Oncology Innovative Pricing deal with NICE on lung cancer drug

A new oncology patient access scheme is currently being proposed to NICE by Astra Zeneca in the UK. This is an interesting proposal of a flat fee coupled with a registry.

Key points:

- NICE is minded not to recommend gefitinib due to the lack of information provided in order to assess the most probable cost/QALY
- NICE has asked AZ to provide additional information
- A patient access scheme is envisioned, which proposes that a fixed cost is charged for each patient treated with gefitinib regardless of the length of treatment.
- AZ proposes setting up a gefitinib registry which will provide real life data. In 3years time, AZ commits to evaluating these data and renegotiating with NICE on the value of gefitinib

In summary, the Appraisal Committee could not assess whether gefitinib is a cost-effective treatment option because it did not have sufficient information to assess the most plausible ICER for gefitinib compared with standard platinum combination therapy or with pemetrexed and cisplatin. Therefore the Appraisal Committee is minded not to recommend gefitinb for the treatment of locally advanced or metastatic NSCLC. It is recommending that clarification should be sought from the manufacturerer, including analyses that use alternative survival extrapolations and application of hazard ratios, amended first-line chemotherapy costs and chemotherapy cycles, alternative prevalence rates of EGFR-TK mutations and alternative assumptions about the cost of the EGFR-TK mutation tests.

In more detail:

Appraisal Committee’s preliminary recommendations

1.1 The Committee is minded not to recommend gefitinib as a treatment option for people with locally advanced or metastatic non-small-cell lung cancer (NSCLC).

1.2 The Committee recommends that NICE requests further clarification on the clinical and cost effectiveness of gefitinib from the manufacturer as described in sections 1.3 to 1.5. This information should be made available for the next Appraisal Committee meeting.

1.3 NICE requests an exploration of alternative probability distributions for the extrapolation of progression-free survival and overall survival beyond the timeframe of the Iressa Pan Asian Study (IPASS). This should include the following.

1.4 Independent survival curves (overall survival and progression-free survival) for both gefitinib and paclitaxel/carboplatin based on the IPASS data and exploration of different approaches to applying the hazard ratio to incorporate other comparators (for example, pemetrexed and other platinum-based regimens). The different approaches to applying the hazard ratio should consider using either gefitinib or paclitaxel/carboplatin as the baseline.

1.5 Examination of alternative probability distributions and consideration of model fit to early trial data and the shape of the curves at the tail of the distribution.

1.6 Observational or epidemiological evidence on long-term survival in patients with locally advanced or metastatic NSCLC and how this relates to the most plausible model fit.

1.7 The provision of individual patient-level data from IPASS to enable the Evidence Review Group (ERG) to validate key aspects of the submitted model, including the modelling of overall survival and progression-free survival, the choice of parameter values, and structural assumptions.

1.8 NICE requests an analysis to determine the robustness of the incremental cost-effectiveness ratio (ICER) to alternative survival distributions for progression-free and overall survival, based on the independent survival curves for gefitinib and paclitaxel/carboplatin from the IPASS data. The analysis should also provide evidence on alternative approaches to applying the hazard ratio to link to other comparators. These cost-effectiveness analyses should include amended costs for first-line chemotherapy to account for a lower level of dosing in female patients and varying the number of first-line chemotherapy cycles between four and six.

1.9 NICE also requests further analyses to explore the sensitivity of the ICER to:

1.10 varying the prevalence of EGFR-TK mutations between 5% and 17%, taking into account different scenarios costs, comorbidities and the probability of obtaining a specimen suitable for testing (including possible repeat biopsy and the possibility of not obtaining a useful result)

1.11 alternative assumptions about the volume, and hence cost, of the EGFR-TK mutation tests carried out.

On the Patient access scheme:
The Committee noted that the patient access scheme involved a fixed cost being charged for each patient treated with gefitinib regardless of the length of treatment. The Committee agreed that such a scheme was probably relatively simple to administer in the NHS. However, the Committee was concerned that although such a scheme may be beneficial across the whole NHS, there could be some areas where patients receive short courses of treatment and the cost of gefitinib under such circumstances would be greater with the scheme than without it.