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Serono offers 'head start' on MS drug access

By Kirsty Barnes, 04-Jul-2007

Related topics: Packaging

EMD Serono has this week announced a plan to give faster and wider access to its multiple sclerosis (MS) drug to those suffering from the most common form of the debilitating disease.

The company's new 'MS LifeLines Access Made Simple' programme is designed to help MS sufferers start therapy on its drug Rebif (interferon beta-1a) "as soon as possible after diagnosis".

Eligible participants are those with relapsing forms of MS who have either been newly prescribed Rebif (interferon beta-1a) or who have restarted the drug after having discontinued for more than 90 days.

Under the programme, which is only being run in the US, participants will receive up to one year of therapy regardless of income level, with no more than a $50 (€37) co-payment required of any patient, said the firm.

Rebif, which has been available in Europe since 1998 and in the US since 2002, is a disease-modifying drug used to treat relapsing forms MS by delaying the progression of disability, reducing the frequency of relapses and reducing medical resonance imaging (MRI) lesion activity and area. It is similar to the interferon beta produced by the human body, a protein that helps modulate the body's immune system fight disease and reduce inflammation. It is not approved for treatment of chronic progressive MS.

The National Multiple Sclerosis Society (NMSS) recommends that initiation of therapy with an immunomodulator be considered as soon as possible following a definite diagnosis of MS with active disease to receive the full benefits from treatment.

However, according to Serono, accessing immunomodulators through the US health insurance system can be complicated and currently it takes "30 or more days, depending on each individual's insurance and income situation, to secure the necessary health insurance approvals or reimbursement assistance and actually begin therapy."

"From our experience, a newly diagnosed MS patient only comes to understand the terms of their insurance once they have received a diagnosis. This can significantly delay their time to treatment," said James Hoyes, chief commercial officer for EMD Serono.

"Our goal with this programme is to allow [eligible] patients the opportunity to begin taking therapy as soon as possible while they work through the necessary insurance and assistance issues. The program also provides them with educational services that are necessary to optimise therapy success."

If patients who join the scheme and begin treatment later turn out to be unable to obtain full insurance coverage for Rebif, they can apply to Serono's MS LifeLines Patient Assistance Program (PAP), which provides financial support to people who cannot otherwise afford therapy, the firm said.

Rebif was the 16th biggest selling biologic drug and the second-biggest selling MS biologic in 2006, with sales of $1.4bn, according to data from business intelligence firm La Merie.

However, Rebif's nearest rival, Avonex (interferon beta-1a) made by Biogen, is one step ahead of it, in position 15 and sales of $1.7bn. Some sceptics may see Serono's latest 'programme' as an attempt to steal market share from its rival and in turn steal the MS crown.

Biogen currently has an 'Avonex Access Program' in place, although eligibility for this is based on patient's insurance status and income level.

Meanwhile, Serono will also be looking to keep Betaferon (interferon beta-1b), the MS drug of its trailing rival, Bayer Schering Pharma, from gaining any ground upon its $1.2bn sales slot.

MS is a chronic, inflammatory condition of the nervous system and the relapsing forms of MS are the most common. Up to 2.5m people suffer from MS, according to the World Health Organization (WHO), and it is the most common, non-traumatic, neurological disease in young adults.

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