The Institute for Quality and Efficiency in Health Care (IQWiG) has published a comprehensive evaluation of pharmacological therapy for smoking cessation in people with severe tobacco dependence. The paper shows clear evidence supporting the efficacy of varenicline and nicotine, while the advantages of bupropion, cytisine, and combination therapy are uncertain due to a lack of data.

Germany's Federal Joint Committee (G-BA), as part of the German statutory health insurance (SHI), commissioned the investigation to compare the efficacy of four approved medications with no drug therapy. The data highlight the benefits of varenicline and nicotine, despite their accompanying adverse effects, for long-term smoking cessation.

Participants who used varenicline or nicotine in combination with non-drug supportive interventions were considerably more likely to remain smoke-free after six months than those who did not use drugs. After 12 months, varenicline abstinence rates remained high, demonstrating its efficacy.

Neuropsychiatric symptoms like sleep disruptions, irritability, and headaches were among the observed adverse effects of varenicline, while nicotine usage was associated with nausea, throat discomfort, and skin itching. IQWiG confirmed the overall effectiveness of these treatments, despite their limitations.

"The evidence demonstrates that the severity of tobacco dependence does not influence the effectiveness of varenicline or nicotine," according to the study.

In contrast, IQWiG discovered no conclusive evidence supporting the efficacy of bupropion, cytisine, or pharmacological combination therapy for severe tobacco dependency. Requests to manufacturers and research authors for unpublished data produced no findings, restricting the breadth of analysis.

Combination therapy studies often employed bupropion in conjunction with nicotine or varenicline. However, the absence of evidence for bupropion precludes drawing meaningful inferences regarding the benefits of these combos.

The lack of data also precludes subgroup analysis of the intensity of dependence for these medicines. This omission has made it unclear if bupropion and cytisine are effective for smokers with severe dependence.

The German Act on the Further Development of Health Care (GVWG) allows smokers with severe tobacco dependency to receive one-time medication therapy as part of evidence-based cessation programs. The "severe dependence" criteria are based on the Fagerström Test for Nicotine Dependency (FTND) or other classification systems.

However, during public consultations on the report, this legal framework faced criticism. Some stakeholders advocated for a less restrictive interpretation, similar to the approach taken for other addictions, such as alcoholism. Despite these issues, IQWiG followed its legal mission and differentiated between severe and less severe dependence in its assessment.

The G-BA, which is in charge of choosing which pharmaceuticals are eligible for reimbursement under SHI, must now decide on the findings. The group will also establish defined criteria for identifying severe tobacco dependency to help guide reimbursement choices.

The IQWiG report emphasizes the need for evidence-based techniques when treating severe tobacco dependence.  By validating the benefits of varenicline and nicotine, it provides a solid platform for public health measures to reduce smoking-related morbidity and mortality.

However, the lack of evidence for alternative treatments underscores a critical research gap that requires attention to ensure comprehensive care for all smokers. The G-BA's ultimate conclusions will determine the accessibility of these medicines and their involvement in Germany's smoking cessation efforts.