It’s no longer “white pills for western markets”
The BioPharma industry is now in the process of re-evaluating the old business model predicated on blockbuster medicines for mature markets. In the words of GSK’s CEO Andrew Witty there is a recognised need to diversify away from the traditional “white pills & western markets” strategy, which no longer works in the new world of healthcare provision.
With the projected growth of 1st and 2nd tier Emerging Markets (EM) based upon rising GDP healthcare expenditure, many companies are now significantly investing in these developing economies. But what are the access considerations for manufacturers?
There are limited options for pharma companies to develop diversification or turnaround strategies which ensure continued sustainable growth. Investment in Rare Diseases stands prominent in the eyes of many manufacturers. This has been driven across the EU by the European Commission, with policies in development since 2005. But unfortunately, policies from the developing economies to encourage manufacturers are few and far between, particularly funding policies for Orphan Drugs (OD).
As a significant number of OD manufacturers expand their businesses across emerging markets (EM), they are faced with restrictive and often non-existent funding pathways. As a result pricing and reimbursement (P&R) negotiations remain very challenging, pushing manufacturers to explore the value of local clinical development in supporting access. Clinical development will potentially have a strong influence on future willingness to pay. Approaches such as Compassionate Use Programmes and Individual Treatment Funding Requests have potential, however, without policy reform at either a national and/or regional level, reimbursement remains a distant prospect. One has to say that pricing considerations will be uppermost in the minds of payers and policy makers and there is much to be learned from the EC approach as a way of moving forward and addressing these concerns.
The European Union Committee of Experts on Rare Diseases (EUCERD) has recommended collaboration between centres of expertise (CEs), healthcare providers, laboratories, patients and individual experts. These are to be the future nodes of European Reference Networks (ERNs).
The analysis of previous and current pilot ERNs 2008-2013 shows that the most valuable services developed by these networks are:
- Shared databases/registries/biobanks at the disposal of the research community;
- Shared tools for tele-expertise at the disposal of the medical community;
- Common production of guidelines/best standards of diagnosis and care and information packages, training tools and training sessions covering both the medical and the social dimension of care.
Perhaps it’s time that some emerging markets looked to learn from the Western economies, certainly in order to inform policy development.