Pfizer's "responsible pricing" allows NICE to back use of Vizimpro as first-line treatment in NSCLC, but AstraZeneca's Tagrisso loses out

The National Institute for Health and Care Excellence published final guidance Friday recommending NHS reimbursement of Pfizer's Vizimpro (dacomitinib) as a first-line treatment option for adults with locally advanced or metastatic non-small-cell lung cancer (NSCLC), who have tested positive for the EGFR mutation. The regulator's previous decision deemed that the once-daily tyrosine kinase inhibitor, which was approved in Europe in April, was not a cost-effective use of NHS resources.

NICE also published guidance on Friday recommending against use of AstraZeneca's Tagrisso (osimertinib) for the same patient population because the cost-effectiveness estimates were above what it normally considers an acceptable use of NHS resources. AstraZeneca said it will appeal the decision, with CEO Pascal Soriot saying "it is time for a comprehensive review of how NICE values innovative medicines."

Commenting on the backing of Vizimpro, Meindert Boysen, director of NICE's Centre for Health Technology Evaluation, remarked "responsible pricing by the company has allowed our committee to reconsider their initial decision." Vizimpro carries a list price of £2703 ($3394) for a 30-day supply, although NICE noted that Pfizer has agreed an undisclosed discount patient access scheme for the drug.

According to NICE, studies have shown that people who took Vizimpro had longer overall survival than those who took AstraZeneca's Iressa (gefitinib), with rates of 34.1 months and 26.8 months, respectively. Meanwhile, Vizimpro also increased the length of time before the disease worsened by 14.7 months, compared to 9.2 months for Iressa, although Pfizer's drug had a higher incidence of side effects.

NICE noted that results from the Phase III FLAURA study showed that first-line treatment with Tagrisso in adults with locally advanced or metastatic NSCLC who have activating EGFR mutations was linked to a median progression-free survival of 18.9 months, versus 10.2 months for Roche and Astellas' Tarceva (erlotinib) and Iressa. However, the regulator's appraisal committee reaffirmed an earlier conclusion that the trial did not provide enough evidence to be confident that the EGFR tyrosine kinase inhibitor offers value for money to the NHS, whilst also noting that the drug does not meet criteria to be considered a life-extending treatment at the end of life (EoL).

In response, Soriot said "NHS data show that the patients in England who would be eligible for first-line treatment with our medicine have very low survival rates and therefore Tagrisso should qualify for end-of-life consideration to evaluate cost-effectiveness." AstraZeneca suggested that if EoL status was granted, it has demonstrated that the drug would be considered a cost-effective use of NHS resources.

Tagrisso gained European approval in this indication in July last year and carries a list price of £5770 ($7242) for a 30-day supply. NICE noted that AstraZeneca has a commercial arrangement which would have applied if the drug had been recommended. The therapy is currently available through the UK's Cancer Drugs Fund as a second-line option for people with advanced NSCLC whose disease is EGFR T790M mutation-positive.

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