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As breakthrough drugs stream out of biopharmaceutical laboratories, how much they should cost and who will get access to them remain thorny issues.

During his campaign for president, Joe Biden indicated that he plans to set reimbursement for specialty biologic drugs through value assessments conducted by a single independent review board, which could prove to be a problem for patients and vulnerable citizens. Review boards conducting similar value assessments can be rife with conflicts of interests and lean on methodologies that disadvantage certain drugs and the patients who may desperately need them.


Specialty biologic drugs are a category that includes many important breakthrough drugs, such as Herceptin (trastuzumab), Humira (adalimumab), and Rituxan (rituximab). The federal government, which pays for these products for Medicare and Medicaid beneficiaries, has a right to assess their value. Yet patients will be denied new and innovative medicines if those assessments are done poorly.

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  • The idea that patients always benefit from rapid access to any new drug is a favourite industry talking point, but the only clear-cut beneficiary of this kind of no-holds-barred access is industry itself.

    For example, many new drugs provide only marginal benefits over existing treatments even according to data from pivotal clinical trials (which tend to overstate efficacy):

    At the same time, these new drugs’ harm profiles are poorly understood, putting patients at risk. Overall, HTAs in Europe are doing a great job of protecting patients from drugs that are neither worth taking nor worth paying for.

    It would be nice if STAT had insisted on a bit more nuance in this contribution.

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