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New HTA Decisions in France
December 2021
Drug name
PEMETREXED SUN (pemetrexed)
Company
Sun Pharma
Decision date
03/11/2021
Therapeutic area
Cancer
Therapeutic sub area
Lung cancer
Official notice date
07/12/2021
Reimbursement %
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
PEMETREXED SUN, in combination with cisplatin, is indicated for the treatment of patients with unresectable malignant pleural mesothelioma who have not received previous chemotherapy.
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
PEMETREXED SUN, in combination with cisplatin, is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, provided the histology is not predominantly squamous.
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
PEMETREXED SUN is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer in patients whose disease has not progressed immediately following platinum-based chemotherapy, provided the histology is not predominantly squamous.
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
PEMETREXED SUN is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, as long as the histology is not predominantly squamous.
Decision Type
New technology assessment
Summary
Considering the conditions are life-threatening, the good benefit-risk profile of PEMETREXED SUN, the lack of alternatives available in the treatment of malignant pleural mesothelioma, the alternatives available in the treatment of NSCLC, the place of PEMETREXED SUN in the therapeutic strategies, and the unlikely impact of PEMETREXED SUN on public health, the committee considered the actual benefit of PEMETREXED SUN to be ‘important’ in the indications of the Marketing Authorisation. PEMETREXED SUN is a hybrid drug and therefore provides no improvement in actual benefit (ASMR V) in these indications. It was concluded that the target populations for PEMETREXED SUN were unlikely to be different from those estimated for the reference specialty ALIMTA® in the committee’s assessments dated 20 April 2016 (malignant pleural mesothelioma: 941 to 1,073 cases per year) and 25 May 2016 (NSCLC 1st line: 10,080 to 10,750 cases per year; NSCLC 2nd line: 3,882 to 4,150 cases per year; NSCLC maintenance: 5,745 to 6,127 cases per year).