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Smart Thinking blog

Insights and expert advice on the key issues facing today’s pharma marketer

Access - the only thing that matters

Our job, at its very core, is to get our medicines into the hands of patients

The only thing that matters

Recent healthcare news feeds have taken a retrospective angle on the year gone by and examined the number of new drug approvals by the FDA and the EMA in 2014.

The numbers are impressive. In 2014, the FDA approved 41 NMEs - the second highest total in almost two decades. The EMA number was also impressive - 82, including generics.

One of the critical elements about these drug approvals and market authorisations is that they give us a window into what types of drugs are being approved. In fact, in 2014 many of them represented novel, new mechanism-of-action drugs and therapies aimed to treat rare diseases. All very good news which should not be glossed over. We absolutely need new medications using novel new pathways and targeting new cellular pathways to treat rare diseases to get approved. We need drug companies to be bold and daring with their R&D efforts.

Our job, at its very core, is to get our medicines into the hands of patients so that they can benefit

The other thing that is critical when we look at approval numbers is whether delays or faster approvals result in a greater number of drug discontinuations or withdrawals. Because the collection of these data takes time and requires us to look back retrospectively, there is an inevitable lag.

Some have suggested that shorter approval times may be a precursor to lower quality assurance for drug safety. But, do drug approval timelines suggest a relationship between the speediness of approvals and safety issues? the implication of this is that drugs that are 'rushed' through the approval process may not have been properly vetted and may have higher rates of withdrawals and discontinuations from the marketplace due to safety concerns.

Well, the data does not suggest that such a relationship exists. In fact, one could argue that not only do reduced review and approval times not result in any added safety concerns but that lengthy approval times may serve to deny patients access to new medicines which may lead to sub-optimal outcomes and eventually drive unnecessary cost down the road.

Meaningful numbers
Despite what I've written above concerning what we can possibly glean from these numbers, drug approvals are still an 'artificial' marker of what we should really be trying to measure, which is timely access to new patented medicines for patients. Drug approval statistics don't tell us anything about time to public and private reimbursement. What would be far more relevant and interesting would be both the absolute and average time to coverage after regulatory approval under both public and private drug plans. And what would be additionally more interesting would be to collect these data across multiple jurisdictions for different drugs from different therapeutic areas.

This data is far more meaningful for policy folks, regulators, governments and patients and will allow for a more meaningful discussion on ways to drive speed, efficiency and access to medicines for patient populations.

As an industry, we should be deeply interested in tracking the 'time to reimbursement' for new patented medicines and incredibly obsessive about finding ways to meet with payers, (public and private), share data and discuss appropriate risk-sharing schemes so that upon approval of new drugs, the time to reimbursement is minimised. One, I suspect, would not be incorrect in assuming that very few manufacturers are tracking this info across all their product portfolios. And one, I suspect, would not be incorrect in assuming that some harmonised global database of time to reimbursement does not exist.

The potential application of such information could be powerful enough to help us get better at negotiating with public and private payers. We could use this information to demonstrate the thinking of other payers in other jurisdictions when faced with similar decisions. Some will suggest that payers live in their own ivory towers and pay little attention to what is happening outside their borders. Maybe. Maybe not. A lot of people said the same thing about pricing; no payer really cares what some other payer is shelling out for the same drug in their own country. And then along came price referencing.

Our job, at its very core, is to get our medicines into the hands of patients so that they can benefit. Forget about whether one drug is better than the other. Of course there are differences between all therapies that make then appealing to different patients for different reasons. Consequently, from both a societal and industry perspective, drug approvals are nice. But access is what really matters. In fact, access is the only thing that matters.

Rohit Khanna is managing director of Catalytic Health, a healthcare communications, advertising and strategy agency. He can be reached at: rohit@catalytichealth.com

2nd April 2015

From: Sales

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