PRMA Insights: The Roadmap to Pricing and Reimbursement Success

Metastatic Breast Cancer

Breast cancer is the most common cancer in women, accounting for almost a quarter of all cancer cases, and globally ranks behind lung cancer, with 1.15 mn incident cases. Europe and North America account for about 50% of breast cancer incidence and 43% of associated mortality globally. Breast cancer ranks fifth as a cause of cancer death. Approximately 10% of patients present with metastatic disease.

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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 the oncology market is expected to double in size by 2014. This is driven by a number of factors including the rising incidence of cancer, the increasingly high prices of new oncologics, and the absolute number of oncologics being developed. Of 861 oncologics currently in clinical development, 106 are for breast cancer. However, budgetary pressures are leading to increased scrutiny from payors around the world as reimbursement for products is sought.

Despite innovative therapeutic advances such as the introduction of molecularly targeted therapies Avastin, Herceptin, and Tyverb/Tykerb, there is still a clear unmet need across all lines of therapy in the metastatic setting. This, combined with the potential size of the patient population, strong advocacy framework, and treatment across multiple lines of therapy, makes breast cancer a very attractive commercial opportunity for pharmaceutical and biotech companies – provided that key market access challenges can be overcome.

Although requirements differ across the major markets, one trend is clear: the evidence requirements to achieve reimbursement and market access are increasing, requiring use of cost-effectiveness data, health technology assessments, risk-sharing agreements, real-world naturalistic data, and head-to-head comparative effectiveness data. In response, a manufacturer launching a new product into an increasingly competitive market will have to provide a compelling evidence-based payor value proposition in order to support price premiums, achieve reimbursement and gain market share.

The probability of commercial success will inevitably be compromised by failure to adequately plan the market access strategy and to systematically evaluate and deliver on evidence requirements– reduced price, reimbursement rejections, smaller-than-planned reimbursed population, and extensive market access delays are all commercially disastrous consequences of poor planning. Key decisions during the development process will impact the P&R opportunity, including the tumor subtype to be studied, patient subpopulation, choice of comparator, inclusion of patient-reported outcome data, and choice of endpoint (progression-free or overall survival). Generating an evidence package that is consistent with the manufacturer’s pricing and commercial aspirations requires early planning (Phase II or earlier) and broad cross-functional cooperation.

PRMA Insights: The Roadmap to Pricing and Reimbursement Success in Metastatic Breast Cancer unravels the complexity around P&R in this market and delivers actionable strategic insights to apply to your global product development program, in order to ensure that you develop a robust evidence-based payor value proposition and achieve commercially success.

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