Last Updated on Tuesday, 8 March, 2022 at 1:41 pm by Andre Camilleri
Amin Farah is the chief Executive officer at Pharmacare Premium Ltd, a pharmaceutical manufacturing company located in Hal Far, dedicated to the production of high potency therapeutic products for world markets.
With an increasingly aging population, healthcare authorities and organisations continue to deal with the constant demand to assess new emerging therapies and their introduction into the care services they provide. At any one time, there are countless innovative technologies being developed with the aim of better managing challenging diseases such as cancer. These innovations are driving demand for new effective safe treatments as well as preventative therapies.
In the field of cancer, we see that the disease is increasingly becoming a chronic, manageable one, treatable with well-tolerated therapies directed against specific molecular targets. It is no longer considered an acute disease that requires practitioners to always resort cytotoxic therapies, surgery or radiotherapy to treat.
Not surprisingly, with increasing demand for more effective treatments health authorities are faced with the challenge of increased expenditure, especially in cancer treatments, a therapeutic sector where such expenditure is most pronounced. Health care providers as well as regulators and pharmaceutical companies have to navigate the volume and diversity of emerging therapeutic anti-cancer treatments to assess and develop procedures for targeted patient specific therapies.
For new drugs to be licensed by health authorities, manufacturers must prove the quality, effectiveness as well as the safety of their use. While meeting these criteria is essential to the release of drugs to the market, the significant and escalating costs of new product development and other associated expenditures is another major hurdle which health authorities working in a reimbursement system have to consider in deciding to make such treatments available. The main concern is the difficulty in arriving at a “fair” standardised method to evaluate the threshold for an economic decision in favour of releasing such novel drugs which in essence also compromises access to innovative cancer drug therapies.
Ultimately market access decisions by post-regulatory agencies must satisfy answers to forthright legitimate questions of: (a) How much more is the product’s clinical effectiveness in comparison to other products currently in use? and (b) What is the cost-effectiveness in terms of measured health-benefits?
While such push-pull challenges faced by post-regulatory agencies are acutely focused on originator novel product introductions, the generic industry provides patent enforced welcome relief for payers in both the public and private domains. This delivers significant cost reductions when compared to originator drugs and therefore makes such generic products widely accessible to patients.
The problem with this, of course, is the time lag of some 20 years for a generic to emerge as an affordable widespread product. This extended timeframe also impacts the willingness of medical professionals and patients to use a therapy no longer deemed to be cutting edge.
The end result is that the lifecycle of product launches continues to be moderated between the see-saw drivers of innovation at a high cost, which narrows user accessibility on the one hand, and that of social and market pressure to provide widespread patient access to generic equivalents on the other.