IHS Global Insight Perspective | |
Significance | A study by the U.K. Cancer Network Pharmacist Forum has highlighted experience on the use of patient-access schemes for four cancer drugs in National Health Service (NHS) trusts. |
Implications | The study, which was based on a survey of 37 NHS Trusts, discusses key difficulties in using the schemes. |
Outlook | Overall, finance-based schemes are viewed as the most straightforward to use. The research shows that the schemes are not being adequately monitored, and as a result, full savings are not being relayed to NHS Trusts. |
The study looked at four drugs that had been recommended for reimbursement by the healthcare guidance and guidelines organisation, the National Institute for Health and Clinical Excellence (NICE), with the help of patient-access scheme agreements with the department of health. The drugs assessed were Velcade (bortezomib; Johnson & Johnson, U.S.) for the treatment of multiple myeloma, Tarceva (erlotinib; Roche, Switzerland) for the treatment of non-small-cell lung cancer (NSCLC), Sutent (sunitinib; Pfizer, U.S.) for the treatment of renal cell carcinoma (RCC) and gastrointestinal stromal tumours (GIST), and Erbitux (cetuximab; Merck KGaA, Germany) for the treatment of advanced colorectal cancer.
Snapshot of Four Patient-Access Schemes | |||
Drug | Indication | Type of Scheme | Proposed Deal |
Tarceva | Second-line treatment of locally advanced or metastatic NSCLC | Finance-based, capped payment scheme | Tarceva should be provided at a price equal to that of French firm Sanofi-Aventis' Taxotere (docetaxel). |
Velcade | Multiple myeloma | Performance-based scheme | The manufacturer would rebate the cost of Velcade for patients whose condition does not respond to treatment after four cycles. |
Sutent | Renal cell carcinoma (RCC) and (GIST) | Finance-based, capped payment scheme | The first treatment cycle would be provided free of charge by the manufacturer. |
Erbitux | Advanced colorectal cancer | Finance-based, dose capped scheme | Treatment would be capped at 16 weeks, after which patients should be assessed for resection of liver metastases. The agreement also includes a 16% refund on the cost of treatment per patient. |
Source: IHS Global Insight Risk-Share Database, 2010 | |||
Study Methods
The study was based on responses received via an on-line questionnaire regarding feedback on the uptake of the patient-access schemes, impact on capacity, and ways in which the schemes could be better implemented. Responses were received from 61 respondents in 37 out of the 131 NHS trusts targeted; the questionnaire was specifically targeted at oncology pharmacists.
Key Findings
A total of 45 respondents said they had one or more of the assessed schemes in operation within their trusts. All trusts in the survey used the patient-access scheme for Velcade. The uptake rate for Sutent, Tarceva, and Erbitux was 62%, 45%, and 15% respectively. Up to 756 patients had received treatment with the four drugs between their introduction and the period ending July 2009.
Uptake of Patient-Access Schemes | ||
Drug | Uptake Rate (%) | Patients Treated |
Tarceva | 45 | 180 |
Velcade | 100 | 295 |
Sutent | 62 | 278 |
Erbitux | 15 | 3 |
Source: Cancer Network Pharmacist Forum, 2009 | ||
Feedback from Respondents on Each Scheme
Tarceva
In terms of the implementation of the scheme, it involved applying a discount to the drug to reduce the price, and the discount would then be credited by Roche. The most common feedback on this patient-access scheme was that it was the least challenging to use; however, it was still difficult to administer, as the use of the credit note meant that it was logistically challenging. The average time to run the scheme per patient was estimated at 17.5 minutes.
Velcade
Comments received for the patient-access scheme for Velcade highlighted concerns about monitoring issues. Pharmacists in particular found it difficult to manage the scheme due to the need for measuring patient response. As a result, it relied on a large amount of collaboration with the clinical teams to track treatment and response. In addition to tracking the use of the drug, the claims process in order to recoup the costs of the drug in patients who have not responded to the treatment is also cumbersome. All refund claims must be made within 60 days of measuring the response. Due to this stringent timeframe, many trusts admitted that they have lost out on claims. Overall, the average time to run the scheme was estimated at 37.5 minutes per patient. Some 60% of respondents rated the scheme as bad or very bad, and 40% rated it as average.
Sutent
The difficulties in administering the patient-access scheme for Sutent centre on issues of reconciling the free first cycle of treatment into pharmacy records, as most pharmacy computer systems cannot process free stock. Another issue identified was the need for communication between those administering the treatment and the pharmacy departments in order to fill out the claim for the free cycle of treatment from the manufacturer. In many cases, the lack of effective communication has meant that the discount is not being effectively passed on to the trust. The average time to run the scheme per patient was estimated at 19 minutes. Some 58% of respondents rated the scheme as average, while 30% felt it was bad or very bad.
Erbitux
The response on the patient-access scheme for Erbitux was limited, making it difficult to paint an accurate picture of issues surrounding its implementation. However, comments received indicate that most respondents felt it was a difficult scheme to use in practice, especially in light of the five-day window for refunds. Many felt that this is impractical and presents a high level of financial risk. The average time to run the scheme per patient was estimated at 45 minutes.
Outlook and Implications
Patient-access schemes are becoming increasingly used as a means of improving access to expensive drugs, especially in oncology. Since introduction of this creative-pricing strategy, very little work has been done to assess its usefulness so far. Although this is only a small study, it highlights key concerns that surround the implementation of the schemes. The main issue is the problem of monitoring. According to this study, out of the four drugs, Tarceva had the most favourable pricing agreement. This is likely to be related to the fact that it is a straightforward price-discount scheme, which therefore presents fewer administrative issues. The patient-access scheme for Sutent is also largely finance based, which also makes it easier to implement; however, applying the free first cycle presents a logistical hurdle. It is fair to say that performance-based schemes are generally frowned upon due to their complexity. This general conclusion was also asserted recently in a British Medical Journal editorial, which identified key failures in the NHS's performance-based patient-access scheme for four multiple sclerosis drugs (see United Kingdom: 7 June 2010: NHS Risk-Share Scheme for MS Drugs Branded Failure by Experts).