Orphan drug pricing and payer management in the United States: Are we approaching the tipping point?

American Health and Drug Benefits

Volumn 3, Issue 1, 2010, Pages 15-22

  Hyde, Rebecca ^a   Dobrovolny, Diana ^b  

^a Global Commercialization   (United States)

^b Ventiv Advance Insights   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGALSIDASE BETA; ECULIZUMAB; ERLOTINIB; GALSULFASE; IDURONATE 2 SULFATASE; IMIGLUCERASE; MIGLUSTAT; ORPHAN DRUG; RECOMBINANT SOMATOMEDIN C; SUNITINIB;

DRUG COST; DRUG INDICATION; DRUG INDUSTRY; DRUG LEGISLATION; DRUG UTILIZATION; FABRY DISEASE; GASTROINTESTINAL STROMAL TUMOR; GAUCHER DISEASE; GROWTH DISORDER; HEALTH CARE COST; HEALTH CARE POLICY; HEALTH INSURANCE; HEALTH PROGRAM; HEALTH SURVEY; HUNTER SYNDROME; KIDNEY CARCINOMA; LUNG NON SMALL CELL CANCER; MAROTEAUX LAMY SYNDROME; MEDICARE; PANCREAS CANCER; PAROXYSMAL NOCTURNAL HEMOGLOBINURIA; RARE DISEASE; REVIEW; UNITED STATES;

EID: 77953423858     PISSN: 19422962     EISSN: 19422970     Source Type: Journal    
DOI: None     Document Type: Review

References (15)

1. US Food and Drug Administration. Developing products for rare diseases and conditions. www.fda.gov/orphan/oda.htm. Accessed August 18, 2008.
2. Borda C. The orphan drug act, 25 years, 1800 designations, 319 product approvals, and counting. PharmaVoice. April 2008. www.imshealth.com/ imshealth/Global/Content/Document/Value-based%20Medicine%20TL/ ODA-PharmaVOICE-April%202008.pdf. Accessed August 18, 2008.
3. Food and Drug Administration, Office of Orphan Products. Orphan drugs approved between 1978 and 1981 (search list). www.accessdata.fda.gov/scripts/ opdlisting/oopd/index.cfm. Accessed May 26, 2009.
4. Kurst KR. FDA orphan drug designations are on the rise. FDA Law Blog of Hyman, Phelps & McNamara, PC. www.fdalawblog.net/fda-law-blog-hyman-phelps/ 2009/02/fda-orphan-drug-designations-are-on-the-rise.html. Accessed May 6, 2009.
5. Ariyanchira S. Biomarket trends: orphan drug arena driven by biologics. Genetic Engineering Biotechnology News. 2008;28. January 1, 2008. www.genengnews.com/articles/chitem-print.aspx?aid=2318&chid=0. Accessed May 25, 2009.
6. Hyde R, Dobrovolny D. Orphan drug pricing: have we reached the tipping point? Presented at the 20th Annual Meeting and Showcase of the Academy of Managed Care Pharmacists. San Francisco, CA; April 16-19, 2008.
7. Advance Insight. Knowledge database. Somerset, NJ. Interviews with payers conducted from February 2008 through March 2009.
8. Kaiser Family Foundation/Health Research & Educational Trust. Employer Health Benefits 2007 Annual Survey. www.kff.org/insurance/7672/upload/ 76723.pdf. Accessed May 26, 2009.
9. Centers for Medicare & Medicaid Services. Medicare program; competitive acquisition of outpatient drugs and biologicals under Part B. Interim final rule with comment period. Fed Regist. 2005;70:39021-39102.
10. Centers for Medicare & Medicaid Services, Department of Health and Human Services. OPPS payment changes for drugs, biologicals, and radiopharmaceuticals. Fed Regist. 2008;73:68502-69380.
11. Maas A. Better cost-sharing approaches can help patients on orphan drugs. AIS Health. September 19, 2008. www.aishealth.com/DrugCosts/specialty/SPN- Orphan-Drugs.html. Accessed May 1, 2009.
12. RxAssist. Medications available by company. http://rxassist.org/Search/ Search-Results-Company-Name.cfm?Search=Genzyme&Seq=Brand&CFID=34 07005&CFTOKEN=75369314. Accessed May 26, 2009.
13. National Organization of Rare Diseases. Programs and services. www.rarediseases.org/programs/medication. Accessed May 26, 2009.
14. Haren MC, McConnell K. Patient cost-sharing on the rise: results from the benefit design index. Am Health Drug Benefits. 2009;2:70-77.
15. Kaiser Family Foundation/American Cancer Society. Spending to survive: cancer patients confront holes in the health insurance system. February 2009. www.kff.org/insurance/upload/7851.pdf. Accessed May 26, 2009.