A pharmaceutical company asked Alacrita to assist in providing an HTA/payer perspective on the proposed label and mechanism of action/clinical positioning for its pain drug, to ensure that the Phase II/III trials were optimally designed. The company’s lead candidate offered analgesia without the typically accompanying GI side effects for a wide patient population, including osteoarthritis, rheumatoid arthritis and ankylosing spondylitis patients. It was clear that pricing and reimbursement issues would be a key driver of commercial success for the product, and would impact discussions with potential licensing partners. Alacrita was asked to conduct a pricing and reimbursement assessment of the new drug in order to:
- Inform future design of pivotal studies (e.g. in terms of endpoints, patient populations and a patient-centred outcomes strategy);
- Facilitate discussions with potential partners;
- Allow preliminary validation of some inputs of the commercial model: particularly price, but also reimbursed patient population.
The project was conducted in three parts:
Task 1: Secondary research
In preparation for the primary research, Alacrita conducted targeted secondary research in key areas important for market access. We reviewed pricing of comparator products across the EU and US, and reviewed the HTA evaluations for two competitor drugs.
Task 2: Primary research – interviews with prescribing clinicians
Alacrita then conducted interviews with a small number of clinicians per country, in order to:
- Gather verification on the clinical product attributes, how the product would be used, and how it would compare with other treatments
- Understand physician views on eligible patients, and feedback on risk stratification
- Probe physician willingness to pay
Task 3: Primary research – interviews with payers in US and UK
Given the very different characteristics of pricing and reimbursement of pain therapeutics across the Altantic, Alacrita recommended conducting research in both the US and EU markets. Interviewees for the core primary research were “real payers” – i.e. individuals currently involved (or with recent experience) in Health Technology Assessments, reimbursement and pricing decisions, at national or regional level and would have been involved in the assessment of similar drugs for coverage and reimbursement. The scope of the interviews covered clinical unmet needs and treatment patterns; discussion of the drug target product profile (TPP), and evidence requirements; and economic implications – e.g. pricing, reimbursement restrictions, and barriers to reimbursement.Back