A UK Epidemic of Testosterone Prescribing
The number of prescription items dispensed for all forms of testosterone preparations in England, Wales and Scotland has increased by nearly 90% from 157 602 to 298 134 prescriptions, between 2001 and 2010.(Fig. 1 panels a & b). The cost of this medication to the NHS showed a remarkable 267% escalation, from £3·2 to £11·7 million over the same period. (Fig. 1, panels c & d). The trend in testosterone prescribing for all three regions is highly congruent, seeing a marked increase in the amount of prescriptions for both transdermal preparations and testosterone undecanoate injection. The rising pattern was most significant for transdermal preparations with a fivefold increase, from 28 247 to 151 676 dispensed items, and a 360% escalation in annual expenditure (£1·46 million–£6·74 million, 2001–2010) (Fig. 2).
(Enlarge Image)
Figure 1.
Quantity and cost of testosterone prescribing in England, Wales and Scotland. Panel a & b: The number of prescription items for all testosterone replacement therapies, from 2001 to 2010. Panel c & d: Net ingredient cost for testosterone replacement, from 2001 to 2010.
(Enlarge Image)
Figure 2.
The number of prescribed items for testosterone replacement according to subtypes in England, Wales and Scotland, 2001–2010.
When transdermal preparation prescriptions were analysed according to their subtypes, a significant sharp rise was observed in testosterone gel since their introduction in 2003, with a 3-fold increase, from 32 300 to 105 300 dispensed items, and 238% escalation in annual expenditure (£1·3 million–£4·54 million; year 2003/2004–2010), as per PCA data in England. On the other hand, the use of some other testosterone preparations, including transdermal patches, mucoadhesive buccal tablets and pellets for subcutaneous implant declined steadily after the introduction of transdermal testosterone gel products.
Of the three currently available testosterone gel products (Testim® [Ferring Pharmaceuticals, West Drayton, UK], Tostran-2%® [ProStrakan, Galashiels, UK] and Testogel® [Bayer Schering, Newbury, Berkshire, UK]), the latter is the most commonly prescribed product, representing 80% of testosterone gel prescribed (2010), constituting 64% of the total expenditure for all types of testosterone in 2010. The overall usage of gels has increased from 32 300–84 900 dispensed items (163%) since the 12-month period following its introduction of the lead product (Testogel®) in 2003.
The PCA data in England also revealed that the use of testosterone undecanoate has been on the rise over the past 10 years, from 31 336 to 65 998 items (111%; 2000–2010). This is solely attributed to the introduction of long-acting testosterone depot injection, Nebido® (Bayer Schering), for which there has been a major rise in prescriptions since its introduction in 2005, with a 365% escalation in dispense items (8 200–38 100; 2005/2006–2010) and a 4·5-fold increase in overall expenditure over the same period (£735 500–£3·29 million). The oral preparation of testosterone undecanoate (Restandol capsule®, Merck Sharp & Dohme Limited, Hoddesdon, Herts, UK) showed a modest fall in the last 10 years (27 400–22 900 items; 2001–2010).
The use of short-acting testosterone injection (testosterone enanthate, testosterone ester and testosterone propionate) has remained relatively stable over the past decade. Sustanon® (Merck Sharp & Dohme Limited) 100 mg (testosterone ester) and Andropatch® (GlaxoSmithKline, Brentford, Middlesex, UK) (transdermal testosterone) have been withdrawn from the UK market since 2010.
Local requests for serum testosterone measurement in men from primary care in the NuTH Biochemistry Department have increased from 347 requests in 2000 to 823 requests in 2010, with a 137% rise (Fig. 3, panel a). However, the number of men with a high likelihood of hypogonadism (testosterone less than 6·0 nm) remained relatively constant at 5·2% in 2000 and 6·3% in 2010. On the other hand, the number of men with total testosterone in the 6–8·9 nm range, where there is greater uncertainty in the diagnosis of hypogonadism, increased by over 2-fold, from 7·51% to 16·99%. (Fig. 3, panel b).
(Enlarge Image)
Figure 3.
Local requests for testosterone level in males at Royal Victoria Infirmary. Panel a. The number of GP requests for testosterone level. Panel b. The trend of serum testosterone level from the local requests.
Results
Analysis of Testosterone Hormone Usage in England (2000–2010), Wales and Scotland (2001–2010)
The number of prescription items dispensed for all forms of testosterone preparations in England, Wales and Scotland has increased by nearly 90% from 157 602 to 298 134 prescriptions, between 2001 and 2010.(Fig. 1 panels a & b). The cost of this medication to the NHS showed a remarkable 267% escalation, from £3·2 to £11·7 million over the same period. (Fig. 1, panels c & d). The trend in testosterone prescribing for all three regions is highly congruent, seeing a marked increase in the amount of prescriptions for both transdermal preparations and testosterone undecanoate injection. The rising pattern was most significant for transdermal preparations with a fivefold increase, from 28 247 to 151 676 dispensed items, and a 360% escalation in annual expenditure (£1·46 million–£6·74 million, 2001–2010) (Fig. 2).
(Enlarge Image)
Figure 1.
Quantity and cost of testosterone prescribing in England, Wales and Scotland. Panel a & b: The number of prescription items for all testosterone replacement therapies, from 2001 to 2010. Panel c & d: Net ingredient cost for testosterone replacement, from 2001 to 2010.
(Enlarge Image)
Figure 2.
The number of prescribed items for testosterone replacement according to subtypes in England, Wales and Scotland, 2001–2010.
When transdermal preparation prescriptions were analysed according to their subtypes, a significant sharp rise was observed in testosterone gel since their introduction in 2003, with a 3-fold increase, from 32 300 to 105 300 dispensed items, and 238% escalation in annual expenditure (£1·3 million–£4·54 million; year 2003/2004–2010), as per PCA data in England. On the other hand, the use of some other testosterone preparations, including transdermal patches, mucoadhesive buccal tablets and pellets for subcutaneous implant declined steadily after the introduction of transdermal testosterone gel products.
Of the three currently available testosterone gel products (Testim® [Ferring Pharmaceuticals, West Drayton, UK], Tostran-2%® [ProStrakan, Galashiels, UK] and Testogel® [Bayer Schering, Newbury, Berkshire, UK]), the latter is the most commonly prescribed product, representing 80% of testosterone gel prescribed (2010), constituting 64% of the total expenditure for all types of testosterone in 2010. The overall usage of gels has increased from 32 300–84 900 dispensed items (163%) since the 12-month period following its introduction of the lead product (Testogel®) in 2003.
The PCA data in England also revealed that the use of testosterone undecanoate has been on the rise over the past 10 years, from 31 336 to 65 998 items (111%; 2000–2010). This is solely attributed to the introduction of long-acting testosterone depot injection, Nebido® (Bayer Schering), for which there has been a major rise in prescriptions since its introduction in 2005, with a 365% escalation in dispense items (8 200–38 100; 2005/2006–2010) and a 4·5-fold increase in overall expenditure over the same period (£735 500–£3·29 million). The oral preparation of testosterone undecanoate (Restandol capsule®, Merck Sharp & Dohme Limited, Hoddesdon, Herts, UK) showed a modest fall in the last 10 years (27 400–22 900 items; 2001–2010).
The use of short-acting testosterone injection (testosterone enanthate, testosterone ester and testosterone propionate) has remained relatively stable over the past decade. Sustanon® (Merck Sharp & Dohme Limited) 100 mg (testosterone ester) and Andropatch® (GlaxoSmithKline, Brentford, Middlesex, UK) (transdermal testosterone) have been withdrawn from the UK market since 2010.
Analysis of Local Community Requests for Serum Total Testosterone Assay in Men, 2000–2010
Local requests for serum testosterone measurement in men from primary care in the NuTH Biochemistry Department have increased from 347 requests in 2000 to 823 requests in 2010, with a 137% rise (Fig. 3, panel a). However, the number of men with a high likelihood of hypogonadism (testosterone less than 6·0 nm) remained relatively constant at 5·2% in 2000 and 6·3% in 2010. On the other hand, the number of men with total testosterone in the 6–8·9 nm range, where there is greater uncertainty in the diagnosis of hypogonadism, increased by over 2-fold, from 7·51% to 16·99%. (Fig. 3, panel b).
(Enlarge Image)
Figure 3.
Local requests for testosterone level in males at Royal Victoria Infirmary. Panel a. The number of GP requests for testosterone level. Panel b. The trend of serum testosterone level from the local requests.
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