Few suspected that payers were doubters of the clinical value of biosimilar agents, and as the first biosimilars were approved (2015-2016) managed care medical and pharmacy executives were somewhat reluctant to embrace them. However, within the past couple of years, managed care pharmacists told me these concerns were dissipating rapidly. (See the recent interview with Steven Avey as an example.)
A new survey on biosimilars released by the Academy of Managed Care Pharmacy (AMCP) confirmed that managed care pharmacists are on-board with biosimilar safety, efficacy, and the potential for switching. Conducted in October 2018, this survey offers solid evidence of the most recent thinking by pharmacy professionals on biosimilar access and promise.
Investigators from the Academy, PRIME Education, and the University of Pennsylvania analyzed the first 300 responses to their broad solicitation of AMCP members and associated professionals. Thirty-eight percent worked within a health plan or insurer setting, 22% in a pharmacy benefit management organization, and 40% in a specialty pharmacy.
The researchers stated, “84% agreed or strongly agreed that FDA-approved biosimilars are safe and effective for patients who switch from a reference biologic.” Although this does not specifically endorse switching to biosimilars from reference products, it does imply that the payers have no problem with the concept. They were still a bit wary of extrapolation of indications, however. A slight majority (54%) agreed or strongly agreed that extrapolation of indications for biosimilars was safe and effective.
The surveyed payers were asked to select the most effective strategies for increasing biosimilar utilization (i.e., overcoming barriers to biosimilar use). The responses rated the following strategies “extremely likely to be effective”:
- Clear FDA guidance for substituting reference biologics with lower-cost biosimilars that meet requirements for interchangeability (54%)
- Expanded Medicare and Medicaid policies that promote biosimilar use (41%)
- Educational programs for prescribers focusing on evidence from studies in which patients switched from reference biologics to biosimilars (39%)
- Formulary policies that promote biosimilar use for treatment-naive patients (39%)
- Educational programs for prescribers focusing on real-world evidence from postmarketing studies on biosimilars, including European studies (34%)
- Reduced cost sharing for patients using biosimilars (34%)
- Incentivizing providers by adjusting fee schedules for biosimilars (34%)
It should be noted that of the 16 potential strategies presented, only 2 (see below) did not garner more than 50% of respondents believing that they were at least “likely” to be effective.
In contrast, the strategies least likely to be effective were:
- Requiring therapeutic drug monitoring for patients who switch to biosimilars to address concerns about immunogenicity (28%)
- Incentivizing providers by using quotas for prescribing biosimilars to treatment-naïve patients (28%)
- Educational programs for prescribers focusing on streamlined billing, coding, and reimbursement processes for biosimilars (12%)
- Laws that promote greater public transparency on pricing of biosimilars and reference biologics (11%)
This survey does demonstrate that pharmacists’ comfort levels with biosimilars are fairly high. At the time of the study, it is likely that they had significant experience with only filgrastim and infliximab biosimilars (based on launch dates of the other approved agents, including epoetin and pegfilgrastim).
| Challenges | Extremely Difficult | Difficult or Extremely Difficult |
| Concerns about biosimilar safety and efficacy among prescribers | 16% | 61% |
| Pricing and contracting issues | 22% | 57% |
| State laws for substitution and interchangeability | 17% | 53% |
| Concerns about biosimilar safety and efficacy among patients | 13% | 49% |
| Formulary management issues | 8% | 35% |
| Concerns about biosimilar safety and effiacy among payers | 7% | 23% |
Data adapted from
https://www.jmcp.org/doi/full/10.18553/jmcp.2019.18412 .
In terms of these pharmacists’ opinions as to the most challenging barriers to biosimilar adoption, they rated as “extremely difficult”: pricing and contracting issues (22%), state substitution and interchangeability laws (17%), and prescriber concerns about efficacy and safety of biosimilars (16%).
When asked what biosimilar manufacturers can do, their responses emphasized pricing: Use contracting “to overcome the current [biologic reference] products’ substantial rebated dollars” and “come to market with more aggressive discounts off [average wholesale price].”
