Pulmonary hypertension (PH) constitutes a group of rare diseases, including pulmonary arterial hypertension (PAH), yet the commercial potential for novel drugs approved for PH indications is considerable, driven by the premium prices that may be charged for drugs in these indications. Several novel therapies for the treatment of PAH have launched in the last five years, including Actelion’s Opsumit (macitentan), Bayer Healthcare’s Adempas (riociguat), United Therapeutics’ Orenitram (oral treprostinil), and Actelion’s Uptravi (selexipag). The launches of these agents, along with the increasing use of combination therapy following the positive results of the Phase III AMBITION trial, have added to the variety of treatments available for PAH. They have also contributed to the increasing complexity of the PAH treatment algorithm. For example, the soluble guanylate cyclase stimulator Adempas represents a novel drug class for the treatment of PAH, is the first therapy to be approved for more than one WHO PH group and is the first therapy to be indicated for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). The use of off-label therapies is another feature of the PH treatment landscape. Despite launches of new agents, off-label use of therapies, and the poor prognosis for patients with PH, the reimbursement environment for PH therapies is challenging, and the healthcare costs associated with PH are substantial. Consequently, the market opportunity for an efficacious, affordable, well-tolerated agent is considerable, although drug developers need to be aware of the unique dynamics of the PH market to ensure access, secure reimbursement, maximize uptake, and realize commercial potential.

Questions Answered:

  • The pulmonary hypertension market is lucrative despite the relatively small number of therapies available. How widespread are formulary exclusions of PH drugs in commercial and Medicare prescription drug plans? Which clinical and economic factors are important to MCO when determining coverage of PH agents? What kinds of restrictions do pulmonologists and cardiologists face in prescribing PH therapies?
  • Despite the availability of PH treatments, prognosis is poor, and treatment options have multiple reimbursement hurdles. How do payers’ decisions influence prescribing of PH therapies? Will combination therapy trials positively affect MCO coverage of these therapies? What percentage of patients do physicians say are paying out-of-pocket for these drugs?
  • New and emerging PH therapies have advantages and disadvantages over their more established competitors. How do MCO pharmacy and medical directors anticipate covering Actelion’s Uptravi based on various pricing scenarios? What do physicians consider to be the top drivers of prescribing for new agents? How can market access to new and emerging PH agents be maximized?

Scope:

Markets covered: United States.

Primary research: Online survey with 54 pulmonologists, 52 cardiologists, and 31 MCO pharmacy and medical directors.

Commercial context: Epidemiology tables, drug-treatment algorithms, and managed care background information.

Therapies covered: Drug classes used for the treatment of PH and PAH: endothelin receptor antagonists, PDE-5 inhibitors, prostacyclin analogues, and a soluble guanylate cyclase stimulator.

Table of contents

  • Pulmonary Hypertension - Access & Reimbursement - Detailed, Expanded Analysis: Pulmonary Arterial Hypertension (US)
    • Actionable Recommendations to Optimize Market Access
      • Optimizing Market Access Opportunities
    • Successes and Stumbles
      • Success Among PH Therapies in the United States
      • Stumbles Among PH Therapies in the United States
      • United States: Reimbursement Success and Stumbles
        • Reimbursement Successes or Stumbles
    • Key Stakeholders in the Road to Market Access
      • Key Stakeholders in the Path to Formulary Access
      • Stakeholder Dynamics in the Road to Reimbursement
    • Key Market Access Roadblocks
      • Key Market Access Roadblocks for PH Therapies in the United States
    • Reimbursement Dynamics
      • United States: Commerical Managed Care Organizations
        • Lessons Learned and Key Takeaways
        • Top Most Influential Factors Influencing Reimbursement of Therapies for Treating PAH
        • Key P & R Drivers
        • Physician-Reported Most Important Restrictions
    • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
      • Patient Share in Key Payer Channel
        • Top Prescribing Drivers
        • Most Influential Factors Affecting Choice of Therapy for PAH Patients
        • Patient Share: PAH
        • Patient Share for Pulmonary Hypertension
        • Patient Share by Drug Class for Pulmonary Hypertension
      • Prescriber Preference
        • Most-Prescribed Agents
        • Most-Preferred Agents
        • Most-Prescribed Agents
        • Most-Preferred Agents
      • Impact of Payer Policy on Prescribing
        • Key Levers and Constraints on Current Therapies
        • Physician-Reported Most Important Restrictions
        • Physician-Reported Most Important Restrictions
    • Market Access Landscape for Emerging Therapies
      • Likely Impact of Emerging Therapy
        • Anticipated Prescribing of PAH Therapies in 2017, Depending on Whether Uptravi Enjoys Preferred Tier Status
        • Anticipated Prescribing of PAH Therapies in 2017, Depending on Whether Uptravi Enjoys Preferred Tier Status
      • Potential Placement of Emerging Therapy at Various Prices
        • Likely Tier Status for Uptravi
      • Prescriber and MCO Opinion on Remaining Unmet Need
        • Desired Pharma Spending on Unmet Needs
    • Appendix
      • Physician Survey
        • Physician Familiarity with Current Therapies
      • MCO Survey
        • Commercial Plans’ Out-of-Pocket Cost
        • How is the out-of-pocket (OOP) maximum calculated?
        • What is the amount of out-of-pocket (OOP) for the timeframe?

Author(s): Alexandra Hemsley

Alexandra Hemsley, M.Sc., Eng.D., is a business insights analyst with the cardiovascular, metabolic, and renal disorders team at Decision Resources, where she primarily focuses on commercial developments in the drug markets for pulmonary hypertension, atrial fibrillation, venous thromboembolism, and osteoporosis. Before joining Decision Resources Group, Alexandra completed an Eng.D. in biochemical engineering and bioprocess leadership at University College London, where she investigated the effect of force and shear on embryonic stem cells and the implications for bioprocessing for regenerative medicine therapies. After completing her doctorate, Alexandra worked as an editor with the Future Science Group, where her responsibilities included market research and competitor analysis, editorial board recruitment, content development, and management of the peer review process. Alexandra also holds an M.Sc. in biochemical engineering from University College London and a B.Sc. in biological sciences from the University of Southampton.


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