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August 13, 2012 9:15 pm

Roche’s Avastin may receive ovarian cancer recommendation from NICE if lower than approved dose is considered

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This article is provided to FT.com readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.biopharminsight.com

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Roche’s (VTX:ROG) Avastin (bevacizumab) may be recommended for use in ovarian cancer by UK pricing regulators, experts said. Though the drug is approved at a 15mg dose, which may not be deemed cost effective, a lower dose of 7.5mg has better chances, they noted.

The National Institute for Health and Clinical Excellence (NICE) will not issue guidance specifically indicating the dose that can be used, a NICE spokesperson explained. NICE will, however, take into consideration all supporting evidence including changes to dosing schedules that are common in clinical practice and all clinical data on how well the drug works, she added.

If document submission from Roche and NICE reviews go as planned, final guidance will be issued in April 2013, the spokesperson noted.

Assuming a mean patient weight of 60.5kg and an average course of 14 cycles, the cost of the 15mg dose/year is GBP 30,800, whilst the cost of the 7.5mg dose/year is GBP 15,400, a Roche spokesperson added.

Avastin was approved by the European Medicines Agency (EMA) in December

2011 as a first-line treatment following surgery for advanced ovarian cancer. It is only approved for use in combination with carboplatin and paclitaxel.

If the drug is recommended at 7.5mg/kg or a range to the 15mg/kg approved dose, NICE would set a precedent, said Dr Graham Dark, senior lecturer in Medical Oncology and Cancer Education, Northern Centre for Cancer Care, Newcastle upon Tyne, UK. If it is not recommended, there will be political outrage with activist groups, he added. Dark noted that Avastin has shown substantial benefit in extending the amount of time a patient goes without his/her disease worsening, known as progression-free survival (PFS).

Lower dose cost effective and efficacious

Avastin in ovarian cancer will be submitted to NICE at the approved dose of 15mg, the Roche spokesperson confirmed. However, at this dose, the drug does not meet the needed economic requirements of quality-adjusted life years (QALYs), said Dark. QALY is a measure of disease burden including both the quality and the quantity of life lived, according to NICE guidelines. It is used in assessing the value for money of a medical intervention.

It is not common practice to recommend use of a drug at anything other than the approved dose, Dark said. However, several investigators on Roche’s final investigation program, ICON7, wrote a letter to NICE urging it to consider the evidence generated that showed efficacy at the 7.5mg/kg dose, he noted.

The Roche spokesperson confirmed that the ICON7 data will be submitted as part of the supporting documents. The study included 147 UK-based sites, and to date the clinical demand for the drug through applications to the Cancer Drug Fund (CDF) have been for the 7.5mg dose, she noted.

Centres are planning to use the drug at the 7.5mg/kg funded by the CDF until a recommendation from NICE is made, Dark concurred.

It is expected of NICE to adhere to the product’s approved dosage recommendations, however oncology community experts are vocal that the lowest effective dose is an aim of treatment, said Brian Lovatt, CEO and reimbursement expert, Vision Healthcare Consultancy, UK. NICE may well consider dose variation, he noted.

If the company submits good quality evidence demonstrating that the lower dose is still effective and meets QALY requirements, then NICE could allow reimbursement for that dose alone, agreed Keiron Sparrowhawk, reimbursement consultant and partner, PriceSpective, UK.

With either dose, the company will need to convince NICE on the drug’s benefit in extending a patient’s life, or overall survival (OS), despite the PFS benefits reported in trials, said a European reimbursement consultant.

PFS is often used as a surrogate marker for OS, however there is some debate about whether increasing PFS relates to increasing OS. A major debate in the development of oncology treatments that only demonstrate benefit on PFS and not OS is whether delaying progression or disease spread is a meaningful goal.

NICE may be concerned that even if Avastin is cost effective at the lower dose, a recommendation would open the gates for it to be used at other doses and in other unapproved indications, noted Oliver Jack, consultant at PriceSpective, UK.

Roche has until 17 August to submit all supporting documents to NICE for Avastin as an adjunctive treatment, the NICE spokesperson said. A first committee meeting is scheduled for November, and a final guidance will be issued in April 2013 if everything goes according to plan, she added.

In addition, the company has been invited to submit documents for use of Avastin in recurrent and advanced ovarian cancer as a monotherapy, the spokesperson explained. Supporting documents must be submitted by 24 September, with a first committee meeting in January 2013, and final guidance planned for June, she confirmed.

Approximately 220,000 women are diagnosed with ovarian cancer annually of which 140,000 women die each year globally. In the UK over 6,500 women are diagnosed with ovarian cancer each year, making it the fifth most common cancer amongst women.

Roche has a current market cap of USD 155.1bn.

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