Afatinib in advanced squamous cell carcinoma of the lung: Added benefit not proven

August 18, 2016, Institute for Quality and Efficiency in Health Care

Afatinib (trade name: Giotrif) has been approved since April 2016 for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) of squamous histology who have already received chemotherapy. In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether in these patients this drug offers advantages over the appropriate comparator therapy. According to the findings, an added benefit of afatinib for these patients is not proven.

Requirements for comparator therapy not met

The Federal Joint Committee (G-BA) specified docetaxel or - if no further chemotherapy is indicated for the patients - best supportive care as appropriate . The drug presented no data for this second research question.

For the first research question - i.e. patients who can receive further chemotherapy - the manufacturer cited the study LUX-Lung 8. In this study, however, afatinib was not compared with docetaxel, but with erlotinib. The manufacturer did not sufficiently justify the therapeutic equivalence of these two drugs in the treatment of with . IQWiG therefore concluded that there was no comparison with the appropriate comparator therapy that could be assessed.

Indirect comparison without informative value

In addition, the manufacturer conducted an indirect comparison with erlotinib as common comparator, using the LUX-Lung 8 study on the afatinib side, and the TAILOR study on the docetaxel side. However, the manufacturer did not attempt to derive an added benefit from this comparison. The information on study design and on the participants in the TAILOR study was actually inadequate to assess whether both studies were sufficiently similar. In addition, the dosage of did not exactly comply with the Summary of Product Characteristics, and only results on overall survival were reported under patient-relevant outcomes.

Hence also from the indirect comparison no conclusion on advantages or disadvantages of afatinib could be derived. IQWiG therefore concluded that an added benefit of afatinib in with the appropriate comparator therapy is not proven.

G-BA decides on the extent of added benefit

The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.

An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the Website gesundheitsinformation.de, published by IQWiG, provides easily understandable German-language information.

More English-language information will be available soon (Sections 2.1 to 2.5 of the dossier assessment as well as subsequently published health information on informedhealth.org).

Explore further: Secukinumab in ankylosing spondylitis or psoriatic arthritis: Added benefit not proven

More information: www.iqwig.de/download/A16-22_A … ertung-35a-SGB-V.pdf

Related Stories

Secukinumab in ankylosing spondylitis or psoriatic arthritis: Added benefit not proven

March 18, 2016
Secukinumab (trade name: Cosentyx) has been approved since November 2015 for adults with active ankylosing spondylitis or psoriatic arthritis. For patients with plaque psoriasis, the drug already underwent an early benefit ...

Ospemifene in vulvovaginal atrophy: Added benefit not proven

August 10, 2016
Ospemifene (tradename: Senshio) is approved for the treatment of moderate to severe symptomatic vulvovaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy. The drug has ...

Idelalisib in second-line treatment for CLL: Added benefit again not proven

July 6, 2016
Already in 2014, the German Institute for Quality and Efficiency in Health Care (IQWiG) examined in an early benefit assessment whether idelalisib offers advantages over the appropriate comparator therapy for patients with ...

Mepolizumab in severe asthma: Added benefit not proven

May 2, 2016
The monoclonal antibody mepolizumab has been approved since the end of 2015 for the treatment of adults with severe refractory eosinophilic asthma. The German Institute for Quality and Efficiency in Health Care (IQWiG) now ...

Necitumumab in NSCLC: Indication of minor added benefit for patients with metastases

July 5, 2016
The monoclonal antibody necitumumab has been approved since February 2016 for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing non-small cell lung cancer (NSCLC) ...

Osimertinib in lung cancer: Added benefit not proven

June 20, 2016
Osimertinib has been approved since February 2016 for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). ...

Recommended for you

Study: What patients really think about opioid vs non-opioid medications for chronic pain

August 14, 2018
Prescriptions of opioids for chronic pain has increased dramatically since the 1990s in spite of their known harms. Despite a shortage of scientific studies on the long-term effectiveness of opioids such as morphine, oxycodone ...

Doctors nudged by overdose letter prescribe fewer opioids

August 9, 2018
In a novel experiment, doctors got a letter from the medical examiner's office telling them of their patient's fatal overdose. The response: They started prescribing fewer opioids.

Unwise opioids for wisdom teeth: Study shows link to long-term use in teens and young adults

August 7, 2018
Getting wisdom teeth removed may be a rite of passage for many teens and young adults, but the opioid painkiller prescriptions that many of them receive could set them on a path to long-term opioid use, a new study finds.

Benzodiazepine and related drug prescriptions have increased among young people in Sweden

August 7, 2018
The prevalence rate of prescriptions for benzodiazepines and benzodiazepine-related drugs (BZD)—medications used to treat anxiety, insomnia, epilepsy and other neuropsychiatric conditions—increased by 22% between 2006 ...

Behavioral nudges lead to striking drop in prescriptions of potent antipsychotic

August 1, 2018
A study led by Columbia University's Mailman School of Public Health has found that letters targeting high prescribers of Seroquel (quetiapine), an antipsychotic with potentially harmful side effects in the elderly, significantly ...

US opioid use not declined, despite focus on abuse and awareness of risk

August 1, 2018
Use of prescription opioids in the United States has not substantially declined over the last decade, despite increased attention to opioid abuse and awareness of their risks, finds a study published by The BMJ today.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.