Research and Markets: Formulary Advantages in Osteoporosis: Rise and Fall of Access in the Wake of Fosamax Generics, Rebat

DUBLIN--(BUSINESS WIRE)-- Research and Markets ( has announced the addition of Decision Resources, Inc.'s new report "Formulary Forum: Formulary Advantages in Osteoporosis" to their offering.

Formulary Advantages in Osteoporosis: Rise and Fall of Access in the Wake of Fosamax Generics, Rebate and Contracting Efforts, and New Drug Launches

With 62 million cases of osteoporosis and osteopenia in the United States and a U.S. market of over $3.8 billion, few brands are competing for a very large appropriation of healthcare dollars. Major brands, however, now have to contend with generic alendronate (Mercks Fosamax, generics) and convince payers that their brand provides a sufficient value proposition for Tier 2 reimbursement. More recently, the osteoporosis market in the United States has seen growing uncertainty as Amgens Prolia (denosumab) received a favorable ruling from an FDA advisory panel, and Eli Lilly announced discontinuation of Phase III clinical development of arzoxifene.

Using tiering and restrictions data from Fingertip Formulary, as well as insight from 50 pharmacy directors, this report determines the key trends in reimbursement in osteoporosis, drivers of these trends, and how stakeholders can capitalize on future shifts in coverage to steal share from the competition.

Questions Answered in This Report:

  • Competition among bisphosphonates: Since Fosamax went generic, Procter & Gamble/sanofi-aventis Actonel (risedronate) has led bisphosphonates in terms of both reimbursement and sales, but Roches Boniva (ibandronate) has made substantial gains in closing the coverage gap between these brands. How far has Boniva come in reimbursement, and where have Bonivas gains come at the expense of Actonel? In which channel has Boniva achieved more favorable reimbursement than Actonel?
  • Rebates: Surveyed pharmacy directors from health plans of all sizes expect to see increasing rebates over the next five years. What group of health plans get the highest rebates today, and how much will other plans catch up over the next five years? For which classes of agents are rebates the most competitive?
  • Emerging oral agents: Eli Lilly/Daiichi-Sankyos Evista (raloxifene) is currently covered as a Tier 2 benefit by the vast majority of commercial and Medicare plans. How will other selective estrogen receptor modulators (SERMs) compare, and how will marketers of emerging SERMs have to price their agents to ensure inclusion on the majority of formularies?
  • Emerging injectable agents: Coverage of Eli Lillys Forteo (teriparatide) serves as a bellwether for likely coverage of Prolia, because both brands are injectable therapies with novel mechanisms of action. What percentage of pharmacy directors report requiring a fracture before reimbursement of Forteo, and what percentage will have this requirement for Prolia? How will Amgen have to price Prolia to achieve parity coverage to Forteo? How does coverage of Novartiss Reclast (zoledronic acid) compare?


  • Current reimbursement: Nationwide coverage of tier placement, prior authorization, and step therapy restriction rates for both commercial and Medicare plans from Fingertip Formularys database of over 1,600 plans. Longitudinal analysis of data over five quarters by both percentage of plans and percentage of covered lives.
  • Primary research: Surveys with 50 U.S. pharmacy directors, each with at least 3 years experience on their plans Pricing and Therapeutic Committees and each responsible for at least 75,000 covered lives.
  • Emerging therapies: Expected formulary restrictions, tier placement, and effect of price on tier placement on both commercial and Medicare plans for Prolia, Pfizers Fablyn (lasofoxifene), Wyeths Aprela (bazedoxifene / conjugated estrogens), and Wyeths Viviant (bazedoxifene).

Key Topics Covered:

1. Key Findings

2. Introduction, Data Sources, and Methodology

3. Formulary Positioning Over Time

a) Current Tier Placement of Osteoporosis Drugs in Private and Medicare Plans

b) Shifts in Tier Status Within Private and Medicare Plans Since 2008

c) Pharmacy Directors Explain Their Plans Reimbursement of Therapies

d) Current Restrictions on Osteoporosis Drugs in Private and Medicare Plans

e) Shifts in Restrictions Within Private and Medicare Plans Since 2008

4. Payer-Reported Shifts in Formularies

a) Shifts in Tiering and Restrictions of Osteoporosis Therapies In Private Plans

b) Shifts in Tiering and Restrictions of Osteoporosis Drugs in Medicare Plans

5. Rebates and Impact on Tier Status

a) Overview of Osteoporosis Rebates

b) Comparison of Rebates in National, Regional and Single-State Plans

c) Impact of Contract Negotiations on Tiering

6. Expected Coverage and Formulary Restrictions of Emerging Brands

a) Reimbursement of Emerging Agents

b) Restrictions for Prolia and SERMS

7. Impact of Price on Tier Status of Emerging Agents

a) Prolia Price Versus Coverage in Private and Medicare Plans

b) SERMs Price Versus Coverage in Private and Medicare Plans

Companies Mentioned:

  • Amgen
  • Daiichi-Sankyo
  • Eli Lilly
  • Merck
  • Novartis
  • Procter & Gamble
  • Roche
  • Sanofi-aventis
  • Wyeth

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Research and Markets
Laura Wood, Senior Manager,
[email protected]
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Fax (outside U.S.): +353-1-481-1716


INDUSTRY KEYWORDS:   Health  Pharmaceutical