Anyone who follows this site knows I am not a fan of using CER to make coverage decisions and that NICE in general is not a model for any health system. However the NICE decision not to recommend Tarceva as maintenance therapy for non-small cell lung cancer, while still framed in terms of quality adjusted life years is really about biomarkers.
Once you get past the wonk talk about Markov estimates and parametric projection models the key considerations were the following:
"no data for the stable disease subgroup were provided to allow separate consideration of the use of erlotinib in squamous and non-squamous disease. Furthermore, no evidence was provided comparing erlotinib with pemetrexed in patients with non-squamous disease who have stable disease after first-line treatment."
And,
"The Committee discussed whether the SATURN study could be generalised to UK clinical practice and noted that there were few UK patients and a high proportion of patients from Southeast Asia in the study. The Committee noted a comment from the ERG that Asian people are known to respond better to lung cancer treatments than other races. The Committee heard from the clinical specialists that there are no significant reasons why the relative benefit of erlotinib in the SATURN trial would not also be seen in the UK population."
And
"It also heard from clinical specialists that patients with EGFR mutations have a longer natural history of disease and a better prognosis than other patients with non-small-cell lung cancer. The clinical specialists also commented that the small proportion of patients with EGFR mutations in the SATURN trial would be similar to the UK population. The Committee noted that no one in the SATURN trial had received first-line treatment with pemetrexed and cisplatin, which is now becoming a commonly used combination chemotherapy regimen for patients with non-squamous disease. It therefore concluded that there was uncertainty about the clinical benefit of erlotinib in patients who had previously received pemetrexed and cisplatin."
Do I think Tarceva should not have been approved. No. Because it would make more sense to allow reimbursement, encourage biomarker development and contribute to personalized medicine.
But the NICE consultation process reveals a deeper appreciation of the role of biomarkers in evaluating treatment effectiveness than the current bone headed approach being funded by AHRQ.
www.nice.org.uk/guidance/index.jsp
effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/
Once you get past the wonk talk about Markov estimates and parametric projection models the key considerations were the following:
"no data for the stable disease subgroup were provided to allow separate consideration of the use of erlotinib in squamous and non-squamous disease. Furthermore, no evidence was provided comparing erlotinib with pemetrexed in patients with non-squamous disease who have stable disease after first-line treatment."
And,
"The Committee discussed whether the SATURN study could be generalised to UK clinical practice and noted that there were few UK patients and a high proportion of patients from Southeast Asia in the study. The Committee noted a comment from the ERG that Asian people are known to respond better to lung cancer treatments than other races. The Committee heard from the clinical specialists that there are no significant reasons why the relative benefit of erlotinib in the SATURN trial would not also be seen in the UK population."
And
"It also heard from clinical specialists that patients with EGFR mutations have a longer natural history of disease and a better prognosis than other patients with non-small-cell lung cancer. The clinical specialists also commented that the small proportion of patients with EGFR mutations in the SATURN trial would be similar to the UK population. The Committee noted that no one in the SATURN trial had received first-line treatment with pemetrexed and cisplatin, which is now becoming a commonly used combination chemotherapy regimen for patients with non-squamous disease. It therefore concluded that there was uncertainty about the clinical benefit of erlotinib in patients who had previously received pemetrexed and cisplatin."
Do I think Tarceva should not have been approved. No. Because it would make more sense to allow reimbursement, encourage biomarker development and contribute to personalized medicine.
But the NICE consultation process reveals a deeper appreciation of the role of biomarkers in evaluating treatment effectiveness than the current bone headed approach being funded by AHRQ.
www.nice.org.uk/guidance/index.jsp
effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/
