Lilly scores FDA approval of tirzepatide for weight management, intensifying rivalry with Novo Nordisk

November 13, 2023

Eli Lilly’s tirzepatide, which the FDA approved last year as a treatment for type 2 diabetes, is now also?approved ?for chronic weight management.?

Lilly markets the drug under the brand name Mounjaro for diabetes but will use the brand name Zepbound for the weight-management product, which the company anticipates will be available by the end of this year.?

The target doses (5 mg, 10 mg, and 15 mg) are the same for both products, and Mounjaro has been used off-label for treating obesity since it was approved.?

Zepbound will have a list price of approximately $1,060 for a month’s supply, which Lilly said is about 20% lower than Novo Nordisk’s Wegovy (semaglutide) 2.4 mg injection (approximately $1,350).?

With the commercial savings card program Lilly is implementing, people with commercial insurance that covers Zepbound could be eligible to pay as little as $25 for a one-month or three-month prescription, Lilly said, and those with commercial insurance that does not cover Zepbound could be eligible to pay as low as $550 for a one-month prescription.?

Zepbound is indicated for adults with obesity (those with a body mass index of at least 30 kg/m2) or adults who are overweight (with a BMI of at least 27 kg/m2) who also have a weight-related health condition, such as hypertension, high cholesterol, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease, “to lose weight and keep it off,” Lilly said in a?press release . The drug is to be used in conjunction with a reduced-calorie diet and increased physical activity.?

According to Lilly, Zepbound is “the first and only obesity treatment of its kind” that activates two incretin hormone receptors — glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

Like Novo Nordisk’s Wegovy, Zepbound is administered as a once-weekly subcutaneous injection. Lilly said Zepbound will be available in six doses ranging from 2.5 mg to 15 mg. When initiating treatment, the dose must be up-titrated over four to 20 weeks until the target dosage of 5 mg, 10 mg, or 15 mg is achieved. ? ?

Lilly noted that the use of Zepbound may sometimes be associated with severe gastrointestinal adverse reactions.?Labeling for Zepbound includes warnings pertaining to multiple health conditions and a boxed warning regarding thyroid C-cell tumors.?

Our Take: The FDA approved Novo Nordisk’s semaglutide product for type 2 diabetes, Ozempic, in 2017, followed by Wegovy for weight management in 2021, giving the Danish drugmaker a considerable head start over Lilly in both indications.??

Demand has outpaced Novo Nordisk’s ability to supply the drug, and off-label use of Ozempic for weight loss has at times resulted in a shortage of the drug for patients with diabetes. Lilly has also had difficulty keeping up with demand for Mounjaro, in part because of its off-label use for weight loss.?

According to the Centers for Disease Control and Prevention, the prevalence of obesity in the U.S. is now 4 in 10 adults. Add in adults who are overweight, and the prevalence climbs to approximately 70%, according to the FDA.?

In light of these numbers, it would seem there’s enough demand to keep both Novo Nordisk and Lilly scaling up their manufacturing capabilities for quite some time —?while earning billions of dollars per quarter.?

Barron’s said the cost of Wegovy and Zepbound “could provoke a spending crisis,” given the demand for the drugs. ?

But, their cost could place them out of reach for many people who could benefit from them, Barron's said. Although several large health insurers cover Wegovy, not many smaller ones do, and Medicare is prohibited from providing coverage for weight-loss treatments. Medicaid coverage for Wegovy is limited.?

Meanwhile, Lilly is investigating the use of tirzepatide as a treatment for obstructive sleep apnea, chronic heart failure with preserved ejection fraction and non-alcoholic steatohepatitis (NASH). The company is also developing an oral version of tirzepatide and has a next-generation oral GLP-1 agonist, orforglipron, in Phase III clinical development for obesity and diabetes. Lilly’s pipeline also has a Phase II candidate called retatrutide in development for diabetes and obesity that acts as a triagonist for GIP receptor, the GLP-1 receptor, and the glucagon receptor.?

In addition to developing an oral version of semaglutide, Novo Nordisk is evaluating the drug as a potential treatment for NASH and for Alzheimer’s disease.?

Wegovy also appears to have cardio-protective benefits beyond those expected in connection with weight loss, based on?trial results ?presented over the weekend at the American Heart Association annual Scientific Sessions in Philadelphia.?

Novo Nordisk also has a long-acting co-agonist of GLP-1 and amylin, called amycretin, that’s in early-stage development as a once-daily oral treatment for obesity.?

AstraZeneca, who scrapped development of a couple of GLP-1 agonists earlier this year,?agreed ?last week to pay Chinese biotech Eccogene $185 million up front for a next-generation oral GLP-1 receptor agonist in development as a treatment for obesity, type 2 diabetes, and other cardiometabolic conditions.?

Pfizer discarded one of its experimental obesity treatments earlier this year, too, because of liver safety concerns, but is continuing development of a candidate called danuglipron. The compound is in Phase II testing as a treatment for both obesity and type 2 diabetes. ? ?

In many ways, it seems as though the potential market for the current and future weight-loss drugs is on the verge of exploding. More than one expert has referred to the drugs as game changers, and entire industries —?like food and travel, for example — could feel the ripple effects. Denmark’s economy already has, thanks to the profits Novo Nordisk has brought in from Wegovy and Ozempic. ?

The game-changing nature of these drugs isn’t just?because of their ability to curb appetite; it’s for all of the additional potential uses for other cardiometabilic?conditions. And if it reduces the urge to eat, could it also be used in the management of other addictive behavior?

Drugs like Enbrel (Amgen) and Humira (Abbvie) achieved eye-popping sales because of their Swiss Army knife-like ability to treat so many conditions beyond their original indications. Are we seeing another crop of drugs with similar potential?

Food for thought.?

Disclosure:?Amgen, AstraZeneca, and Novo Nordisk are Darwin Research Group clients.

What else you need to know

Mass General Brigham is collaborating with Best Buy?to scale the health system’s technology-enabled Home Hospital clinical care delivery model. The intent is twofold: to expand access to acute-level hospital care at home for patients with health conditions such as heart disease and chronic obstructive pulmonary disease, and to address workforce shortages, according to a?press release . Through the collaboration, Mass General Brigham and Best Buy will develop customized systems and capabilities to support patients and their care teams, with the ultimate goal of having 10% of the health system’s inpatient care at any given time being delivered in the home, Mass General Brigham’s chief clinical and innovation officer, Dr. Stephen Dorner, told Home Health Care News.

Best Buy will also support the health system’s Home Care program, which offers non-acute care for patients recovering from illnesses and injuries. Further, Mass General Brigham and Best Buy will offer scholarships to students interested in nursing, paramedic, and digital technology careers focused on the in-home care setting. Best Buy established home care partnerships with Atrium Health and Geisinger this year; the collaboration with Mass General Brigham is the company’s first partnership with a health system that operates a Medicare-certified home health business.?

Cigna is considering selling its Medicare Advantage (MA) business,?Reuters reported last Monday, citing “people familiar with the matter.” The sources told Reuters that Cigna has engaged an investment bank to evaluate options for divesting the line of business but discussions with interested buyers are at an early stage and may not result in a sale. Cigna’s MA business accounted for 4.4% of the company’s $179.4 billion in revenue from external customers last year, according to Reuters, and the company anticipates that changes in CMS’ reimbursement model and star rating system are likely to hamper its MA performance in the upcoming plan year. Cigna recently agreed to a settlement of $172.3 million to resolve allegations that it submitted false diagnosis codes for MA members so it would receive higher reimbursements. The settlement included a five-year corporate integrity agreement with the Department of Health and Human Services.?

Editor’s note: Everything I know about Cigna suggests that it’s unlikely to walk away from its MA business, an?important patient population for its Corewell unit. In fact, in recent years it’s been?slowly growing its MA population?through acquisition. But if reimbursement continues to plunge under?CMS’ HCC Version 28 ?— set to be fully implemented by 2025 — the company may just decide that MA?patients are too much of a money losing proposition.

NorthShore – Edward-Elmhurst Health (NS-EEH) is partnering with Lumeris?to incorporate Lumeris’ population health data platform into the Evanston, Ill.-based health system’s value-based care strategy. They also plan to deliver joint services to support providers in NS-EEH’s clinically integrated network — which includes more than 3,000 system-employed and affiliated physicians and nine hospitals in and around Chicago. The services will pertain to care management, pharmacy management, patient engagement, and other key areas, according to the?announcement . Through their payer-agnostic partnership, NS-EEH and Lumeris will form new ACO models as well, initially focusing on participation in CMS’ ACO REACH model and later expanding into other types of accountable care and population health models. ?

CMS issued a proposed rule with guardrails for brokers?who sell Medicare Advantage plans. The rule is designed to discourage brokers from recommending MA plans based on “excessive” compensation they might be offered rather than how well the plans meet beneficiaries’ needs. CMS said in a?press release ?it is concerned that some MA plan organizations are circumventing existing payment rules by offering financial incentives to brokers who steer beneficiaries into their plans, a practice that could drive smaller MA plan organizations out of business and further consolidate the MA market. To address these “predatory marketing” practices, CMS is proposing a fixed compensation payment of $642, regardless of the plan a beneficiary chooses. This fixed rate would include “all activities associated with the sales to/enrollment of a beneficiary into a Medicare Advantage plan or Part D plan,” according to a CMS?fact sheet . The proposed rule also seeks to prohibit arrangements such as volume-based bonuses between MA plan organizations and third-party marketing organizations.?

CMS is expanding access to behavioral health care?through policies?included in the 2024 Medicare Physician Fee Schedule final rule. For the first time in Medicare’s history, marriage and family therapists and mental health counselors can enroll in Medicare (effective immediately) and start billing for their services in January, CMS said in a?press release . Mental health counselors include eligible individuals who provide addiction, alcohol, and drug counseling and meet qualification requirements. The final rule also increases payment for several types of behavioral health care. Details are available in a?fact sheet .?

Grassroots organizers launched?The Pharmacy Guild ?in an effort to unionize?pharmacists and pharmacy technicians who work at retail pharmacies. To help build the necessary infrastructure, the organizers are receiving guidance from IAM Healthcare, a union of health care professionals affiliated with the International Association of Machinists and Aerospace Workers. In late September and October, pharmacy workers at CVS and Walgreens participated in multiple walkouts; several who were quoted in news reports referred to conditions such as chronic understaffing and unreasonable workloads, which they said were compromising patient safety.

What we’re reading

Untapped opportunities for health system pharmacies . McKinsey & Company, 11.7.23

Primary Care Redesign for Value-Based Care . NEJM Catalyst, 11.3.23 (summary?available, subscription required for full article)

From Training To Trapping: The Paradox Of Training Repayment Agreements In Nursing . Health Affairs, 11.7.23

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