Amgen/GSK's Prolia will be preferred as second- or third-line therapy for osteoporosis

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the majority of surveyed clinicians say they will use Amgen/GlaxoSmithKline's Prolia as either a second- or third-line therapy for osteoporosis if the drug receives regulatory approval for the indication. Prolia, which is expected to receive approval from the Food and Drug Administration in early 2010, will be prescribed in later lines of therapy as most surveyed clinicians indicate that they will likely continue using bisphosphonates as first-line treatments. Bisphosphonates, most notably alendronate (Merck's Fosamax, generics) and Sanofi-Aventis/Procter & Gamble's Actonel, currently dominate the osteoporosis and osteopenia drug markets.

The new Physician & Payer Forum report entitled How Will Clinician and Payer Attitudes Determine How Prolia Will Compete with Established Brands in the Dynamic Osteoporosis Market? finds that surveyed endocrinologists, PCPs and gynecologists are more likely to consider Prolia to be the most efficacious drug to treat osteoporosis, than any existing drug. However, between 25 percent and 45 percent of these clinicians consider Prolia to be less safe than existing drugs. The report also finds that approximately two thirds of endocrinologists and PCPs, and a third of gynecologists, do not see a need for additional agents within the selective estrogen receptor modulator (SERM) drug class. Clinicians say they expect to prescribe two emerging therapies from this drug class -- Pfizer's Viviant and Pfizer/Ligand Pharmaceuticals' Aprela -- to fewer patients with osteoporosis or osteopenia than the existing agent in this drug class, Eli Lilly's Evista.

"Clinicians expect to prescribe Viviant to between four and nine percent of their osteoporosis patients and to between four and 10 percent of their osteopenia patients," said Decision Resources Analyst Christine Helliwell, Ph.D. "The outlook for Aprela is slightly more favorable, with clinicians saying they will prescribe Aprela to between four and 14 percent of their osteoporosis patients and to between three and 14 percent of their osteopenia patients."

The report also finds that more than half of surveyed managed care organizations' (MCOs) pharmacy directors expect to place Prolia, Aprela and Viviant on tier 3 or higher in their commercial and Medicare plan formularies. All surveyed MCOs expect to include Prolia and Aprela in their formularies, while ninety percent of surveyed MCOs indicate they will include Viviant in their formularies.

How Will Clinician and Payer Attitudes Determine How Prolia Will Compete with Established Brands in the Dynamic Osteoporosis Market? is based on a U.S. survey of 51 endocrinologists, 51 gynecologists, 52 PCPs and 20 MCO pharmacy directors.