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Step Therapy and IV Selenium

The Issue with Step Therapy (Fail First Policies)

Step therapy is an insurance practice that mandates patients try and fail medications preferred by their insurer before they can utilize treatments prescribed by their doctor. It is also known as a “fail first” protocol. While the practice can sometimes help contain the costs of prescription drugs, it can also have serious negative impact on patients, including delayed access to the most effective treatments, severe side effects, and irreversible disease progression.

Step Therapy

What You Can Do

A bill is being considered in the House and Senate called the Safe Step Act (H.R. 2279/S. 2546). This bill establishes important guardrails that protect patients when step therapy is mandated by establishing a transparent appeals process and an expedited review for at-risk patients.

You can urge your members of Congress to improve patient access to appropriate care by co-sponsoring the Safe Step Act. Action is especially needed from members in Pennsylvania, North Carolina, Tennessee, Connecticut, Michigan, and Washington.

  •  Identify your two U.S. Senators and your member of Congress (available at www.govtrack.us).

  •  Check if your Senators or member of Congress are currently co-sponsoring the bill. See www.congress.gov/bill/116th-congress/senate-bill/2546/cosponsors and www.congress.gov/bill/116th-  congress/house-bill/2279/cosponsors or call their offices.

  •  Contact their D.C. offices by phone or email and ask for the staffer who handles health-care issues. You can use the template below to guide your conversation and/or correspondence. Or, if they are already co-sponsors, you can thank them and state why the bill is important to you. If you call and they are not available to talk to you, ask to leave a message for them with the staffer you’re speaking with, or get their email address.

  • Visit the websites for each Senator and House member to find their social media pages (often at the bottom of the website homepage) and tag them in your posts. Here are some suggested social media posts (Twitter, Facebook, Instagram, LinkedIn, etc.):

               “@___, please cosponsor the #SafeStepAct [use S. 2546 for Senate, H.R. 2279 for House]. Protect patient access and #ReformStepTherapy.”

               “Step therapy impedes the doctor-patient relationship and makes it harder for patients to access essential treatment. Congress must #ReformStepTherapy and pass #SafeStepAct.”


IV Selenium

The Issue

As discussed in the September/October issue of this newsletter, the FDA has approved a new IV selenium product from American Regent, in a new concentration (see www.oley.org/Update-on-IV-Selenium). It is currently the only IV selenium available and it is significantly more expensive than the previously available product (a lower concentration, also from American Regent).

In addition to the high price, the company has not done extended stability studies and the product insert states that once the product is added to parenteral nutrition (PN), the bag should be used within twenty-four hours. This is impractical for PN consumers who get several bags of PN delivered to their home weekly. We have been told that American Regent is working on the necessary studies. In the meantime, some infusion companies have adequate supply of the older IV selenium product that they can continue using; or you may be getting selenium as part of MTE-5 (a multi–trace element product); or (for adults) you may be asked if you can absorb an oral form of selenium to supplement your PN. If none of these pertain to you, you may not be getting selenium.

As noted in the IV selenium article by Penny Allen, RD, LDN, CNSC, mentioned above, “Pediatric patients DO need individual selenium added to their PN bags since the neonatal and pediatric trace element combinations do not have selenium in them. Please check with your doctor and your company to make sure they are continuing to prescribe and provide the IV selenium in your child’s PN bag.”

What You Can Do

  • You should be made aware of any changes to your prescription. If you have any questions or notice a change on your label, call your physician and/or your home infusion company to ask questions.
  • Oley has joined the American Society for Parenteral and Enteral Nutrition (ASPEN) and the National Home Infusion Association (NHIA) in asking American Regent to reconsider the price and to conduct extended stability studies.
  • We encourage you to share your story with American Regent and urge them to consider how the pricing and extended stability studies impact you. Email Lisa, at the Oley office, for contact information (metzgel@amc.edu).

Please let Lisa know what you are doing. It helps us as we advocate for you as an organization, and it helps us understand what is important to you.

Urge members of Congress to improve patient access to appropriate care by co-sponsoring the Safe Step Act.


Template to Urge Co-sponsorship of the Safe Step Act

Hi [Staffer’s Name],

               My name is [Your Name] and I am a constituent from [Your City, State]. I am contacting you today to ask that your office please co-sponsor the Safe Step Act [use S. 2546 for Senate, H.R. 2279 for House]. This important legislation works to improve patient access by reforming insurance-mandated step therapy.

               Step therapy is a tool used by health insurers that requires patients to fail first on the insurance company’s preferred treatment before they can access treatments prescribed by their doctors. If left unchecked, the practice can impede the doctor-patient relationship and cause serious harm to patients. The Safe Step Act establishes important guardrails that protect patients when step therapy is mandated by establishing a transparent appeals process and an expedited review for at-risk patients. [Include your personal experience with step therapy briefly, if applicable.]

               Thank you for your consideration. Please let me know if your office will co-sponsor this important legislation.

Sincerely,

[Your Name]

[Your Address] 



LifelineLetter, November/December 2019

 

This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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