Step Therapy For Anti-Inflammatories, ESAs Coming To UnitedHealthcare Medicare Plans

Remicade, Procrit, Aranesp and biosimilars will be subject to step therapy in limited number of Medicare Advantage plans in 2019.

[UnitedHealthCare] will apply step therapy to Medicare Part B drugs in its Medicare Advantage plans for the first time in 2019, but is only making a limited foray into the practice.

Step therapy management means that beneficiaries will have to try and fail on less expensive options before coverage is granted for the requested drug. The Centers for Medicare and Medicaid Services recently announced that Medicare Advantage plans will be allowed to implement step therapy on Part B drugs as a way to help lower prices. (Also see "Step Therapy For Medicare Part B Drugs Will Lower Costs By 20%, HHS Projects" - Pink Sheet, 8 Aug, 2018.)

The insurer will bring the cost management tool to a handful of drugs in two of the highest-cost treatment categories – anti-inflammatories and erythropoiesis simulating agents.

Drugs impacted will include Janssen Pharmaceutical Cos.’s Remicade (infliximab) and two of its biosimilars, Pfizer Inc. and Celltrion Inc.’s Inflectra (infliximab-dyyb) and Merck & Co. Inc.’s Renflexis (infliximab-abda) – according to a recent UnitedHealthcare bulletin to providers. Inflectra and Renflexis will be preferred agents in the category.

Also subject to step therapy restrictions will be Janssen’s Procrit (epoetin alfa) and Amgen Inc.’s Aranesp (darbepoetin alfa), while Pfizer’s biosimilar Retacrit (epoetin alfa-epbx) is listed as a preferred drug.

Step therapy will not apply to Amgen's Epogen (epoetin alfa) or Roche’s Mircera (methoxy PEG-epoetin beta), the insurer noted, indicating United is satisfied with the prices it has negotiated for those products.

But it will also be used for managing access to a number of hyaluronic acid polymers, which are FDA approved as devices, including Bioventus Inc.’ Gelsyn and Durolane and Sanofi’s Synvisc.

CMS is hoping that Medicare Advantage plans will be able to negotiate lower prices for Part B drugs if they have access to additional formulary management tools. The concept was among the policy proposals in the Trump Administration's blueprint for lowering drug prices. Step therapy has not previously been allowed for Part B drugs, though it is used for physician-administered drugs in commercial insurance and for Medicare Part D drugs.

UnitedHealth has been a proponent of the move. “Expanding the use of step therapy is a positive step toward lowering prescription prices for Medicare beneficiaries,” UnitedHealthcare Chief Pharmacy Officer for Medicare Michael Anderson said in an Aug. 30 release. “Consumers will maintain access to safe and effective treatments they require, while sharing in significant savings. “

UnitedHealth is not limiting step therapy to non-preferred drugs with the program. Remicade, Procrit and Aranesp have non-preferred status on MA formularies, with higher cost sharing, and Inflectra, Renflexis and Retacrit are preferred agents.

Limited Exposure Among MA Beneficiaries

Step therapy will be used next year in MA plans including UnitedHealthcare Dual Complete special needs plans for beneficiaries eligible for Medicaid and Medicare and the Medica HealthCare and Preferred Care Partners plans of Florida.

Plans excluded from the program include MA plans offered in Arizona, California, Colorado, Hawaii, Nevada and Washington. Also excluded are employer group MA plans nationwide, Erickson Advantage plans, UnitedHealthcare Connected plans, UnitedHealthcare Dual Complete plans in New Jersey and Tennessee and UnitedHealthcare Senior Care options in Massachusetts.

In keeping with CMS’ guidance, step therapy will not apply if members have already started on a drug and are actively taking it (defined as having a paid claim within 120 days).

United will also share the savings generated by the program with members as part of a care coordination program. CMS has stipulated that MA plans pass up to 50% of savings back to consumers through rewards.

Commenting on the new step therapy requirements, a Janssen spokesperson said that "United’s plan to implement step therapy requirements affects only its Medicare Advantage members, and we are pleased that existing patients will remain on therapy. ... We are monitoring how plans are responding to the recent CMS guidance regarding Medicare Advantage coverage of Part B medicines and continue to share our view that any changes in Part B should preserve patient access and physician choice."

[Editor's Note: This story was updated after publication to clarify that Inflectra, Renflexis and Retacrit will be preferred agents in 2019.]