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Overall attribute scores ranged from 2.8 to 5.4, with the highest scores for a decrease in barriers to treatment (5.4), less use of counterfeit medicines (5.0), improved psychological wellbeing and increased quality of life (4.0), and increased public awareness and reduced stigmatisation (4.0). There was consensus amongst experts that the risks were low/unlikely to occur and would not have a significant clinical impact.
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Likelihood mean score: 0, the behaviour will almost never occur; 3, the behaviour is likely to be frequent. Clinical impact mean score: 0, there would be no clinical impact; 3, the clinical impact would be high. There was consensus of a moderate to high clinical impact if there were less use of counterfeit medicines (2.5). There was also agreement of a moderate clinical impact from empowering men to self-manage their condition (1.8) and for the economic benefits (1.7). For the other incremental benefits, consensus was not reached but the mean clinical impact ranged from 1.7 to 2.3. The information on the outer carton was considered to sufficiently manage the risks. Consensus was reached on how likely 12 out of 14 incremental risks were to occur and of a low clinical impact for 11 of them (Table 4, shaded boxes).
Strength and substitute
The speaker and Public Health consultant participated in discussions but did not rate the risks and benefits. The meeting was thus chaired and run by the independent group of experts with no input or participation from pharmaceutical companies. The evidence for each incremental benefit and risk domain identified in the literature review for tadalafil is summarised below in Tables 1, 2. Post-marketing safety data are reported using periodic safety update reports (PSUR) and periodic benefit-risk evaluation reports (PBRER) for tadalafil that have been submitted to regulatory authorities by Lilly as required by regulations since the first marketing authorisation for tadalafil on 15 October 2002 up to 15 October 2020. Post-marketing adverse event reports from 84,674,000 patients exposed to Cialis worldwide from 2002 to 2020 (EMTEX, 2021). The overall attribute scores were much lower than for the benefits, ranging from 0.2 to 2.2, with 11 risks scoring 1.0 or less. An increase in drug-drug interactions were deemed unlikely for tadalafil with nitrates due to their low and decreasing usage in Germany (0.8); in 2020, there were 53 million defined daily doses (DDD) of long-acting nitrates prescribed (reduced from 233 million DDDs in 2011), 52 million DDDs of molsidomine and 31 million DDDs of glyceryl trinitrate. In the context of this reducing use, the warning on the package (see below) was considered sufficient mitigation for this risk. IMPORTANT: Do not use if you are taking either of the following two medicines: • Nitrate medicine for chest pain (angina pectoris) or heart failure • Nitrate medicine for chest pain (angina pectoris) or heart failure • Riociguat for high blood pressure in the lungs • Riociguat for high blood pressure in the lungs The warning messages in the PIL are: What you need to know before you take *TM* (*TM* is a placeholder for the approved brand name). Take any medicines called nitrates or nitric oxide donors (such as glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate for the relief of chest pain or heart failure, or amyl nitrite also known as “poppers”, nicorandil, molsidomine or sodium nitroprusside). These are often used for the relief of chest pain (angina pectoris), or heart failure. Using *TM* with any of these medicines may lead to a dangerous fall in blood pressure. If it were to occur, the mean clinical impact score was rated low to moderate (1.7).
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Each incremental benefit was scored in two rounds of ratings, Table 3. Shaded boxes indicate where consensus was reached (all scores within 1 point of each other). According to the second round of scoring, the expert panel considered that all incremental benefits were likely, with the exception of one expert who did not think there would be an increased likelihood of diagnosis of underlying health conditions. Individual scores ranged from low to high with mean likelihood scores of 1.7–2.3 but there was no consensus. D = do not know; Shaded boxes = consensus reached. All experts agreed there was very low likelihood of an increase in drug-drug interaction with doxazosin (0.5) or other alpha-blockers (0.7) and that there would be a minimal clinical impact (0.7) as they are not regularly used in Germany for hypertension.
17.3 Cardiovascular Considerations
Both the likelihood and clinical impact were scored from 0 (none) to 3 (high) or a “do not know” option. Results were fed back to the panel. Where consensus was not achieved, defined as scores more than 1 point apart, further open discussion was initiated. Overall scores were calculated from multiplying the mean likelihood of behaviour or event and the mean clinical impact providing an overall benefit or risk score between 0 and 9. A Public Health consultant provided expertise in relation to the health economic and public health benefits but not for the clinical benefits and risks. In 2020, there were 123 million defined daily doses (DDDs) of alpha blockers used to treat hypertension compared with 2,589 million DDDs of calcium channel blockers and 6,050 million DDDs of ACE inhibitors (Schwabe/Ludwig Hrsg, 2021). Similarly, there was low concern about any increase in interaction with other antihypertensives, with an overall attribute score of 0.4 because of the evidence of extremely few cases of such complications in the post-marketing safety data for 84,674,000 patients who have been exposed to Cialis worldwide from 2002 to 15 October 2020. The expert panel viewed the likelihood of an increase in interaction with riociguat a little higher because of the recent approval for treatment of post thrombotic pulmonary hypertension meaning more men could be at risk. The mean clinical impact score of 1.7 and overall attribute score of 2.2 reflected a moderate level of concern, but being under the care of a specialist and the clear warning messages on the pack (shown above) and in the PIL (see below) were felt to be strong mitigating factors. The warning message in the PIL is: Do not take *TM* if you are taking a medicine called riociguat (or other medicines of a group called guanylate cyclase stimulators), used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs due to blood clots). There was agreement that the likelihood of alcohol interaction occurring more frequently if tadalafil were available without prescription was low, as was the clinical impact with an overall score of 0.6, reflecting the evidence from clinical pharmacology studies that was reviewed by the experts during the meeting. The experts also agreed that men may be more likely to use tadalafil to enhance sexual performance (2.3), but that this would have a low clinical impact (0.7) as there was no evidence to suggest that the risks to health from use to enhance clinical performance would be clinically significant. There were mixed opinions on whether intentional use at a higher dose/frequency would increase, but consensus was that this would have a low clinical impact (0.5) according to the evidence and patient reported experiences. The overall attribute scores reflected consensus of a low likelihood or clinical impact of increased use in men with severe renal or hepatic disease (0.7), failure to read/understand safety information for men unfit to have sex due to cardiovascular disease (CVD) (1.0), use with “poppers” (1.0), use in women (0.2) or accidental ingestion by children (0.4). All considerations of the low clinical impact were based on evidence from published studies and 18 years of post-marketing safety data for patients exposed to Cialis worldwide that were reviewed by the experts in the meeting. Finally, there were differing views on the likelihood (1.0) and clinical impact (0.8) of delayed diagnosis of CVD and other underlying conditions. If ED were the only early symptom of CVD, it was felt to be unlikely that a man would arrange to see a cardiologist, therefore taking tadalafil would not delay a diagnosis of CVD. However, self-treating ED may reduce the likelihood of seeing an urologist and so could lead to a delay in diagnosis of an underlying urological condition. On balance, the overall attribute of this scenario was scored low (0.7). If tadalafil were to be reclassified to non-prescription status in Germany, training would be provided to pharmacists highlighting the contraindications, potential drug-drug interactions and conditions where men should first consult their physician. Messages on the carton and patient information leaflet (PIL) would include contraindications, safety information, dosage and side effects. These messages have been tested in men in three separate studies to ensure comprehension.
Bottom line
The Brass value tree and evidence for each incremental benefit and risk were circulated to an expert clinical panel prior to the consensus meeting. The expert panel comprised four urologists, one of whom chaired the meeting, a cardiologist, a pharmacist, and the speaker was a clinical pharmacologist. This mix of specialties ensured that different important perspectives could be captured with the necessary clinical expertise to critically review the evidence, identify any additional benefits and risks, and understand the clinical impact of making a PDE5 inhibitor for the treatment of ED available without prescription. The objective of the meeting was to achieve an expert consensus on the benefits and risks; hence a Group Delphi technique was utilised. The speaker presented the evidence, it was discussed, and then the panel gave independent ratings on the likelihood and clinical impact of each incremental benefit and risk (Okoli and Pawlowski, 2004; Brass et al., 2013). The expert panel felt that these measures were appropriate and sufficient to mitigate against the identified incremental risks and that the results of the studies demonstrated that the information was sufficiently well understood and that consumers would make appropriate self-selection decisions.