Guest Column | March 28, 2018

Partnering With Insurers To Improve Biosimilar Access In The U.S.

A conversation with Gregory Gierer, SVP of policy, America’s Health Insurance Plans (AHIP)

Gears In Hands

Drug developers have found a powerful ally in their campaign to advance biosimilar adoption in the U.S. — the nation’s health insurance providers. Insurers are keen to drive down the price of reference biologics, and they view biosimilars as an important way to accomplish that goal.

America’s Health Insurance Plans (AHIP), a political advocacy and trade association for the health insurance industry, has been outspoken in its support of biosimilars in recent months. In fact, the organization’s SVP of public policy, Gregory Gierer, wrote a guest expert article for Biosimilar Development last month, calling for specific public policy changes that would ensure a competitive biosimilar market. After publishing the article, we decided to follow up with Gierer to ask him about AHIP’s biosimilar-related initiatives, the ways in which biosimilar developers and insurers can collaborate, and emerging healthcare trends that will directly impact the biosimilar market.

What work is AHIP doing related to biosimilars?

Assuring a robust and competitive biosimilars market is a top priority for us. A vibrant biosimilars marketplace can help ensure that consumers and patients have access to high-quality and more affordable medications and biologics. We have developed policy recommendations — some legislative and some regulatory — that hold great promise. These include:

  • Finalizing FDA guidance necessary to assure a robust and workable pathway for biosimilars, such as the rules around interchangeability
  • Shortening the exclusivity period for brand name biologics to promote greater price competition
  • Removing state-level barriers and prohibiting abuse of the patent process
  • Reforming reimbursement for Medicare Part D covered drugs
  • Expanding research and funding on treatment effectiveness.

We are also pleased that Congress recently took action, as part of the Bipartisan Budget Act, to promote a more competitive biosimilars marketplace. Specifically, as part of the larger agreement to close the Part D coverage gap, Congress extended the coverage gap discount program to biosimilar drug manufacturers. This policy change will make these biosimilar products more affordable to patients and help assure a level playing field between brand name biologics and their biosimilar counterparts.

AHIP also strongly supports adoption of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act — bipartisan legislation in Congress that would help bring more generics and biosimilars to the market sooner and deliver more choices and more competition.

What challenges are you facing in advocating for biosimilars today, and how can biosimilars makers assist in addressing these challenges?

The biosimilar market faces many challenges. Both legal and regulatory barriers have undermined product availability, uptake, and savings, which has prevented the market from flourishing. On the legal front, aggressive patent litigation by reference biologic companies has delayed FDA-approved biosimilars from coming to market and being made available to patients. Legislative and regulatory barriers have also worked to undermine a truly competitive biosimilars market. That is why we have been focused on advancing policy solutions that address the barriers to competition and can help deliver cost savings for consumers.

We welcome the opportunity to work with all stakeholders — including biosimilar manufacturers — to collaborate on solutions. There are important areas of alignment between health insurance providers and biosimilar manufacturers, where we can work together to drive toward improvements that benefit patients. Beyond advancing shared policy goals, promising areas of collaboration include working to educate physicians and patients about the safety and effectiveness of biosimilar drugs, and collaborating to incentivize prescribing and use.

What are the biggest questions or concerns your members have about biosimilars?

The largest concern is the limited availability of biosimilars. To date, FDA has approved nine biosimilars, but only three are available to consumers. More competition leads to more treatment options for patients — and lower prices for everyone. This has certainly been the experience with generic drugs, where widespread availability of generics drove down prices and yielded savings for the healthcare system.

We recommend a number of ways to address these challenges. First, we need to address the abuse of the patent process and counter the anti-competitive strategies adopted by drug companies that prevent biosimilars from coming to market. Second, the FDA can accelerate the availability of biosimilars by finalizing regulations related to interchangeability and product labeling. Third, the FDA can accelerate efforts to approve complex generic and biosimilar drugs, focusing on approvals for multiple biosimilars in a given therapeutic market.

In what specific ways can biosimilar manufacturers better partner/collaborate with your members?

There are many opportunities to collaborate with generic and biosimilar drug manufacturers for better affordability and access. These include working closely to identify barriers to biosimilar development, promoting greater clinical confidence in the safety and efficacy of biosimilars, and exploring ways to better align coverage and benefit design to increase utilization of biosimilar drugs. One example is placing less expensive bisomilar drugs on preferred tiers with lower cost sharing and related incentives to encourage greater patient adoption.

Are there any broader healthcare trends your members are keeping their eyes on that biosimilar companies should be watching?

Value-based care models and alternative payment models are a promising area. For example, value-based contracting — arrangements between health insurance providers and drug manufacturers where reimbursement is tied to patient outcomes and other quality measures — can be an important part of the solution. Insurance providers have done a lot of work and experimentation to identify value-based approaches that yield real results. We can make much more progress by agreeing on our goals and working together to deliver for patients.

How do you anticipate these trends will impact the biosimilar market/industry?

Innovative contracting and reimbursement models can help support a competitive biosimilars market, but they are only one part of the solution. We need broad stakeholder involvement and shared responsibility. The government and the FDA can play an important role in assuring a robust pathway for biosimilars by finalizing regulations, so all stakeholders have clarity on the rules of the road. Congress and regulatory agencies can help by scrutinizing anti-competitive behavior by pharmaceutical companies that prevents biosimilars and generics from coming to market. Addressing the barriers to biosimilar development in a thoughtful and targeted way can help assure greater access to treatment alternatives and drive affordability throughout the healthcare system.