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Oncology - Cancer Drug Fund decision summaries 2015


The Chemotherapy Clinical Reference Group ( CRG ) has reviewed drugs and drug indications for inclusion on the National cancer drugs fund list.
The decision summaries record how each drug/drug indication scored using the CDF prioritisation tool and include a summary of the CRG’s final decision.

1) Bevacizumab [ Avastin ]

Bevacizumab in combination with 2nd/3rd line Oxaliplatin–based combination chemotherapy for metastatic colorectal cancer

The panel’s scores were as follows: 2 for progression free survival ( 7.3 vs 4.7 months, delta 2.6 months ); 2 for overall survival ( 12.9 vs 10.8 months, delta 2.1 months ); 0 for QOL; minus 1 for toxicity; 0 for unmet need.
It resulted in a total of 3B.

The cost of Bevacizumab per 2-week cycle at the list price ( including VAT ) for a patient of body weight 75kg for this indication is 1109 pounds.

Conclusion

The median drug cost of Bevacizumab resulted in this indication scoring a value within the confidential CDF cost scoring system which when combined with the clinical score of 3 resulted in an overall score which was insufficient for the CDF panel to retain the use of Bevacizumab in combination with Oxaliplatin-based combination chemotherapy as 2nd/3rd line chemotherapy of colorectal cancer.

Bevacizumab in combination with Paclitaxel chemotherapy for triple negative metastatic breast cancer

The panel’s scores for the triple negative group were as follows: 3 for progression free survival ( 10.6 vs 5.3 months, delta 5.3 months ); 0 for overall survival ( no statistical significant difference ); 1 for QOL; minus 1 for toxicity; 0 for unmet need. It resulted in a total of 3B.
The median duration of treatment in this group was 9.7 months.

The panel’s scores for the intention-to-treat group were as follows: 4 for progression free survival (11.4 vs 5.8 months, delta 5.6 months ); 0 for overall survival ( no statistical significant difference ); 1 for QOL; minus 1 for toxicity; 0 for unmet need. It resulted in a total of 4B.
The median duration of treatment in this group was 7.1 months.
Although this intention to treat overall score was greater accompanied by a shorter duration of treatment than the triple negative subgroup, the CDF Panel still chose to use the intention-to-treat figures.
The CDF Panel has considered that its scoring of 0 for overall survival was appropriate as there had been no statistical significant difference observed in overall survival and crossover to Bevacizumab from the control arm had not been allowed in this study.

The cost of Bevacizumab per 2-week cycle at the list price ( including VAT ) for a patient of body weight 75kg for this indication is 2219 pounds.

Conclusion

The median drug cost of Bevacizumab resulted in this indication scoring a value within the confidential CDF cost scoring system which when combined with the clinical score of 4 resulted in an overall score which represented insufficient value for retention within the CDF.

Bevacizumab in combination with chemotherapy for advanced cervical cancer

The CDF panel scored this application as follows: 2 for progression free survival ( 8.2 vs 5.9 months, delta 2.3 months ); 3 for overall survival ( 17.0 vs 13.3 months, delta 3.7 months ); 1 for QOL; minus 1 for toxicity; and 0 for unmet need.
It resulted in a total of 5B.

The cost of Bevacizumab per 3-week cycle at the list price ( including VAT ) for a patient of body weight 75kg for this indication is 3328 pounds ( 3-week cycle ).

Conclusion

The median drug cost of Bevacizumab resulted in this indication scoring a value within the confidential CDF cost scoring system which when combined with the clinical score of 5 resulted in an overall score which was considered insufficient by the CDF panel for retention of use of Bevacizumab in combination with 1st line Platinum-based combination chemotherapy in recurrent or metastatic cervical cancer.

2) Cetuximab [ Erbitux ]

Cetuximab as monotherapy in patients progressing after 2 or more previous lines of chemotherapy for metastatic colorectal cancer in patients with RAS wild type ( nonmutated ) tumours

The CDF Panel recognised that it did not have the RAS wild type data for this indication but considered that it would at least match that of the KRAS wild type group. In terms of the Cetuximab study, the CDF Panel scored the KRAS wild type subgroup as follows: 0 for progression free survival ( 3.7 vs 1.9 months, delta 1.8 months ); 3 for overall survival ( 9.5 vs 4.8 months, delta 4.7 months ); 2 for QOL; minus 1 for toxicity; 0 for unmet need.
It resulted in a total of 4B.

The cost of Cetuximab per 2-week cycle at the list price ( including VAT ) for a patient of body surface area 1.8 m² for this indication is 1923 pounds.

Conclusion

The median drug cost of Cetuximab resulted in this indication scoring a value within the confidential CDF cost scoring system which when combined with the clinical score of 4 resulted in an overall score which was insufficient for the CDF panel to retain the use of Cetuximab monotherapy as treatment for chemotherapy-refractory RAS wild type metastatic colorectal cancer.

3) Everolimus [ Afinitor ]

Everolimus in renal cell cancer patients progressing on therapy with a tyrosine kinase inhibitor

The CDF Panel’s scores for Everolimus after one previous TKI in metastatic renal cell carcinoma were as follows: 3 for progression free survival ( 5.4 vs 1.9 months, delta 3.5 months ); 3 for overall survival ( cross over effect and OS benefit assumed to be the same as PFS ); 1 for QOL; minus 1 for toxicity; 0 for unmet need.
It resulted in a total of 6B.

The CDF Panel recalled that Axitinib [ Inlyta ] had been approved by NICE as 2nd line treatment after 1st line therapy with a TKI and that in NHS practice this is likely to trump any CDF option as Axitinib has been shown to be cost effective according to NICE's usual standards and Everolimus has not. Further patients are likely to have an expectation that NICE guidance will be followed in their case, and clinicians are expected to take account of NICE guidance and to depart from it only for a sufficient reason. Baseline funding is made available for the implimentation of NICE guidance, and the Panel was mindful that if CDF funding was used for patients who had access to a NICE recommended treatment, that funding would not then be available for other patients who might otherwise have benefited from the CDF and who might not have any systemic treatment options available to them in baseline commissioning. The Panel regarded that as potentially an issue of health equality.
The Panel was concerned that the CDF should not disrupt exisiting treatment pathways in the NHS, particularly where these result from the detailed evidence assessment which informs NICE guidance. As a consequence, the CDF Panel did not approve the retention of Everolimus in the CDF as 2nd line therapy for those patients who were eligible for Axitinib.

The CDF had previously removed the use of Everolimus as 3rd line therapy and this remained the CDF’s position as re-scoring the impact of 3rd line Everolimus even allowing for the progression free survival benefit to be fully translated into overall survival benefit would give 3rd line Everolimus a combined score that was below the threshold for remaining in the Cancer Drugs Fund.

The CDF Panel also considered the clinical scenario in which a patient with renal cancer would not tolerate a 2nd line TKI as a consequence of previous hypertension, hand foot syndrome and bleeding with 1st line therapy. The Panel considered that its assessment and scoring for Everolimus as set out above still applied to this situation and thus for those patients in which 2nd line Axitinib is contra-indicated, use of Everolimus as 2nd line therapy was retained in the CDF.

The CDF Panel also recognised that there would be some patients treated with 2nd line Axitinib who would develop toxicities which would necessitate discontinuation of Axitinib within 3 months of commencing the drug. In these patients, the CDF Panel agreed to exercise its clinical judgement to allow Everolimus use provided that there was no evidence of disease progression in that 3 month treatment period with Axitinib.

In addition, the CDF Panel affirmed its previous decision for 3rd line Everolimus treatment not to be funded from the CDF.

The cost of Everolimus per 4-week cycle at the list price ( including VAT ) for a patient for this indication is 3326 pounds.

Conclusion

The median drug cost of Everolimus as 2nd line treatment for renal cancer after previous treatment with one TKI resulted in this indication scoring a value within the confidential CDF cost scoring system which when combined with the clinical score of 6 resulted in an overall score which represented sufficient value for retention within the CDF but only for those patients in whom either 2nd line Axitinib therapy is contra-indicated or have toxicity which necessitates discontinuation of Axitinib within a period of 3 months of starting Axitinib and at which time there is no evidence of disease progression.

4) nab-Paclitaxel [ Abraxane ]

Nanoparticle albumin bound Paclitaxel as part of 1st line chemotherapy in metastatic adenocarcinoma of the pancreas

The CDF Panel scored the application of nab-Paclitaxel in metastatic pancreatic adenocarcinoma as follows: 0 for progression free survival ( 5.5 vs 3.7 months, delta 1.8 months ); 2 for overall survival ( 8.7 vs 6.6 months, delta 2.1 months ); 0 for QOL; minus 1 for toxicity; 0 for unmet need.
The overall total score was 1B/U1.

The cost of nab-Paclitaxel for a 4-week cycle at the list price ( including VAT ) for a patient of body surface area 1.8m² is 2657 pounds.

Conclusion

The CDF Panel concluded that the clinical benefits of nab-Paclitaxel in metastatic pancreatic adenocarcinoma to be insufficient to merit retention within current CDF funding.

5) Panitumumab [ Vectibix ]

Panitumumab as monotherapy in patients progressing after 2 or more previous lines of chemotherapy for metastatic colorectal cancer in patients with RAS wild type ( non-mutated ) tumours

In terms of the Panitumumab study, the CDF Panel scored the RAS wild type subgroup as follows: 0 for progression free survival ( 3.3 vs 1.6 months, delta 1.7 months ); 0 for overall survival ( no significant difference ); 2 for QOL; minus 1 for toxicity; 0 for unmet need.
It resulted in a total of 1B/U1.

However, given the survival advantage for Cetuximab in a trial without any crossover, the CDF Panel accepted a similar survival advantage for Panitumumab in this setting.
The CDF score for Cetuximab [ Erbitux ] monotherapy as 3rd/4th line treatment would have been 0 for progression free survival, 3 for overall survival, 2 for QOL, minus 1 for toxicity and 0 for unmet need, thus making a score of 4B. It considered that a similar score should be awarded to Panitumumab monotherapy ie 4B.

The cost of Panitumumab per 2-week cycle at the list price ( including VAT ) for a patient of body weight 75kg for this indication is 2276 pounds.

Conclusion

The median drug cost of Panitumumab resulted in this indication scoring a value within the confidential CDF cost scoring system which when combined with the clinical score of 4 resulted in an overall score which was insufficient for the CDF Panel to retain the use of Panitumumab monotherapy as treatment chemotherapy-refractory RAS wild type metastatic colorectal cancer.

6) Radium-223 [ Xofigo ]

Radium-223 in metastatic castrate resistant prostate cancer in patients with symptomatic bone metastases

The CDF scored the impact of Radium-223 in mCRPC patients with bony but not visceral metastases: 0 for progression free survival ( FSSE not accepted as measure of PFS ); 3 for overall survival ( 14.9 vs 11.3 months ); 2 for quality of life; 0 for toxicity; 0 for unmet need.
The CDF overall total score was therefore 5B.

The cost of Radium-223 per 4-week cycle at the list price ( including VAT ) for a patient does not depend on body surface area or weight and for this indication is £ 4848 ( 4-week cycle ).

Conclusion

The median drug cost of Radium-223 resulted in this indication scoring a value within the confidential CDF cost scoring system which when combined with the clinical score of 5 resulted in an overall score which represented insufficient value for retention within the CDF.

The CDF Panel recognised that Radium-223 had a positive NICE recommendation, currently only for those patients previously treated with Docetaxel. It recognised that final NICE guidance is currently scheduled to be issued in early 2016 and thus there could be a short period in between removal from the CDF for all patients and subsequent NICE approval, albeit for a subgroup of the total patient population assessed by the CDF.
The CDF would wish to work with NICE and NHS England in managing this issue once the content of and time frames for the issuing of NICE guidance became clearer.

7) Trastuzumab Emtansine [ Kadcyla ]

Trastuzumab Emtansine as a further line of chemotherapy for HER-2 positive locally advanced or metastatic breast cancer

The CDF Panel’s scores were as follows: 2 for progression free survival ( 9.6 vs 6.8 months, delta 3.2 months ); 4 for overall survival ( 30.9 vs 25.1 months, delta 5.8 months ); 1 for QOL; 1 for toxicity; 0 for unmet need.
It resulted in a total of 8B.

The cost of Trastuzumab emtansine per 3-week cycle at the list price for a patient of body weight 75kg ( including VAT ) is 5908 pounds.

Conclusion

The median drug cost of Trastuzumab emtansine resulted in this indication scoring a value within the confidential CDF cost scoring system which, when combined with the clinical score of 8, resulted in an overall score which represented insufficient value for retention within the CDF. ( Xagena )

Source: NHS, 2015

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