What might the current Westminster Government mean for ... - BOPA

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What might the Westminster Government mean for access to new cancer drugs? With the coalition Government in place in Westminster, Mark Evans, Bethan Tranter and Mary Maclean set out some of the potential implications for access to new cancer drugs in England, Wales and Scotland respectively England Central to the assessment of new high cost medicines in England is NICE. The coalition Government’s programme contains a pledge to reform NICE. In the absence of substantive detail, the effect of this on access to high cost cancer medicines remains largely speculative. Making NICE more independent of Government would certainly be in line with other coalition health policies, such as a reduction in ‘top down’ reorganisation and the establishment of a new independent NHS health board. The Government has also said it intends to move to value based pricing, where the price paid for a drug is determined by its health benefits. That this is mooted in the context of NICE reform suggests that NICE may play a key role in this strategy. Indeed, the assessments required to establish value-based pricing, such as the determination of cost effectiveness, are already largely undertaken by NICE. With the acceptance of patient access schemes in its health technologies and the introduction of the patient access scheme liaison unit, NICE has already gone someway towards value-based pricing. An independent NICE with a responsibility to determine value based pricing does not therefore seem to be a vision incompatible with Governmental thinking. The programme for Government also sets out the establishment (by April 2011) of a £200million fund to enable patients to access the cancer drugs ‘their doctors think will help them’. This includes medicines that have been turned down previously by NICE and so how this fund will work without undermining the NICE process is not yet clear. Moreover, a fund equating to roughly £400,000 per 100,000 population might soon be exhausted by the breadth of expensive anti-cancer medicines on the market, and therefore prioritisation and assessment will be necessary. Perhaps a more effective and pragmatic solution would be to amend the NICE framework to account for the added perceived value of life extending anticancer medicines. Such work has already begun, with the introduction of NICE’s end of life criteria (in January 2009) which have facilitated access to drugs such as sunitinib (for renal cell carcinoma) and lenalidomide (for myeloma). Increasing spending on the NHS in real terms each year of the Westminster parliament is among the conservative party pledges that have been agreed in the ‘programme for Government’. However, in an environment of continually increasing demands on the NHS, investment in new high cost drugs is going to be heavily dependant on making efficiency savings. This is very much the mantra of the new secretary of state for Health for England, Andrew Lansley, who stresses that the NHS will have to go even further than the planned annual efficiency savings, approximating to £20billion by 2013/14, set out by the previous labour Government. These levels of efficiency savings can surely only be realised with quite significant restructuring of the NHS. The effects of this restructuring (such as the scrapping of strategic health authorities by 2012) on regional decision making groups and processes for new cancer drugs remains to be seen. Wales With Wales following NICE guidance, any changes to NICE and its remit have the potential to impact on access BOPA Bulletin Issue 1 Summer 2010
to new cancer drugs in Wales. The All Wales Medicine Strategy Group (see box1) has already recommended valuebased pricing to the Welsh Assembly Government (WAG), and so any moves to introduce more elements of this concept into NICE deliberations would not seem to be incompatible with this line of thinking. Funding for health in Wales, which ultimately trickles down to cancer care and to high cost drugs, is ‘protected’ for the current financial year but, after this, there is uncertainty. The Westminster Government is planning to review the formula whereby money is allocated to Wales. Moreover, the current health minister has shown real commitment to cancer services. With WAG elections to take place next year, this seemingly ‘exalted status’ for cancer treatments and services might be under threat. Scotland Scotland has its own system for the managed entry of all newly licensed medicines, through the Scottish Medicines Consortium, which provides advice as close to launch as possible. Changes to NICE, therefore, will have limited direct impact on patient access to new cancer drugs since only multiple technology appraisals are adopted, if considered applicable to Scotland by Quality Improvement Scotland. Of greater significance is the recent Scottish Government guidance set out in CEL17(2010) (see box2). The overall budget for Scotland has been agreed for the current year. However, as with Wales, the effects of any subsequent reviews of the allocation of money to Scotland, and the implications of these for healthcare spending in general and access to new cancer drugs in particular, are unknown. NHS boards are expected to fund SMC-accepted medicines but have to manage this within their general revenue allocation. On a final note, it is worth pointing out that the SMC, as a consortium of stakeholders from NHS board Drug and Therapeutic Committees, is already independent of the Scottish Government. Mark Evans is lead pharmacist, Mount Vernon Cancer Network, Bethan Tranter is chief pharmacist, Velindre Cancer Centre and Mary Maclean is regional cancer care pharmacist, west of Scotland AWMSG Established in 2002, AWMSG provides advice on prescribing and medicines management to Wales’ minister for health and social services. AWMSG recommendations are interim to NICE, should NICE subsequently issue guidance. Three advisory subgroups report to AWMSG and provide expert advice, these are the: • New Medicines Group • NHS Industry Forum • All Wales Prescribing Advisory Group CEL17(2010) Debate Article The Welsh Medicines Partnership (WMP) supports the activities of AWMSG and its subgroups. Since 2007, the focus of AWMSG has been on newly-licenced medicines for cancer and cardiovascular disease and on high cost drugs. As of 1 October, this will be extended to include all newly-licensed medicines, providing that an assessment is not on the intended work programme for NICE within the next 12 months. Following ministerial approval, AWMSG decisions about a new medicine are currently communicated to the relevant company by WMP, posted on the AWMSG website and sent by e-mail to a broad circulation. This communication procedure is currently under review. Following the challenges they experienced in seeking access to cetuximab for bowel cancer, Tina McGeever and her late husband Michael Gray set out to improve the processes for all patients accessing cancer medicines in NHS Scotland. CEL17(2010) is the outcome of a petition submitted by Mrs McGeever to the Scottish Parliament. Introduced in May, following wide consultation, the CEL provides a framework for NHS boards to put in place written policies to manage the introduction and availability of newly-licensed medicines. While the SMC provides a fair, rigorous and quick system for evaluating the role of medicines in NHS Scotland, it was clear from the review by the Scottish Parliament’s Petitions Committee that navigating the system is not always easy, particularly when patients and carers are dealing with difficult circumstances. Openness and transparency is a key requirement of the CEL; each board will be expected to publish its policies and processes on its website. This will enable easy comparison between boards and, together with a requirement for boards to share good practice, will promote a consistency of approach. Policies must take into account advice from the SMC and NHS QIS regarding NICE Multiple Technology Appraisals. Where processes cross board boundaries and link to regional arrangements, such as cancer networks, there is an expectation that these will be applied consistently through shared agreement. For medicines that are yet to be assessed, or are not recommended by the SMC, CEL17(2010) also identifies certain key features for NHS boards to address when considering individual patient treatment requests, including how decisions should be communicated to individual patients, their families and carers and the time scales according to which decisions will be made. Members of the public should be able to be involved in the development of policies, which need to be in place by April 2011. BOPA Bulletin Issue 1 Summer 2010 13
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