Opportunities and Challenges for Value Added Medicines: Results of a Scoping Research Based on Expert Interviews

Speaker(s)

Petykó Z1, Inotai A2, Espin J3, O’Keeffe DT4, O'Mahony JF5, Czech M6, Kalo Z2
11. Semmelweis University, Center for Health Technology Assessment; 2. Syreon Research Institute, Budapest, Hungary, 21. Semmelweis University, Center for Health Technology Assessment; 2. Syreon Research Institute, Budapest, PE, Hungary, 3Andalusian School of Public Health, Granada, GR, Spain, 4HIVE Lab, Lambe Institute, School of Medicine, National University of Ireland, Galway, Ireland, 5Trinity College Dublin, Dublin, D, Ireland, 6Institute of Mother and Child at Warsaw University of Technology, Warsaw, MZ, Poland

Presentation Documents

OBJECTIVES:

Despite the wide range of benefits provided by value-added medicines (VAMs) for different stakeholders, several barriers complicate their market access. This scoping research aims to identify the opportunities, challenges and relevant value elements related to VAMs in Ireland, Spain and Poland.

METHODS:

Structured interviews were carried out with five health policy experts. Three similar interviews with a group of market access managers of pharmaceutical companies were also conducted. The focus of the interviews was on 1) the policy environment 2) potential value attributes and 3) perceived barriers related to VAMs. Based on these, country reports were drafted and discussed with health policy experts in follow-up interviews.

RESULTS:

Repositioning of off-patent pharmaceuticals in new indications with high unmet need is perceived as desirable in each country. However, practice is limited regarding differentiation from generic medicines in clinical guidelines, special reimbursement status or exclusion from pharmacy substitution, all of which inhibits incentives to invest in this type of innovation. Reformulated or combined off-patent medicines may not be subject to pharmacy-level substitution and their differentiation in clinical guidelines is possible. A white paper about benefits of VAMs, problems with the current system and rationale for changes is recommended in each country involving representatives of multiple stakeholders. A repository of ad-hoc reference cases may stimulate regulators and health care payers to consider the development of a national policy framework for VAMs. VAM manufacturers should take steps to improve the validity and evidence-base of claims for repurposed medicines.

CONCLUSIONS:

Although conclusion is based on limited number of interviews, there is appetite for change in the national regulatory and policy environment for VAMs in each country. While the main policy actions could be similar across countries, context-specific consideration mean the content of policy documents, and other policy actions should remain particular to each country.

Code

HPR95

Topic

Health Policy & Regulatory

Topic Subcategory

Approval & Labeling, Coverage with Evidence Development & Adaptive Pathways, Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

STA: Generics