Comparing the U.S. and the European Union, where do patients have greater access to cancer drugs?
This question isn’t as easy to answer as it would seem. Patient access to pharmaceuticals is multidimensional; the two main dimensions being the regulatory framework and pricing and reimbursement.
The regulatory dimension is relatively straightforward. In the U.S. the approvals process is centralized for all drugs, while in the European Union it is centralized for cancer drugs and biologics. Leaving aside complicating factors such as off-label uses, access depends first on whether drugs are approved and the speed to approval. During the period 2000-2017, 106 cancer drugs (new molecular entities and biologics) were approved by FDA, while 87 were approved by the EMA.
Of the cancer drugs approved by both agencies over 85% were approved first by FDA. It would appear that regulatory incentives such as accelerated approval and priority review mechanisms have played an important role.
The next access dimension is pricing and reimbursement; whether approved cancer drugs get covered, conditions of reimbursement, and how much patients must share in the costs of treatment. The U.S. doesn’t have a centralized approach to cancer drug pricing and reimbursement, nor does the E.U.
There are as many approaches to pricing and reimbursement as there are E.U. nations. Agencies in each nation review approved products and make pricing and reimbursement decisions accordingly.
They employ different metrics, some with cost-effectiveness thresholds, others not.
The different approaches to pricing and reimbursement combine the monopsonist power of national authorities to determine prices, with coverage denials for some newly approved cancer drugs, conditions of reimbursement for others, and in many cases delays in reaching reimbursement decisions.
There is significant variation in pricing and reimbursement across the E.U., resulting in access inequality. In some cases this can be extreme.
For example, a patient in Poland may not have access to certain cancer drugs that have been available to patients in France for years. For some patients in Europe the question then might be, what good is centralized approval of cancer drugs when that is far from being a guarantee of patient access?
Price controls in Europe do, on the other hand, result in improved affordability for payers. And, for those drugs that are approved and on formulary, patients have access with little or no cost-sharing.
In the U.S. pricing and reimbursement decisions are decentralized for the most part, with no price controls. Legislative mandates at the state and federal levels prohibit coverage denials for almost all cancer drugs.
Broadly, payers reimburse virtually all approved cancer drugs, while imposing relatively high levels of patient cost-sharing and varying degrees of conditions of reimbursement. Higher prices and substantial patient cost-sharing in the U.S. can have a negative impact on access for the un- and under-insured patient populations, with the exception of those who are eligible for pharmaceutical industry sponsored patient assistance programs.
On balance, across the two main access dimensions, access to cancer drugs is better in the U.S. More drugs get approved and at a faster pace, with fewer reimbursement restrictions, higher patient cost-sharing notwithstanding.
Greater access in the U.S. would appear to contribute to improved outcomes for certain cancers. Indeed, cancer care is often considered a bright spot in the U.S. healthcare system.
In the U.S., some experts deem cancer prices too high in relation to their benefit. Policymakers are considering ways to bring down cancer drug prices. An important policy question is whether greater access may in part be due to a lack of price controls.
The U.S. pricing and reimbursement environment has been conducive towards extraordinary levels of investment in cancer drug research.
This is because such investment is a function of anticipated market conditions for the products being invested in. In effect, favorable pricing and reimbursement conditions indirectly impact the numbers of approvals and speed to approval.
Invariably policymaking is a balancing act. In adopting measures to contain the growth in cancer drug prices policymakers must ensure that pharmaceutical innovation isn’t stifled.