PRMA Insights: The Roadmap to Pricing and Reimbursement Success

NSCLC

Non-Small Cell Lung Cancer (NSCLC) is the leading cause of cancer-related mortality in the major pharmaceutical markets. There is still a clear unmet need in the treatment of NSCLC despite products such as Alimta, Avastin, Iressa and Tarceva demonstrating improvements in overall survival, but the prognosis for advanced patients remains bleak.

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Oncology is now the leading therapy area by value with global sales of $US 48 BN in 2008. Compound annual growth rates are estimated at over 10% and by 2014 the oncology market is expected to double in size. This is driven by a number of factors including the increasing incidence of cancer, the increasingly high prices of new oncology products and the absolute number of oncology products in clinical development. According to PhRMA 861 medicines are in human development for the treatment of oncology including 122 for NSCLC. These budgetary pressures are leading to increased scrutiny from payers around the world as products seek reimbursement. Treatment is aimed at extending survival by months, symptom palliation and improvement or maintenance of Health Related Quality of Life (HRQoL). NSCLC offers a very attractive commercial opportunity for pharmaceutical and biotech companies if key market access challenges can be surmounted.

Requirements differ across the major markets, but one trend is clear: the evidence requirements for achieving reimbursement and market access are increasing. Consequently, the hurdles to market access are rising with greater use of cost-effectiveness, health technology assessment (HTA), risk sharing agreements, real-world naturalistic data and head to head comparative effectiveness.

In response, companies launching a new product into an increasingly competitive NSCLC market will have to provide a compelling evidence-based payer value proposition in order to either support price premiums or gain market share. Key decisions during the development process will impact the pricing and reimbursement opportunity, including choice of comparator, inclusion of patient-reported outcome (PRO) data, inclusion of patients according to histology and the choice of progression-free survival (PFS), response rates, or overall survival (OS) as endpoints.

Generating an evidence package consistent with companies’ pricing and commercial ambitions, requires early planning (Phase II or earlier) and broad cross-functional co-operation. Failure to adequately plan market access strategy and evaluate evidence generation requirements risks a variety of issues that would significantly reduce the chances of commercial success. Reduced price, smaller than planned reimbursed population and extensive market access delays are all commercially disastrous consequences.

PRMA Insights: The Roadmap to Pricing and Reimbursement Success in NSCLC unravels the complexity around pricing and reimbursement and delivers actionable insights to apply to your global product development program in order to develop a robust evidence-based payer value proposition and achieve commercially attractive market access success.

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