Tag: managed care pharmacy

New Managed Care Pharmacy Survey Shows Broad Support for Biosimilar Adoption

According to a study published in the Journal of Managed Care and Specialty Pharmacy, managed care pharmacy executives are fully onboard with encouraging the use of biosimilars: Eighty-four percent agree that these FDA-approved agents are safe and effective for use in patients who are taking a reference product.

The researchers sent survey invitations to more than 10,000 members and contacts of the Academy of Managed Care Pharmacy. The survey, conducted in October 2018 was limited to the first 300 respondents. All potential pharmaceutical industry participants were excluded through the use of screening questions. Roughly two-thirds of those participating were pharmacy directors or clinical pharmacists.

The survey asked whether they believed certain policies would improve biosimilar uptake. The results indicated respondents’ belief that prescriber education was still a principal problem (Table). However, they also looked inward, as formulary policies and reduced patient cost sharing may also be key opportunities for improving uptake. Indeed, only 20% of those surveyed were working in health plans or insurers that have established preferences and policies to promote biosimilars over reference products. Eleven percent (at the time of the study) preferred biologics to biosimilars. This may have changed significantly, based on UnitedHealthcare’s recent moves to favor reference agents.

TABLE: LIKELIHOOD THAT SPECIFIC STRATEGIES CAN OVERCOME BARRIERS TO BIOSIMILAR UPTAKE

Strategy Extremely or Likely to Be Successful
Prescriber education on switching studies 91%
Clear FDA guidance on substitution 90%
Formulary policy for treatment-naïve patients 88%
Prescriber education on real-world studies 86%
Expanded Medicare/Medicaid policies 84%
Reduced patient cost sharing for biosimilars 80%
Formulary policies for switching 73%
Government-funded interchangeability studies 70%

When asked about how formidable these challenge were to overcome, 61% said that provider education was “extremely difficult” or “difficult” to overcome. The inevitable pricing and contracting issues were a close second, at 57%. Respondents offered that this was a competitive hurdle that biosimilar manufacturers must tackle—they need to be more aggressive at launch in terms of discounts off of retail prices and contracting. Concerns about biosimilar safety and efficacy among payers were the least worrisome, with only 23% rating this challenge difficult or extremely difficult.

Only 9 months ago, when the survey was conducted, the US biosimilar arena was far different. It took place after approval and launch of the first pegfilgrastim biosimilar but before the launch of the cancer-treating biosimilars. The discussion of rebate safe harbors was in full swing, the federal government was thinking through its approach to peeling back the patent thicket, and a war on drug pricing was being waged. Today, only the drug pricing efforts are still ongoing. Any hopes for an adalimumab biosimilar launch before 2023 have disappeared. However, a handful of critical launches (e.g., Udenyca®, Kanjinti®, Mvasi®) have pressed more immediate discussion of biosimilar uptake.

The results of this survey demonstrate once again that pharmacists working in managed care organizations are very open to helping spur biosimilar access. Both the manufacturers and payers need to take advantage of this opportunity today.

Managed Care Pharmacists Survey: We’re on Board With Biosimilars, and Maybe Even Switching

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”:

  1. Clear FDA guidance for substituting reference biologics with lower-cost biosimilars that meet requirements for interchangeability (54%)
  2. Expanded Medicare and Medicaid policies that promote biosimilar use (41%)
  3. Educational programs for prescribers focusing on evidence from studies in which patients switched from reference biologics to biosimilars (39%)
  4. Formulary policies that promote biosimilar use for treatment-naive patients (39%)
  5. Educational programs for prescribers focusing on real-world evidence from postmarketing studies on biosimilars, including European studies (34%)
  6. Reduced cost sharing for patients using biosimilars (34%)
  7. 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:

  1. Requiring therapeutic drug monitoring for patients who switch to biosimilars to address concerns about immunogenicity (28%)
  2. Incentivizing providers by using quotas for prescribing biosimilars to treatment-naïve patients (28%)
  3. Educational programs for prescribers focusing on streamlined billing, coding, and reimbursement processes for biosimilars (12%)
  4. 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].”