.
While manufacturers may now better know what is expected of them as biosimilar applicants, we still do not know how manufacturers will market biosimilars. For example, for biosimilars that are not interchangeable, it is likely that manufacturers will need to employ a sales force to educate prescribers and drive sales. Whether or not manufacturers use co-pay cards to increase uptake remains to be seen, and this strategy would contrast with how generics are currently sold in the small molecule space. Furthermore, it is feasible that brand manufacturers may increase rebate offerings in an attempt to compete with biosimilars and secure preferred tiering status on plan formularies.
Many Changes Coming
The marketing of biosimilars will bring many changes and challenges for the industry. We expect manufacturers to pilot strategies and try to home in on tactics that prove effective in driving market share to the new biosimilar. These strategies will most likely differ, based on the level of interchangeability of the biosimilar.
Industry stakeholders will play an important part in driving acceptance or not. The drug compendia have provided a current view into the biosimilar drug groupings, but how will interchangeability impact these groupings? Payers will use managed-care edits to drive preferred product usage, but the strategy is not defined. Pharmacists should start asking their wholesalers about access to procuring biosimilars and the wholesalers’ strategies for identifying preferred products, if any. State laws will impact product launch and market acceptance. Finally, pharmacists should start preparing to take full advantage of the opportunity with the introduction of biosimilars. CT
Alan Sekula, Pharm.D., and Ann Johnson, Pharm.D., are consultants with PHSI. Sekula has an expertise in MAC pricing, generic drug launch analysis and forecasting, drug database, data and process analysis, adjudication and reimbursement, rebate analysis, pharmacy management systems, and business processes. Johnson currently has a focus in analytics and pricing reimbursement, financial models, and market research. The authors can be reached at firstname.lastname@example.org and email@example.com.