New products or new indications evaluated during the previous year in the New Products section of our French edition are eligible for the Prescrire Drug Awards.
Pilule d'Or/Golden Pill 2015
The "Pilule d'Or" ("Golden Pill") has been granted since 1981 to drugs that constitute a major therapeutic advance in a field in which no treatment was previously available.
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| NOT AWARDED FOR 2015 |
| For the list of all the Pilule d'Or (Golden Pill) awards given out 1981-2015, click > HERE |
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 Honours List 2015
Drugs are included on the "Honours List" because they represent a clear advance for some patients compared with existing therapeutic options, albeit with limitations.
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| HEMANGIOL° (propranolol oral solution) |
Pierre Fabre Dermatology |
Severe infantile haemangioma (Prescrire Int n° 162) |
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Noteworthy
Drugs deemed "Noteworthy" provide a modest improvement in patient care.
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| TOPISCAB° (permethrin 5% cream) |
Codexial Dermatologie |
Scabies from 2 months of age
(Rev Prescrire n° 384) |
KÉTOCONAZOLE HRA° (ketoconazole)
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HRA Pharma |
Endogenous
Cushing’s syndrome (Rev Prescrire n° 386) |
About the 2015 Drug Awards
Each month, the Prescrire Editorial Staff presents systematic comparative assessment of available data on drugs newly approved in France and in the EU, and on new therapeutic indications granted for existing drugs. The goal is to help the reader distinguish, among the plethora of lavishly promoted new products, those medications worth adding to their drug list or worth using instead of existing products, as well as drugs to be avoided.
This evaluation is based on rigorous procedures that include a thorough literature search, input from a group of reviewers specific to each review, and various quality controls to verify that the text is consistent with the data in the references.
Full details > HERE
Total independence
This work is carried out by the Prescrire Editorial Staff in total independence, free from any industry or institutional influence. Prescrire is financed exclusively by its subscribers. Neither the French nor the English edition carries any paid advertising, nor do we receive grants or subsidies of any kind (see our annual financial report in each June issue of Prescrire International, and available online > HERE.
At the end of each year, the Prescrire Drug Awards are based on the reviews published that year in the French edition, and take into account any new data made available since the initial articles were published.
These awards honour drugs that constitute a therapeutic advance, in that they offer better efficacy, fewer or less severe adverse effects (for similar efficacy), or safer or easier administration.
The rules governing the Prescrire Awards are available (in French) > HERE
No Golden Pill awarded in 2015
Three of the products featured in the New Products section of our French edition in 2015 earned a Prescrire Drug Award this year. One was included on the Honours List, two were deemed “Noteworthy”, but none constituted a sufficient therapeutic advance to warrant a Golden Pill Award. None of these three products contain a novel active ingredient. However, in the clinical situation for which they were granted marketing authorisation, they constitute an advance over the products already available.
Propranolol oral solution and severe haemangioma: a chance discovery, followed by development of a paediatric form
Some infants have a severe haemangioma that could cause complications (due to its size and location), ulceration, bleeding or disfigurement. Propranolol oral solution has become the drug of choice in this situation. It is more effective than placebo and its adverse effects are more acceptable overall than that of long-term oral corticosteroid therapy. Treatment initiation and dose increases should take place in hospital, with careful monitoring of the child. Propranolol oral solution has been granted marketing authorisation in the European Union solely for paediatric use. Its packaging is conducive to safe use and safe dose preparation.
Permethrin in scabies, ketoconazole in Cushing's syndrome: welcome marketing authorisations
Permethrin 5% cream is at last readily obtainable in France to treat classic scabies, since being granted full marketing authorisation, and being made available in the community and reimbursable by the national health insurance system. Its main value is for the treatment of young children, because ivermectin is not approved for use in children weighing less than 15 kg.
After about 30 years of off-label use in the rare but serious endogenous Cushing’s syndrome, oral ketoconazole has finally been granted marketing authorisation for this indication. In this situation, data from non-comparative case series in a total of 800 patients suggest that oral ketoconazole is effective in more than half of patients. However, its use requires precautions on account of its hepatotoxicity and strong potential for drug interactions.
Few therapeutic advances
While many new marketing authorisations were granted in 2015, few constituted a real therapeutic advance. Knowing how to sift through the multitude of available drugs to identify those with the best harm-benefit balance in a given situation, and knowing to avoid drugs that are more dangerous than useful is also an area where important advances can be made for the benefit of patients.
See : > Drugs to avoid, in the name of better patient care: 2016 update
Regulators and policy makers should impose stricter requirements on new drugs, by demanding evidence that they actually constitute a therapeutic advance. This would prevent inundation of the market with products that offer no advantages in patient care and that, in some cases, are more dangerous than useful. It would also help contain the excesses this situation generates: extravagant marketing aimed at health professionals and patients, incentives to prescribe and purchase drugs, and spiralling health expenditure.
©Prescrire February 2016
"The Prescrire Awards 2015" Prescrire Int 2016: 25 (169) 78-81. (pdf, free)
