Access Battle for New Generation Obesity Drugs Health Equity 04/04/2024 • Zuzanna Stawiska Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) The new generation of obesity drugs have reached sky-high popularity – and command high prices. Demand for diabetes drugs such as Wegovy, Ozempic, Rybelsis and Trulicity has soared since they have been clinically proven to help weight loss – but they are massively overpriced in the US and unavailable in most low- and middle-income countries (LMIC), according to Médecins Sans Frontières (MSF). The mark-up for these drugs – called glucagon-like peptide 1 agonists (GLP-1) – in the US is almost 40,000%, according to a paper published in JAMA last week authored by Yale University’s Dr Melissa Barber and MSF’s Dr Dzintars Gotham, Dr Helen Bygrave and Christa Cepuch. The authors modelled the manufacturing costs of a variety of diabetes medications and added a modest profit margin. “MSF’s study estimates that GLP-1s for diabetes could be sold at a profit for just $0.89 per month, compared to the price of $95 per month charged in Brazil, $115 per month charged in South Africa, $230 charged in Latvia and at least $353 charged in the US [based on Medicare price], which is a 39,562% markup over what the estimated generic price could be,” according to MSF’s press release. In fact, the US drug costs are usually much higher, reaching as much as about $1000 monthly. Novo Nordisk makes both Ozempic and Wegovy (which contains a higher dose of the active ingredient, semaglutide, than Ozempic), while Eli Lilly makes Trulicity. Some are oral pills and others are injections. US Senator Bernie Sanders has called on Novo Nordisk to lower the price of Ozempic Wegovy in the US to no more than what they charge for this drug in Canada. “The American people are sick and tired of paying, by far, the highest prices in the world for prescription drugs while the pharmaceutical industry enjoys huge profits,” said Sanders in a statement. “As a result of a major grassroots movement, Novo Nordisk did the right thing by recently reducing the price of its insulin products by some 75% in America. Novo Nordisk, a company that made nearly $15 billion in profits last year, must now do the right thing with respect to Ozempic and Wegovy,” added Sanders, who chairs the US Senate Health, Education, Labor, and Pensions Committee. FDA approval for weight management While GLP-1 drugs were made to treat diabetes, in 2021 the US Food and Drug Administration (FDA) approved Wegovy for weight management in people with a body-mass index (BMI) of over 30, or a BMI of over 27 with underlying conditions such as high blood pressure. “Novo Nordisk and Eli Lilly are the only producers of these GLP-1s today, and their intellectual property barriers on the drugs and injection devices block any generic manufacturing that could help drive prices down,” MSF notes. “The corporations have not even announced a price for low- and middle-income countries, nor have they licensed these drugs so that generic manufacturers could make them, which would help to meet global demand and drive prices down,” MSF says, noting that because they are now being used for weight loss in high-income countries, the companies are “unable to meet the massive demand”. Co-author Christa Cepuch, pharmacist coordinator at MSF’s Access Campaign, describes the new drugs as “an absolute game changer for people living with diabetes”, but cannot be accessed by people in LMICs. “Eli Lilly and Novo Nordisk can in no way supply the world with the amount of these medicines needed to meet global demand, so they must immediately relinquish their stranglehold and allow them to be produced by more manufacturers around the world,” said Cepuch. The steep price of the drugs is hampering access even in the US, although the country’s federal health insurance programme, Medicare, recently struck a deal with Novo Nordisk, to cover the cost of Wegovy – but strictly for preventing heart attacks and strokes not for weight loss, Reuters reported. “The American people are sick and tired of paying, by far, the highest prices in the world for prescription drugs while the pharmaceutical industry enjoys huge profits,” said sen. Bernie Sanders, Chairman of the Senate Committee on Health, Education, Labor, and Pensions on the US cost of GLP-1s. “Ozempic has the potential to be a game changer in the diabetes and obesity epidemics in America. But, if we do not substantially reduce the price of this drug, millions who need it will be unable to afford it,” he continued. Obesity’s heavy burden The GLP-1 drugs stimulate insulin production and feeling of satiety (fullness), promote weight loss, lower blood pressure and cholesterol, improve blood flow in the heart and uptake of glucose in the muscles, according to the US National Institute of Health. Side effects can include commonly nausea, diarrhea, vomiting, constipation, stomach pain, headache or stomach flu, and less often, depression with suicidal thoughts or kidney failure. Doctors warn that they need to be taken alongside a healthy diet and exercise. The US accounts for almost three-quarters of the sale of Novo-Nordisk’s Ozempic, Wegovy and Rybelsus, according to Pew Research Center. The country has an adult obesity rate of 42%, according to the American CDC, one of the highest in the world. Despite steep prices and side-effects, GLP-1s have become wildly popular in the last few years, especially in the US. Obesity is a growing problem worldwide, affecting 890 million adults – 16% of the global population – in 2022, according to the World Health Organization (WHO). The prevalence of this condition more than doubled between 1990 and 2022. Global costs of obesity and overweight are predicted to reach $3 trillion per year by 2030 and more than $18 trillion by 2060 at the current rate. In relation to obesity, World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus recently stressed that the private sector “must be held accountable for the health impacts of their products” as Health Policy Watch reported – a reference to the impact of products such as ultra-processed food and sugary drinks on obesity. Being overweight and obese increases people’s risk for type 2 diabetes, heart disease and cancer, WHO highlights, also affecting bone health and reproduction and increase the risk of certain cancers. Both conditions can be affected by gene composition, but are mostly a result of an imbalance of energy intake (diet) and energy expenditure (physical activity). As such, are largely dependent on the options the environment offers. “Obesity is a societal rather than an individual responsibility, with the solutions to be found through the creation of supportive environments and communities,” WHO says. The analytics platform, Airfinity, argues that it would be beneficial for public health to administer Wegovy to not only to diabetics type 2 patients, as the current Medicare deal allows, but to all people in the US with a BMI over 40. If 60% of people living with obesity and 40% of those of a BMI above 35 received the drugs, this could prevent as many as 300 000 heart failures in the US by 2030, according to Airfinity World distribution of obesity. Safe the extreme numbers for small populations (on the right), some Middle Eastern countries and the US show highest percentages. The demand for the Novo Nordisk drugs has more than quadrupled between 2019 and 2021, reaching 8.2 million prescriptions. In fact, the demand was so high that it caused many months of shortages in the US, making it difficult for many to obtain their doses, Reuters reports. Even those who do not have any medical reason to take GLP-1s often ask their doctors for a prescription. The drugs, seen as a miraculous way to achieveachieve wards a perfect body shape, feed hope that impossible beauty standards can be attained with a weekly injection. Despite the surge in demand for these drugs, it’s important to recognize that they alone cannot address the societal challenges associated with obesity. According to the WHO website, “Stopping the rise in obesity demands multisectoral actions such as food manufacturing, marketing and pricing and others that seek to address the wider determinants of health (such as poverty reduction and urban planning).” “While we are unaware of the analysis used in the [MSF] study, we have always recognized the need for continuous evaluation of innovation and affordability levers to support greater access of our products,” said Novo Nordisk in a statement. “We continue to support greater health equity to those in need of diabetes treatment and care.” Image Credits: Chemist4u, Pew Research Center. 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