Medicines funded through risk-sharing must offer tangible value
Costs and benefits of medicines used within risk-sharing schemes should
be assessed as carefully as the costs and benefits of other medicines
to make sure they genuinely offer the NHS value for money, according
to a position
statement from the Cancer Network Pharmacists Forum that
is endorsed by the British Oncology Pharmacy Association.
Following approval by the Department of Health of the Velcade response
scheme — as part of the National Institute for Health and Clinical
Excellence appraisal of bortezomib for multiple myeloma (PJ,
27 October 2007, p461) — an
increasing number of risk-sharing initiatives are being offered to NHS
trusts by pharmaceutical companies. The schemes
are proposed as a means of securing entry of new drugs into the challenging
UK market, says the CNPF (see Panel).
Such initiatives are inconsistent in the way they work, which increases
the financial, administrative and governance risks to NHS organisations,
the statement says. Although the schemes save on drug acquisition costs
they can require significant extra work from pharmacy and finance departments
to ensure their success. These costs need to be factored into the overall
evaluation of the benefits to the NHS, it adds.
The CNPF warns that NHS organisations are under increasing scrutiny about
the decisions they make, particularly for oncology medicines, and there
is a risk that the offer of a discount scheme may lead trusts to make
decisions outside their established policies.
Several recommendations are made, including that the industry should
offer these schemes across the NHS and should not target specific organisations
where uptake of the drug in question is slow. The forum also believes
that the DoH should develop a position on whether risk-sharing schemes
offered only as an interim measure are acceptable.
The CNPF says the DoH is not planning to issue guidance for NHS organisations
on the adoption of schemes outside of NICE appraisals but that the Association
of the British Pharmaceutical Industry has been asked to produce good
practice guidance for the industry on preparing and administering the
schemes. The CNPF has published the position statement to inform this
process and to provoke wider debate. It is available on the BOPA website.
Risk-sharing schemes
There appear to be three scenarios for which risk-sharing schemes
are being proposed:
• Where a company wants to get a
foothold in the market before a National Institute for Health and
Clinical Excellence appraisal
and competitor therapies are cheaper
• Where a company wishes to reduce the cost per quality adjusted
life year (QALY) after a negative NICE appraisal
• Where a company wishes to reduce the cost per QALY and allow
the product to hit the NICE threshold at the time of a technology
appraisal |
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