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BIOSKETCH AND CURRICULUM VITAE
November 2015
PAUL C. LANGLEY
B.Sc. (Econ). M.A., Ph.D.
Dr Paul Langley is a professional economist. His undergraduate training was in the UK,
University of Hull (B. Sc [Econ]) with postgraduate training in Canada at Carleton University
(M.A.) and Queen’s University (Ph.D.). Dr Langley has taught in the UK (University of
Lancaster) and in Australia (La Trobe University) with visiting appointments at Carleton
University, the University of Ohio and the University of California (Irvine). Although initially
focusing on labor economics, Dr Langley moved into health economics – specifically the
economic evaluation of pharmaceutical products - in the early 1990s. The impetus for this move
was the decision, in 1992, by the Australian Department of Health to require companies seeking
formulary approval for new products to make a cost-effectiveness case in order to justify the unit
cost of the product and its formulary listing.
Following this decision by the Australian authorities, a number of other countries (Canada, New
Zealand) began developing their own formulary submission guidelines and evidentiary and
analytical standards for economic evaluations emerged. Although guidelines had not yet been
introduced within the United States, there was considerable interest among both drug
manufacturers and academic health economics groups in the emergence of guidelines
requirements and in the need to improve understanding of the new evaluative techniques as they
applied to a range of new products and disease areas. As a result of his early work in Australia,
Dr Langley was appointed Associate Professor at the University of Arizona (College of
Pharmacy; Center for Pharmaceutical Economics) in July 1994 and moved from Australia to the
United States. Following a successful three years at Arizona (where Dr Langley authored some
20 publications in this area and managed a number of significant research projects), Dr Langley
was appointed Professor at the University of Colorado (School of Pharmacy, University of
Colorado Health Sciences Center) in July 1997. One of Dr Langley’s tasks at Colorado was to
establish a Center for Pharmaceutical Economics. Following a successful two years at Colorado,
Dr Langley moved to 3M Pharmaceuticals in September 1999 (through July 2005) as US and
International Manager, Health Economics with worldwide responsibilities for economic
evaluations as they apply to drug development, reimbursement and post-market entry support.
A major focus of Dr Langley’s activities both at universities and as a consultant has been in the
development of training programs in pharmaceutical economics, health economics and the
burden of illness. At the University Of Arizona Dr Langley was instrumental in establishing the
Certificate Program in Pharmacoeconomics in the mid-1990s. A similar program was developed
at the University of Colorado. Dr Langley has developed packages for distance learning in
pharmaceutical economics as well as general and disease specific training programs for
healthcare systems and pharmaceutical companies.
1
Since leaving 3M pharmaceuticals, Dr Langley has managed his consulting company, Maimon
Research LLC, undertaking a number of consultancy projects in major disease areas as well as
advising on document management and minimum evidentiary standards for drug development
decisions and reimbursement.
One of the major forums for developing and publicizing new ideas is through management
monographs. Dr Langley has published a number of these: Pharmacoeconomics: Achieving Gold
Standards (London: Financial Times Healthcare, 1997); Disease Management Outcomes
(London: Financial Times Healthcare, 1998). Dr Langley’s management monograph is Health
Economics in the Drug Life Cycle (London: Urch Publishing 2002) established critical paths for
drug development to incorporate health outcomes activities over the drug life cycle.
Dr Langley has extensive experience in working with pharmacy and therapeutics committees in
drug evaluation. He was the first author to publish guidelines for formulary evaluation of
pharmaceuticals in the US (Foundation Health of California, 1996; Blue Cross and Blue Shield
of Colorado and Nevada 1999) and was instrumental in developing the guidelines recommended
by the Academy of Managed Care Pharmacy. Dr Langley has strong links with managed care
and is often asked to speak at their conferences. Needless to say, Dr Langley has extensive
experience in pharmacoeconomics and in the wider area of health technology assessment. He
brings a global perspective to this area. Dr Langley has pioneered the notion of document
management and dossier development to support a product through drug development, market
entry and the balance of the product life cycle. Such a dossier brings together all the relevant
components of the health technology assessment case for a product (epidemiology, comparator
clinical assessments, cost-effective models, system impact models) to meet reimbursement
requirements for market segments with the US and at national levels globally. At the same time
Dr Langley is advising pharmaceutical companies on the most appropriate way to develop an
evidentiary base to support value proposition for clinical, cost-effectiveness and budget impact
claims. Notably for the US, Canada, the EU and Australia/New Zealand.
To support dossier development and to provide a single-source framework for drug development
and market access support, Maimon Research has developed a Global Value Dossier software
package. This package allows the creation of text, the preparation of formulary submission
documentation through templates, document storage and URL links to references and websites.
This package has been adopted by a number of pharmaceutical companies over the past 6 years.
A demonstration version of the package is available and, in any long term relationship with
either a consultant group of a drug company, licensing and training support are available.
Dr Langley has published in the area of population health, focusing on the societal burden of
pain and pain co-morbidities. Three aspects of disease burden are considered: (i) health related
quality of life and self-reported health status; (ii) employment status, absenteeism and
presenteeism; and (iii) healthcare resource utilization. Ten papers have been published covering
the UK, France, Germany, Spain, Italy and China.
Most recently (November 2015) Dr Langley was invited to organize a special supplement for the
Journal of Medical Economics on ‘The status of modeled claims in pharmacoeconomics’. This
2
focuses on the credibility of cost-outcomes claims and the importance of developing testable
claims to support formulary submissions and ongoing disease area and therapeutic class reviews.
Dr Langley is currently Director, Maimon Research LLC, a health economics consulting and
research company based in Tucson, AZ. Dr Langley is also Adjunct Professor, Graduate School,
College of Pharmacy, University of Minnesota.
Contact: Maimon Research LLC
5061 N Apache Hills Trail
Tucson AZ 85750.
Email: Langley@maimonresearch.com
Tel: (520) 577-0436
3
PUBLICATIONS
Langley PC. The spatial allocation of migrants in England and Wales. Scottish Journal
of Political Economy. 1974;21(3): 259-77. Reprinted in J.E.King, ed., Readings in
Labor Economics. Oxford University Press, 1980
Langley PC. Interregional migration and economy opportunity: Australia 1966-71.
Economic Record 1977;53(1):61-69
Langley PC. Labor market segmentation: A reconsideration. Industrial and Labor
Relations Review 1978;32(1):86-92
Langley PC. The private gains to long-distance migration in the United States. Economic
Journal. 1979;89:120-26.
Lipsey RG, Mahoney DM, Langley PC. Positive Economics for Australian Students,
Weidenfeld and Nicholson, London (1st ed., 1981, 850pp; 2nd ed., 1985): A first year
economics text based on RG Lipsey's, Positive Economics (UK edition), and RG Lipsey
and PO Steiner's, Economics (US edition). This became the largest selling first year
university economics text in Australia for 4 consecutive years.
Langley PC, Peterson HM. "Earnings and Work Experience in Australian Country
Towns." in: Chapman BJ, Isaac JE, Niland JR (Eds), Australian Labor Economics
Readings, 3rd ed., 1985.
Langley PC. "The Determinants of Labor Force Migration in Australia, 1966-71," in
Chapman BJ, Isaac JE, Niland JR (Eds), Australian Labor Economics Reading, 3rd ed.,
1985.
Langley PC. Employment and Occupational Trends in Victoria: 1985-2000 TAFE
National Center for Research and Development, Adelaide, 1985.
Langley PC, Luscombe R. Employment Projections for Metropolitan Melbourne,
Victoria, Ministry of Planning and Environment, 1987.
Langley PC. (Principal consultant and project manager) Workcare: A Strategy for Reform
within the Schools Division. Victoria, Ministry of Education, 1987 (A Report to a Select
Committee of the Parliament of Victoria).
Langley PC. Evaluating the economic and social impact of vocational rehabilitation
programs in Victoria. Performance Improvement Quarterly 1989; 2(2): 30-46.
Langley PC. The role of pharmacoeconomic guidelines for formulary approval: The
Australian experience. Clinical Therapeutics 1993;15(6): 1154-1176.
Langley PC. Outcomes research and modeling therapeutic interventions. Clinical
4
Therapeutics 1994; 16(3): 538-562.
Ortmeier BG, Sauer KA, Langley PC, Bealmear BK. A cost-benefit analysis of four
hormonal contraceptive methods. Clinical Therapeutics 1994; 16(4): 707-713.
Langley PC. Therapy evaluation, patient distribution, and cost-outcomes ratios. Clinical
Therapeutics 1995, 17(2): 341-347.
Langley PC. Pharmacoeconomic evaluation and the modeling of disease interventions.
Pharmaceutical News 1995; 2(4).
Langley PC. Comment: Substantiation in pharmacoeconomic evaluations. The Annals
of Pharmacotherapy 1995; 29(9): 942-943
Langley PC. Pharmacoeconomics and the quality of decision making by pharmacy and
therapeutics committees. American Journal of Health-System Pharmacy 1995; 52(S3):
S26-S28.
Langley PC. Cost Effectiveness profiles with an expanding treatment population.
Clinical Therapeutics 1995; 17(6); 1207-1212.
Armstrong EP, Langley PC. Disease management programs. American Journal of
Health-System Pharmacy 1996; 53: 53-58.
Langley PC. The November 1995 revised Australian guidelines for the economic
evaluation of pharmaceuticals. PharmacoEconomics. 1996; 9(4): 341-352.
Langley PC. Cost effectiveness and the allocation of therapies in a treating population.
PharmacoEconomics 1996; 10(1): 93-98.
Langley PC. Langley-Hawthorne CE, Martin RE, Armstrong EP. Establishing the basis
for successful disease management contracting. American Journal of Managed Care
1996; 2(8): 1099-1108.
Langley PC, Sullivan SD. Pharmacoeconomic evaluation: Guidelines for drug
purchasers. Journal of Managed Care Pharmacy 1996; 2(6): 671-677.
Langley PC. Outcomes and costs in health care interventions: Implications for pharmacy
practice. The California Journal of Health-System Pharmacy; September 1996.
Langley PC. Pharmacoeconomic Guidelines: Australia and Canada in IMS America.
Health Economics in the USA. London, 1996.
Langley PC. The future role of pharmacoeconomics in drug R and D in the United
States. The European Medicines Evaluation Annual Ltd. October 1996.
5
Langley PC. Assessing the input costs of disease management programs. Clinical
Therapeutics 1996; 18(6): 1334-1340.
Johnson ES, Sullivan SD, Mozaffari E, Langley PC, Bodsworth NJ. A utility assessment
of oral and intravenous ganciclovir for the maintenance treatment of AIDS-related
cytomegalovirus retinitis. PharmacoEconomics 1996, 10(6): 623-629.
Langley PC, Martin RE. Guidelines for Formulary Submissions. Integrated
Pharmaceutical Services and Foundation Health Corporation, Rancho Cordova, CA.
October 1996.
Langley PC, Martin RE. Analytical and informational requirements in disease
management proposals: A managed care perspective. The Journal of Pharmacy
Technology, 1997; 13(1): 15-20.
Langley PC, Coons SJ. Peripheral Vascular Disorders: A pharmacoeconomic and
quality of life review. PharmacoEconomics 1997; 11(3): 225-236.
Harrison DL, Draugalis JR, Slack MK, Langley PC. Cost-effectiveness of regional
poison control centers. Archives of Internal Medicine 1996; 156: 2601-2608.
Langley PC. The FDA and pharmacoeconomic research. Drug Benefit Trends 1997;
9(1): 17-25.
Hawkins DW, Langley PC, Krueger KP. Pharmacoeconomic model of enoxaparin versus
heparin for prevention of deep vein thrombosis after total hip replacement. American
Journal of Health-System Pharmacy 1997; 54: 1185-1190.
Johnson JA, Coons SJ, Hays RD, Sabers D, Jones P, Langley PC. A comparison of
satisfaction with mail versus traditional pharmacy services. Journal of Managed Care
Pharmacy 1997; 3(3): 327-337.
Langley PC, Bhattacharyyaa SK. Treatment costs, equilibrium and the allocation of the
patients between therapy alternatives. Clinical Therapeutics 1997; 19(1): 830-836.
Langley PC. The Future of Pharmacoeconomics: A Commentary. Clinical Therapeutics,
1997; 19(1): 762-769.
Langley PC, Martin RE. Managed care guidelines for economic evaluation of
pharmaceuticals. American Journal of Managed Care. 1997, 3(7): 1013-1021.
Langley PC. Pharmacoeconomics: Achieving Gold Standards, London: Financial Times
Healthcare, 1997 (145pp.)
Langley PC. Improving health care outcomes through reallocation of health care
expenditures. Clinical Therapeutics, 1997; 19(5): 1092-1100.
6
Langley PC and Jacobsen ES, Review and Analysis of Pharmacoeconomic Guidelines,
Spectrum, Decision Resources, Inc., December 1997.
Langley PC. Does pharmacoeconomics have a future? Pharmaceutical News, 1998; 5(1):
7-10.
Langley PC. Pharmacoeconomic evaluations and clinical trials. Applied Clinical Trials,
1998; 7(3): 38-44
Hawkins DW, Langley PC, Krueger KP. A Pharmacoeconomic assessment of
enoxaparin and warfarin as prophylaxis for deep vein thrombosis in patients undergoing
knee replacement surgery. Clinical Therapeutics, 1998; 20(1): 182-195.
Davies A, Langley PC, Keks NA, Catts SV, Lambert T, Schweitzer I. Risperidone versus
Haloperidol: II. Cost-Effectiveness. Clinical Therapeutics, 1998; 20(1): 196-213.
Kortt MA, Langley PC, Cox ER. A review of cost-of-illness studies on obesity. Clinical
Therapeutics, 1998; 20(4): 772-779.
Langley PC. Disease Management Outcomes, London: Financial Times Healthcare,
1998 (122pp.)
Langley PC. Information requirements of health systems as drug purchasers: does the
FDA have a role in setting evidentiary standards? Journal of Managed Care Pharmacy,
November/December, 1998, 4(6): 593-598.
Langley PC. Criteria for the economic evaluation of lipid studies in health systems.
Value in Health, The Journal of the International Society for Pharmacoeconomics and
Outcomes Research, November/December, 1998, 1(4): 208-211.
Langley PC, Hay JW, Schwartz JS, Smith SC, McKenney J. From research into
practice: how should healthcare organizations/governments decide about lipid
therapy and who will pay? Reactor panel and open forum. Value Health. 1998
Nov;1(4):243-50.
Langley PC, Guidelines for Formulary Submissions for Pharmaceutical Product
Evaluation, Blue Cross and Blue Shield of Colorado and Nevada, Denver, CO.
October 1998.
Langley PC. The technology of metered-dose inhalers and treatment costs in asthma: a
retrospective study of breath actuation versus traditional press-and-breathe inhalers.
Clinical Therapeutics, 1999, 21(1): 236-253.
Langley PC, Tyring SK, Smith MS. The cost effectiveness of patient-applied versus
provider-administered intervention strategies for the treatment of external genital warts.
7
American Journal of Managed Care, 1999, 5(1): 69-77.
Langley PC. Meeting the information needs of drug purchasers: The evolution of
formulary submission guidelines, Clinical Therapeutics, 1999; 21(4):768-787.
Richwald GA, Langley PC. Management of external genital warts: Diagnosis and
clinical management, Family Practice Recertification, 1999, 21(9):5-12.
Langley PC, Richwald GA. Management of external genital warts: Pharmacoeconomic
considerations, Family Practice Recertification, 1999, 21(9):13-17.
Armstrong EP and Langley PC. Treatment of Pneumonias in a Managed-Care
Organisation, Disease Management and Health Outcomes, 1999; 6(3): 159-173
Langley PC, Formulary Submission Guidelines for Blue Cross and Blue Shield of
Colorado and Nevada: Structure, Application and Manufacturer Responsibilities,
Pharmacoeconomics, 1999; 16(3): 211-224.
Armstrong EP and Langley PC. The Impact of a Disease Management Intervention on the
Treatment of Infectious Disease in a Managed Care Organization, Disease Management,
1999; 2(3):61-77.
Langley PC, Integrating Pharmacoeconomics into Clinical Trials, Spectrum, Decision
Resources, Inc., June 1999.
Langley PC, Richwald GA and Smith MH. Modeling the impact of treatment options in
genital warts: Patient applied versus physician administered therapies, Clinical
Therapeutics, 1999; 21(12):1-13.
Langley PC, Budget Impacts and Pharmacoeconomic Evaluations, Pharmacoeconomics
and Outcomes News, 19 February 2000, pp. 3-4.
Langley PC, Is Cost-Effectiveness Modeling Useful? (Editorial), American Journal of
Managed Care, 2000; 6(2): 250-251.
W I van der Meijden, A Notowicz, F B Blog and P C Langley, A Retrospective Analysis
of Costs and Patterns of Treatment for External Genital Warts in the Netherlands,
Clinical Therapeutics, January 2002; 24(1):183-196.
P C Langley, Health Economics in the Life cycle of a Drug, Regulatory Affairs Focus,
July 2002.
P C Langley, Health Economics in the Drug Life Cycle, London: Urch Publishing,
November 2002 (135 pp)
P C Langley, The importance of health economics in successfully achieving a sustainable
8
price for reimbursement, The Pharmaceutical Pricing Compendium, pp. 49-60 (London:
Urch Publishing, 2003).
P C Langley, Health Economics in Drug Development, Pharmacoeconomics and
Outcomes News Weekly, Adis International, 17 May 2003, pp. 3-5.
P C Langley In all probability …., Scrip Magazine, June 2003.
P C Langley, D White, S Drake, Patterns of Treatment and Resource Utilization in the
Treatment of External Genital Warts in England and Wales: The Results of a Clinical
Audit, International Journal of STD and AIDS, 2004; 15: 473-468.
P C Langley, D White, S Drake, The costs of treating external genital warts in England
and Wales: A treatment pattern analysis, International Journal of STD and AIDS, 2004;
15:501-508.
P C Langley, Focusing Pharmacoeconomic Activities: Reimbursement or the drug life
cycle, Current Medical Research and Opinion, 2004; 20(2): 181-188.
M K Higashi, D L Veenstra, P C Langley, Health Economic Evaluation of Non-
Melanoma Skin Cancer and Actinic Keratosis, Pharmacoeconomics, 2004; 22(2):83-94.
P C Langley, The NICE Reference Case Requirement: Implications for Manufacturers
and Health Systems, Pharmacoeconomics, 2004; 22(4): 267-271.
P C Langley, Recent Developments in the Health Technology Assessment Process in TR
Fulda and A I Wertheimer, Handbook of Pharmaceutical Public Policy, New York,
Haworth Press, 2007, pp. 457-477.
Langley PC. A cost-effectiveness analysis of sinecatechins in the treatment of
external genital warts. J Med Econ. 2010;13(1):1-7
Langley PC, Patkar AD, Boswell KA, Benson CJ, Schein JR. Adverse event profile of
tramadol in recent clinical studies of chronic osteoarthritis pain. Curr Med Res Opin.
2010;26(1):239-51.
Langley PC, Muller-Schwefe G, Nicolaou A et al. The societal impact of pain in the
European Union: health-related quality of life and healthcare resource utilization. J Med
Econ. 2010;13(2):571-81.
Langley PC, Muller-Schwefe G, Nicolaou A et al. The impact of pain on labor force
participation, absenteeism and presenteeism in the European Union. J Med Econ.
2010;13(4):662-72
Langley PC. The prevalence, correlates and treatment of pain in the European
Union. Curr Med Res Opin. 2011 Feb;27(2):463-80.
9
Langley P, Ruiz-Iban M, Molina J et al. The prevalence, correlates and treatment of pain
in Spain. J Med Econ. 2011;14(3): 367-80
Langley PC, Mu R, Wu M, Dong P, Tang B The impact of rheumatoid arthritis on the
burden of disease in urban China. J Med Econ. 2011;14(6):709-19
Langley P, Hernandez C, Margarit C, et al. Pain, health related quality of life and
healthcare resource utilization in Spain. J Med Econ. 2011;14(5):628-38
Langley PC, Tornero Molina J, Margarit Ferri C, et al. The association of pain with labor
force participation, absenteeism, and presenteeism in Spain. J Med Econ.
2011;14(6):835-45
Langley PC. The societal burden of pain in Germany: Health related quality of life, health
status and direct medical costs. J Med Econ. 2012 (August epub)
Langley PC, Van Litsenburg C, Cappelleri J et al. The burden associated with
neuropathic pain in Western Europe. J Med Econ. 2013;16(1):85-95
Langley PC, Liedgens H. Time since diagnosis, treatment pathways and current pain
status: a retrospective assessment in a back pain population. J Med Econ.
2013;16(5):701-9
10
11

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PCLProfileCVNovemberl2015

  • 1. BIOSKETCH AND CURRICULUM VITAE November 2015 PAUL C. LANGLEY B.Sc. (Econ). M.A., Ph.D. Dr Paul Langley is a professional economist. His undergraduate training was in the UK, University of Hull (B. Sc [Econ]) with postgraduate training in Canada at Carleton University (M.A.) and Queen’s University (Ph.D.). Dr Langley has taught in the UK (University of Lancaster) and in Australia (La Trobe University) with visiting appointments at Carleton University, the University of Ohio and the University of California (Irvine). Although initially focusing on labor economics, Dr Langley moved into health economics – specifically the economic evaluation of pharmaceutical products - in the early 1990s. The impetus for this move was the decision, in 1992, by the Australian Department of Health to require companies seeking formulary approval for new products to make a cost-effectiveness case in order to justify the unit cost of the product and its formulary listing. Following this decision by the Australian authorities, a number of other countries (Canada, New Zealand) began developing their own formulary submission guidelines and evidentiary and analytical standards for economic evaluations emerged. Although guidelines had not yet been introduced within the United States, there was considerable interest among both drug manufacturers and academic health economics groups in the emergence of guidelines requirements and in the need to improve understanding of the new evaluative techniques as they applied to a range of new products and disease areas. As a result of his early work in Australia, Dr Langley was appointed Associate Professor at the University of Arizona (College of Pharmacy; Center for Pharmaceutical Economics) in July 1994 and moved from Australia to the United States. Following a successful three years at Arizona (where Dr Langley authored some 20 publications in this area and managed a number of significant research projects), Dr Langley was appointed Professor at the University of Colorado (School of Pharmacy, University of Colorado Health Sciences Center) in July 1997. One of Dr Langley’s tasks at Colorado was to establish a Center for Pharmaceutical Economics. Following a successful two years at Colorado, Dr Langley moved to 3M Pharmaceuticals in September 1999 (through July 2005) as US and International Manager, Health Economics with worldwide responsibilities for economic evaluations as they apply to drug development, reimbursement and post-market entry support. A major focus of Dr Langley’s activities both at universities and as a consultant has been in the development of training programs in pharmaceutical economics, health economics and the burden of illness. At the University Of Arizona Dr Langley was instrumental in establishing the Certificate Program in Pharmacoeconomics in the mid-1990s. A similar program was developed at the University of Colorado. Dr Langley has developed packages for distance learning in pharmaceutical economics as well as general and disease specific training programs for healthcare systems and pharmaceutical companies. 1
  • 2. Since leaving 3M pharmaceuticals, Dr Langley has managed his consulting company, Maimon Research LLC, undertaking a number of consultancy projects in major disease areas as well as advising on document management and minimum evidentiary standards for drug development decisions and reimbursement. One of the major forums for developing and publicizing new ideas is through management monographs. Dr Langley has published a number of these: Pharmacoeconomics: Achieving Gold Standards (London: Financial Times Healthcare, 1997); Disease Management Outcomes (London: Financial Times Healthcare, 1998). Dr Langley’s management monograph is Health Economics in the Drug Life Cycle (London: Urch Publishing 2002) established critical paths for drug development to incorporate health outcomes activities over the drug life cycle. Dr Langley has extensive experience in working with pharmacy and therapeutics committees in drug evaluation. He was the first author to publish guidelines for formulary evaluation of pharmaceuticals in the US (Foundation Health of California, 1996; Blue Cross and Blue Shield of Colorado and Nevada 1999) and was instrumental in developing the guidelines recommended by the Academy of Managed Care Pharmacy. Dr Langley has strong links with managed care and is often asked to speak at their conferences. Needless to say, Dr Langley has extensive experience in pharmacoeconomics and in the wider area of health technology assessment. He brings a global perspective to this area. Dr Langley has pioneered the notion of document management and dossier development to support a product through drug development, market entry and the balance of the product life cycle. Such a dossier brings together all the relevant components of the health technology assessment case for a product (epidemiology, comparator clinical assessments, cost-effective models, system impact models) to meet reimbursement requirements for market segments with the US and at national levels globally. At the same time Dr Langley is advising pharmaceutical companies on the most appropriate way to develop an evidentiary base to support value proposition for clinical, cost-effectiveness and budget impact claims. Notably for the US, Canada, the EU and Australia/New Zealand. To support dossier development and to provide a single-source framework for drug development and market access support, Maimon Research has developed a Global Value Dossier software package. This package allows the creation of text, the preparation of formulary submission documentation through templates, document storage and URL links to references and websites. This package has been adopted by a number of pharmaceutical companies over the past 6 years. A demonstration version of the package is available and, in any long term relationship with either a consultant group of a drug company, licensing and training support are available. Dr Langley has published in the area of population health, focusing on the societal burden of pain and pain co-morbidities. Three aspects of disease burden are considered: (i) health related quality of life and self-reported health status; (ii) employment status, absenteeism and presenteeism; and (iii) healthcare resource utilization. Ten papers have been published covering the UK, France, Germany, Spain, Italy and China. Most recently (November 2015) Dr Langley was invited to organize a special supplement for the Journal of Medical Economics on ‘The status of modeled claims in pharmacoeconomics’. This 2
  • 3. focuses on the credibility of cost-outcomes claims and the importance of developing testable claims to support formulary submissions and ongoing disease area and therapeutic class reviews. Dr Langley is currently Director, Maimon Research LLC, a health economics consulting and research company based in Tucson, AZ. Dr Langley is also Adjunct Professor, Graduate School, College of Pharmacy, University of Minnesota. Contact: Maimon Research LLC 5061 N Apache Hills Trail Tucson AZ 85750. Email: Langley@maimonresearch.com Tel: (520) 577-0436 3
  • 4. PUBLICATIONS Langley PC. The spatial allocation of migrants in England and Wales. Scottish Journal of Political Economy. 1974;21(3): 259-77. Reprinted in J.E.King, ed., Readings in Labor Economics. Oxford University Press, 1980 Langley PC. Interregional migration and economy opportunity: Australia 1966-71. Economic Record 1977;53(1):61-69 Langley PC. Labor market segmentation: A reconsideration. Industrial and Labor Relations Review 1978;32(1):86-92 Langley PC. The private gains to long-distance migration in the United States. Economic Journal. 1979;89:120-26. Lipsey RG, Mahoney DM, Langley PC. Positive Economics for Australian Students, Weidenfeld and Nicholson, London (1st ed., 1981, 850pp; 2nd ed., 1985): A first year economics text based on RG Lipsey's, Positive Economics (UK edition), and RG Lipsey and PO Steiner's, Economics (US edition). This became the largest selling first year university economics text in Australia for 4 consecutive years. Langley PC, Peterson HM. "Earnings and Work Experience in Australian Country Towns." in: Chapman BJ, Isaac JE, Niland JR (Eds), Australian Labor Economics Readings, 3rd ed., 1985. Langley PC. "The Determinants of Labor Force Migration in Australia, 1966-71," in Chapman BJ, Isaac JE, Niland JR (Eds), Australian Labor Economics Reading, 3rd ed., 1985. Langley PC. Employment and Occupational Trends in Victoria: 1985-2000 TAFE National Center for Research and Development, Adelaide, 1985. Langley PC, Luscombe R. Employment Projections for Metropolitan Melbourne, Victoria, Ministry of Planning and Environment, 1987. Langley PC. (Principal consultant and project manager) Workcare: A Strategy for Reform within the Schools Division. Victoria, Ministry of Education, 1987 (A Report to a Select Committee of the Parliament of Victoria). Langley PC. Evaluating the economic and social impact of vocational rehabilitation programs in Victoria. Performance Improvement Quarterly 1989; 2(2): 30-46. Langley PC. The role of pharmacoeconomic guidelines for formulary approval: The Australian experience. Clinical Therapeutics 1993;15(6): 1154-1176. Langley PC. Outcomes research and modeling therapeutic interventions. Clinical 4
  • 5. Therapeutics 1994; 16(3): 538-562. Ortmeier BG, Sauer KA, Langley PC, Bealmear BK. A cost-benefit analysis of four hormonal contraceptive methods. Clinical Therapeutics 1994; 16(4): 707-713. Langley PC. Therapy evaluation, patient distribution, and cost-outcomes ratios. Clinical Therapeutics 1995, 17(2): 341-347. Langley PC. Pharmacoeconomic evaluation and the modeling of disease interventions. Pharmaceutical News 1995; 2(4). Langley PC. Comment: Substantiation in pharmacoeconomic evaluations. The Annals of Pharmacotherapy 1995; 29(9): 942-943 Langley PC. Pharmacoeconomics and the quality of decision making by pharmacy and therapeutics committees. American Journal of Health-System Pharmacy 1995; 52(S3): S26-S28. Langley PC. Cost Effectiveness profiles with an expanding treatment population. Clinical Therapeutics 1995; 17(6); 1207-1212. Armstrong EP, Langley PC. Disease management programs. American Journal of Health-System Pharmacy 1996; 53: 53-58. Langley PC. The November 1995 revised Australian guidelines for the economic evaluation of pharmaceuticals. PharmacoEconomics. 1996; 9(4): 341-352. Langley PC. Cost effectiveness and the allocation of therapies in a treating population. PharmacoEconomics 1996; 10(1): 93-98. Langley PC. Langley-Hawthorne CE, Martin RE, Armstrong EP. Establishing the basis for successful disease management contracting. American Journal of Managed Care 1996; 2(8): 1099-1108. Langley PC, Sullivan SD. Pharmacoeconomic evaluation: Guidelines for drug purchasers. Journal of Managed Care Pharmacy 1996; 2(6): 671-677. Langley PC. Outcomes and costs in health care interventions: Implications for pharmacy practice. The California Journal of Health-System Pharmacy; September 1996. Langley PC. Pharmacoeconomic Guidelines: Australia and Canada in IMS America. Health Economics in the USA. London, 1996. Langley PC. The future role of pharmacoeconomics in drug R and D in the United States. The European Medicines Evaluation Annual Ltd. October 1996. 5
  • 6. Langley PC. Assessing the input costs of disease management programs. Clinical Therapeutics 1996; 18(6): 1334-1340. Johnson ES, Sullivan SD, Mozaffari E, Langley PC, Bodsworth NJ. A utility assessment of oral and intravenous ganciclovir for the maintenance treatment of AIDS-related cytomegalovirus retinitis. PharmacoEconomics 1996, 10(6): 623-629. Langley PC, Martin RE. Guidelines for Formulary Submissions. Integrated Pharmaceutical Services and Foundation Health Corporation, Rancho Cordova, CA. October 1996. Langley PC, Martin RE. Analytical and informational requirements in disease management proposals: A managed care perspective. The Journal of Pharmacy Technology, 1997; 13(1): 15-20. Langley PC, Coons SJ. Peripheral Vascular Disorders: A pharmacoeconomic and quality of life review. PharmacoEconomics 1997; 11(3): 225-236. Harrison DL, Draugalis JR, Slack MK, Langley PC. Cost-effectiveness of regional poison control centers. Archives of Internal Medicine 1996; 156: 2601-2608. Langley PC. The FDA and pharmacoeconomic research. Drug Benefit Trends 1997; 9(1): 17-25. Hawkins DW, Langley PC, Krueger KP. Pharmacoeconomic model of enoxaparin versus heparin for prevention of deep vein thrombosis after total hip replacement. American Journal of Health-System Pharmacy 1997; 54: 1185-1190. Johnson JA, Coons SJ, Hays RD, Sabers D, Jones P, Langley PC. A comparison of satisfaction with mail versus traditional pharmacy services. Journal of Managed Care Pharmacy 1997; 3(3): 327-337. Langley PC, Bhattacharyyaa SK. Treatment costs, equilibrium and the allocation of the patients between therapy alternatives. Clinical Therapeutics 1997; 19(1): 830-836. Langley PC. The Future of Pharmacoeconomics: A Commentary. Clinical Therapeutics, 1997; 19(1): 762-769. Langley PC, Martin RE. Managed care guidelines for economic evaluation of pharmaceuticals. American Journal of Managed Care. 1997, 3(7): 1013-1021. Langley PC. Pharmacoeconomics: Achieving Gold Standards, London: Financial Times Healthcare, 1997 (145pp.) Langley PC. Improving health care outcomes through reallocation of health care expenditures. Clinical Therapeutics, 1997; 19(5): 1092-1100. 6
  • 7. Langley PC and Jacobsen ES, Review and Analysis of Pharmacoeconomic Guidelines, Spectrum, Decision Resources, Inc., December 1997. Langley PC. Does pharmacoeconomics have a future? Pharmaceutical News, 1998; 5(1): 7-10. Langley PC. Pharmacoeconomic evaluations and clinical trials. Applied Clinical Trials, 1998; 7(3): 38-44 Hawkins DW, Langley PC, Krueger KP. A Pharmacoeconomic assessment of enoxaparin and warfarin as prophylaxis for deep vein thrombosis in patients undergoing knee replacement surgery. Clinical Therapeutics, 1998; 20(1): 182-195. Davies A, Langley PC, Keks NA, Catts SV, Lambert T, Schweitzer I. Risperidone versus Haloperidol: II. Cost-Effectiveness. Clinical Therapeutics, 1998; 20(1): 196-213. Kortt MA, Langley PC, Cox ER. A review of cost-of-illness studies on obesity. Clinical Therapeutics, 1998; 20(4): 772-779. Langley PC. Disease Management Outcomes, London: Financial Times Healthcare, 1998 (122pp.) Langley PC. Information requirements of health systems as drug purchasers: does the FDA have a role in setting evidentiary standards? Journal of Managed Care Pharmacy, November/December, 1998, 4(6): 593-598. Langley PC. Criteria for the economic evaluation of lipid studies in health systems. Value in Health, The Journal of the International Society for Pharmacoeconomics and Outcomes Research, November/December, 1998, 1(4): 208-211. Langley PC, Hay JW, Schwartz JS, Smith SC, McKenney J. From research into practice: how should healthcare organizations/governments decide about lipid therapy and who will pay? Reactor panel and open forum. Value Health. 1998 Nov;1(4):243-50. Langley PC, Guidelines for Formulary Submissions for Pharmaceutical Product Evaluation, Blue Cross and Blue Shield of Colorado and Nevada, Denver, CO. October 1998. Langley PC. The technology of metered-dose inhalers and treatment costs in asthma: a retrospective study of breath actuation versus traditional press-and-breathe inhalers. Clinical Therapeutics, 1999, 21(1): 236-253. Langley PC, Tyring SK, Smith MS. The cost effectiveness of patient-applied versus provider-administered intervention strategies for the treatment of external genital warts. 7
  • 8. American Journal of Managed Care, 1999, 5(1): 69-77. Langley PC. Meeting the information needs of drug purchasers: The evolution of formulary submission guidelines, Clinical Therapeutics, 1999; 21(4):768-787. Richwald GA, Langley PC. Management of external genital warts: Diagnosis and clinical management, Family Practice Recertification, 1999, 21(9):5-12. Langley PC, Richwald GA. Management of external genital warts: Pharmacoeconomic considerations, Family Practice Recertification, 1999, 21(9):13-17. Armstrong EP and Langley PC. Treatment of Pneumonias in a Managed-Care Organisation, Disease Management and Health Outcomes, 1999; 6(3): 159-173 Langley PC, Formulary Submission Guidelines for Blue Cross and Blue Shield of Colorado and Nevada: Structure, Application and Manufacturer Responsibilities, Pharmacoeconomics, 1999; 16(3): 211-224. Armstrong EP and Langley PC. The Impact of a Disease Management Intervention on the Treatment of Infectious Disease in a Managed Care Organization, Disease Management, 1999; 2(3):61-77. Langley PC, Integrating Pharmacoeconomics into Clinical Trials, Spectrum, Decision Resources, Inc., June 1999. Langley PC, Richwald GA and Smith MH. Modeling the impact of treatment options in genital warts: Patient applied versus physician administered therapies, Clinical Therapeutics, 1999; 21(12):1-13. Langley PC, Budget Impacts and Pharmacoeconomic Evaluations, Pharmacoeconomics and Outcomes News, 19 February 2000, pp. 3-4. Langley PC, Is Cost-Effectiveness Modeling Useful? (Editorial), American Journal of Managed Care, 2000; 6(2): 250-251. W I van der Meijden, A Notowicz, F B Blog and P C Langley, A Retrospective Analysis of Costs and Patterns of Treatment for External Genital Warts in the Netherlands, Clinical Therapeutics, January 2002; 24(1):183-196. P C Langley, Health Economics in the Life cycle of a Drug, Regulatory Affairs Focus, July 2002. P C Langley, Health Economics in the Drug Life Cycle, London: Urch Publishing, November 2002 (135 pp) P C Langley, The importance of health economics in successfully achieving a sustainable 8
  • 9. price for reimbursement, The Pharmaceutical Pricing Compendium, pp. 49-60 (London: Urch Publishing, 2003). P C Langley, Health Economics in Drug Development, Pharmacoeconomics and Outcomes News Weekly, Adis International, 17 May 2003, pp. 3-5. P C Langley In all probability …., Scrip Magazine, June 2003. P C Langley, D White, S Drake, Patterns of Treatment and Resource Utilization in the Treatment of External Genital Warts in England and Wales: The Results of a Clinical Audit, International Journal of STD and AIDS, 2004; 15: 473-468. P C Langley, D White, S Drake, The costs of treating external genital warts in England and Wales: A treatment pattern analysis, International Journal of STD and AIDS, 2004; 15:501-508. P C Langley, Focusing Pharmacoeconomic Activities: Reimbursement or the drug life cycle, Current Medical Research and Opinion, 2004; 20(2): 181-188. M K Higashi, D L Veenstra, P C Langley, Health Economic Evaluation of Non- Melanoma Skin Cancer and Actinic Keratosis, Pharmacoeconomics, 2004; 22(2):83-94. P C Langley, The NICE Reference Case Requirement: Implications for Manufacturers and Health Systems, Pharmacoeconomics, 2004; 22(4): 267-271. P C Langley, Recent Developments in the Health Technology Assessment Process in TR Fulda and A I Wertheimer, Handbook of Pharmaceutical Public Policy, New York, Haworth Press, 2007, pp. 457-477. Langley PC. A cost-effectiveness analysis of sinecatechins in the treatment of external genital warts. J Med Econ. 2010;13(1):1-7 Langley PC, Patkar AD, Boswell KA, Benson CJ, Schein JR. Adverse event profile of tramadol in recent clinical studies of chronic osteoarthritis pain. Curr Med Res Opin. 2010;26(1):239-51. Langley PC, Muller-Schwefe G, Nicolaou A et al. The societal impact of pain in the European Union: health-related quality of life and healthcare resource utilization. J Med Econ. 2010;13(2):571-81. Langley PC, Muller-Schwefe G, Nicolaou A et al. The impact of pain on labor force participation, absenteeism and presenteeism in the European Union. J Med Econ. 2010;13(4):662-72 Langley PC. The prevalence, correlates and treatment of pain in the European Union. Curr Med Res Opin. 2011 Feb;27(2):463-80. 9
  • 10. Langley P, Ruiz-Iban M, Molina J et al. The prevalence, correlates and treatment of pain in Spain. J Med Econ. 2011;14(3): 367-80 Langley PC, Mu R, Wu M, Dong P, Tang B The impact of rheumatoid arthritis on the burden of disease in urban China. J Med Econ. 2011;14(6):709-19 Langley P, Hernandez C, Margarit C, et al. Pain, health related quality of life and healthcare resource utilization in Spain. J Med Econ. 2011;14(5):628-38 Langley PC, Tornero Molina J, Margarit Ferri C, et al. The association of pain with labor force participation, absenteeism, and presenteeism in Spain. J Med Econ. 2011;14(6):835-45 Langley PC. The societal burden of pain in Germany: Health related quality of life, health status and direct medical costs. J Med Econ. 2012 (August epub) Langley PC, Van Litsenburg C, Cappelleri J et al. The burden associated with neuropathic pain in Western Europe. J Med Econ. 2013;16(1):85-95 Langley PC, Liedgens H. Time since diagnosis, treatment pathways and current pain status: a retrospective assessment in a back pain population. J Med Econ. 2013;16(5):701-9 10
  • 11. 11