London Cancer New Drugs Group position statement on patient access schemes: expert responses

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

Response from BOPA

The London Cancer New Drugs Group (LCNDG) has said it will not take into consideration the potential financial impact of a proposed or existing patient access scheme (PAS) relating to any new treatment. In 2008, in its position statement on risksharing schemes in oncology,¹ the British Oncology Pharmacy Association (BOPA) warned of many of the issues highlighted by the LCNDG. The BOPA statement noted the following:
• The number of risk-sharing schemes open to the NHS is increasing
• Risk-sharing schemes saved on drug acquisition costs but required significant extra work from pharmacy, finance departments and clinicians
• The cost of such work should be factored into the overall evaluation of the benefits offered by risk-sharing schemes
• The increased administrative, and hence financial, burden could be minimised by active collaboration between the NHS and pharmaceutical manufacturers resulting in mutually acceptable schemes
• A high level of consistency between schemes is crucial to their acceptability
• It is essential to ensure that nationally approved schemes can be easily implemented in a way that genuinely offers the NHS value for money

Although there is now dialogue between the NHS and the pharmaceutical manufacturers—via the Patient Access Scheme Liaison Unit (PASLU) at the National Institute for Health and Clinical Excellence (NICE)—it is not clear that this is an active collaboration aimed at the development of consistent and mutually acceptable schemes.

BOPA remains keen to collaborate actively with all stakeholders to develop schemes that can easily be implemented in the NHS and provide access to treatments for patients while offering true value for money.

Reference

1. British Oncology Pharmacy Association. Position statement on “risk sharing” schemes in oncology. Avaliable at: http://www.bopawebsite.org/tiki-page.php?pageName=Position+Statements (accessed April 2010).

David Thomson
Chair, BOPA

Response from NECDAG

The North of England Cancer Drug Approvals Group (NECDAG) notes with interest the position taken by the London Cancer New Drugs Group (LNCDG). NECDAG was an early adopter of patient access schemes (PASs) to allow access to high-cost cancer medicines for patients in the North East of England and Cumbria. In particular, NECDAG has used PASs to facilitate access to treatments before approval by the National Institute for Health and Clinical Excellence (NICE). For example, erlotinib in non-small-cell lung cancer and sunitinib in renal cell cancer were both approved at least 12 months before the respective reports from NICE.

NECDAG has successfully worked with the pharmaceutical industry to ensure PASs are workable, but it also recognises that these schemes can be difficult to manage.¹ Consequently, NECDAG has rejected schemes that it considered unworkable in the NHS North East and is constantly exploring ways to make PASs more manageable. Furthermore, when NECDAG recently considered the ongoing acceptability of PASs as part of its decision-making process, it decided that, if managed properly, PASs could allow cancer patients access to medicines that would not otherwise be available via the NHS.

As a result, NECDAG is not prepared to ban the use of such schemes. NECDAG proposes dialogue between secondary care trusts and primary care trusts to consider investment of a proportion of the savings on drug costs generated by PASs into the funding of staff to manage such schemes and ensure they deliver the promised financial benefits. Future schemes approved by the NICE Patient Access Scheme Liaison Unit (PASLU) will take account of the need for staff to financially manage the PAS and ensure refunds are paid. Nevertheless, NECDAG believes that the commissioning challenges posed by PASs require them to be kept under continual review. NECDAG also feels that for medicines not recommended by NICE, it is for local health technology decision-making bodies to decide whether PASs can or should be accepted as part of their process.

Reference

1. Williamson S. Patient access schemes for high-cost cancer medicines. Lancet Oncol 2010; 11: 111–112

Steve Williamson
Professional Secretary, NECDAG

Response from Succinct Healthcare Communications

As an agency facilitating joint-working approaches between the pharmaceutical industry and the NHS, Succinct welcomes the recommendation from the London Cancer New Drugs Group (LCNDG) that patient access schemes (PASs) should not be taken into consideration when assessing the costeffectiveness of technologies in the absence of guidelines from the National Institute for Health and Clinical Excellence (NICE).

The emergence of PASs, whilst well intended, was brought about by politicians with little knowledge of the workings of multinational pharmaceutical companies, market dynamics or the financial flows of our own health service. Now—with PASs in such abundance and in so many different guises—it is almost impossible to monitor these schemes.

Furthermore, in many areas they simply do not work. Succinct is, therefore, pleased to see that an influential group such as the LCNDG has come out with a statement that reflects what a number of other groups have wanted to say for a long time.

Meanwhile, the problem that prompted the development of PASs remains—our NHS often refuses to pay what the industry considers to be market rates for new technologies. These prices are paid in other countries, and pharmaceutical companies cannot simply reduce their list prices for the UK—hence the profusion of convoluted schemes.

When discussing the option of a PAS with an industry client, Succinct always emphasises simplicity—in fact a straightforward discount is the best way. Succinct is well aware of the contortions NHS staff (pharmacists mainly) undergo whilst attempting to monitor complex PASs, and make them work financially. It has been made clear countless times that the effort involved in making a PAS work often far outweighs the potential saving for the NHS. Indeed many pharmacists are simply not monitoring PASs. Recent data from the British Oncology Pharmacy Association (BOPA) has highlighted some of the difficulties.¹

It may seem strange for Succinct, which consults with the industry on PASs, to welcome the LCNDG statement. However, it is our firm belief that until PASs become more manageable, or the industry adopts simple discount arrangements, joint working will not happen.

To address this important challenge, Succinct recommends a meeting for the industry and BOPA, to debate the issues and agree a mutually acceptable way forward. The ultimate beneficiary, of course, will be the patient.

Reference

1. Williamson S. Patient access schemes for high-cost cancer medicines. Lancet Oncol 2010; 11: 111–112.

Sean McGrath
Managing Director, Succinct Healthcare Communications