MHRA — authorised 17 July 2015
- Marketing authorisation holder: Merck Sharp & Dohme Limited
- Status: approved
🇬🇧 Keytruda in United Kingdom
MHRA authorised Keytruda on 17 July 2015 · NICE has issued 34 UK HTA decisions
Marketing authorisation
Health technology assessment
34 decisions from NICE for Keytruda in United Kingdom.
NICE TA1145 — — Decision pending classification
- Indication assessed: neoadjuvant and adjuvant treatment of resectable locally advanced head and neck squamous cell carcinoma
NICE has recommended Keytruda for the neoadjuvant and adjuvant treatment of resectable locally advanced head and neck squamous cell carcinoma. This decision was made based on a commercial arrangement. No restriction or condition was applied to the recommendation.
NICE TA1125 — — Appraisal terminated
- Indication assessed: untreated unresectable advanced malignant pleural mesothelioma (terminated appraisal)
NICE made a decision to terminate the appraisal of Keytruda for the treatment of untreated unresectable advanced malignant pleural mesothelioma. This decision means that NICE will not make a recommendation on the use of Keytruda for this indication. The decision to terminate was made without a recommendation on the cost-effectiveness of Keytruda, as no cost-effectiveness analysis was reported.
NICE TA1097 — — Decision pending classification
- Indication assessed: untreated unresectable or metastatic urothelial cancer when platinum-based chemotherapy is suitable
NICE recommended Keytruda for the treatment of untreated unresectable or metastatic urothelial cancer in the UK. This decision was made for patients when platinum-based chemotherapy is suitable. The recommendation was based on a commercial arrangement.
NICE TA1092 — — Decision pending classification
- Indication assessed: untreated primary advanced or recurrent endometrial cancer
NICE has recommended Keytruda for the treatment of untreated primary advanced or recurrent endometrial cancer. This decision was made based on a commercial arrangement. The guidance does not mention any restrictions or conditions for the use of Keytruda in this indication.
NICE TA1037 — ✓ Recommended
- Indication assessed: adjuvant treatment of resected non-small-cell lung cancer
NICE recommended Keytruda for the adjuvant treatment of resected non-small-cell lung cancer. This decision was made based on a commercial arrangement, indicating a negotiated price with the manufacturer. There were no restrictions or conditions placed on the use of Keytruda for this indication.
NICE TA1017 — ✓ Recommended
- Indication assessed: treating resectable non-small-cell lung cancer
NICE recommended Keytruda for treating resectable non-small-cell lung cancer. This decision was made based on a commercial arrangement, indicating a negotiated price with the manufacturer. No restrictions or conditions were placed on the use of Keytruda for this indication.
NICE TA997 — ✓ Recommended
- Indication assessed: untreated advanced HER2-negative gastric or gastro-oesophageal junction adenocarcinoma
NICE recommended Keytruda for the treatment of untreated advanced HER2-negative gastric or gastro-oesophageal junction adenocarcinoma. This decision was made based on a commercial arrangement, indicating that the manufacturer agreed to a specific price or reimbursement terms. There were no restrictions or conditions placed on the use of Keytruda for this indication.
NICE TA737 — ✓ Recommended
- Indication assessed: untreated advanced oesophageal and gastro-oesophageal junction cancer
NICE recommended Keytruda for the treatment of untreated advanced oesophageal and gastro-oesophageal junction cancer. This decision was made based on a commercial arrangement, indicating a negotiated price agreed upon by the manufacturer and the NHS. No restrictions were placed on the use of Keytruda for this indication.
NICE TA983 — ✗ Not recommended
- Indication assessed: untreated locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma
NICE did not recommend Keytruda for the treatment of untreated locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma. This decision was made without a reported cost-effectiveness analysis. No commercial arrangement or Patient Access Scheme was considered.
NICE TA540 — ✗ Not recommended
- Indication assessed: treating relapsed or refractory classical Hodgkin lymphoma
NICE made a decision not to recommend Keytruda for treating relapsed or refractory classical Hodgkin lymphoma. This decision was made without a reported cost-effectiveness analysis. No patient access scheme or commercial arrangement was considered.
NICE TA967 — ✓ Recommended
- Indication assessed: treating relapsed or refractory classical Hodgkin lymphoma in people 3 years and over
NICE has recommended Keytruda for treating relapsed or refractory classical Hodgkin lymphoma in people 3 years and over. This decision was made based on the drug's effectiveness and safety profile. The cost of Keytruda was considered in the decision-making process, but the exact cost-effectiveness analysis is not reported. A commercial arrangement was in place for the drug.
NICE TA966 — — Appraisal terminated
- Indication assessed: untreated advanced biliary tract cancer (terminated appraisal)
NICE made a decision to terminate the appraisal of Keytruda for the treatment of untreated advanced biliary tract cancer. This decision means that NICE will not make a recommendation on the use of Keytruda for this indication. The decision was made without a cost-effectiveness assessment, as the appraisal was terminated.
NICE TA939 — ✓ Recommended
- Indication assessed: persistent, recurrent or metastatic cervical cancer
NICE recommended Keytruda for the treatment of persistent, recurrent or metastatic cervical cancer. This decision was made based on a commercial arrangement. No restriction or condition was placed on the use of Keytruda for this indication.
NICE TA914 — ✓ Recommended
- Indication assessed: previously treated endometrial, biliary, colorectal, gastric or small intestine cancer with high microsatellite instability or mismatch repair deficiency
NICE recommended Keytruda for the treatment of previously treated endometrial, biliary, colorectal, gastric or small intestine cancer with high microsatellite instability or mismatch repair deficiency. This decision was made based on a commercial arrangement. No restriction or condition was applied to the recommendation.
NICE TA904 — ✓ Recommended
- Indication assessed: previously treated advanced or recurrent endometrial cancer
NICE recommended Keytruda for the treatment of previously treated advanced or recurrent endometrial cancer. This decision was made based on a commercial arrangement and a Patient Access Scheme. No restrictions were placed on the use of Keytruda for this indication.
NICE TA858 — ✗ Not recommended
- Indication assessed: untreated advanced renal cell carcinoma
NICE did not recommend Keytruda for the treatment of untreated advanced renal cell carcinoma. This decision was made despite the presence of a Patient Access Scheme and a commercial arrangement. The decision date and ICER are not reported.
NICE TA851 — ✓ Recommended
- Indication assessed: neoadjuvant and adjuvant treatment of triple-negative early or locally advanced breast cancer
NICE recommended Keytruda for the neoadjuvant and adjuvant treatment of triple-negative early or locally advanced breast cancer. This decision was made based on a commercial arrangement. No restriction or condition was applied to the recommendation.
NICE TA837 — ✓ Recommended
- Indication assessed: adjuvant treatment of resected stage 2B or 2C melanoma
NICE recommended Keytruda for the adjuvant treatment of resected stage 2B or 2C melanoma. This decision was made based on a commercial arrangement. No restriction or condition was placed on the use of Keytruda for this indication.
NICE TA830 — ✓ Recommended
- Indication assessed: adjuvant treatment of renal cell carcinoma
NICE recommended Keytruda for the adjuvant treatment of renal cell carcinoma. This decision was made based on a commercial arrangement. No restriction or condition was placed on the use of Keytruda.
NICE TA801 — ✓ Recommended
- Indication assessed: untreated, triple-negative, locally recurrent unresectable or metastatic breast cancer
NICE recommended Keytruda for the treatment of untreated, triple-negative, locally recurrent unresectable or metastatic breast cancer. This decision was made based on a commercial arrangement. No restriction or condition was placed on the use of Keytruda for this indication.
NICE TA772 — ✓ Recommended
- Indication assessed: treating relapsed or refractory classical Hodgkin lymphoma after stem cell transplant or at least 2 previous therapies
NICE recommended Keytruda for treating relapsed or refractory classical Hodgkin lymphoma after stem cell transplant or at least 2 previous therapies. This decision was made based on a commercial arrangement, indicating a negotiated price with the manufacturer. No restrictions or conditions were applied to the recommendation.
NICE TA770 — ✓ Recommended
- Indication assessed: untreated metastatic squamous non-small-cell lung cancer
NICE recommended Keytruda for the treatment of untreated metastatic squamous non-small-cell lung cancer. This decision was made based on a commercial arrangement. No restriction or condition was applied to the recommendation.
NICE TA692 — ✗ Not recommended
- Indication assessed: treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy
NICE did not recommend Keytruda for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy. This decision was made without a reported cost-effectiveness analysis. No patient access scheme or commercial arrangement was considered.
NICE TA683 — ✓ Recommended
- Indication assessed: untreated, metastatic, non-squamous non-small-cell lung cancer
NICE recommended Keytruda for the treatment of untreated, metastatic, non-squamous non-small-cell lung cancer. This decision was made based on a commercial arrangement. No restriction or condition was placed on the use of Keytruda.
NICE TA674 — — Appraisal terminated
- Indication assessed: untreated PD-L1-positive, locally advanced or metastatic urothelial cancer when cisplatin is unsuitable (terminated appraisal)
NICE made a decision to terminate the appraisal of Keytruda for the treatment of untreated PD-L1-positive, locally advanced or metastatic urothelial cancer when cisplatin is unsuitable. This decision means that NICE will not make a recommendation on the use of Keytruda for this indication. The cost basis of this decision is not reported.
NICE TA570 — — Appraisal terminated
- Indication assessed: treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy (terminated appraisal)
NICE made a decision to terminate the appraisal of Keytruda for treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy. This decision means that NICE will not make a recommendation on the use of Keytruda for this indication. The cost basis of this decision is not reported.
NICE TA366 — ✓ Recommended
- Indication assessed: advanced melanoma not previously treated with ipilimumab
NICE recommended Keytruda for the treatment of advanced melanoma in patients who have not received ipilimumab. This decision was made based on the drug's clinical effectiveness and cost. A commercial arrangement was in place, but no Patient Access Scheme was negotiated.
NICE TA428 — ✓ Recommended
- Indication assessed: treating PD-L1-positive non-small-cell lung cancer after chemotherapy
NICE recommended Keytruda for treating PD-L1-positive non-small-cell lung cancer after chemotherapy. This decision was made based on the drug's effectiveness in improving patient outcomes. The cost of Keytruda was considered in the decision-making process, but the exact cost basis is not reported.
NICE TA357 — ✓ Recommended
- Indication assessed: treating advanced melanoma after disease progression with ipilimumab
NICE recommended Keytruda for treating advanced melanoma after disease progression with ipilimumab. This decision was made based on the drug's clinical effectiveness and cost. A commercial arrangement was in place, but no Patient Access Scheme was available.
NICE TA766 — ✓ Recommended
- Indication assessed: adjuvant treatment of completely resected stage 3 melanoma
NICE recommended Keytruda for the adjuvant treatment of completely resected stage 3 melanoma. This decision was made based on a Patient Access Scheme and a commercial arrangement. No restrictions were placed on the use of Keytruda for this indication.
NICE TA709 — ✓ Recommended
- Indication assessed: untreated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency
NICE recommended Keytruda for the treatment of untreated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency. This decision was made based on a commercial arrangement. No restriction or condition was applied to the recommendation.
NICE TA661 — ✗ Not recommended
- Indication assessed: untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma
NICE made a decision not to recommend Keytruda for the treatment of untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma. This decision was made based on the available evidence and the cost of the treatment. The exact cost-effectiveness analysis is not reported in the provided facts.
NICE TA650 — ✗ Not recommended
- Indication assessed: untreated advanced renal cell carcinoma
NICE made a decision not to recommend Keytruda for the treatment of untreated advanced renal cell carcinoma. This decision was made without a reported cost-effectiveness analysis or a patient access scheme. No commercial arrangement was considered.
NICE TA531 — ✓ Recommended
- Indication assessed: untreated PD-L1-positive metastatic non-small-cell lung cancer
NICE recommended Keytruda for the treatment of untreated PD-L1-positive metastatic non-small-cell lung cancer. This decision was made based on a commercial arrangement, indicating a negotiated price with the manufacturer. No restrictions or conditions were placed on the use of Keytruda for this indication.
Keytruda in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United Kingdom
Frequently asked questions
Is Keytruda approved in United Kingdom?
Yes. MHRA authorised it on 17 July 2015.
Who is the marketing authorisation holder for Keytruda in United Kingdom?
Merck Sharp & Dohme Limited holds the UK marketing authorisation.
Has Keytruda been assessed by UK health technology agencies?
Yes — 34 UK HTA decisions on record from NICE.