The Freedom of Treatment Act, A Good Idea All Along

“New ideas pass through three periods: 1) It can't be done. 2) It probably can be done, but it's not worth doing. 3) I knew it was a good idea all along!”

Arthur C. Clarke

Such is often the case even with the best of ideas. And such, I believe, will be the case with the new Freedom of Treatment Act being sponsored by the Abigail Alliance.

The model legislation addresses several important “holes” in patient access issues. However, in this blog I am focused on just one: Requiring insurers to cover Right to Try eligible investigational therapies on a basis no less favorable than that for hospice and palliative care.

I do not believe that drug developers are “evil” or “greedy.” Certainly there are bad actors in the industry, but there are bad actors in every industry. These are for-profit entities, and clearly money matters to them at their core, big or small. And so, as I have written before, I believe that the best way to get them to increase pre-approval access to their drugs for patients with life threatening diseases in a meaningful fashion are economic incentives. We could argue about whether or not that “should” be the case and what their societal obligations may be, but none of that is likely to help patients with life- threatening diseases today. This new model legislation, if enacted into law, can do just that. It will obligate insurers to pay something for Right to Try-eligible treatments.

Insurers in every state are licensed by the state. A state can simply say that if you want to sell insurance in our state, you must provide such and such coverage. No one has ever questioned a state’s right to do so. This movement will start as a state by-state campaign, and that is a very good thing. Once the Right to Try state laws started to pick up momentum, they passed sweepingly throughout the country. In many states they passed by unanimous votes even in severely divided state legislatures. Their popularity proved so great, that the Federal Law was passed by unanimous consent in the U.S. Senate. Something still unfathomable to most.

And we must not underestimate the importance to drug developers. I recently had the opportunity to discuss a Right to Try treatment program with the manager of pre-approval access for a large European-based Pharma company. He had a budget for pre-approval access for a particular product and he was trying to figure out how best to “spread” that budget around the world. Typically, he explained, they might treat 200 patients in France, where there is reimbursement (usually between one-half and two- thirds of the expected market price), and maybe 5 patients in Spain, where there is considerably less, and maybe 8 patients in Brazil, where there isn’t any. And all for a product that is going to have a U.S. first launch. My point here is not that I think the French system is the “right” system (although I do), but that it clearly impacts the decision to make the drug available to hundreds of patients instead of a few. This is so, even though the total amount of money spent is an amount that would be too small for this company to find in its financial statements. When you drill down in these companies, every dollar is allocated and fought over, and yes, scarce. Again, we could argue about their profits, how these companies allocate their spending, and a hundred different issues, but this is the reality of how our drug development industry has evolved. This is the reality we need to address to help patients in need gain meaningful access.

In my blog about the Novartis lottery, I wrote that I didn’t know what the right model is for getting compensation to drug developers to improve access to investigational therapies for meaningful numbers of patients, but that the sooner we started talking about ways to “pay” them, the sooner we would start to see results. This model law, this idea to mandate insurance coverage at least equal to end of life “treatment” for potentially saving life treatment, is one such idea.

People will say that it can’t be done. People will say that it’s too hard. But I think we have all seen this movie before. At the end of the day, everyone will be saying what a great idea this has always been.

#freedomoftreatmentact #accesshopecro #abigailalliance #righttotry