Step Therapy

ASRS opposes step-therapy protocols that require patients to try and fail certain treatments before allowing access to other, potentially more appropriate treatments. We are particularly concerned about step-therapy policies that require the off-label use of Avastin when branded drugs (Eylea® and Lucentis®) are available as it undermines the authority of the Food and Drug Administration.

The most appropriate course of treatment for a given medical condition depends on the patient’s unique clinical situation. While a particular drug or therapy might be generally considered appropriate for a condition, the presence of comorbidities, potential drug-drug interactions, or patient intolerances, for example, may necessitate the selection of an alternative drug as the first course of treatment. Step-therapy requirements interfere with medical decision-making and often delay getting patients the right treatment at the right time. For some patients, this could result in unrecoverable sight loss. 

Despite our long-standing opposition, the Centers for Medicare and Medicaid Services (CMS) in an August 7, 2018 memo to Medicare Advantage (MA) Organizations entitled “Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage,” rescinded its September 17, 2012 memo prohibiting MA plans from using step therapy for Part B drugs. If the controversial plan stands, Medicare Advantage plans would be allowed to utilize step-therapy protocols for physician-administered drugs covered under Medicare Part B beginning in 2019.

ASRS is actively and vigorously opposing this change as it undermines patient-physician decision-making and creates dangerous barriers and delays to effective care, especially for the sickest patients. 


Advocacy Timeline

  • Further Analysis of Final Rule Allowing Step Therapy in Medicare Advantage Plans May 22, 2019

  • ASRS Joins Forces Opposing Step Therapy in Medicare Advantage; Urges CMS to Withdraw New Policy with January letter to CMSAlliance comments and opthalmology coalitionJanuary 2019

  • ASRS signed on to an American Medical Association letter calling on CMS Administrator Seema Verma to reinstate its policy prohibiting Medicare Advantage Plans from utilizing step-therapy models for Part B drugs and look for ways to reduce costs that do not create barriers to appropriate and timely treatment for patients. September 7, 2018
  • Co-sponsored an Alliance for Specialty Medicine letter that not only urges CMS to rescind its August 2018 memo, but points out that CMS policy as written places insufficient requirements on insurers to ensure that patients are not harmed. September 2018
  • The ASRS sent a letter to Magellan Rx opposing its policy to restrict the use of aflibercept, a policy recently adopted by Blue Cross and Blue Shield of Tennessee. Avastin- first policies are increasingly being promoted to health plans by pharmaceutical management companies as a way to control costs. ASRS continues to fight for physician choice. April 2018
  • ASRS and Alliance gained bipartisan support to circulate a “Dear Colleague” letter to US Representatives that urges CMS to review and place tighter restrictions on the prior authorization process for Medicare Advantage plans, which is increasingly being implemented along with step therapy to limit the use of branded anti-VEGFs. 
  • In June 2018, ASRS sent a letter to Blue Cross Blue Shield of Minnesota to oppose step-therapy policies.
  • In May 2018, ASRS sent letters to Magellan, a benefit management company, and Kaiser Foundation Health Plan challenging  their roll-outs of Avastin-first policies.
  • In April 2018, ASRS sent letters to Blue Cross and Blue Shield of Tennessee and Providence Health Plans to oppose policies that require physicians to use Avastin first. 
  • In 2017, ASRS wrote letters to Blue Cross and Blue Shield regarding its Federal Employee Benefits Program and to Highmark regarding its intravitreal injection medical policies.
  • In 2014, ASRS sent a letter to Humana to oppose its step-therapy policy aimed at restricting the use of medications to treat age-related macular degeneration (AMD) and other retinal diseases. The letter corresponded with the ASRS Buyer Beware Campaign, an effort to encourage members to discuss step-therapy policy changes with patients enrolled in Humana’s commercial plans so they would know their plans had instituted barriers to accessing the FDA-approved treatments vital to saving their sight.

 You can view additional letters that ASRS has sent to payors to guide the development of your own letters opposing these policies.

Please contact monica.horton@asrs.org if you have evidence that an insurance plan is enforcing a step-therapy policy or is restricting beneficiaries’ access to Part B drugs or services.

 

 

 

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