Trends in Market Access for Specialty Biologics: Challenges & Promises
Requires Subscription or Fee PDF


Specialty Biologics
Market Access


Specialty biologics are the fastest growing class of bio/pharmaceutical products in terms of the number of new brand launches and rates of health care spending in the U.S. and globally. Innovative biologics meant to treat a range of hitherto untreatable conditions in oncology, inflammation, CNS, endocrinology and other chronic conditions seek to offer radical improvements in efficacy and patient well-being. Such products can command premium prices, often costing over $100K per year per patient - triggering a raft of challenges to ensuring that eligible patients have adequate access.

 This article outlines important trends impacting market access to specialty biologics in the U.S. and globally. Particular importance is placed on evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access. The reshaping of the specialty product market access landscape in the U.S. through the availability of oral biologic formulations distributed to patients via high-touch, high-involvement specialty pharmacies is examined. The rising role of risk sharing between specialty product manufacturers and insurers as a way to balance rewards of access with the risks inherent in radical new specialty therapeutics is discussed. Challenges posed by specialty biosimilars to traditional ways of ensuring market access and fair reimbursement are outlined. The impact of health care reforms on market access for specialty biologics in the U.S. is discussed in the context of the growing need for comparative outcomes research and the application of the principles of health technology assessments - adapted, in part from their apparent success in ensuring equitable and cost-effective access to biologics in the E.U.
Requires Subscription or Fee PDF


EMD Serono. EMD Serono Specialty Digest, 7th Edition. 2011

Bach, B. Peter, Lenoard B. Saltz & Robert E. Wittes, ‘In Cancer Care, Cost Matters’, The Opinion Pages, The New York Times, October 14, 2012

Morgan, Sarah, ‘Specialty Pharma Coverage At The Crossroads’, Medical Marketing & Media, March 1, 2014

Rao, Sanjay K., ‘PM360 Feature: Strategic Priorities For Specialty Care Products’, PM360, August 2011

Medical Pharmacy & Oncology Trend Report; Magellan Pharmacy Solutions & Icore Healthcare, 2012

The 2013 Genentech Oncology Trend Report, Genentech

The Community Oncology Practice Impact Report & Update; Community Oncology Alliance, April, 2012 & June 2013

Total Cost of Cancer Care by Site of Service: Physician Office vs. Outpatient Hospital. Avalere Health, May, 2012; & Site of Service Cost Differences for Medicare Patients Receiving Chemotherapy. Milliman, October, 2011.

Barlas, Stephen, ‘Federal Investigative Report Questions 340B Contract Pharmacy Programs; Office of Pharmacy Affairs Promises Regulatory Response’; P&T Magazine, v39, No.4, April 2014

D. Guy & Rodgers, S., ‘Most Cancer Patients Will Be Treated in Integrated Delivery Networks (IDN) and Cancer Institutions by 2016, Predicts New Report’, Inside Oncology, August 15, 2012.

Mullen, Patrick, ‘The Arrival of ASP’; Biotechnology Healthcare, June 2007; & Bradbury, Keith, ‘Specialty Drugs – Rich Pipeline That Needs To Be Managed’; Biotechnology Healthcare, Oct/Nov. 2009

Holcombe, Dawn G.,’Is oncology compatible with specialty pharmacy?’ Community Oncology, March-April 2005

Rao, Sanjay K., ‘Pricing Biologics : Issues, strategic priorities and a conceptual model’, Journal of Commercial Biotechnology, v17, I, 7-23, 2011

Carlson, Josh, Louis P. Garrison, Sean D. Sullivan; ‘Paying for outcomes: innovative coverage & reimbursement schemes for pharmaceuticals’; Journal of Managed Care Pharmacy, v15, # 8, 2009

Garrison, Louis P et al, ‘Performance-based risk-sharing arrangements-Good practices for design, implementation, and evaluation: report of the ISPOR task force’; Value In Health, v16, 703-719; 2013

EMD Serono. EMD Serono Specialty Digest, 8th Edition. 2012

Trosman et al. , ‘Health Technology Assessment and Private Payers’ Coverage of Personalized Medicine, Journal of Oncology Practice’, Vol. 7, May 2011 (3 Suppl) & Mullins C. Daniels et al, ‘How Do U.S. Healthcare Payers React To & Use Pharmcoeconomic Information?’ International Journal of the Economics of Business, , v18, No. 2, 2011

Barnes, Lauren et al, ‘Oral Oncolytics / Addressing the Barriers to Access & Identifying Areas for Engagement’, Avalere, supported by funds from the Community Oncology Alliance, 2010

Pollack, Andrew, ‘Gov. Brown of California Vetoes Biotech Drug Bill’, New York Times, October 13, 2013

The OPTUM ACO survey of 1000 MDs and 400 Hospital Executives (June 2012); & Murphy, Kyle ‘ACOs doubled during past year, Medicare outpaced commercial’, EHR Intelligence, 2013

See http: //; ‘Survey reveals hospital executives reluctant to implement ACO models’; Purdue Healthcare Advisors, Dec. 20, 2013

Unless specified by prior arrangement, the author agrees to the following terms and assurances:

  1. For myself and on behalf of the other authors listed on this work, I assign to thinkBiotech LLC the copyright* in the contribution for the full term throughout the world.
  2. I/we further give to the following assurances
    1. I am the sole author of the contribution, or, if not, I have the written authority of the other authors to transfer the copyright* to thinkBiotech LLC and give these warranties;
    2. I and (where appropriate) the other authors are entitled to transfer the copyright to thinkBiotech LLC and no one else would be entitled to prevent us from publishing the contribution;
    3. To the best of my/our knowledge, all the facts in the contribution are true and accurate;
    4. The content of the contribution is entirely original to me (and where appropriate to the other authors) or, if not, the written permission of the owner of the copyright in any material copied from elsewhere has been obtained for all media (all such permissions to be attached to the contribution as supplementary files);
    5. Nothing in the contribution is obscene or libellous;
    6. Nothing in the contribution infringes any duty of confidentiality which I/or the other authors may owe to anyone else.
    7. I and/or the other authors have obtained the appropriate clearances from my/our employer(s) or other concerned institution(s).
* Works by US government employees prepared as part of official duties are in the public domain and the authors are therefore exempt from copyright assignment.