With the cost of cancer drugs increasing at a rate that is generally thought to be unsustainable, many countries are faced with the difficult question of how to ensure access to these drugs without breaking the financial resources of individuals and systems paying for them.
One solution to this dilemma has been programs sponsored by pharmaceutical companies to help defray the cost. Programs such as patient access schemes (PAS) in the UK and patient assistance programs (PAPs) in the U.S. offer specific risk-sharing or cost-sharing formulas for select high-cost cancer drugs.
In the UK where the nationalized healthcare system absorbs the cost of drugs and services, the hope was that PAS would help reduce the cost of a high-cost drug to the National Health Service (NHS).
But has PAS proven effective? A recent report by the British Oncology Pharmacy Association (BOPA) found that PAS was plagued by poor management, a shortage of manpower, and a lack of implementation, all of which means the NHS may still be shouldering the financial burden (see Table 1).
Problems with PAS
In the UK, the cost of drugs is particularly important for access. The approval of drugs accessible through the NHS depends on their proven clinical- and cost-effectiveness, which is determined by the National Institute for Health and Clinical Excellence (NICE). Once approved, drugs are provided to patients through hospital provider trusts, which are in turn reimbursed for the cost of the drug through the patient's local primary care trust (PCT).
Currently, a number of PAS have been approved by NICE for use through NHS. The BOPA report compiled data from 31 NHS hospital provider trusts, including 756 patients entered in PAS that had been running in the UK for at least 12 months between 2007 and 2009 (see Table 1).
"The purpose of PAS is to allow drug prices to better reflect value to NHS patients and increase access to cost-effective innovative medicines," said David Thomson, MRPharmS, BOPA chair and lead pharmacist at the Yorkshire Cancer Network based in Harrogate. "This research shows that the NHS may be failing in delivering this worthy purpose, and unless properly managed and supported, the NHS will bear the financial risk of the schemes."
Among the key findings of the study, according to Mr. Thomson, was that refunds for two of the most common PAS, sunitinib (Sutent) and bortezomib(Drug information on bortezomib) (Velcade), were not being passed on to the funding PCT in 47% of cases.
Pfizer Oncology, the maker of sunitinib, supports a PAS in the UK, and a spokesperson for the company pointed out that the "uptake of new, innovative medicines remains low in the UK in comparison to other European markets. This is despite the fact that the cost of these medicines is often actually lower than in other markets, and that the UK actually spends less of its health budget on medicines than the rest of Western Europe."
The Pfizer spokesperson said that it continually monitors PAS to determine if the programs are actually improving access to medicines in a financially sustainable way for the company and the NHS.
Another key finding of the BOPA report was the current incapacity of NHS to manage more PAS without funding staff time to manage, coordinate, and track the schemes, Mr. Thomson added.
Despite this finding, Mr. Thomson believes more PAS will be created in the future. "I have no doubt that schemes will continue to increase, but it is our hope that NICE, the department of health, and pharma will work with the NHS to develop a standard 'template' for schemes that the NHS can implement relatively easily," he said.
The need for a standard template for schemes was also highlighted by the BOPA report, in which most respondents (73%) thought it would be beneficial to allow manufacturers to select a familiar "off-the-shelf" scheme.
Until a standard template is developed and implemented, according to Mr. Thomson, "it appears that pharma will continue to present ever more complex and differing schemes to the NHS, which, it would appear, the NHS is already struggling with."
Finally, the report highlighted the need for improvements in the way NHS supports the implementation of PAS. A step in this direction has already been taken with the recent formation by NICE of the Patient Access Scheme Liaison Unit (PASLU), a coordination body that will help oversee the PAS.
"The new arrangements will provide a robust process through which these schemes can be assessed and will increase opportunities for individuals working in the NHS to contribute to the review process," according to a NICE representative.