Question

• What are the pros and cons of the of the risk-sharing scheme for patients, physicians, the NHS, and pharmaceutical companies?
• How should companies adapt their product development and launch strategies to the NICE technology appraisal process? Should every country set up a similar process?

Answer 1

Ans)

Pros and cons

The potential advantages of risk-sharing schemes include the following:

• Medicines are made available in the global arena of linked market prices but with localised cost-effectiveness targets

• Healthcare should improve, with the right patient being treated at the right time

•Speed of uptake of new medicines should improve

•The system is value-based

•Outcomes of treatment will be in the public domain

•Sales of medicines will increase and manufacturers’ profitability should improve

•Opportunities for partnerships between industry and the NHS will increase

Potential problems include the following:

•The potential administrative burden

• Financial flows in the NHS are complex and there is a need for reconciliation between the risk-sharing scheme and the movement of funding between the suppliers, providers and commissioners

• Schemes may require the transfer of individual patient data (with implications for confidentiality)

• Auditing of the schemes may be complex because all sides need to be assured of fairness

•Mechanisms need to be agreed for measuring clinical criteria

• Specific objective measures of clinical response are not available for all treatments

• As clinical experience grows and patient response rates improve, the return to the NHS could fall

• The patient response rates will not be consistent across the NHS (eg, tertiary centres treat resistant patients)

• Clinicians may treat more freely with medicines they perceive to be free

•Abuse of the schemes by all parties is possible.

Appraisal committee:
The appraisal committee considers and discusses the evidence for a technology.
The appraisal committee is an independent standing committee that produces recommendations.

- NICE recruits committee members through open, competitive advertising and appoints
members initially for a 3-year term. Committee members are from:
• the NHS
• lay backgrounds (with an understanding of patient
and public perspectives on healthcare issues)
• academia
• pharmaceutical and medical devices industries.
Full details of how NICE recruits members can be found in the recruitment and selection procedure for advisory bodies.
NICE allocates members to 1 of 4 standing committees. Members will normally remain in the same committee for the duration of their
membership. Sometimes members may be needed to join another committee to ensure that the meeting is quorate and that business
can be done in line with the committee standing orders and terms of reference.