Current drug pricing trends, particularly in the specialty drug sector, seriously threaten the affordability of health care in the United States. For years, patients and purchasers have shouldered prices of more than $100,000 a year for certain medicines—particularly those that treat relatively rare disorders. But in a concerning new development, the industry is increasingly applying rare-disease pricing to treatments for diseases afflicting millions: hepatitis, cancer, high cholesterol, multiple sclerosis and diabetes. If this trend is left unchecked, American health care will soon face an untenable choice: reduce access to medications needed to manage common chronic conditions or face increasingly unaffordable cost burdens. NCHC supports the following policy solutions:
Accelerate Food and Drug Administration (FDA) Review of Competitor Drugs
- Prioritize FDA review of 2nd in class medicines, when such a review would speed treatment alternatives to the market and lower costs for remedies that have a system-wide cost impact
- Provide FDA with the additional funding needed to more rapidly process new generic drug applications
Require Transparency in Launch Pricing for Prescription Drugs
- Require brand name manufacturers to provide planned price and target population prior to launch of prescription drugs with high cost impact, allowing public programs and private payers to anticipate financing needs and adjust accordingly
Invest in Comparative Effectiveness Research
- Enhance public funding of studies comparing the clinical effectiveness and safety of drugs; lift restrictions on study of the relative cost-effectiveness of drugs and other treatments
Provide a Strong Pathway for Generic Biosimilar Drugs
Support federal regulation and state policies that:
- Require generic biosimilar and originator products to use the same International Non-proprietary Name (INN)
- Encourage appropriate substitution of biosimilar drugs for brand name biologics and oppose regulations and state laws preventing substitution of biosimilars
- Ensure CMS makes reimbursement policy changes in Medicare Parts B and D necessary to assure adequate reimbursement for biologics and thereby promote biosimilar development
Resources
NCHC Comment Letter Regarding FDA Draft Guidance on Non-proprietary Naming of Biological Products (October 2015)
CSRxP Report – Super Spending: U.S. Trends in High-Cost Medication Use (May 2015)
CSRxP Report – Specialty Drug Hyperinflation (April 2015)
Joint Letter to the FDA on Naming Protocols for Biosimilar Medications (July 2014)
CSRxP Report – Sovaldi: The Greatest Threat Yet to Sustainable Drug Pricing (May 2014)
NCHC Campaign – The Campaign for Sustainable Rx Pricing (CSRxP)