Patient Prescription Advocacy

The next step is to integrate payors into new drug approvals. Many payors will not reimburse for newer therapies due to higher costs for recently developed drugs.  Patent law protects developers for 16 years in order that Pharma companies can recoup their cost for R & D.

Getting the FDA to approve drugs faster is seen as one way to get the access that many patients and their families want. Vice President Pence and many other legislators seem to have been persuaded that the FDA is the roadblock. It isn’t. The real barrier is payers of prescription drug benefits, such as health insurance companies and self-insured employers.

The premise that the FDA needs to speed things up worked in the late 1980s when AIDS activists and cancer groups successfully pressured the FDA to make the drug approval process faster. But this won’t work today because payers, which weren’t nearly as influential 30 years ago, now regulate access to drugs. To speed access to new treatments, then, groups need to incorporate payers into their strategies.

Payers of prescription drug benefits have become crucial in controlling access to drugs over the last three decades. During that time, tens of millions of people gained coverage for prescription drugs. This has improved access to drugs for those with coverage. But it has also taken the decisions that individual patients once made about whether or not to pay for prescriptions and aggregated them under the authority of payers.  Payers make decisions that balance the needs of the covered group as a whole against their organizational objectives, rather than focusing on individual patient situations. Coverage for the group often comes at the cost of an individual patient.

In the early days of prescription drug coverage, payers mostly paid the bills as pharmacies submitted them. But as prescription drug benefit plan costs soared from expanding use and escalating prices, payers began narrowing coverage policies and applying aggressive utilization oversight. Now payers are demanding evidence of drug safety and effectiveness that goes far beyond what the FDA requires for market approval as a basis for prescription drug coverage.

Groups looking to speed access to new therapies need to work with payers to identify clinical benefits and economic value at the same time that they push for rapid regulatory approval. This is not easy during the pre-approval, clinical trial period. However, patient groups and pharmaceutical developers could use their expanded access programs and patient registries to generate the evidence that payers need to evaluate new drugs.

Access to new treatments will not improve just by beating on the FDA. It will mean cooperating with payers, too.

This places the burden for proof of efficacy and cost effectiveness on the patient and the providers.

Perhaps this is a new focus for Patient Prescription Advocacy .  

NYU School of Medicine Working Group on Compassionate Use and Pre-Approval Access

This source of information goes into great deal about the approval process.

The FDA isn’t the only roadblock to accessing to new therapies