Good evening from your Close Concerns team ... we've got our heads down working on our final ADA report as we enjoy the California sunshine after a busy week in Chicago. Tonight, we have plenty of news on the technology front: a piece on CGM use in clinical trials (our views on this important area, including key benefits and barriers), two updates on the BGM competitive bidding front (all the latest including Congress' letter and Abbott's compelling message to patients), and obesity updates from EnteroMedics and GI Dynamics.

Diabetes Drugs

1. Use of CGM in clinical trials of diabetes drugs - a look at the EU and implications elsewhere

Diabetes Technology

2. CMS BGM update - Congress submits letter to CMS asking it to delay implementing Round 2 of competitive bidding - solid bipartisan support but no change as July 1 deadline comes and goes

3. Abbott airs two advertisements on Medicare's payment adjustments (summary below)

4. GSMA mHealth cycling study to use Dexcom's Gen 5 CGM, sending real-time glucose data directly to smartphone (summary below)


5. NIH/JDRF/FDA Final Report: "Workshop on Innovation Towards an Artificial Pancreas"

6. ADA 2013 daily reports, in case you missed them: Day #1, Day #2, Day #3, Day #4, and Day #5. We're hard at work on our final report!


7. EnteroMedics files PMA with the FDA for its VBLOC Therapy (summary below)

8. GI Dynamics receives approval from the French Ministry of Social Affairs and Health for a two- year clinical utility study of the EndoBarrier (summary below)


1. Following the 2012 release of new EMA guidelines on developing diabetes drugs, we've been thinking a lot about the potential use of CGM in clinical trials of diabetes drugs and what will happen in the EU - click here to read our thoughts on how CGM is moving ahead. Our piece outlines key benefits to using CGM in clinical trials and the key barriers to overcome, based on a range of interesting discussions with HCPs. We also provide some examples of drug trials using CGM and highlight our list of key questions. We think this is a topic that will get much more attention in the coming years from companies and regulators - read our report to find out why.

2. On June 12, Congress submitted a letter to the Centers for Medicare and Medicaid Services' Administrator Marilyn Tavenner requesting that CMS delay implementing the Round 2 competitive bidding program through the end of 2013 - ultimately this did not make a difference - read our report. Currently, the program is slated to go into effect on July 1. The letter was signed by 227 members of the House of Representatives and had solid bipartisan support. About 60% of House Republicans and 40% of House Democrats signed, according to the news headline. Our full report includes discussion on the letter and on the Medicare DMEPOS Market Pricing Program Act of 2013. We hope that CMS will be open to rethinking competitive bidding and its approach to curbing healthcare expenditures in a way that places patients' best interests at the forefront of the discussion. With competitive bidding just three days away, we look to CMS to see whether any action will be taken.

3. With payment amounts from the national competitive bidding program slated to go into effect on July 1, Abbott has recently shown two television spots on Medicare's payment adjustments - one of the advertisements can be viewed on Abbott's homepage here (click on the triangular play button next to the "Medicare Part B" sign). The pieces mention that suppliers could try to switch patients to a brand "you've never heard of" and "that might not be as accurate." (The list of the contracted suppliers is available at this link. The Arriva Medical, which was acquired by Alere in 2011, was the only supplier familiar to us on the list.) In November 2010, CMS finalized the Anti-Switching provision as part of the competitive bidding program, which "prohibits contract suppliers from influencing or incentivizing beneficiaries to switch their current glucose monitor and testing supplies brand to another brand." We certainly know (and Abbott's commercial seems to suggest) that suppliers are circumventing this provision, and there has been public discussion about whether CMS lacks the resources to widely enforce it. The latter is, unfortunately, not surprising given the House of Representatives' letter to CMS (see above), which suggested that the Round 2 competitive bidding program may not have been properly executed according to its present design: "Further analyses also suggest that many contract suppliers in Round 2 bid areas are not accredited, nor certified in the specific product category for which they have been awarded a contract." As a reminder, the national mail-order competitive bidding program for diabetes supplies was conducted in concert with Round 2; we can't imagine that the new CMS prices can support quality, accuracy, or future innovation. In very winning style, Abbott's television spots reaffirm its commitment to Medicare patients, a welcome statement amidst the challenges and uncertainties affecting the US blood glucose monitoring market. There were a number of statements at ADA that this would have been an excellent venue for various stakeholders to discuss the implications of this CMS change; we hope that some sort of forum takes place at AADE.

4. GSMA recently announced a unique clinical study for its mHealth Grand Tour in September 2013 - read the press release. The tour is in partnership with IDF Europe and is intended to raise awareness of diabetes and promote mHealth solutions. Notably, the 13-day cycling ride will feature a live research study of the effects of multi-day endurance exercise on blood glucose levels - riders wearing the next-gen Dexcom G5 glucose monitor will have their glucose levels transmitted wirelessly (via ANT+) to smartphones. Heart rate and bike computer statistics will also be wirelessly sent to the mobile devices. We're glad to see this seamless integration and transmission of glucose and other data - we think collecting and aggregating health data in a hassle free way is the first step towards enabling patients and HCPs to make actionable changes in therapy (the second step is of course turning the collected data into something comprehensible and useful). We couldn't agree more with Rod Morris, VP of ANT Wireless, "The key to mHealth is to simply and unobtrusively track physiological data and deliver it to the cloud. When that data is delivered seamlessly to a variety of hubs for analysis, people realize the real benefits."

5. FDA/JDRF/NIH Workshop on Innovation Towards an Artificial Pancreas - rich discussion on the next steps in AP development. In today's missive, we bring you our full coverage of the FDA/JDRF/NIH Workshop on Innovation Towards an Artificial Pancreas - read our report. The meeting was held in Bethesda, Maryland on April 9-10. Looking back, we are struck by the vast number of bright minds that the meeting brought together and the diversity of organizations represented. The workshop provided both forum and fodder for rich discussion on how best to overcome barriers to artificial pancreas development. We thought the dialogue was highly valuable and hope to see it influence near-term approaches. Overwhelmingly, speakers encouraged the community to adopt a "big picture" view of AP systems and consider them in the context of today's standard of care. The sentiment that "perfect should not be the enemy of good" underlaid much of the discussion. For our major conference takeaways and individual presentation coverage, see our full report.

6. We're been hard at work on our final ADA 2013 full report and themes, but in case you missed them, here are the links to our daily reports: Day #1, Day #2, Day #3, Day #4, and Day #5 and our exhibit report. Stay tuned for much more coverage on ADA 2013, and if you have thoughts on the meeting that you would like to share with us, please send along!

7. On June 25, Enteromedics submitted the PMA for its obesity treatment VBLOC Therapy to the FDA - read the press release. The filing is on target with the timeline forecasted in the company's 1Q13 update. At that time, management had also expected an advisory committee panel for the device to be held in 4Q13/1Q14 and described a "receptiveness" on the part of the Agency towards obesity interventions. As a reminder, VBLOC therapy intermittently blocks vagal- nerve signaling and is delivered through an implantable, pacemaker-like device. For detail on the company's US pivotal trial, ReCharge, see our February 8 Closer Look email - as a reminder, results fell short of the predefined efficacy endpoint.

3. GI Dynamics recently announced that the French Ministry of Social Affairs and Health approved a two-year clinical utility study (ENDOMETAB) for the EndoBarrier Gastrointestinal Liner - read the press release. ENDOMETAB is intended to support national reimbursement for the EndoBarrier in France. The multi-center study (n=174) will compare the cost and health impact of 12 months of EndoBarrier therapy to 12 months of standard care (lifestyle counseling and modification). ENDOMETAB will include obese patients with and without diabetes, perhaps setting the stage for wide market potential. The approval could represent an important vote of confidence in the device from French authorities, who will also be financing the 1.16 million euro study (~$1.55 million). As previously stated in GI Dynamics' quarterly updates, national reimbursement is a key part of the company's commercial strategy and long-term revenue stream. We'll be interested to see ENDOMETAB could facilitate easier approval for reimbursement studies in other European countries. At the time of GI Dynamics' Annual Meeting this May, management was aiming to secure approval for government-funded reimbursement studies in both France and the UK in 2013. As a reminder, the EndoBarrier is a flexible, tube-shaped liner. Partially digested food  passes from the stomach and through the EndoBarrier; the body's natural peristalsis moves food inside of the liner, while bile and enzymes pass outside the EndoBarrier. The device was available at 37 commercial centers worldwide at the end of 1Q13. For greater discussion on GI Dynamics, the EndoBarrier, and the company's ongoing US pivotal trial, see our coverage of GI Dynamics' Annual Meeting here.

Have a great rest of the week. Happy 4th of July to those who celebrate!

very best, kelly

Kelly L. Close


Close Concerns

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