Britain & Belgium ban Ozempic for Weight Loss ; AMA urges all Payers to Cover Obesity Medications; An Incredible Transformation in Obesity Care; and Being Overweight is the New Normal in America.
From Reuters, reporting on Novo Nordisk’s Ozempic, ‘…Britain and Belgium have temporarily banned its use for weight loss to secure availability for diabetics.’
The American Medical Association said it will ‘…urge all payers to ensure coverage parity for evidence-based treatment of obesity, including FDA-approved medications without exclusions or additional carve-outs…’ from STAT.
Martin Lange, Novo Nordisk executive vice president of development has ‘…a clear vision of being an established cardiovascular company, just as we see ourselves as leaders in diabetes and obesity…’ as per Elaine Chen at STAT.
Dr. Ania Jastreboff from Yale University describes ‘…an incredible transformation…’ in obesity care, in a post from Dr. Ted Kyle at ConscienHealth.
Dr. Jayne, a frontline physician, writes a HIStalk article on ‘…Telehealth organizations across the US are jumping into the weight loss business, making it easier for patients to obtain prescriptions for costly injectable medications.’
WalletHub, a personal finance company with free consumer tools, begins an article with ‘…Being overweight is becoming the new normal in America’.
NEWS
From Reuters, reporting on Novo Nordisk’s Ozempic, ‘…Britain and Belgium have temporarily banned its use for weight loss to secure availability for diabetics.’
Further, Ozempic for type 2 diabetes ‘…has increasingly been prescribed off-label to treat weight loss because it has the same active ingredient as hugely popular but scarce Wegovy.’
German regulator BfArM President Karl Broich was quoted to think about ‘…imposing an export ban so that enough remains in the country for the patients that need it…’ with demand driven by weight loss.
Affordable Medicines Europe, a lobby group of drug wholesale companies said that ‘…exports are not the cause of Ozempic shortages and that countries should instead consider measures to regulate off-label prescription.’
Accordingly, Austria, France, Greece and the Czech Republic have banned exports of Ozempic, and Portugal, Poland, Romania, Belgium, Slovakia and Spain ‘…have rules in place that likely make it impossible to export the drug.’
I fully appreciate the intent here, but making type II diabetes a more worthwhile chronic disease than obesity is not right; the critical issue here is to provide enough of the drug for all who need it, whether their chronic disease is obesity, type II diabetes, or other.
This past Monday, the American Medical Association said it will ‘…urge all payers to ensure coverage parity for evidence-based treatment of obesity, including FDA-approved medications without exclusions or additional carve-outs…’ from Brittany Trang and Elaine Chen at STAT.
Medicare coverage is non-existent and commercial payers are variable; ‘…many insurers viewing them as cosmetic rather than medical treatments…’ with additional concerns on costs, the need for lifelong treatment, and the over 100 million Americans who would be eligible.
Hot on the heels of Novo Nordisk disclosure last week to spend $6 billion Euros on a new production facility in Denmark, competitor Eli Lilly announces ‘…plans new 2 billion Euro German plant.’
A source said ‘…said that the new site would make diabetes drugs with the potential use to treat obesity…’ that are in high demand and low supply right now.
OPINION
Matthew Herper at STAT ‘…sat down with Lilly’s chief scientific officer, Dan Skovronsky, at the AHA meeting…’ in Philadelphia last week to review the recent results of Novo’s SELECT study, amongst other topics.
Skovronsky reviewed the ‘…opportunity for improvement off of 10% weight loss…’ and is ‘…super excited to see this.’
And on the new name, Zepbound, for the obesity drug version of tirzetapide, the Eli Lilly executive said ‘…when we went out to talk to patients, with people with obesity, one of the things that we heard from a lot of people is I want a medicine that I know has been designed for me and tested in people like me…’ though is also aligned with negotiations on drug supply, pricing and indications, through pharmacy benefit managers and insurers.
Martin Lange, Novo Nordisk executive vice president of development has ‘…a clear vision of being an established cardiovascular company, just as we see ourselves as leaders in diabetes and obesity…’ in relation to the recent results of the SELECT study on cardiovascular outcomes for those on its GLP- drug Wegovy, or tirzetapide, as per Elaine Chen at STAT.
Beyond a pure weight loss effect, Lange appropriately posits ‘…inflammation appears to play an important role in the heart benefit that Wegovy provides… [with] …a big unmet need in treatment on inflammation.’
Importantly, and somewhat misunderstood by many, ‘…the cardiovascular risk reduction in patients on Wegovy emerged early on, before big changes in weight…’ such that ‘…patients experienced reductions in high-sensitivity C-reactive protein (hs-CRP), a measure of inflammation.’
In 2020, Novo acquired a drug ziltivekimab that is ‘…a monoclonal antibody directed against interleukin-6 (IL-6), a protein that helps regulate immune responses…’ and with the associated results of the SELECT study could be ‘…a completely novel way to treat cardiovascular disease.’
Dr. Ania Jastreboff from Yale University describes ‘…an incredible transformation…’ in obesity care, in a post from Dr. Ted Kyle at ConscienHealth, related to her podium discussion of the recently presented SELECT study results in Philadelphia.
She adds ‘…we are thinking beyond weight reduction…’ to treating obesity, and improving health outcomes such as a ‘…20% reduction in major adverse cardiovascular events (MACE) – a composite endpoint of cardiovascular death, non-fatal MI, and non-fatal stroke.’
But also, the SELECT trial ‘…limits the generalizability of these results for other populations…’ as it mainly recruited white, non-Hispanic males.
Dr. Jastreboff finishes with ‘…now is the time to treat obesity, improving health outcomes in people with heart disease.’ I could not agree more, nor be more hopeful.
Kate Ruder writes at the Journal of the American Medical Association, or JAMA, on the soaring popularity and adverse effects of semaglutide.
Ruder focuses upon ‘…rare but serious adverse effects have recently emerged for this class of hormone-mimicking medications…’ in reference to the ‘…American Society of Anesthesiologists issued new guidance to stop taking GLP-1 agonists before elective surgery because of safety concerns about vomiting while under anesthesia.’
Dr. Susan Yanovski, at the Office of Obesity Research at the National Institute of Diabetes and Digestive and Kidney Diseases states ‘…Although the incidence is low, people should know about serious adverse effects…’ though ‘…the benefits of these medications are quite likely to outweigh the risks.’
Serious though rare side effects of pancreatitis, gallstones, bowel obstruction and gastroparesis, or stomach paralysis ‘…reinforce that these are potent medications, and all medications have side effects.’
In furtherance, ‘…case reports of depression and suicidality prompted the European Medicines Agency to review about 150 instances of possible self-injury and suicidal thoughts among people using liraglutide or semaglutide.’
There are also long-term risks, including a rare form of thyroid cancer, based on studies in rodents.
Yanovski reasonably adds that ‘…Starting low and going slow is important to minimize side effects…’ in reference to the dosing regimen, and more so that ‘…These drugs don’t work for everybody.’
Total percentage of weight loss for the recent studies on GLP-1 medications is all the rage, but the type of weight lost is important too; more specifically, fat versus lean muscle mass.
STAT news extensively profiles newer medications, that may be provided together with GLP-1 agonists, to preserve, or even increase lean muscle mass, in alignment with fat loss.
For example, BioAge, a California startup focused on increasing the number of healthy years a person lives licensed an oral drug called azelaprag from Amgen in 2021.
Indeed, ‘…azelaprag mimics apelin, a peptide that is released in response to exercise and regulates metabolism and muscle biology.’
There are now plans to ‘…launch a Phase 2 trial in mid-2024 testing whether combining azelaprag with Zepbound [Eli Lilly’s brand name for tirzetapide licensed to treat obesity] could boost weight loss.’
Dr. Jayne, a frontline physician, writes a HIStalk article on ‘…Telehealth organizations across the US are jumping into the weight loss business, making it easier for patients to obtain prescriptions for costly injectable medications.’
Employers are trying to curtail costs, such as ‘…Mayo Clinic’s employee health plan has announced that it will cap weight loss medication expenditures at $20,000 per patient as a lifetime maximum.’
This rightly leads to ‘…an unregulated, uncontrolled clinical trial where time and financial means will be influencing outcomes…’ akin to the two-year maximum period for such medications in the U.K.’s National Health Service.
In the U.S., there is ‘…no incentive for a commercial payer to absorb the cost today in order to realize the savings down the road.’
Mayo Clinic is not alone; others have also removed or reduced coverage for their employees, ‘…including Hennepin Healthcare, Ascension, and the University of Texas System in Austin.’
The Weekly Gist from Chas Roades and Dr. Lisa Bielamowicz relays the same sentiment, in that ‘…We have entered a new era in treating obesity [such that] consumer demand for the drugs has been strong enough to outpace supply.’
From a more rational standpoint, ‘…While these drugs will undoubtedly contribute to higher healthcare spending in the short term, the long-term benefits… could lower healthcare costs over the patient’s lifespan.’
Despite this, the ‘…payer holding the bag for the cost today may not see the return, given that as many as 20 percent of individuals with commercial insurance switch carriers every year.’
‘Wegovy is about to go mainstream…’ is the sub-heading in Yasmin Tayag’s article at The Atlantic, though currently ‘…Wegovy is far too expensive, under-covered by insurance, and in limited supply to be a routine part of health care.’
Kyla Lara-Breitinger, a cardiologist at the Mayo Clinic stated that ‘…Obesity drugs are here to stay…’ and ‘…There’s only going to be more and more of them.’
In the spirit of onward progress to treat cardiovascular disease and obesity, the drugs may even ‘…joining the ranks of commonly used drugs such as statins and metformin.’
Tayag reviews the SELECT study presented at the AHA meeting last week, in that ‘…lower rates of cardiovascular events began showing up before participants lost weight…’ that may be due to ‘…the drug’s impact on inflammation, which is associated with heart disease.’
Reflecting upon the past week, ‘…obesity drugs leapt a new era – one in which they are about to become significantly more mainstream…’ such that ‘…the potential for obesity drugs to truly change America has never felt closer.’
DATA
STAT News Obesity Drug Tracker is updated, to inform on how ‘…the dozens of weight loss drugs in development to catch a booming market.’
Valuable to review for sure.
The tracker will be updated each quarter, and ‘…gives a sense of what new mechanisms could hit the market, how they would be taken and how often, and which companies are running the most trials.’
WalletHub, a personal finance company with free consumer tools, begins an article with ‘…Being overweight is becoming the new normal in America’.
I would posit that this already is the case, with ‘…more than seven in 10 U.S. adults aged 20 and older are either overweight or obese.’
Even more concerning is that ‘…68.6 million Americans aged 6 and older were completely inactive in 2022.’
To ‘…determine where obesity and overweight most dangerously persist, WalletHub compared the 50 states and the District of Columbia across 31 key metrics.’
West Virginia, Mississippi, Kentucky, and Louisiana top the list, with Hawaii, Utah, Colorado, and Massachusetts having the lowest ranked scores.
Closer to my home, Pennsylvania almost tops the list of comfort foods with a Philly Cheese Steak coming in at a whopping 1146 calories per serving; just pipped by 1190 calories for a serving of Wisconsin fried cheese curds.
And at the other end of the spectrum, head to Alaska for king crab legs with butter, at just 220 calories per serving.
It has been reported by the American Society of Clinical Oncology that ‘…40% of obese patients receive insufficient chemotherapy doses and exposures, which may lead to reduced efficacy.’
The paper published in the Journal of Clinical Pharmacology from researchers at the University of North Carolina reviewed the effect of obesity on drug pharmacokinetics and pharmacodynamics – essentially, what the body does to the drug, and what the drug does to the body.
These factors are critically important to ensure dosing and response is just right, not too low that the drug does not have the desired effect, and not too high, such that there are toxic side effects to the patient.
Thus, the optimal dosing metric may be different based on presence and degree of obesity and morbid obesity in patients with cancer.
