Pediatricians are hesitating to prescribe medicines like Wegovy, citing their newness and uncertainties around them.Dr. Edward Lewis, a pediatrician in Rochester, N.Y., has seen hundreds of children with obesity over the years in his medical practice. He finally may have a treatment for their medical condition — the powerful weight loss drug Wegovy.But that does not mean Dr. Lewis is prescribing it. Nor are most other pediatricians.“I am reluctant to prescribe medications we don’t use on a day-to-day basis,” Dr. Lewis said. And, he added, he is disinclined to use “a medicine that is a relative newcomer to the scene in kids.”Regulators and medical groups have all said that these drugs are appropriate for children as young as 12. But like Dr. Lewis, many pediatricians hesitate to prescribe Wegovy to young people, fearful that too little is known about long term effects, and mindful of past cases when problems emerged years after a drug was approved.Twenty-two percent of adolescents age 12 to 19 have obesity. Research shows that most are unlikely to ever overcome the condition — advice to diet and exercise usually has not helped. The reason, obesity researchers say, is that obesity is not caused by a lack of will power. Instead, it is a chronic disease characterized by an overwhelming desire to eat.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? 

People with the genetic disease have new opportunities to eliminate their symptoms, but the treatments come with obstacles that limit their reach.On Friday, the Food and Drug Administration approved the first gene editing therapy ever to be used in humans, for sickle cell disease, a debilitating blood disorder caused by a single mutated gene.The agency also approved a second treatment using conventional gene therapy for sickle cell that does not use gene editing.For the 100,000 Americans with the disease, most of them Black, the approvals offer hope for finally living without an affliction that causes excruciating pain, organ damage and strokes.While patients, their families and their doctors welcome the F.D.A.’s approvals, getting either therapy will be difficult, and expensive.“It is practically a miracle that this is even possible,” said Dr. Stephan Grupp, chief of the cellular therapy and transplant section at Children’s Hospital of Philadelphia. Dr. Grupp, who consults for Vertex, said his medical center was hoping to begin treating sickle cell patients next year.But, he added, “I am very realistic about how hard this is.”The obstacles to treatment are myriad: an extremely limited number of medical centers authorized to provide it; the requirement that each patient’s cells be edited or have a gene added individually; procedures that are so onerous that not everyone can tolerate them; and a multimillion-dollar price tag and potential insurance obstacles.As a result, sickle cell experts said, only a small fraction of patients in the United States are expected to receive the new treatment (to say nothing of the millions of sickle cell patients overseas, particularly in Africa, for whom it may be completely out of reach for now). The F.DA. estimates that about 20,000 patients — who are 12 and older and have had episodes of debilitating pain — will be eligible for the therapies.The gene editing treatment, called Exa-cel and using the brand name Casgevy, was jointly developed by Vertex Pharmaceuticals of Boston and CRISPR Therapeutics of Switzerland. It uses CRISPR, the Nobel Prize-winning gene editing tool, to snip patients’ DNA. For a small number of subjects in clinical trials, it corrected the effects of the mutation, which results in red blood cells that are shaped like sickles or crescents that become caught in blood vessels, blocking them.Casgevy is the first treatment to be approved that uses CRISPR. Patients will also need expensive, intensive medical care and a long hospitalization.The other treatment, called Lyfgenia and made by Bluebird Bio of Somerville, Mass., uses a common gene therapy method to add a good hemoglobin gene to patients’ DNA.Vertex says its price to edit a patient’s genes will be $2.2 million; for, Bluebird it will be $3.1 million.But living with the disease is also extremely costly: On average, $1.7 million for those with commercial insurance over a patient’s lifetime. Patients themselves may pay about $44,000 out of pocket on average over the course of their lives.For patients and the doctors who treat them, it is tantalizing to think of being free from the complications of sickle cell. So despite the many unknowns, medical centers say they are compiling lists of interested patients who are ready to pursue treatment when it becomes available.“We are talking for the first time about survivorship,” said Dr. Sharl Azar, medical director of the comprehensive sickle cell disease treatment center at Massachusetts General Hospital. Patients, said Dr. Azar, who previously consulted for Vertex, are starting to hope they can live into their 70s and 80s rather than dying young.Opportunities and ObstaclesIn clinical trials, Exa-cel corrected the effects of a mutation in red blood cells that forms shapes like sickles or crescents that become caught in blood vessels, blocking them.BSIP SA/Alamy Treatment will start with hospital visits to collect patients’ bone marrow stem cells — the precursors of red blood cells that are treated to enable the production of healthy blood cells. Stem cells must be released from the marrow into the blood so they can be collected. To release them, doctors inject patients with a drug, plerixafor.It can take months to get enough stem cells to send to a central facility for treatment. And Vertex has only one gene editing facility in the United States, in Tennessee, and one in Europe, in Scotland. Bluebird’s facility is in New Jersey.After editing a patient’s cells with CRISPR, technicians do a sequence of quality checks. About 16 weeks after the process begins, the cells will be shipped back to the medical center to be infused into the patient, said Dr. Julie Kanter, director of the adult sickle cell center at the University of Alabama at Birmingham.At that point, doctors must clear the patient’s marrow with intensive chemotherapy to make way for the new cells. Patients remain in the hospital for a month or more while their edited stem cells repopulate their marrows, during which time they have no functioning immune system.That is if they can find a medical center that offers the new therapy. Most hospitals will not be able to offer Casgevy even if they want to. So far, Vertex has authorized only nine centers to provide its treatment. The company says it will eventually authorize about 50.Bluebird has 27 authorized centers and also plans to add more.The gene editing treatment is so challenging and requires so many resources that leading medical centers say that even if they are authorized to provide it they would probably only be able to treat a small number of patients a year.“We can’t do more than 10 a year,” said Dr. Kanter, who has in the past consulted for Vertex and Bluebird Bio.And, Dr. Kanter said, “we’re really good at it,” adding that her medical center had extensive experience treating sickle cell patients and participating in the Bluebird clinical trials.Others said the same. “Five to 10 a year,” said Dr. Jean-Antoine Ribeil, clinical director of the Center of Excellence in Sickle Cell Disease at Boston Medical Center, which says it is the largest sickle cell center in New England and is one approved by Vertex to offer its therapy.Vertex has not revealed how many patients’ cells it will be able to edit each year, saying only that it is confident it can meet the demand at the time the treatment is introduced.Nor has Bluebird. But, Dr. Grupp said, Bluebird’s gene therapy for thalassemia — a genetic disorder in which the body does not make enough hemoglobin — gives a hint. Bluebird, he said, has only been able to treat the cells of 50 patients a year since the drug was approved in August 2022. And that is “for the entire country,” Dr. Grupp said.Insurance payments pose another obstacle. Before treatment starts, a patient’s insurer has to agree to pay. That can take months, said Dr. David Jacobsohn, chief of the division of blood and marrow transplantation at Children’s National Hospital in Washington. His medical center is among those authorized to provide the Vertex and the Bluebird treatments.Most sickle cell patients are insured through Medicaid, noted Dr. John DiPersio, director of the Center for Gene and Cellular Immunotherapy at the Washington University School of Medicine in St. Louis. Dr. DiPersio consults for Vertex and Bluebird.“If every sickle cell patient in Missouri gets treated, the state couldn’t afford it,” he said.Another concern involves unknowns about the new therapy. While a panel of F.D.A. experts concluded that the benefits outweighed the risks, doctors remain mindful of unexpected outcomes.“We don’t know yet what the long-term effects will be,” Dr. DiPersio said. “We haven’t followed patients long enough — just a couple of years.” And stem cells, he added, “will live forever,” so if CRISPR or the Bluebird gene therapy does genetic damage, it will remain.Exa-cel was jointly developed by Vertex Pharmaceuticals of Boston and CRISPR Therapeutics of Switzerland.Joseph Prezioso/Agence France-Presse — Getty ImagesHow Patients and Doctors FeelHaja Sandi, a 19-year-old student at Rowan University in New Jersey, hopes to be at the top of the list at the Children’s Hospital of Philadelphia.She has frequent hospitalizations for pain so intense she has to take morphine. Her symptoms have forced her into remote schooling. “There is no way I could do it in person,” she said.Hearing about the Vertex therapy, she contacted the hospital in Philadelphia asking if she could get it.“God willing, I will go forward with it,” she said.The Children’s Hospital of Philadelphia, among others, is hoping to get on Vertex’s list of approved centers and is planning to take eligible patients on a first-come-first-served basis.Still others, like Children’s National Hospital in Washington, will give priority to the sickest patients.Dr. Azar intends to take a different approach if Massachusetts General is approved. He said he wanted to proceed with extreme caution, starting with just one patient and going through the entire process before accepting more.He worries that a misstep could sully the treatment for those who could be helped.Going forward, the therapies will be provided without the extensive support that the companies gave to clinical trial participants. And it will be a test case for using CRISPR gene editing to treat other diseases. CRISPR Therapeutics is now studying gene editing to treat cancer, diabetes, and A.L.S., among others.“It is a blessing and curse that we are going first,” Dr. Azar said. “Sickle cell disease has never been first for anything.”The people seeking the therapy — mostly Black patients — often mistrust the health care system, he added.“We want to do this right,” Dr. Azar said. “We don’t want patients to feel like they are guinea pigs.”

The NewsA lifesaving cancer treatment may itself cause cancers, the Food and Drug Administration reported on Tuesday.The treatment, called CAR-T, was first approved in November 2017 for life-threatening blood cancers. But, the F.D.A. said, it had received 19 reports of new blood cancers in patients who received the treatment.A composite colored scanning electron micrograph of T cells, blue, and a lymphoma cancer cell, red.Steve Gschmeissner/Science SourceA Number That Sums It Up: Thousands of lives have been saved with CAR-T.CAR-T involves removing a type of white blood cell — T cells — from a patient’s blood, then genetically engineering to make proteins — chimeric antigen receptors (CAR) — which allow the T cells to attach to cancer cells and kill them. The engineered cells are then infused back into the patient’s blood.The F.D.A. has approved six commercial CAR-T products. Cancer specialists said the treatments have saved the lives of thousands of patients with blood cancers. Even if there is a causal link between the treatments and a small risk of a new blood cancer, the regulators said on Tuesday, the benefits of the treatment outweigh the risks. That sentiment was echoed by doctors involved in cancer treatment.While the hypothetical risk was known, “we haven’t observed it” in patients, Dr. Marcela V. Maus, director of cellular immunotherapy at Massachusetts General Hospital, said.Dr. John DiPersio, director of the center for genetic and cellular immunotherapy at Washington University School of Medicine in St. Louis, said his center had treated 500 to 700 patients. And, he said, “I haven’t seen a single one” develop a new T cell cancer.CAR-T therapy has been reserved for patients who would die without it, he added.“They are all going to die and they are all going to die quickly without this treatment. It saves their life,” Dr. DiPersio said. “It works in a substantial portion of patients. The benefit is enormous.”Facts to Keep in Mind: What triggered the F.D.A.’s investigation.The F.D.A. said in its announcement that the reports of additional cancers included serious consequences — hospitalizations and deaths. And, the agency said, it is known that the way CAR-T cells are produced has a risk of causing cancers in recipients.When patients’ T cells are engineered to make proteins that attack cancer cells, a virus helps slip new genes into T cell DNA. That has the potential to disrupt other genes, leading to cancer.But there are other potential explanations. CAR-T therapy is used when patients have already had at least one round of conventional treatments with intense chemotherapy and, often, radiation. Those treatments can themselves elicit new blood cancers. Even without chemotherapy or radiation, Dr. Maus added, patients with blood cell cancers are especially susceptible to developing other blood cell cancers.What Happens Next: The search for a smoking gun.One unanswered question, Dr. Maus and Dr. DiPersio said, is whether the new cancers involved T cells carrying the added CAR proteins. That does not prove the gene insertion caused the cancers. But Dr. DiPersio said, “it is more of a smoking gun.”The F.D.A. did not describe any anticipated outcomes of its investigation but said that it was “evaluating the need for regulatory action.”

The first treatment that relies on CRISPR is expected to receive U.S. approval next month. But it may cost millions of dollars per patient.Regulators in Britain on Thursday approved the first treatment derived from CRISPR, the revolutionary gene-editing method. Called Casgevy, the treatment is intended to cure sickle-cell disease and a related condition, beta thalassemia.The manufacturers, Vertex Pharmaceuticals, based in Boston, and CRISPR Therapeutics, based in Switzerland, say about 2,000 patients in Britain with sickle-cell disease or beta thalassemia are expected to be eligible for the treatment.The companies anticipate that the Food and Drug Administration will approve Casgevy for sickle-cell patients in the United States in early December. The agency will decide on approval for beta thalassemia next year.In late December, the F.D.A. is expected to approve another sickle cell gene therapy by Bluebird Bio of Somerville, Mass. That treatment does not rely on gene editing, instead using a method that inserts new DNA into the genome.Sickle-cell disease is caused by a defective gene that leads to the creation of abnormal hemoglobin, the oxygen-carrying component in red blood cells. The cells themselves become malformed, causing episodes of extreme pain. About 100,000 Americans, who are mostly Black and Hispanic, are believed to have the illness.In beta thalassemia, the defective gene leads to deficient levels of hemoglobin in red blood cells. The condition is rare.Casgevy relies on CRISPR to nick the DNA, activating a gene that produces an alternative form of hemoglobin. To receive the sickle-cell treatment, patients in Britain must be at least 12 years old and have experienced repeated episodes of extreme pain.There is no upper age limit, nor are patients excluded because they have suffered too much organ damage from sickle-cell disease, said Dr. David Altshuler, Vertex’s chief scientific officer.But the patients must have no other options. Sickle-cell disease can be cured with a bone-marrow transplant, but few patients have compatible donors.For people struggling with the illness, the Vertex and Bluebird treatments have been a long time coming. Pain is not the only complication — people with sickle-cell disease also suffer bone and organ damage and strokes. The misshapen blood cells do not survive long, resulting in anemia.Still, the CRISPR and Bluebird treatments are onerous and will require expertise that most hospitals lack.Patients must receive intense chemotherapy to clear their bone marrow of abnormal stem cells and make room for the genetically altered cells. Then the patients must stay a month or more in a hospital while their marrow regrows.And gene editing is expensive. Vertex and CRISPR Therapeutics have not set a price yet in Britain — that will depend on conversations with those who will be paying for it, said Stuart Arbuckle, executive vice president and chief operating officer at Vertex.The price in the United States, though, is expected to be millions of dollars per patient. Sickle-cell disease itself is expensive, however, costing the U.S. health system an estimated $3 billion a year.In the United States, Bluebird already has a gene therapy approved for beta thalassemia. It costs $2.8 million per patient.Dr. Altshuler said Vertex was testing its sickle-cell treatment in children ages 5 to 11, hoping to prevent the irreversible organ damage that occurs over time.The company’s first sickle-cell patient, Victoria Gray, said on Thursday that the treatment changed her life.Ms. Gray, a Walmart associate in Forest, Miss., was diagnosed with sickle-cell disease when she was 3 months old and had a pain crisis. Those episodes became a part of her life, resulting in frequent hospitalizations.“A lot of my dreams, I couldn’t do,” she said. “The smallest things — cold, changing weather — I would end up in the hospital.”She had the gene editing treatment in 2019, when she was 33. Now, she said, all her symptoms have vanished.“It meant a new beginning,” Ms. Gray said. “It is more than I ever dreamed of, for everything to be gone.”

The NewsOn Saturday, after a 12-year effort, the Department of Veterans Affairs reached a long-term goal — it enrolled the millionth veteran in a genetic database, the Million Veteran Program.According to the V.A., the Million Veteran Program is the largest such database in the world. It includes not only genetic information but also is linked to the department’s electronic medical records and even contains records of diet and environmental exposure.The department says its data are available for now only to V.A. doctors and scientists, most of whom also have academic appointments. They have published hundreds of studies using what has already been collected.A U.S. Army veteran prepared to kayak during a Veterans Affairs health care network kayaking and sailing event on the Hudson River in August.Spencer Platt/Getty ImagesA Moment That Sums It Up: 3:46 p.m.The millionth vet joined the database on the afternoon of Nov. 11. Employees who had waited a dozen years for this moment wept.As the goal approached, the department had started an intensive email campaign, encouraging vets to sign up online or at V.A. medical centers. In the few weeks building up to the millionth vet, what had been a few hundred enrollees a day turned into thousands. The department created a ticker, which it posted online, showing the numbers.“This is a gift to the world,” said Denis McDonough, secretary of veterans affairs.The V.A. will continue to enroll more vets to the database, but this was a symbolic moment.Why It Matters: A diverse database yields disease insights.For years, researchers have been building large databases for genetic research. Using them they have found, for example, genes that appear to confer resistance to dementia and ones that most likely contribute to obesity. The discoveries provide paths to understanding these diseases and developing treatments.There are other large genetic databases, but they have mostly been built in Europe and include few minorities. The V.A. says its database offers a more diverse population: 175,000 people with African ancestry and 80,000 Hispanics joined the Million Veteran Program. The database also includes 100,000 women.“It’s a massive investment and scientific opportunity,” said Dr. Amit V. Khera, a genetic researcher at Massachusetts General Hospital. He is not a V.A. researcher, but he has used the data through collaborations with researchers who are affiliated with the department.As the database acquired participants, about 600 V.A. researchers registered to use it. The result so far has been more than 350 papers on diseases and disorders, including post-traumatic stress disorder, heart disease, high blood pressure and nonalcoholic liver disease.For example, said Dr. Sumitra Muralidhar, director of the Million Veteran Program, researchers found genes linked to having flashbacks of traumatic events, a feature of post-traumatic stress. Now, Dr. Muralidhar said, investigators can study those genes and the role they play, which may help in developing treatments for PTSD.The department also says it is being mindful of patient privacy. Although researchers can examine genetic and other data and links to medical records, fewer than 10 people at the V.A. have the links that tie records to individuals. Those records, Dr. Muralidhar said, are held at a facility in Boston that is “heavily secured.”What It Looks Like: Veterans hope the database will help.In 2019, a nurse at a V.A. hospital told Octavia Harris, 60, of San Antonio, about the Million Veteran Program. She signed up and said participating was a chance to help other vets and to help herself.Ms. Harris, who retired from the Navy in 2012 after 30 years of service, said three conditions run in her family — diabetes, high blood pressure and arthritis. She is hoping that with her genetic and health information added to that of so many others, researchers will make useful discoveries.In her family, Ms. Harris said, people died young.“We haven’t lived beyond the age of 70,” she said. “I want to go past 70.”

The trial involved only 10 patients, but it suggests cholesterol can be permanently reduced with a single treatment for patients at risk of heart disease.The handful of patients had severe heart disease that had caused chest pain and heart attacks. After trying available cholesterol-lowering medications, they could not get their cholesterol as low as cardiologists recommended.So they volunteered for an experimental cholesterol-lowering treatment using gene editing that was unlike anything tried in patients before.The result, reported Sunday by the company Verve Therapeutics of Boston at a meeting of the American Heart Association, showed that the treatment appeared to reduce cholesterol levels markedly in patients and that it appeared to be safe.The trial involved only 10 patients, with an average age of 54. Each had a genetic abnormality, familial hypercholesterolemia, that affects around one million people in the United States. But the findings could also point the way for millions of other patients around the world who are contending with heart disease, which remains a leading cause of death. In the United States alone, more than 800,000 people have heart attacks each year.And while more trials in a broader range of patients will need to be carried out, gene editing experts and cardiologists said the treatment had the potential to transform preventive cardiology.“Even for seasoned veterans of this field like myself, this is a day we will look back on,” said Fyodor D. Urnov, a gene editor at the Innovative Genomics Institute in Berkeley, Calif.. “I see today as crossing a Rubicon, in a good way. This is not a small step. It is a leap into new territory.”Impressed with the data and the potential it shows, the pharmaceutical giant Eli Lilly paid $60 million to to collaborate with Verve Therapeutics and opted to acquire additional rights to Verve’s programs for an additional $250 million. If the editing continues to look promising, Eli Lilly expects to help with larger studies.“Until now, we thought of gene editing as a treatment we should reserve for very rare diseases where there is no other treatment,” said Dr. Daniel Skovronsky, Eli Lilly’s chief scientific and medical officer. “But if we can make gene editing safe and widely available, why not go after a more common disease?”The new study was led by Dr. Sekar Kathiresan, chief executive of Verve. Patients received a single infusion of microscopic lipid nanoparticles containing within them a molecular factory to edit a single gene in the liver, the site of cholesterol synthesis. The gene, PCSK9, raises levels of LDL cholesterol, the bad kind. The plan was to block it.The little lipid spheres were carried through the blood directly to the liver. They entered liver cells and opened up, revealing two molecules. One instructs DNA to make a gene editing tool, and the other is a guide to take the editing tool to the gene that needs editing.The treatment “is almost like science fiction,” said Dr. Martha Gulati, director of preventive cardiology at the Smidt Heart Institute of Cedars-Sinai Medical Center in Los Angeles and president of the American Society for Preventive Cardiology, who was not involved in the trial.The gene editing tool acts like a pencil and an eraser. The eraser wipes out one letter of the target gene, and the pencil writes in a new one, turning off PCSK9.The goal: a single cholesterol-lowering treatment that results in lifelong protection from heart disease.Patients received varying doses. LDL levels in the three who received the highest doses fell by 39 to 55 percent — enough to get them toward their cholesterol goal.In the small study, those who received the higher doses had flulike symptoms for a few hours. Two patients had serious adverse events that the study’s independent data safety and monitoring board deemed a result of their underlying severe heart disease. The board advised the researchers not to stop the study.One had a fatal cardiac arrest five weeks after receiving the infusion. An autopsy showed that several of his coronary arteries were blocked.The other patient had a heart attack the day after the infusion. It turned out that he had been having chest pain before receiving the infusion but had not reported it. If the investigators had known, he would not have received the treatment.In a way, the treatment is a culmination of studies that began a decade ago when researchers discovered rare but healthy individuals with cholesterol levels that seemed impossibly low. The reason was that their PCSK9 gene was mutated and no longer functioned. As a result, these people were protected from heart disease.That led to the development of antibodies to block the gene. Patients inject themselves with the antibodies once a week. Then came a twice-yearly RNA injection that prevents PCSK9 from being made.It seemed possible that those treatments, as well as statins for those whose cholesterol is more easily controlled, could help solve the heart disease problem.But heart disease persists as a killer. Even after people are diagnosed with heart disease, less than 60 percent of all patients take a statin. Only a quarter take one of the more effective, high-intensity statins, Dr. Gulati said.“Patients take it initially, and then they forget or decide they don’t need it,” she explained. “That happens more than you’d think.”Dr. Michelle O’Donoghue, a cardiologist at Brigham and Women’s Hospital, said that because patients so often do not take their pills or injections, “there is a lot of interest, through gene editing, of a one and done — a single treatment and a lifetime response.”Family history was the inspiration for Dr. Kathiresan at Verve Therapeutics. His uncle and grandmother died of heart attacks. His father had a heart attack at age 54. And then, on Sept. 12, 2012, his 42-year-old brother, Senthil, returned from a run dizzy and sweaty. He was having a heart attack. He died nine days later.At that moment, Dr. Kathiresan said, he vowed to find a way to prevent what had happened to his brother from happening to anyone else.Of course, even if gene editing works, applying it to young people with heart risk is well into the future. But, Dr. Gulati said, early gene editing of younger patients with genetically high cholesterol levels might prevent arteries from hardening.“It could be an incredible medicine,” she said.All this depends on success and safety of the gene editing and on its effects lasting. The first patient was treated just six months ago. But a previous study in monkeys lasted two and a half years, and the results of the gene editing persisted.Dr. Urnov, who said he has a genetic risk for heart disease, is optimistic for himself and his 6-year-old daughter.“I honestly cannot wait for this medicine to become available for heart disease prevention,” he said. “I love the idea of having gene editing as a vaccine for the prevention of heart disease.”

Zepbound, which is already sold by Eli Lilly as the diabetes treatment Mounjaro, was shown to reduce patients’ weight by as much as one-fifth in drug trials.The Food and Drug Administration on Wednesday approved an obesity drug from the company Eli Lilly that will be a direct competitor to the wildly popular Wegovy.The drug is called tirzepatide and will be sold under the name Zepbound. It joins a class of new medications that are transforming obesity, a condition that affects 100 million American adults and is linked to a spectrum of diseases including diabetes, heart disease, sleep apnea, liver disease, kidney disease and joint pain.Patients who used tirzepatide lost an average of 18 percent of their body weight, according to the F.D.A., when it was taken at its highest dose in a drug trial. That’s compared with Wegovy, manufactured by Novo Nordisk, which produced an average 15 percent weight loss.The F.D.A. approved Zepbound for people with obesity and for those who are overweight and have at least one obesity-related condition.Tirzepatide is already approved for diabetes under the brand name Mounjaro where it competes with Novo Nordisk’s diabetes drug semaglutide, known better as Ozempic. But until now, Wegovy — also semaglutide but with a higher maximum dose than Ozempic — was the only approved drug that could safely elicit substantial weight loss in people with obesity alone.Side effects with Zepbound, similar to those with Wegovy, Ozempic and Mounjaro, are mostly gastrointestinal, like nausea and diarrhea. Most patients tolerated or overcame them.In a news release, Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders and Obesity in the F.D.A.’s Center for Drug Evaluation and Research, said, “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”Susan Yanovski, co-director of the office of obesity research at the National Institute of Diabetes and Digestive and Kidney Diseases, said, “Just a few years ago it would be difficult to imagine two medications like semaglutide and tirzepatide that lead to weight loss that previously was only seen when people had bariatric surgery,” referring to a surgical treatment that is a proven effective treatment for obesity.The approval comes at a time when Novo Nordisk is unable to produce enough Wegovy to satisfy the huge demand for the drug. Tirzepatide, which patients take by a self-administered injection once a week, as they do with Wegovy, could ease those shortages.Competition could also result in lower net prices for both drugs, or how much payers actually spend on them. The prices are high for Wegovy — with a list price up to $1,349 every four weeks in one recent analysis, and a net price around $700. Zepbound is starting with a list price of around $1,060, according to Eli Lilly.“You’d want the price competition to come sooner rather than later,” said Craig Garthwaite, a health care economist at Northwestern University. Once people start taking one of these drugs, he said, “they get locked in.” They resist switching even if a competing drug costs less.Development of Zepbound began in 2017 with a small study involving 300 people with type 2 diabetes. After 3 months, many lost at least 13 percent of their body weight. Eli Lilly presented the data at a diabetes meeting in Germany. Some in the audience gasped. Then came a large 72-week study sponsored by Eli Lilly of tirzepatide in 2,539 people with obesity.In a packed room at a meeting of the American Diabetes Association last year, the study’s principal investigator, Dr. Ania Jastreboff of Yale, revealed the results. More than half the patients receiving the highest dose lost at least 20 percent of their body weight.No drug has ever before shown such a profound weight loss.For Eli Lilly, the results were a culmination of research that began a decade ago. But like Novo Nordisk, the company was trying to produce a new diabetes drug.“Obesity wasn’t a main focus for us,” Dr. Daniel Skovronsky, the chief scientific and medical officer at Eli Lilly, said, adding that “it was not seen as a commercial opportunity.”The sad history of weight loss drugs was a lesson, he thought. “There had never been a successful obesity drug,” he said, “and previous drugs didn’t cause enough weight loss to have an impact on peoples’ health.”But researchers at Eli Lilly had started investigating a diabetes drug that combined two molecules. One molecule acts like a hormone, GLP-1, that prompts the body to secrete insulin when blood sugar rises. That was similar to the effects of Novo Nordisk’s Ozempic and Wegovy. And like those drugs, it also suppresses appetite.But more than one hormone is involved when the body regulates blood sugar, so the company’s scientists decided to try combining the molecule that mimics GLP-1 with a second molecule that acts like the gut hormone GIP. Although GIP has a more modest effect when given alone, it amplified GLP-1’s effect when the two hormone mimics were combined.In mice, the two-drug combination not only lowered blood sugar but also had a profound effect on weight. It was “the most weight loss we’d ever seen,” Dr. Skovronsky said.The company’s scientists tested the drug in healthy volunteers. Even though they did not have obesity, the people lost weight.Suddenly, Eli Lilly’s opinion of studying weight loss changed.“We thought, ‘This medicine can change the world,’” Dr. Skovronsky said. “We said: ‘This is the one. This is our priority.’”They decided to speed development with an approach known as “investing at risk” in which they do not wait for each stage of testing to be completed before starting the next, and in which they start building manufacturing capability before studies are completed. The result was a pace that was a record for the company — six years from the first dose in human volunteers to F.D.A. approval. A similar strategy was also used to speed up Covid vaccine development.The hope is that Zepbound can reduce the chances that people with obesity will develop the potentially deadly complications that accompany the condition.But Zepbound is only the beginning for Eli Lilly. The company and other pharmaceutical manufacturers are working on drugs that could be even more powerful.The next Lilly drug adds glucagon, another gut hormone, to the two in Zepbound. It apparently stimulates metabolism and draws fat out of the liver.And, like Novo Nordisk and other companies, Eli Lilly is working on a pill form of tirzepatide. It is undergoing clinical testing.Making injectable drugs is complicated and challenging. Pills are simpler and cheaper, which could improve the supply problem that has affected patients who use Ozempic and Wegovy.It is estimated that by 2030, a billion people in the world will have obesity.“All the companies in the world cannot make that many injections,” Dr. Skovronsky said. “Clearly if we are going to meet the needs of the global epidemic, we need oral drugs.”

The decision by an advisory committee may lead to Food and Drug Administration approval of the first treatment for humans that uses the CRISPR gene-editing system.A panel of experts said on Tuesday that a groundbreaking treatment for sickle cell disease was safe enough for clinical use, setting the stage for likely federal approval by Dec. 8 of a powerful potential cure for an illness that afflicts more than 100,000 Americans.The Food and Drug Administration had previously found that the treatment, known as exa-cel and jointly developed by Vertex Pharmaceuticals of Boston and CRISPR Therapeutics of Switzerland, was effective. The panel’s conclusion on Tuesday about exa-cel’s safety sends it to the F.D.A. for a decision on greenlighting it for broad patient use.Exa-cel frees patients from the debilitating and painful effects of this chronic, deadly disease. If approved, the Vertex product would be the first medicine to treat a genetic disease with the CRISPR gene-editing technique.It could also be the first of a series of new options to cure the excruciating illness. By Dec. 20, the F.D.A. will decide on a second potential cure for sickle cell, a gene therapy devised by the company Bluebird Bio of Somerville, Mass.Sickle cell disease is caused by a gene mutation that makes blood cells misshapen, so that they resemble sickles or crescents. It affects millions of people worldwide, most of whom have African ancestry. The misshapen cells get stuck in blood vessels, causing strokes, organ damage and episodes of agonizing pain as muscles are starved of oxygen.Sickle cell’s toll starts early in life. Evelyn Islam of Milwaukee, now 8, had 22 blood transfusions and had to have her spleen removed before she was 3. “Gene therapy is our last hope for a cure,” said her mother, Melissa Nicole Allen.Ashley Valentine, a co-founder of the national advocacy group Sick Cells, at her parents’ home in Lisle, Ill. Her brother Marqus, pictured on the wall, died in 2020.Mustafa Hussain for The New York TimesBut the new gene therapies will come too late for many.Ashley Valentine, a co-founder of the national advocacy group Sick Cells, had to take three months off from work in 2016 to help her brother Marqus deal with symptoms of sickle cell. When he had a hip replacement in 2018, her father ended up accepting a layoff from his job to help care for him.“And that’s just us,” she said.Marqus died in 2020, at age 36, from a stroke caused by sickle cell.New treatments like the one that was endorsed on Tuesday are expected to cost millions of dollars per patient, though Vertex has not yet said what it will charge. But lifelong care for patients with the disease is also enormously expensive, costing the health care system an estimated $3 billion a year.It’s not yet clear how many people will seek the new therapy. The new therapies are also not easy to endure and come with hardships for patients, who will have to undergo chemotherapy and spend more than a month in the hospital. Family members are affected too — they may need to take time off work during the most intensive phase of the treatment.Additionally, most Americans with sickle cell are Black and may not trust a health care system that has often failed to provide the most basic preventive and therapeutic care for those with the disease. Some with sickle cell are anxious about undergoing a medical treatment that is on the cutting edge of biotechnology.But for doctors who have spent years watching patients suffer, and many parents who have seen their children endure years of agony, there is elation at what lies ahead.“We are finally at a spot where we can envision broadly available cures for sickle cell disease,” said Dr. John Tisdale, director of the cellular and molecular therapeutics branch at the National Heart, Lung and Blood Institute and a member of the advisory committee.Dana Jones of San Antonio wants her daughters Kyra, 18, and Kami, 20, to have a chance at one of the new therapies. Both had strokes that left them with learning disabilities — injuries that could probably have been avoided if they had been given a screening test and treatment long known to prevent nine out of 10 strokes in children with the disease. Kyra is now in intensive care as doctors try to control her pain.Ms. Jones is overwhelmed by the possibility that her daughters could be cured.“It is my prayer that Kami and Kyra can be cured of this awful disease and finally be able to truly live,” she said.A New Treatment and a New TechnologySickle cell disease is caused by a gene mutation that makes blood cells misshapen. The misshapen cells can get stuck in blood vessels, causing strokes, organ damage and episodes of agonizing pain.F. Gilbert/CDC, via Associated PressThe cause of sickle cell has been known for nearly 70 years, but research lagged, a situation many say occurred at least in part because so many patients were Black and from poor and working-class families.There are a number of treatments to reduce sickle cell’s impact. Some patients are able to get bone marrow transplants that can cure the condition. But that requires finding a donor and, after the transplant, taking drugs to prevent the body from rejecting the foreign cells.In recent years, a number of biotechnology companies have tried novel approaches. While Bluebird Bio is advancing its gene therapy technique, Vertex and CRISPR Therapeutics focused on the gene-editing system CRISPR-Cas9, which can home in on specific areas of DNA and turn genes on or off. CRISPR has allowed researchers to disable genes to assess their importance in biomedical research. But until now it has not been used as a treatment for patients with a genetic disease.To treat sickle cell, CRISPR snips a piece of DNA in bone marrow stem cells. That frees a blocked gene to make a form of hemoglobin that normally is produced only by a fetus. The fetal gene directs the production of hemoglobin that does not form into the sickle shape. In clinical trials, patients no longer had the complications of sickle cell disease and no longer needed blood transfusions.But there is a concern that CRISPR could inadvertently snip a piece of DNA in the wrong part of a patient’s genome. That might disrupt a gene and cause a blood cancer.No such issues have turned up in the clinical trials, but the Vertex trial involved only 44 patients, and just 30 have been followed for at least 16 months. The company did extensive comparisons of patients’ DNA with that of people in large databases asking how likely such CRISPR misfires could be.Vertex said it plans to follow clinical trial patients for 15 years. The company’s data were sufficiently reassuring that the expert committee said on Tuesday they saw no reason to hold the treatment back.There can always be additional studies, noted committee member Alexis Komor, a professor of chemistry and biochemistry at the University of California, San Diego. But, she said, that would be “expecting perfection at the expense of progress.”Dr. Joseph Wu of Stanford added, “We all agree that the benefits outweigh the risks. These patients are quite sick and this is a good therapy.”Scot Wolfe of the University of Massachusetts Chan Medical School said, “We want to be careful not to let the perfect be the enemy of the good.”“There is a huge unmet need,” he added.If It’s Safe, Who Gets It?Vertex Pharmaceuticals’ headquarters in Boston.Bill Sikes/Associated PressVertex estimates that 20,000 people could be eligible for its treatment, and says Medicaid and private insurers have suggested a willingness to pay for it.“There is almost no way they could not pay,” said Dr. David Williams, chief of the division of hematology and oncology at Boston Children’s Hospital.Dr. Williams, who has consulted for Vertex and Bluebird Bio, added that insurers pay “$3 million a pop” for other gene therapies produced by Bluebird Bio for the diseases thalassemia and adrenoleukodystrophy. With sickle cell, and its large number of Black patients, he said, there is an issue of “equity in access and the tremendous medical need.”Some people with the disease may not be eligible, depending on the F.D.A.’s decisions. They could include young children with sickle cell and older patients whose bodies have been so damaged that the treatment could pose heightened risks.Kevin Wake of Kansas City, Mo., hopes he is not too old, at 55, or too damaged. He has had three strokes caused by the disease.The treatments, though curative, are difficult.Patients first have eight weeks of blood transfusions followed by a treatment to release bone marrow stem cells into their bloodstream. The stem cells are then removed and sent to the companies to be treated. Next, patients receive intense chemotherapy to clear their marrows for the treated cells. The treated cells are infused back into the patients, but they have to remain in the hospital for at least a month while the new cells grow and repopulate their marrows.That treatment “cannot be delivered at most hospitals,” said Dr. Alexis Thompson, chief of the division of hematology at Children’s Hospital of Philadelphia, who consults for Vertex.Another issue is how quickly Vertex can ramp up production. Each patient’s cells must be treated individually in a sterile environment, an arduous prospect.Stuart Arbuckle, executive vice president and chief operating officer at Vertex, is confident. “We are launch ready,” he said. But he added that he did not expect a huge wave of patients immediately.“This is a pretty big decision for a patient to go through,” Mr. Arbuckle said. Dana Jones with her daughter Kyra, now 18, in 2020. Kyra and her sister Kami have had strokes that caused them to have learning disabilities, and Kyra is currently in intensive care as doctors try to control her pain.Ilana Panich-Linsman for The New York TimesOne of the Vertex clinical trial patients, Marie-Chantal Tornyenu, 22, who is a senior at Cornell University, said patients also had to be prepared for “mental adjustment” after treatment.Ms. Tornyenu said she no longer had the pain crises that plagued her, especially in high school when she was hospitalized nearly every month.But she has spent much of her life taking precautions and worrying about pain and complications from sickle cell. Those habits are hard to break.“It’s a major learning curve from having sickle cell my whole life,” she said. “I’m still struggling with that mind-set — ‘sickle cell is you.’”

The treatment from the company Vertex would be the first medicine to use the gene editing tool CRISPR.The LatestOn Tuesday, Oct. 31, an advisory committee to the Food and Drug Administration will consider a gene editing treatment for sickle cell disease, a potentially deadly, excruciatingly painful, lifelong condition in which blood cells are deformed.If the panel finds the safety data acceptable and does not think the treatment needs additional study, and the F.D.A.’s commissioner concurs with its assessment, it will be the first medicine to use the revolutionary tool, CRISPR, to snip out a piece of DNA. Other comparable treatments for sickle cell could follow.“This is a huge deal,” said Dr. John Tisdale, director of the cellular and molecular therapeutics branch at the National Heart, Lung and Blood Institute.A sickle cell disease patient received a blood transfusion to alleviate his pain at a hospital in Kansas City, Mo.Tammy Ljungblad/The Kansas City Star/Tribune News Service, via Getty ImagesWhy It Matters: A disease with a toll that is difficult to imagine.An estimated 100,000 people in the United States have sickle cell disease, most of whom have African ancestry. Sickle cell shortens lives, injures organs and bones and causes episodes of searing pain that can repeatedly send patients to emergency rooms, or lead to lengthy hospital stays.A report by the Institute for Clinical and Economic Review said that for people who don’t have sickle cell disease, “it is hard to understand the physical, emotional and mental toll.” People with the disease, the report added, “not only described intense fatigue, anxiety and depression, but at times extreme hopelessness.”One patient, Mariah Jacqueline Scott, 32, who lives in Highland Park, N.J., has had two hip replacements, two shoulder replacements, a splenectomy, a gall bladder removal and a tonsillectomy because of the disease. She spent the year after her daughter was born in and out of the hospital being treated for extreme pain caused by blocked blood vessels. She had her second shoulder replacement after her shoulder collapsed while she was holding her baby.The only cure has been a bone-marrow transplant, which requires finding a donor, undergoing intensive chemotherapy and taking immunosuppressive drugs. But gene editing offers an alternative. Vertex and CRISPR Therapeutics, the makers of the treatment being taken up by the F.D.A. committee on Tuesday, said that in clinical trials, symptoms of the disease went away after patients had the treatment. So far, the patients appear to be cured. The technique activates a gene that can make normally functioning blood cells.Ms. Scott said she knew gene editing was arduous, but she was seriously considering undergoing the treatment when it became available.Facts to Keep in Mind: Gene therapies bring their own challenges.Vertex’s therapy starts when doctors remove stem cells from the blood and send them for treatment. Next comes intense chemotherapy to completely clear the bone marrow before the treated cells are injected. After that, patients must spend at least a month in a hospital while the treated cells repopulate the bone marrow.Because each patient’s cells must be treated individually there are questions about how quickly companies can ramp up production.“Manufacturing is very complicated,” said Dr. Stephan Grupp, chief of the cellular therapy and transplant section of Children’s Hospital of Philadelphia, who consults for Vertex.Treatment will be extremely expensive, potentially in the millions of dollars per patient, and the companies will not say how many patients they expect to be able to treat at first.Gene editing can also impose personal hardship on patients and their families. A hospital with the expertise to administer the treatment and care for patients may be far from home. And patients must stay there for a long period of time.What’s next: More F.D.A. decisions and more drugs.If the advisory committee recommends the Vertex treatment, the F.D.A. will decide whether to approve it on Dec. 8.On Dec. 20, the F.D.A. will decide on another application for sickle cell gene therapy made by Bluebird Bio. Two other companies and an academic center, Boston Children’s Hospital, are testing their own sickle cell gene therapies.While these therapies could reduce the suffering of sickle cell patients in the United States and other wealthy countries, there is an even greater need for them in some developing countries like Nigeria. However, they will be difficult to export to developing countries because the treatments are extremely expensive and they can only be administered at hospitals where doctors have expertise in a number of advanced techniques.One company, Beam, is testing a way to provide gene editing that requires nothing more than a single infusion in a doctor’s office. Vertex has what it calls an “aspirational” method that would deliver gene editing in a pill.

Drug companies are making billions from a new class of in-demand weight-loss treatments. But the prices are not what they seem.The problem is daunting: Powerful but expensive new drugs could help many of the 100 million American adults who have obesity and alleviate a grave public health concern.But how can the nation afford lifelong treatments for so many people, with sticker prices for each patient ranging from about $900 to $1,300 every four weeks?Some researchers, like Dr. Walter C. Willett, professor of epidemiology and nutrition at the Harvard T.H. Chan School of Public Health, have warned that the drugs could add 50 percent to the country’s health care spending.“You can see this ballooning completely out of control,” he said.But there is one factor often left out of these discussions: The drugs’ list prices are generally very different from the net prices, which companies receive after making secret deals with health insurers or the intermediaries known as pharmacy benefit managers. Companies generally do not reveal net prices, but there are data sources that can be used to estimate them.A recent paper published by the American Enterprise Institute revealed that the net prices for the new obesity drugs are just a fraction of the published annual list prices.And while the drugs’ prices remain out of reach for many, economists anticipate they will soon be driven down. More than a dozen companies are developing obesity drugs. As they enter the market, greater choice is expected to make prices plummet, as has happened with other expensive drugs.“My prediction is that as competition increases, prices will decrease accordingly,” said Jalpa Doshi, professor of medicine and director of the economics evaluation unit at the University of Pennsylvania.Strong Demand, Falling Prices?For now, manufacturers are reaping the rewards of soaring demand.Investors expect Novo Nordisk, the manufacturer of Wegovy, to earn $4 billion in revenue this year. The company’s other drug, Ozempic, is expected to bring in $11 billion. The drugs are driving such a bonanza that they account for almost all of the latest economic growth in Denmark, the home of Novo Nordisk.Those revenues are based on the net prices.For their analysis, Benedic N. Ippolito, an economist at the American Enterprise Institute, and Joseph F. Levy, a health economist at Johns Hopkins Bloomberg School of Public Health, relied on data from SSR Health, which uses company financial filings and estimates of the number of prescriptions filled.The economists derived net prices by using data from SSR Health for the second quarter of 2022 through the first quarter of 2023. The exception is Mounjaro, made by Eli Lilly, for which only data from the first quarter of 2023 was available.Net prices, the revenue divided by the number of prescriptions in their analysis, appear to be around $700 every four weeks for Wegovy, or about $650 less than the list price; about $300 for Ozempic, or nearly $650 less than the list price; and approximately $215 for Mounjaro, or about $800 less than its list price.That means Wegovy’s net price is about half of its list price, Ozempic’s is nearly two-thirds lower and Mounjaro’s net price is nearly 80 percent lower than its list price.Dr. Ippolito cautioned that because prices and prescriptions are in flux, these figures might change over time, but added that “these estimates give a good sense for the likely amount paid by many insurers and give a good sense for the amount of discounting going on.”Pragya Kakani, an economist at Weill Cornell Medical College, analyzed similar data with similar results but was not involved in Dr. Ippolito and Dr. Levy’s research.Novo Nordisk’s other drug, Ozempic, is expected to bring the company $11 billion.Tom Little/ReutersCraig Garthwaite, a health care economist at Northwestern University, is especially intrigued by the net prices of Ozempic and Mounjaro. Both are approved for people with diabetes but also cause weight loss. Wegovy, the same drug as Ozempic, is approved for weight loss. But the price of Ozempic is substantially lower than Wegovy’s price.The reason may be that Ozempic has a direct competitor in Mounjaro.But even Wegovy, which so far has the market for the new obesity drugs to itself, has an unexpectedly low net price, Amitabh Chandra, a health care economist at Harvard, said.“One might have naïvely thought that these are new medicines that are in great demand, so rebates would be small to nil,” Dr. Chandra said.“I was shocked,” he said, “by the extent of the rebates.”A Price We Already PayOne question looms, experts say: What is weight loss worth to patients and society?Obesity itself is expensive because it increases the risk for expensive diseases like diabetes and heart disease. One study found that obesity was associated with $1,861 excess yearly health costs per person, accounting for $172.74 billion in annual extra costs.The Institute for Clinical and Economic Review, an influential nonprofit group, asked about a year ago if the new weight-loss drugs are cost-effective, meaning that their value in terms of a better quality of life, a longer life and benefit to society exceeds their cost.Wegovy, the group reported, was not cost-effective. But the institute relied on an early and less precise estimate of the drug’s net price.When shown Wegovy’s estimated net price in the A.E.I. research, the group’s chief medical officer, Dr. David M. Rind, said that if the calculations were correct, Wegovy was cost-effective but “still poses major budget challenges.”Ozempic’s price is substantially lower than Wegovy’s price, which may be because Ozempic has a direct competitor in Mounjaro. George Frey/ReutersDr. Willett, of Harvard, added in an interview: “I don’t think anyone can predict exactly where this will go because competition may reduce prices, and the uptake is still not clear, but the potential cost could go way beyond anything we have seen.”Still, the expectation is that with less obesity, there will be fewer expensive obesity-related health problems, including type 2 diabetes.Not only can diabetes lead to kidney failure, blindness and amputations, it also doubles the risk for heart attacks and strokes.Patients may also get relief from the extreme social stigma and, often, self-loathing that accompanies obesity.Until recently, the idea that treating obesity would reduce obesity-related health risks was based on anecdotes and correlations, not cause and effect.Then in August Novo Nordisk announced the results of a large study, showing that Wegovy can reduce the risk of heart attacks, strokes, hospitalizations for heart failure and heart disease deaths by 20 percent.That outcome alters the picture, Dr. Garthwaite said.Some insurers do not cover drugs like Wegovy and may view obesity medications as vanity drugs. In response, some patients are suing their insurers.With a cardiovascular benefit, he said, that rationale for not covering the drugs is “out the window.”Costs We Can’t All AffordWhile the net prices of the drugs may be lower than expected, they remain too expensive for many potential patients.Those on Medicare, for instance, have no insurance coverage for Wegovy because Medicare is prevented by law from covering weight-loss drugs. Few state Medicaid programs cover the drug.And while Novo Nordisk says that 80 percent of private insurers cover Wegovy, the drug is not affordable for all insured patients.Katherine Baicker, a health economist, provost at the University of Chicago and an Eli Lilly board member, said that cheaper health insurance includes co-pays and deductibles that often render Wegovy out of reach. Patients with low-premium plans offered through the Affordable Care Act would similarly be priced out.A large study by Novo Nordisk showed that Wegovy can reduce the risk of heart attacks, strokes, hospitalizations for heart failure and heart disease deaths by 20 percent.Tom Little/ReutersDr. Scott Ramsey, a health economist at Fred Hutchinson Cancer Center, worries that poorer patients, who are uninsured or whose insurance requires high co-pays, will be looking on longingly as wealthier patients get the drugs.“We spent 15 years talking about the soaring cost of obesity to the health care system,” Dr. Garthwaite, the Northwestern economist, added. But with a way to cut that cost in reach, he said the attitude of some insurers seems to be, “we don’t want you to come up with a fix that costs money.”Waves and PeaksRelief should be coming soon, health economists predict, with companies rushing to develop their own drugs. Competition may lead to lower prices.That happened, for example, with drugs for hepatitis C. An effective cure for the liver disease initially cost as much as $84,000, leading to dire warnings that the cost would be comparable to “total spending in the United States on all drugs.”The list price of the hepatitis C treatment plunged, as competitors entered the market. Pharmacy benefit managers, which negotiate with drug makers, had more leverage as companies competed. Net prices fell accordingly.A similar scenario may play out with Wegovy, which “is riding the wave of not having any direct competition,” Dr. Doshi said. But that status will end soon.A version of Mounjaro by Eli Lilly is expected to be approved this year for obesity — a potential opening for insurers to agree to cover Wegovy but not Mounjaro, for example, if Wegovy’s price were to be sufficiently reduced.Dr. Ippolito added that with more than 70 obesity drugs in development, he expected that competition would only increase.For now, although the price of the drugs is likely at its peak, Dr. Chandra, the Harvard health care economist, argued that it is imperative for access to the drugs to be increased, even if that imposes a cost to society.The purpose of health insurance is not to save money, he said, but “to improve the quality of life, happiness and self-esteem.”