Transatlantic payer research and strategic market access

For an established US biotech cognizant of the importance of incorporating market access factors into clinical trial design, Alacrita’s pharma market access consultants conducted strategic research for a novel advanced breast cancer therapy about to enter Phase II trials. We developed hypotheses from desk research of the current market for breast cancer therapies, focussing particularly on labels and clinical trials designs for recently launched products.

Based on two scenarios for the product’s performance, we conducted a series of interviews with payers and KOLs in the USA, Germany, France and the UK. The key objective was to understand the extent to which HEOR data would be valued by payers in each scenario and exactly what kinds of HEOR data would be useful (e.g. mobility, pain, which QoL metrics are preferred by payers, caregiver burden and other patient reported outcomes). We also explored the broader market access environment in advanced breast cancer. Our findings informed the design of Phase II trials, ensuring that the differentiation elements perceived (and valued) by payers were adequately captured prospectively.

For a US venture-funded biotech planning a pivotal trial with a highly efficacious infectious disease therapy, Alacrita’s pharma market access consultants conducted a high level ‘gap analysis’ to identify shortcomings in the proposed trial protocol from a European market access perspective. Alacrita identified a number of issues that, if addressed, would put the company on a sounder basis when approaching European Health Technology Assessment bodies. We ranked each issue by severity and set out recommendations to the biotech company about how best to address them. Some issues were easily overcome by modifying the protocol through, for example, adding certain secondary endpoints. Others required more in depth research to implement, but they all had a significant impact on the value of the asset in Europe and enhanced the company’s ex-US partnering prospects.

For an emerging specialty pharma company facing an urgent partnering transaction deadline, Alacrita’s strategic market access consultants conducted a series of payer interviews across the USA and EU3 to assess the likely reimbursement and pricing of a new therapy in a crowded therapy area facing competition from both inexpensive generics and selected premium products.

Positioning the product to optimize pricing and volume posed material challenges. At the commodity end of the market, existing therapies were both generic and extremely cheap; moreover, they were largely perceived as ‘good enough’ in most settings, despite documented side effects. The premium market position was occupied by a small number of injectibles aimed at specific sub-populations in the broad target indication. The aim of the project was to determine the feasibility of ‘pricing down’ from the high end rather than ‘pricing up’ from generics without the risk of constraining the potential product volume due to restricted market access in specific sub-groups. A core part of the analysis was to identify the specific supporting data that would align prescriber/clinical drivers with payer drivers.

Starting with a clearly defined target product profile, Alacrita’s payer research consultants conducted desk research to understand the current recommended standard of care for IDA in the USA and EU3. Based on this, they formulated a list of questions and hypotheses summarising the issues facing the product. Alacrita conducted a series of focusses interviews with ‘real payers’ i.e. individuals currently or (where legally required) very recently involved in actual formulary, pricing and reimbursement decisions at local, regional or national levels.

The interviews revealed an unexpectedly consistent message across both sides of the Atlantic. Payer value drivers (factors which payers find most pivotal and data most convincing), appropriate treatment comparators and approaches to pricing relative to the high end of the market were dissected and analysed to validated the expected pricing range for the product. The interviews shed light on evidence requirements that would underpin the proposed premium pricing, which in turn provided useful input to launch and strategic marketing plans for the product.

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