REMS: A Standardized Approach to Risk Management
Risk Evaluation and Mitigation Strategies. Until recently, the Federal Drug Administration’s REMS program impacted drugs that would not have been otherwise approved due to their risks.
The hurdles, costs and additional barriers in getting a drug to market were faced by few. Yet increasingly, risk mitigation is becoming a key feature in the American pharmaceutical landscape.
Where the FDA once focused on individual high-risk products, it has now turned its attention to drug-class REMS, such as those affecting long-acting opioids. And criticism is mounting. Increasingly, stakeholders want more input into the development of the REMS process, and greater transparency in REMS decisions.
And while increased REMS requirements will undoubtedly affect drug companies, pharmacists, health plans, physicians and their patients, there are benefits, from improved promotional opportunities and value propositions to drug life extension.
In REMS: A Standardized Approach to Risk Management, FirstWord examines how the industry faces increasing regulatory hurdles through the implementation—and expansion—of federal risk management initiatives. The sharply-written report addresses the drawbacks and benefits to drug-class REMS, as well as insights into how such programs have affected drug roll-out and marketing. Based on the most current information, interviews and news, the report offers the pharmaceutical industry a much-needed roadmap to how REMS will affect business.
The report offers insights into:
KEY FEATURES
CASE STUDIES EXAMINED IN THE REPORT
The hurdles, costs and additional barriers in getting a drug to market were faced by few. Yet increasingly, risk mitigation is becoming a key feature in the American pharmaceutical landscape.
Where the FDA once focused on individual high-risk products, it has now turned its attention to drug-class REMS, such as those affecting long-acting opioids. And criticism is mounting. Increasingly, stakeholders want more input into the development of the REMS process, and greater transparency in REMS decisions.
And while increased REMS requirements will undoubtedly affect drug companies, pharmacists, health plans, physicians and their patients, there are benefits, from improved promotional opportunities and value propositions to drug life extension.
In REMS: A Standardized Approach to Risk Management, FirstWord examines how the industry faces increasing regulatory hurdles through the implementation—and expansion—of federal risk management initiatives. The sharply-written report addresses the drawbacks and benefits to drug-class REMS, as well as insights into how such programs have affected drug roll-out and marketing. Based on the most current information, interviews and news, the report offers the pharmaceutical industry a much-needed roadmap to how REMS will affect business.
The report offers insights into:
- The benefits and drawbacks to REMS
- The implications to the industry of drug-class REMS
KEY FEATURES
- Complete background on the historical and regulatory development of REMS
- Breakdown of the challenges and negative impacts associated with REMS
- Examination of the case for and against class-wide REMS
- Chart outlining best practices and recommendations from recent stakeholder meetings
CASE STUDIES EXAMINED IN THE REPORT
- Biogen Idec’s TOUCH program
- Cephalon’s COVERS program
- Amgen’s NEXUS program
- Celgene’s STEPS program
EXECUTIVE SUMMARY
BACKGROUND
REMS versus RiskMAPs
From RiskMAPs to REMS
REMS components
CHALLENGES ASSOCIATED WITH REMS
Impact on timelines
Impact on drug sponsors
Impact on primary care physicians
Impact on revenue potential
OPPORTUNITIES WITH REMS
Improving the promotional mix
Improving the value proposition
Extending the life of a drug
UNINTENDED CONSEQUENCES OF REMS
Effect on generic drugs
CLASS-WIDE REMS
Examples of class-wide REMS
EXTENDED-RELEASE OPIOID DRUG PRODUCTS
Industry response
Public consultations
Onsolis REMS
Future outlook
CONCLUSION
Best practices and recommendations
INDEX
BACKGROUND
REMS versus RiskMAPs
From RiskMAPs to REMS
REMS components
CHALLENGES ASSOCIATED WITH REMS
Impact on timelines
Impact on drug sponsors
Impact on primary care physicians
Impact on revenue potential
OPPORTUNITIES WITH REMS
Improving the promotional mix
Improving the value proposition
Extending the life of a drug
UNINTENDED CONSEQUENCES OF REMS
Effect on generic drugs
CLASS-WIDE REMS
Examples of class-wide REMS
EXTENDED-RELEASE OPIOID DRUG PRODUCTS
Industry response
Public consultations
Onsolis REMS
Future outlook
CONCLUSION
Best practices and recommendations
INDEX
