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Biologic therapies have come to play an increasingly important role in specialty care, representing some of the most advanced treatments available for patients affected by a wide range of serious illnesses, ranging from cancer and rheumatoid arthritis to many other specialties. However, due to the ever-increasing costs of specialty medications in the U.S., biosimilars have been cited as an emerging and necessary class of specialty drugs.

Biosimilars are highly-similar, biologic products designed to replicate the purity and potency of an existing biologic therapy. Since they are approved through abbreviated FDA pathways, they avoid duplicating costly clinical trials. To be approved, biosimilars must provide clinical evidence that there are no meaningful differences in terms of safety and effectiveness to the reference product.

Bringing more biosimilars to the market is widely expected to curb and even reduce the exploding costs of specialty care medications in the U.S. Yet while biosimilars have seen wide success in Europe, the path forward in the U.S. is not without its challenges. In Europe, 54 biosimilars are approved and almost all have commercially launched. In contrast, the FDA has approved 26 biosimilars, but only 12 have commercially launched to date. Of those nine, we have seen mixed adoption results in the practice setting.

We have identified the main barriers to biosimilar adoption within three categories: clinical, operational, and economical.

Clinical
Safety and efficacy are always top of mind when it comes to pharmaceuticals, and biosimilars are no exception. Specific questions can arise, including:

  • What is a biosimilar?
  • Is the biosimilar as effective? Is it safe to switch from brand to biosimilar?
  • Is the biosimilar approved for all the same indications?
  • Who is this manufacturer?
  • Are there patient support resources?

Operational
Products that are harder to use than other options will logically be less widely accepted. When it comes to biosimilars, practices may ask:

  • Which payers cover this biosimilar?
  • Do patients need prior authorization?
  • Does the biosimilar manufacturer offer benefits investigation support?
  • Does the biosimilar manufacturer offer patient support services like financial assistance/co-pay support?
  • How do I submit biosimilar reimbursement claims to Medicare?

Economical
The financial advantages of using biologics may not always be clear. Specifically, practices may wonder:

  • How will my reimbursement amount change over time?
  • How will that compare with changes in purchasing costs?

Biosimilar Reimbursement: Four Steps to Success
Proactively addressing these challenges and questions can go a long way towards achieving success with biosimilars. As the government has implemented step therapy in Medicare Advantage plans, and some commercial payers are preferring biosimilars, clarity around biosimilars and their reimbursement channels is paramount for providers and biosimilar pharmaceutical companies alike.

With the right assistance, providers can establish a framework for understanding and implementing a reimbursement process for biosimilars to help solve this critical barrier. At the heart of it, success is a simple, four-step process.

Step One – Educate the Practice
It’s critical to educate physicians and staff about the clinical aspects of the drugs as well as the practical implications of using them, like new or different billing requirements. Physicians need to understand the FDA review process so they can explain it to patients, and they should be ready to cite research supporting their use. Because biosimilars are new for payers too, there’s a learning curve for staff who may need different or additional information to get claims paid.

Step Two – Educate Patients
Patients facing serious illnesses and overwhelming treatment plans are already dealing with a lot of stress, and choosing or switching to a medication that’s new, can make that worse. That’s why it’s so important to educate patients about biosimilars, using scientific data to assure them the drug has been tested and found to be safe and effective. They also need to be made aware of any copay or patient assistance programs. In many cases, the biosimilar may be a less expensive option for the patient.

Step Three – Prepare the practice to educate the payers
The more information the practice has on hand, the easier it will be to work with payers. The practice should first reach out to payer representatives to find out whether the payers have medical policies set up to handle biosimilars. If not, the practice should work with pharmaceutical representatives to gather FDA label information to submit with the unspecified code until the Q-code is assigned prior to submitting any claims.

Step Four – Budget for potential payment delays
Each major private payer has different guidelines for biosimilar usage, which can delay claim adjudication and appeal. Delays may also occur for Medicare claims if a biosimilar has just recently been commercially launched and has not yet had an HCPCS code assigned from CMS.

Some biosimilar manufacturers may offer extended dating payment terms at launch to help account for these delays. Keep in mind though that a claim cycle that typically takes 20-24 days could take 35 days or longer for biosimilars. The practice needs to have a strategy in place to anticipate when it will need to provide additional documentation to the payer. It should also look at its operating budget and account for delays.

Photo: AndrijTer, Getty Images

 

 



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