The Centers for Medicare & Medicaid Services (CMS) introduced a final rule permitting Medicare Part B plans, including those administered through Medicare Advantage*, to impose step therapy on naïve patients for Part B drugs, back in May 2019. This policy has now been expanded to include biosimilars, including Retacrit (epoetin alfa-epbx), Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda), Zarxio (filgrastim-sndz), and Udenyca (pegfilgrastim-cbqv).

The step therapy approach means that, for example, the epoetin alfa biosimilar Retacrit is the preferred drug when considering treatment with erythropoietic agents. The ‘non-preferred drug(s)’ are originator biologicals Aranesp and Procrit. The rule then specifies that Aranesp or Procrit may only be used when all of the criteria listed (in A, B or C) are satisfied. Criteria for use of the originators include:

A.  1. History of use of Retacrit resulting in minimal clinical response to therapy; and
      2. Physician attests that in their clinical opinion the clinical response would be expected to be superior with Aranesp or
      Procrit than with Retacrit.
      OR
B.  1. History of intolerance or adverse event to Retacrit;
      2. Physician attests that in their clinical opinion the same intolerance or adverse event would not be expected to occur with
      Aranesp or Procrit; and
      3. For patients, who are unable to tolerate Retacrit or in the rare instance that Retacrit is contraindicated for a patient,
      documentation is required that clearly indicates the reason that the patient cannot use Retacrit.
      OR
C.  Continuation of prior therapy within the past 365 days

According to authors from MedCityNews, despite these barriers to the adoption of biosimilars in the US still exist and can be categorized into clinical, operational and economic issues. They highlighted the type of questions that can arise in each of these categories:

Clinical
Main issues are the safety and efficacy of the biosimilar. Questions include:
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
If a product is more difficult to use it will be less widely accepted. Questions include:
Which payers cover this biosimilar?
Do patients need prior authorization?
Does the biosimilar maker offer benefits investigation support?
Does the biosimilar maker offer patient support services like financial assistance/ co pay support?
How do I submit biosimilar reimbursement claims to Medicare?

Economic
The financial advantages of using one biological rather than another may not always be clear. Questions include:
How will my reimbursement amount change over time?
How will that compare with changes in purchasing costs?

Therefore, in order to improve the uptake of biosimilars, clarity, especially with respect to their reimbursement, is paramount for both healthcare providers and biosimilar makers. Four steps are recommended to provide understanding of the reimbursement process: education for practices, education for patients, practices need to educate payers, and budget for payment delays.

*In a Medicare Advantage plan, a Medicare beneficiary pays a monthly premium to a private insurance company and receives coverage for inpatient hospital (Part A) and outpatient (Part B) services. Typically, the plan also includes prescription drug (Part D**) coverage.
**Medicare Part D, also called the Medicare prescription drug benefit, is an optional US federal-government programme to help Medicare beneficiaries pay for self-administered prescription drugs through prescription drug insurance premiums.

Related article
Biosimilars approved in the US

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars pricing slowing uptake in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from: www.gabionline.net/Reports/Biosimilars-pricing-slowing-uptake-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Lack of confidence in biosimilars slowing uptake in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from: www.gabionline.net/Reports/Lack-of-confidence-in-biosimilars-slowing-uptake-in-the-US

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