from the editor

August 23, 2013

When our team first laid out diaTribe’s mission statement more than 50 issues ago, we knew that we would be writing for those who believe in optimal management of their diabetes. That goal can mean so many different things, and the topics we write about – including new therapies, lifestyle changes, and technologies in development– strive to show the different ways to achieve better diabetes management. For most of us, good management starts with optimal blood glucose monitoring. Accurate and reliable test strips are an essential part of diabetes care, but they are not always easy to access.

We recognize how hard it is for many patients to pay for optimal glucose monitoring. Some have lost insurance, some never had it, and others have restricted access to strips. In a small gesture to help 20 diaTribe readers, for this month’s issue, we are giving away a year’s supply of strips to one winner as well as a prize of 100 strips each to 19 runner-ups. Visit diatribe.org/giveaway/mystrips to enter. Even if you don’t need strips, you can enter to win and then donate them to someone who does! All winners will receive the test strip brand of their choice, and the giveaway will run until September 30, 2013.

These prizes are meant to call attention to the diminished access to strips, because a new Medicare policy called “competitive bidding” may threaten the quality of test strips for millions of people with diabetes. The details can be fairly technical, but competitive bidding aims to cut Medicare spending on various medical supplies, including test strips, by awarding contracts to the lowest bidders. While a drop in the price of a 50-strip box from $35.91 to $10.41 sounds good in theory, especially for patients who pay for the full cost out of pocket, such a drop in cost also has serious tradeoffs. Many companies are already experiencing declining revenues, and the 70% cut in Medicare payments means less money to fund innovative products, conduct proper quality checks, and provide customer service (e.g. we fear that there will be no 1-800 helpline numbers to call on some strips when products are not working as they should).

And what happens to test strip accuracy in light of competitive bidding? The answer is unknown at present, but it’s a real concern when the program institutes a system that prioritizes low prices over high quality and reliable products. All blood glucose strips are not created equal, and not all actually meet the quality standards for which they were originally approved, something the FDA acknowledged in May. This is a huge issue for patients, because the use of less reliable strips can lead to poorer glucose control as well as increased risks resulting from incorrect insulin dosing for those that take insulin. Watch this video from patient advocate, SixUntilMe blogger, and diaTribe columnist Kerri Sparling on this subject.

But hey! We’re going to have a real opportunity to have our voices heard on this issue just next week. The FDA has scheduled a meeting on September 9 to discuss the performance of blood glucose strips following approval. diaTribe will be attending, and we’re particularly interested in hearing from patient advocate Bennet Dunlap from the Strip Safely campaign. Bennet will speak on behalf of patients and emphasize the importance of accurate glucose test strips, the need for ongoing monitoring of test strip quality, and more. Let Bennet know here what you would want to tell the FDA.

What we’d like to see come out of this meeting is for the FDA to provide a clear plan for how it will establish and enforce strip and meter accuracy on an ongoing basis. Currently, there is no mechanism in place to ensure that approved test strips and meters maintain accuracy and quality over time. In our view, the FDA has a clear responsibility to actively monitor device performance, especially in an area as critical as glucose meter accuracy. We hope the FDA will also address monitoring the quality of strips made overseas, by companies both big and small; while products manufactured internationally are obviously not necessarily less reliable, international production makes it harder for the FDA to ensure proper procedures during manufacturing. How they assess the “supply chain” is a challenge we would love to see addressed. All this will certainly cost money, and we know that the FDA is significantly under-resourced - we don't expect them to fund this without a lot of help.

We also hope to advocate for the FDA to create a patient-led advisory committee on diabetes - something diaTribe first called for back in 2007.  We've always thought a lot about the impact the FDA can have on diabetes care. We were very encouraged to see that the agency is holding a series of 20 patient meetings in 2014 and 2015, with each meeting focused on a major disease. The FDA has already announced plans to hold sixteen of these meetings on diseases such as breast cancer, HIV, and lung cancer (diseases with very active advocacy!), but diabetes has not been included. We’ve started a petition to urge the agency to hold a patient meeting on diabetes - our goal is to show that patients care about this disease, that we have plenty of personal expertise to weigh in on the approval of new therapies (this is what FDA does, after all), and perhaps most importantly, to share our perspective on what living with diabetes is like. Please sign it here and persuade anyone you know who cares about diabetes to sign – there are only four meetings left and it is unacceptable in our view for diabetes to be excluded from such an important public health dialogue. For more ideas on how to make your voice heard, check out our previous piece on patient advocacy. Remember you’ll always have an advocate in diaTribe; we’ll be at the September 9 meeting and other important events, and if you have any comments you would us to pass along to the FDA, please send them to us.

Again, please don’t forget to enter our Test Strip Giveaway for a chance to win a year’s supply of test strips for you or a friend. ‘Til next month…

Very best,

Kelly L. Close

 

 

the fine print*

  • While it’s true that optimal glucose management is important to all people with diabetes, what “optimal” might mean can vary, and some people need very infrequent glucose management. For example, patients who are at their targets and are not at risk of hypoglycemia; for example, recently diagnosed patients with type 2 diabetes who do not take sulfonylureas (see a list of drugs of this type here) or insulin. For these patients, structured glucose monitoring (testing pre- and post-meals and before bedtime over a two or three day period) or periodic use of CGM may be more valuable – we always urge patients to check with their healthcare teams to make sure their glycemic management is optimal on a long-term basis.
  • How does competitive bidding work? In essence, companies submit bids to supply Medicare beneficiaries with diabetes products, and Medicare gives contracts to the lowest bidders. The goal is to reduce the spending by Medicare while theoretically maintaining high quality, hence contracts generally go to the lower bidders. The system tends to eliminate companies that sell their products at higher prices, often in favor of lesser-known companies that sell strips at much lower prices. We think there should be a balance between making affordable products and enabling companies to invest in research, innovation, and customer service. Based on our research, companies are now receiving 70% less funding for the same product they sold before July 1, leaving fewer resources to go into areas of investment we feel are important – research and development, customer service, and quality control. Pricing ‘pressure’ is not new – and a price cut this large was not expected. Profitability per company is not disclosed, but revenue has been falling for several years.
  • The FDA has acknowledged that not all currently available strips meet the accuracy standards for which they were originally approved. Some unreliable strips currently remain on the market, and we know it is much more challenging for the FDA to monitor the quality of all strips, particularly those that are manufactured in regions that are more challenging and expensive for them to inspect. A recent study published in the Journal of Diabetes, Science, and Technology compared the performance of seven blood glucose meters: the Accu-Chek Aviva Plus (Roche), Advocate Redi-Code, Element, Embrace, Prodigy Voice, TRUEbalance, and WaveSense Presto. None of the less well-known meters or strips met the newest International Standard for glucose meter accuracy for all samples tested, while the Aviva Plus did. For full disclosure, the study was sponsored by Roche (maker of the Accu-Chek Aviva Plus), though we believe the data is worth acknowledging, especially because it was published in a peer-reviewed journal. In our view, the important takeaway comes back to the FDA's conclusion - all currently available strips do not meet the accuracy standards for which they were originally approved. We hope the September 9 meeting crystallizes the problems and proposes some solutions and next steps. 

* While I’ve tried to keep the letter as straightforward as possible, our more technically inclined readers may want to check out this section for the full details behind some of our points, including some context and resources for those who want to learn more.

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