Highlights
Introduction to WellDrug’s reimbursement case.
Imagine you are working for WellDrug and the regulatory authorities have just approved WellDrug’s new drug, Protectol® for congestive heart failure (CHF). It is now your responsibility, as head for Price and Reimbursement to develop the reimbursement strategy, and to summarize the strategy in terms of a reimbursement dossier. It’s based on this dossier the Dental and Pharmaceutical Benefits Agency in Sweden (TLV) will decide whether to reimburse the drug.
You are expected to develop a convincing strategy on which you can expect reimbursement. You can develop this strategy in many ways, and you need not follow the way we proceed in the class. We have, however, some guidelines for you to follow. Your analysis should be transparent, i.e., replicable. You need to discuss not only the short run effects within the trial (seminar 1, 3, 4, and 5), but also long run effects (seminar 2). You should stay true to the evidence, i.e. emphasize the strength of your analyses but, at the same time, acknowledge the weaknesses.
It may be the case that the drug is not cost-effective for the whole population who is enrolled in the study. In that case, you can either still argue for reimbursement, but emphasize other aspects that TLV find important for reimbursement. The three guest lectures will discuss such other aspects. You can also argue for reimbursement of a specific sub-population. In that case, you need to document cost-effectiveness for such sub-populations.
To that end, you are expected:
1. Gain some understanding of the disease area in question (congestive heart failure) and the data on which you will base your reimbursement dossier. Demonstrate an expertise in valuing outcomes achieved, and resources consumed both within and potentially after the trial. Choose an appropriate evaluation method and perspective for your purposes, and justify your choice and assumptions.
2. Write this work up in terms of a reimbursement dossier including:
1. Introduction;
2. Description of the study design, study population (Seminar 1) and the clinical results;
3. Health-economic evaluation in the short- and long run including time horizon, model structure for long-run evaluation, data sources, assumptions, and possible sub-populations important to study;
4. Results in the short and long run and impact of sensitivity analyses;
5. Discussion of your reimbursement strategy, and Conclusions;
6. In the appendix, we have summarized which questions are expected to be answered under which section. References and Appendices including explanation of your work in excel, the excel file, and graphs. References are considered critical. Limit the length of the dossier to 3-6 pages single-spaced (excluding the reference list and the appendices).
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