Wegovy for Medicare Beneficiaries; Bariatric Surgery Restrictions Eased by GLP-1 Costs; $6B Spend on GLP-1s by Medicare in 2022; $5 Per Month to Manufacture Ozempic; Viking Therapeutics Stock Charges

AT A GLANCE

  • San Diego biotech Viking Therapeutics shares were up 20% on news that the oral version of dual GLP-1/GIP drug VK2735 had succeeded its phase 1 trial.
  • Peter Loftus at The Wall Street Journal reports CVS Health, Elevance Health and Kaiser Permanente would cover Wegovy for Medicare beneficiaries.
  • Miriam E. Tucker at Medscape suggests ‘GLP-1 Costs May Ease Restrictions to Bariatric Surgery.’
  • The Kaiser Family Foundation analyzed Medicare spend on GLP-1 medications, rising from $57 million in 2018 to $5.7 billion in 2022, mostly from Ozempic.
  • The journal Gastroenterology notes an increased risk of aspiration pneumonia associated with endoscopic procedures among patients with GLP-1 drug use.
  • In JAMA Network Openan economic evaluation of manufacturing costs of monthly injectable Ozempic came in at between $0.89 to $4.73.

NEWS

  • San Diego biotech Viking Therapeutics shares were up 20% on news that the oral version of its dual GLP-1/GIP drug VK2735 had succeeded in its phase 1 trial.
    • At four weeks, there was up to 5.3% total weight loss, with additional weight loss likely beyond the 28-day treatment period.
    • Chief executive Brian Lian PhD said the results highlight the ‘…promising early weight loss and tolerability profile when dosed as an oral tablet.’
    • For patients on the highest dose, only 25% experienced nausea, which was mild in nature – this is much lower than other similar medications – but note the treatment period of just four weeks.
    • The drug is due to be moved to more extensive phase two trials.
    • Most recently, the Company said that the injectable form of VK2735 helped patients lose up to 15% weight over three months, with a doubling of the share price doubled on that announcement.
    • Viking is now a $9 billion company, and a prime acquisition target for Novo, Eli Lilly, Pfizer and other major players.
  • Peter Loftus at The Wall Street Journal reports CVS Health, Elevance Health and Kaiser Permanente ‘…said they would cover Novo Nordisk’s Wegovy for the use of reducing the risk of heart attacks and strokes in people who have cardiovascular disease, meet body-weight criteria and are covered by a Medicare drug-benefit plan.’
    • Kaiser Permanente is making the coverage change effective immediately, while Elevance and others will do so in the coming weeks; naturally, other Medicare and commercial health plans might now feel pressure to follow suit and begin coverage. 
    • And billions of dollars in additional sales for Novo Nordisk and Eli Lilly.
    • At time of writing, Humana said it is reviewing the CMS guidance while mammoth UnitedHealth Group declined to comment.
    • We are truly beyond the point of no return to manage obesity as a chronic disease… which is great news.
    • Beyond this, we need to be focused upon a multimodal approach to care delivery, incorporating nutrition, behavioral, exercise, medication and surgical therapies, just like we take manage all other chronic diseases; a pill or injection in silo is not enough, nor viable.  

OPINION

  • Dr. Mara Gordon, a family physician in Camden, New Jersey writes in NPR that patients ‘…believe Ozempic will give them higher self-esteem, happier marriages, more energy, less back pain.
    • People seem convinced this medication can do it all.’ Dr. Gordon continues ‘…Our society is obsessed with thinness…’ and ‘…that our bodies are never good enough.’
    • On the miracle drug Ozempic, rather than ‘…fixing discrimination against people with bigger bodies, we tell patients to fix themselves.’
    • I am ambivalent on the note that GLP-1 medications do not ‘…undo the harms of diet culture, distorted body image and pervasive weight stigma.’
    • Indeed, medications for weight loss help to destigmatize obesity as a failure of willpower; rather a chronic disease that can and should be treated in the same manner as we do for people with diabetes, hypertension, and cancer.
    • It is woefully true that whilst Ozempic can treat obesity and its co-morbidities, ‘…it can’t fix fat phobia.’
    • That is a much bigger mountain for us to climb, and propagated by the off-label use of such medications – just as was mentioned in the recent Eli Lilly commercial during this year’s Oscars’ ceremony.
  • Miriam E. Tucker at Medscape suggests ‘GLP-1 Costs May Ease Restrictions to Bariatric Surgery.’
    • For example, Geisinger Health of Pennsylvania and Blue Cross/Blue Shield of Massachusetts expanded BMI eligibility for bariatric surgery procedures, while Blue Cross Blue Shield of Michigan dropped prior authorization requirements.
    • This may be in response to the high costs of GLP-1 medications, and a lack of data on cost-effectiveness.
    • However, Dr. Chris Still at Geisinger Medical Center said ‘…Geisinger Health Plan’s change in May 2023 to lower the BMI surgery eligibility cutoff from 35 to 30 for people with comorbidities was not related to the cost of GLP-1 drugs…’ and more focused upon the effective and enduring treatment of obesity and its co-morbidities.
    • The Geisinger Health Plan does not currently cover anti-obesity medications.
    • Health economist James Chambers at Tufts University says ‘…So now that you have these expensive drugs, it’s not that surgeries become less expensive, but it does make you interpret the cost differently.
    • Cristy Gallagher, at the STOP Obesity Alliance at the Milken Institute School of Public Health at George Washington University, added ‘…you will not see a decrease in bariatric surgery in the near term, by any means.’
    • agree wholeheartedly with Ted Kyle – it is not an either/or proposition – we need to think of it as the right treatment for the right patient at the right time – just as we take care of patients with cancer – radiotherapy, chemotherapy and surgery are all combined to achieve cure.
    • We need to be bullish ‘…toward more integrated approaches to obesity…’ with surgery as a key tenet of care.  
  • STAT publishes from Lisa Shah, chief medical officer at metabolic disease company Twin Health, who ‘…was troubled by Oprah’s support for these [GLP-1] drugs.’
    • She states the show ‘…sounded to me more like an hour-long infomercial…’ with the conversation being ‘…driven by pharmaceutical companies and their proxies, rather than practicing clinicians.’
    • The drugs are expensive, need to be taken forever, have notable side effects, and ‘…for most people, GLP-1 drugs aren’t sustainable.
    • Dr. Shah writes that the ‘…lasting solution will be unique to each individual because no two people’s metabolisms, genetics, and preferences are exactly alike…’ in a likely nod to the precision treatment program powered by the Whole Body Digital Twin technology at Twin Health.
    • For me, the jury is still out on precision medicine approaches to obesity care; we do not need to overthink this one.

DATA

  • The Kaiser Family Foundation analyzed Medicare Part D outpatient drug benefit program, in terms of the spend on GLP-1 medications.
    • There has been an alarming rise from $57 million in 2018 to $5.7 billion in 2022, mostly from Ozempic and more recently in 2022 from Mounjaro too.
    • Ozempic rose from a 10th place ranking with gross spending of $2.6 billion, to 6th place in 2022, with spending of $4.6 billion.
    • Further, Ozempic accounted for 2% of the total gross spending under Medicare Part D at $240 billion in 2022.
    • The article continues ‘…Medicare could select this product for drug price negotiation as early as 2025…’, which is just over seven years past its earliest FDA approval in late 2017.
    • Indeed, a negotiated Medicare price would be available beginning in 2027, with intent to lower total Medicare spending on semaglutide products, including Ozempic, Rybelsus, and Wegovy.
    • In the interim, be prepared for intense demand, new uses, and high prices to place tremendous pressure on Medicare spending, and premiums too.
  • Aspiration pneumonia, due to gastric contents refluxing into the lungs, is a serious complication of any anesthetic procedure.
    • A study published in medical journal Gastroenterology notes an increased risk of aspiration pneumonia associated with endoscopic procedures among patients with GLP-1 drug use.
    • The risk was low, at 0.83%, but was 33% higher than those not on GLP-1s.
    • Ali Rezaie, study author and medical director of the GI Motility Program at Cedars-Sinai said ‘…They’re here to stay and their use is going to increase. They just have this complication.’
    • Consider from the 20 million endoscopies taking place in the US every year; just 1% is 200,000 patients – certainly not an insignificant number.
  • In JAMA Network Openan economic evaluation of manufacturing costs of diabetes medicines, with a focus on GLP-1 drugs, landed at $0.75 to $72.49 per month.
    • Injectable semaglutide, or Ozempic came in at between $0.89 to $4.73, with the oral version more expensive at between $38.62 to $72.49.
    • Data was taken from a commercial database of trade shipments and combined with costs of formulation and other operating expenses, plus a profit margin with an allowance for tax.
    • The prices were substantially lower than current prices and suggest that robust generic and biosimilar competition could reduce prices to more affordable levels and enable expansion of diabetes treatment globally.

DR.RAJESH TWENTLY 30 HEALTH


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