RE: in other words12 Feb 2019 16:05
all you have to remember is .......... "current Standard of Care" .............. we have "Synergy with it"i
Pembrolizumab is available at a cost of £1,315.00
per 50 mg vial (excluding VAT; British national
formulary online, accessed March 2017).
The pricing arrangement considered during guidance
development was that the company had agreed a
patient access scheme with the Department of
Health. This scheme would provide a simple discount
to the list price of pembrolizumab with the discount
applied at the point of purchase or invoice. The level
of the discount is commercial in confidence. The
Department of Health considered that this patient
access scheme would not constitute an excessive
administrative burden on the NHS.
The committee was aware that the median overall survival was not
reached in KEYNOTE-024. There were 44 and 64 deaths in the
pembrolizumab and standard care arms respectively. The committee
noted that both the intention-to-treat results (hazard ratio [HR] 0.60; 95%
confidence interval (CI) 0.41 to 0.89) and the crossover adjusted results
(HR 0.50; 95% CI 0.34 to 0.76) suggested a statistically significant
survival benefit for pembrolizumab compared with standard care. This
was confirmed by the updated 19-month median follow-up intention-totreat overall survival results which the company presented during
consultation (the results were submitted as academic in confidence). The
committee concluded that based on the trial data, pembrolizumab had an
important extension-to-life benefit for people with untreated metastatic
PD-L1-positive NSCLC compared with standard care.
What Pembrolizumab Is Used For:
Treatment of recurrent or metastatic cervical cancer in patients whose tumors express PD-L1 (combined positive score [CPS] = 1), as determined by an approved test, and with disease progression on or after chemotherapy.
Treatment of recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients whose tumors express PD-L1 (CPS = 1), as determined by an approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy, and if appropriate, HER2/neu-targeted therapy.
"For the treatment of unresectable or metastatic melanoma."
Patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy.
For treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
Treatment of primary mediastinal large B-cell lymphoma (PMBCL) in adult or pediatric patients with refractory disease ow ho have relapsed after 2 or more prior lines of therapy.
For treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who h
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