On Friday, June 4th, the Meals and Drug Administration (FDA) permitted Novo Nordisk’s weight problems drug Wegovy (semaglutide), a glucagon-like peptide 1 receptor agonist, to be injected subcutaneously once-weekly. Wegovy is a higher-dose – 2.4 mg – model of the diabetes drug Ozempic (semaglutide).
Wegovy is indicated for adults who’re overweight (physique mass index ≥30) or chubby (physique mass index ≥27), and who even have sure weight-related medical circumstances, comparable to kind 2 diabetes, hypertension, and excessive ldl cholesterol. The drug is for use for long-term weight administration along with a lowered calorie meal plan and elevated bodily exercise.
FDA permitted Wegovy primarily based on section 3 information which confirmed that Wegovy helped 33% of sufferers lose greater than 20% of their physique weight over a 68-week scientific trial interval. The high-dose version of semaglutide is a primary of its sort weight problems medicine in that it’s dosed on a once-weekly foundation.
The Wegovy approval continues a development through which producers of diabetes medication repurpose them to deal with different circumstances which might be frequent in diabetic sufferers. So, for instance, the diabetes medication Jardiance (empagliflozin) and Victoza (liraglutide) now have approvals for decreasing the chance of coronary heart assault, stroke and loss of life in cardiovascular sufferers.
Weight problems impacts greater than one-third of adults within the U.S. Since 1980, the weight problems price amongst adults has greater than doubled. Reversing the development has confirmed troublesome. Although important to profitable weight reduction applications, weight loss program and train usually must be supplemented by medical interventions, comparable to surgical procedure and pharmaceutical therapies.
Wegovy provides to the armamentarium of pharmacologic therapies focusing on weight reduction, which previously decade has expanded to incorporate Saxenda (liraglutide), Contrave (bupropion/naltrexone), and Qysmia (phentermine/topiramate).
Novo Nordisk hasn’t revealed Wegovy’s listing value, however hinted that it is going to be much like the value of its drug Saxenda, a weight reduction remedy that retails at $1,300 monthly with out insurance coverage. Saxenda is claimed to assist sufferers lose 5% of their physique weight on common. In studies launched by Novo Nordisk, contributors taking Wegovy had a median weight lack of 15% of their physique weight.
Although Wegovy holds promise, it can doubtless should take care of uptake challenges. Gross sales of weight reduction medication have disenchanted for many years.
Lingering security doubts persist after a number of high-profile withdrawals, together with the mix drug fenfluramine/phentermine in 1997, Meridia (sibutramine) in 2010, and Belviq (lorcaserin) in early 2020. Different as soon as promising weight reduction medication, comparable to Acomplia (rimonabant), failed to achieve U.S. approval attributable to security considerations.
Older medication like Xenical (orlistat) have had comparatively unimpressive scientific and cost-effectiveness numbers, along with uncomfortable side effects that some discovered insupportable. And, on their very own, with out extra behavioral therapies, weight reduction medication have traditionally proven restricted effectiveness, which has restrained doctor prescribing of those merchandise.
Past security and scientific effectiveness considerations, there’s the problem of how payers will view a drug like Wegovy and the weight problems situation it treats. If seen as a way of life medicine, Wegovy will invariably battle to achieve favor with payers. From smoking cessation to weight administration to alopecia (hair loss), many insurers restrict protection of what they deem are way of life medication. Within the case of hair loss, for instance, Medicare doesn’t cowl medication, except they’re thought-about medically essential to deal with a illness that has brought on baldness.
Till now, the proof counsel that many public payers (Medicare, Medicaid, Inexpensive Care Act (ACA) exchanges) view weight reduction remedies as way of life drugs, which they’re reluctant to pay for. By not reimbursing, these payers are de facto signalling they don’t view weight problems as a illness.
Certainly, insurance coverage protection for weight problems remedies stays very uneven. Within the non-commercial space, particularly, protection is scant. By statute, all Medicare plans are precluded from masking weight reduction drugs. Additional, a examine analyzing protection within the Medicaid and Inexpensive Care Act change markets of weight problems medication, comparable to phentermine/topiramate (Qysmia), liraglutide (Saxenda) and bupropion/naltrexone (Contrave) discovered that solely 7 state Medicaid applications lined any of the medication, and amongst 136 change plans merely 11% had some protection for any of the three medication talked about.
Novo Nordisk acknowledges that for Wegovy entry and reimbursement might be challenges. The company says it has “been laying the groundwork” for Wegovy’s rollout, and has already begun to work with payers. It’s unknown what “working with payers” entails. Maybe the corporate intends to pursue some form of value-based pricing preparations. Extra importantly, possibly Novo Nordisk is in search of to change payer notion of weight problems; altering it from a way of life subject to a persistent illness.
Scientific trial information counsel that Wegovy works higher for treating weight problems than every other beforehand permitted drug. Absolutely, if the scientific proof holds up in the actual world and is sturdy over time, the scientific profit and security profile could justify payers reimbursing the product as a medically needed remedy for the eligible overweight inhabitants. And if reimbursed universally, this could induce extra insured individuals to take the product as their out-of-pocket prices can be a lot decrease.