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Kevan Wind is medicines procurement specialist pharmacist,
London and East of England
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Position statement
The Cancer Networks Pharmacy Forum has
published a position
statement on risk-sharing schemes, endorsed by the British Oncology
Pharmacy Association.
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Submitting Comments
Readers are invited to
submit 900-word Comments on
topical issues. Submissions should be e-mailed to
hannah.pike@pharmj.org.uk
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Operational issues are arising in the NHS as a result of the pharmaceutical
industry’s development of risk-sharing schemes for high cost medicines.
The
introduction of Janssen-Cilag’s Velcade
(bortezomib) response scheme has attracted publicity (The Pharmaceutical
Journal 2007;279:461), and similar schemes are proposed for Pfizer’s
Sutent (sunitinib) and Roche’s Tarceva (erlotinib).
The schemes are designed in the main to support patient access to new
drugs in the transitional period between the grant of a marketing authorisation
by the Medicines and Healthcare products Regulatory Agency and the accrual
of sufficient outcome-based trial data for organisations such as the
National Institute for Health and Clinical Excellence to review the drug’s
comparative place in treatment.
Risk-sharing or rebate schemes (also called patient access schemes) allow
a manufacturer to maintain a global market price but also reach the NICE
threshold for price per quality adjusted life year. The concept is that
payment for a treatment will be deferred or refunded if it can be shown
to have been ineffective in a specific patient. Thus the NHS only pays
where patient benefit accrues.
These schemes should allow greater access to medicines and may speed
their uptake — something that the NHS has been accused of failing
to manage. They are by definition value-based and give transparency to
outcomes. However, they require potentially burdensome administration
and their introduction is complicated by the variety of funding arrangements
possible, each of which has specific implications.
Most of the funding methods create a complex audit trail. Many are labour
intensive for pharmacy staff (eg, by involving multiple computer entries),
and some are labour intensive for clinical and financial staff. 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
Recommendations
To reduce the disadvantages of risk-sharing schemes and maximise the
potential benefit for patients, the NHS and industry, the following features
are recommended:
Simplicity Schemes should be patient-centred, with patient agreement,
and based on easily measured clinical outcomes.
One model To reduce administrative burdens, all schemes should comply
with a single preferred model.
Communication Schemes must be jointly developed between the NHS (providers
and commissioners) and industry.
Infrastructure costs The costs required to administer the schemes must
be factored in for all participants (providers may need a data manager).
Financial clarity Schemes must address the twin issues of reconciliation
of patient outcomes with financial flows back to commissioners. Financial
flows within trusts must also be accommodated and prices paid not vary.
Ideally the payments to industry should be deferred until the decision
to continue treatment is made.
Registration Before commencing treatment, patients should be registered
with all three participants in the scheme (providers, commissioners and
manufacturers).
Summary
Risk sharing schemes are not new, but have recently undergone something
of a renaissance. While these arrangements can improve the speed of access
to new medicines, they need to be managed correctly to ensure that they
do not become a burden to healthcare systems.
Acknowledgements
Tim Root, specialist pharmacist, clinical
governance and technical services, East and South East England
Ann Jacklin,
chief
pharmacist, Hammersmith Hospital and Charing Cross Hospital, London
Steve Williamson, consultant pharmacist, cancer services, Northumbria
Healthcare NHS Foundation Trust |
Hospital Pharmacist