Pembrolizumab (6) – Keytruda®
Squamous cell carcinoma head and neck
Characteristics
| Start date | 15.10.2018 – Marketing authorisation: 04.09.2018 |
|---|---|
| Resolution | 04.04.2019 |
| Limitation date | 01.10.2019 limitation repealed |
| INN | Pembrolizumab |
| Brand name | Keytruda® |
| Pharm. company | MSD SHARP & DOHME GMBH |
| G-BA Procedure ID | D-396 |
| ATC code | L01FF02 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C00.0Malignant neoplasm of lipstick area of upper lip, C00.1Malignant neoplasm of lower lip NOS, C00.2Malignant neoplasm of vermilion border of lip NOS, C00.3Malignant neoplasm of buccal aspect of upper lip, C00.4Malignant neoplasm of buccal aspect of lower lip, C00.5Malignant neoplasm of buccal aspect of lip, unspecified, C00.6Malignant neoplasm of commissure of lip, unspecified, C00.8Malignant neoplasm of overlapping sites of lip, C00.9Malignant neoplasm of lip, unspecified, C01Malignant neoplasm of base of tongue, C02.0Malignant neoplasm of dorsal surface of tongue, C02.1Malignant neoplasm of tip of tongue, C02.2Malignant neoplasm of anterior two-thirds of tongue, ventral surface, C02.3Malignant neoplasm of middle third of tongue NOS, C02.4Malignant neoplasm of lingual tonsil, C02.8Malignant neoplasm of two or more contiguous sites of tongue, C02.9Malignant neoplasm of tongue, unspecified, C03.0Malignant neoplasm of upper gum, C03.1Malignant neoplasm of lower gum, C03.9Malignant neoplasm of gum, unspecified, C04.0Malignant neoplasm of anterior to the premolar-canine junction, C04.1Malignant neoplasm of lateral floor of mouth, C04.8Malignant neoplasm of overlapping sites of floor of mouth, C04.9Malignant neoplasm of floor of mouth, unspecified, C05.0Malignant neoplasm of hard palate, C05.1Malignant neoplasm of soft palate, C05.2Malignant neoplasm of uvula, C05.8Malignant neoplasm of overlapping sites of palate, C05.9Malignant neoplasm of roof of mouth, C06.0Malignant neoplasm of buccal mucosa NOS, C06.1Malignant neoplasm of buccal sulcus (upper) (lower), C06.2Malignant neoplasm of retromolar area, C06.8Malignant neoplasm of overlapping sites of other and unspecified parts of mouth, C06.9Malignant neoplasm of minor salivary gland, unspecified site, C07Malignant neoplasm of parotid gland, C08.0Malignant neoplasm of submaxillary gland, C08.1Malignant neoplasm of sublingual gland, C08.8, C08.9Malignant neoplasm of salivary gland (major) NOS, C09.0Malignant neoplasm of tonsillar fossa, C09.1Malignant neoplasm of tonsillar pillar (anterior) (posterior), C09.8Malignant neoplasm of overlapping sites of tonsil, C09.9Malignant neoplasm of tonsil NOS, C10.0Malignant neoplasm of vallecula, C10.1Malignant neoplasm of anterior surface of epiglottis, C10.2Malignant neoplasm of lateral wall of oropharynx, C10.3Malignant neoplasm of posterior wall of oropharynx, C10.4Malignant neoplasm of branchial cyst [site of neoplasm], C10.8Malignant neoplasm of junctional region of oropharynx, C10.9Malignant neoplasm of oropharynx, unspecified, C11.0Malignant neoplasm of roof of nasopharynx, C11.1Malignant neoplasm of adenoid, C11.2Malignant neoplasm of fossa of Rosenmüller, C11.3Malignant neoplasm of floor of nasopharynx, C11.8Malignant neoplasm of overlapping sites of nasopharynx, C11.9Malignant neoplasm of nasopharyngeal wall NOS, C12Malignant neoplasm of pyriform sinus, C13.0Malignant neoplasm of postcricoid region, C13.1Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect, C13.2Malignant neoplasm of posterior wall of hypopharynx, C13.8Malignant neoplasm of overlapping sites of hypopharynx, C13.9Malignant neoplasm of hypopharyngeal wall NOS, C14.0Malignant neoplasm of pharynx, unspecified, C14.2Malignant neoplasm of Waldeyer´s ring, C14.8Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx, C30.0Malignant neoplasm of nasal cavity, C30.1Malignant neoplasm of middle ear, C31.0Malignant neoplasm of antrum (Highmore) (maxillary), C31.1Malignant neoplasm of ethmoidal sinus, C31.2Malignant neoplasm of frontal sinus, C31.3Malignant neoplasm of sphenoid sinus, C31.8Malignant neoplasm of overlapping sites of accessory sinuses, C31.9Malignant neoplasm of accessory sinus, unspecified, C32.0Malignant neoplasm of intrinsic larynx, C32.1Malignant neoplasm of supraglottis, C32.2Malignant neoplasm of subglottis, C32.3Malignant neoplasm of laryngeal cartilage, C32.8Malignant neoplasm of overlapping sites of larynx, C32.9Malignant neoplasm of larynx, unspecified Show more >> |
| Alpha-ID codes (AIS) | I102135Malignant neoplasm of the anterior part of the tongue n.c, I102313Malignant neoplasm of the tongue at the transition zone, I103335Malignant neoplasm of the anterior surface of the epiglottis, I103467Malignant neoplasm of the junction between the hard and soft palate, I104480Malignant neoplasm of the oral vestibule, I104900Malignant neoplasm of the postcricoid region, I104906Malignant neoplasm of the thyroid cartilage, I105337Malignant neoplasm of the lateral wall of the oropharynx, I105338Malignant neoplasm of the posterior wall of the oropharynx, I105339Malignant neoplasm of the oropharynx, I105738Malignant neoplasm of the inside of the lip, I105739Malignant neoplasm of the lip commissure, I106104Malignant neoplasm of the upper wall of the nasopharynx, I106105Malignant neoplasm of the posterior wall of the nasopharynx, I106106Malignant neoplasm of the lateral wall of the nasopharynx, I106109Malignant neoplasm of the anterior wall of the nasopharynx, I106112Malignant neoplasm of the nasopharynx, I107094Malignant neoplasm of the posterior wall of the hypopharynx, I17123Malignant neoplasm of the tongue, I18831Malignant neoplasm of the lip, I24894Malignant neoplasm of the base of the tongue, I25253Malignant neoplasm of the outer upper lip, I25260Malignant neoplasm of the outer lower lip, I25262Malignant neoplasm of the inner side of the upper lip, I25265Malignant neoplasm of the inside of the lower lip, I25279Malignant neoplasm of the back of the tongue, I25287Malignant neoplasm of the lower surface of the tongue, I25294Malignant neoplasm of the tonsil of the tongue, I25301Malignant neoplasm of the parotid gland, I25307Malignant neoplasm of the submandibular gland, I25313Malignant neoplasm of the sublingual gland, I25320Malignant neoplasm of the gums, I25323Malignant neoplasm of the floor of the mouth, I25324Malignant neoplasm of the buccal mucosa, I25330Malignant neoplasm of the hard palate, I25333Malignant neoplasm of the soft palate, I25336Malignant neoplasm of the uvula, I25381Malignant neoplasm of the tonsils, I25382Malignant neoplasm of the palatal arch, I25385Malignant neoplasm of the piriform recess, I25391Malignant neoplasm of the hypopharynx, I25392Malignant neoplasm of the Waldeyer pharyngeal ring, I25430Malignant neoplasm of the paranasal sinus, I25438Malignant neoplasm of the nasal cavity, I25446Malignant neoplasm of the middle ear, I25450Malignant neoplasm of the maxillary sinus, I25457Malignant neoplasm of the ethmoid sinus, I25463Malignant neoplasm of the frontal sinus, I25467Malignant neoplasm of the sphenoid sinus, I25472Malignant neoplasm of the glottis, I25474Malignant neoplasm of the subglottis, I29848Malignant neoplasm of the edge of the tongue, I29869Malignant neoplasm of the anterior part of the floor of the mouth, I29872Malignant neoplasm of the lateral part of the floor of the mouth, I29875Malignant neoplasm of the palate, I29882Malignant neoplasm of the retromolar region, I29886Oral cancer, I29888Malignant neoplasm of the tonsillar fossa, I29892Malignant neoplasm of the epiglottic vallecula, I29931Malignant neoplasm of the oropharynx, I29998Malignant neoplasm of the larynx, I30003Malignant neoplasm of the supraglottis, I84691Malignant neoplasm of the pharynx, I84747Malignant neoplasm of the red border of the lips, I84771Malignant neoplasm of the lower jaw gums, I84773Malignant neoplasm of the maxillary gums, I84903Malignant neoplasm of a branchiogenic cyst, I84958Malignant neoplasm of large salivary glands, I84962Malignant neoplasm of the transitional region of the oropharynx, I85649Malignant neoplasm of the hypopharyngeal side of the aryepiglottic fold Show more >> |
| DDD | 9.5 mg P |
| Therapeutic area | Oncological diseases Squamous cell carcinoma |
| Reason for procedure | New therapeutic indication |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with PD-L1 expressing tumours (TPS ≥ 50 %) and cancer progression during or after prior platinum-based therapy. | Nivolumab |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (KEYNOTE 040) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 26.03.2019 – nach Dossiereinreichung, Änderung der Therapiestandards |
- Clinical trials
- The pharmaceutical manufacturer submitted data from the open-label, randomised, controlled KEYNOTE 040 trial for the benefit assessment procedure, which compared pembrolizumab with a treatment of the clinician’s choice (selecting from methotrexate, cetuximab or docetaxel).
Adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) with PD-L1-expressing tumours (TPS ≥ 50 per cent) and disease progression during or following prior platinum-based therapy
- The additional benefit is not proven.
- No data are available to enable an assessment of the additional benefit.
- The comparator therapy in the KEYNOTE 040 trial does not correspond to the appropriate comparator therapy (nivolumab) specified in this resolution, which is why the results submitted in the dossier for the benefit assessment, which are intended for direct comparison with the comparator therapy in the KEYNOTE 040 trial, do not allow for an assessment of the additional benefit of pembrolizumab.
- Morbidity – Progression-free survival
- No data are available.
- Health-related quality of life – Health status (EQ-5D VAS)
- No usable data.
- Summary of the assessment
- Nivolumab was identified as the appropriate comparator therapy.
- For the benefit assessment, the pharmaceutical manufacturer has submitted the results of the open-label, randomised, controlled KEYNOTE 040 trial, in which pembrolizumab was compared with a treatment of the clinician’s choice (selecting from methotrexate, cetuximab or docetaxel).
- The comparator therapy in the KEYNOTE 040 study therefore does not correspond to the appropriate comparator therapy (nivolumab) specified in this resolution; consequently, the results submitted do not allow for an assessment of the additional benefit of pembrolizumab.
- Consequently, it is concluded that the additional benefit of pembrolizumab is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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