Archive for February, 2014

Access to Immunosuppressive Drugs under Medicare Part D is at Risk — Transplant Community Needs to Act Now!

February 12th, 2014

New: Congressional Briefings on Preserving & Protecting the 6 Protected Classes Scheduled

Feb 12th — Noon: B340 Rayburn House Office Building

Feb 13th — Noon: Capitol Visitors Center Room SVC 200

The blog is cross-posted with permission from the National Kidney Foundation. Other comments are completely my own.

All those you have been transplanted, are waiting for a transplant, love someone who has had a transplant, donated a loved one’s organs to give the gift of life and want to make sure it is not endangered OR just folks who believe that CMS should not engage in the practice of medicine please read and make your opinion known.

Access to Immunosuppressive Drugs under Medicare Part D is at Risk

Medicare beneficiaries who do not qualify for immunosuppressive drug coverage under Medicare Part B (the Medicare program that covers outpatient care) typically receive coverage of their immunosuppressive drugs under the Medicare prescription drug program known as Medicare Part D.  Under current Medicare Part D protections, organ recipients have access to all approved immunosuppressive drugs. This protection allows physicians to tailor drug combinations to best meet the needs of the individual patients. However, a proposal released by the Centers for Medicare & Medicaid Services (CMS) on January 6, 2014 would eliminate this protection and allow Medicare Part D health plans to restrict access to immunosuppressive drugs.

Without the current protections, Part D plans, not doctors, will decide which immunosuppressive drugs patients can access. This proposal reflects a misunderstanding by CMS that immunosuppression to avoid organ rejection is a one-size fits all therapy. Patients and transplant physicians know that there is no one drug combination that works for every patient. Some patients may experience harmful side-effects with a particular drug combination that might work wonderfully for someone else.  It takes a delicate balance to properly suppress the immune system in order to preserve the organ, while minimizing side-effects for each patient.

Rest assured that NKF is engaged on this issue and is educating legislators and the media about flaws in CMS’s proposal. To date, our conversations with congressional offices are encouraging. We are also reaching out to CMS to help them better understand how immunosuppression works and why it is important to cover all immunosuppressive drugs.  However, we still need your help.  Please email nkfadvocacy@kidney.org and share your story about how your physician was able to find the right combination of medications for you.  Did the first combination of drugs work right away or did you need to try multiple combinations before the right one was found?  Sharing your stories with policymakers helps us grow momentum in order to get CMS to reverse this proposal.

Additional Information:

CMS fact sheet on changes. http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-Sheets/2014-Fact-sheets-items/2014-01-06.html

CMS proposed rule http://op.bna.com/hl.nsf/id/bbrk-9f4szl/$File/MAJan62014.pdf

Foley Hoag analysis http://www.foleyhoag.com/publications/alerts-and-updates/2014/january/cms-proposes-changes-to-six-protected-class-rule-under-medicare-part-d

Submit comments on www.regulations.gov http://www.regulations.gov/#!submitComment;D=CMS-2014-0007-0002

Learn more about the Medicare Access for Patients Rx Coalition http://maprx.info/

 

Let Patient Safety Guide FTC Decisions on Biosimilar Naming

February 4th, 2014

Today the Federal Trade Commission is conducting an workshop to determine, in part, if follow-on versions of biologic medications will have the same name as the original versions of the medications or if they will be designated by a distinguishable name or code so if there is an adverse event the doctors, patients, and regulatory agencies can track back and find the responsible product.  They would still be on the market, still be (presumably) at a lower cost, but just not able to hide.  What do you think?

Below is a link to my views in a conversation with  former Asst. Commission of FDA, Peter Pitts and a blog post from the Alliance for Patient Access which includes a letter signed my major patient associations.

Drugwonks Interview: http://drugwonks.com/blog/patients-are-a-virtue-but-not-at-the-ftc

Blog Post from the Alliance for Patient Access

By Brian Kennedy, Alliance for Patient Access

As a representative of an organization that advocates for greater patient access to approved therapies and appropriate clinical care, I am hopeful that when biosimilars are introduced into the U.S. market (later this year or early next), patients nationwide will have increased access to certain life-altering and life-saving treatments. It’s disappointing though that the Federal Trade Commission (FTC) is driving a discussion about market access and competition for biologics and biosimilars this week, yet they left important perspectives – namely patients, providers with experience prescribing biologics, and health system pharmacists – out of that dialogue.
While the U.S. Food and Drug Administration (FDA) – not the FTC – ultimately sets federal policy around the approvals pathway for biosimilars, any public discussion driven by a federal government agency is going to get attention; because of the FTC’s omission of these important perspectives, the Alliance for Patient Access (AfPA), along with the California Healthcare Institute (CHI) and thirteen other health advocacy organizations, signed a letter that has been submitted to the FTC and urges that patient safety and consumer protection be at the forefront of the FTC’s considerations, particularly when discussing the issue of the naming of biosimilar products.
Before approving biosimilars in the U.S., FDA will first need to establish naming policy for these products. Given the vast differences between chemical compounds and biologics – including biosimilars, the FDA should require distinguishable names for all biologic products, rather than requiring biosimilars and their innovator reference product to share the same name.
Patients across the country will be best served if distinguishable names are required for all biologics. By providing clarity of which medication is being recommended at the point of prescription, distinguishable names facilitate the process of determining the cause of an adverse effect and allowing patients and their medical teams route back to the origin of the problem. Issues that may be particular to a specific biological product may even be entirely untraceable without distinguishable names or other distinct identifiers.
Accordingly, through the way it sets naming policy, FDA can provide the best possible protection for patients, while simultaneously ensuring the highest credibility for biosimilars as they enter the marketplace.

Original Post and letter: http://www.allianceforpatientaccess.org/health-advocacy-organizations-submit-letter-ftc-regarding-biosimilars-naming-policy/

FTC Workshop  on Competitive Impacts of State Regulations and Naming Conventions Concerning Follow-on Biologics: http://www.ftc.gov/news-events/press-releases/2013/11/ftc-host-workshop-competitive-impacts-state-regulations-naming