Special Edition of Prescrire International

NEW PRODUCTS

Cladribine: insufficient clinical benefit in multiple sclerosis C ladribine is a purine analogue with immunosup- pressive effects linked to a prolonged cytotoxic action on B and T lymphocytes. Since 2017, it has been authorised in the European Union (as Mavenclad°) for oral administration in some patients with multiple sclerosis (1,2). In late 2018, the French pharmacoeconomic com- mittee, which provides recommendations on drug reimbursement, issued an unfavourable opinion regarding the inclusion of cladribine for multiple sclerosis in the list of drugs that are eligible for reimbursement by the French health insurance system. The medical benefit was rated as “insuffi- cient” due in particular to inappropriate evaluation and uncertainties regarding the serious long-term adverse effects of cladribine (2). This conclusion is consistent with what is known about the evaluation of cladribine in this situation. It carries a risk of infections, including opportunistic infections, and cancers (1). This opinion makes it unlikely that Mavenclad° will be marketed in France, which is welcome news, thus protecting patients from the drug’s adverse effects. ©Prescrire ▶▶ Translated from Rev Prescrire February 2019 Volume 39 N° 424 • Page 105 Selected references from Prescrire’s literature search 1- Prescrire Editorial Staff “Oral cladribine and multiple sclerosis” Prescrire Int 2018; 27 (196): 207. 2- HAS - Commission de la transparence“Compte rendu de la réunion du 19 septembre 2018” + “Avis-Mavenclad” 19 September 2018: 58 pages.

COMMON STEM

NN

-afil According to the nomenclature established by theWorld Health Organization (WHO) to devise international non- proprietary names (INNs), the INNs of phosphodies- terase type-5 inhibitors with vasodilator action end in the common stem -afil (1). Four drugs with this stem ( avanafil , sildenafil , tadal­ afil and vardenafil ) were marketed in France as of 2 Janu- ary 2019, for erectile dysfunction or benign prostatic hyperplasia. Sildenafil and tadalafil are also authorised for the treatment of pulmonary arterial hypertension. ©Prescrire ▶▶ Translated from Rev Prescrire February 2019 Volume 39 N° 424 • Page 103  Sources  1- World Health Organization“The use of stems in the selec- tion of International Nonproprietary Names (INN) for pharmaceutical substances -WHO/EMP/RHT/TSN/2013.1”: 63. A drug’s real name

Prescrire Int • June 2019

PRESCRIRE’S RATINGS Our judgement is based on the therapeutic advance of the new product. It considers not only the inherent value of each product in terms of its harm-benefit balance, but also its advantages and disadvantages relative to existing products available in France. Note that the relative value of new products can vary from one country to another.

Quality of information from pharmaceutical companies In response to our systematic requests

 BRAVO  The product is a major therapeutic advance in an area where previously no treatment was available.  A REAL ADVANCE  The product is an important therapeutic advance but has certain limitations.  OFFERS AN ADVANTAGE  The product has some value but does not fundamentally change the present therapeutic practice.  POSSIBLY HELPFUL  The product has minimal additional value, and should not change prescribing habits except in rare circumstances.

 NOTHING NEW  The product is a new substance but with no evidence that it has more clinical value than other substances of the same group. It can be a me-too or a near me-too.

Company provided detailed information including unpublished

data and packaging items.

Company provided information limited to published administrative data or packaging items.

 NOT ACCEPTABLE  Product without evident benefit but with potential or real disadvantages.

Company provided minimal information, mainly administrative

 JUDGEMENT RESERVED  The editors postpone their rating until better data and a more thorough evaluation of the drug are available.

and packaging items.

Company provided no information.

P age 8 • P rescrire I nternational S pecial E dition 2019