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London Cancer New Drugs Group position statement on patient access schemes: expert responses
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London Cancer New Drugs Group position statement on patient access schemes March 2010: expert responses
Dear Colleagues,
The London Cancer New Drugs Group (LCNDG) has issued a position statement saying it will not take patient access schemes (PASs) into account when evaluating new treatments. Citing the complexity of PASs and a general lack of capacity to manage these schemes, the LCNDG says it does not currently support PASs as a method of cost reduction. In summary, the LCNDG states that it will “continue to evaluate and make recommendations with respect to new treatments at full cost and will not take into consideration the potential financial impact of a proposed or existing PAS related to the treatment.” This stance is at odds with the National Institute for Health and Clinical Excellence (NICE), which has developed these schemes in collaboration with the pharmaceutical industry to facilitate access to more expensive treatments within the NHS, and has even set up the Patient Access Scheme Liaison Unit (PASLU) to help implement PASs.
Although NICE has yet to comment, experts have been quick to respond to the LCNDG’s position statement. You can read the reactions of David Thomson, British Oncology Pharmacy Association (BOPA) Chair, Steve Williamson, Professional Secretary, North of England Cancer Drugs Approval Group (NECDAG), and Sean McGrath, Managing Director, Succinct Healthcare Communications, in this issue of Cancer Services Forum.
To comment on the position statement, and the responses presented in the article, please click here. To view the position statement in full, please click here.
Editor, Cancer Services Forum
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Discussion.
Having engaged with the Department of Health in England and with PASAG in Scotland on a patient access scheme (PAS) for our renal cancer drug towards the end of 2009/ early 2010, I would like to comment on this article from an industry perspective.
Putting a PAS in place is not an option we took on lightly. We are too aware, as an industry, of the financial pressures the National Health Service faces and wish very much to work in partnership with different organisations to ensure patients have access to licensed medication as quickly as possible post approval.
In doing so Novartis UK bears in mind that patients in other parts of the world can sometimes benefit from effective licensed treatments to which patients in the UK are denied access.
From an industry perspective there are numerous challenges:
• No clear guidance has been provided to industry on how to develop or design these schemes - this can lead to delay.
• Patient Access schemes carry internal administrative and financial burden for the industry - often requiring us to engage additional staff, make alterations to computer systems; set up tracking spread sheets etc. The pressure it puts on industry resource could be more effectively taken into account.
• The NHS across the UK is increasingly differentiated on a country and SHA level, one model does not fit all. This can be inefficient.
• NICE methodology must be adapted to end of life treatments to allow PAS to reflect their benefits. NICE currently applies a QALY threshold to all drug appraisals irrelevant of disease state, which many have acknowledged is arbitrary. Delivering sufficient data within an oncology arena where patients life expectancy is often short, patient numbers low, and studies are done in the metastatic setting is a challenge. (Cross-over in studies commonly confuses the picture further). Driving strong HE data in a short time frame after EMEA approval is therefore difficult.
• Pricing of drugs across Europe and changes in exchange rates has become more complex. This leads to challenges in drug supply, and to risks where patients may not have ease of access to their medication.
Patient access schemes are attempting to enable access for UK patients to medicines for which they would otherwise have to pay privately or be deprived. Whilst agreeing that the solution may not be ideal, the NHS and Department of Health have not offered alternative solutions.
There is significant talk of value-based pricing, but the definition of this is unclear and however it is defined the administrative burden and challenges of tracking different patients must be taken into account. Criticisism of PASs should not detract from their aims of providing earlier access to medicines and to possibly enable patients to live longer and/or experience a better quality of life.
Innovation, access to medicines and patient care should be at the forefront of this debate.
Nicola Redfern
Head of Market Access: Oncology/Haematology
Novartis Pharmaceuticals UK Ltd
Registered in England 119006
Registered Office: Frimley Business Park, GB- Frimley/Camberley, Surrey GU16 7SR