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About the special issue

In this era of precision medicine, the link between correct diagnosis of the molecular characterization of tumors and selection of appropriate therapies cannot be underestimated. In the same fashion, the increasing presence of drugs aimed at targeting rare diseases increases the need for their timely diagnosis via advanced lab methods.

The availability of sophisticated diagnostic tests that support the definition of malignancy histotypes and rare diseases raises interesting health economic issues.

Often, a reliable estimate of the full cost borne by healthcare facilities for each diagnostic test is missing, and this lack of information impacts the way they are reimbursed by third-party payers.

According to some clinicians, a bundled payment scheme (that implies a lump sum to be reimbursed to health care facility for a disease-specific set of diagnostic tests conditional on a priori classification of the severity of patient’s health state) is expected to be more efficient than an outpatient tariff-based approach (that foreshadows a reimbursement for each single diagnostic test performed). For others, is the other way round. However, both parties agree on the need for a transparent approach that links the full cost of diagnostic tests with the way they are reimbursed by the healthcare system.

In addition, the way diagnostic tests for neoplasms and rare diseases are paid may cause the hospitals to shift the diagnosis process from the outpatient to the inpatient setting in the attempt to maximize the reimbursement obtained from the third party-payer.

Finally, an insufficient or delayed reimbursement of diagnostic by third-party payer may represent a threat to equity in health care, forcing patients to pay them out-of-pocket and start effective and personalized treatments later than recommended by clinical guidelines.

With the ambitious aim of synthesizing contributions on this topic, Expert Review of Pharmacoeconomics & Outcomes Research, alongside Guest Advisor Professor Carlo Lazzaro, is excited to present this special issue on cost and reimbursement of lab tests for the diagnosis of tumors and rare diseases.

Potential submissions could include:

– Empirical studies on the costs and cost-effectiveness of diagnostic tests for tumors and rare diseases (submissions on micro-costing and full cost are particularly welcomed).

–Studies and discussions investigating costs of diagnostic tests for tumors and rare diseases and their budgeting, regulatory and reimbursement issues.

-Studies and reviews on the cost burden of diagnostic delay, inaction to treat, and misdiagnosis

-Discussions on decision analytic modelling and economic evaluation of diagnostic tests

-Recommendations on budget and resource allocation for diagnostic tests in different settings (hospitals, Local Health Authority, and other jurisdictions).

-Perspectives on the relationship between health economics of diagnostic tests, and health equity, personalized medicine and patient outcomes.

– Contributions exploring patient survival, outcomes, quality-of-life and preferences, in the content of tumors and rare diseases diagnosed with advanced tests.

We welcome submissions of Original Research, Reviews, Perspectives, Meeting Reports and Editorials for consideration in this special focus issue.

If you are interested in contributing or would like to learn more, then please reach out to the Commissioning Editor, James Crosby, who will be happy to assist.

About the Guest Advisor:

Doctor Magistralis in Business Administration from “Luigi Bocconi” University, Milan, Italy, Carlo is a 29-year experienced health economist.

His professional and research interests include empirical and decision model-supported cost-effectiveness analysis, stochastic and probabilistic sensitivity analysis, value of information analysis, biostatistics, and health econometrics.

He is a 14-year experienced regular Stata user (mainly for regressions, panel data econometrics, mixed models, and multiple imputation of missing values) and contributor to the Stata forum.

Carlo is the Research Director of his firm, Studio di Economia Sanitaria, that he founded in 1994 in Milan. The Studio di Economia Sanitaria performs health economic and statistical analyses and supports pharmaceuticals and medical device manufacturers in creating value-propositions for price-reimbursement dossiers to be submitted to regulatory agencies in Italy and abroad.

From early ’90s to 2003 he was non-resident research fellow at the Centre for Research on Healthcare Management (CeRGAS), “Luigi Bocconi” University.

Since 2004 Carlo has been serving as Appointed Professor of Health Economics and Pharmacoeconomics at the post-graduated two-year, II^ level master “Discipline Regolatorie G. Benzi” for Regulatory Affairs professionals, Biology and Biotechnologies Department “Lazzaro Spallanzani”, University of Pavia, Pavia, Italy.

Publish in 3 – 5 weeks from submission

Submission to acceptance: 2 – 3 weeks
1 – 2 weeks for peer review
1 week for author revision

Acceptance to online publication: 1 – 2 weeks, with proofs within 5 working days and 48 hours for author review

Cost per article: $7000 / €6200 / £5500

Publish in 7 – 9 weeks from submission

Submission to acceptance: 5 – 6 weeks
3 – 4 weeks for peer review
2 weeks for author revision

Acceptance to online publication: 2 – 3 weeks, with proofs within 10 working days

Cost per article: $3900 / €3400 / £3000