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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). 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.

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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.

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Cialis Generic	2.5mg	20 Pills	40.73€ 38.79€	Buy
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Likelihood mean score: 0, the behaviour will almost never occur; 3, the behaviour is likely to be frequent.

1 Introduction

Clinical impact mean score: 0, there would be no clinical impact; 3, the clinical impact would be high.

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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.

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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.

Dr Philip Ryan Whitman

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. 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).

• Pharmacists can provide guidance on tadalafil use.
• Tadalafil may be contraindicated with certain health conditions.
• Discuss your medical history before buying tadalafil.
• Tadalafil may cause side effects that require medical attention.
• Pregnant or nursing women should avoid tadalafil.
• Elderly patients may need dose adjustments.
• Follow your healthcare provider’s advice closely.

For the other incremental benefits, consensus was not reached but the mean clinical impact ranged from 1.7 to 2.3. 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. 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).

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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. 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). 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.

Q4: What should I do if the 20mg tablet does not give me a strong enough result the first time?

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 tadalafil weekend pill 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.

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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). 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. 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 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).

2 Materials and methods

Take any medicines called nitrates or nitric oxide donors (such as glyceryl trinitrate, isosorbide mononitrate, isosorbide tadalafil weekend pill dinitrate for the relief of chest pain or heart failure, or amyl nitrite also known as “poppers”, nicorandil, molsidomine or sodium nitroprusside).

• Tadalafil works by increasing blood flow to the penis.
• The medication is typically taken 30 minutes before activity.
• Side effects may include headache, flush, or upset stomach.
• Tadalafil should be stored in a cool, dry place away from children.
• Dosage varies depending on individual health needs.
• Tadalafil may interact with certain medications like nitrates.
• Avoid alcohol consumption while using tadalafil.

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). 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. 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.

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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. An additional suggested measure was to add a warning regarding the potential drug-drug interaction with veriziguat which was recently approved for chronic heart failure. The Brass decision analysis tool worked well in terms of achieving the objectives of the meeting. The identification of the incremental benefits and risks and collation of evidence from a diverse range of information sources including clinical trials, real-world studies and patient safety data was helpful in providing an evidence-based foundation to facilitate a comprehensive and rational assessment of the benefit-risk analysis. The Group Delphi technique provided the opportunity for divergent opinions to be frankly discussed and the experiences and expertise of the different specialists to be presented.

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In many cases, this led to narrowing of the range of scores where a second round of voting occurred, thereby gaining or moving towards consensus. The lack of consensus regarding the degree of likelihood and clinical impact of the majority of identified incremental benefits may in part be due to the complex number of factors involved in achieving each benefit. Importantly, the discussion about benefits is hypothetical as there is no PDE5 inhibitor available without prescription in Germany. Data from the UK regarding the experience with Viagra Connect was presented, but this was not felt to be directly applicable because of the differences in healthcare systems.

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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).

• Illegal tadalafil sales can pose health risks.
• Unregulated pills may contain harmful fillers.
• Purchasing from unverified sources is risky.
• Fake tadalafil may cause adverse reactions.
• Always ensure medication authenticity before use.
• Report suspicious sellers to authorities.
• Purchase only from licensed pharmacies for safety.

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.

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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).

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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.

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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. 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.

Country	Sale Allowed	Prescription Required	Online Purchase Allowed	Notable Restrictions
USA	Yes	Yes	Yes	Age over 18 required
Canada	Yes	Yes	Yes	Limited to licensed pharmacies
Germany	Yes	Yes	No	Strict medical oversight
India	Yes	No	Yes	Unregulated market

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.

• Tadalafil sales are influenced by regional drug laws.
• Legal status varies from country to country.
• Online sales may be restricted in some jurisdictions.
• Importing tadalafil without proper authorization may be illegal.
• Always check local regulations before purchase.
• Beware of websites selling tadalafil illegally.
• Compliance ensures safe and legal medication use.

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. 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. An additional suggested measure was to add a warning regarding the potential drug-drug interaction with veriziguat which was recently approved for chronic heart failure. The Brass decision analysis tool worked well in terms of achieving the objectives of the meeting. The identification of the incremental benefits and risks and collation of evidence from a diverse range of information sources including clinical trials, real-world studies and patient safety data was helpful in providing an evidence-based foundation to facilitate a comprehensive and rational assessment of the benefit-risk analysis. The Group Delphi technique provided the opportunity for divergent opinions to be frankly discussed and the experiences and expertise of the different specialists to be presented. In many cases, this led to narrowing of the range of scores where a second round of voting occurred, thereby gaining or moving towards consensus. The lack of consensus regarding the degree of likelihood and clinical impact of the majority of identified incremental benefits may in part be due to the complex number of factors involved in achieving each benefit. Importantly, the discussion about benefits is hypothetical as there is no PDE5 inhibitor available without prescription in Germany. Data from the UK regarding the experience with Viagra Connect was presented, but this was not felt to be directly applicable because of the differences in healthcare systems.