Merck Fosamax Once-Weekly Is Priced Same Per Day As Its Daily Strengths

Merck's new once-weekly 70 mg Fosamax formulation is set at the same price per day of therapy as the daily 5 mg and 10 mg formulations of the osteoporosis drug.

Merck's direct catalog price for the "patient-friendly" blister package containing four once-weekly tablets is $49.39, or approximately $12.35 a pill. The company's direct catalog price for the 5 mg and 10 mg daily tablets is slightly more than $1.76 per pill, or the same $49.39 for a four-week supply.

FDA approved Fosamax (alendronate) 70 mg Oct. 20 for once-weekly dosing for the treatment of postmenopausal osteoporosis, and Fosamax 35 mg as a once-weekly regimen for the prevention of postmenopausal osteoporosis.

The new strengths correspond to seven times the daily alendronate 10 mg (used for osteoporosis treatment) and 5 mg (used for osteoporosis prevention) formulations.

Pricing has not yet been set for the 35 mg dosage, but since the 5 mg and 10 mg formulations are priced the same, the prices for the 35 mg and 70 mg formulations are also likely to be very close.

With the new approvals, "Fosamax now provides physicians and healthcare providers with the option to prescribe the once-weekly regimen at the same catalog price as a week's worth of the daily regimen," Merck said.

Merck already has a 40 mg formulation indicated as a daily regimen for treating Paget's disease in men and women, listed in Merck's catalog as $30.94 for 30 tablets, or $4.42 per pill ($17.62 for four weeks if taken weekly). However, this dosage is only available through an exclusive distribution agreement with CVS ProCare (¹ (Also see "Merck Fosamax 40 mg Distribution Plan Leaves Room For Once-Weekly Agent" - Pink Sheet, 4 Sep, 2000.)).

The Paget's Patient Support Program requires doctors to submit prescriptions for the 40 mg dose directly to CVS ProCare, and prescriptions for the dose will only be filled for Paget's patients. The arrangement has given Merck considerable pricing flexibility for the 35 mg formulation.

When Fosamax 40 mg was available at all pharmacies, physicians are understood to have prescribed the less expensive once weekly formulation instead of Fosamax 5 mg for osteoporosis prevention in order to save their patients money. Because Fosamax 40 mg is now restricted, however, it is unlikely that Fosamax 40 mg prescriptions will be substituted for the 35 mg dose.

Merck's direct price for the 5 mg and 10 mg formulations is $1.76 per tablet following a 4.3% price increase in August.

The competing 5 mg daily formulation of the postmenopausal/glucocorticoid-induced osteoporosis agent Actonel, co-marketed by Proctor & Gamble/Aventis and approved for the osteoporosis indications in April, is priced at a 20% discount to the 5 mg and 10 mg Fosamax strengths, at average wholesale prices.

Besides prevention/treatment of postmenopausal osteoporosis and treatment of Paget's disease, Fosamax is already approved for treatment of glucocorticoid-induced osteoporosis in men and women, and was most recently approved as a treatment to increase bone mass in men with osteoporosis.

Clinical trials demonstrated therapeutic equivalence of once-weekly 70 mg Fosamax and once-daily 10 mg Fosamax, as well as therapeutic equivalence of the 5 mg and 35 mg strengths, new product labeling says. "The overall safety and tolerability profiles" of the weekly and daily Fosamax formulations were also "similar," according to labeling.

Although bone fracture data for the new formulations was not included in labeling, Merck said the information was collected throughout the studies and will be part of the two-year 35 mg/70 mg follow-up data presented at the American College of Rheumatology conference in Philadelphia Oct. 30.

The company said that it is currently enrolling patients in clinical studies of the 70 mg and 35 mg once-weekly formulations in men.

FDA has deferred the pediatric studies requirement for Fosamax until December 31, 2002, but acknowledged in the approval letter for the once-weekly formulations that Merck has "submitted a pediatric development plan" for the new dosage forms.