Teva forces Dutch market to use pre-filled MTX syringes

Genéricos/Novedades | Posted 25/06/2010 post-comment

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Until recently, the generic disease-modifying anti-rheumatic drug methotrexate (MTX) was available in The Netherlands in large vials, of which (hospital) pharmacists prepared ready-to-use (RTU) syringes for the weekly treatment of patients with rheumatoid arthritis (RA).

However, on 17 February 2010, Teva introduced licensed pre-filled MTX syringes called Metoject 50 mg/mL –licensed from Medac in Hamburg, Germany– on the Dutch market. As of 1 March 2010, Metoject became available in dosages of 10 mg, 15 mg, 20 mg and 25 mg; the 7.5 mg dosage (for children) became available as of 1 April 2010. The syringes have extra graduation marks, making it possible to both prescribe and use intermediate dosages.

The Dutch Healthcare Inspectorate (IGZ) of the Ministry of Public Health, Welfare and Sports (VWS) announced on 17 March 2010 that the traditional RTU syringes for doses of 10 mg, 15 mg, 20 mg and 25 mg (but not yet 7.5 mg) may no longer be prepared on a large scale by hospital pharmacists.

As of April 2010, Metoject had not been included in the Dutch Reimbursement System (GVS) because Teva has not applied for it yet, but the company stresses it will soon do so. However, in practice many health insurers already reimburse Metoject and no longer reimburse the traditional MTX product in their basic insurance (or the identical Danish product called Metex, unavailable because of supply shortages in The Netherlands). For example, as of 1 March 2010, the Dutch health insurer CZ is reimbursing Metoject, and as of 1 May 2010 it will no longer reimburse pharmacy-prepared MTX. However, if in particular cases it turns out to be necessary to make a non-licensed dose via large-scale (pharmacy prepared) preparation, this can still be reimbursed by health insurers if it can be described as ‘rational pharmacotherapy’. The Dutch Reumapatiëntenbond stated in April 2010 on its website (www.reumabond.nl) that it is currently studying the confusion around the reimbursement of RTU and pharmacy-prepared MTX syringes.

According to the website www.huidziekten.nl, Metoject is ‘not, or scarcely, more expensive’ than pharmacy-prepared MTX. It states that the syringe has been designed with wings, making it easy to inject for RA patients, and the needle is fixed thanks to a ‘Luer lock’. Furthermore, Metoject has a shelf life of two years and does not have to be stored in the refrigerator, in contrast to pharmacy-prepared MTX syringes that have a short shelf life (usually up to 30 days) and need to be stored in the refrigerator.

Teva is accused in the Pharmaceutisch Weekblad (the journal of the KNMP or Royal Dutch Association for the Advancement of Pharmacy) of 9 April 2010, of evading the normal reimbursement routes and thus only making the new formulation available for people with a higher level of health insurance. The KNMP fears that patients will have to pay more for Teva’s formulation, being unable to claim reimbursement for the hospital pharmacy formulation on the basic rate because a commercial brand is now available. However Teva counters this charge on their website and explains that they received approval to market Metoject very rapidly due to unusual circumstances, and are therefore late with their reimbursement application to the Health Insurance Board. They are working on it now, but are resisting the price originally envisaged by the Health Insurance Board, which was for multidose packs. Both sides hope that reimbursement at the basic rate of insurance will be approved by June 2010.

According to the website of the Dutch Internist Association (www.internisten.nl), excellent results are obtained with low dose MTX in dermatology and rheumatology. However, due to a lack of knowledge on the part of community pharmacists and pharmacy technicians, physicians and assistants with regard to once-a-week MTX dosage regimes and toxicity, 13 accidents have taken place with MTX in The Netherlands since 2007 (four of which took place in 2009 and six of which were fatal), despite repeated warnings by the IGZ.

Reference:

Veranderingen in de markt methotrexaat-injectiespuiten – Verkorte productinformatie MetojectÒ 50 mg/ml. Letter Teva Pharma Nederland. March 2010

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