A bumper two-week review, with Noom on GLP-1s, Chrissy Farr and Rock Health review metabolic health, bariatric surgery in teens, and more.
June 4, 2023
Noom, a behavior change platform, announces a new program — “Noom Med” — to incorporate anti-obesity medications.
Restriction of access to Ozempic and Wegovy, by ‘…employers’ health plans [who] won’t pay for them…’, is covered by The Wall Street Journal.
Rock Health focuses on whole person view of obesity care, to comprise a serviceable addressable market of almost $13B.
Sima Sistani, CEO at Weightwatchers, is extensively profiled by Lauren Goode in WIRED magazine.
My good friend Chrissy Farr teams up with Sami Inkinen at Virta Health with ‘Obesity is a complex chronic disease - and it's time we treated it as such.’
Oral semaglutide achieved 15.1% weight loss (17.4% if all people adhered to treatment) in adults with obesity or overweight from Novo Nordisk.
In JAMA Surgery this week, bariatric surgery leads to ‘…substantial and long-lasting reduction in the use of lipid-lowering and antidiabetic medications compared with no surgery for obesity…’
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Hope you all had a restful Memorial Day last weekend, are enjoying the summer sunshine, and taking care of the seasonal allergies!
Noom, founded in 2008 as ‘…a consumer-first digital health platform that empowers its users to achieve holistic health outcomes through behavior change and the latest in modern medicine…’ announced a new program, Noom Med, to incorporate anti-obesity medications.
I am completely aligned with the statement ‘…For the millions of Americans who are taking or who have taken GLP-1 medication, though, lasting success is not achievable without a comprehensive behavior change program…’ This is supported by CEO Saeju Jeong’s statement, the ‘…goal isn’t just to help people lose weight – it is to help them avoid chronic illness, increase their lifespan, and enhance their ability to enjoy their lives…’ I could not say it better myself.
The ‘…proven track record of providing personalized and destigmatized weight loss solutions…’ is spot on, and admirable, together with the ‘…strict, clinician-created protocols, and only users who qualify are prescribed medication.’ Noom’s Chief of Medicine, Dr. Linda Anegawa, ratifies the ‘…use of a comprehensive clinical approach, paired with psychological change education and support… to achieve long-term health outcomes.’
It is of interest this program is solely offered for individuals, and not currently a part of the Noom for Work, employer benefit offering; we have seen a number of D2C [direct-to-consumer] weight loss companies expand, or pivot, to D2E [direct-to-employer] offerings, and I see it as only a matter of time before this is the same for Noom Med.
Emma Court at Fortune covers the launch of Noom Med, ‘…aiming to capitalize on the drugs that help people feel fuller and eat less with relatively few side effects.’ Linda Anegawa, Noom’s Chief of Medicine, is quoted: ‘…lasting success is really not often achievable without having that anchor in behavioral change…’, followed by a more aggressive stance that I agree with: ‘…I can throw all the Wegovy at you in the world, but if you don’t have a comprehensive lifestyle program in place, people can still gain weight.’
Restriction of access to Ozempic and Wegovy, by ‘…employers’ health plans [who] won’t pay for them…’, is the thorny topic covered by Anna Wilde Mathews and Ray A. Smith in The Wall Street Journal. The overused and traditional approach for any payer of healthcare is to ‘…add extra requirements to qualify for approval.’ Cody Midlam at Willis Towers Watson, a global insurance broker, states the obvious ‘…It would be unsustainable for many employers…’ and ‘…It’s not something that’s likely been budgeted for.’
A chart sourced by the Journal from the International Foundation of Employee Benefit Plans is well worth the review: about 25% of employer plans offer benefits for Prescription drug coverage for weight loss, 40-60% offer benefits for Bariatric surgery, around 40% offer Fertility benefits, and between 30-50% offer Acupuncture.
Sherry Welliver at Mercer, a large and global human resources and financial consulting services firm, surprises no one in saying that ‘…Many employer health plans are trying to limit off-label use of Ozempic by requiring a diabetes diagnosis and, in some cases, a pharmacy-claims history that shows the patient has taken metformin or another diabetes treatment...’. Or, to put it simply, ‘Extra hoops to jump through…’
To likely avoid favoritism, Tracy Spencer at Aon, another global professional services and management consulting firm, is quoted: ‘…Employers are looking for the guardrails…’ and ‘…to be sure the drugs are used appropriately.’
This is a complex set of scenarios we have entered with respect to payers, providers, pharma, and patients. With TikTok and Instagram hype, fueled by direct-to-consumer telehealth start-up advertising, e.g., ‘A weekly shot to lose weight’, and tempered with clinical effectiveness instilled through multimodal coaching, nutrition and behavioral therapies, I refer to Tara from Kansas City who is pre-diabetic and wary of developing type 2 diabetes, ‘…But for me, it’s a need… It’s a health issue.’
The bias and stigma that has existed for people with obesity should not pervade on access to effective therapies, though I do hang my hat on the absolute necessity to instill a whole-person, multi-modal approach to delivery of care, to the right patient at the right time, over a multi-year period – that includes nutrition, behavioral and physical therapies, with medication and surgery, as and when appropriate. As we know, the only way to truly pay for this approach at a population level, is to develop and deliver a value-based system of care for people with obesity and metabolic disease.
With an extension of the bias that weight is the key factor [through an image of a person standing on a weighing scale], Meg Tirrell in CNN focuses her article on the ‘…new crop of drugs on the market for type 2 diabetes and obesity...’ and the coming transition from weekly injections to a daily pill. But wait, it is not so simple as to pop a pill. The strict requirements of the oral form mean that patients ‘…can’t eat, drink anything other than 4 ounces of water or take other medicines within 30 minutes of taking the drug, or its effects could be diminished…’ as per Dr. Priya Jaisinghani at NYU Langone Health. I do think there is validity in the comment from Dr. Willa Hsueh on ‘…some patients prefer a once-a-week injection rather than a pill, especially if they already take a handful of pills daily.’
A new report from Rock Health on whole person view of obesity care, to stay competitive in an evolving market is published by Camille Bridger, Ali Sussman and Robert Chamberlain. Indeed ‘…weight loss medications are transforming the standard of care in obesity treatment…’ but ‘…they’re not a silver bullet.’ The authors ‘…highlight the importance of a comprehensive and multimodal approach to obesity care…’ with an interesting take on the ‘…twin innovation cycles of GLP-1 development and digital health innovation…’ to comprise a serviceable addressable market of almost $13B. A market map of digital health solutions addressing the obesity market with and without medication are reviewed, from the Found, Calibrate and Noom, to BODi and DietBet, and Virta, Omada and Zanadio. Yours truly was also approached and provided a brief quote on outcomes beyond just weight loss, to ‘…reduction[s] in comorbidities and/or improvement in health, together with a reduction in total cost of care.’ Three competitive takeaways are listed, in terms of a comprehensive and personalized approach to multimodal care, design for health equity to ensure treatment is reaching those who need it most, and third, to generate data to prove impact.
‘Ozempic in Teens Is a Mess’ is the eye-catching headline from Yasmin Tayag in The Atlantic, in reference to the FDA approval back in December for Wegovy as a treatment for teenagers with obesity, currently at 22% of 12-19 year olds. Dr. Aaron Kelly at the University of Minnesota states that ‘…the degree of weight reduction in adolescents was better than what was observed in the adult trials.’ The article continues ‘…Because obesity is a chronic disease, developing it early can be devastating. In many cases, it can result in illnesses such as type 2 diabetes and fatty liver at a young age…’ and to ‘…intervene before the effects of obesity snowball…’ as per Dr. Fatima Cody Stanford of Harvard Medical School. Irrespective of the known challenges, ‘…only two major studies have been conducted on semaglutide in teens, and neither has involved a long follow-up period…’ not only for maintenance of weight loss, but also the physiological impact on pubertal development, and the onward psychological effects. They key is to develop a shared understanding with the patient of their desired goals, and align with treatment through best evidence on risks and benefits, for both short and long term.
Sima Sistani, CEO at Weightwatchers is extensively profiled by Lauren Goode in WIRED magazine. The article describes Sistani’s expression of interest in the company in 2020 on its ‘…emphasis on community…’ and how that ‘…sense of community that had set the company apart from its earliest days…’ since starting in 1962, through to 1968 when it had a million members around the world. A focus on GLP-1 medications for ‘…the communities that need it most do not have access…’ to ‘…try to move policy…’ fully resonates with me. Not for me to get too zealous on the science, but the note from Ms. Sistani that ‘…We’re now able to address the hungry gut through the medications, but still the part that is missing is the hungry brain…’ is too simplistic. GLP-1 medications do not only focus upon gut hormones; they too have an impact upon hedonistic aspects of brain physiology; I think the point that is trying to be made here is correct, on a ‘…dual-action support with medications and behavioral interventions…’ which is based upon medication therapy aligned with nutrition, behavioral and exercise therapy, in a multi-modal, multi-year and individualized, whole-person manner.
A recent survey from Obesity Action Coalition is profiled in Fierce Healthcare, in that ‘…44% of people with obesity would change jobs to gain coverage for treatment.’ such that ‘…Health plan sponsors are facing increasing pressure to cover these medications.’ The narrative from Isabelle Kenyon, CEO at Calibrate, on what she hears from employers is helpful in that they ‘…want to cover these drugs and [I] want to do it in a way that guarantees outcomes and [I] want to do it in a way that contains cost.’ Dr. Jeff Levin-Scherz, population health leader at insurance services company Willis Towers Watson says it well ‘…Employers can also put in a prior authorization or step therapy that people have to go through such as medically guided diets or try less expensive medicines before they go to these more expensive medicines…’ mirrored by Kenyon’s approach to ‘…right medication, right person, right amount of time.’ As we have heard previously, CEO Sir Andrew Witty at UnitedHealth Group, is clear to advance a ‘…a stringent approach to reimbursing these next-generation obesity medications.’
My dear friend Chrissy Farr [who basically told me to start an obesity and metabolic care company back in July 2021] teams up with Sami Inkinen, CEO at Virta Health with the sub-title ‘Obesity is a complex chronic disease - and it's time we treated it as such.’ The message that ‘…3 in 10 Americans are interested in trying a GLP-1…’ is not far off, since almost 1 in 2 Americans will be obese by the year 2030. The total bill for over 100 million Americans to go onto to a GLP-1 medication, at $16,000 per year, is $1.6 trillion, per year, and ‘…almost twice as much as we spend on the military in the U.S. each year.’ Consider this, the ‘…economic cost of excess weight, including things like absenteeism from work, is an estimated $1.7 trillion.’ Even more importantly, across the board of treatments for obesity and metabolic disease, ‘…these approaches should be distributed equitably and made available to those who most need them – not just whoever can afford them.’ In addition to Sami, the article quotes Dr. Michael Albert from Accomplish Health, obesity medicine physicians Dr. Nisha Patel, Dr. Disha Narang, and Dr. Arya Sharma, with the intent to ‘…to treat the right people at the right place.’ And thanks to Chrissy and Sami for the mention of twenty30 health ‘…which advocates for a surgery and medicines plus lifestyle approach.’
‘Oral semaglutide 50 mg achieved 15.1% weight loss (17.4% if all people adhered to treatment) in adults with obesity or overweight in the OASIS 1 trial…’ was the Company Announcement from Novo Nordisk this week. From ‘…667 adults with obesity or overweight with one or more comorbidities… a statistically significant and superior weight loss at week 68 with oral semaglutide 50 mg versus placebo…’ was demonstrated. In addition, ‘…most common adverse events were gastrointestinal, and the vast majority were mild to moderate and diminished over time…’ Whilst I am supportive of this advance in biotechnology, I am more concerned on the real-world level of medication adherence of a once-daily oral pill, versus a weekly subcutaneous injectable; with my prediction that the latter, albeit an injection, will be superior in terms of maintenance of therapy.
The press release was covered by Damian Garde in STAT News, in reference to TD Cowen analyst Michael Nedelcovych ‘…first safe, highly efficacious weight-loss pill ever marketed…’ with plans from Novo Nordisk to ‘…submit oral semaglutide for U.S. and E.U. approvals later this year.’ The runaway train of GLP-1 medications continues to gather speed, more quickly than the railroad tracks are being laid, by health plans, providers, and all associated stakeholders.
Researchers at Pfizer published in JAMA Network Open on ‘Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron...’ on efficacy, safety, and tolerability in 411 adults with type 2 diabetes, from 97 clinical research sites in 8 countries or regions, over a 16-week period. Importantly, this is a phase 2b clinical study, in that the ‘…primary efficacy end point was change from baseline in HbA1c at week 16…’ in conjunction with safety defined in terms of recorded adverse events. There was a reduction in glycated hemoglobin of 1.16% across all groups, with a greater than 5% loss of body weight in 6% to 47% of subjects, compared to 2% of those in the placebo arm of the trial. On safety, over half [55%] of participants experienced adverse events, with about two thirds reported as mild; the ‘…most commonly reported TEAEs [treatment-emergent adverse events] were nausea… diarrhea… and vomiting.’ The key here is that the oral molecule achieved improvements in glycemic control, and weight loss, over a relatively short 16-week time period.
In JAMA Surgery this week, authors from Sweden, Finland and England sought to ‘…clarify the long-term use of lipid-lowering, cardiovascular, and antidiabetic medication after bariatric surgery compared with no surgery for morbid obesity…’ on over 26,000 Swedish and Finnish patients having undergone bariatric surgery in comparison with over 130,000 who were similar in obesity and co-morbidities, but did not have surgery. At two years after bariatric surgery, fewer patients were taking lipid lowering [from baseline 20% to 13%], cardiovascular [from baseline 60% to 43%], and antidiabetic [from baseline 28% to 10%] medications. By 15 years after surgery, though many of the patients who had had bariatric surgery were back on their original lipid, cardiac and diabetic medications, for lipid and diabetic medications, this was a far lower percentage of patients than those who had not undergone surgery. To clarify further, antidiabetic medication use was back up to 24% of those in the surgery group [compared to 28% at baseline, and 10% at 2 years], but antidiabetic medication usage had increased substantially from 28% at baseline to a whopping 54% after 15 years. The take home message here is that bariatric surgery leads to ‘…substantial and long-lasting reduction in the use of lipid-lowering and antidiabetic medications compared with no surgery for obesity…’ thought the effect was not prominent for the same with cardiovascular medications. Two additional items – first that registries and recording of clinical data at a population level is complete and impressive in Sweden and Finland; and second that long-term analyses of data in a robust scientific manner are rare. And lastly, the authors clearly state ‘…Economically, the long-lasting reductions in medication use for hyperlipidemia, cardiovascular morbidity, and diabetes suggest that surgical treatment of morbid obesity may infer savings in medication expenses for patients, health care, and society.’ Well said!
A research letter in JAMA Pediatrics sets the scene with ‘…Pediatric obesity is associated with cardiometabolic comorbidities, liver and kidney disease, and lower quality of life, and these associations continue into adulthood.’ This is closely followed by ‘…among youth with severe obesity… Metabolic and bariatric surgery (MBS) is a safe and effective treatment.’ Based upon the 2019 guidelines form the American Academy of Pediatrics to increase adolescent access to MBS, and through review of data from over 1.3 million patients in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database, the authors found ‘…Use of and access to MBS have increased among US youth and among most racial and ethnic groups.’ Indeed, the authors continue to state that there is ‘…cautious optimism regarding the decreasing barriers to MBS for those US youth in need.’
‘…thorough screening for mental health problems in patients with obesity is urgently called for to allow prevention and facilitate adequate treatment’ is the call to action from researchers in Vienna, Austria. They linked data on just over 3 million patients, between a hospital diagnosis of obesity and psychiatric disorders, between 1997 and 2014. They key finding was that ‘…Receiving a diagnosis of obesity significantly increased the odds for a large spectrum of psychiatric disorders across all age groups, including depression, psychosis-spectrum, anxiety, eating and personality disorders....’ and ‘…with women showing increased risk for all disorders…’ in addition to those ‘…in young age groups.’
Not entirely unsurprising data was published in JAMA Network Open on almost 100,000 patients with diabetes and/or heart failure on ‘…adherence to glucagon-like peptide-1 receptor agonist (GLP1-RA)…’ in view of prescription co-payments. Medication adherence at 80% or greater over a one-year period for those on GLP-1 medications was 38% lower with a medium [$10 to <$50] co-payment, and 53% lower in those with a high [>$50] co-payment, compared to those with a low [<$10] co-payment. The final message is ‘…Lowering high out-of-pocket prescription costs may be key to improving adherence to guideline-recommended therapies and advancing overall quality of care in T2D and HF management.’
Elaine Chen at STAT News covered the co-payment study, with the note that ‘…insurance coverage alone doesn’t guarantee that people can afford or would be willing to pay continuously for chronic disease medications like Ozempic.’
The world renown Dana-Faber Cancer Institute reports on a clinical trial ‘…that a telephone-based weight loss program can help patients with breast cancer whose body mass index is in the overweight or obese range lower their weight by a meaningful degree.’ The findings are due to be presented at the American Society of Clinical Oncology meeting in Chicago this week, with the intent to ‘…set the stage for follow-up research into whether this type of program can extend patients' survival and lower their risk of a breast cancer recurrence.’ Principal investigator Dr. Jennifer Ligibel states ‘…Women who received the telephone-based intervention lost an average of 4.8% of their baseline body weight, compared to an average 0.9% increase in body weight among those in the control group…’ with the hope ‘…that healthy lifestyle change after a cancer diagnosis has a positive impact on outcomes.’
Kind regards, Raj
Very informative.