Until now, Zepbound has been packaged in a single device, an injection pen that contains both the medication and the needle. Patients press a button on one end to insert a needle on the other end, which delivers the dose.
With the new vials, patients use a syringe to draw up their dose and then inject it into themselves.
Indianapolis-based Lilly said it was bringing the vials to market primarily to improve overall supply due to high demand because vials are easier to manufacture than injection pens.
“The main reason is supply,” said Patrik Jonsson, president of cardiometabolic health at Lilly. “We have seen unprecedented demand. The vials represent a new opportunity to increase supply.”
The ampoules represent a cheaper alternative for many people whose health insurance still does not cover the cost of anti-obesity medications.
The vials are available in Zepbound’s two lowest dosages, with four-week supplies costing $399 for the 2.5-milligram dose and $549 for the 5-mg dose.
For comparison, the list price for a month’s supply of Zepbound injection pens is $1,060. Some patients pay less because their insurance covers them or offers Lilly savings programs. However, others must pay the full list price if their insurance does not cover the cost and they do not qualify for Lilly savings programs.
With its foray into ampoules, Lilly is also targeting competition from cheaper imitations sold by pharmacies that manufacture drugs themselves.
Compounding pharmacies are allowed to make alternative versions of prescription drugs when the original brand is in short supply, as was the case with Zepbound. Many patients resort to prescription versions, which are also usually sold in vials, because they are cheaper and have been available during times when the originals were difficult to find due to shortages.
The lower prices for Zepbound vials are more competitive than what some people pay for compounded versions of weight loss drugs. Good Life Meds, for example, offers a compounded version of Zepbound at a retail price of $279 per month, up from the regular price of $349, it says on its website.
Lilly and Novo Nordisk, the maker of Wegovy, another leading obesity drug, have questioned the safety of weight-loss drug formulations.
The Food and Drug Administration has said it cannot vouch for the safety and effectiveness of any formulations of the drug. Both Lilly and Novo have taken legal action to stop the sale of some formulations of the drug or to force sellers to refrain from using brand names in advertising. However, many of the products remain available.
To withdraw Zepbound from an ampoule, patients need to go through more steps and steps. They must draw the medication from the ampoule using a separate syringe and then inject it into themselves.
The FDA approved Lilly’s plan to sell Zepbound in vials in March. The FDA approved packaging that includes detailed instructions on how to safely administer the drug to patients from a vial.
Each ampoule contains a single dose for a weekly injection, which is intended to prevent overdose. Patients can draw the entire contents of the ampoule into the syringe and do not need to measure the dose.
Lilly will sell its vials exclusively through its new online service, LillyDirect, which delivers Zepbound and other Lilly drugs directly to your home. The website also sells syringes and needles for the vials.
For the FDA-approved use of the drug for chronic weight management in people with a high body mass index, patients need a valid prescription.
The vials could be especially helpful for patients with Medicare, the government health insurance program for older adults and some disabled people, because the prescription price for anti-obesity drugs like Zepbound does not apply when used solely for weight loss.
In addition, Medicare members are not eligible for direct copayment assistance from drug manufacturers because the government typically views these as bribes.
Zepbound doses above 5 mg will continue to be available only in injection pens, so the lower dose vials may not be a cost-effective option for people who need to take higher doses. Typically, patients start with the lowest dose for the first month and then gradually increase the dose up to 15 mg per week.
Write to Peter Loftus at [email protected]
