Re: Glucocorticoid replacement
The current price of hydrocortisone in the UK is a regulatory issue not a clinical one. Members of the Addison’s Disease Self-Help Group who are resident in France pay €3.20 for a packet of 25 x 10mg hydrocortisone tablets manufactured by Sanofi Aventis, or 13 cents per tablet. The comparable UK product costs £1.95 per tablet. Why does the MHRA not allow the Sanofi Aventis product to be imported?
In early 2010 – in the absence of the regulatory price controls applying to branded drugs – the monopoly UK supplier of hydrocortisone radically inflated the price of generic hydrocortisone, from less than 2 pence a tablet, to £1.48. (1) Over the next 3 years the price was increased to reach its current £1.95 per 10mg tablet. (2)
This monopolistic pricing made the longer-acting steroids appear more attractive on cost grounds, as these are still priced at around 3 pence a tablet. However, other long-term costs, such as more frequent monitoring for – and treatment of – bone loss and hyperglycaemia, should be factored into the cost-benefit analysis of these apparently cheaper drug options.(3) Arguably, it could be seen as unethical to expose patients to these avoidable risks, when hydrocortisone has a better safety profile.
In any case, the cost of replacement steroid drugs will be less, over the lifetime of most adrenal patients, than the cost of their emergency medical care during episodes of adrenal crisis.(4) If endocrinologists are seeking to reduce the lifetime costs of patient care, then a more systematic approach to steroid education, for prevention and self-treatment of adrenal emergencies, would be a good place to start. Promising programmes of group education are now being developed in some centres, led by specialist endocrine nurses.(5,6,7) These deserve wider encouragement.
If the Department of Health wishes to reduce the lifetime costs of patient medication, then a rethink of the current market-led approach to generic pricing is overdue. It is unfair to expect patients to bear the burden of monopoly pricing behavior when pricing solutions could be rapidly achieved, by opening up the UK market to new suppliers from within the EU.
Hydrocortisone is bioidentical to the natural human hormone, cortisol. It is rapidly absorbed and activated in the bloodstream, making it the drug of choice for emergency parenteral treatment of adrenal crisis, anaphylaxis or acute asthma, as well the best available treatment for oral steroid replacement therapy.(8,9)
Katherine G White (Chair)
Alison Mainwaring, (nursing awareness coordinator)
Frances Hambidge (member support, forum moderator)
Addison’s Disease Self-Help Group
1. Hydrocortisone price rise – and how, Addison’s Disease Self-Help Group Newsletter 101, Sept 2010.
2. Pharmaceutical Services Negotiating Committee, July price concessions, (further update) July 2014, http://psnc.org.uk/our-news/july-price-concessions-further-update/
3. Koetz KR, Ventz M, Diederich S, Quinkler M. Bone mineral density is not significantly reduced in adult patients on low-dose glucocorticoid replacement therapy. J Clin Endocrinol Metab 2012;97:85-92
4. White K, Arlt W, Adrenal crisis in treated Addison's disease: a predictable but under-managed event, Eur J Endocrinol. 2010 Jan;162(1):115-20. doi: 10.1530/EJE-09-0559
5. Munday J, Chong L, Kar P, Group education improves patient confidence in managing steroid sick day rules, Endocrine Abstracts (2010) 21 P331
6. Saeed M, Aung T, MacDonald J, Wass JAH & Karavitaki N, Steroid Replacement Education: Impact on Patients and their Carers, Endocrine Abstracts (2011) 25 P286
7. Julie Andrew, Sophie May & Robert Murray, Adequacy of documented evidence of education in glucocorticoid deficient patients and subsequent nurse-led initiatives, Endocrine Abstracts (2012) 28 P15
8. Wass JAH, Howlett T, Arlt W, Pearce S, Monson J, Caring for the Addison’s patient: information for GPs, Addison’s Clinical Advisory Panel, Addison’s Disease Self-Help Group March 2013, http://www.addisons.org.uk/comms/publications/gpaddisonsleaflet.pdf
9. Husebye ES, Allolio B, Arlt W, Badenhoop K, Bensing S, Betterle C et al, Consensus statement on the diagnosis, treatment and follow-up of patients with primary adrenal insufficiency, J Intern Med. 2014 Feb;275(2):104-15. doi: 10.1111/joim.12162
Competing interests: No competing interests